Last updated on May 2nd, 2024 at 03:32 pm
Title 16—Commercial Practices–Volume 2
CHAPTER II—CONSUMER PRODUCT SAFETY COMMISSION
SUBCHAPTER A—GENERAL
PART 1000—COMMISSION ORGANIZATION AND FUNCTIONS
§ 1000.1 The Commission.
(a) The Consumer Product Safety Commission is an independent regulatory agency formed on May 14, 1973, under the provisions of the Consumer Product Safety Act (Pub. L. 92-573, 86 Stat. 1207, as amended (15 U.S.C. 2051, et seq.)). The purposes of the Commission under the CPSA are:
(1) To protect the public against unreasonable risks of injury associated with consumer products;
(2) To assist consumers in evaluating the comparative safety of consumer products;
(3) To develop uniform safety standards for consumer products and to minimize conflicting State and local regulations; and
(4) To promote research and investigation into the causes and prevention of product-related deaths, illnesses, and injuries.
(b) The Commission is authorized to consist of five members appointed by the President, by and with the advice and consent of the Senate, for terms of seven years. However, the Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations Act, 1993, Public Law 102-389, limited funding to that for three Commissioners for fiscal year 1993 and thereafter.
§ 1000.2 Laws administered.
The Commission administers five acts:
(a) The Consumer Product Safety Act (Pub. L. 92-573, 86 Stat. 1207, as amended (15 U.S.C. 2051, et seq.)).
(b) The Flammable Fabrics Act (Pub. L. 90-189, 67 Stat. 111, as amended (15 U.S.C. 1191, et seq.)).
(c) The Federal Hazardous Substances Act (Pub. L. 86-613, 74 Stat. 380, as amended (15 U.S.C. 1261, et seq.)).
(d) The Poison Prevention Packaging Act of 1970 (Pub. L. 91-601, 84 Stat. 1670, as amended (15 U.S.C. 1471, et seq.)).
(e) The Refrigerator Safety Act of 1956 (Pub. L. 84-930, 70 Stat. 953, (15 U.S.C. 1211, et seq.)).
§ 1000.3 Hotline.
(a) The Commission operates a toll-free telephone Hotline by which the public can communicate with the Commission. The number for use in all 50 states is 1-800-638-CPSC (1-800-638-2772).
(b) The Commission also operates a toll-free Hotline by which hearing or speech-impaired persons can communicate with the Commission by teletypewriter. The teletypewriter number for use in all states is 1-800-638-8270.
(c) The Commission also makes available to the public product recall information, its public calendar, and other information through its worldwide Web site at http://www.cpsc.gov. The public may also report product hazards or other information to the Commission at its e-mail address: [email protected].
§ 1000.4 Commission address.
The principal Offices of the Commission are at 4330 East West Highway, Bethesda, Maryland 20814. All written communications with the Commission, including those sent by U.S. Postal Service, private express and messenger should be addressed to the Consumer Product Safety Commission at that address, unless otherwise specifically directed.
§ 1000.5 Petitions.
Any interested person may petition the Commission to issue, amend, or revoke a rule or regulation by submitting a written request to the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814. Petitions must comply with the Commission’s procedure for petitioning for rulemaking at 16 CFR part 1051.
§ 1000.6 Commission decisions and records.
(a) Each decision of the Commission, acting in an official capacity as a collegial body, is recorded in Minutes of Commission meetings or as a separate Record of Commission Action. Copies of Minutes or of a Record of Commission Action may be obtained by e-mail ([email protected]) or written request to the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814, or may be examined at Commission headquarters. Requests should identify the subject matter of the Commission action and the approximate date of the Commission action, if known.
(b) Other records in the custody of the Commission may be requested by e-mail ([email protected]) or in writing from the Office of the Secretary pursuant to the Commission’s Procedures for Disclosure or Production of Information under the Freedom of Information Act (16 CFR part 1015).
§ 1000.7 Advisory opinions and interpretations of regulations.
(a) Advisory opinions. Upon written request, the General Counsel provides written advisory opinions interpreting the acts and administrative regulations (e.g., Freedom of Information Act regulations) the Commission administers, provided the request contains sufficient specific factual information upon which to base an opinion. Advisory opinions represent the legal opinions of the General Counsel and may be changed or superseded by the Commission. Requests for advisory opinions should be sent to the General Counsel, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814. Previously issued advisory opinions are available on the CPSC Web site at http://www.cpsc.gov/library/foia/advisory/advisory.html. A copy of a particular previously issued advisory opinion or a copy of an index of such opinions may also be obtained by written request to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814.
(b) Interpretations of regulations. Upon written request, the Assistant Executive Director for Compliance will issue written interpretations of Commission regulations pertaining to the safety standards and the enforcement of those standards, provided the request contains sufficient specific factual information upon which to base an interpretation. Interpretations of regulations represent the interpretations of the staff and may be changed or superseded by the Commission. Requests for such interpretations should be sent to the Assistant Executive Director for Compliance, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814.
§ 1000.8 Meetings and hearings; public notice.
(a) The Commission may meet and exercise all its powers in any place.
(b) Meetings of the Commission are held as ordered by the Commission and, unless otherwise ordered, are held at the principal office of the Commission at 4330 East West Highway, Bethesda, Maryland. Meetings of the Commission for the purpose of jointly conducting the formal business of the agency, including the rendering of official decisions, are generally announced in advance and open to the public, as provided by the Government in the Sunshine Act (5 U.S.C. 552b) and the Commission’s Meetings Policy (16 CFR part 1012).
(c) The Commission may conduct any hearing or other inquiry necessary or appropriate to its functions anywhere in the United States. It will publish a notice of any proposed hearing in the
(d) Notices of Commission meetings, Commission hearings, and other Commission activities are published in a Public Calendar, as provided in the Commission’s Meetings Policy (16 CFR part 1012). The Public Calendar is available on the Commission Web site at http://www.cpsc.gov.
§ 1000.9 Quorum.
Three members of the Commission constitute a quorum for the transaction of business. If there are only three members serving on the Commission, two members constitute a quorum. If there are only two members serving on the Commission because of vacancies, two members constitute a quorum, but only for six months from the time the number of members was reduced to two.
The Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations Act, 1993, Pub. L. 102-389, limited funding to that for three Commissioners for fiscal year 1993 and thereafter.
§ 1000.10 The Chairman and Vice Chairman.
(a) The Chairman is the principal executive officer of the Commission and, subject to the general policies of the Commission and to such regulatory decisions, findings, and determinations as the Commission is by law authorized to make, he or she exercises all of the executive and administrative functions of the Commission.
(b) The Commission shall annually elect a Vice Chairman for a term beginning on June 1. The Vice Chairman shall serve until the election of his or her successor. The Vice Chairman acts in the absence or disability of the Chairman or in case of a vacancy in the Office of the Chairman.
§ 1000.11 Delegation of functions.
Section 27(b)(9) of the Consumer Product Safety Act (15 U.S.C. 2076(b)(9)) authorizes the Commission to delegate any of its functions and powers, other than the power to issue subpoenas, to any officer or employee of the Commission. Delegations are documented in the Commission’s Directives System.
§ 1000.12 Organizational structure.
The Consumer Product Safety Commission is composed of the principal units listed in this section.
(a) The following units report directly to the Chairman of the Commission:
(1) Office of the General Counsel;
(2) Office of Congressional Relations;
(3) Office of the Inspector General;
(4) Office of Equal Employment Opportunity and Minority Enterprise;
(5) Office of the Executive Director.
(b) The following units report directly to the Executive Director of the Commission:
(1) Office of Financial Management, Planning and Evaluation;
(2) Office of Hazard Identification and Reduction;
(3) Office of Information and Public Affairs;
(4) Office of Compliance and Field Operations;
(5) Office of Human Resources Management;
(6) Office of Information and Technology Services;
(7) Office of International Programs and Intergovernmental Affairs.
(c) The following units report directly to the Assistant Executive Director for Hazard Identification and Reduction:
(1) Directorate for Economic Analysis;
(2) Directorate for Epidemiology;
(3) Directorate for Health Sciences;
(4) Directorate for Engineering Sciences;
(5) Directorate for Laboratory Sciences.
§ 1000.13 Directives System.
The Commission maintains a Directives System which contains delegations of authority and descriptions of Commission programs, policies, and procedures. A complete set of directives is available for inspection in the public reading room at Commission headquarters.
§ 1000.14 Office of the General Counsel.
The Office of the General Counsel provides advice and counsel to the Commissioners and organizational components of the Commission on matters of law arising from operations of the Commission. It prepares the legal analysis of Commission legislative proposals and comments on relevant legislative proposals originating elsewhere. The Office, in conjunction with the Department of Justice, is responsible for the conduct of all Federal court litigation to which the Commission is a party. The Office also advises the Commission on administrative litigation matters. The Office provides final legal review of and makes recommendations to the Commission on proposed product safety standards, rules, regulations, petition actions, and substantial hazard actions. It also provides legal review of certain procurement, personnel, and administrative actions and drafts documents for publication in the
§ 1000.15 Office of Congressional Relations.
The Office of Congressional Relations is the principal contact with the committees and members of Congress and state legislative bodies. It performs liaison duties for the Commission, provides information and assistance to Congress on matters of Commission policy, and coordinates testimony and appearances by Commissioners and agency personnel before Congress.
§ 1000.16 Office of the Inspector General.
The Office of the Inspector General is an independent office established under the provisions of the Inspector General Act of 1978, 5 U.S.C. appendix, as amended. This Office independently initiates, conducts, supervises, and coordinates audits, operations reviews, and investigations of Commission programs, activities, and operations. The Office also makes recommendations to promote economy, efficiency, and effectiveness within the Commission’s programs and operations. The Office receives and investigates complaints or information concerning possible violations of law, rules, or regulations, mismanagement, abuse of authority, and waste of funds. It reviews existing and proposed legislation concerning the economy, efficiency, and effectiveness of such legislation on Commission operations.
§ 1000.17 Office of Equal Employment Opportunity and Minority Enterprise.
The Office of Equal Employment Opportunity and Minority Enterprise is responsible for assuring compliance with all laws and regulations relating to equal employment opportunity. The Office provides advice and assistance to the Chairman and Commission staff on all EEO related issues including the agency Small and Disadvantaged Business Utilization Program. The Office develops agency EEO program policies. The Office manages the discrimination complaint process, including the adjudication of discrimination complaints, and facilitates Affirmative Employment Program (AEP) planning for women, minorities, individuals with disabilities and disabled veterans. The Office plans and executes special emphasis programs and special programs with minority colleges, and EEO, diversity, prevention of sexual harassment and related training. The Office identifies trends, personnel policies and practices that have an impact on EEO and makes recommendations to the Chairman on the effectiveness and efficiency of EEO programs and methods to enhance equal opportunity.
§ 1000.18 Office of Executive Director.
The Executive Director with the assistance of the Deputy Executive Director, under the broad direction of the Chairman and in accordance with Commission policy, acts as the chief operating manager of the agency, supporting the development of the agency’s budget and operating plan before and after Commission approval, and managing the execution of those plans. The Executive Director has direct line authority over the following directorates and offices: the Office of Financial Management, Planning and Evaluation, the Office of Hazard Identification and Reduction, the Office of Information and Public Affairs, the Office of Compliance and Field Operations, the Office of Human Resources Management, the Office of Information and Technology Services, and the Office of International Programs and Intergovernmental Affairs.
§ 1000.19 Office of Financial Management, Planning and Evaluation.
The Office of Financial Management, Planning and Evaluation is responsible for developing the Commission’s funds control system, long-range strategic plans, annual performance budgets and operating plans; analysis of major policy and operational issues; performing evaluations and management studies of Commission programs and activities; ensuring that Commission resources are procured and expended as planned and according to purchasing regulations; the review, control, and payment of Commission financial obligations; and, reporting on the use and performance of Commission resources. The Office recommends actions to the Executive Director to enhance the effectiveness of Commission programs and the management of budget, planning and evaluation, financial, and procurement activities. The Office serves as the staff support to the Commission Chief Financial Officer.
§ 1000.20 Office of Information and Public Affairs.
The Office of Information and Public Affairs, which is managed by the Director of the Office, is responsible for the development, implementation, and evaluation of a comprehensive national information and public affairs program designed to promote product safety. This includes responsibility for developing and maintaining relations with a wide range of national groups such as consumer organizations; business groups; trade associations; state and local government entities; labor organizations; medical, legal, scientific and other professional associations; and other Federal health, safety and consumer agencies. The Office also is responsible for implementing the Commission’s media relations program nationwide. The Office serves as the Commission’s spokesperson to the national print and broadcast media, develops and disseminates the Commission’s news releases, and organizes Commission news conferences.
§ 1000.21 Office of Compliance and Field Operations.
The Office of Compliance and Field Operations conducts compliance and administrative enforcement activities under all administered acts, provides advice and guidance on complying with all administered acts and reviews proposed standards and rules with respect to their enforceability. The Office’s responsibilities also include identifying and addressing safety hazards in consumer products already in distribution, promoting industry compliance with existing safety rules, and conducting administrative litigation. It conducts field enforcement efforts, including providing program guidance, advice, and case guidance to field staff. It enforces the Consumer Product Safety Act reporting requirements. It reviews consumer complaints, conducts inspections and in-depth investigations, and analyzes available data to identify those consumer products containing defects posing a substantial risk of injury or which do not comply with existing safety requirements. The Office negotiates and monitors corrective action plans for products that are defective or fail to comply with specific regulations. It gathers information on product hazards that may be addressed through rulemaking or voluntary standards. The Office develops surveillance strategies and programs designed to assure compliance with Commission standards and regulations. The Office of Compliance and Field Operations also assists the Office of Information and Public Affairs in implementing consumer information activities nationwide, including wide-ranging public information and education programs designed to reduce consumer product injuries and deaths, and maintaining liaison with, and providing support to, other components of the Commission and appropriate State and local government offices.
§ 1000.22 Office of Human Resources Management.
The Office of Human Resources Management, which is managed by the Director of the Office, provides human resources management support to the Commission in the areas of recruitment and placement, position classification, training and executive development, employee and labor relations, employee benefits and retirement assistance, employee assistance programs, drug testing, leave administration, disciplinary and adverse actions, grievances and appeals, and performance management.
§ 1000.23 Office of Information and Technology Services.
The Office of Information and Technology Services houses the Commission’s Secretariat, which facilitates the preparation of the Commission’s agenda; coordinates Commission business at official meetings; maintains the dockets and other materials for the Commission’s public and non-public administrative and adjudicative meetings and hearings; prepares and publishes the Public Calendar; maintains the Commission’s Injury Information Clearinghouse; issues Commission Orders; provides legal notice of Commission decisions through publication in the
§ 1000.24 Office of International Programs and Intergovernmental Affairs.
The Office of International Programs and Intergovernmental Affairs provides a comprehensive and coordinated effort in consumer product safety standards development and implementation at the international, Federal, State and local level. The office conducts activities and creates strategies aimed at ensuring greater import compliance with recognized American safety standards and exportation of CPSC regulatory policies, technologies and methodologies into other jurisdictions. The office also works to harmonize the use of standards worldwide.
§ 1000.25 Office of Hazard Identification and Reduction.
The Office of Hazard Identification and Reduction, under the direction of the Assistant Executive Director for Hazard Identification and Reduction, is responsible for managing the Commission’s Hazard Identification and Analysis Program and its Hazard Assessment and Reduction Program. The Office reports to the Executive Director, and has line authority over the Directorates for Epidemiology and Health Sciences, Economic Analysis, Engineering Sciences, and Laboratory Sciences. The Office develops strategies for and implements the agency’s operating plans for these two hazard programs. This includes the collection and analysis of data to identify hazards and hazard patterns, the implementation of the Commission’s safety standards development projects, the coordination of voluntary standards activities, and providing overall direction and evaluation of projects involving hazard analysis, data collection, emerging hazards, mandatory and voluntary standards, petitions, and labeling rules. The Office assures that relevant technical, environmental, economic, and social impacts of projects are comprehensively and objectively presented to the Commission for decision.
§ 1000.26 Directorate for Epidemiology.
The Directorate for Epidemiology, managed by the Associate Executive Director for Epidemiology, is responsible for the collection and analysis of data on injuries and deaths associated with consumer products. The Directorate has two divisions: the Data Systems Division and the Hazard Analysis Division. The Data Systems Division operates the national data collection systems which provide the data that serve as the basis for the Commission’s estimates of the numbers of deaths and injuries associated with consumer products. These data systems include the National Electronic Injury Surveillance System, a nationally representative sample of hospital emergency departments; a death certificate file, which contains data obtained from death certificates on deaths associated with consumer products; and the Injury and Potential Injury Incident file, which contains information on, among other things, incidents associated with consumer products, based on news clips, medical examiner reports, hotline reports, Internet complaints, and referrals. The Hazard Analysis Division conducts statistical analysis of these data and conducts epidemiologic studies to estimate the numbers of injuries and deaths associated with various consumer products and to examine factors associated with these injuries and deaths. In addition, staff in the Hazard Analysis Division design special studies, design and analyze data from experiments for testing of consumer products, and provide statistical expertise and advice to Commission staff in support of regulation development.
§ 1000.27 Directorate for Health Sciences.
The Directorate for Health Sciences is managed by the Associate Executive Director for Health Sciences and is responsible for reviewing and evaluating the human health effects and hazards related to consumer products and assessing exposure, uptake and metabolism, including information on population segments at risk. Directorate staff conducts health studies and research in the field of consumer product-related injuries. The Directorate performs risk assessments for chemical, physiological and physical hazards based on methods such as medical injury modeling, and on injury and incident data for mechanical, thermal, chemical and electrical hazards in consumer products. It provides the Commission’s primary source of scientific expertise for implementation of the Poison Prevention Packaging Act and the Federal Hazardous Substances Act. The Directorate assists in the development and evaluation of product safety standards and test methods based on scientific and public health principles. It provides support to the Commission’s regulatory development and enforcement activities. It manages hazard identification and analysis, and hazard assessment and reduction projects as assigned. The Directorate provides liaison with the National Toxicology Program, the Department of Health and Human Services (including the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health), the Occupational Health and Safety Administration, the Environmental Protection Agency, other Federal agencies and programs, and other organizations concerned with reducing the risk to consumers from exposure to consumer product hazards.
§ 1000.28 Directorate for Economic Analysis.
The Directorate for Economic Analysis, which is managed by the Associate Executive Director for Economic Analysis, is responsible for providing the Commission with advice and information on economic and environmental matters and on the economic, social and environmental effects of Commission actions. It analyzes the potential effects of CPSC actions on consumers and on industries, including effects on competitive structure and commercial practices. The Directorate acquires, compiles, and maintains economic data on movements and trends in the general economy and on the production, distribution, and sales of consumer products and their components to assist in the analysis of CPSC priorities, policies, actions, and rules. It plans and carries out economic surveys of consumers and industries. It studies the costs of accidents and injuries. It evaluates the economic, societal, and environmental impact of product safety rules and standards. It performs regulatory analyses and studies of costs and benefits of CPSC actions as required by the Consumer Product Safety Act, The National Environmental Policy Act, the Regulatory Flexibility Act and other Acts, and by policies established by the Consumer Product Safety Commission. The Directorate manages hazard assessment and reduction projects as assigned.
§ 1000.29 Directorate for Engineering Sciences.
The Directorate for Engineering Sciences, which is managed by the Associate Executive Director for Engineering Sciences, is responsible for developing technical policy for and implementing the Commission’s engineering programs. The Directorate manages hazard assessment and reduction projects as assigned by the Office of Hazard Identification and Reduction; provides engineering technical support and product safety assessments for the Office of Compliance and Field Operations; provides engineering, scientific, and technical expertise to the Commission and Commission staff as requested; and provides engineering technical support to other Commission organizations, activities, and programs as needed. The Directorate develops and evaluates product safety standards, product safety tests and test methods, performance criteria, design specifications, and quality control standards for consumer products, based on engineering and scientific methods. It conducts engineering analysis and testing of the safety of consumer products, and evaluates and participates in the development of mandatory and voluntary standards for consumer products including engineering and human factors analyses in support of standards development and product compliance testing. The Directorate performs or monitors research for consumer products in a broad array of engineering disciplines including chemical, electrical, fire protection, human factors, and mechanical engineering. It conducts and coordinates engineering research, testing, and evaluation activities with other Federal agencies, private industry, and consumer interest groups. The Directorate conducts human factors studies and research of consumer product related injuries, including evaluations of labels, signs and symbols, instructions, and other measures intended to address the human component of injury prevention. The Directorate provides technical supervision and direction of engineering activities including tests and analyses conducted in the field.
§ 1000.30 Directorate for Laboratory Sciences.
The Directorate for Laboratory Sciences, which is managed by the Associate Executive Director for Laboratory Sciences, is responsible for conducting engineering analyses and testing of consumer products, supporting the development of voluntary and mandatory standards, and supporting the Agency’s compliance activities through product safety assessments. A wide variety of products are tested and evaluated to determine the causes of failure and the hazards presented. Product safety tests involve mechanical, electrical, and combustion engineering, as well as thermal and chemical analyses. Test protocols are developed, test fixtures and setups are designed and fabricated, and tests are conducted following the requirements and guidance of voluntary and mandatory standards and/or using sound engineering and scientific judgment. The Laboratory participates with and supports other agency directorates on multi-disciplinary teams in the development of voluntary and mandatory standards. The Laboratory coordinates and cooperates with other Federal agencies, private industry, and consumer interest groups by sharing engineering and scientific research, test, and evaluation expertise. Additionally, Corrective Action Plans, proposed by manufacturers to correct a product defect, are tested and evaluated to assure that the proposed changes adequately resolve the problem. Regulated products, such as children’s products, sleepwear, and bicycle helmets, are routinely tested and evaluated for compliance with the Consumer Product Safety Act, the Federal Hazardous Substances Act, the Flammable Fabrics Act, and the Poison Prevention Packaging Act. The Directorate is composed of the Mechanical Engineering Division, the Electrical Engineering Division (which includes flammable fabrics), and the Chemical Division. Overall, the directorate provides engineering, scientific, and other technical expertise to all entities within the Consumer Product Safety Commission.
PART 1009—GENERAL STATEMENTS OF POLICY OR INTERPRETATION
§ 1009.3 Policy on imported products, importers, and foreign manufacturers.
(a) This policy states the Commission’s views as to imported products subject to the Consumer Product Safety Act (15 U.S.C. 2051) and the other Acts the Commission administers: The Federal Hazardous Substances Act (15 U.S.C. 1261), the Flammable Fabrics Act (15 U.S.C. 1191), the Poison Prevention Packaging Act (15 U.S.C. 1471), and the Refrigerator Safety Act (15 U.S.C. 1211). Basically, the Policy states that in order to fully protect the American consumer from hazardous consumer products the Commission will seek to ensure that importers and foreign manufacturers, as well as domestic manufacturers, distributors, and retailers, carry out their obligations and responsibilities under the five Acts. The Commission will also seek to establish, to the maximum extent possible, uniform import procedures for products subject to the Acts the Commission administers.
(b) The Consumer Product Safety Act recognizes the critical position of importers in protecting American consumers from unreasonably hazardous products made abroad and accordingly, under that Act, importers are made subject to the same responsibilities as domestic manufacturers. This is explicitly stated in the definition of “manufacturer” as any person who manufacturers or imports a consumer product (Section 3(a)(4); 15 U.S.C. 2052(a)(4)).
(c) The Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.), the Flammable Fabrics Act (15 U.S.C. 1191 et seq.), the Poison Prevention Packaging Act (15 U.S.C. 1471 et seq.), which were transferred to the jurisdiction of the Consumer Product Safety Commission under its enabling act, all assign responsibilities to importers comparable to those of manufacturers and distributors.
(d) Historically, foreign-made products entering the United States were “cleared” by those agencies with particular jurisdiction over them. Products so cleared were limited in number relative to total imports. The Consumer Product Safety Commission has jurisdiction over a far larger number of products entering the United States through over 300 ports of entry. In addition, the total number of imports has dramatically increased over the years and modern technology has brought air transport and containerized freight for rapid handling and distribution of consumer and other products. For the Commission to effectively “clear” such products through ports of entry could seriously impede and delay the transport of consumer products and impose additional costs to both the consumer and the importer.
(e) The Consumer Product Safety Act provides alternative means to both assure the consumer safe products and facilitate the free movement of consumer products in commerce. For example, it requires certification by manufacturers (foreign and domestic), importers and private labelers of products that are subject to a consumer product safety standard. Such certification must be based on a test of each product or upon a reasonable testing program. The other acts enforced by the Commission do not specifically require certificates; however, both the Flammable Fabrics Act and the Federal Hazardous Substances Act encourage guarantees of compliance by protecting from criminal prosecution persons who have in good faith received such guarantees (15 U.S.C. 1197(a); 16 CFR 302.11; 15 U.S.C. 1264(b)).
(f) In the interest of giving the American consumer the full measure of protection from hazardous products anticipated by the Congress, it is the Commission’s policy to assure that importers and foreign manufacturers carry out their responsibilities under all laws administered by this Commission. Specifically:
(1) Importers have responsibilities and obligations comparable to those of domestic manufacturers. Rules and regulations promulgated by the Commission will reflect these responsibilities and obligations.
(2) In promulgating its rules and regulations, the Commission encourages the participation and comments of the import community, including importers and foreign manufacturers.
(3) All imported products under the jurisdiction of the Consumer Product Safety Commission shall, to the maximum extent possible, be subject to uniform import procedures. The Commission recognizes the need to establish and implement procedures that minimize delay and expense involved in inspecting cargo at a port of entry. The Commission encourages cooperation between importers, foreign manufacturers and foreign governments, which increases the safety of the consumer and facilitates the free movement of goods between countries.
(4) When enforcement actions are appropriate, they will be directed toward the responsible officials of any import organization and will not be restricted to action solely against the product.
(5) Legal actions sought by the Commission will usually be primarily directed toward the owner or consignee of imported goods rather than against the customs broker even though his or her name may appear as the importer of record. However, the Commissioner believes it will not serve the public interest to impede the Commission’s rights of investigation and enforcement by exempting a customs broker from the coverage of the law merely because of his or her title or usual form of business. It may be relevant that a customs broker, who does not have an ownership interest in the goods but who is acting as an agent for the actual owner or consignee, signs the entry documents as importer of record. What effect and possible need for inclusion this will have in a particular case can be judged by the Commission on a case-by-case basis.
(6) Commission procedures on imports shall be developed in the context of the overall responsibilities, authorities, priorities, resources, and compliance philosophy of this Commission. Any existing procedures which have been inherited from predecessor agencies will be reviewed and revised, if necessary, to be consistent with the authority and philosophy of this Commission.
(g) The Commission recognizes that the importer may not be the only person to be held responsible for protecting American Consumers from unreasonably hazardous products made abroad, but the importer is, at least, in a strategic position to guarantee the safety of imported products.
(h) Whenever, in the application of this policy, it appears that barriers to free trade may arise, the Commission may consider exceptions to this policy insofar as it can be done without compromising the Commission’s responsibilities to assure safe products to the consumer.
(i) Whenever, in the application of this policy, it appears that administrative or procedural aspects of the Commission’s regulations are unduly burdening the free flow of goods, the Commission may consider modifications which alleviate such burdens. However, the Commission cannot consider any modifications which do not assure the consumer the same protection from unsafe foreign goods as from unsafe domestic goods.
§ 1009.8 Policy on establishing priorities for Commission action.
(a) This document states the Consumer Product Safety Commission’s policy on establishing priorities for action under the five acts the Commission administers. The policy is issued pursuant to sections 4(f)(2) and 4(f)(3) of the Consumer Product Safety Act, as amended, and in further implementation of the Commission’s statement of policy dated September 21, 1973.
(b) It is the general policy of the Commission that priorities for Commission action will be established by a majority vote of its members. The policy will be reflected by votes on all requests for appropriations, an annual operating plan, and any revisions thereof. Recognizing that these documents are the result of a lengthy planning process, during which many decisions are made that substantially determine the content of the final documents, the Chairman shall continually keep the Commission apprised of, and seek its guidance concerning, significant problems, policy questions and alternative solutions throughout the planning cycle leading to the development of budget requests and operating plans.
(1) Requests for appropriations. Requests for appropriations are submitted concurrently to the President or the Office of Management and Budget and to the Congress pursuant to section 27(k)(1) of the Consumer Product Safety Act.
(2) Annual operating plan. The operating plan shall be as specific as possible with regard to products, groups of products, or generic hazards to be addressed. It shall be submitted to the Commission for approval at least 30 days prior to the beginning of the fiscal year.
(c) In establishing and revising its priorities, the Commission will endeavor to fulfill each of its purposes as set forth in section 2(b) of the Consumer Product Safety Act. In so doing, it will apply the following general criteria:
(1) Frequency and severity of injuries. Two major criteria in determining priorities are the frequency and severity of injuries associated with consumer products. All available data including the NEISS hazard index and supplementary data collection systems, such as fire surveys and death certificate collection, shall be used to attempt to identify the frequency and severity of injuries. Consideration shall also be given to areas known to be undercounted by NEISS and a judgment reached as to the probable frequency and severity of injuries in such areas. The judgment as to severity shall include an evaluation of the seriousness of the injury.
(2) Causality of injuries. Consideration shall then be given to the amenability of a product hazard to injury reduction through standard setting, information and education, or other Commission action. This step involves an analysis of the extent to which the product and other factors such as consumer behavior are causally related to the injury pattern. Priority shall be assigned to products according to the extent of product causality involvement and the extent of injuries that can reasonably be expected to be reduced or eliminated through commission action.
(3) Chronic illness and future injuries. Certain products, although not presently associated with large numbers of frequent or severe injuries, deserve priority attention if there is reason to believe that the products will in the future be associated with many such injuries. Although not as susceptible to measurements as other product related injuries and illnesses, these risks shall be evaluated on the basis of the best information available and given priority on the basis of the predicted future illnesses and injuries and the effectiveness of Commission action in reducing or eliminating them.
(4) Cost and benefit of CPSC action. Consideration shall be given on a preliminary basis to the prospective cost of Commission action to consumers and producers, and to the benefits expected to accrue to society from the resulting reduction of injuries. Consideration of product cost increases will be supplemented to the extent feasible and necessary by assessments of effects on utility or convenience of the product; product sales and shifts to substitutes; and industry supply factors, competitive structure, or employment. While all these facets of potential social “cost” cannot be subsumed in a single, quantitative cost measure, they will be weighed, to the extent they are available, against injury reduction benefits. The benefit estimates will be based on (i) explicitly stated expectations as to the effectiveness of regulatory options (derived from criterion (2), “causality of injuries”); (ii) costs of injuries and deaths based on the latest injury cost data and analyses available to the Commission; (iii) explicit estimates or assumptions as to average product lives; and (iv) such other factors as may be relevant in particular cases. The Commission recognizes that in analyzing benefits as well as costs there will frequently be modifying factors—e.g., criteria (5) and (6)—or analytical uncertainties that complicate matters and militate against reliance on single numerical expressions. Hence the Commission cannot commit itself to priorities based solely on the preliminary cost/benefit comparisons that will be available at the stage of priority setting, nor to any one form of comparison such as net benefits or cost-benefit ratios. Commission costs will also be considered. The Commission has a responsibility to insure that its resources are utilized efficiently. Assuming other factors to be equal, a higher priority will be assigned to those products which can be addressed using fewer Commission resources.
(5) Unforeseen nature of the risk. Other things being equal, consideration should be to the degree of consumer awareness both of the hazard and of its consequences. Priority could then be given to unforeseen and unforeseeable risks arising from the ordinary use of a product.
(6) Vulnerability of the population at risk. Children, the elderly, and the handicapped are often less able to judge or escape certain dangers in a consumer product or in the home environment. Because these consumers are, therefore, more vulnerable to danger in products designed for their special use or frequently used by them, the Commission will usually place a higher priority, assuming other factors are equal, on preventing product related injury to children, the handicapped, and senior citizens.
(7) Probability of exposure to hazard. The Commission may also consider several other things which can help to determine the likelihood that a consumer would be injured by a product thought to be hazardous. These are the number of units of the product that are being used by consumers, the frequency with which such use occurs, and the likelihood that in the course of typical use the consumer would be exposed to the identified risk of injury.
(8) Additional criteria. Additional criteria may arise that the staff believes warrant the Commission’s attention. The Commission encourages the inclusion of such criteria for its consideration in establishing priorities. The Commission recognizes that incontrovertible data related to the criteria identified in this policy statement may be difficult to locate or develop on a timely basis. Therefore, the Commission may not require extensive documentation on each and every criterion before making a decision. In addition, the Commission emphasizes that the order of listing of the criteria in this policy is not intended to indicate either the order in which they are to be considered or their relative importance. The Commission will consider all the criteria to the extent feasible in each case, and as interactively or jointly as possible.
§ 1009.9 Policy regarding the granting of emergency exemptions from Commission regulations.
(a) This document states the Consumer Product Safety Commission’s policy with respect to emergency requests for exemptions for companies which inadvertently produce products that do not conform to Commission regulations issued under the five acts the Commission administers. These acts are the Consumer Product Safety Act, the Federal Hazardous Substances Act, the Flammable Fabrics Act, the Poison Prevention Packaging Act of 1970 and the Refrigerator Safety Act. While the Commission is reluctant to grant such requests, it believes that the public should be apprised of the manner in which it rules on exemption requests and therefore is publishing the policy to provide guidance to industry and others making such requests. The publication of the policy will also serve to inform the public of the criteria that the Commission uses in ruling upon such requests. This policy is intended to cover emergency requests for exemptions and, while relevant, is not intended to limit the discretion of CPSC staff to close or not to open cases in the routine enforcement of CPSC regulations.
(b) The policy governs requests for exemption from any regulation under any act the Commission administers. The policy lists criteria the Commission considers in deciding whether to grant or deny an exemption request and therefore, should provide guidance to companies on the types of information to be submitted with requests. In addition, published Commission procedures regarding petitioning for amendments to regulations may assist companies in determining what supporting data to submit with a request. (See, for example, existing Commission procedures at 16 CFR 1110, 16 CFR 1607.14, 16 CFR 1500.82 and 16 CFR 1500.201). The exemption requests themselves should be filed with the Office of the Secretary of the Commission.
(c) It is the general policy of the Commission that when a particular exemption request is made and granted, all similarly situated persons are accorded the same relief as the person who requested the exemption. Therefore, when any amendment to a Commission regulation is proposed or a statement of enforcement policy is issued, the document to the extent practicable will be phrased in objective terms so that all similarly situated persons will be able to determine whether their products would fall within the relief.
(d) In deciding whether to grant or deny an exemption request, the Commission considers the following general criteria:
(1) The degree to which the exemption if granted would expose consumers to an increased risk of injury: The Commission does not believe it should exempt products which would present a significantly greater risk to consumers than complying products. Therefore, the Commission will not grant exemption requests in such cases.
(2) The cost to the Commission of granting emergency requests: Granting emergency exemption requests will in most cases require drafting a proposed and a final amendment or a statement of enforcement policy for publication in the
(3) The precedential effect of exempting some products: The Commission recognizes that decisions to exempt some products set precedents in at least two ways. First, they indicate to companies that the CPSC will permit deviations to a given regulation. Second, they indicate to companies that the CPSC will permit deviations to regulations in general. Both precedents, if set carelessly by the CPSC, could result in many requests for exemption and could undermine the stability and integrity of the Commission’s regulations.
(e) In deciding whether to grant or deny an exemption request, the Commission also considers the following factors which relate specifically to the company making the request: (If the request is granted, all similarly situated companies, however, will be accorded the same relief).
(1) The nature of the emergency exemption request: The Commission will not reward bad quality control or faulty design work by permitting companies to market their mistakes. Although it is difficult to detail specific instances, the Commission is sympathetic to companies that produced noncomplying products due to factors beyond their immediate control or despite their best efforts.
(2) The economic loss which a company will suffer if its emergency request is denied: The greater the loss a company may suffer the more likely the Commission will favorably consider an exemption. However, the Commission does not believe economic loss alone should be determinative of an emergency exemption request.
(3) The fairness to competitors: The Commission is reluctant to grant relief if it could place the company at an unfair competitive advantage over other companies which have successfully complied with the same regulation. Therefore, the Commission will afford the same relief to similarly situated companies, and will decline to grant a request where unfair competitive advantage may result.
PART 1010 [RESERVED]
PART 1011—NOTICE OF AGENCY ACTIVITIES
§ 1011.1 General policy considerations; scope.
(a) In order for the Consumer Product Safety Commission to properly carry out its mandate to protect the public from unreasonable risks of injury associated with consumer products, the Commission has determined that it must involve the public in its activities to the fullest possible extent.
(b) To ensure public confidence in the integrity of Commission decisionmaking, the Agency, to the fullest possible extent, will conduct its business in an open manner free from any actual or apparent impropriety.
(c) This part 1011 presents general provisions concerning public notice for various types of Agency activities.
§ 1011.2 Definitions.
As used in this part 1011, the following terms shall have the meanings set forth:
(a) Agency. The entire organization which bears the title Consumer Product Safety Commission (CPSC).
(b) Agency staff. Employees of the Agency other than the five Commissioners.
(c) Commissioner. An individual who belongs to the collegial body heading the CPSC.
(d) Commission. The Commissioners of the Consumer Product Safety Commission acting in an official capacity.
(e) Commission Meeting. A meeting of the Commissioners subject to the Government in the Sunshine Act, 5 U.S.C. 552b. This term is more fully defined in the Commission’s regulations under the Government in the Sunshine Act, 16 CFR part 1013.
(f) Agency meeting. A meeting between Agency personnel, including individual Commissioners, and outside parties. This term and the term “outside party” are more fully defined in the Commission’s Meeting Policy, 16 CFR part 1012.
§ 1011.3 General requirements for various kinds of meetings.
Meetings which involve Agency staff or the Commissioners, other than Commission meetings, are classified in the following categories and shall be held according to the procedures outlined within each category.
(a) Hearings. Hearings are public inquiries held by direction of the Commission for the purpose of fact finding or to comply with statutory requirements. The Office of the Secretary is responsible for providing transcription services at the hearings. Where possible, notice of forthcoming hearings will be published in the Public Calendar and the
(b) Meetings between Commissioners or Agency staff and outside parties. The requirements for Agency meetings between Commissioners or Agency staff and outside parties involving substantial interest matters are contained in 16 CFR part 1012.
(c) Commission meetings. The requirements for Commission meetings under the Government in the Sunshine Act, 5 U.S.C. 552b are contained in 16 CFR part 1013.
(d) Staff meetings. As a general rule, only Agency employees attend staff meetings. At the discretion of the participants, Staff meetings may be listed on the Public Calendar and attendance by the public may be permitted. Recordkeeping is at the discretion of the participants.
(e) Advisory committee meetings. Meetings of the Agency’s advisory committees are scheduled by the Commission. Advance notice will be given in both the Public Calendar and the
§ 1011.4 Forms of advance public notice of meetings; Public Calendar/Master Calendar and Federal Register.
Advance notice of Agency activities is provided so that members of the public may know of and participate in these activities to the fullest extent possible. Where appropriate, the Commission uses the following types of notice for both Agency meetings subject to 16 CFR part 1012 and Commission meetings subject to 16 CFR part 1013:
(a) Public Calendar/Master Calendar. (1) The printed Public Calendar and the Master Calendar maintained in the Office of the Secretary are the principal means by which the Agency notifies the public of its day-to-day activities. The Public Calendar and/or Master Calendar provide advance notice of public hearings, Commission meetings, Agency meetings with outside parties involving substantial interest matters, other Agency meetings, selected staff meetings, advisory committee meetings, and other activities such as speeches and participation in panel discussions, regardless of the location. The Public Calendar also lists recent CPSC
(2) Upon request in writing to the Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207, any person or organization will be sent the Public Calendar on a regular basis free of charge. In addition, interested persons may contact the Office of the Secretary to obtain information from the Master Calendar which is kept current on a daily basis.
(3) The Public Calendar and the Master Calendar, supplemented by meeting summaries, are intended to serve the requirements of section 27(j)(8) of the Consumer Product Safety Act (15 U.S.C. 2076(j)(8)).
(b) Federal Register.
PART 1012—MEETINGS POLICY—MEETINGS BETWEEN AGENCY PERSONNEL AND OUTSIDE PARTIES
§ 1012.1 General policy considerations; scope.
(a) To achieve its goals of involving the public in its activities and conducting its business in an open manner, the Agency, whenever practicable, shall notify the public in advance of all meetings involving matters of substantial interest held or attended by its personnel, and shall permit the public to attend such meetings. Furthermore, to ensure the widest possible exposure of the details of such meetings, the Agency will keep records of them freely available for inspection by the public.
(b) This part 1012, the Agency’s Meetings Policy, sets forth requirements for advance public notice, public attendance, and recordkeeping for Agency meetings.
§ 1012.2 Definitions.
(a) As used in this part 1012, the following terms have the respective meanings set forth in paragraphs (a)-(d) of § 1011.2 of this subchapter: “Agency,” “Agency staff,” “Commissioner,” “Commission.”
(b) Agency meeting. Any face-to-face encounter, other than a Commission meeting subject to the Government in the Sunshine Act, 5 U.S.C. 552b, and part 1013, in which one or more employees, including Commissioners, discusses with an outside party any subject relating to the Agency or any subject under its jurisdiction. The term Agency meeting does not include telephone conversations, but see § 1012.8 which relates to telephone conversations.
(c) Outside party. Any person not an employee, not under contract to do work for the Agency, or not acting in an official capacity as a consultant to the Consumer Product Safety Commission, such as advisory committee members or offeror personnel. Examples of persons falling within this definition are representatives from industry and consumer groups. Members of the news media when acting in a newsgathering capacity are not outside parties. (See also § 1012.7.) Officers and employees of the Federal Government when acting in their official capacities (except when advocating a particular course of action on behalf of an outside party) are not outside parties.
(d) Substantial interest matter. Any matter, other than that of a trivial nature, that pertains in whole or in part to any issue that is likely to be the subject of a regulatory or policy decision by the Commission. Pending matters, i.e., matters before the Agency in which the Agency is legally obligated to make a decision, automatically constitute substantial interest matters. Examples of pending matters are: Scheduled administrative hearings; matters published for public comments; petitions under consideration; and mandatory standard development activities. The following are some examples of matters that do not constitute substantial interest matters: Inquiries concerning the status of a pending matter; discussions relative to general interpretations of existing laws, rules, and regulations; inspection of nonconfidential CPSC documents by the public; negotiations for contractual services; and routine CPSC activities such as recruitment, training, meetings involving consumer deputies, or meetings with hospital staff and other personnel involved in the National Electronic Injury Surveillance System.
§ 1012.3 Advance public notice of agency meetings.
(a) Commissioners and Agency employees are responsible for reporting meeting arrangements for Agency meetings to the Office of the Secretary so that they may be published in the Public Calendar or entered on the Master Calendar at least seven days before a meeting, except as provided in paragraph (d) of this section. These reports shall include the following information:
(1) Probable participants and their affiliations;
(2) Date, time and place of the meeting;
(3) Subject of the meeting (as fully and precisely described as possible);
(4) Who requested the meeting;
(5) Whether the meeting involves matters of substantial interest;
(6) Notice that the meeting is open or reason why the meeting or any portion of the meeting is closed (e.g., discussion of trade secrets); and
(7) Names and telephone number of the CPSC host or CPSC contact person.
(b) Once a report has been made to the Office of the Secretary, Agency employees subsequently desiring to attend the meeting need not notify the Office of the Secretary.
(c) When there is no opportunity to give seven days advance notice of a meeting, Agency employees (other than the Commissioners or their personal staff) who desire to hold or attend such a meeting must obtain the approval of the General Counsel or his or her designee. Requests for waiver of the seven-day advance notice requirement by members of the staff who report to the Executive Director may only be submitted to the General Counsel or his or her designee in writing by the Executive Director or his or her designee. Personal staff of Commissioners must obtain the approval of their respective Commissioners. If the short notice is approved, the Agency employee must notify the Office of the Secretary in advance of the meeting to record the meeting on the Master Calendar. The Office of the Secretary shall publish notice of the meeting as an addendum to the next Public Calendar.
(d) Exceptions. The notice requirement shall not apply to:
(1) Meetings with outside parties not involving substantial interest matters (although such meetings should be limited where the public interest would be served);
(2) Meetings with outside parties held during the normal course of surveillance, inspection, or investigation under any of the Acts administered by the Commission, including informal citation hearings under the Federal Hazardous Substance Act or the Poison Prevention Packaging Act;
(3) Meetings with outside parties concerning the settlement or negotiation of an individual case, including proposed remedial action, or meetings concerning any administrative or judicial action in which the outside party is a participant, party, or amicus curiae;
(4) Routine speeches given by CPSC personnel before outside parties. However, for information purposes, personnel are encouraged to submit advance notice of these speeches to the Office of the Secretary for inclusion in the Public Calendar;
(5) Meetings with other Federal personnel that are also attended by outside parties except where a specific matter to be discussed is also pending before the Commission or its staff;
(6) Meetings with state, local or foreign government personnel concerning intergovernmental cooperative efforts and not the advocacy of a particular course of action on behalf of a constituency of the governmental entity;
(7) Meetings or discussions with or at the request of either members of Congress and their staffs relating to legislation, appropriation or oversight matters, or Management and Budget personnel relating to legislation or appropriation matters;
(8) Pre-proposal conferences involving confidential contracts made pursuant to 41 U.S.C. 252(c)(12) in connection with potential litigation matters.
§ 1012.4 Public attendance at agency meetings.
(a) Any person may attend any meeting involving a substantial interest matter unless that meeting has been listed as a closed meeting. For meetings not involving substantial interest matters, the chairperson of the meeting may exercise his or her discretion to allow attendance by a member of the public.
(b) When meetings between Agency employees and outside parties are open to the public, attendance may be limited by space. When feasible, a person or organization desiring to attend such a meeting should give at least one day advance notice to one of the employees holding or attending the meeting so that sufficient space can be arranged for all those wishing to attend.
(c) Members of the public attending Agency meetings generally may observe only. The chairperson of the meeting may exercise his or her discretion to permit members of the public to participate as well.
(d) The following Agency meetings are not open to the public:
(1) Meetings, or, if possible, portions of meetings where the General Counsel or his or her designee has determined that proprietary data are to be discussed in such a manner as to imperil their confidentiality;
(2) Meetings held by outside parties at which limits on attendance are imposed by lack of space, provided that such meetings are open to the news media;
(3) Meetings with outside parties held during the normal course of surveillance, inspection, or investigation under any of the Acts administered by the Commission, including informal citation hearings under the Federal Hazardous Substances Act or the Poison Prevention Packaging Act;
(4) Meetings with outside parties concerning the settlement or negotiation of an individual case, including proposed remedial action, or meetings concerning any administrative or judicial action in which the outside party is a participant, party, or amicus curiae;
(5) Meetings with other Federal personnel that are attended by outside parties except where a specific matter to be discussed is also pending before the Commission or its staff;
(6) Meetings with state, local or foreign government personnel concerning intergovernmental cooperative efforts and not the advocacy of a particular course of action on behalf of a constituency of the governmental entity;
(7)(i) Meetings between Agency staff (other than Commissioners and their personal staff) and an outside party when the General Counsel or his or her designee determines that extraordinary circumstances require that the meeting be closed. Requests for exemption by members of the staff who report to the Executive Director may be submitted to the General Counsel or his or her designee in writing only by the Executive Director or his or her designee. In such a case, the reasons for closing the meeting or a portion of the meeting shall be stated in the Public Calendar notice announcing the meeting;
(ii) Meetings between a Commissioner (or his or her personal staff) and an outside party when, in the opinion of the Commissioner, extraordinary circumstances require that the meeting be closed. In such a case, the reasons for closing the meeting or a portion of the meeting must be stated in the Public Calendar notice announcing the meeting;
(8) Meetings or discussions with or at the request of either members of Congress and their staffs relating to legislation, appropriation or oversight matters, or Management and Budget personnel relating to legislation or appropriation matters; and
(9) Pre-proposal conferences involving confidential contracts made pursuant to 41 U.S.C. 252(c)(12), in connection with the potential litigation matters.
§ 1012.5 Recordkeeping for agency meetings.
(a) This section describes and establishes requirements for the two types of records maintained for Agency meetings, Agency meeting summaries and transcripts.
(b) Agency meeting summaries. Agency meeting summaries are written records settling forth the issues discussed at all Agency meetings with outside parties involving substantial interest matters. Any Commission employee who holds or attends an Agency meeting involving a substantial interest matter must prepare a meeting summary. However, only one agency meeting summary is required for each meeting even if more than one CPSC employee holds or attends the meeting. Agency meeting summaries are generally available to the public in the Agency’s Public Reading Room in the Office of the Secretary as described in paragraph (b)(2) of this section.
(1) An agency meeting summary should state the essence of all substantive matters relevant to the Agency, especially any matter discussed which was not listed on the Public Calendar, and should describe any decisions made or conclusions reached regarding substantial interest matters. An agency meeting summary should also indicate the date of the meeting and the identity of persons who attended.
(2) An agency meeting summary or a notice of cancellation of the meeting must be submitted to the Office of the Secretary within twenty (20) calendar days after the meeting for which the summary is required. The Office of the Secretary shall maintain a file of the meeting summaries in chronological order, which shall be available to the public to the extent permitted by law.
(c) Transcripts. Transcripts are generally taken at public hearings and certain Agency meetings when complex subjects indicate verbatim records are desirable. The transcript may also include exhibits submitted to be part of the formal record of an Agency meeting. Copies of such transcripts are placed on file for public inspection in the Office of the Secretary.
§ 1012.6 The news media.
The Agency recognizes that the news media occupy a unique position in informing the public of the Agency’s activities. The Commission believes that the inherently public nature of the news media allows their activities to be exempt from the requirements of this part whenever Agency meetings are held with the news media for the purpose of informing them about Agency activities. Such Agency meetings are not exempt in the event that any representative of the news media attempts to influence any Agency employee on a substantial interest matter.
§ 1012.7 Telephone conversations.
(a) Telephone conversations present special problems regarding Agency meetings. The Commission recognizes that persons outside the Agency have a legitimate right to receive information and to present their views regarding Agency activities. The Commission also recognizes that such persons may not have the financial means to travel to meet with Agency employees. However, because telephone conversations, by their very nature, are not susceptible to public attendance, or participation, Agency employees must take care to ensure that telephone conversations are not utilized to circumvent the provisions of this part.
(b) Two basic rules apply to telephone conversations:
(1) Any Agency employee holding a telephone conversation in which substantial interest matters are discussed with an outside party must prepare a telephone call summary of the conversation. The summary must meet the requirements of § 1012.5(b), and must be submitted to the Office of the Secretary within twenty (20) calendar days of the conversation. The Office of the Secretary shall maintain file of telephone call summaries in chronological order which shall be available to the public to the extent permitted by law.
(2) All Agency employees must exercise sound judgment in discussing substsantial interest matters during a telephone conversation. In the exercise of such discretion Agency employees should not hesitate to terminate a telephone conversation and insist that the matters being discussed be postponed until an Agency meeting with appropriate advance public notice may be scheduled, or, if the outside party is financially or otherwise unable to meet with the Agency employee, until the matter is presented to the Agency in writing.
PART 1013—GOVERNMENT IN THE SUNSHINE ACT, RULES FOR COMMISSION MEETINGS
§ 1013.1 General policy considerations; scope.
(a) In enacting the Government in the Sunshine Act, 5 U.S.C. 552b, the Congress stated the policy that, to the fullest practicable extent, the public is entitled to information regarding the decisionmaking processes of the Federal Government. The purpose of the Government in the Sunshine Act is to provide the public with such information while protecting both the rights of individuals and the ability of the Government to carry out its responsibilities. When the Commissioners of the Consumer Product Safety Commission hold meetings for the purpose of jointly conducting or disposing of Commission business they will conduct these meetings in accordance with the provisions of the Government in the Sunshine Act.
(b) This part 1013 prescribes rules the Commission follows in carrying out the Government in the Sunshine Act.
§ 1013.2 Definitions.
(a) As used in this part 1013, the following terms shall have the respective meanings set forth in paragraphs (a), (c) and (d) of § 1011.2 of this subchapter: “Agency,” “Commissioner,” “Commission.”
(b) Majority of the Commission. Three or more of the Commissioners.
(c) Commission meeting. The joint deliberations of at least a majority of the Commission where such deliberations determine or result in the joint conduct or disposition of official Agency business. This term does not include meetings required or permitted by § 1013.4(b) (to determine whether a meeting will be open or closed), meetings required or permitted by § 1013.3(e) (to change the subject matter of a meeting or the determination to open or close a meeting after the public announcement) or meetings required or permitted by 1013.3(c) (to dispense with the one week advance notice of a meeting).
§ 1013.3 Announcement of Commission meetings and changes after announcement.
(a) The Secretary of the Commission is responsible for preparing and making public the announcements and notices relating to Commission meetings that are required in this part.
(b) The Agency shall announce each Commission meeting in the Public Calendar or Master Calendar at least one week (seven calendar days) before the meeting. The Agency shall concurrently submit the announcement for publication in the
(1) The date, time, and place of the meeting;
(2) The subject matter of the meeting;
(3) Whether the meeting will be open or closed to the public;
(4) The name and phone number of the official who responds to requests for information about the meeting.
(c) If a majority of the Commission determines by recorded vote that Agency business requires calling a meeting without seven calendar days advance public notice, the Office of the Secretary shall announce this determination in the Public Calendar or Master Calendar at the earliest practicable time and shall concurrently transmit the announcement for publication in the
(d) When necessary and at the direction of the Chairman, the Secretary shall change the time of a Commission meeting after the announcement in the Public Calendar or Master Calendar. Any such change shall be entered on the Master Calendar and such other notice shall be given as is practicable.
(e) After announcement of a Commission meeting in the Public Calendar or Master Calendar, the Commission may change the subject matter of a Commission meeting or the decision to open or close a Commission meeting or portion thereof to the public, only if a majority of the Commission determines by recorded vote that Agency business so requires, and only if a majority of the Commission determines by recorded vote that no earlier announcement of the change was possible. The Commission shall announce the change in the Public Calendar or Master Calendar at the earliest practicable time before the meeting and shall concurrently transmit the announcement for publication in the
§ 1013.4 Public attendance at Commission meetings.
(a) Attendance by the public. Every portion of every Commission meeting shall be open to public observation except as provided in paragraph (b) of this section. Notwithstanding the applicability of the exemptions contained in paragraph (b) of this section, a Commission meeting or portions thereof shall be open to public observation when the Commission determines that the public interest so requires. The Commission shall take into account in all cases the relative advantages and disadvantages to the public of conducting the Commission meeting in open session. The number of public observers shall be limited only by availability of space. Attendance by the public shall usually be limited to observation and shall not include participation except where, by majority vote, the Commission determines that data or views from certain members of the public will be permitted. To the extent their use does not interfere with the conduct of open meetings, cameras and sound-recording equipment may be used at open Commission meetings. The Chairman or presiding Commissioner shall insure that use of such equipment does not disrupt the meeting.
(b) Exemptions to the requirement of openness. The requirement in paragraph (a) of this section that all Commission meetings be open to public observation shall not apply to any Commission meeting or portion thereof for which the Commission has determined in accordance with the procedures for closing meetings set forth in paragraph (c) of this section, that such meeting or portion thereof is likely to:
(1) Disclose matters that are specifically authorized under criteria established by an Executive Order to be kept secret in the interest of national defense or foreign policy and in fact are properly classified pursuant to such Executive Order;
(2) Relate solely to the internal personnel rules and practices of the Agency;
(3) Disclose matters specifically exempted from disclosure by statute (other than 5 U.S.C. 552): Provided, That such statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld;
(4) Disclose trade secrets and commercial or financial information obtained from a person and privileged or confidential;
(5) Involve accusing any person of a crime, or formally censuring any person;
(6) Disclose information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy;
(7) Disclose investigatory records compiled for law enforcement purposes or information which if written would be contained in such records, but only to the extent that the production of such records or information would,
(i) Interfere with enforcement proceedings,
(ii) Deprive a person of a right to a fair trial or an impartial adjudication,
(iii) Constitute an unwarranted invasion of personal privacy,
(iv) Disclose the identity of a confidential source and, in the case of a record compiled by a criminal law enforcement authority in the course of a criminal investigation, or by an agency conducting a lawful national security intelligence investigation, confidential information furnished only by the confidential source,
(v) Disclose investigative techniques and procedures or,
(vi) Endanger the life or physical safety of law enforcement personnel;
(8) Disclose information contained in or related to examination, operating or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions;
(9) Disclose information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed Agency action. This provision does not apply in any instance where the Agency has already disclosed to the public the content or nature of its proposed action, or where the Agency is required by law to make such disclosure on its own initiative prior to taking final agency action on such proposal; or
(10) Specifically concern the Agency’s issuance of a subpoena, or the Agency’s participation in a civil action or proceeding, an action in a foreign court or international tribunal, or an arbitration, or the initiation, conduct, or disposition by the Agency of a particular case of formal agency adjudication pursuant to the procedures in 5 U.S.C. 554 or otherwise involving a determination on the record after opportunity for a hearing.
(c) Procedure for closing Commission Meetings. The following procedure shall be followed in closing a Commission meeting or portion thereof to public observation:
(1) A majority of the Commission must vote to close a meeting or portion thereof to public observation pursuant to paragraph (b) of this section. A separate vote of the Commission shall be taken for each matter with respect to which a Commission meeting is proposed to be closed to public observation. Each such vote may, at the discretion of the Commission, apply to that portion of any meeting held within the following thirty days in which such matter is to be discussed. The vote of each Commissioner participating in such vote shall be recorded and no proxies shall be allowed.
(2) Any person whose interest may be directly affected if a portion of a Commission meeting is open may request in writing to the Office of the Secretary that the Commission close that portion of the meeting on the basis of paragraph (b) (5), (6), or (7) of this section. The Commission shall vote on such requests if at least one Commissioner desires to do so.
(3) Before the Commission may hold a closed meeting the General Counsel must certify that in his or her opinion, the meeting may properly be closed to the public. Such certification shall be in writing and shall state each relevant exemptive provision.
(4) Within one day of a vote in accordance with paragraph (c) (1) or (2) of this section to close a Commission meeting or portion thereof, the Secretary shall make available to the public a notice setting forth:
(i) The results of the vote reflecting the vote of each Commissioner;
(ii) A full explanation of the action of the Commission closing the meeting or portion thereof, including reference to the specific basis for such closing (see paragraph (b) of this section) and an explanation, (without disclosing exempt information), of why the Commission concludes on balance, taking into account the relative advantages and disadvantages to the public of conducting the meeting in open or closed session, that the public interest would best be served by closing the meeting;
(iii) A list of all non-Agency personnel expected to attend the meeting and their affiliations; and
(iv) A certification by the General Counsel that in his or her opinion, the meeting may properly be closed to the public. If a vote to close a Commission meeting takes place on the same day as the meeting, the certification must be made available to the public before the meeting is convened.
(5) The public release of the portion of the written statement required by paragraph (c)(4)(ii) of this section may be delayed upon a determination by the Commission, by recorded vote, that such a notice, or portion thereof, would disclose information which may be withheld in accordance with paragraphs (b) (1) through (10) of this section.
(d) Reconsideration of a decision to open or close a Commission meeting. The Commission may, in accordance with the procedures in § 1013.3(3) or paragraph (c)(2) of this section, reconsider its decision to open or close a Commission meeting when it finds that the public interest so requires.
§ 1013.5 Recordkeeping requirements.
(a) Commission meetings, transcripts, recordings, or minutes.
(1) The Agency shall maintain a complete transcript or electronic recording of each Commission meeting, whether open or closed, except that in the case of a Commission meeting or portion thereof closed to the public pursuant to paragraph (b)(10) of § 1013.4, the Agency may elect to maintain a set of meeting minutes instead of a transcript or a recording. Minutes of such closed Commission meetings shall:
(i) Fully and clearly describe all matters discussed, and
(ii) Provide a full and accurate summary of any actions taken and the reasons therefor, including a description of each of the views expressed on any item and the record of any roll call vote (reflecting the vote of each Commissioner on the question). All documents considered in connection with any action shall be identified in the meeting minutes.
(2) The transcript, recording or minutes of closed Commission meetings shall include the certification by the General Counsel or by his or her designee, required by § 1013.4(c)(3) and a statement by the presiding Commissioner setting forth the date, time and place of the meeting and the persons present.
(3) The transcript, recording, or minutes of any Commission meeting may include attachments such as Commission opinions, briefing papers, or other documents presented at the meeting.
(4) The transcript and accompanying material shall be maintained by the Secretary for a period of at least two years after the meeting, or until one year after the conclusion of any Agency proceeding with respect to which the meeting, or portion thereof, was held, whichever occurs later.
(b) Minutes of Commission Decisions. Minutes of Commission Decisions summarizing the issues presented to the Commission for decision and indicating the vote of each Commissioner document the decisions of the Commission, whether made at open or closed meetings or by ballot vote. The Commission’s final Minutes of Commission Decisions, issued by the Office of the Secretary, constitute the official means of recording the decisions of the Commission and the votes of individual Commissioners.
§ 1013.6 Public availability of transcripts, recordings and minutes of Commission meetings.
(a) Availability of transcripts, recordings or minutes. The Agency shall make available to the public the transcript, recording or minutes of Commission meetings. However, unless the Commission finds that the public interest requires otherwise, any portion of the transcript, recording or minutes of a closed Commission meeting which is determined to contain information which may properly be withheld from the public on the basis of paragraphs (b) (1) through (10) of § 1013.4 need not be made available to the public.
(b) Procedures for making available transcripts, recordings or meeting minutes. Meeting records will be made available for inspection, or copies will be furnished, as requested, in accordance with the following procedures.
(1) Requests. Requests for inspection or copies shall be in writing addressed to the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207. A request must reasonably describe the Commission meeting, or portion thereof, including the date and subject matter or any other information which may help to identify the requested material.
(2) Responses to requests. The responsibility for responding to requests for meeting records is vested in the Secretary of the Commission. In any case where the Secretary or his or her designee, in his or her discretion, determines that a request for an identifiable meeting record should be initially determined by the Commission, the Secretary or his or her designee may certify the matter to the Commission for decision. In that event, the Commission decision shall be made within the time limits set forth in paragraph (b)(5)(iii) of this section and shall be final.
(3) Time limitations on responses to requests. The Secretary or his or her designee shall respond to all written requests for copies of meeting records within ten (10) working days. The time limitations on responses to requests shall begin to run as of the time a request for records is received and date stamped by the Office of the Secretary.
(4) Responses. Form and content. When a requested meeting record has been identified and is available for disclosure the requester shall either be informed as to where and when the records will be made available for inspection or be supplied with a copy. A response denying a written request for a meeting record of a closed Commission meeting shall be in writing signed by the Secretary and shall include:
(i) A reference to the specific exemptions under the Government in the Sunshine Act (5 U.S.C. 552b(c)) authorizing the denial; and
(ii) A statement that the denial may be appealed to the Commission pursuant to paragraph (b)(5) of this section.
(5) Appeals to the Commissioners. (i) When the Secretary or his or her designee has denied a request for records in whole or in part, the requester may, within 30 days of its receipt, appeal the denial to the Commissioners of the Consumer Product Safety Commission by writing to the attention of the Chairman, Consumer Product Safety Commission, Washington, D.C. 20207.
(ii) The Commission will act upon an appeal within 20 working days of its receipt. The time limitations on an appeal begin to run as of the time an appeal is received by the Office of the Chairman and date stamped.
(iii) The Commission’s action on appeal shall be in writing, signed by the Chairman of the Commission if the appeal is denied and shall identify the Commissioners who voted for a denial. A denial in whole or in part of a request on appeal for records of a closed meeting shall set forth the exemption relied on and a brief explanation (without disclosing exempt information) of how the exemption applies to the records withheld. A denial in whole or in part shall also inform the requester of his or her right to seek judicial review as specified in 5 U.S.C. 552b(h).
(6) Fees. (i) Fees shall be charged for copies of transcriptions of recording or minutes in accordance with the schedule contained in paragraph (b)(6)(iii) of this section.
(ii) There shall be no fee charged for services rendered in connection with production or disclosure of meeting records unless the charges, calculated according to the schedule below, exceed the sum of $25.00. Where the charges are calculated to be an amount in excess of $25.00, the fee charged shall be the difference between $25.00 and the calculated charges.
(iii) The schedule of charges for furnishing copies of meeting records is as follows:
(A) Reproduction, duplication or copying of transcripts or minutes: 10 cents per page.
(B) Reproduction of recordings: actual cost basis.
(C) Transcription (where meeting records are in the form of a recording only): actual cost basis.
(D) Postage: actual cost basis.
PART 1014—POLICIES AND PROCEDURES IMPLEMENTING THE PRIVACY ACT OF 1974
§ 1014.1 Purpose and scope.
This part sets forth the regulations of the Consumer Product Safety Commission implementing the Privacy Act of 1974 (Pub. L. 93-579). The purpose of these regulations is to inform the public about records maintained by the Commission which contain personal information about individuals, and to inform those individuals how they may seek access to and correct records concerning themselves. These regulations do not apply to requests for information made pursuant to the Freedom of Information Act (except where such disclosures would constitute an invasion of privacy of an individual).
§ 1014.2 Definitions.
As used in this part:
(a) Individual means a person who is a citizen of the United States or an alien lawfully admitted for permanent residence.
(b) Privacy Act means the Privacy Act of 1974 (Pub. L. 93-579).
(c) Record means any item of personal information relating to an individual, such as educational, employment, financial or medical information.
(d) Statistical record means a record in a system of records maintained for statistical research or reporting purposes only and not used in whole or in part in making any determination about an identifiable individual.
(e) System of records or records systems means a group of records maintained by the Commission from which information may be retrieved by the name of an individual or some other individual identifier.
(f) Maintain includes the collection, use, storage, and dissemination of information.
§ 1014.3 Procedures for requests pertaining to individual records.
(a) Any individual may request the Commission to inform him or her whether a particular record system named by the individual contains a record pertaining to him or her. The request may be made by mail or in person during business hours (8:30 a.m. to 5 p.m.) to the Freedom of Information/Privacy Act Officer, Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland (mailing address: Consumer Product Safety Commission, Washington, DC 20207).
(b) An individual who believes that the Commission maintains a record pertaining to him or her but who cannot determine which record system may contain the record, may request assistance by mail or in person at the Office of the Secretary during business hours.
(c) A Commission officer or employee or former employee who desires to review or obtain a copy of a personnel record pertaining to him or her may make a request by mail or in person at the Office of Human Resources Management, Room 523, 4330 East West Highway, Bethesda, Maryland (mailing address: Consumer Product Safety Commission, Washington, DC 20207).
(d) Each individual requesting the disclosure of a record or a copy of a record shall furnish the following information to the extent known with the request to the Freedom of Information/Privacy Act Officer or to the Division of Personnel’s Processing Unit, as applicable:
(1) A description of the record sought;
(2) The approximate date of the record;
(3) The name or other description of the record system containing the record;
(4) Proof as required in § 1014.4 that he or she is the individual to whom the requested record relates; and
(5) Any other information required by the notice describing the record system.
(e) An individual personally inspecting his or her records may be accompanied by other persons of his or her own choosing. The individual shall sign a written statement authorizing disclosure of the record in the other person’s presence.
(f) Any individual who desires to have a record concerning himself or herself disclosed to or mailed to another person may authorize that person to act as his or her agent for that specific purpose. The authorization shall be in writing, signed by the individual, and shall be notarized. An agent requesting the review or copy of another’s record shall submit with the request the authorization and proof of his or her identify as required by § 1014.4(c).
(g) The parent of any minor individual or the legal guardian of any individual who has been declared by a court of competent jurisdiction to be incompetent, due to physical or mental incapacity or age, may act on behalf of that individual in any matter covered by this part. A parent or guardian who desires to act on behalf of such individual shall present suitable evidence of parentage or guardianship, by birth certificate, certified copy of a court order, or similar documents, and proof of the individual’s identity in a form that complies with § 1014.4(c).
(h) An individual may request an accounting of all disclosures made to other persons or agencies of his or her record, except those disclosures made to law enforcement agencies pursuant to section (b)(7) of the Privacy Act (5 U.S.C. 552a(b)(7)). A request for accounting, whenever made, shall be treated as a request for disclosure of records.
§ 1014.4 Requirements for identification of individuals making requests.
The following proof of identity is required for requests for records made pursuant to § 1014.3:
(a) An individual seeking a record about himself or herself in person may establish his or her identity by the presentation of a single document bearing a photograph (such as a passport or driver’s license) or by a presentation of two items of identification which do not bear a photograph but do bear both a name and address. An individual who cannot provide documentation of his or her identity may provide a written statement affirming his or her identity and the fact that he or she understands the penalties for making false statements (18 U.S.C. 1001 and 5 U.S.C. 552a(i)(3)).
(b) An individual seeking a record by mail shall include a statement signed by the individual and properly notarized, that he or she appeared before a notary public and submitted proof of identity acceptable to the notary public.
(c) Requests made by an agent, parent, or guardian shall, in addition to establishing the identity of the minor or other person he or she represents as required by paragraphs (a) and (b), establish his or her agency, parentage, or guardianship by documentation.
(d) In any case in which the Commission determines that the proof of identity is not adequate, it may request the individual to submit additional proof of identity.
§ 1014.5 Disclosure of requested information to individuals.
(a) Upon submission of proof of identity, the Office of the Secretary or the Director of Resource Utilization, as applicable, shall promptly forward the request to the system manager who will promptly allow the individual to see and/or have a copy of the requested record or send a copy of the record to the individual by mail, as requested by the individual. If the individual asks to see the record, the record should be made available for review and/or copying at the location where the record is maintained, in the Office of the Secretary, or the Director of Resource Utilization, or at the nearest Area Office.
(b) If the system manager should determine, for any reason, that the requested records are exempt from the right of access, a notice of denial shall be sent to the requester stating the reasons for denial, and the requester’s right to appeal the denial in accordance with the procedures set forth in § 1014.8 of these regulations.
§ 1014.6 Request for correction or amendment to a record.
(a) Any individual who has reviewed a record pertaining to himself or herself may request the Executive Director to correct or amend all or any part of the record.
(b) Each request for a correction or amendment of a record shall be in writing and shall contain the following information:
(1) The name of the individual requesting the correction or amendment;
(2) The name or other description of the system of records in which the record sought to be amended is maintained;
(3) The location of that record in the system of records to the extent that it is known;
(4) A copy of the record sought to be amended or a description of that record;
(5) A statement of the material in the record that should be corrected or amended;
(6) A statement of the specific wording of the correction or amendment sought; and
(7) A statement of the basis for the requested correction or amendment including any material that the individual can furnish to substantiate the reasons for the amendment sought.
§ 1014.7 Agency review of request for correction or amendment of a record.
(a) Not later than 10 working days after the receipt of the request for the correction or amendment of a record under § 1014.6, the responsible Commission official shall acknowledge receipt of the request and inform the individual whether further information is required before the correction or amendment can be considered.
(b) The responsible Commission official will promptly review the request and either make the requested correction or amendment or notify the individual of his or her refusal to do so, including in the notification the reasons for the refusal, and the appeal procedures provided by § 1014.8.
(c) The responsible Commission official will make each requested correction or amendment to a record if that correction or amendment will correct anything within the record that is not accurate, relevant, timely, or complete. A copy of each corrected or amended record shall be furnished to the individual who requested the action. If an accounting of disclosure has been kept, all previous recipients of the record shall be notified of the correction and its substance.
§ 1014.8 Appeal of initial denial of access, correction or amendment.
(a) Any individual whose request for access, correction or amendment to a record is denied, in whole or in part, may appeal that decision within 30 working days to the Chairman, Consumer Product Safety Commission, Washington, D.C. 20207.
(b) The appeal shall be in writing and shall:
(1) Name the individual making the appeal;
(2) Identify the record to which access is sought or which is sought to be corrected or amended;
(3) Name or describe the record system in which the record is contained;
(4) Contain a short statement describing the correction of amendment sought;
(5) State the name and location of the Commission official who initially denied the correction or amendment; and
(6) State the date of the initial denial.
(c) Not later than 30 working days after the date on which the appeal is received, the Chairman shall complete a review of the appeal and make a final decision thereon. However, for good cause shown, the Chairman of the Commission may extend the 30-day period. If the Chairman so extends the period, he or she shall promptly notify the individual requesting the review that the extension has been made.
(d) If after review of an appeal request, the Chairman also refuses to amend the record or grant access to the record in accordance with the request, he or she shall send a written notice to the requester containing the following information:
(1) The decision and the reasons for the decision;
(2) The right of the requester to institute a civil action in a Federal District Court for judicial review of the decision; and
(3) The right of the requester to file with the Chairman a concise statement setting forth the reasons for his or her disagreement with the denial of the correction or amendment. A copy of the statement of disagreement shall be filed with the record in issue, and the record in issue shall be so marked as to indicate that there is a disagreement. The system manager shall make the statement of disagreement available to prior recipients of the disputed record to the extent that an accounting of disclosures was maintained, and to any person to whom the record is later disclosed, together with a brief statement, if deemed appropriate, of the reasons for denying the requested correction or amendment.
§ 1014.9 Disclosure of record to person other than the individual to whom it pertains.
(a) Any person or agency (other than an officer or employee of the Commission who has a need for individual records in the performance of his or her duty) seeking disclosure of personal records of another individual which are contained in a system of records shall submit a request in accordance with the Commission’s Procedures for Disclosure of Production of Information under the Freedom of Information Act (16 CFR part 1015, subpart A).
(b) The determination of whether or not the requested disclosure is proper will be made in accordance with the provisions of the Freedom of Information Act, as amended (5 U.S.C. 552) and the Commission’s policies and procedures issued thereunder (16 CFR part 1015).
§ 1014.10 Fees.
The Commission shall not charge an individual for the costs of making a search for a record, the costs of reviewing or copying a record, or the cost of correcting or amending a record.
§ 1014.11 Penalties.
Any person who makes a false statement in connection with any request for a record, or an amendment thereto, under this part, is subject to the penalties prescribed in 18 U.S.C. 494, 495, and 1001; and 5 U.S.C. 552a(i)(3).
§ 1014.12 Specific exemptions.
(a) Injury information. (1) The Bureau of Epidemiology maintains a file of Accident Reports (In-Depth Investigations) which are conducted on a sample of product related injuries reported to the Commission by selected hospital emergency rooms, by consumers through the Commission’s “Hot-Line” telephone service and through written consumer complaints and by other means such as newspaper reports. The purpose of this record system is to compile accident statistics for analyzing the incidence and severity of product related injuries.
(2) Inasmuch as the maintenance of the record system listed in paragraph (a)(1) of this section is authorized by section 5 of the Consumer Product Safety Act (15 U.S.C. 2054) and the data are used solely as statistical records, the system is exempted from the requirements of the Privacy Act relating to making available the accounting of disclosures, correction or amendment of the record and the application of these rules to the system of records. Specifically, the system is exempt from 5 U.S.C. 552a(c)(3); (d) (2) and (3); (e)(1); (e)(4) (G), (H) and (I); and (f). However, Accident Reports made by Commission employees are disclosable in accordance with paragraph (a)(3) of this section.
(3) Section 25(c) of the Consumer Product Safety Act (15 U.S.C. 2074(c)) provides that accident or investigation reports made by an officer or employee of the Commission shall be made available to the public in a manner which will not identify any injured person or any person treating him or her, without the consent of the person identified. Consequently, an accident or investigation report which identifies individuals is available to the injured party or the person treating him or her but would not be available for disclosure to a third party without the consent of the injured party or person treating him or her.
(4) Since accident or investigation reports are compiled only for statistical purposes and are not used in whole or in part in making any determination about an individual, they are exempted from the requirement to correct or amend a record as provided by subsection (d)(2) of the Privacy Act (5 U.S.C. 552a (d)(2)). Exceptions from this paragraph, insofar as they relate to amendments or additions, may be allowed by the Executive Director.
(b) Inspector General Investigative Files—CPSC-6. All portions of this system of records which fall within 5 U.S.C. 552a(k)(2) (investigatory materials compiled for law enforcement purposes) and 5 U.S.C. 552a(k)(5) (investigatory materials solely compiled for suitability determinations) are exempt from 5 U.S.C. 552a(c)(3) (mandatory accounting of disclosures); 5 U.S.C. 552a(d) (access by individuals to records that pertain to them); 5 U.S.C. 552a(e)(1) (requirement to maintain only such information as is relevant and necessary to accomplish an authorized agency purpose); 5 U.S.C. 552a(e)(4)(G) (mandatory procedures to notify individuals of the existence of records pertaining to them); 5 U.S.C. 552a(e)(4)(H) (mandatory procedures to notify individuals how they can obtain access to and contest records pertaining to them); 5 U.S.C. 552a(e)(4)(I) (mandatory disclosure of records source categories); and the Commission’s regulations in 16 CFR part 1014 which implement these statutory provisions.
(c) Enforcement and Litigation Files—CPSC-7. All portions of this system of records that fall within 5 U.S.C. 552a(k)(2) (investigatory materials compiled for law enforcement purposes) are exempt from 5 U.S.C. 552a(c)(3) (mandatory accounting of disclosures); 5 U.S.C. 552a(d) (access by individuals to records that pertain to them); 5 U.S.C. 552a(e)(1) (requirement to maintain only such information as is relevant and necessary to accomplish an authorized agency purpose); 5 U.S.C. 552a(e)(4)(G) (mandatory procedures to notify individuals of the existence of records pertaining to them); 5 U.S.C. 552a(e)(4)(H) (mandatory procedures to notify individuals how they can obtain access to and contest records pertaining to them); 5 U.S.C. 552a(e)(4)(I) (mandatory disclosure of records source categories); and the Commission’s regulations in 16 CFR part 1014 that implement these statutory provisions.
PART 1015—PROCEDURES FOR DISCLOSURE OR PRODUCTION OF INFORMATION UNDER THE FREEDOM OF INFORMATION ACT
Subpart A—Production or Disclosure Under 5 U.S.C. 552(a)
§ 1015.1 Purpose and scope.
(a) The regulations of this subpart provide information concerning the procedures by which Consumer Product Safety Commission records may be made available for inspection and the procedures for obtaining copies of records from the Consumer Product Safety Commission. Official records of the Consumer Product Safety Commission consist of all documentary material maintained by the Commission in any format, including an electronic format. These records include those maintained in connection with the Commission’s responsibilities and functions under the Consumer Product Safety Act, as well as those responsibilities and functions transferred to the Commission under the Federal Hazardous Substances Act, the Poison Prevention Packaging Act of 1970, the Refrigerator Safety Act, the Flammable Fabrics Act, the Children’s Gasoline Burn Prevention Act, the Virginia Graeme Baker Pool and Spa Safety Act, and the Child Nicotine Poisoning Prevention Act, and those maintained under any other authorized activity. Official records do not, however, include objects or articles such as tangible exhibits, samples, models, equipment, or other items of valuable property; books, magazines, or other reference material; or documents routinely distributed by the Commission in the normal course of business such as copies of Federal Register notices, pamphlets, and laws. Official records include only existing records. Official records of the Commission made available under the requirements of the Freedom of Information Act (5 U.S.C. 552) shall be furnished to the public as prescribed by this part 1015. A request by an individual for records about himself or herself that are contained in the Commission’s system of records under the Privacy Act (5 U.S.C. 552a) will be processed under the Privacy Act and the FOIA. Documents routinely distributed to the public in the normal course of business will continue to be furnished to the public by employees of the Commission informally and without compliance with the procedures prescribed herein.
(b) The Commission’s policy with respect to requests for records is that disclosure is the rule and withholding is the exception. All records or portions of records not exempt from disclosure will be made available. Records which may be exempted from disclosure will be made available unless: Disclosure is prohibited by law; the Commission reasonably foresees that disclosure would harm an interest protected by an exemption described in 5 U.S.C. 552(b); or disclosure is exempted under 5 U.S.C. 552(b)(3). See § 1015.15(b). Section 6(a)(2) of the Consumer Product Safety Act, 15 U.S.C. 2055(a)(2), prohibits the disclosure of trade secrets or other matters referred to in 18 U.S.C. 1905; section 6(b) and section 25(c) of the CPSA. The Commission will consider the record’s age, content, and character in assessing whether it reasonably foresees that disclosure of the document would harm an interest protected by an exemption. Additionally, the Commission will consider whether partial disclosure of information is possible whenever the Commission determines that a full disclosure of a requested record is not possible and will take reasonable steps necessary to segregate and release nonexempt information.
(c) Assistant General Counsel, Office of the General Counsel, Division of the Secretariat is the designated Chief Freedom of Information Officer who, subject to the authority of the Chairman, is responsible for compliance with and implementation of 5 U.S.C. 552(j).
(d) The General Counsel is the designated authority for the Commission’s Freedom of Information Act (FOIA) appeals and is responsible for reviewing and responding to appeals from denials or partial denials of requests for records under this chapter.
§ 1015.2 Public inspection.
(a) The Consumer Product Safety Commission (CPSC) will maintain in a public reference room or area the materials relating to the CPSC that are required by 5 U.S.C. 552(a)(2) and 552(a)(5) to be made available for public inspection in an electronic format. The principal location will be in the Office of the General Counsel, Division of the Secretariat. The address of this office is: Office of the General Counsel, Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814.
(b) The CPSC will maintain an electronic reading room on the internet at: https://www.cpsc.gov for records that are required by 5 U.S.C. 552(a)(2) to be available by computer telecommunications. Records that the FOIA requires CPSC to make available for public inspection in an electronic format can be accessed through the CPSC’s FOIA web page, which is accessible by visiting: https://www.cpsc.gov.
(c) Subject to the requirements of section 6 of the Consumer Product Safety Act (CPSA), the CPSC will make available for public inspection in an electronic format, copies of all records, regardless of form or format, which:
(1) Have been released to any person under 5 U.S.C. 552(a)(3);
(2) Because of the nature of their subject matter, the FOIA Office determines have become or are likely to become the subject of subsequent requests for substantially the same records; or
(3) Have been requested three or more times.
§ 1015.3 Requests for records.
(a) A request for access to records of the Commission shall be in writing addressed to the Chief FOIA Officer and shall be submitted through any of the following methods: The e-FOIA Public Access Link at https://www.cpsc.gov; email to [email protected] mail to Consumer Product Safety Commission, 4330 East West Highway, Room 820, Bethesda, MD 20814; or facsimile to 301-504-0127. Any written request for records covered by this part shall be deemed to be a request for records pursuant to the Freedom of Information Act, whether or not the Freedom of Information Act is mentioned in the request. An oral request for records will not be considered a request for records pursuant to the Freedom of Information Act. Responses to oral requests for records shall be made as promptly as resources and time restraints permit.
(b) A request for access to records must reasonably describe the records requested. Where possible, specific information regarding dates, title, file designations, and other information which may help identify the records should be supplied by the requester. If the request relates to a matter in pending litigation, where the Commission is a party, the court and its location should be identified. Where the information supplied by the requester is not sufficient to permit identification and location of the records by Commission personnel without an unreasonable amount of effort, the requester will be contacted and asked to supply the necessary information. Every reasonable effort shall be made by Commission personnel to assist in the identification and location of requested records. Before submitting their requests, requesters may contact the Commission’s FOIA contact or FOIA Public Liaison to discuss the records they seek and to receive assistance in describing the records.
(c) If it is determined that a request would unduly burden or interfere with the operations of the Commission, the response shall so state and shall extend to the requester an opportunity to confer with appropriate Commission personnel in an attempt to reduce the request to manageable proportions by reformulation and by agreeing on an orderly procedure for the production of the records.
(d) If a requested record cannot be located from the information supplied, or is known to have been destroyed or otherwise disposed of, the requester shall be so notified by the Secretariat or delegate of the Chief FOIA Officer.
(e) The Consumer Product Safety Commission uses a multitrack system to process requests under the Freedom of Information Act that is based on the amount of work and/or time involved in processing requests. Requests for records are processed in the order they are received within each track. Upon receipt of a request for records, the Chief FOIA Officer or delegate of the Chief FOIA Officer will determine which track is appropriate for the request. The Chief FOIA Officer or delegate of the Chief FOIA Officer may contact requesters whose requests do not appear to qualify for the fastest tracks and provide such requesters the opportunity to limit their requests so as to qualify for a faster track. Requesters who believe that their requests qualify for the fastest tracks and who wish to be notified if the Chief FOIA Officer or delegate of the Chief FOIA Officer disagrees may so indicate in the request and, where appropriate and feasible, will also be given an opportunity to limit their requests.
§ 1015.4 Responses to requests for records; responsibility.
The ultimate responsibility for responding to requests for records is vested in the Chief FOIA Officer of the Consumer Product Safety Commission. The Chief FOIA Officer, or the delegate of the Chief FOIA Officer, can respond directly, or forward the request to any other office of the CPSC for response. The Chief FOIA Officer’s response shall be in the form set forth in § 1015.7(d), for action on appeal. If no response is made by the FOIA Office within 20 working days, or any extension of the 20-day period, the requester and the General Counsel or the delegate of the General Counsel can take the action specified in § 1015.7(e).
§ 1015.5 Time limitation on responses to requests for records and requests for expedited processing.
(a) The Chief FOIA Officer, or the delegate of the Chief FOIA Officer, shall respond to all written requests for records within twenty (20) working days (excepting Saturdays, Sundays, and legal public holidays). The time limitations on responses to requests for records submitted by mail shall begin to run at the time a request for records is received and date-stamped by the Office of the General Counsel, Division of the Secretariat. The Office of the General Counsel, Division of the Secretariat shall date-stamp the request the same day that it receives the request. The time limitations on responses to requests for records submitted electronically during working hours (8 a.m. to 4:30 p.m. EST) shall begin to run at the time the request was electronically received, and the time limitations on responses to requests for records submitted electronically during non-working hours will begin to run when working hours resume.
(b) The time for responding to requests for records can be extended by the Chief FOIA Officer at the initial stage, or by the General Counsel, at the appellate stage, up to an additional ten (10) working days, under the following unusual circumstances:
(1) The need to search for and collect the requested records from field facilities or other establishments that are separate from the Office of the General Counsel, Division of the Secretariat;
(2) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records that are demanded in a single request; or
(3) The need to consult, which shall be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request, or among two or more components of the CPSC having substantial subject matter interest.
(c) Any extension of time must be accompanied by written notice to the person making the request, setting forth the reason(s) for such extension, and the time within which a response is expected.
(d) If the Chief FOIA Officer at the initial stage, or the General Counsel at the appellate stage, determines that an extension of time greater than ten (10) working days is necessary to respond to a request satisfying the “unusual circumstances” specified in paragraph (b) of this section, the Chief FOIA Officer, or the General Counsel, shall notify the requester, and give the requester the opportunity to:
(1) Limit the scope of the request so that it may be processed within the time limit prescribed in paragraph (b) of this section; or
(2) Arrange with the Chief FOIA Officer, or the General Counsel, an alternative time frame for processing the request or a modified request.
(e) If an extension of time greater than ten (10) working days is necessary, the Commission shall make available its FOIA Public Liaison for this purpose. A list of the Commission FOIA Public Liaisons is available at https://www.cpsc.gov/Newsroom/FOIA. The Commission will also notify requesters in writing to the availability of the Office of Government Information Services of the National Archives and Records Administration to provide dispute resolution services.
(f) The Chief FOIA Officer, or the delegate of the Chief FOIA Officer, may aggregate and process as a single request, requests by the same requester, or a group of requesters acting in concert, if the Chief FOIA Officer, or delegate, reasonably believes that the requests actually constitute a single request that would otherwise satisfy the “unusual circumstances” specified in paragraph (b) of this section, and the requests involve clearly related matters.
(g) The Chief FOIA Officer, or the delegate of the Chief FOIA Officer, will provide expedited processing of requests in cases where the requester requests expedited processing and demonstrates a compelling need for such processing.
(1) The term “compelling need” means:
(i) That a failure to obtain requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or
(ii) With respect to a request made by a person primarily engaged in disseminating information, that there is an urgency to inform the public concerning actual or alleged Federal Government activity.
(2) Requesters for expedited processing must include in their requests, which may be submitted through any of the methods described in § 1015.3(a), a statement setting forth the basis for the claim that a “compelling need” exists for the requested information, certified by the requester to be true and correct to the best of his or her knowledge and belief.
(3) The Chief FOIA Officer or the delegate of the Chief FOIA Officer will determine whether to grant a request for expedited processing and will notify the requester of such determination within ten (10) calendar days of receipt of the request.
(4) Denials of requests for expedited processing may be appealed to the Office of the General Counsel, as set forth in § 1015.7. The General Counsel will determine expeditiously any such appeal.
(5) The Chief FOIA Officer, or the delegate of the Chief FOIA Officer, will process, as soon as is practicable, the documents responsive to a request for which expedited processing is granted.
(h) The Chief FOIA Officer may be unable to comply with the time limits set forth in paragraphs (a) through (d) of this section, when disclosure of documents responsive to a request under this part is subject to the requirements of section 6 of the Consumer Product Safety Act, 15 U.S.C. 2055, and the regulations implementing that section, 16 CFR part 1101. The Chief FOIA Officer, or the delegate of the Chief FOIA Officer, will notify requesters whose requests will be delayed for this reason.
§ 1015.6 Responses: Form and content.
(a) When a requested record has been identified and is available for disclosure, the requester shall be supplied with a copy or notified as to where and when the record will be made available for public inspection in an electronic format. If the payment of fees is required the requester shall be advised by the Chief FOIA Officer in writing of any applicable fees under § 1015.9 hereof. The requester will be notified of the right to seek assistance from the Commission’s FOIA Public Liaison.
(b) A response denying or partially denying a written request for a record shall be in writing, dated, and signed by the Chief FOIA Officer or delegate of the Chief FOIA Officer and shall include:
(1) The identity of each person responsible for the denial.
(2) A reference to the specific exemption or exemptions under the Freedom of Information Act authorizing the withholding of the record with a brief explanation of how the exemption applies to the record withheld; and
(3) An estimation of the volume of requested material withheld. When only a portion or portions of a document are withheld, the amount of information deleted shall be indicated on the released portion(s) of the record. When technically feasible, the indication of the amount of material withheld will appear at the place in the document where any deletion is made. Neither an estimation of the volume of requested material nor an indication of the amount of information deleted shall be included in a response if doing so would harm an interest protected by the exemption in 5 U.S.C. 552(b) pursuant to which the material is withheld.
(4) A statement that the denial can be appealed to the General Counsel, as specified in § 1015.1(d). Any such appeal must be made within 90 calendar days after the date of the denial or partial denial from the Chief FOIA Officer, or the delegate of the Chief FOIA Officer.
(5) A statement that the requester has the right to seek dispute resolution services from the Commission’s FOIA Public Liaison or the Office of Government Information Services.
(c) If no response is made within twenty (20) working days or any extension thereof, the requester can consider his or her administrative remedies exhausted and seek judicial relief in a United States District Court as specified in 5 U.S.C. 552(a)(4)(B). When it appears that no response can be made to the requester within the applicable time limit, the Chief FOIA Officer or delegate of the Chief FOIA Officer may ask the requester to forego judicial relief until a response can be made. The Chief FOIA Officer or delegate of the Chief FOIA Officer shall inform the requester of the reason for the delay, of the date on which a response may be expected and of his/her right to seek judicial review as specified in 5 U.S.C. 552(a)(4)(B).
§ 1015.7 Appeals from initial denials.
(a) When the Chief FOIA Officer, or the delegate of the Chief FOIA Officer, has denied a request for records, in whole or in part, the requester can, within 90 calendar days after the date of the denial or partial denial, appeal the denial to the General Counsel of the Consumer Product Safety Commission, attention: Division of the Secretariat. Appeals may be submitted through any of the following methods: the e-FOIA Public Access Link at https://www.cpsc.gov; email to: [email protected]; U.S. mail to: 4330 East-West Highway, Room 820, Bethesda, MD 20814; or by facsimile to: 301-504-0127. To facilitate handling, the requester should mark both the appeal letter and envelope, or subject line of the electronic transmission, “Freedom of Information Act Appeal.”
(b) The General Counsel will act upon an appeal within 20 working days of its receipt. The time limitations on an appeal submitted by mail shall begin to run at the time an appeal is received and date-stamped by the Division of the Secretariat. The Division of the Secretariat will date-stamp the appeal the same day that it receives the appeal. The time limitations on an appeal submitted electronically during working hours (8 a.m. to 4:30 p.m. EST) shall begin to run at the time the appeal is received electronically; and the time limitations on appeals submitted electronically during non-working hours will begin to run when working hours resume.
(c) After reviewing the appeal, the General Counsel will issue a decision either to grant or deny the appeal, in whole or in part. If the General Counsel decides to grant the appeal in whole or in part, the General Counsel will inform the requester and submitter of the information, in accordance with §§ 1015.6(a) and 1015.18(b). Thereafter, the Chief FOIA Officer will provide the records in accordance with the General Counsel’s decision.
(d) The General Counsel shall have the authority to grant or deny all appeals and, as an exercise of discretion, to disclose records exempt from mandatory disclosure under 5 U.S.C. 552(b). In unusual or difficult cases, the General Counsel can, in his/her discretion, refer an appeal to the Chairman for determination.
(e) The General Counsel’s decision on appeal shall be in writing, shall be signed by the General Counsel, and shall constitute final agency action. A denial in whole or in part of a request on appeal shall set forth the exemption relied upon; a brief explanation, consistent with the purpose of the exemption, of how the exemption applies to the records withheld; and the reasons for asserting it. The decision will inform the requester of the right to seek dispute resolution services from CPSC’s FOIA Liaison, or the Office of Government Information Services. A denial in whole or in part shall also inform the requester of his/her right to seek judicial review of the General Counsel’s final determination in a United States district court, as specified in 5 U.S.C. 552(a)(4)(B).
(f) If no response is made to the requester within 20 working days or any extension thereof, the requester may consider his/her administrative remedies exhausted and seek judicial relief in a United States district court. When no response can be made within the applicable time limit, the General Counsel shall inform the requester of the reason for the delay, of the date by which a response may be expected, and of the requester’s right to seek judicial review as specified in 5 U.S.C. 552(a)(4)(B).
(g) Copies of all appeals and copies of all actions on appeal shall be furnished to and maintained in a public file by the Office of the General Counsel, Division of the Secretariat.
§ 1015.8 Requests received during the course of administrative hearings. [Reserved]
§ 1015.9 Fees for production of records.
(a) The CPSC will provide, at no charge, certain routine information. For other CPSC responses to information requests, the Chief FOIA Officer, or the delegate of the Chief FOIA Officer, shall determine and levy fees for duplication, search, review, and other services, in accordance with this section.
(b) Fees shall be paid to the Treasury of the United States according to the directions provided by the Commission.
(c) The following definitions shall apply under this section:
(1) Direct costs means those expenditures which an agency actually incurs in searching for and duplicating (and in the case of commercial requesters, reviewing) documents to respond to a FOIA request.
(2) Search includes all time spent looking for material that is responsive to a request, including page-by-page or line-by-line identification of material within documents and the reasonable efforts expended to locate and retrieve information from electronic records.
(3) Duplication refers to the process of making a copy of a document, including electronically, necessary to respond to a FOIA request. The Commission will honor the requester’s preference for receiving a record in a particular format when it can readily reproduce it in the form or format requested.
(4) Review refers to the process of examining documents located in response to a commercial use request to determine whether any portion of any document located is permitted to be withheld.
(5) Commercial use request refers to a request that seeks information for a use or purpose that furthers commercial, trade, or profit interests.
(6) Educational institution refers to an entity organized and operated exclusively for educational purposes, whose purpose is scholarly.
(7) Non-commercial scientific institution refers to an entity organized and operated exclusively for the purpose of conducting scientific research, the results of which are not intended to promote any particular product or industry.
(8) Representative of the news media refers to any person or entity that gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into a distinct work, and distributes that work to an audience. The term “news” means information that is about current events or that would be of current interest to the public. Examples of news media entities include television or radio stations that broadcast “news” to the public at large and publishers of periodicals that disseminate “news” and make their products available through a variety of means to the general public, including news organizations that disseminate solely on the Internet. A request for records supporting the news-dissemination function of the requester will not be considered to be for a commercial use. “Freelance” journalists who demonstrate a solid basis for expecting publication through a news media entity will be considered as a representative of the news media. A publishing contract would provide the clearest evidence that publication is expected; however, the Commission can also consider a requester’s past publication record in making this determination. These examples are not all-inclusive.
(d) A commercial use request may incur charges for duplication, search, and review. The following requests may incur charges only for duplication: A request from an educational institution for records not sought for commercial use; a request from a non-commercial scientific institution for records not sought for commercial use; a request from a representative of the news media. Any other request may incur charges for duplication and search.
(e) The following fee schedule will apply:
(1) Duplication. (i) Manual photocopies: $0.15 per page.
(ii) Computer printouts that are sent from a computer to a printer or photocopier machine: $0.15 per page.
(iii) Compact discs, DVDs, or other similar media duplications: Direct-cost basis. The exact fees for duplication of records on these forms of media will be calculated and published annually and are available to the public on the CPSC’s FOIA web page at: https://www.cpsc.gov, and from the Office of the General Counsel, Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814.
(iv) There is no duplication fee for producing records provided to requesters in electronic format, or for pages redacted in full in any format.
(v) Requesters can request and be provided records in any format that is readily reproducible by the agency, including electronic format.
(vi) When records available only in paper format must be scanned to comply with a requester’s preference to receive records in an electronic format, the requester must pay the direct costs of scanning those materials. The exact fees for scanning these materials will be assessed on a quarter-hour basis, will be calculated and published annually, and are available to the public on the CPSC’s FOIA web page at: https://www.cpsc.gov, and from the Office of the General Counsel, Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814.
(2) Searches. Fees for searches are assessed on a quarter-hour basis. The exact fees for searches are calculated and published annually and are available to the public on the CPSC’s FOIA web page at: https://www.cpsc.gov, and from the Office of the General Counsel, Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814.
(i) Manual file searches. Manual search fees are calculated using the basic hourly pay rate of the average grade and step of employees who charged hours in this category (GS 14/7), plus 16 percent to account for the cost of benefits.
(ii) Computer searches. Computer search fees are calculated using the basic hourly pay rate of the average grade and step of employees who charged hours in this category (GS 12/4), plus 16 percent to account for the cost of benefits.
(3) Review. Fees for review are assessed on a quarter-hour basis. The exact fee for review is calculated and published annually and is available to the public on the CPSC’s FOIA web page at: https://www.cpsc.gov and from the Office of the General Counsel, Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814. The review fee is calculated using the basic hourly pay rate of the average grade and step of employees who charged hours in this category (GS 12/9), plus 16 percent to account for the cost of benefits. Fees for reviewing records will only be charged to commercial requesters.
(4) Postage. If the requester wants special handling, or if the volume or dimensions of the materials requires special handling, the FOIA Office will charge the direct cost of mailing such requested materials.
(5) Other charges. (i) Materials requiring special reproducing or handling, such as photographs, slides, blueprints, video and audio tape recordings, or other similar media: Direct-cost basis.
(ii) Any other service: Direct-cost basis.
(f) Notice of anticipated fees in excess of $25:
(1) When the FOIA Office determines or estimates that the fees to be assessed will exceed $25, the FOIA Office shall promptly notify the requester of the actual or estimated amount of the fees, including a breakdown of the fees for search, review, and duplication, if applicable, and any applicable fee waivers that would apply to the request, unless the requester has indicated a willingness to pay fees as high as those anticipated. The notice shall specify that the requester may confer with agency staff with the objective of reformulating the request to meet the requester’s needs at a lower cost. If only a portion of the fee can be estimated readily, the FOIA Office will advise the requester, accordingly. If the request is not from a commercial use requester, the notice shall specify that the requester is entitled to 100 pages of duplication at no charge, and if the requester is charged search fees, 2 hours of search time at no charge.
(2) When a requester has been provided notice of anticipated fees in excess of $25, the FOIA Office shall toll processing of the request, and further work will not be completed until the requester commits in writing to pay the actual or estimated total fee, or designates the amount of fees the requester is willing to pay. In the case of a requester who is not a commercial requester, the requester may designate that the requester seeks only those services that can be provided in paragraphs (g)(2) and (3) of this section, without charge. The CPSC is not required to accept payment in installments.
(3) If the requester has committed to pay a designated amount of fees, but the FOIA Office determines or estimates that the total fee will exceed that amount, the FOIA Office shall toll processing of the request and notify the requester of the actual or estimated fees in excess of the requester’s commitment. The FOIA Office shall inquire whether the requester wishes to revise the amount of fees the requester is willing to pay or wishes to modify the request. Once the requester responds, the administrative time limits in § 1015.5 will resume.
(4) The Chief FOIA Officer shall make available the FOIA Public Liaison to assist requesters in reformulating a request to meet the requester’s needs at a lower cost.
(5) If a requester does not commit in writing to pay the actual or estimated total fee or designate in writing the amount of fees the requester is willing to pay within 30 working days from the date of the notification letter, the request shall be closed. The FOIA Office shall notify the requester that the request has been closed.
(6) Any adverse determination made by the Chief FOIA Officer, or the designee of the Chief FOIA Officer, concerning a dispute over actual or estimated fees can be appealed by the requester to the General Counsel, in the manner described at § 1015.7.
(g)(1) There are three categories of requesters: Commercial; educational institutions, noncommercial scientific institutions, and representatives of the news media; and all other requesters, including members of the general public.
Table 1 to Paragraph
| Requester category | Search | Review | Duplication |
|---|---|---|---|
| Commercial (including law firms) | Fee | Fee | Fee. |
| Educational, noncommercial scientific institutions, or news media | No Fee | No Fee | Fee after first 100 pages. |
| All other requesters (including members of the general public) | Fee After First 2 Hours | No Fee | Fee after first 100 pages. |
(2) Fees shall be assessed as follows:
(i) Full fees shall apply to commercial-use requests.
(ii) The first 100 pages of duplication shall be free for requests from the categories of educational institutions, noncommercial scientific institutions, representatives of the news media, and all other requesters (including members of the general public).
(iii) The first 2 hours of search time shall be free for the category of all other requesters (including members of the general public).
(iv) The Chief FOIA Officer, or the designee of the Chief FOIA Officer, shall waive or reduce fees whenever disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government, and disclosure of the requested information is not primarily in the commercial interest of the requester.
(v) In making a determination under paragraph (g)(2)(iv) of this section, the Chief FOIA Officer, or the designee of the Chief FOIA Officer, shall consider the following factors:
(A) The subject of the request: Whether the subject of the requested records concerns the operations or activities of the Government.
(B) The informative value of the information to be disclosed: Whether the disclosure is likely to contribute to an understanding of Government operations or activities.
(C) The contribution to an understanding of the subject by the general public likely to result from disclosure: Whether disclosure of the requested information will contribute to public understanding.
(D) The significance of the contribution to public understanding: Whether the disclosure is likely to contribute significantly to public understanding of Government operations or activities.
(E) The existence and magnitude of a commercial interest: Whether the requester has a commercial interest that would be furthered by the requested disclosure; and, if so
(F) The primary interest in disclosure: Whether the magnitude of the identified commercial interest of the requester is sufficiently large, in comparison with the public interest in disclosure, that disclosure is primarily in the commercial interest of the requester.
(vi) Search fees shall not be charged for all requests and duplication fees shall not be charged for requests from educational institutions, noncommercial scientific institutions, and representatives of the news media, if the FOIA Office fails to comply with any time limit under §§ 1015.5(a) and (g)(3) and 1015.7(b) and 5 U.S.C. 552(a)(6), other than the exceptions stated in 5 U.S.C. 552(a)(4)(A)(viii)(ll). Those exceptions include:
(A) If the FOIA Office has determined that “unusual circumstances,” as defined in § 1015.5(b) apply, and the FOIA Office provided timely written notice to the requester, as required by § 1015.5(c) or § 1015.7(f), then failure to comply with the time limit in §§ 1015.5(a) and (g)(3) and 1015.7(b) and 5 U.S.C. 552(a)(6) is excused for 10 additional working days; or
(B) If the FOIA Office has determined that “unusual circumstances,” as defined in § 1015.5(b), apply and more than 5,000 pages are necessary to respond to the request, and the FOIA Office has provided timely written notice in accordance with § 1015.5(c) and (e), and the FOIA Office has discussed with the requester via written mail, email, or telephone (or has made not less than three good-faith efforts to do so), how the requester could effectively limit the scope of the request; or
(C) If a court has determined that exceptional circumstances exist, as defined in 5 U.S.C. 552(a)(6)(C), then failure to comply with §§ 1015.5(a) and (g)(3) and 1015.7(b) and 5 U.S.C. 552(a)(6) shall be excused for the length of time provided by the court order.
(vii) No fee will be charged when the total fee is equal to or less than $25.
(viii) Any determination made by the Chief FOIA Officer, or the designee of the Chief FOIA Officer, concerning fee reductions or fee waivers may be appealed by the requester to the General Counsel, in the manner described at § 1015.7.
(h) Collection of fees shall be in accordance with the following:
(1) Interest will be charged on amounts billed, starting on the 31st day following the day on which the requester receives the bill. Interest will be charged at the rate prescribed in 31 U.S.C. 3717.
(2) Search fees may be charged, even if no responsive documents are located, or if the search leads to responsive documents that are withheld under an exemption to the Freedom of Information Act.
(3) The FOIA Office may aggregate requests, for the purposes of billing, whenever it reasonably believes that a requester, or, on rare occasions, a group of requesters, is attempting to separate a request into more than one request to evade fees. The FOIA Office shall not aggregate multiple requests on unrelated subjects from one requester.
(i)(1) For requests other than those described in paragraphs (i)(2) and (3) of this section, the FOIA Office shall not require a requester to make advance payment (i.e., payment made before the FOIA Office commences or continues work on a request). Payment owed for work already completed (i.e., payment before copies are sent to a requester) does not constitute an advance payment for purposes of this part.
(2) When the FOIA Office determines or estimates that a total fee to be charged under this section will exceed $250, and the requester has no history of payment, the FOIA Office shall notify the requester of the actual or estimated fee, and may require the requester to make an advance payment of the entire anticipated fee before beginning to process the request. A notice under this paragraph (i)(2) shall offer the requester an opportunity to discuss the matter with FOIA Office staff to modify the request to meet the requester’s needs at a lower cost.
(3) When a requester has previously failed to pay a properly charged FOIA fee to the CPSC within 30 calendar days of the date of billing, the FOIA Office may notify the requester that the requester is required to pay the full amount owed, plus any applicable interest, and to make an advance payment of the full amount of any anticipated fee, before the FOIA Office begins to process a new request or continues processing a pending request from that requester.
(4) When the CPSC FOIA Office requires advance payment, the FOIA Office will not further process the request until the required payment is made. The FOIA Office will toll the processing of the request while it notifies the requester of the advanced payment due, and the administrative time limits in § 1015.5 will begin only after the agency has received the advance payments. If the requester does not pay the advance payment within 30 calendar days from the date of the FOIA Office’s fee notice, the FOIA Office will presume that the requester is no longer interested in the records and notify the requester that the request has been closed.
§ 1015.10 [Reserved]
§ 1015.11 Disclosure of trade secrets to consultants and contractors; nondisclosure to advisory committees and other government agencies.
(a) In accordance with section 6(a)(2) of the CPSA, the Commission may disclose information which it has determined to be a trade secret or other matter referred to under 5 U.S.C. 552(b)(4) to Commission consultants and contractors for use only in their work for the Commission. Such persons are subject to the same restrictions with respect to disclosure of such information as any Commission employee.
(b) In accordance with section 6(a)(2) of the CPSA, the Commission is prohibited from disclosing information which it has determined to be a trade secret or other matter referred to under 5 U.S.C. 552(b)(4) to advisory committees, except when required in the official conduct of their business, or to other Federal agencies and state and local governments except when permitted by the provisions of section 29(f) of the CPSA.
§ 1015.12 Disclosure to Congress.
(a) All records of the Commission shall be disclosed to Congress upon a request made by the chairman or ranking minority member of a committee or subcommittee of Congress acting pursuant to committee business and having jurisdiction over the matter about which information is requested.
(b) An individual member of Congress who requests a record for his or her personal use or on behalf of any constituent shall be subject to the same rules that apply to members of the general public.
Subpart B—Exemptions From Production and Disclosure Under 5 U.S.C. 552(b)
§ 1015.15 Purpose and scope.
(a) The regulations of this subpart provide information concerning the types of records which may be withheld from production and disclosure by the Consumer Product Safety Commission. These regulations also provide information on the method whereby persons submitting information to the Commission may request that the information be considered exempt from disclosure, and information concerning the Commission’s treatment of documents submitted with a request that they be treated as exempt from disclosure.
(b) No identifiable record requested in accordance with the procedures contained in this part shall be withheld from disclosure unless it falls within one of the classes of records exempt under 5 U.S.C. 552(b). The Commission will make available, to the extent permitted by law, records authorized to be withheld under 5 U.S.C. 552(b) unless the Commission reasonably foresees that disclosure would harm an interest protected by the exemption or disclosure is prohibited by law or otherwise exempted from disclosure under 5 U.S.C. 552(b)(3). In this regard the Commission will not ordinarily release documents that provide legal advice to the Commission concerning pending or prospective litigation where the release of such documents would significantly interfere with the Commission’s regulatory or enforcement proceedings.
(c) Draft documents that are agency records are subject to release upon request in accordance with this regulation. However, in order to avoid any misunderstanding of the preliminary nature of a draft document, each draft document released will be marked to indicate its tentative nature. Similarly, staff briefing packages, which have been completed but not yet transmitted to the Commission by the Office of the Secretariat are subject to release upon request in accordance with this regulation. Each briefing package or portion thereof released will be marked to indicate that it has not been transmitted to or acted upon by the Commission. In addition, briefing packages, or portions thereof, which the Secretariat upon the advice of the Office of the General Counsel has determined would be released upon request in accordance with this regulation, will be made available for public inspection in an electronic format through the Commission’s Web site at https://www.cpsc.gov promptly after the briefing package has been transmitted to the Commissioners by the Office of the Secretariat. Such packages will be marked to indicate that they have not been acted upon by the Commission.
(d) The exemptions contained in 5 U.S.C. 552(b) will be interpreted in accordance with the applicable law at the time a request for production or disclosure is considered.
§§ 1015.16-1015.17 [Reserved]
§ 1015.18 Information submitted to the Commission; request for treatment as exempt material.
(a) A person who is submitting information to the Commission, after being notified by the Commission of his/her opportunity to request confidential treatment for information, must accompany the submission with a request that the information be considered exempt from disclosure or indicate that a request will be submitted within 10 working days of the submission. The failure to make a request within the prescribed time limit will be considered an acknowledgment that the submitter does not wish to claim exempt status.
(b) A person who has previously submitted information to the Commission, that is now the subject of a Freedom of Information request, after being notified by the Commission of his/her opportunity to request confidential treatment for the information, must submit a request that the information be considered exempt from disclosure within 5 working days from receipt of notification. The failure to make a request within the prescribed time limit will be considered an acknowledgment that the submitter does not wish to claim exempt status.
(c) Each request for exemption from disclosure under 5 U.S.C. 552(b)(4) as a trade secret or privileged or confidential commercial or financial information must:
(1) Specifically identify the exact portion(s) of the document claimed to be confidential;
(2) State whether the information claimed to be confidential has ever been released in any manner to a person who was not an employee or in a confidential relationship with the company;
(3) State whether the information so specified is commonly known within the industry or is readily ascertainable by outside persons with a minimum of time and effort;
(4) State how release of the information so specified would be likely to cause substantial harm to the company’s competitive position; and
(5) State whether the submitter is authorized to make claims of confidentiality on behalf of the person or organization concerned.
(d) Material received with a request that it be considered exempt shall not be maintained in a public file. If, in complying with a request for the disclosure of records, it is determined that some or all of the material relative to the request has been claimed to be exempt from disclosure, the requester will be supplied with a list of this material and informed that those portions found not to be exempt will be made available as soon as possible.
(e) No request for exemption from disclosure under 5 U.S.C. 552(b)(4) should be made by any person who does not intend in good faith to assist the Commission in the defense of any judicial proceeding that might thereafter be brought to compel the disclosure of information which the Commission has determined to be a trade secret or privileged or confidential commercial or financial information.
§ 1015.19 Decisions on requests for exemption from disclosure under 5 U.S.C. 552(b)(4).
(a) The Commission generally will not decide whether material received with a request for exemption from disclosure under 5 U.S.C. 552(b)(4) is entitled to be withheld until a request for production or disclosure is made for that information. The determination will be based on the most authoritative judicial interpretations available at the time a request for disclosure or production is considered. Any reasonably segregable portion of a record will be disclosed to any person requesting such record after deletion of any portions determined to be exempt under 5 U.S.C. 552(b)(4). The requester will be given a brief description of any information found to be exempt.
(b) If material received with a request for exemption from disclosure under 5 U.S.C. 552(b)(4) is found to be disclosable, in whole or in part, the person submitting the material will be notified in writing and given 10 calendar days from the receipt of the letter to seek judicial relief. In no event, however, will the material be returned to the person submitting it.
Subpart C—Disclosure of Commission Accident or Investigation Reports Under 15 U.S.C. 2074(c)
§ 1015.20 Public availability of accident or investigation reports.
(a) Accident or investigation reports made by an officer, employee, or agent of the Commission are available to the public under the procedures set forth in subpart A of this part 1015 unless such reports are subject to exemptions contained in the Freedom of Information Act (5 U.S.C. 552(b)) except that portions identifying any injured person or any person treating such injured person will be deleted in accordance with section 25(c)(1) of the CPSA. Where disclosure of an accident or investigation report is requested by supplying the name of the person injured or other details of a specific accident (other than cases where the report is requested by the injured person or the injured person’s legal representative), the Commission will offer to obtain the written consent of the injured party or the injured party’s representative to the disclosure of the report without deleting the party’s identity. No deletion of identifying portions of such reports or refusal to disclose without the Commission having first obtained written consent shall be considered as a denial by the Commission of disclosure of Commission records.
(b) Research reports, demonstration reports, and reports of other related activities of the Commission are available to the public under the procedures set forth in subpart A of this part 1015.
PART 1016—POLICIES AND PROCEDURES FOR INFORMATION DISCLOSURE AND COMMISSION EMPLOYEE TESTIMONY IN PRIVATE LITIGATION
§ 1016.1 Purpose and policy.
(a) The Commission’s policy is to make official records available to private litigants, to the fullest extent possible.
(b) The Commission’s policy and responsibility is to conserve the time of its employees for work on Commission projects and activities. Participation of Commission employees in private litigation, in their official capacities, is generally contrary to this policy and responsibility. In addition, such participation could impair the effectiveness of Commission employees as witness in litigation in which the Commission is directly involved.
§ 1016.2 Definition.
Private litigation refers to any legal proceeding which does not involve the United States government, or any department or agency of the U.S. government, as a party.
§ 1016.3 Disclosure and certification of information and records.
(a) Identifiable information and records in the Commission’s possession will be made available to private litigants in accordance with the Commission’s Procedures for Disclosure or Production of Information under the Freedom of Information Act (16 CFR part 1015), the Freedom of Information Act (5 U.S.C. 552), sections 6 and 25(c) of the Consumer Product Safety Act (15 U.S.C. 2055 and 2074(c)), and any other applicable statutes or regulations.
(b) The Secretary of the Commission shall certify the authenticity of copies of Commission records. Requests must be in writing and must include the records to be certified. Requests should be sent to: Secretary, Consumer Product Safety Commission, Washington, DC 20207.
(c) Any subpoena duces tecum served on a Commission employee will be handled by the Office of the Secretary in conjunction with the Office of the General Counsel. Whenever necessary to prevent the improper disclosure of documents, the General Counsel will take steps, in conjunction with the Department of Justice, to quash such subpoenas or seek protective orders.
§ 1016.4 Testimony of Commission employees in private litigation.
(a) No Commission employee shall testify in his or her official capacity in any private litigation, without express authorization from the Commission’s General Counsel. The Commission may, in its discretion, review a decision by the General Counsel to authorize such employee testimony. The General Counsel shall in such instances, where time permits, advise the Commission, on a no objection basis, of the authorization of such employee testimony.
(b) If any Commission employee is served with a subpoena seeking testimony in private litigation, he or she must immediately notify the Office of the General Counsel. The Office of the General Counsel, in conjunction with the Department of Justice, will (1) take steps to quash the subpoena or (2) direct the employee to appear in response to the subpoena but refuse to testify on the ground that it is prohibited by this section.
(c) If the General Counsel becomes aware of private litigation in which testimony by a Commission employee would be in the interests of the Commission, he or she may authorize such testimony, notwithstanding paragraph (b) of this section. The Commission may, in its discretion, review a decision by the General Counsel to authorize such employee testimony. The General Counsel shall in such instances, where time permits, advise the Commission, on a no objection basis, of the authorization of such employee testimony. Any such testimony must be provided in a way that minimizes the use of Commission resources as much as possible.
PART 1017 [RESERVED]
PART 1018—ADVISORY COMMITTEE MANAGEMENT
Subpart A—General Provisions
§ 1018.1 Purpose.
This part contains the Consumer Product Safety Commission’s regulations governing the establishment, operations and administration of advisory committees under its jurisdiction. These regulations are issued pursuant to section 8(a) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App. I), and supplement Executive Order No. 11769 (39 FR 7125 (1974)) and Office of Management and Budget Circular No. A-63 (Rev.) (39 FR 12369 (1974)).
§ 1018.2 Definitions.
(a) Advisory Committee Act or Act means the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App. I (1974)).
(b) OMB Circular No. A-63 means Office of Management and Budget Circular No. A-63 (Rev.), entitled “Advisory Committee Management” (39 FR 12369, April 5, 1974), as amended.
(c) Advisory Committee means any committee, board, commission, council, conference, panel, task force or other similar group, or any subcommittee or other subgroup, thereof, which is established or used by the Commission in the interest of obtaining advice or recommendations and which is not composed wholly of full-time officers or employees of the Federal Government.
(d) Statutory advisory committee means an advisory committee established or directed to be established by Congress.
(e) Non-statutory advisory committee means an advisory committee established by the Commission, including a committee which was authorized, but not established by Congress.
(f) Ad hoc advisory committee means a non-continuing, non-statutory advisory committee established by the Commission for the stated purpose of providing advice or recommendations regarding a particular problem which must be resolved immediately or within a limited period of time.
(g) Non-Commission established advisory committee means an advisory committee established by a Federal, State, or local instrumentality other than the Commission, or by a private organization or group and utilized by the Commission for advisory services.
(h) GSA Secretariat means the Committee Management Secretariat of the General Services Administration.
(i) Chairman means the Chairman of the Consumer Product Safety Commission.
§ 1018.3 Policy.
In application of this part, Commission officials shall be guided by the Advisory Committee Act, the statutes creating the Commission’s advisory committees, and by the directives in Executive Order No. 11769 and OMB Circular No. A-63. Principles to be followed include:
(a) Limiting the number of advisory committees to those that are essential and terminating any committee not fulfilling its purpose;
(b) Insuring effective use of advisory committees and their recommendations, while assuring that decisional authority is retained by the responsible Commission officers;
(c) Providing clear goals, standards, and uniform procedures with respect to the establishment, operation, and administration of advisory committees;
(d) Ensuring that adequate information is provided to the public regarding advisory committees; and
(e) Ensuring adequate opportunities for access by the public to advisory committee meetings and information.
§ 1018.4 Applicability.
(a) This part shall apply to all advisory committees (whether statutory or non-statutory) subject to the jurisdiction of the Commission. This part also shall apply to ad hoc advisory committees and non-Commission established advisory committees when they are performing advisory services for the Commission.
(b) Nothing in this part shall apply to any of the following types of organizations:
(1) Any local civic group whose primary function is that of rendering a public service with respect to a Federal program;
(2) Any state or local government committee, council, board, commission, or similar group established to advise or make recommendations to State or local officials or agencies;
(3) Any committee whether advisory, interagency, or intraagency which is composed wholly of full-time officers or employees of the Federal Government;
(4) Persons or organizations having contractual relationships with the Commission; and
(5) Persons or organizations developing consumer product safety standards under section 7 of the Consumer Product Safety Act (15 U.S.C. 2056).
(c) This part shall not apply to a committee or other group to the extent that it is specifically exempted by statute from the Federal Advisory Committee Act.
§ 1018.5 Advisory Committee Management Officer.
The Chairman shall designate an Advisory Committee Management Officer who shall:
(a) Exercise control and supervision over the establishment, procedures, and accomplishments of all advisory committees established or utilized by the Commission;
(b) Assemble and maintain the reports, records, and other papers of any such committee during its existence, and carry out, on behalf of the Secretary of the Commission, the provisions of section 552 of Title 5, United States Code (Freedom of Information Act) and the Commission’s Procedures for Disclosure or Production of Information Under the Freedom of Information Act (16 CFR part 1015) with respect to such reports, records, and other papers; and
(c) Perform such other functions as specified in this part.
Subpart B—Establishment of Advisory Committees
§ 1018.11 Charters.
(a) No advisory committee shall meet or take any action until its charter has been filed with the GSA Secretariat in accordance with the requirements of section 9(c) of the Federal Advisory Committee Act.
(b) The Advisory Committee Management officer shall have responsibility for the preparation and filing of charters.
§ 1018.12 Statutory advisory committees.
The Commission has one statutory advisory committee subject to the Federal Advisory Committee Act. The Toxicological Advisory Board was established by the Commission on December 22, 1978, pursuant to section 20 of the Federal Hazardous Substances Act, as amended (Pub. L. 95-631, 92 Stat. 3747, 15 U.S.C. 1275).
§ 1018.13 Non-statutory advisory committees.
(a) In proposing to establish a non-statutory advisory committee, the Commission shall follow the procedural requirements of section 9(a)(2) of the Advisory Committee Act and section 6(a) of OMB Circular No. A-63.
(b) A non-statutory advisory committee shall not be established if the proposed function can be performed effectively by Commission personnel, by an existing advisory committee, or by another Federal agency.
§ 1018.14 Non-Commission established advisory committees.
(a) To the extent practicable, the Commission shall utilize advisory committees already established by Federal, State, or local government or by private organizations, rather than establish a new advisory committee or expand the functions of an existing Commission advisory committee.
(b) In utilizing a non-Commission established advisory committee, Commission officials shall follow the applicable provisions of this part and the requirements of the Advisory Committee Act.
§ 1018.15 Membership composition.
The Toxicological Advisory Board, as specified in section 20 of the Federal Hazardous Substances Act, as amended (Pub. L. 95-631, 92 Stat. 3747, 15 U.S.C. 1275), shall be composed of nine members appointed by the Commission. Each member of the Board shall be qualified by training and experience in one or more fields applicable to the duties of the Board, and at least three of the members of the Board shall be members of the American Board of Medical Toxicology. The Commission will seek a balanced membership, including individuals representative of consumers, government and industry.
§ 1018.16 Membership selection.
(a) Whenever new applicants are required for a Commission advisory committee, public notice will be issued in the
(b) An applicant for membership on an advisory committee shall disclose all affiliations, either paid or as a volunteer, that bear any relationship to the subject area of product safety or to membership on the advisory committee. This disclosure shall include both current affiliations and relevant past affiliations.
(c) The Secretary of the Commission shall, from time to time, appoint a Candidate Evaluation Panel consisting of qualified, staff members of the Commission, including the Advisory Committee Management Officer.
(d) The Candidate Evaluation Panel, using selection criteria established by the Commission, shall evaluate all candidates and submit to the Commissioners the names of those candidates it recommends for membership. Where possible, at least three candidates shall be recommended for each appointment to be made. Final selection for membership shall be made by the Commissioners.
(e) The membership of each Commission Advisory Committee shall be fairly balanced in terms of geographic location, age, sex, and race.
§ 1018.17 Appointments.
(a) The Chairman shall appoint as members to advisory committees those persons selected by the Commissioners.
(b) The term of appointment to an advisory committee shall be for two years, unless otherwise specified by the Commission. To promote maximum participation, an advisory committee member may serve for only one consecutive full term. This subsection shall not be deemed to affect the term of appointment of any present member of an advisory committee in effect on the original effective date of this part, September 24, 1975.
(c) A vacancy that occurs during the term of an appointment normally will be filled by the Commission from the applications or nominations on file. Appointment to any such vacancy will be for the unexpired portion of the original appointment. Appointees to such an unexpired term may be reappointed for a full two-year term.
(d) Notwithstanding paragraphs (b) and (c) above, members of the Toxicological Advisory Board shall be appointed for terms of three years. Members may be reappointed for a subsequent three-year term. Any vacancy on the Board shall be filled in the same manner in which the original appointment was made. Any person appointed to fill a vacancy occurring before the expiration of the term for which his or her predecessor was appointed shall serve only for the remainder of such term.
Subpart C—Operation of Advisory Committees
§ 1018.21 Calling of meetings.
Advisory committees shall, as a general rule, meet four times per year, except that, as provided by statute, the Toxicological Advisory Board shall meet not less than two times each year. No advisory committee shall hold a meeting without advance approval of the Chairman or the Commission official designated under § 1018.23(a). Before giving such advance approval, the Chairman or Commission official shall notify the Commission of the date of the proposed meeting.
§ 1018.22 Notice of meetings.
(a) Meetings shall be called by written and/or oral notice to all members of the advisory committee.
(b) Notice of each advisory committee meeting shall be published in the
(c) A meeting notice shall include:
(1) The official designation of the committee;
(2) The address and site of the meeting;
(3) The time of the meeting;
(4) The purpose of the meeting, including where appropriate, a summary of the agenda;
(5) Whether, or the extent to which, the public will be permitted to attend or participate;
(6) An explanation of how any person who wishes to do so may file a written statement with the committee before, during, or after the meeting; and
(7) The procedure by which a public attendee may present an oral statement or question to members of the committee.
§ 1018.23 Designated Commission employee.
(a) The Chairman shall designate a member of the Commission or other Commission officer or employee to chair or attend each meeting of each advisory committee.
(b) Unless otherwise provided in the statute creating a statutory advisory committee, the committee normally will be chaired, on a rotating basis, by a member of the Commission.
(c) No advisory committee shall conduct any meeting in the absence of the officer or employee designated under paragraph (a) of this section.
(d) The officer or employee designated under paragraph (a) of this section is authorized to adjourn any advisory committee meeting whenever he or she determines adjournment to be in the public interest.
§ 1018.24 Agenda.
Prior to each advisory committee meeting, the Advisory Committee Management Officer shall prepare and, after approval by the officer or employee designated under § 1018.23 (a), shall distribute to each committee member the agenda for that meeting. The agenda for a meeting shall list the matters to be discussed at the meeting and shall indicate whether and when any part of the meeting will concern matters which are exempt from public disclosure under the Freedom of Information Act (5 U.S.C. 552(b) or section 6(a)(2) of the Consumer Product Safety Act (15 U.S.C. 2045(a)(2)).
§ 1018.25 Minutes and meeting reports.
(a) The Advisory Committee Management Officer shall be responsible for the preparation of detailed minutes of each meeting of each advisory committee. The minutes shall include at least the following:
(1) The time and place of the meeting;
(2) A list of advisory committee members and staff and Commission employees present at the meeting;
(3) A complete summary of all matters discussed and conclusions reached;
(4) Copies of all reports received, issued, or approved by the advisory committee; and
(5) A description of public participation, including a list of members of the public who presented oral or written statements and an estimate of the number of members of the public who attended the meeting.
(b) The chairman of the advisory committee shall certify the accuracy of the minutes.
(c) Whenever a non-Commission established committee convenes and, at the request of the Commission, a portion of the session is allocated to the rendering of advisory services to the Commission, the Advisory Committee Management Officer shall attend and prepare minutes for that portion of the meeting in accordance with this section.
(d) In addition to the information required by subsection (a) of this section, the minutes of the Toxicological Advisory Board shall specify the reasons for all conclusions reached and, where conclusions are not unanimous, the Board is encouraged to submit minority or dissenting opinions.
§ 1018.26 Advisory functions.
(a) Unless otherwise specifically provided by statute, advisory committees shall be utilized solely for advisory functions.
(b) The Commission shall ensure that the advice and recommendations of advisory committees shall not be in-appropriately influenced by the Commission, its staff, or by any special interest, but will be the result of the advisory committee’s independent judgment.
§ 1018.27 Public participation.
(a) The Commission is committed to a policy of encouraging public participation in its activities and will hold all advisory committee meetings open to the public.
(b) The guidelines in section 8(c) of OMB Circular A-63 shall be followed in providing public access to advisory committee meetings.
§ 1018.28 Records and transcripts.
(a) Subject to section 552 of title 5, United States Code (Freedom of Information Act) and 16 CFR part 1015 (Commission’s Procedures for Disclosure or Production of Information under the Freedom of Information Act), the records, reports, transcripts, minutes, appendices, working papers, drafts, studies, agendas or other documents which were made available to or prepared for or by an advisory committee shall be made available for public inspection and copying in the Commission’s Office of the Secretary.
(b) Advisory Committee documents shall be made available until the advisory committee ceases to exist. Disposition of the advisory committee documents shall be determined by the Secretary of the Commission at that time.
§ 1018.29 Appeals under the Freedom of Information Act.
Appeals from the denial of access to advisory committee documents shall be considered in accordance with the Commission’s Procedures for Disclosure or Production of Information under the Freedom of Information Act (16 CFR part 1015).
Subpart D—Administration of Advisory Committees
§ 1018.31 Support services.
Unless the statutory authority for a particular advisory committee provides otherwise, the Advisory Committee Management Officer shall be responsible for providing and overseeing all necessary support services for each advisory committee established by or reporting to the Commission. Support services include providing committee staff, meeting rooms, supplies, and funds, including funds for the publication of reports.
§ 1018.32 Compensation and travel expenses.
(a) A single rate of compensation will be offered to members of all advisory committees with the exception of government employees and those individuals whose company or organization prohibits such payment. This rate shall be $100 per day for each day in attendance at the meeting and for each day of travel.
(b) The Commission shall determine per diem and travel expenses for members, staffs, and consultants in accordance with section 7(d) of the Advisory Committee Act and section 11 of OMB Circular No. A-63.
(c) Members of advisory committees, while engaged in the performance of their duties away from their homes or regular place of business, may be allowed travel expenses including per diem in lieu of expenses as authorized by 5 U.S.C. 5703.
§ 1018.33 Change of status.
Any advisory committee member who changes his or her affiliation or who assumes an additional affiliation, so as to actually or potentially affect his or her representational capacity on an advisory committee (upon which the member’s application was based), shall immediately notify, in writing, the Advisory Committee Management Officer. Such notification shall include all relevant information concerning the change in affiliation and a statement by the member expressing his or her opinion regarding the implications of such change. The notification and any other relevant information shall be evaluated by the Commissioners to determine the appropriateness of the member’s continued membership on the advisory committee.
§ 1018.34 Conflict of interest.
Members of the Commission’s statutory advisory committees are not legally subject to the standards of conduct and conflict of interest statutes and regulations applicable to Commission employees. However, it is important to avoid situations in which a member of an advisory committee has an actual or apparent conflict of interest between the member’s private interests (or the interests of the member’s organization) and the member’s interest in properly performing his or her duties as an advisory committee member. To preclude any such actual or apparent conflict of interest, committee members shall be subject to the following guidelines:
(a) Committee members should not personally participate, either for themselves or on behalf of an organization, in negotiations, or the preparation of negotiations, for contracts with or grants from the Commission. Nor should committee members, either as an individual or on behalf of an organization, become personally involved in the performance of work under such a negotiated contract or grant awarded by the Commission. Committee members may participate in preparing bids for and performing work under advertised contracts where price is the single factor in the determination of award.
(b) Committee members should not become personally involved in the preparation or submission of a proposal to develop a safety standard or regulation under any of the Acts administered by the Commission.
(c) Committee members representing anyone in a professional capacity in a proceeding before the Commission should, pursuant to paragraph (e) and (f) of this section, advise the committee chairperson and the other members of the committee on which he or she serves of the representation prior to the committee’s discussion regarding that proceeding. Where the chairperson of the committee determines that the representation involves a conflict or the appearance of a conflict of interest, the member will be asked to withdraw from the discussion of the proceeding. In circumstances where withdrawal from the committee’s discussion or consideration of the matter is determined by the Commission to be insufficient to avoid a conflict or apparent conflict of interest, continued representation may be considered incompatible with membership on the committee.
(d) Committee members should exercise caution to ensure that their public statements are not interpreted to be official policy statements of the Commission.
(e) Committee members shall disclose to the committee chairperson and to the other members of the committee on which he or she serves, any special interest in a particular proceeding or matter then pending before the committee which in any way may affect that member’s position, views or arguments on the particular proceeding or matter. The disclosure shall be made orally prior to the commencement of the discussion. “Special interest” is not intended to include a member’s general interest in presenting a position, views, or arguments in his or her representational capacity.
(f) Where the chairperson of the committee determines that the disclosure referred to in paragraph (e) of this section reveals a conflict or apparent conflict of interest with respect to a member’s involvement in the committee’s consideration or discussion of a particular matter, the member will be asked to withdraw from the discussion of the matter.
(g) The provisions of paragraphs (a) and (b) of this section do not apply to state and local government officers and employees.
§ 1018.35 Termination of membership.
Advisory committee membership may be terminated at any time upon a determination by the Commission that such action is appropriate.
Subpart E—Records, Annual Reports and Audits
§ 1018.41 Agency records on advisory committees.
(a) In accordance with section 12(a) of the Advisory Committee Act, the Advisory Committee Management Officer shall maintain, in the Office of the Secretary, records which will fully disclose the nature and extent of the activities of each advisory committee established or utilized by the Commission.
(b) The records shall include a current financial report itemizing expenditures and disclosing all funds available for each advisory committee during the current fiscal year.
(c) The records shall also include a complete set of the charters of the Commission’s advisory committee and copies of the annual reports on advisory committees.
§ 1018.42 Annual report.
(a) The Advisory Committee Management Officer shall prepare an annual report on the Commission’s advisory committees for inclusion in the President’s annual report to Congress as required by section 6(c) of the Advisory Committee Act. This report shall be prepared and submitted in accordance with General Services Administration guidelines (39 FR 44814, December 27, 1974).
(b) Results of the annual comprehensive review of advisory committee made under § 1018.43 shall be included in the annual report.
§ 1018.43 Comprehensive review.
A comprehensive review of all Commission established or utilized advisory committees shall be made annually in accordance with section 10 of the GSA Circular No. A-63, as amended, and shall be submitted to the GSA Secretariat by November 30 of each year.
Subpart F—Termination and Renewal
§ 1018.61 Statutory advisory committees.
A new charter shall be filed for each statutory advisory committee in accordance with section 9(c) of the Advisory Committee Act and § 1018.11 upon the expiration of each successive two-year period following the date of enactment of the statute establishing or requiring the establishment of the committee.
§ 1018.62 Non-statutory advisory committees.
(a) Each non-statutory advisory committee established by the Commission after the effective date of this part shall terminate not later than two years after its establishment unless prior to that time it is renewed in accordance with paragraph (c) of this section.
(b) Each non-statutory advisory committee which is renewed by the Commission shall terminate not later than two years after its renewal unless prior to that time it is again renewed in accordance with paragraph (c) of this section.
(c) Before a non-statutory advisory committee can be renewed by the Commission, the chairman shall inform the GSA Secretariat by letter not more than 60 days nor less than 30 days before the committee expires of the following:
(1) His or her determination that renewal is necessary and is in the public interest;
(2) The reasons for his or her determination;
(3) The Commission’s plan to attain balanced membership of the committee, and;
(4) An explanation of why the committee’s functions cannot be performed by the Commission or by another existing advisory committee.
(d) If the GSA Secretariat concurs, the Chairman shall certify in writing that the renewal of the advisory committee is in the public interest and shall publish notice of the renewal in the
PART 1019—EXPORT OF NONCOMPLYING, MISBRANDED, OR BANNED PRODUCTS
Subpart A—Procedures for Export of Noncomplying, Misbranded, or Banned Products
§ 1019.1 Purpose, applicability, and exemptions.
(a) Purpose. The regulations in this subpart A of this part 1019 establish the procedures exporters must use to notify the Consumer Product Safety Commission of their intent to export from the United States products which are banned or fail to comply with an applicable safety standard, regulation, or statute. These regulations also set forth the procedures the Commission uses in transmitting the notification of export of noncomplying products to the country to which those products will be sent. The Consumer Product Safety Act Authorization Act of 1978 (Pub. L. 95-631), which became effective November 10, 1978, established these notification requirements and authorizes the Commission to issue regulations to implement them.
(b) Applicability. These regulations apply to any person or firm which exports from the United States and item which is:
(1) A consumer product that does not conform to an applicable consumer product safety rule issued under sections 7 and 9 of the Consumer Product Safety Act (15 U.S.C. 2056, 2058), or which has been declared to be a banned hazardous product under provisions of sections 8 and 9 of that Act (15 U.S.C. 2057, 2058); or
(2) A misbranded hazardous substance or a banned hazardous substance within the meaning of sections 2(p) and 2(q) of the Federal Hazardous Substances Act (15 U.S.C. 1261); or
(3) A fabric or related material or an item of wearing apparel or interior furnishing made of fabric or related material which fails to conform with an applicable flammability standard or regulations issued under section 4 of the Flammable Fabrics Act (15 U.S.C. 1191, 1193).
(c) Exemption for certain items with noncomplying labeling. The exporter of an item that fails to comply with a standard or regulation only because it is labeled in a language other than English need not notify the Commission prior to export if the product is labeled with the required information in the language of the country to which the product will be sent.
(d) Exemption for samples. The exporter of an item that fails to comply with a standard or regulation, but which is intended for use only as a sample and not for resale, need not notify the Commission prior to export, if the item is conspicuously and labeled in English with the statement: “Sample only. Not for resale.” (The Commission encourages exporters to provide this label, in addition, in the language of the importing country, but does not require the foreign language labeling.) To qualify as a sample shipment under this exemption, the quantity of goods involved must be consistent with prevalent trade practices with respect to the specific product.
(e) Exemption for items not in child-resistant packaging. The exporter of an item which is a “misbranded hazardous substance” within the meaning of section 2(p) of the Federal Hazardous Substances Act (15 U.S.C. 1261(p)) only because it fails to comply with an applicable requirement for child-resistant packaging under the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.) need not notify the Commission prior to export.
§ 1019.2 Definitions.
As used in this subpart A of this part 1019:
(a) Consignee means the person, partnership, corporation or entity in a foreign country to whom noncomplying goods are sent;
(b) Export means to send goods outside the United States or United States possessions for purposes of trade, except the term does not apply to sending goods to United States installations located outside the United States or its possessions;
(c) Exporter means the person, partnership, corporation or entity that initiates the export of noncomplying goods;
(d) Noncomplying goods means any item described in § 1019.1(b), except for those items excluded from the requirements of these regulations by § 1019.1 (c), (d), and (e).
§ 1019.3 General requirements for notifying the Commission.
Not less than 30 days before exporting any noncomplying goods described in § 1019.1(b), the exporter must file a statement with the Consumer Product Safety Commission, as described in §§ 1019.4 and 1019.5 of this subpart A. The exporter need not notify the Commission about the export of items described in § 1019.1 (c), (d), or (e). As described in § 1019.5, the exporter may request the Commission to allow the statement to be filed between 10 and 29 days before the intended export, and the request may be granted for good cause.
§ 1019.4 Procedures for notifying the Commission; content of the notification.
(a) Where notification must be filed. The notification of intent to export shall be addressed to the Assistant Executive Director for Compliance, Consumer Product Safety Commission, Washington, DC 20207.
(b) Coverage of notification. An exporter must file a separate notification for each country to which noncomplying goods are to be exported. Each notification may include a variety of noncomplying goods being shipped to one country. The notification may include goods intended to be shipped to one country in any one year, unless the Assistant Executive Director of Compliance directs otherwise in writing.
(c) Form of notification. The notification of intent to export must be in writing and must be entitled: “Notification of Intent to Export Noncomplying Goods to [indicate name of country].” The Commission has no notification forms, but encourages exporters to provide the required information in the order listed in paragraphs (d) and (e) of this section.
(d) Content of notification; required information. The notification of intent to export shall contain the information required by this subsection. If the notification covers a variety of noncomplying goods the exporter intends to export to one country, the information required below must be clearly provided for each class of goods, and may include an estimate of the information required in paragraphs (d) (3) and (5) of this section. The required information is:
(1) Name, address and telephone number of the exporter;
(2) Name and address of each consignee;
(3) Quantity and description of the goods to be exported to each consignee, including brand or trade names or model or other identifying numbers;
(4) Identification of the standards, bans, regulations and statutory provisions applicable to the goods being exported, and an accurate description of the manner in which the goods fail to comply with applicable requirements; and
(5) Anticipated date of shipment and port of destination.
(e) Optional information. In addition to the information required by paragraph (d) of this section, the notification of intent to export may contain, at the exporter’s option, the following information:
(1) Copies of any correspondence from the government of the country of destination of the goods indicating whether the noncomplying goods may be imported into that country; and
(2) Any other safety-related information that the exporter believes is relevant or useful to the Commission or to the government of the country of intended destination.
(f) Signature. The notification of intent to export shall be signed by the owner of the exporting firm if the exporter is a sole-proprietorship, by a partner if the exporter is a partnership, or by a corporate officer if the exporter is a corporation.
§ 1019.5 Time notification must be made to Commission; reductions of time.
(a) Time of notification. The notification of intent to export must be received by the Commission’s Assistant Executive Director for Compliance at least 30 days before the noncomplying goods are to leave the customs territory of the United States. If the notification of intent to export includes more than one shipment of noncomplying goods to a foreign country, the Assistant Executive Director for Compliance must receive the notification at least 30 days before the first shipment of noncomplying goods is to leave the customs territory of the United States.
(b) Incomplete notification. Promptly after receiving notification of intent to export, the Assistant Executive Director will inform the exporter if the notification of intent to export is incomplete and will described which requirements of § 1019.4 are not satisfied. The Assistant Executive Director may inform the exporter that the 30-day advance notification period will not begin until the Assistant Executive Director receives all the required information.
(c) Requests for reduction in 30-day notification requirement. Any exporter may request an exemption from the requirement of 30-day advance notification of intent to export by filing with the Commission’s Assistant Executive Director for Compliance (Washington, DC 20207) a written request that the time be reduced to a time between 10 and 30 days before the intended export. The request for reduction in time must be received by the Assistant Executive Director for Compliance at least 3 working days before the exporter wishes the reduced time period to begin. The request must:
(1) Be in writing;
(2) Be entitled “Request for Reduction of Time to File Notification of Intent to Export Noncomplying Goods to [indicate name of country]”;
(3) Contain a specific request for the time reduction requested to a time between 10 and 30 days before the intended export); and
(4) Provide reasons for the request for reduction in time.
(d) Response to requests for reduction of time. The Assistant Executive Director for Compliance has the authority to approve or disapprove requests for reduction of time. The Assistant Executive Director shall indicate the amount of time before export that the exporter must provide the notification. If the request is not granted, the Assistant Executive Director shall explain the reasons in writing.
§ 1019.6 Changes to notification.
If the exporter causes any change to any of the information required by § 1019.4, or learns of any change to any of that information, at any time before the noncomplying goods reach the country of destination, the exporter must notify the Assistant Executive Director for Compliance within two working days after causing or learning of such change, and must state the reason for any such change. The Assistant Executive Director will promptly inform the exporter whether the 30-day advance notification period will be discontinued, and whether the exporter must take any other steps to comply with the advance notification requirement.
§ 1019.7 Commission notification of foreign governments.
After receiving notification from the exporter, or any changes in notification, the Assistant Executive Director for Compliance shall inform on a priority basis the appropriate government agency of the country to which the noncomplying goods are to be sent of the exportation and the basis on which the goods are banned or fail to comply with Commission standards, regulations, or statutes, and shall send all information supplied by the exporter in accordance with § 1019.4(d). The Assistant Executive Director shall also enclose any information supplied in accordance with § 1019.4(e), but he or she may also state that the Commission disagrees with or takes no position on its content, including its relevance or accuracy. The Assistant Executive Director shall take whatever other action is necessary to provide full information to foreign countries and shall also work with and inform the U.S. State Department and foreign embassies and international organizations, as appropriate. The Assistant Executive Director shall also seek acknowledgment of the notification from the foreign government. Foreign governments intending to prohibit entry of goods that are the subject of a notification from the Commission should initiate action to prevent such entry and should notify the exporter directly of that intent.
§ 1019.8 Confidentiality.
If the exporter believes any of the information submitted should be considered trade secret or confidential commercial or financial information, the exporter must request confidential treatment, in writing, at the time the information is submitted or must indicate that a request will be made within 10 working days. The Commission’s regulations under the Freedom of Information Act, 16 CFR part 1015, govern confidential treatment of information submitted to the Commission.
Subpart B—Statement of Policy and Interpretation Concerning Export of Noncomplying, Misbranded, or Banned Products
§ 1019.31 Purpose and scope.
(a) This subpart B of this part 1019 states the policy of the Consumer Product Safety Commission and its interpretation of the Consumer Product Safety Act and the Federal Hazardous Substances Act with regard to exportation of products which have been sold, offered for sale, or distributed in commerce for use in the United States which:
(1) Fail to comply with an applicable consumer product safety standard or banning rule issued under provisions of the Consumer Product Safety Act (15 U.S.C. 2051 et seq.); or
(2) Are “misbranded hazardous substances” or “banned hazardous substances” as those terms are used in the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.).
(b) The policy expressed in this subpart B of part 1019 does not apply to any of the following products:
(1) Products which could be regulated only under provisions of the Consumer Product Safety Act but which are not subject to a consumer product safety standard or banning rule issued under that Act.
(2) Consumer products which are subject to and fail to comply with an applicable standard or banning rule issued under provisions of the Consumer Product Safety Act but which have never been distributed in commerce for use in the United States. See section 18(b) of the Consumer Product Safety Act 15, U.S.C. 2067(b), and subpart A of this part 1019 for requirements governing export of such products.)
(3) Products which could be regulated under one or more sections of the Federal Hazardous Substances Act but which are neither “misbranded hazardous substances” nor “banned hazardous substances” as those terms are used in the Act.
(4) Products which are “misbranded hazardous substances” or “banned hazardous substances” as those terms are used in the Federal Hazardous Substances Act but which have never been sold or offered for sale in domestic commerce. (See sections 5(b) and 14(d) of the Federal Hazardous Substances Act (15 U.S.C. 1264(b) and 1273(d) and subpart A of this part 1019 for requirements governing export of such products.)
(5) Products for which the Commission has granted an exemption from an applicable standard, ban, or labeling requirement under the CPSA, FHSA, or FFA, in accordance with provisions of 16 CFR 1009.9. (These products remain subject to the notification requirements of subpart A of this part 1019.)
(6) Products which fail to comply with an applicable standard of flammability issued under provisions of the Flammable Fabrics Act (15 U.S.C. 1191 et seq.). The Commission’s policy regarding export of such products is set forth in the Commission’s Memorandum Decision and Order In the Matter of Imperial Carpet Mills, Inc., CPSC Docket No. 80-2, July 7, 1983, and allows export without regard to whether the products have been distributed in domestic commerce. (See section 15 of the Flammable Fabrics Act, 15 U.S.C. 1202, and subpart A of this part 1019 for requirements governing export of such products.)
§ 1019.32 Statutory provisions.
(a) Section 18(a) of the Consumer Product Safety Act (15 U.S.C. 2057(a)) states:
This Act [the Consumer Product Safety Act] shall not apply to any consumer product if: (1) It can be shown that such product is manufactured, sold, or held for sale for export from the United States (or that such product was imported for export), unless (A) such consumer product is in fact distributed in commerce for use in the United States, or (B) the Commission determines that exportation of such product presents an unreasonable risk of injury to consumers within the United States, and (2) such consumer product when distributed in commerce, or any container in which it is enclosed when so distributed, bears a stamp or label stating that such consumer product is intended for export; except that this Act shall apply to any consumer product manufactured for sale, offered for sale, or sold for shipment to any installation of the United States located outside of the United States.
(b) Section 4 of the Federal Hazardous Substances Act (15 U.S.C. 1263) states in part:
The following acts and the causing thereof are hereby prohibited: (a) The introduction or delivery for introduction into interstate commerce of any misbranded hazardous substance or banned hazardous substance. * * * (c) The receipt in interstate commerce of any misbranded hazardous substance or banned hazardous substance and the delivery or proffered delivery thereof for pay or otherwise.
(c) Section 5(b) of the Federal Hazardous Substances Act (15 U.S.C. 1264(b)) provides in part:
No person shall be subject to the penalties of this section * * * (3) for having violated subsection (a) or (c) of section 4 with respect to any hazardous substance shipped or delivered for shipment for export to any foreign country, in a package marked for export on the outside of the shipping container and labeled in accordance with the specifications of the foreign purchaser and in accordance with the laws of the foreign country, but if such hazardous substance is sold or offered for sale in domestic commerce, or if the Consumer Product Safety Commission determines that exportation of such substance presents an unreasonable risk of injury to persons residing within the United States, this clause shall not apply.
§ 1019.33 Statement of policy and interpretation.
(a) In its enforcement of the Consumer Product Safety Act, the Commission interprets the provisions of that Act to prohibit the export of products which fail to comply with an applicable consumer product safety standard or banning rule issued under that Act if those products have at any time been distributed in commerce for use in the United States.
(b) In its enforcement of the Federal Hazardous Substances Act, the Commission interprets the provisions of the Act to prohibit the export of products which are misbranded substances or banned hazardous substances as those terms are used in that Act if those products have at any time been sold or offered for sale in domestic commerce.
PART 1020—SMALL BUSINESS
§ 1020.1 Why is the Commission issuing this rule?
(a) To state the Commission’s policies on small businesses;
(b) To assure that the Commission continues to treat small businesses fairly;
(c) To assure that small businesses do not bear a disproportionate share of any burden or cost created by a Commission regulatory, enforcement, or other action; and
(d) To assure that small businesses are given every opportunity to participate fully in the Commission’s regulatory process.
§ 1020.2 What is the definition of “small business”?
As used in this part, the term small business means any entity that is either a small business, small organization, or small governmental jurisdiction, as those terms are defined at 5 U.S.C. 601(3), (4), and (5), respectively.
§ 1020.3 What are the qualifications and duties of the Small Business Ombudsman?
(a) The Chairman will appoint a senior, full-time Commission employee as Small Business Ombudsman. The Ombudsman must:
(1) Have a working knowledge of the Commission’s statutes and regulations;
(2) Be familiar with the industries and products that the Commission regulates;
(3) Develop a working knowledge of the regulatory problems that small businesses experience;
(4) Perform the Ombudsman duties in addition to, and consistently with, other Commission responsibilities; and
(5) Not work in the Office of Compliance or Office of Hazard Identification and Reduction.
(b) The duties of the Small Business Ombudsman will include, but not be limited to, the following:
(1) Developing and implementing a program to assist small businesses that is consistent with § 1020.4;
(2) Working to expedite Commission responses to small businesses and providing information, guidance, and technical assistance to small businesses;
(3) Performing a review, at least twice a year, of the Commission’s regulatory agenda for actions likely to have a significant impact on small businesses; and
(4) Pursuing the interests of small businesses by maintaining a working relationship with appropriate officials in the Small Business Administration, in national trade associations that represent small businesses, and in the Commission.
§ 1020.4 What is the Small Business Program?
(a) Whenever the Commission is aware of the interests of small businesses, it will consider those interests before taking any action that will likely have a significant effect on small businesses.
(b) Small businesses may request and receive special assistance from the Commission, as appropriate and consistent with Commission resources. Examples of such assistance are:
(1) Small businesses may contact the Small Business Ombudsman to obtain information about Commission statutes, regulations, or programs; to obtain technical assistance; to determine who in the agency has particular expertise that might be helpful to the small business; or to help expedite a small business’s request.
(2) Small businesses may request assistance from the Commission by using the small business extension on the Commission’s hotline telephone system. The number is 1-800-638-2772, extension 234.
(3) The Small Business Ombudsman will directly provide small businesses with the requested assistance, or will direct the small business to the appropriate Commission staff for help.
(c) Whenever the Commission issues a final regulatory flexibility analysis for a rule, under the Regulatory Flexibility Act (5 U.S.C. 604), the Commission will publish a compliance guide for small businesses. The guide will explain in easy-to-understand language what action a small business must take to comply with the rule.
(d) The Commission may take other appropriate actions to assist small businesses, but such actions will not treat any other Commission constituent unfairly.
§ 1020.5 What is the Small Business Enforcement Policy?
(a) When appropriate, the Commission will, subject to all applicable statutes and regulations and paragraph (b) of this section:
(1) Waive or reduce civil penalties for violations of a statutory or regulatory requirement by a small business and/or
(2) Consider a small business’s ability to pay in determining a penalty assessment against that small business,
(b) The Commission may decline to waive civil penalties or consider a small business’s ability to pay, under paragraph (a) of this section, when one or more of the following circumstances applies:
(1) The small business’s violations posed serious health or safety threats.
(2) The small business was subject to multiple enforcement actions by the Commission.
(3) The small business’s violations involved willful or criminal conduct.
(4) The small business failed to correct violations within a reasonable time.
(5) The small business failed to make a good faith effort to comply with the law.
(6) The small business acted in any other way that would make it unfair or inappropriate for the Commission to provide a benefit under paragraph (a) of this section.
PART 1021—ENVIRONMENTAL REVIEW
Subpart A—General
§ 1021.1 Purpose.
This part contains Consumer Product Safety Commission procedures for review of environmental effects of Commission actions and for preparation of environmental impact statements (EIS) and related documents. These procedures supersede any Commission procedures previously applicable. The procedures provide for identification of effects of a proposed action and its alternatives on the environment; for assessment of the significance of these effects; for consideration of effects at the appropriate points in the Commission’s decision-making process; and for preparation of environmental impact statements for major actions significantly affecting the environment. These procedures are intended to implement the Council on Environmental Quality’s final regulations of November 29, 1978 (43 FR 55978; 40 CFR part 1500, et seq.) concerning agency compliance with the National Environmental Policy Act, as amended (NEPA) (15 U.S.C. 4321-4347 as amended by Pub. L. 94-83, August 8, 1975).
§ 1021.2 Policy.
It is the policy of the Commission to weigh and consider the effects upon the human environment of a proposed action and its reasonable alternatives. Actions will be designed to avoid or minimize adverse effects upon the quality of the human environment wherever practicable.
§ 1021.3 Definitions.
(a) The term CPSC actions means rulemaking actions; enforcement actions; adjudications; legislative proposals or reports; construction, relocation, or renovation of CPSC facilities; decisions on petitions; and any other agency activity designated by the Executive Director as one necessitating environmental review.
(b) The term Commission means the five Commissioners of the Consumer Product Safety Commission.
(c) The term CPSC means the entire organization which bears the title Consumer Product Safety Commission.
(d) The term NEPA regulations means the Council of Environmental Quality regulations of November 29, 1978 (43 FR 55978) for implementing the provisions of the National Environmental Policy Act, as amended (42 U.S.C 4321, et. seq).
(e) The term environmental review process refers to all activities associated with decisions to prepare an environmental assessment, a finding of no significant impact, or an environmental impact statement.
(f) The definitions given in part 1508 of the Council’s NEPA regulations are applicable to this part 1021 and are not repeated here.
§ 1021.4 Overview of environmental review process for CPSC actions.
The environmental review process normally begins during the staff development of a proposed action and progresses through the following steps:
(a) Environmental assessment. (Section 1508.9 of the NEPA regulations). The assessment is initiated along with the staff development of a proposal and the identification of realistic alternatives. The assessment shall be available to the Commission before the Commission votes on a proposal and its alternatives. Its purpose is to identify and describe foreseeable effects on the environment, if any, of the action and its alternatives. The assessment culminates in a written report. This report generally contains analyses of the same categories of information as would an EIS, but in a much less detailed fashion. (See § 1021.10(a), below.) It contains sufficient information to form a basis for deciding whether effects on the environment are likely to be “significant.” (See § 1508.27 of the NEPA regulations.).
(b) Decision as to significance of effects on the environment. This decision is made by the Executive Director of the CPSC and is based upon the results of the environmental assessment as well as any other pertinent information. If the effects are significant, CPSC publishes in the
(c) Finding of no significant impact. This is a written document which gives reasons for concluding that the effects of a proposed action, or its alternatives, on the environment will not be significant. Together with the environmental assessment, it explains the basis for not preparing an EIS. The finding of no significant impact is signed by the Executive Director. The finding of no significant impact and the environmental assessment accompany the proposed action throughout the Commission decision-making process.
(d) Draft environmental impact statement. The content of a draft EIS is described in § 1021.12, below. For a particular proposal, the breadth of issues to be discussed is determined by using the scoping process described in § 1501.7 of the NEPA regulations. The draft EIS pertaining to a proposed rule is before the Commission at the time it considers the proposed action and is available to the public when the notice of proposed rulemaking is published or as soon as possible thereafter. In appropriate instances, the
(e) Final EIS. The content of this document is described in § 1021.12. A final EIS responds to all substantive comments on the draft statement. It is before the Commission when it considers a final action.
(f) Supplemental statements. When CPSC makes changes in the proposed action that are important to environmental issues or when there is significant new environmental information, the Executive Director instructs CPSC staff to prepare supplements to either the draft or final EIS (See § 1502.9(c) of the NEPA regulations).
(g) Record of decision. (Sections 1505.2 and 1506.1 of the NEPA regulations.) At the time of a decision on a proposed action which involves an EIS, CPSC prepares a written record of decision explaining the decision and why any alternatives discussed in the EIS were rejected. This written record is signed by the Secretary of the Commission for the Commission. No action going forward on the proposal may be taken until the record of decision is signed and filed in the Office of the Secretary of the Commission.
§ 1021.5 Categories of CPSC actions.
(a) There are no CPSC actions which ordinarily produce significant environmental effects. Therefore, there are no actions for which an environmental impact statement is normally required.
(b) The following categories of CPSC actions have the potential of producing environmental effects and therefore, normally require environmental assessments but not necessarily environmental impact statements:
(1) Regulatory actions dealing with health risks.
(2) Actions requiring the destruction or disposal of large quantities of products or components of products.
(3) Construction, relocation, or major renovation of CPSC facilities.
(4) Recommendations or reports to Congress on proposed legislation that will substantially affect the scope of CPSC authority or the use of CPSC resources, authorize construction or razing of facilities, or dislocate large numbers of employees.
(5) Enforcement actions which result in the widespread use of substitute products, which may present health risks.
(c) The following categories of CPSC actions normally have little or no potential for affecting the human environment; and therefore, neither an environmental assessment nor an environmental impact statement is required. (These categories are termed “categorical exclusions” in the NEPA regulations; see §§ 1507.3(b)(2) and 1508.4):
(1) Rules or safety standards to provide design or performance requirements for products, or revision, amendment, or revocation of such standards.
(2) Product certification or labeling rules.
(3) Rules requiring poison prevention packaging of products or exempting products from poison prevention packaging rules.
(4) Administrative proceedings to require individual manufacturers to give notice of and/or to correct, repair, replace, or refund the purchase price of banned or hazardous products. Other administrative adjudications which are primarily law enforcement proceedings.
(5) Recommendations or reports to Congress on proposed legislation to amend, delete or add procedural provisions to existing CPSC statutory authority.
(6) Decisions on petitions for rulemaking.
(7) Issuance of subpoenas, general orders, and special orders.
(d) In exceptional circumstances, actions within category in paragraph (c) of this section (“categorical exclusions”) may produce effects on the human environment. Upon a determination by the Executive Director that a normally excluded proposed action may have such an effect, an environmental assessment and a finding of no significant impact or an environmental impact statement shall be prepared.
Subpart B—Procedures
§ 1021.6 Responsible official.
(a) The Executive Director of the CPSC shall have the responsibility to ensure that the Commission’s policies and procedures set forth in this part are carried out. He or she shall have the following specific powers and duties:
(1) To ensure that CPSC environmental review is conducted in accordance with the NEPA regulations as well as this part 1021.
(2) To evaluate the significance of effects of a CPSC action on the environment and to determine whether a finding of no significant impact or an EIS should be prepared.
(3) To determine when a categorical exclusion requires environmental review because of exceptional circumstances indicating that the otherwise excluded action may produce an environmental effect.
(4) To instruct CPSC staff to prepare supplements to either draft or final EIS’s where there is new environmental information or when CPSC makes changes in a proposed action that are important to environmental issues.
(5) To ensure that environmental documents are before the Commission at all stages of review of proposed action.
(6) To make provisions for soliciting public comment on the anticipated effects on the environment of proposed CPSC actions and their reasonable alternatives at any stage of the environmental review process, whenever he or she decides that such comment will be helpful. The Executive Director, for example, shall have the power to require that provision for soliciting such comments, written or oral, be included in any announcement of a public hearing on proposed rulemaking or on the merits of a petition for rulemaking.
(7) To call upon all resources and expertise available to CPSC to ensure that environmental review is accomplished through an interdisciplinary effort.
(8) To delegate any of his or her powers and duties, other than paragraphs (a) (2) and (3) of this section, to any officer or employee of the CPSC.
§ 1021.7 Coordination of environmental review with CPSC procedures.
(a) The Commission shall consider all relevant environmental documents in evaluating proposals for Commission action. The preparation and completion of assessments and statements required by this part shall be scheduled to assure that available environmental information is before the Commission at all appropriate stages of development of CPSC actions along with technical and economic information otherwise required. The range of alternatives discussed in appropriate environmental documents shall be encompassed by the range of alternatives considered by the Commission for an action.
(b) An environmental assessment on a proposed rulemaking action requiring environmental review shall be available to the commission before the Commission votes on a proposed rule, and its alternatives. If the Executive Director determines that an EIS is needed, the draft EIS shall normally be before the Commission at the time it votes to publish a proposed rule. A final EIS shall be before the Commission when it considers final action on a proposed rule. Relevant environmental documents shall accompany the proposed rulemaking action throughout the Commission’s decisionmaking process.
(c) Draft EISs or findings of no significant impact together with environmental assessments shall be made available to the public for comment at the time of publication in the
(d) Whenever the Commission decides to solicit offers by an outside person or organization to develop a proposed consumer product safety standard in accordance with section 7 of the Consumer Product Safety Act (15 U.S.C. 2056) and the Executive Director has determined that environmental review is needed, the Executive Director shall recommend to the Commission whether the “offeror” should perform an environmental assessment during development of the proposed standard. In making this recommendation, the Executive Director shall take into account the resources of the “offeror”, including the expertise and money available to it. If the Commission decides that the “offeror” should perform an assessment, the agreement between the Commission and the offeror shall so provide. CPSC, however, shall independently evaluate any assessment prepared and shall take responsibility for the scope and content of the assessment.
(e) CPSC adjudications are primarily law enforcement proceedings and therefore are not agency actions within the meaning of NEPA. (See § 1508.18(8) of the NEPA regulations.) However, in CPSC formal rulemaking proceedings, all available environmental information, including any supplements to a draft or final EIS, shall be filed in the Office of the Secretary and shall be made part of the formal record of the proceeding.
§ 1021.8 Legislative proposals.
Draft EISs on legislative proposals which may significantly affect the environment shall be prepared as described in § 1506.8 of the NEPA regulations. The draft EIS, where feasible, shall accompany the legislative proposal or report to Congress and shall be available in time for Congressional hearings and deliberations. The draft EIS shall be forwarded to the Environmental Protection Agency in accordance with § 1506.9 of the NEPA regulations. Comments on the legislative statement and CPSC’s responses shall be forwarded to the appropriate Congressional committees.
§ 1021.9 Public participation, notice, and comment.
(a) Information and comments are solicited from and provided to the public on anticipated environmental effects of CPSC actions as follows:
(1) Promptly after a decision is made to prepare a draft EIS, a notice of intent to prepare the draft EIS shall be published in the CPSC Public Calendar and in the
(2) As soon as practicable after a finding of no significant impact is completed, a copy of the finding together with the environmental assessment report shall be forwarded to the Office of the Secretary of the Commission to be made available to the public. Any information and comments received from the public on the documents will be considered and will accompany the documents throughout the CPSC decisionmaking process, but comments will not ordinarily be answered individually.
(3)(i) Upon completion of a draft EIS, a notice of its availability for comment should be published in the CPSC Public Calendar and in the
(ii) Copies of the draft EIS shall be sent to public and private organizations known by CPSC to have special expertise with respect to the environmental effects involved, those who are known to have an interest in the action, and those who request an opportunity to comment. Also, copies shall be circulated for comment to Federal, State, and local agencies with jurisdiction by law and special expertise with respect to environmental effects involved. Part 1503 of the NEPA regulations shall be consulted for further details of this procedure.
(iii) Draft EIS’s shall be available to the public in the Office of the Secretary at Commission headquarters.
(4) Upon completion of a final EIS, a notice of its availability in the Office of the Secretary, shall be published in the CPSC Public Calendar and if deemed appropriate, in the
(5) A list of EIS’s under preparation and of EIS’s or findings of no significant impact and environmental assessments completed shall be available to the public in the Office of the Secretary, at Commission headquarters. The list shall be continuously updated.
(6) In addition to publication in the CPSC Public Calendar and the
§ 1021.10 Emergencies.
Where emergency circumstances make it necessary to take an action without observing all the provisions of these implementing procedures or the NEPA regulations, CPSC will consult with the Council on Environmental Quality about alternative arrangements.
§ 1021.11 Information regarding NEPA compliance.
Interested persons may contact the Commission’s Office of the Executive Director (301-504-0550) for information regarding CPSC NEPA compliance.
Subpart C—Contents of Environmental Review Documents
§ 1021.12 Environmental assessment.
(a) An environmental assessment shall first briefly describe the proposed action and realistic alternative actions. Next, it shall identify all effects on the environment that can be expected to result from the proposed and alternative actions. After each anticipated effect is identified, it shall be described as fully as can be done with available data in order to show its magnitude and significance. Sources of information for assessment include CPSC staff studies and research reports, information gathered at hearings or meetings held to obtain the views of the public on the proposed action, and other information received from members of the public and from governmental entities.
(b) The assessment shall identify and describe any methods or approaches which would avoid or minimize adverse effects on the environment.
§ 1021.13 Finding of no significant impact.
(a) A finding of no significant impact shall cite and be attached to the environmental assessment upon which it is based. It shall refer to anticipated effects upon the environment identified in the environmental assessment and give the reason(s) why those effects will not be significant. The final paragraph of the finding shall give the reasons why the overall impact on the environment is not regarded as significant.
(b) The signature of the Executive Director shall appear at the end of the finding of no significant impact.
§ 1021.14 Environmental impact statement.
(a) Draft and final EIS’s, unless there is a compelling reason to do otherwise, shall conform to the recommended format specified in § 1502.10 of the NEPA regulations and shall contain the material required by §§ 1502.11 through 1502.18 of those regulations.
(b) It may be necessary to include in an EIS a description of effects which are not effects on the natural or physical environment, but rather are, for example, purely economic or health effects. For this reason, an EIS may include issues and facts that are thoroughly analyzed in other comprehensive CPSC documents such as hazard analyses, economic impact analyses, or analyses of impact on particular age groups among consumers. In such cases, the EIS shall not duplicate the other documents, but rather shall cite and summarize from them. A list of background documents and sources of data cited in the EIS shall appear at the end of every EIS.
PART 1025—RULES OF PRACTICE FOR ADJUDICATIVE PROCEEDINGS
Subpart A—Scope of Rules, Nature of Adjudicative Proceedings, Definitions
§ 1025.1 Scope of rules.
The rules in this part govern procedures in adjudicative proceedings relating to the provisions of section 15 (c), (d), and (f) and 17(b) of the Consumer Product Safety Act (15 U.S.C. 2064 (c), (d), (f); 2066(b)), section 15 of the Federal Hazardous Substances Act (15 U.S.C. 1274), and sections 3 and 8(b) of the Flammable Fabrics Act (15 U.S.C. 1192, 1197(b)), which are required by statute to be determined on the record after opportunity for a public hearing. These rules will also govern adjudicative proceedings for the assessment of civil penalties under section 20(a) of the Consumer Product Safety Act (15 U.S.C. 2068(a)), except in those instances where the matter of a civil penalty is presented to a United States District Court in conjunction with an action by the Commission for injunctive or other appropriate relief. These Rules may also be used for such other adjudicative proceedings as the Commission, by order, shall designate. A basic intent of the Commission in the development of these rules has been to promulgate a single set of procedural rules which can accommodate both simple matters and complex matters in adjudication. To accomplish this objective, broad discretion has been vested in the Presiding Officer who will hear a matter being adjudicated to allow him/her to alter time limitations and other procedural aspects of a case, as required by the complexity of the particular matter involved. A major concern of the Commission is that all matters in adjudication move forward in a timely manner, consistent with the Constitutional due process rights of all parties. It is anticipated that in any adjudicative proceedings for the assessment of civil penalties there will be less need for discovery since most factual matters will already be known by the parties. Therefore, the Presiding Officer should, whenever appropriate, expedite the proceedings by setting shorter time limitations than those time limitations generally applicable under these Rules. For example, the 150-day limitation for discovery, as provided in § 1025.31(g), should be shortened, consistent with the extent of discovery reasonably necessary to prepare for the hearing.
§ 1025.2 Nature of adjudicative proceedings.
Adjudicative proceedings shall be conducted in accordance with Title 5, United States Code, sections 551 through 559, and these Rules. It is the policy of the Commission that adjudicative proceedings shall be conducted expeditiously and with due regard to the rights and interests of all persons affected and in locations chosen with due regard to the convenience of all parties. Therefore, the Presiding Officer and all parties shall make every effort at each stage of any proceedings to avoid unnecessary delay.
§ 1025.3 Definitions.
As used in this part:
(a) Application means an ex parte request by a party for an order that may be granted or denied without opportunity for response by any other party.
(b) Commission means the Consumer Product Safety Commission or a quorum thereof.
(c) Commissioner means a Commissioner of the Consumer Product Safety Commission.
(d) Complaint Counsel means counsel for the Commission’s staff.
(e) Motion means a request by a party for a ruling or order that may be granted or denied only after opportunity for responses by all other parties.
(f) Party means any named person or any intervenor in any proceedings governed by these Rules.
(g) Person means any individual, partnership, corporation, unincorporated association, public or private organization, or a federal, state or municipal governmental entity.
(h) Petition means a written request, addressed to the Commission or the Presiding Officer, for some affirmative action.
(i) Presiding Officer means a person who conducts any adjudicative proceedings under this part, and may include an administrative law judge qualified under Title 5, United States Code, section 3105, but shall not include a Commissioner.
(j) Respondent means any person against whom a complaint has been issued.
(k) Secretary means the Secretary of the Consumer Product Safety Commission.
(l) Staff means the staff of the Consumer Product Safety Commission.
Subpart B—Pleadings, Form, Execution, Service of Documents
§ 1025.11 Commencement of proceedings.
(a) Notice of institution of enforcement proceedings. Any adjudicative proceedings under this part shall be commenced by the issuance of a complaint, authorized by the Commission, and signed by the Associate Executive Director for Compliance and Enforcement.
(b) Form and content of complaint. The complaint shall contain the following:
(1) A statement of the legal authority for instituting the proceedings, including the specific sections of statutes, rules and regulations involved in each allegation.
(2) Identification of each respondent or class of respondents.
(3) A clear and concise statement of the charges, sufficient to inform each respondent with reasonable definiteness of the factual basis or bases of the allegations of violation or hazard. A list and summary of documentary evidence supporting the charges shall be attached.
(4) A request for the relief which the staff believes is in the public interest.
(c) Notice to the public. Once issued, the complaint shall be submitted without delay to the
§ 1025.12 Answer.
(a) Time for filing. A respondent shall have twenty (20) days after service of a complaint to file an answer.
(b) Contents of answer. The answer shall contain the following:
(1) A specific admission or denial of each allegation in the complaint. If a respondent is without knowledge or information sufficient to form a belief as to the truth of an allegation, the respondent shall so state. Such statement shall have the effect of a denial. Allegations that are not denied shall be deemed to have been admitted.
(2) A concise statement of the factual or legal defenses to each allegation of the complaint.
(c) Default. Failure of a respondent to file an answer within the time provided, unless extended, shall constitute a waiver of the right to appear and contest the allegations in the complaint, and the Presiding Officer may make such findings of fact and conclusions of law as are just and reasonable under the circumstances.
§ 1025.13 Amendments and supplemental pleadings.
The Presiding Officer may allow appropriate amendments and supplemental pleadings which do not unduly broaden the issues in the proceedings or cause undue delay.
§ 1025.14 Form and filing of documents.
(a) Filing. Except as otherwise provided in these Rules, all documents submitted to the Commission or the Presiding Officer shall be addressed to, and filed with, the Secretary. Documents may be filed in person or by mail and shall be deemed filed on the day of filing or mailing.
(b) Caption. Every document shall contain a caption setting forth the name of the action, the docket number, and the title of the document.
(c) Copies. An original and three (3) copies of all documents shall be filed. Each copy must be clear and legible.
(d) Signature. (1) The original of each document filed shall be signed by a representative of record for the party or participant; or in the case of parties or participants not represented, by the party or participant; or by a partner, officer or other appropriate official of any corporation, partnership, or unincorporated association, who files an appearance on behalf of the party or participant.
(2) By signing a document, the signer represents that the signer has read it and that to the best of the signer’s knowledge, information and belief, the statements made in it are true and that it is not filed for purposes of delay.
(e) Form. (1) All documents shall be dated and shall contain the address and telephone number of the signer.
(2) Documents shall be on paper approximately 8
(3) Documents that fail to comply with this section may be returned by the Secretary.
§ 1025.15 Time.
(a) Computation. In computing any period of time prescribed or allowed by these rules, the day of the act, event, or default from which the designated period of time begins to run shall not be included. The last day of the period so computed shall be included, unless it is a Saturday, a Sunday, or a legal holiday, in which event the period runs until the end of the next day which is not a Saturday, a Sunday, or a legal holiday. When the period of time prescribed or allowed is less than seven (7) days, intermediate Saturdays, Sundays, and legal holidays shall be excluded in the computation. As used in this rule, “legal holiday” includes New Year’s Day, Washington’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans’ Day, Thanksgiving Day, Christmas Day, and any other day declared as a holiday by the President or the Congress of the United States.
(b) Additional time after service by mail. Whenever a party is required or permitted to do an act within a prescribed period after service of a document and the document is served by mail, three (3) days shall be added to the prescribed period.
(c) Extensions. For good cause shown, the Presiding Officer may extend any time limit prescribed or allowed by these rules or by order of the Commission or the Presiding Officer, except for those sections governing the filing of interlocutory appeals and appeals from Initial Decisions and those sections expressly requiring Commission action. Except as otherwise provided by law, the Commission, for good cause shown, may extend any time limit prescribed by these rules or by order of the Commission or the Presiding Officer.
§ 1025.16 Service.
(a) Mandatory service. Every document filed with the Secretary shall be served upon all parties to any proceedings, i.e., Complaint Counsel, respondent(s), and party intervenors, as well as the Presiding Officer. Every document filed with the Secretary shall also be served upon each participant, if the Presiding Officer or the Commission so directs.
(b) Service of complaint, ruling, petition for interlocutory appeal, order, decision, or subpoena. A complaint, ruling, petition for interlocutory appeal, order, decision, or subpoena shall be served in one of the following ways:
(1) By registered or certified mail. A copy of the document shall be addressed to the person, partnership, corporation or unincorporated association to be served at his/her/its residence or principal office or place of business and sent by registered or certified mail; or
(2) By delivery to an individual. A copy of the document may be delivered to the person to be served; or to a member of the partnership to be served; or to the president, secretary, or other executive officer, or a director of the corporation or unincorporated association to be served; or to an agent authorized by appointment or by law to receive service; or
(3) By delivery to an address. If the document cannot be served in person or by mail as provided in paragraph (b)(1) or (b)(2) of this section, a copy of the document may be left at the principal office or place of business of the person, partnership, corporation, unincorporated association, or authorized agent with an officer or a managing or general agent; or it may be left with a person of suitable age and discretion residing therein, at the residence of the person or of a member of the partnership or of an executive officer, director, or agent of the corporation or unincorporated association to be served; or
(4) By publication in the
(c) Service of other documents. Except as otherwise provided in paragraph (b) of this section, when service of a document starts the running of a prescribed period of time for the submission of a responsive document or the occurrence of an event, the document may be served as provided in paragraph (b) of this section or by ordinary first-class mail, properly addressed, postage prepaid.
(d) Service on a representative. When a party has appeared by an attorney or other representative, service upon that attorney or other representative shall constitute service upon the party.
(e) Certificate of service. The original of every document filed with the Commission and required to be served upon all parties to any proceedings, as well as participants if so directed by the Presiding Officer, shall be accompanied by a certificate of service signed by the party making service, stating that such service has been made upon each party and participant to the proceedings. Certificates of service may be in substantially the following form:
I hereby certify that I have served the attached document upon all parties and participants of record in these proceedings by mailing, postage prepaid, (or by delivering in person) a copy to each on
(f) Date of service. The date of service of a document shall be the date on which the document is deposited with the United States Postal Service, postage prepaid, or is delivered in person.
§ 1025.17 Intervention.
(a) Participation as an intervenor. Any person who desires to participate as a party in any proceedings subject to these rules shall file a written petition for leave to intervene with the Secretary and shall serve a copy of the petition on each party.
(1) A petition shall ordinarily be filed not later than the convening of the first prehearing conference. A petition filed after that time will not be granted unless the Presiding Officer determines that the petitioner has made a substantial showing of good cause for failure to file on time.
(2) A petition shall:
(i) Identify the specific aspect or aspects of the proceedings as to which the petitioner wishes to intervene,
(ii) Set forth the interest of the petitioner in the proceedings,
(iii) State how the petitioner’s interest may be affected by the results of the proceedings, and
(iv) State any other reasons why the petitioner should be permitted to intervene as a party, with particular reference to the factors set forth in paragraph (d) of this section. Any petition relating only to matters outside the jurisdiction of the Commission shall be denied.
(3) Any person whose petition for leave to intervene is granted by the Presiding Officer shall be known as an “intervenor” and as such shall have the full range of litigating rights afforded to any other party.
(b) Participation by a person not an intervenor. Any person who desires to participate in the proceedings as a non-party shall file with the Secretary a request to participate in the proceedings and shall serve a copy of such request on each party to the proceedings.
(1) A request shall ordinarily be filed not later than the commencement of the hearing. A petition filed after that time will not be granted unless the Presiding Officer determines that the person making the request has made a substantial showing of good cause for failure to file on time.
(2) A request shall set forth the nature and extent of the person’s alleged interest in the proceedings. Any request relating only to matters outside the jurisdiction of the Commission shall be denied.
(3) Any person who files a request to participate in the proceedings as a non-party and whose request is granted by the Presiding Officer shall be known as a “Participant” and shall have the right to participate in the proceedings to the extent of making a written or oral statement of position, filing proposed findings of fact, conclusions of law and a post hearing brief with the Presiding Officer, and filing an appellate brief before the Commission if an appeal is taken by a party or review is ordered by the Commission in accordance with § 1025.53 or § 1025.54, as applicable, of these rules.
(c) Response to petition to intervene. Any party may file a response to a petition for leave to intervene after the petition is filed with the Secretary, with particular reference to the factors set forth in paragraph (d) of this section.
(d) Ruling by Presiding Officer on petition. In ruling on a petition for leave to intervene, the Presiding Officer shall consider, in addition to all other relevant matters, the following factors:
(1) The nature of the petitioner’s interest, under the applicable statute governing the proceedings, to be made a party to the proceedings;
(2) The nature and extent of the petitioner’s interest in protecting himself/herself/itself or the public against unreasonable risks of injury associated with consumer products;
(3) The nature and extent of the petitioner’s property, financial or other substantial interest in the proceedings;
(4) Whether the petitioner would be aggrieved by any final order which may be entered in the proceedings;
(5) The extent to which the peititioner’s intervention may reasonably be expected to assist in developing a sound record;
(6) The extent to which the petitioner’s interest will be represented by existing parties;
(7) The extent to which the petitioner’s intervention may broaden the issues or delay the proceedings; and
(8) The extent to which the petitioner’s interest can be protected by other available means.
(e) Ruling by Presiding Officer on request. In ruling on a request to participate as a participant, the Presiding Officer, in the exercise of his/her discretion, shall be mindful of the Commission’s mandate under its enabling legislation (see 15 U.S.C. 2051 et seq.) and its affirmative desire to afford interested persons, including consumers and consumer organizations, as well as governmental entities, an opportunity to participate in the agency’s regulatory processes, including adjudicative proceedings. The Presiding Officer shall consider, in addition to all other relevant matters, the following factors:
(1) The nature and extent of the person’s alleged interest in the proceedings;
(2) The possible effect of any final order which may be entered in the proceedings on the person’s interest; and
(3) The extent to which the person’s participation can be expected to assist the Presiding Officer and the Commission in rendering a fair and equitable resolution of all matters in controversy in the proceedings.
(f) Designation of single representative. If the Presiding Officer determines that a petitioner pursuant to paragraph (a) of this section or a person requesting to participate pursuant to paragraph (b) of this section is a member of a class of prospective intervenors or participants, as applicable, who share an identity of interest, the Presiding Officer may limit such intervention or participation, as applicable, through designation of a single representative by the prospective intervenors or participants, as applicable, or, if they are unable to agree, by designation of the Presiding Officer.
§ 1025.18 Class actions.
(a) Prerequisites to a class action. One or more members of a class of respondents may be proceeded against as representative parties on behalf of all respondents if:
(1) The class is so numerous or geographically dispersed that joinder of all members is impracticable;
(2) There are questions of fact or issues of law common to the class;
(3) The defenses of the representative parties are typical of the defenses of the class; and
(4) The representative parties will fairly and adequately protect the interests of the class.
(b) Composition of class. A class may be composed of:
(1) Manufacturers, distributors, or retailers, or a combination of them, of products which allegedly have the same defect, or
(2) Manufacturers, distributors, or retailers, or a combination of them, of products which allegedly fail to conform to an applicable standard, regulation, or consumer product safety rule, or
(3) Manufacturers, distributors, or retailers, or a combination of them, who have themselves allegedly failed to conform to an applicable standard, regulation, or consumer product safety rule.
(c) Notice of commencement. A complaint issued under this section shall identify the class, the named respondents considered to be representative of the class, and the alleged defect or nonconformity common to the products manufactured, imported, distributed or sold by the members of the class. The complaint shall be served upon the parties in accordance with § 1025.16.
(d) Proper class action determination. Upon motion of Complaint Counsel and as soon as practicable after the commencement of any proceedings brought as a class action, the Presiding Officer shall determine by order whether the action is a proper class action. It is a proper class action if the prerequisites of paragraph (a) of this section are met and if the Presiding Officer finds that:
(1) The prosecution of separate actions against individual members of the respondent class might result in (i) inconsistent or varying determinations with respect to individual members of the class which might produce incompatible or conflicting results, or (ii) determinations with respect to individual members of the class which would, as a practical matter, be dispositive of the interests of the other members who are not parties to the proceedings or would substantially impair or impede the ability of the absent members to protect their interests; or
(2) The Commission has acted on grounds generally applicable to the class, thereby making appropriate an order directed to the class as a whole.
(e) Revision of class membership. Upon motion of any party or any member of the class, or upon the Presiding Officer’s own initiative, the Presiding Officer may revise the membership of the class.
(f) Orders in conduct of class actions. In proceedings to which this section applies, the Presiding Officer may make appropriate orders:
(1) Determining the course of the proceedings or prescribing measures to prevent undue repetition and promote the efficient presentation of evidence or argument;
(2) Requiring (for the protection of the members of the class, or otherwise for the fair conduct of the action) that notice be given, in such manner as the Presiding Officer may direct, of any step in the action, of the extent of the proposed order, or of the opportunity for members to inform the Presiding Officer whether they consider the representation to be fair and adequate, or of the opportunity for class members to intervene and present defenses;
(3) Requiring that the pleadings be amended to eliminate allegations concerning the representation of absent persons; or
(4) Dealing with other procedural matters.
(g) Scope of final order. In any proceedings maintained as a class action, any Decision and Order of the Presiding Officer or the Commission under § 1025.51 or § 1025.55, as applicable, whether or not favorable to the class, shall include and describe those respondents whom the Presiding Officer or the Commission finds to be members of the class.
(h) Notice of results. Upon the termination of any adjudication that has been maintained as a class action, the best notice practicable of the results of the adjudication shall be given to all members of the class in such manner as the Presiding Officer or the Commission directs.
§ 1025.19 Joinder of proceedings.
Two or more matters which have been scheduled for adjudicative proceedings and which involve similar issues may be consolidated for the purpose of hearing or Commission review. A motion for consolidation may be filed by any party to such proceedings not later than thirty (30) days prior to the hearing and served upon all parties to all proceedings in which joinder is contemplated. The motion may include a request that the consolidated proceedings be maintained as a class action in accordance with § 1025.18 of these rules. The proceedings may be consolidated to such extent and upon such terms as may be proper. Such consolidation may also be ordered upon the initiative of the Presiding Officer or the Commission. Single representatives may be designated by represented parties, intervenors, and participants with an identity of interests.
Subpart C—Prehearing Procedures, Motions, Interlocutory Appeals, Summary Judgments, Settlements
§ 1025.21 Prehearing conferences.
(a) When held. Except when the presiding officer determines that unusual circumstances would render it impractical or valueless, a prehearing conference shall be held in person or by conference telephone call within fifty (50) days after publication of the complaint in the
(1) Petitions for leave to intervene;
(2) Motions, including motions for consolidation of proceedings and for certification of class actions;
(3) Identification, simplification and clarification of the issues;
(4) Necessity or desirability of amending the pleadings;
(5) Stipulations and admissions of fact and of the content and authenticity of documents;
(6) Oppositions to notices of depositions;
(7) Motions for protective orders to limit or modify discovery;
(8) Issuance of subpoenas to compel the appearance of witnesses and the production of documents;
(9) Limitation of the number of witnesses, particularly to avoid duplicate expert witnesses;
(10) Matters of which official notice should be taken and matters which may be resolved by reliance upon the laws administered by the Commission or upon the Commission’s substantive standards, regulations, and consumer product safety rules;
(11) Disclosure of the names of witnesses and of documents or other physical exhibits which are intended to be introduced into evidence;
(12) Consideration of offers of settlement;
(13) Establishment of a schedule for the exchange of final witness lists, prepared testimony and documents, and for the date, time and place of the hearing, with due regard to the convenience of the parties; and
(14) Such other matters as may aid in the efficient presentation or disposition of the proceedings.
(b) Public notice. The Presiding Officer shall cause a notice of the first prehearing conference, including a statement of the issues, to be published in the
(c) Additional conferences. Additional prehearing conferences may be convened at the discretion of the Presiding Officer, upon notice to the parties, any participants, and to the public.
(d) Reporting. Prehearing conferences shall be stenographically reported as provided in § 1025.47 of these rules and shall be open to the public, unless otherwise ordered by the Presiding Officer or the Commission.
(e) Prehearing orders. The Presiding Officer shall issue a final prehearing order in each case after the conclusion of the final prehearing conference. The final prehearing order should contain, to the fullest extent possible at that time, all information which is necessary for controlling the course of the hearing. The Presiding Officer may require the parties to submit a jointly proposed final prehearing order, such as in the format set forth in appendix I.
§ 1025.22 Prehearing briefs.
Not later than ten (10) days prior to the hearing, unless otherwise ordered by the Presiding Officer, the parties may simultaneously serve and file prehearing briefs which should set forth:
(a) A statement of the facts expected to be proved and of the anticipated order of proof;
(b) A statement of the issues and the legal arguments in support of the party’s contentions with respect to each issue; and
(c) A table of authorities relied upon.
§ 1025.23 Motions.
(a) Presentation and disposition. During the time a matter in adjudication is before the Presiding Officer, all motions, whether oral or written, except those filed under § 1025.42(e), shall be addressed to the Presiding Officer, who shall rule upon them promptly, after affording an opportunity for response.
(b) Written motions. All written motions shall state with particularity the order, ruling, or action desired and the reasons why the action should be granted. Memoranda, affidavits, or other documents supporting a motion shall be served and filed with the motion. All motions shall contain a proposed order setting forth the relief sought. All written motions shall be filed with the Secretary and served upon all parties, and all motions addressed to the Commission shall be in writing.
(c) Opposition to motions. Within ten (10) days after service of any written motion or petition or within such longer or shorter time as may be designated by these Rules or by the Presiding Officer or the Commission, any party who opposes the granting of the requested order, ruling or action may file a written response to the motion. Failure to respond to a written motion may, in the discretion of the Presiding Officer, be considered as consent to the granting of the relief sought in the motion. Unless otherwise permitted by the Presiding Officer or the Commission, there shall be no reply to the response expressing opposition to the motion.
(d) Rulings on motions for dismissal. When a motion to dismiss a complaint or a motion for other relief is granted, with the result that the proceedings before the Presiding Officer are terminated, the Presiding Officer shall issue an Initial Decision and Order in accordance with the provisions of § 1025.51. If such a motion is granted as to all issues alleged in the complaint in regard to some, but not all, respondents or is granted as to any part of the allegations in regard to any or all respondents, the Presiding Officer shall enter an order on the record and consider the remaining issues in the Initial Decision. The Presiding Officer may elect to defer ruling on a motion to dismiss until the close of the case.
§ 1025.24 Interlocutory appeals.
(a) General. Rulings of the Presiding Officer may not be appealed to the Commission prior to the Initial Decision, except as provided in this section.
(b) Exceptions. (1) Interlocutory appeals to Commission. The Commission may, in its discretion, consider interlocutory appeals where a ruling of the Presiding Officer:
(i) Requires the production of records claimed to be confidential;
(ii) Requires the testimony of a supervisory official of the Commission other than one especially knowledgeable of the facts of the matter in adjudication;
(iii) Excludes an attorney from participation in any proceedings pursuant to § 1025.42(b);
(iv) Denies or unduly limits a petition for intervention pursuant to the provisions of § 1025.17.
(2) Procedure for interlocutory appeals. Within ten (10) days of issuance of a ruling other than one ordering the production of records claimed to be confidential, any party may petition the Commission to consider an interlocutory appeal of a ruling in the categories enumerated above. The petition shall not exceed fifteen (15) pages. Any other party may file a response to the petition within ten (10) days of its service except where the order appealed from requires the production of records claimed to be confidential. The response shall not exceed fifteen (15) pages. The Commission shall decide the petition or may request such further briefing or oral presentation as it deems necessary.
(3) If the Presiding Officer orders the production of records claimed to be confidential a petition for interlocutory appeal shall be filed within five (5) days of the entry of the order. Any opposition to the petition shall be filed within five (5) days of service of the petition. The order of the Presiding Officer shall be automatically stayed until five (5) days following the date of entry of the order to allow an affected party the opportunity to file a petition with the Commission for an interlocutory appeal pursuant to § 1025.24(b)(2). If an affected party files a petition with the Commission pursuant to § 1025.24(b)(2) within the 5-day period, the stay of the Presiding Officer’s order is automatically extended until the Commission decides the petition.
(4) Interlocutory appeals from all other rulings—(i) Grounds. Interlocutory appeals from all other rulings by the Presiding Officer may proceed only upon motion to the Presiding Officer and a determination by the Presiding Officer in writing that the ruling involves a controlling question of law or policy as to which there is substantial ground for differences of opinion and that an immediate appeal from the ruling may materially advance the ultimate termination of the litigation, or that subsequent review will be an inadequate remedy. The Presiding Officer’s certification shall state the reasons for the determination.
(ii) Form. If the Presiding Officer makes the determination described in paragraph (b)(4)(i) of this section, a petition for interlocutory appeal under this subparagraph may be filed in accordance with paragraph (b)(2) of this section.
(c) Proceedings not stayed. Except as otherwise provided under this section, a petition for interlocutory appeal shall not stay the proceedings before the Presiding Officer unless the Presiding Officer or the Commission so orders.
§ 1025.25 Summary decisions and orders.
(a) Motion. Any party may file a motion, with a supporting memorandum, for a Summary Decision and Order in its favor upon all or any of the issues in controversy. Complaint Counsel may file such a motion at any time after thirty (30) days following issuance of a complaint, and any other party may file a motion at any time after issuance of a complaint. Any such motion by any party shall be filed at least twenty (20) days before the date fixed for the adjudicative hearing.
(b) Response to motion. Any other party may, within twenty (20) days after service of the motion, file a response with a supporting memorandum.
(c) Grounds. A Summary Decision and Order shall be granted if the pleadings and any depositions, answers to interrogatories, admissions, or affidavits show that there is no genuine issue as to any material fact and that the moving party is entitled to a Summary Decision and Order as a matter of law.
(d) Legal effect. A Summary Decision and Order upon all the issues being adjudicated shall constitute the Initial Decision of the Presiding Officer and may be appealed to the Commission in accordance with § 1025.53 of these rules. A Summary Decision, interlocutory in character, may be rendered on fewer than all issues and may not be appealed prior to issuance of the Initial Decision.
(e) Case not fully adjudicated on motion. A Summary Decision and order that does not dispose of all issues shall include a statement of those material facts about which there is no substantial controversy and of those material facts that are actually and in good faith controverted. The Summary Order shall direct such further proceedings as are appropriate.
§ 1025.26 Settlements.
(a) Availability. Any party shall have the opportunity to submit an offer of settlement to the Presiding Officer.
(b) Form. Offers of settlement shall be filed in camera and the form of a consent agreement and order, shall be signed by the respondent or respondent’s representative, and may be signed by any other party. Each offer of settlement shall be accompanied by a motion to transmit the proposed agreement and order to the Commission. The motion shall outline the substantive provisions of the agreement and state reasons why it should be accepted by the Commission.
(c) Contents. The proposed consent agreement and order which constitute the offer of settlement shall contain the following:
(1) An admission of all jurisdictional facts;
(2) An express waiver of further procedural steps and of all rights to seek judicial review or otherwise to contest the validity of the Commission order;
(3) Provisions that the allegations of the complaint are resolved by the consent agreement and order;
(4) A description of the alleged hazard, noncompliance, or violation;
(5) If appropriate, a listing of the acts or practices from which the respondent shall refrain; and
(6) If appropriate, a detailed statement of the corrective action(s) which the respondent shall undertake. In proceedings arising under Section 15 of the Consumer Product Safety Act, 15 U.S.C. 2064, this statement shall contain all the elements of a “Corrective Action Plan,” as outlined in the Commission’s Interpretation, Policy, and Procedure for Substantial Product Hazards, 16 CFR part 1115.
(d) Transmittal. The Presiding Officer may transmit to the Commission for decision all offers of settlement and accompanying memoranda that meet the requirements enumerated in paragraph (c) of this section. The Presiding Officer shall consider whether an offer of settlement is clearly frivolous, duplicative of offers previously made and rejected by the Commission or contrary to establish Commission policy. The Presiding Officer may, but need not, recommend acceptance of offers. Any party may object to the transmittal to the Commission of a proposed consent agreement by filing a response opposing the motion.
(e) Stay of proceedings. When an offer of settlement has been agreed to by all parties and has been transmitted to the Commission, the proceedings shall be stayed until the Commission has ruled on the offer. When an offer of settlement has been made and transmitted to the Commission but has not been agreed to by all parties, the proceedings shall not be stayed pending Commission decision on the offer, unless otherwise ordered by the Presiding Officer or the Commission.
(f) Commission ruling. The Commission shall rule upon all transmitted offers of settlement. If the Commission accepts the offer, the Commission shall issue an appropriate order, which shall become effective upon issuance.
(g) Commission rejection. If the Commission rejects an offer of settlement, the Secretary, in writing, shall give notice of the Commission’s decision to the parties and the Presiding Officer. If the proceedings have been stayed, the Presiding Officer shall promptly issue an order notifying the parties of the resumption of the proceedings, including any modifications to the schedule resulting from the stay of the proceedings.
(h) Effect of rejected offer. Neither rejected offers of settlement, nor the fact of the proposal of offers of settlement are admissible in evidence.
Subpart D—Discovery, Compulsory Process
§ 1025.31 General provisions governing discovery.
(a) Applicability. The discovery rules established in this subpart are applicable to the discovery of information among the parties in any proceedings. Parties seeking information from persons not parties may do so by subpoena in accordance with § 1025.38 of these rules.
(b) Discovery methods. Parties may obtain discovery by one or more of the following methods:
(1) Written interrogatories;
(2) Requests for production of documents or things;
(3) Requests for admission; or
(4) Depositions upon oral examination.
(c) Scope of discovery. The scope of discovery is as follows:
(1) In general. Parties may obtain discovery regarding any matter, not privileged, which is within the Commission’s statutory authority and is relevant to the subject matter involved in the proceedings, whether it relates to the claim or defense of the party seeking discovery or to the claim or defense of any other party, including the existence, description, nature, custody, condition and location of any books, documents, or other tangible things and the identity and location of persons having knowledge of any discoverable matter. It is not ground for objection that the information sought will be inadmissible at the hearing if the information sought appears reasonably calculated to lead to the discovery of admissible evidence.
(2) Privilege. Discovery may be denied or limited, or a protective order may be entered, to preserve the privilege of a witness, person, or governmental agency as governed by the Constitution, any applicable Act of Congress, or the principles of the common law as they may be interpreted by the Commission in the light of reason and experience.
(3) Hearing preparation: materials. Subject to the provisions of paragraph (c)(4) of this section, a party may obtain discovery of documents and tangible things otherwise discoverable under paragraph (c)(1) of this section and prepared in anticipation of litigation or for hearing by or for another party or by or for that other party’s representative (including his attorney or consultant) only upon a showing that the party seeking discovery has substantial need of the materials in the preparation of his case and that he is unable without unique hardship to obtain the substantial equivalent of the materials by other means. In ordering discovery of such materials when the required showing has been made, the Presiding Officer shall protect against disclosure of the mental impressions, conclusions, opinions, or legal theories of an attorney or other representative of a party.
(4) Hearing preparation: experts. Discovery of facts known and opinions held by experts, otherwise discoverable under the provisions of paragraph (c)(1) of this section and acquired or developed in anticipation of litigation or for trial, may be obtained only as follows:
(i)(A) A party may through interrogatories require any other party to identify each person whom the other party expects to call as an expert witness at trial, to state the subject matter on which the expert is expected to testify, to state the substance of the facts and opinions to which the expert is expected to testify, and to provide a summary of the grounds for each opinion.
(B) Upon motion, the Presiding Officer may order further discovery by other means upon a showing of substantial cause and may exercise discretion to impose such conditions, if any, as are appropriate in the case.
(ii) A party may discover facts known or opinions held by an expert who has been retained or specially employed by another party in anticipation of litigation or preparation for trial and who is not expected to be called as a witness at trial only upon a showing of exceptional circumstances under which it is impracticable for the party seeking discovery to obtain facts or opinions on the same subject by other means.
(iii) The Presiding Officer may require as a condition of discovery that the party seeking discovery pay the expert a reasonable fee, but not more than the maximum specified in 5 U.S.C. 3109 for the time spent in responding to discovery.
(d) Protective orders. Upon motion by a party and for good cause shown, the Presiding Officer may make any order which justice requires to protect a party or person from annoyance, embarrassment, competitive disadvantage, oppression, or undue burden or expense, including one or more of the following:
(1) That the discovery shall not be had;
(2) That the discovery may be had only on specified terms and conditions, including a designation of the time or place;
(3) That the discovery shall be had only by a method of discovery other than that selected by the party seeking discovery;
(4) That certain matters shall not be inquired into or that the scope of discovery shall be limited to certain matters;
(5) That discovery shall be conducted with no one present except persons designated by the Presiding Officer;
(6) That a trade secret or other confidential research, development, or commercial information shall not be disclosed or shall be disclosed only in a designated way or only to designated parties; and
(7) That responses to discovery shall be placed in camera in accordance with § 1025.45 of these rules.
(e) Sequence and timing of discovery. Discovery may commence at any time after filing of the answer. Unless otherwise provided in these Rules or by order of the Presiding Officer, methods of discovery may be used in any sequence and the fact that a party is conducting discovery, whether by deposition or otherwise, shall not operate to delay any other party’s discovery.
(f) Supplementation of responses. A party who has responded to a request for discovery with a response that was complete when made is under a duty to supplement that response to include information later obtained.
(g) Completion of discovery. All discovery shall be completed as soon as practical but in no case longer than one hundred fifty (150) days after issuance of a complaint, unless otherwise ordered by the Presiding Officer in exceptional circumstances and for good cause shown. All discovery shall be commenced by a date which affords the party from whom discovery is sought the full response period provided by these Rules.
(h) Service and filing of discovery. All discovery requests and written responses, and all notices of deposition, shall be filed with the Secretary and served on all parties and the Presiding Officer.
(i) Control of discovery. The use of these discovery procedures is subject to the control of the Presiding Officer, who may issue any just and appropriate order for the purpose of ensuring their timely completion.
§ 1025.32 Written interrogatories to parties.
(a) Availability; procedures for use. Any party may serve upon any other party written interrogatories to be answered by the party served or, if the party served is a public or private corporation or a partnership or unincorporated association or governmental entity, by any officer or agent, who shall furnish such information as is available to the party. Interrogatories may, without leave of the Presiding Officer, be served upon any party after the filing of an answer.
(b) Procedures for response. Each interrogatory shall be answered separately and fully in writing under oath, unless it is objected to, in which event the reasons for objection shall be stated in lieu of an answer. Each answer shall be submitted in double-spaced typewritten form and shall be immediately preceded by the interrogatory, in single-spaced typewritten form, to which the answer is responsive. The answers are to be signed by the person making them, and the objections signed by the person or representative making them. The party upon whom the interrogatories have been served shall serve a copy of the answers, and objections if any, within 30 days after service of the interrogatories. The Presiding Officer may allow a shorter or longer time for response. The party submitting the interrogatories may move for an order under § 1025.36 of these rules with respect to any objection to, or other failure to answer fully, an interrogatory.
(c) Scope of interrogatories. Interrogatories may relate to any matters which can be inquired into under § 1025.31(c), and the answers may be used to any extent permitted under these rules. An interrogatory otherwise proper is not objectionable merely because an answer to the interrogatory would involve an opinion or contention which relates to fact or to the application of law to fact, but the Presiding Officer may order that such an interrogatory need not be answered until a later time.
(d) Option to produce business records. Where the answer to an interrogatory may be derived or ascertained from the business records of the party upon whom the interrogatory has been served, or from an examination, audit, or inspection of such business records, or from a compilation, abstract, or summary of those records, and the burden of deriving the answer is substantially the same for the party serving the interrogatory as for the party served, it is a sufficient answer to the interrogatory to specify the records from which the answer may be derived or ascertained and to afford to the party serving the interrogatory reasonable opportunity to examine, audit, or inspect such records and to make copies, compilations, abstracts, or summaries.
§ 1025.33 Production of documents and things.
(a) Scope. Any party may serve upon any other party a request:
(1) To produce and permit the party making the request, or someone acting on behalf of that party, to inspect and copy any designated documents (including writings, drawings, graphs, charts, photographs, phono-records, and any other data compilation from which information can be obtained, translated, if necessary, by the party in possession through detection devices into reasonably usable form), or to inspect and copy, test, or sample any tangible things which constitute or contain matters within the scope of § 1025.31(c) and which are in the possession, custody, or control of the party upon whom the request is served, or
(2) To permit entry upon designated land or other property in the possession or control of the party upon whom the request is served for the purpose of inspection (including photographing), or sampling any designated object or operation within the scope of § 1025.31(c).
(b) Procedure for request. The request may be served at any time after the filing of an answer without leave of the Presiding Officer. The request shall set forth the items to be inspected, either by individual item or by category, and shall describe each item or category with reasonable particularity. The request shall specify a reasonable time, place, and manner for making the inspection and performing the related acts.
(c) Procedure for response. The party upon whom the request is served shall respond in writing within thirty (30) days after service of the request. The Presiding Officer may allow a shorter or longer time for response. The response shall state, with respect to each item or category requested, that inspection and related activities will be permitted as requested, unless the request is objected to, in which event the reasons for objection shall be stated. If objection is made to only part of an item or category, that part shall be specified. The party submitting the request may move for an order under § 1025.36 with respect to any objection to or other failure to respond to the request or any part thereof, or to any failure to permit inspection as requested.
(d) Persons not parties. This section does not preclude an independent action against a person not a party for production of documents and things.
§ 1025.34 Requests for admission.
(a) Procedure for request. A party may serve upon any other party a written request for the admission, for the purposes of the pending proceedings only, of the truth of any matters within the scope of § 1025.31(c) set forth in the request that relate to statements of fact or of the application of law to fact, including the genuineness of any documents described in the request. Copies of documents shall be served with the request unless they have been or are otherwise furnished or made available for inspection and copying. The request may, without leave of the Presiding Officer, be served upon any party after filing of the answer. Each matter about which an admission is requested shall be separately set forth.
(b) Procedure for response. The matter about which an admission is requested will be deemed admitted unless within thirty (30) days after service of the request, or within such shorter or longer time as the Presiding Officer may allow, the party to whom the request is directed serves upon the party requesting the admission a written answer or objection addressed to the matter, signed by the party or the party’s representative and stating the reasons for the objections. The answer shall specifically admit or deny the matter or set forth in detail the reasons why the answering party cannot truthfully admit or deny the matter. A denial shall fairly meet the substance of the requested admission. When good faith requires that a party qualify an answer or deny only a part of the matter to which an admission is requested, the party shall specify the portion that is true and qualify or deny the remainder. An answering party may not give lack of information or knowledge as a reason for failure to admit or deny a fact unless the party states that he/she has made reasonable inquiry and that the information known or readily available to him/her is insufficient to enable him/her to admit or deny a fact. A party who considers that a matter to which an admission has been requested presents a genuine issue for hearing may not, on that ground alone, object to the request but may deny the matter or set forth reasons why the party cannot admit or deny it. The party who has requested an admission may move to determine the sufficiency of any answer or objection in accordance with § 1025.36 of these Rules. If the Presiding Officer determines that an answer does not comply with the requirements of this section, he/she may order that the matter be deemed admitted or that an amended answer be served.
(c) Effect of admission. Any matter admitted under this section is conclusively established unless the Presiding Officer on motion permits withdrawal or amendment of such admission. The Presiding Officer may permit withdrawal or amendment when the presentation of the merits of the action will be served thereby and the party who obtained the admission fails to satisfy the Presiding Officer that withdrawal or amendment will prejudice that party in maintaining an action or defense on the merits. Any admission made by a party under this section is for the purposes of the pending adjudication only and is not an admission by that party for any other purposes, nor may it be used against that party in any other proceedings.
§ 1025.35 Depositions upon oral examination.
(a) When depositions may be taken. At any time after the first prehearing conference, upon leave of the Presiding Officer and under such terms and conditions as the Presiding Officer may prescribe, any party may take the deposition of any other party, including the agents, employees, consultants, or prospective witnesses of that party at a place convenient to the deponent. The attendance of witnesses and the production of documents and things at the deposition may be compelled by subpoena as provided in § 1025.38 of these rules.
(b) Notice of deposition—(1) Deposition of a party. A party desiring to take a deposition of another party to the proceedings shall, after obtaining leave from the Presiding Officer, serve written notice of the deposition on all other parties and the Presiding Officer at least ten (10) days before the date noticed for the deposition. The notice shall state:
(i) The time and place for the taking of the deposition;
(ii) The name and address of each person to be deposed, if known, or if the name is not known, a general description sufficient to identify him/her; and
(iii) The subject matter of the expected testimony. If a subpoena duces tecum is to be served on the person to be deposed, the designation of the materials to be produced, as set forth in the subpoena, shall be attached to or included in the notice of deposition.
(2) Deposition of a non-party. A party desiring to take a deposition of a person who is not a party to the proceedings shall make application for the issuance of a subpoena, in accordance with § 1025.38 of these rules, to compel the attendance, testimony, and/or production of documents by such non-party. The paty desiring such deposition shall serve written notice of the deposition on all other parties to the proceedings, after issuance of the subpoena. The date specified in the subpoena for the deposition shall be at least twenty (20) days after the date on which the application for the subpoena is made to the Presiding Officer.
(3) Opposition to notice. A person served with a notice of deposition may oppose, in writing, the taking of the deposition within five (5) days of service of the notice. The Presiding Officer shall rule on the notice and any opposition and may order the taking of all noticed depositions upon a showing of good cause. The Presiding Officer may, for good cause shown, enlarge or shorten the time for the taking of a deposition.
(c) Persons before whom depositions may be taken. Depositions may be taken before any person who is authorized to administer oaths by the laws of the United States or of the place where the examination is held. No deposition shall be taken before a person who is a relative, employee, attorney, or representative of any party, or who is a relative or employee of such attorney or representative, or who is financially interested in the action.
(d) Taking of deposition—(1) Examination. Each deponent shall testify under oath, and all testimony shall be recorded. All parties or their representatives may be present and participate in the examination. Evidence objected to shall be taken subject to any objection. Objections shall include the grounds relied upon. The questions and answers, together with all objections made, shall be recorded by the official reporter before whom the deposition is taken. The original or a verified copy of all documents and things produced for inspection during the examination of the deponent shall, upon a request of any party present, be marked for identification and made a part of the record of the deposition.
(2) Motion to terminate or limit examination. At any time during the deposition, upon motion of any party or of the deponent, and upon a showing that the examination is being conducted in bad faith or in such manner as unreasonably to annoy, embarrass or oppress the deponent or party, the Presiding Officer may order the party conducting the examination to stop the deposition or may limit the scope and manner of taking the deposition as provided in § 1025.31(d) of these rules.
(3) Participation by parties not present. In lieu of attending a deposition, any party may serve written questions in a sealed envelope on the party conducting the deposition. That party shall transmit the envelope to the official reporter, who shall unseal it and read the questions to the deponent.
(e) Transcription and filing of depositions—(1) Transcription. Upon request by any party, the testimony recorded at a deposition shall be transcribed. When the testimony is fully transcribed, the deposition shall be submitted to the deponent for examination and signature and shall be read to or by the deponent, unless such examination and signature are waived by the deponent. Any change in form or substance which the deponent desires to make shall be entered upon the deposition by the official reporter with a statement of the reasons given by the deponent for making them. The deposition shall then be signed by the deponent, unless the deponent waives signature or is ill or cannot be found or refuses to sign. If the deposition is not signed by the deponent within thirty (30) days of its submission to him/her, the official reporter shall sign the deposition and state on the record the fact of the waiver of signature or of the illness or absence of the deponent or of the refusal to sign, together with a statement of the reasons therefor. The deposition may then be used as fully as though signed, in accordance with paragraph (i) of this section.
(2) Certification and filing. The official reporter shall certify on the deposition that it was taken under oath and that the deposition is a true record of the testimony given and corrections made by the deponent. The official reporter shall then seal the deposition in an envelope endorsed with the title and docket number of the action and marked “Deposition of [name of deponent]” and shall promptly file the deposition with the Secretary. The Secretary shall notify all parties of the filing of the deposition and shall furnish a copy of the deposition to any party or to the deponent upon payment of reasonable charges.
(f) Costs of deposition. The party who notices the deposition shall pay for the deposition. The party who requests transcription of the deposition shall pay for the transcription.
(g) Failure to attend or to serve subpoena; expenses. If a party who notices a deposition fails to attend or conduct the deposition, and another party attends in person or by a representative pursuant to the notice, the Presiding Officer may order the party who gave the notice to pay to the attending party the reasonable expenses incurred. If a party who notices a deposition fails to serve a subpoena upon the deponent and as a result the deponent does not attend, and if another party attends in person or by a representative because that party expects the deposition to be taken, the Presiding Officer may order the party who gave notice to pay to the attending party the reasonable expenses incurred.
(h) Deposition to preserve testimony—(1) When available. By leave of the Presiding Officer, a party may take the deposition of his/her own witness for the purpose of perpetuating the testimony of that witness. A party who wishes to conduct such a deposition shall obtain prior leave of the Presiding Officer by filing a motion. The motion shall include a showing of substantial reason to believe that the testimony could not be presented at the hearing. If the Presiding Officer is satisfied that the perpetuation of the testimony may prevent a failure of justice or is otherwise reasonably necessary, he/she shall order that the deposition be taken.
(2) Procedure. Notice of a deposition to preserve testimony shall be served at least fifteen (15) days prior to the deposition unless the Presiding Officer authorizes less notice when warranted by extraordinary circumstances. The deposition shall be taken in accordance with the provisions of paragraph (d) of this section. Any deposition taken to preserve testimony shall be transcribed and filed in accordance with paragraph (e) of this section.
(i) Use of depositions. At the hearing or upon a petition for interlocutory appeal, any part or all of a deposition may be used against any party who was present or represented at the deposition or who had reasonable notice of the deposition, in accordance with any of the following:
(1) Any deposition may be used by any party for the purpose of contradicting or impeaching the testimony of the deponent as a witness.
(2) The deposition of anyone who at the time of the taking of the deposition was an officer, director, managing agent, or person otherwise designated to testify on behalf of a public or private corporation, partnership or unincorporated association or governmental entity which is a party to the proceedings, may be used by any adverse party for any purpose.
(3) The deposition of a witness may be used by any party for any purpose if the Presiding Officer finds:
(i) That the witness is dead; or
(ii) That the witness is out of the United States, unless it appears that the absence of the witness was procured by the party offering the deposition; or
(iii) That the witness is unable to attend or testify because of age, illness, infirmity, or imprisonment; or
(iv) That the party offering the depostion has been unable to procure the attendance of the witness by subpoena; or
(v) That such exceptional circumstances exist as to make it desirable, in the interest of justice and with due regard for the importance of presenting the testimony of witnesses orally during the hearing, to allow the deposition to be used.
(4) If only part of a deposition is offered in evidence by a party, any other party may move to introduce any other part of the deposition.
§ 1025.36 Motions to compel discovery.
If a party fails to respond to discovery, in whole or in part, the party seeking discovery may move within twenty (20) days for an order compelling an answer, or compelling inspection or production of documents, or otherwise compelling discovery. For purposes of this section, an evasive or incomplete response is to be treated as a failure to respond. When taking depositions, the discovering party shall continue the examination to the extent possible with respect to other areas of inquiry before moving to compel discovery.
§ 1025.37 Sanctions for failure to comply with discovery orders.
If a party fails to obey an order to provide or permit discovery, the Presiding Officer may take such action as is just, including but not limited to the following:
(a) Infer that the admission, testimony, document or other evidence would have been adverse to the party;
(b) Order that for the purposes of the proceedings, the matters regarding which the order was made or any other designated facts shall be taken to be established in accordance with the claim of the party obtaining the order;
(c) Order that the party withholding discovery not introduce into evidence or otherwise rely, in support of any claim or defense, upon the documents or other evidence withheld;
(d) Order that the party withholding discovery not introduce into evidence, or otherwise use at the hearing, information obtained in discovery;
(e) Order that the party withholding discovery forfeit its right to object to introduction and use of secondary evidence to show what the withheld admission, testimony, documents, or other evidence would have shown;
(f) Order that a pleading, or part of a pleading, or a motion or other submission by the party, concerning which the order was issued, be stricken, or that decision on the pleadings be rendered against the party, or both; and
(g) Exclude the party or representative from the proceedings, in accordance with § 1025.42(b) of these rules.
§ 1025.38 Subpoenas.
(a) Availability. A subpoena shall be addressed to any person not a party for the purpose of compelling attendance, testimony, and production of documents at a hearing or deposition, and may be addressed to any party for the same purposes.
(b) Form. A subpoena shall identify the action with which it is connected; shall specify the person to whom it is addressed and the date, time, and place for compliance with its provisions; and shall be issued by order of the Commission and signed by the Secretary or by the Presiding Officer. A subpoena duces tecum shall specify the books, papers, documents, or other materials or data-compilations to be produced.
(c) How obtained—(1) Content of application. An application for the issuance of a subpoena, stating reasons, shall be submitted in triplicate to the Presiding Officer. The Presiding Officer shall bring the application to the attention of the Commission by forwarding it or by communicating its contents by any other means, e.g., by telephone, to the Commission.
(2) Procedure for application. The original and two copies of the subpoena, marked “original,” “duplicate” and “triplicate,” shall accompany the application. The Commission shall rule upon an application for a subpoena ex parte, by issuing the subpoena or by issuing an order denying the application.
(d) Issuance of a subpoena. The Commission shall issue a subpoena by authorizing the Secretary or the Presiding Officer to sign and date each copy in the lower right-hand corner. The “duplicate” and “triplicate” copies of the subpoena shall be transmitted to the applicant for service in accordance with these Rules; the “original” shall be retained by, or be forwarded to, the Secretary for retention in the docket of the proceedings.
(e) Service of a subpoena. A subpoena may be served in person or by registered or certified mail, return receipt requested, as provided in § 1025.16(b) of these rules. Service shall be made by delivery of the signed “duplicate” copy to the person named therein.
(f) Return of service. A person serving a subpoena shall promptly execute a return of service, stating the date, time, and manner of service. If service is effected by mail, the signed return receipt shall accompany the return of service. In case of failure to make service, a statement of the reasons for the failure shall be made. The “triplicate” copy of the subpoena, bearing or accompanied by the return of service, shall be returned without delay to the Secretary after service has been completed.
(g) Motion to quash or limit subpoena. Within five (5) days of receipt of a subpoena, the person to whom it is directed may file a motion to quash or limit the subpoena, setting forth the reasons why the subpoena should be withdrawn or why it should be limited in scope. Any such motion shall be answered within five (5) days of service and shall be ruled on immediately. The order shall specify the date, if any, for compliance with the specifications of the subpoena.
(h) Consequences of failure to comply. In the event of failure by a person to comply with a subpoena, the Presiding Officer may take any of the actions enumerated in § 1025.37 of these rules, or may order any other appropriate relief to compensate for the withheld testimony, documents, or other materials. If in the opinion of the Presiding Officer such relief is insufficient, the Presiding Officer shall certify to the Commission a request for judicial enforcement of the subpoena.
§ 1025.39 Orders requiring witnesses to testify or provide other information and granting immunity.
(a) Applicability to Flammable Fabrics Act only. This section applies only to proceedings arising under the Flammable Fabrics Act.
(b) Procedure. A party who desires the issuance of an order requiring a witness or deponent to testify or provide other information upon being granted immunity from prosecution under title 18, United States Code, section 6002, may make a motion to that effect. The motion shall be made and ruled on in accordance with § 1025.23 of these rules and shall include a showing:
(1) That the testimony or other information sought from a witness or deponent, or prospective witness or deponent, may be necessary to the public interest; and
(2) That such individual has refused or is likely to refuse to testify or provide such information on the basis of that individual’s privilege against self-incrimination.
(c) Approval of the Attorney General. If the Presiding Officer determines that the witness’ testimony appears necessary and that the privilege against self-incrimination may be invoked, he/she may certify to the Commission a request that it obtain the approval of the Attorney General of the United States for the issuance of an order granting immunity.
(d) Issuance of order granting immunity. Upon application to and approval by the Attorney General of the United States, and after the witness has invoked the privilege against self-incrimination, the Presiding Officer shall issue the order granting immunity unless he/she determines that the privilege was improperly invoked.
(e) Sanctions for failure to testify. Failure of a witness to testify after a grant of immunity or after a denial of a motion for the issuance of an order granting immunity shall result in the imposition of appropriate sanctions as provided in § 1025.37 of these rules.
Subpart E—Hearings
§ 1025.41 General rules.
(a) Public hearings. All hearings conducted pursuant to these Rules shall be public unless otherwise ordered by the Commission or the Presiding Officer.
(b) Prompt completion. Hearings shall proceed with all reasonable speed and, insofar as practicable and with due regard to the convenience of the parties, shall continue without suspension until concluded, except in unusual circumstances or as otherwise provided in these Rules.
(c) Rights of parties. Every party shall have the right of timely notice and all other rights essential to a fair hearing, including, but not limited to, the rights to present evidence, to conduct such cross-examination as may be necessary for a full and complete disclosure of the facts, and to be heard by objection, motion, brief, and argument.
(d) Rights of participants. Every participant shall have the right to make a written or oral statement of position and to file proposed findings of fact, conclusions of law, and a post hearing brief, in accordance with § 1025.17(b) of these Rules.
(e) Rights of witnesses. Any person compelled to testify in any proceedings in response to a subpoena may be accompanied, represented, and advised by legal counsel or other representative, and may purchase a transcript of his/her testimony.
§ 1025.42 Powers and duties of Presiding Officer.
(a) General. A Presiding Officer shall have the duty to conduct full, fair, and impartial hearings, to take appropriate action to avoid unnecessary delay in the disposition of proceedings, and to maintain order. He/she shall have all powers necessary to that end, including the following powers:
(1) To administer oaths and affirmations;
(2) To compel discovery and to impose appropriate sanctions for failure to make discovery;
(3) To rule upon offers of proof and receive relevant, competent, and probative evidence;
(4) To regulate the course of the proceedings and the conduct of the parties and their representatives;
(5) To hold conferences for simplification of the issues, settlement of the proceedings, or any other proper purposes;
(6) To consider and rule, orally or in writing, upon all procedural and other motions appropriate in adjudicative proceedings;
(7) To issue Summary Decisions, Initial Decisions, Recommended Decisions, rulings, and orders, as appropriate;
(8) To certify questions to the Commission for its determination; and
(9) To take any action authorized by these Rules or the provisions of title 5, United States Code, sections 551-559.
(b) Exclusion of parties by Presiding Officer. A Presiding Officer shall have the authority, for good cause stated on the record, to exclude from participation in any proceedings any party, participant, or representative who violates the requirements of § 1025.66 of these rules. Any party, participant or representative so excluded may appeal to the Commission in accordance with the provisions of § 1025.24 of these rules. If the representative of a party or participant is excluded, the hearing may be suspended for a reasonable time so that the party or participant may obtain another representative.
(c) Substitution of Presiding Officer. In the event of the substitution of a new Presiding Officer for the one originally designated, any motion predicated upon such substitution shall be made within five (5) days.
(d) Interference. In the performance of adjudicative functions, a Presiding Officer shall not be responsible to or subject to the supervision or direction of any Commissioner or of any officer, employee, or agent engaged in the performance of investigative or prosecuting functions for the Commission. All directions by the Commission to a Presiding Officer concerning any adjudicative proceedings shall appear on and be made a part of the record.
(e) Disqualification of Presiding Officer. (1) When a Presiding Officer considers himself/herself disqualified to preside in any adjudicative proceedings, he/she shall withdraw by notice on the record and shall notify the Chief Administrative Law Judge and the Secretary of such withdrawal.
(2) Whenever, for good and reasonable cause, any party considers the Presiding Officer to be disqualified to preside, or to continue to preside, in any adjudicative proceedings, that party may file with the Secretary a motion to disqualify and remove, supported by affidavit(s) setting forth the alleged grounds for disqualification. A copy of the motion and supporting affidavit(s) shall be served by the Secretary on the Presiding Officer whose removal is sought. The Presiding Officer shall have ten (10) days to respond in writing to such motion. However, the motion shall not stay the proceedings unless otherwise ordered by the Presiding Officer or the Commission. If the Presiding Officer does not disqualify himself/herself, the Commission shall determine the validity of the grounds alleged, either directly or on the report of another Presiding Officer appointed to conduct a hearing for that purpose and, in the event of disqualification, shall take appropriate action by assigning another Presiding Officer or requesting loan of another Administrative Law Judge through the U.S. Office of Personnel Management.
§ 1025.43 Evidence.
(a) Applicability of Federal Rules of Evidence. Unless otherwise provided by statute or these rules, the Federal Rules of Evidence shall apply to all proceedings held pursuant to these Rules. However, the Federal Rules of Evidence may be relaxed by the Presiding Officer if the ends of justice will be better served by so doing.
(b) Burden of proof. (1) Complaint counsel shall have the burden of sustaining the allegations of any complaint.
(2) Any party who is the proponent of a legal or factual proposition shall have the burden of sustaining that proposition.
(c) Admissibility. All relevant and reliable evidence is admissible, but may be excluded by the Presiding Officer if its probative value is substantially outweighed by unfair prejudice or confusion of the issues, or by considerations of undue delay, waste of time, immateriality, or needless presentation of cumulative evidence.
(d) Official notice—(1) Definition. Official notice means use by the Presiding Officer or the Commission of facts not appearing on the record and legal conclusions drawn from those facts. An officially noticed fact or legal conclusion must be one not subject to reasonable dispute in that it is either:
(i) Generally known within the jurisdiction of the Commission or
(ii) Capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.
(2) Method of taking official notice. The Presiding Officer and/or the Commission may at any time take official notice upon motion of any party or upon its own initiative. The record shall reflect the facts and conclusions which have been officially noticed.
(e) [Reserved]
(f) Offer of proof. When an objection to proffered testimony or documentary evidence is sustained, the sponsoring party may make a specific offer, either in writing or orally, of what the party expects to prove by the testimony or the document. When an offer of proof is made, any other party may make a specific offer, either in writing or orally, of what the party expects to present to rebut or contradict the offer of proof. Written offers of proof or of rebuttal, adequately marked for identification, shall accompany the record and be available for consideration by any reviewing authority.
§ 1025.44 Expert witnesses.
(a) Definition. An expert witness is one who, by reason of education, training, experience, or profession, has peculiar knowledge concerning the subject matter to which his/her testimony relates and from which he/she may draw inferences based upon hypothetically stated facts or offer opinions from facts involving scientific or technical knowledge.
(b) Method of presenting testimony of expert witness. Except as may otherwise be ordered by the Presiding Officer, the direct testimony of an expert witness shall be in writing and shall be filed on the record and exchanged between the parties no later than ten (10) days preceding the commencement of the hearing. The written testimony of an expert witness shall be incorporated into the record and shall constitute the direct testimony of that witness. Upon a showing of good cause, the party sponsoring the expert witness may be permitted to amplify the written direct testimony during the hearing.
(c) Cross-examination and redirect examination of expert witness. Cross-examination, redirect examination, and re-cross-examination of an expert witness shall proceed in due course based upon the written testimony and any amplifying oral testimony.
(d) Failure to file or exchange written testimony. Failure to file or exchange written testimony of expert witnesses as provided in this section shall deprive the sponsoring party of the use of the expert witness and of the conclusions which that witness would have presented, unless the opposing parties consent or the Presiding Officer otherwise orders in unusual circumstances.
§ 1025.45 In camera materials.
(a) Definition. In camera materials are documents, testimony, or other data which by order of the Presiding Officer or the Commission are kept confidential and excluded from the public record.
(b) In camera treatment of documents and testimony. The Presiding Officer or the Commission shall have authority, when good cause is found on the record, to order documents or testimony offered in evidence, whether admitted or rejected, to be received and preserve in camera. The order shall specify the length of time for in camera treatment and shall include:
(1) A description of the documents or testimony;
(2) The reasons for granting in camera treatment for the specified length of time; and
(3) The terms and conditions imposed by the Presiding Official, if any, limiting access to or use of the in camera material.
(c) Access and disclosure to parties. (1) Commissioners and their staffs, Presiding Officers and their staffs, and Commission staff members concerned with judicial review shall have complete access to in camera materials. Any party to the proceedings may seek access only in accordance with paragraph (c)(2) of this section.
(2) Any party desiring access to, or disclosure of, in camera materials for the preparation and presentation of that party’s case shall make a motion which sets forth its justification. The Presiding Officer or the Commission may grant such motion for good cause shown and shall enter a protective order prohibiting unnecessary disclosure and requiring any other necessary safeguards. The Presiding Officer or the Commission may examine the in camera materials and excise any portions prior to disclosure of the materials to the moving party.
(d) Segregation of in camera materials. In camera materials shall be segregated from the public record and protected from public view.
(e) Public release of in camera materials. In camera materials constitute a part of the confidential records of the Commission and shall not be released to the public until the expiration of in camera treatment.
(f) Reference to in camera materials. In the submission of proposed findings, conclusions, briefs, or other documents, all parties shall refrain from disclosing specific details of in camera materials. However, such refraining shall not preclude general references to such materials. To the extent that parties consider necessary the inclusion of specific details of in camera materials, those references shall be incorporated into separate proposed findings, conclusions, briefs, or other documents marked “Confidential, Contains In Camera Material,” which shall be placed in camera and become part of the in camera record. Those documents shall be served only on parties accorded access to the in camera materials by these rules, the Presiding Officer, or the Commission.
§ 1025.46 Proposed findings, conclusions, and order.
Within a reasonable time after the closing of the record and receipt of the transcript, all parties and participants may file, simultaneously unless otherwise directed by the Presiding Officer, post-hearing briefs, including proposed findings of fact and conclusions of law, as well as a proposed order. The Presiding Officer shall establish a date certain for the filing of the briefs, which shall not exceed fifty (50) days after the closing of the record except in unusual circumstances. The briefs shall be in writing and shall be served upon all parties. The briefs of all parties shall contain adequate references to the record and authorities relied upon. Replies shall be filed within fifteen (15) days of the date for the filing of briefs unless otherwise established by the Presiding Officer. The parties and participants may waive either or both submissions.
§ 1025.47 Record.
(a) Reporting and transcription. Hearings shall be recorded and transcribed by the official reporter of the Commission under the supervision of the Presiding Officer. The original transcript shall be a part of the record of proceedings. Copies of transcripts are available from the reporter at a cost not to exceed the maximum rates fixed by contract between the Commission and the reporter. In accordance with Section 11 of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. appendix I), copies of transcripts may be made by members of the public or by Commission personnel, when available, at the Office of the Secretary at reproduction costs as provided in § 1025.49.
(b) Corrections. Corrections of the official transcript may be made only when they involve errors affecting substance and then only in the manner described in this section. The Presiding Officer may order corrections, either on his/her own motion or on motion of any party. The Presiding Officer shall determine the corrections to be made and shall so order. Corrections shall be interlineated or otherwise inserted in the official transcript so as not to obliterate the original text.
§ 1025.48 Official docket.
The official docket in any adjudicatory proceedings shall be maintained in the Office of the Secretary and be available for public inspection during normal business hours of the Commission.
§ 1025.49 Fees.
(a) Fees for deponents and witnesses. Any person compelled to appear in person in response to a subpoena or notice of deposition shall be paid the same attendance and mileage fees as are paid witnesses in the courts of the United States, in accordance with title 28, United States Code, section 1821. The fees and mileage referred to in this paragraph shall be paid by the party at whose instance deponents or witnesses appear.
(b) Fees for production of records. Fees charged for production or disclosure of records contained in the official docket shall be in accordance with the Commission’s “Procedures for Disclosures or Production of Information Under the Freedom of Information Act,” title 16, Code of Federal Regulations, § 1015.9.
Subpart F—Decision
§ 1025.51 Initial decision.
(a) When filed. The Presiding Officer shall endeavor to file an Initial Decision with the Commission within sixty (60) days after the closing of the record or the filing of post-hearing briefs, whichever is later.
(b) Content. The Initial Decision shall be based upon a consideration of the entire record and shall be supported by reliable, probative, and substantial evidence. The Initial Decision shall include:
(1) Findings and conclusions, as well as the reasons or bases for such findings and conclusions, upon the material questions of fact, material issues of law, or discretion presented on the record, and should, where practicable, be accompanied by specific page citations to the record and to legal and other materials relied upon; and
(2) An appropriate order.
(c) By whom made. The Initial Decision shall be made and filed by the Presiding Officer who presided over the hearing, unless otherwise ordered by the Commission.
(d) Reopening of proceedings by Presiding Officer; termination of jurisdiction. (1) At any time prior to, or concomitant with, the filing of the Initial Decision, the Presiding Officer may reopen the proceedings for the reception of further evidence.
(2) Except for the correction of clerical errors, or where the proceeding is reopened by an order under paragraph (d)(1) of this section, the jurisdiction of the Presiding Officer is terminated upon the filing of the Initial Decision, unless and until such time as the matter may be remanded to the Presiding Officer by the Commission.
§ 1025.52 Adoption of initial decision.
The Initial Decision and Order shall become the Final Decision and Order of the Commission forty (40) days after issuance unless an appeal is noted and perfected or unless review is ordered by the Commission. Upon the expiration of the fortieth day, the Secretary shall prepare, sign, and enter an order adopting the Initial Decision and Order, unless otherwise directed by the Commission.
§ 1025.53 Appeal from initial decision.
(a) Who may file notice of intention. Any party may appeal an Initial Decision to the Commission, provided that within ten (10) days after issuance of the Initial Decision such party files and serves a notice of intention to appeal.
(b) Appeal brief. An appeal is perfected by filing a brief within forty (40) days after service of the Initial Decision. The appeal brief must be served upon all parties. The appeal brief shall contain, in the order indicated, the following:
(1) A subject index of the matters in the brief, with page references, and a table of cases (alphabetically arranged), textbooks, statutes, and other material cited, with page references thereto;
(2) A concise statement of the case;
(3) A statement containing the reasons why the party believes the Initial Decision is incorrect;
(4) The argument, presenting clearly the points of fact and law relied upon to support each reason why the Initial Decision is incorrect, with specific page references to the record and the legal or other material relied upon; and
(5) A proposed form of order for the Commission’s consideration in lieu of the order contained in the Initial Decision.
(c) Answering brief. Within thirty (30) days after service of the appeal brief upon all parties, any party may file an answering brief which shall contain a subject index, with page references, and a table of cases (alphabetically arranged), textbooks, statutes, and other material cited, with page references thereto. Such brief shall present clearly the points of fact and law relied upon in support of the reasons the party has for each position urged, with specific page references to the record and legal or other materials relied upon.
(d) Participant’s brief. Within thirty (30) days after service of the appeal brief upon all parties, any participant may file a brief on appeal, presenting clearly the position urged.
(e) Cross appeal. If a timely notice of appeal is filed by a party, any other party may file a notice of cross appeal within ten (10) days of the date on which the first notice of appeal was filed. Cross appeals shall be included in the answering brief and shall conform to the requirements for form, content, and filing specified in paragraph (b) of this section for an appeal brief. If an appeal is noticed but not perfected, no cross appeal shall be permitted and the notice of cross appeal shall be deemed void.
(f) Reply brief. A reply brief shall be limited to rebuttal of matters presented in answering briefs, including matters raised in cross-appeals. A reply brief shall be filed and served within fourteen (14) days after service of an answering brief, or on the day preceding the oral argument, whichever comes first.
(g) Oral argument. The purpose of an oral argument is to emphasize and clarify the issues. The Commission may order oral argument upon request of any party or upon its own initiative. A transcript of oral arguments shall be prepared. A Commissioner absent from an oral argument may participate in the consideration of and decision on the appeal.
§ 1025.54 Review of initial decision in absence of appeal.
The Commission may, by order, review a case not otherwise appealed by a party. Should the Commission so order, the parties shall, and participants may, file briefs in accordance with § 1025.53, except that the Commission may, in its discretion, establish a different briefing schedule in its order. The Commission shall issue its order within forty (40) days after issuance of the Initial Decision. The order shall set forth the issues which the Commission will review and may make provision for the filing of briefs. If the filing of briefs is scheduled by the Commission, the order shall designate which party or parties shall file the initial brief and which party or parties may thereafter file an answering brief, or the order may designate the simultaneous filing of briefs by the parties.
§ 1025.55 Final decision on appeal or review.
(a) Consideration of record. Upon appeal from or review of an Initial Decision, the Commission shall consider the record as a whole or such parts of the record as are cited or as may be necessary to resolve the issues presented and, in addition, shall, to the extent necessary or desirable, exercise all the powers which it could have exercised if it had made the Initial Decision.
(b) Rendering of final decision. In rendering its decision, the Commission shall adopt, modify, or set aside the findings, conclusions, and order contained in the Initial Decision, and shall include in its Final Decision a statement of the reasons for its action and any concurring or dissenting opinions. The Commission shall issue an order reflecting its Final Decision.
(c) Except as otherwise ordered by the Commission, the Commission shall endeavor to file its Decision within ninety (90) days after the filing of all briefs or after receipt of transcript of the oral argument, whichever is later.
§ 1025.56 Reconsideration.
Within twenty (20) days after issuance of a Final Decision and Order by the Commission, any party may file a petition for reconsideration of such decision or order, setting forth the relief desired and the grounds in support of the petition. Any petition filed under this section must be confined to new questions raised by the decision or order upon which the petitioner had no previous opportunity to argue. Any party desiring to oppose such a petition shall file an opposition to the petition within ten (10) days after sevice of the petition. The filing of a petition for reconsideration shall not stay the effective date of the Final Decision and Order or toll the running of any statutory time period affecting the Decision or Order unless specifically ordered by the Commission.
§ 1025.57 Effective date of order.
(a) Orders in proceedings arising under the Consumer Product Safety Act. An order of the Commission in proceedings arising under the Consumer Product Safety Act becomes effective upon receipt, unless otherwise ordered by the Commission.
(b) Orders in proceedings arising under the Flammable Fabrics Act—(1) Consent orders. An order in proceedings arising under the Flammable Fabrics Act, which has been issued following the Commission’s acceptance of an offer of settlement in accordance with § 1025.26 of these rules, becomes effective upon receipt of notice of Commission acceptance, unless otherwise ordered by the Commission.
(2) Litigated orders. All other orders in proceedings arising under the Flammable Fabrics Act become effective upon the expiration of the statutory period for court review specified in Section 5(c) of the Federal Trade Commission Act, title 15, United States Code, section 45(c), or, if a petition for review has been filed, upon a court’s affirmance of the Commission’s order.
(c) Consequences of failure to comply with effective order. A respondent against whom an order has been issued who is not in compliance with such order on or after the date the order becomes effective is in violation of such order and is subject to an immediate action for the civil or criminal penalties provided for in the applicable statute.
§ 1025.58 Reopening of proceedings.
(a) General. Any proceedings may be reopened by the Commission at any time, either on its own initiative or upon petition of any party to the proceedings.
(b) Exception. Proceedings arising under the Flammable Fabrics Act shall not be reopened while pending in a United States court of appeals on a petition for review after the transcript of the record has been filed, or while pending in the Supreme Court of the United States.
(c) Commission-originated reopening—(1) Before effective date of order. At any time before the effective date of a Commission order, the Commission may, upon its own initiative and without prior notice to the parties, reopen any proceedings and enter a new decision or order to modify or set aside, in whole or in part, the decision or order previously issued.
(2) After effective date of order. Whenever the Commission is of the opinion that changed conditions of fact or law or the public interest may require that a Commission decision or order be altered, modified, or set aside in whole or in part, the Commission shall serve upon all parties to the original proceedings an order to show cause, stating the changes the Commission proposes to make in the decision or order and the reasons such changes are deemed necessary. Within thirty (30) days after service of an order to show cause, any party to the original proceedings, may file a response. Any party not responding to the order to show cause within the time allowed shall be considered to have consented to the proposed changes.
(d) Petition for reopening. Whenever any person subject to a final order is of the opinion that changed conditions of fact or law require that the decision or order be altered, modified, or set aside, or that the public interest so requires, that person may petition the Commission to reopen the proceedings. The petition shall state the changes desired and the reasons those changes should be made, and shall include such supporting evidence and argument as will, in the absence of any opposition, provide the basis for a Commission decision on the petition. The petition shall be served upon all parties to the original proceedings. Within thirty (30) days after service of the petition, Complaint Counsel shall file a response. Any other party to the original proceedings also may file a response within that period.
(e) Hearings—(1) Unopposed. Where an order to show cause or petition to reopen is not opposed, or is opposed but the pleadings do not raise issues of fact to be resolved, the Commission, in its discretion, may decide the matter on the order to show cause or petition and responses, or it may serve upon the parties a notice of hearing containing the date when the matter will be heard. The proceedings normally will be limited to the filing of briefs but may include oral argument when deemed necessary by the Commission.
(2) Factual issues. When the pleadings raise substantial factual issues, the Commission may direct such hearings as it deems appropriate. Upon conclusion of the hearings, and after opportunity for the parties to file post-hearing briefs containing proposed findings of fact and conclusions of law, as well as a proposed order, the Presiding Officer shall issue a Recommended Decision, including proposed findings and conclusions, and the reasons, as well as a proposed Commission order. If the Presiding Officer recommends that the Commission’s original order be reopened, the proposed order shall include appropriate provisions for the alteration, modification or setting aside of the original order. The record and the Presiding Officer’s Recommended Decision shall be certified to the Commission for final disposition of the matter.
(f) Commission disposition. Where the Commission has ordered a hearing, upon receipt of the Presiding Officer’s Recommended Decision, the Commission shall make a decision and issue an order based on the hearing record as a whole. If the Commission determines that changed conditions of fact or law or the public interest requires, it shall reopen the order previously issued; alter, modify, or set aside the order’s provisions in whole or in part; and issue an amended order reflecting the alterations, modifications, or deletions. If the Commission determines that the original order should not be reopened, it shall issue an order affirming the original order. A decision stating the reasons for the Commission’s order shall accompany the order.
Subpart G—Appearances, Standards of Conduct
§ 1025.61 Who may make appearances.
A party or participant may appear in person, or by a duly authorized officer, partner, regular employee, or other agent of the party or participant, or by counsel or other duly qualified representative, in accordance with § 1025.65.
§ 1025.62 Authority for representation.
Any individual acting in a representative capacity in any adjudicative proceedings may be required by the Presiding Officer or the Commission to show his/her authority to act in such capacity. A regular employee of a party who appears on behalf of the party may be required by the Presiding Officer or the Commission to show his/her authority to so appear.
§ 1025.63 Written appearances.
(a) Filing. Any person who appears in any proceedings shall file a written notice of appearance with the Secretary or deliver a written notice of appearance to the Presiding Officer at the hearing, stating for whom the appearance is made and the name, address, and telephone number (including area code) of the person making the appearance and the date of the commencement of the appearance. The written appearance shall be made a part of the record.
(b) Withdrawal. Any person who has previously appeared in any proceedings may withdraw his/her appearance by filing a written notice of withdrawal of appearance with the Secretary. The notice of withdrawal of appearance shall state the name, address, and telephone number (including area code) of the person withdrawing the appearance, for whom the appearance was made, and the effective date of the withdrawal of the appearance. Such notice of withdrawal shall be filed within five (5) days of the effective date of the withdrawal of the appearance.
§ 1025.64 Attorneys.
Any attorney at law who is admitted to practice before any United States court or before the highest court of any State, the District of Columbia, or any territory or commonwealth of the United States, may practice before the Commission. An attorney’s own representation that he/she is in good standing before any of such courts shall be sufficient proof thereof, unless otherwise directed by the Presiding Officer or the Commission.
§ 1025.65 Persons not attorneys.
(a) Filing and approval of proof of qualifications. Any person who is not an attorney at law may be admitted to appear in any adjudicative proceedings as a representative of any party or participant if that person files proof to the satisfaction of the Presiding Officer that he/she possesses the necessary knowledge of administrative procedures, technical, or other qualifications to render valuable service in the proceedings and is otherwise competent to advise and assist in the presentation of matters in the proceedings. An application by a person not an attorney at law for admission to appear in any proceedings shall be submitted in writing to the Secretary, not later than thirty (30) days prior to the hearing. The application shall set forth in detail the applicant’s qualifications to appear in the proceedings.
(b) Exception. Any person who is not an attorney at law and whose application has not been approved shall not be permitted to appear in Commission proceedings. However, this provision shall not apply to any person who appears before the Commission on his/her own behalf or on behalf of any corporation, partnership, or unincorporated association of which the person is a partner or general officer.
§ 1025.66 Qualifications and standards of conduct.
(a) Good faith transactions. The Commission expects all persons appearing in proceedings before the Commission or the Presiding Officer to act with integrity, with respect, and in an ethical manner. Business transacted before and with the Commission or the Presiding Officer shall be conducted in good faith.
(b) Exclusion of parties, participants, or their representatives. To maintain orderly proceedings, the Commission or the Presiding Officer may exclude parties, participants, or their representatives for refusal to comply with directions, continued use of dilatory tactics, refusal to adhere to reasonable standards of orderly and ethical conduct, failure to act in good faith, or violation of the prohibition in § 1025.68 against certain ex parte communications.
(c) Exclusions from the record. The Presiding Officer or the Commission may disregard and order the exclusion from the record of any written or oral submissions or representations which are not made in good faith or which are unfair, incomplete, or inaccurate.
(d) Appeal by excluded party. An excluded party, participant, or representative may petition the Commission to entertain an interlocutory appeal in accordance with § 1025.24 of these rules. If, after such appeal, the representative of a party or participant is excluded, the hearing shall, at the request of the party or participant, be suspended for a reasonable time so that the party or participant may obtain another representative.
§ 1025.67 Restrictions as to former members and employees.
(a) Generally. Except as otherwise provided in paragraph (b) of this section, the post-employee restrictions applicable to former Commission members and employees, as set forth in the Commission’s “Post Employment Restrictions Applicable to Former Commission Officers and Employees”, 16 CFR part 1030, subpart L, shall govern the activities of former Commission members and employees in matters connected with their former duties and responsibilities.
(b) Participation as witness. A former member or employee of the Commission may testify in any proceeding subject to these Rules concerning his/her participation in any Commission activity. This section does not constitute a waiver by the Commission of any objection provided by law to testimony that would disclose privileged or confidential material. The provisions of 18 U.S.C. 1905 prohibiting the disclosure of trade secrets also applies to testimony by former members and employees.
(c) Procedure for requesting authorization to appear. In cases to which paragraph (a) of this section is applicable, a former member or employee of the Commission may request authorization to appear or participate in any proceedings or investigation by filing with the Secretary a written application disclosing the following information:
(1) The nature and extent of the former member’s or employee’s participation in, knowledge of, and connection with the proceedings or investigation during his/her service with the Commission;
(2) Whether the files of the proceedings or investigation came to his/her attention;
(3) Whether he/she was employed in the directorate, division, or other organizational unit within the Commission in which the proceedings or investigation is or has been pending;
(4) Whether he/she worked directly or in close association with Commission personnel assigned to the proceedings or investigation and, if so, with whom and in what capacity; and
(5) Whether during service with the Commission, he/she was engaged in any matter concerning the person involved in the proceedings or investigation.
(d) Denial of request to appear. The requested authorization shall not be given in any case:
(1) Where it appears that the former member or employee, during service with the Commission, participated personally and substantially in the proceedings or investigation; or
(2) Where the Commission is not satisfied that the appearance or participation will not involve any actual or apparent impropriety; or
(3) In any case which would result in a violation of title 18, United States Code, section 207.
§ 1025.68 Prohibited communications.
(a) Applicability. This section is applicable during the period commencing with the date of issuance of a complaint and ending upon final Commission action in the matter.
(b) Definitions—(1) Decision-maker. Those Commission personnel who render decisions in adjudicative proceedings under these rules, or who advise officials who render such decisions, including:
(i) The Commissioners and their staffs;
(ii) The Administrative Law Judges and their staffs;
(iii) The General Counsel and his/her staff, unless otherwise designated by the General Counsel.
(2) Ex parte communication. (i) Any written communication concerning a matter in adjudication which is made to a decision-maker by any person subject to these Rules, which is not served on all parties; or
(ii) Any oral communication concerning a matter in adjudication which is made to a decision-maker by any person subject to these Rules, without advance notice to all parties to the proceedings and opportunity for them to be present.
(c) Prohibited ex parte communications. Any oral or written ex parte communication relative to the merits of any proceedings under these Rules is a prohibited ex parte communication, except as otherwise provided in paragraph (d) of this section.
(d) Permissible ex parte communications. The following communications shall not be prohibited under this section.
(1) Ex parte communications authorized by statute or by these rules. (See, for example, § 1025.38 which governs applications for the issuance of subpoenas.)
(2) Any staff communication concerning judicial review or judicial enforcement in any matter pending before or decided by the Commission.
(e) Procedures for handling prohibited ex parte communication—(1) Prohibited written ex parte communication. To the extent possible, a prohibited written ex parte communication received by any Commission employee shall be forwarded to the Secretary rather than to a decision-maker. A prohibited written ex parte communication which reaches a decision-maker shall be forwarded by the decision-maker to the Secretary. If the circumstances in which a prohibited ex parte written communication was made are not apparent from the communication itself, a statement describing those circumstances shall be forwarded with the communication.
(2) Prohibited oral ex parte communication. (i) If a prohibited oral ex parte communication is made to a decision-maker, he/she shall advise the person making the communication that the communication is prohibited and shall terminate the discussion; and
(ii) In the event of a prohibited oral ex parte communication, the decision-maker shall forward to the Secretary a signed and dated statement containing such of the following information as is known to him/her.
(A) The title and docket number of the proceedings;
(B) The name and address of the person making the communication and his/her relationship (if any) to the parties and/or participants to the proceedings;
(C) The date and time of the communication, its duration, and the circumstances (e.g., telephone call, personal interview, etc.) under which it was made;
(D) A brief statement of the substance of the matters discussed; and
(E) Whether the person making the communication persisted in doing so after being advised that the communication was prohibited.
(3) Filing. All communications and statements forwarded to the Secretary under this section shall be placed in a public file which shall be associated with, but not made a part of, the record of the proceedings to which the communication or statement pertains.
(4) Service on parties. The Secretary shall serve a copy of each communication and statement forwarded under this section on all parties to the proceedings. However, if the parties are numerous, or if other circumstances satisfy the Secretary that service of the communication or statement would be unduly burdensome, he/she, in lieu of service, may notify all parties in writing that the communication or statement has been made and filed and that it is available for insection and copying.
(5) Service on maker. The Secretary shall forward to the person who made the prohibited ex parte communication a copy of each communication or statement filed under this section.
(f) Effect of ex parte communications. No prohibited ex parte communication shall be considered as part of the record for decision unless introduced into evidence by a party to the proceedings.
(g) Sanctions. A person subject to these Rules who make, a prohibited ex parte communication, or who encourages or solicits another to make any such communication, may be subject to any appropriate sanction or sanctions, including but not limited to, exclusion from the proceedings and an adverse ruling on the issue which is the subject of the prohibited communication.
Subpart H—Implementation of the Equal Access to Justice Act in Adjudicative Proceedings With the Commission
§ 1025.70 General provisions.
(a) Purpose of this rule. The Equal Access to Justice Act, 5 U.S.C. 504 (called “the EAJA” in this subpart), provides for the award of attorney fees and other expenses to eligible persons who are parties to certain adversary adjudicative proceedings before the Commission. An eligible party may receive an award when it prevails over Commission complaint counsel, unless complaint counsel’s position in the proceeding was substantially justified or special circumstances make an award unjust. This subpart describes the parties eligible for awards and the proceedings covered. The rules also explain how to apply for awards and the procedures and standards that the Commission will use to make them.
(b) When the EAJA applies. The EAJA applies to any adversary adjudicative proceeding pending before the Commission at any time between October 1, 1981 and September 30, 1984. This includes proceedings commenced before October 1, 1981, if final Commission action has not been taken before that date, and proceedings pending on September 30, 1984, regardless of when they were initiated or when final Commission action occurs.
(c) Proceedings covered. (1) The EAJA and this rule apply to adversary adjudicative proceedings conducted by the Commission. These are adjudications under 5 U.S.C. 554 in which the position of the Commission or any component of the Commission is represented by an attorney or other representative who enters an appearance and participates in the proceeding. The rules in this subpart govern adversary adjudicative proceedings relating to the provisions of sections 15 (c), (d) and (f) and 17(b) of the Consumer Product Safety Act (15 U.S.C. 2064 (c) (d) and (f); 2066(b)), sections 3 and 8(b) of the Flammable Fabrics Act (15 U.S.C. 1192, 1197(b)), and section 15 of the Federal Hazardous Substances Act (15 U.S.C. 1274), which are required by statute to be determined on the record after opportunity for a public hearing. These rules will also govern administrative adjudicative proceedings for the assessment of civil penalties under section 20(a) of the Consumer Product Safety Act (15 U.S.C. 2068(a)). See 16 CFR 1025.1.
(2) The Commission may designate a proceeding not listed in paragraph (c)(1) of this section as an adversary adjudicative proceeding for purposes of the EAJA by so stating in an order initiating the proceeding or designating the matter for hearing. The Commission’s failure to designate a proceeding as an adversary adjudicative proceeding shall not preclude the filing of an application by a party who believes the proceeding is covered by the EAJA. Whether the proceeding is covered will then be an issue for resolution in proceedings on the application.
(3) If a proceeding includes both matters covered by the EAJA and matters specifically excluded from coverage, any award made will include only fees and expenses related to covered issues.
(d) Eligibility of applicants. (1) To be eligible for an award of attorney fees and other expenses under the EAJA, the applicant must be a party to the adversary adjudication for which it seeks an award. The term “party” is defined in 5 U.S.C. 551(3) and 16 CFR 1025.3(f). The applicant must show that it meets all conditions of eligibility set out in this paragraph and in § 1025.71.
(2) The types of eligible applicants are:
(i) Individuals with a net worth of not more than $1 million;
(ii) Sole owners of unincorporated businesses who have a net worth of not more than $5 million including both personal and business interests, and not more than 500 employees;
(iii) Charitable or other tax-exempt organizations described in section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)) which have not more than 500 employees;
(iv) Any other partnership, corporation, association, or public or private organization with a net worth of not more than $5 million and which have not more than 500 employees.
(3) For the purpose of eligibility, the net worth and number of employees of an applicant shall be determined as of the date the proceeding was initiated.
(4) An applicant who owns an unincorporated business will be considered as an “individual” rather than as a “sole owner of an unincorporated business” if the issues on which the applicant prevails are related primarily to personal interests rather than to business interests.
(5) The number of employees of an applicant include all persons who regularly perform services for remuneration for the applicant, under the applicant’s direction and control. Part-time employees shall be included on a proportional basis.
(6) The net worth and number of employees of the applicant and all of its affiliates shall be aggregated to determine eligibility. For this purpose, affiliate means (i) An individual, corporation or other entity that directly or indirectly controls or owns a majority of the voting shares or other interest of the applicant, or (ii) Any corporation or other entity of which the applicant directly or indirectly owns or controls a majority of the voting shares or other interest. However, the presiding officer may determine that such treatment would be unjust and contrary to the purposes of the EAJA in light of the actual relationship between the affiliated entities. In addition, the presiding officer may determine that financial relationships of the applicant other than those described in this paragraph constitute special circumstances that would make an award unjust.
(7) An applicant that participates in a proceeding primarily on behalf of one or more other persons or entities that would be ineligible is not itself eligible for an award.
(8) An applicant that represents himself/herself regardless of whether he is licensed to practice law may be awarded all such expenses and fees available to other prevailing eligible parties. See 16 CFR 1025.61 and 1025.65 of the Commission’s rules.
(e) Standards for awards. (1) An eligible prevailing applicant may receive an award for fees and expenses incurred in connection with a proceeding, or in a significant and discrete substantive portion of the proceeding, unless the position of Commission complaint counsel over which the applicant has prevailed was substantially justified. Complaint counsel bear the burden of proof that an award should not be made to an eligible prevailing applicant. Complaint counsel may avoid the granting of an award by showing that its position was reasonable in law and fact.
(2) An award will be reduced or denied if the applicant has unduly or unreasonably protracted the proceeding or if special circumstances make the award sought unjust.
(f) Allowable fees and expenses. (1) Awards will be based on rates customarily charged by persons engaged in the business of acting as attorneys, agents and expert witnesses, even if the services were made available without charge or at a reduced rate to the applicant.
(2) No award for the fee of an attorney or agent under these rules may exceed $75 per hour. No award to compensate an expert witness may exceed the highest rate at which the Commission is authorized to pay expert witnesses. However, an award may also include the reasonable expenses of the attorney, agent, or witness as a separate item, if the attorney, agent or witness ordinarily charges clients separately for such expenses.
(3) In determining the reasonableness of the fee sought for an attorney, agent or expert witness, the presiding officer shall consider the following:
(i) If the attorney, agent or witness is in private practice, his or her customary fee for similar services, or, if an employee of the applicant, the fully allocated cost of the services;
(ii) The prevailing rate for similar services in the community in which the attorney, agent or witness ordinarily performs services;
(iii) The time actually spent in the representation of the applicant;
(iv) The time reasonably spent in light of the difficulty or complexity of the issues in the proceeding; and
(v) Such other factors as may bear on the value of the services provided.
(4) The reasonable cost of any study, analysis, engineering report, test, project or similar matter prepared on behalf of a party may be awarded, to the extent that the charge for the service does not exceed the prevailing rate for similar services, and the study or other matter was necessary for preparation of the applicant’s case.
(5) Fees may be awarded to eligible applicants only for service performed after the issuance of a complaint and the commencement of the adjudicative proceeding in accordance with 16 CFR 1025.11(a).
(g) Rulemaking on maximum rates for attorney fees. (1) If warranted by an increase in the cost of living or by special circumstances, the Commission may adopt regulations providing that attorney fees may be awarded at a rate higher than $75 per hour in some or all of the types of proceedings covered by this subpart. The Commission will conduct any rulemaking proceedings for this purpose under the informal rulemaking procedures of the Administrative Procedure Act, 5 U.S.C. 533.
(2) Any person may file with the Commission a petition for rulemaking to increase the maximum rate for attorney fees, in accordance with the Administrative Procedure Act, 5 U.S.C. 553(e). The petition should identify the rate the petitioner believes the Commission should establish and the types of proceedings in which the rate should be used. The petition should also explain fully the reasons why the higher rate is warranted. The Commission will respond to the petition within a reasonable time after it is filed, by initiating a rulemaking proceeding, denying the petition, or taking other appropriate action.
(h) Presiding officer. The presiding oficer in a proceeding covered by this regulation is a person as defined in the Commission’s Rules, 16 CFR 1025.3(i), who conducts an adversary adjudicative proceeding.
§ 1025.71 Information required from applicant.
(a) Contents of application. (1) An application for an award of fees and expenses under the EAJA shall identify the applicant and the proceeding for which an award is sought. The application shall show that the applicant has prevailed and identify the position of complaint counsel in the adjudicative proceeding that the applicant alleges was not substantially justified. Unless the applicant is an individual, the application shall also state the number of employees of the applicant and describe briefly the type and purpose of its organization or business.
(2) The application shall also include a verified statement that the applicant’s net worth does not exceed $1 million (if an individual) or $5 million (for all other applicants, including their affiliates). However, an applicant may omit this statement if it attaches a copy of a ruling by the Internal Revenue Service that it qualifies as an organization described in section 501(c)(3) of the Internal Revenue Code or, in the case of a tax-exempt organization not required to obtain a ruling from the Internal Revenue Service on its exempt status, a statement that describes the basis for the applicant’s belief that it qualifies under such section.
(3) The application shall state the amount of fees and expenses for which an award is sought.
(4) The application may also include any other matters that the applicant wishes the Commission to consider in determining whether and in what amount an award should be made.
(5) The application shall be signed by the applicant or an authorized officer or attorney of the applicant. It shall also contain or be accompanied by a written verification under oath or under penalty of perjury that the information provided in the application is true and correct.
(b) Net worth exhibit; confidential treatment. (1) Each applicant except a qualified tax-exempt organization or cooperative association must provide with its application a detailed exhibit showing the net worth of the applicant and any affiliates (as defined in § 1025.70(d)(6) of this subpart) when the proceeding was initiated. The exhibit may be in any form convenient to the applicant that provides full disclosure of the applicant’s and its affiliates’ assets and liabilities and is sufficient to determine whether the applicant qualifies under the standards in this subpart. The presiding officer may require an applicant to file additional information to determine its eligibility for an award.
(2) Ordinarily, the net worth exhibit will be included in the public record of the proceeding. However, an applicant that objects to public disclosure of information in any portion of the exhibit or to public disclosure of any other information submitted, and believes there are legal grounds for withholding it from disclosure, may move to have that information kept confidential and excluded from public disclosure in accordance with § 1025.45 of the Commission rules for in camera materials, 16 CFR 1025.45. This motion shall describe the information sought to be withheld and explain, in detail, why it falls within one or more of the specific exemptions from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b)(1)-(9).
(3) Section 6(a)(2) of the Consumer Product Safety Act, 15 U.S.C. 2055(a)(2), provides that certain information which contains or relates to a trade secret or other matter referred to in section 1905 of title 18, United States Code, or subject to 5 U.S.C. 552(b)(4) shall not be disclosed. This prohibition is an Exemption 3 statute under the Freedom of Information Act, 5 U.S.C. 552(b)(3). Material submitted as part of an application for which in camera treatment is granted shall be available to other parties only in accordance with 16 CFR 1025.45(c) of the Commission Rules and, if applicable, section 6(a)(2) of the CPSA. If the presiding officer determines that the information should not be withheld from disclosure because it does not fall within section 6(a)(2) of the CPSA, he shall place the information in the public record but only after notifying the submitter of the information in writing of the intention to disclose such document at a date not less than 10 days after the date of receipt of notification. Otherwise, any request to inspect or copy the exhibit shall be disposed of in accordance with the Commission’s established procedures under the Freedom of Information Act (see 16 CFR part 1015).
(c) Documentation of fees and expenses. The application shall be accompanied by full documentation of the fees and expenses, including the cost of any study, analysis, engineering report, test, project or similar matter, for which an award is sought. A separate itemized statement shall be submitted for each professional firm or individual whose services are covered by the application, showing the hours spent in connection with the proceeding by each individual, a description of the specific services performed, the rate at which each fee has been computed, any expenses for which reimbursement is sought, the total amount claimed, and the total amount paid or payable by the applicant or by any other person or entity for the services provided. The presiding officer may require the applicant to provide vouchers, receipts; or other substantiation for any expenses claimed.
(d) When an application may be filed. (1) An application may be filed whenever the applicant has prevailed in a proceeding covered by this subpart or in a significant and discrete substantive portion of the proceeding. However, an application must be filed no later than 30 days after the Commission’s final disposition of such a proceeding.
(2) If review or reconsideration is sought or taken of a decision as to which an applicant believes it has prevailed, proceedings for the award of fees shall be stayed pending final disposition of the underlying controversy.
(3) If review or reconsideration is sought or taken of a decision as to which an applicant believes it has prevailed, proceedings for the award of fees shall be stayed pending final disposition of the underlying controversy.
(4) For purposes of this subpart, final disposition means the later of:
(i) The date on which an initial decision by the presiding officer becomes final, see 16 CFR 1025.52;
(ii) The date on which the Commission issues a final decision (See 16 CFR 1025.55);
(iii) The date on which the Commission issues an order disposing of any petitions for reconsideration of the Commission’s final order in the proceeding (See 16 CFR 1025.56; or
(iv) Issuance of a final order or any other final resolution of a proceeding, such as a settlement or voluntary dismissal, which is not subject to a petition for reconsideration.
(e) Where an application must be filed. The application for award and expenses must be submitted to the Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207 in accordance with the application requirements of this section.
§ 1025.72 Procedures for considering applications.
(a) Filing and service of documents. Any application for an award or other pleading or document related to an application shall be filed and served on all parties to the proceeding in the same manner as provided in the Commission’s Rules of Practice, 16 CFR 1025.11-1025.19.
(b) Answer to application. (1) Within 30 days after service of an application for an award of fees and expenses, complaint counsel in the underlying administrative proceeding upon which the application is based may file an answer to the application. Unless complaint counsel requests an extension of time for filing or files a statement of intent to negotiate under paragraph (b)(2) of this section, failure to file an answer within the 30-day period may be treated as a consent to the award requested.
(2) If complaint counsel and the applicant believe that the issues in the fee application can be settled, they may jointly file a statement of their intent to negotiate a settlement. The filing of this statement shall extend the time for filing an answer for an additional 30 days, and further extensions may be granted by the presiding officer upon request by complaint counsel and the applicant.
(3) The answer shall explain in detail any objections to the award requested and identify the facts relied on in support of Commission counsel’s position. If the answer is based on any alleged facts not already in the record of the proceeding, complaint counsel shall include with the answer either supporting affidavits or a request for further proceedings under paragraph (f) of this section.
(c) Reply. Within 15 days after service of an answer, the applicant may file a reply. If the reply is based on any alleged facts not already in the record of the proceeding, the applicant shall include with the reply either supporting affidavits or a request for further proceedings under paragraph (f) of this section.
(d) Comments by other parties. Any party to a proceeding other than the applicant and complaint counsel may file comments on an application within 30 days after it is served or on an answer within 15 days after it is served. A commenting party may not participate further in proceedings on the application unless the presiding officer determines that the public interest requires such participation in order to permit full exploration of matters raised in the comments.
(e) Settlement. The applicant and complaint counsel may agree on a proposed settlement of the award before final action on the application, either in connection with a settlement of the underlying proceeding, or after the underlying proceeding has been concluded, in accordance with the Commission’s standard settlement procedure (See 16 CFR 1115.20(b), 1118.20, 1025.26, and 1605.3). If a prevailing party and complaint counsel agree on a proposed settlement of an award before an application has been filed, the application shall be filed with the proposed settlement.
(f) Further proceedings. (1) Ordinarily, the determination of an award will be made on the basis of the written record. However, on request of either the applicant or complaint counsel, or on his or her own initiative, the presiding officer may order further proceedings. Such further proceedings shall be held only when necessary for full and fair resolution of the issues arising from the application, and shall be conducted as promptly as possible.
(2) A request that the presiding officer order further proceedings under this paragraph shall specifically identify the information sought or the disputed issues and shall explain why the additional proceedings are necessary to resolve the issues.
(g) Initial decision. The presiding officer shall endeavor to issue an initial decision on the application within 30 days after completion of proceedings on the application. The decision shall include written findings and conclusions on the applicant’s eligibility and status as a prevailing party, and an explanation of the reasons for any difference between the amount requested and the amount awarded. The decision shall also include, if at issue, findings on whether the complaint counsel’s position was substantially justified, whether the applicant unduly protracted the proceedings, or whether special circumstances make an award unjust. If the applicant has sought an award against more than one agency, the decision of this Commission will only address the allocable portion for which this Commission is responsible to the eligible prevailing party.
(h) Agency review. (1) Either the applicant or complaint counsel may seek review of the initial decision on the fee application, or the Commission may decide to review the decision on its own initiative, in accordance with 16 CFR 1025.54, 1025.55 and 1025.56.
(2) If neither the applicant nor Commission complaint counsel seeks review and the Commission does not take review on its own initiative, the initial decision on the application shall become a final decision of the Commission 30 days after it is issued.
(3) If an appeal from or review of an initial decision under this subpart is taken, the Commission shall endeavor to issue a decision on the application within 90 days after the filing of all briefs or after receipt of transcripts of the oral argument, whichever is later, or remand the application to the presiding officer for further proceedings.
(i) Judicial review. Judicial review of final Commission decisions on awards may be sought as provided in 5 U.S.C. 504(c)(2).
(j) Payment of award. An applicant seeking payment of an award shall submit to the Secretary of the Commission a copy of the Commission’s final decision granting the award, accompanied by a verified statement that the applicant will not seek review of the decision in the United States courts. (Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207.) The Commission will pay the amount awarded to the applicant within 60 days, unless judicial review of the award or of the underlying decision of the adversary adjudication has been sought by the applicant or any other party to the proceeding. Comments and accompanying material may be seen in or copies obtained from the Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207, during working hours Monday through Friday.
Appendix I to Part 1025—Suggested Form of Final Prehearing Order
A final prehearing conference was held in this matter, pursuant to Rule 21 of the Commission’s Rules of Practice for Adjudicative Proceedings (16 CFR 1025.21), on the ______ day of ______, 19__, at __ o’clock, _ stm.
Counsel appeared as follows:
For the Commission staff:
For the Respondent(s):
Others:
1. Nature of Action and Jurisdiction. This is an action for __________ and the jurisdiction of the Commission is invoked under United States Code, Title______, Section ______ and under the Code of Federal Regulations, Title ____, Section ____. The jurisdiction of the Commission is (not) disputed. The question of jurisdiction was decided as follows:
2. Stipulations and Statements. The following stipulation(s) and statement(s) were submitted, attached to, and made a part of this order:
(a) A comprehensive written stipulation or statement of all uncontested facts;
(b) A concise summary of the ultimate facts as claimed by each party. (Complaint Counsel must set forth the claimed facts, specifically; for example, if a violation is claimed, Complaint Counsel must assert specifically the acts of violation complained of; each respondent must reply with equal clarity and detail.)
(c) Written stipulation(s) or statement(s) setting forth the qualifications of the expert witnesses to be called by each party;
(d) Written list(s) of the witnesses whom each party will call, written list(s) of the additional witnesses whom each party may call, and a statement of the subject matter on which each witness will testify;
(e) An agreed statement of the contested issues of fact and of law, or separate statements by each party of any contested issues of fact and law not agreed to;
(f) A list of all depositions to be read into evidence and statements of any objections thereto;
(g) A list and brief description of any charts, graphs, models, schematic diagrams, and similar objects that will be used in opening statements or closing arguments but will not be offered in evidence. If any other such objects are to be used by any party, those objects will be submitted to opposing counsel at least three days prior to the hearing. If there is then any objection to their use, the dispute will be submitted to the Presiding Officer at least one day prior to the hearing;
(h) Written waivers of claims or defenses which have been abandoned by the parties.
The foregoing were modified at the pretrial conference as follows:
3. Complaint Counsel’s Evidence. 3.1 The following exhibits were offered by Complaint Counsel, received in evidence, and marked as follows:
The authenticity of these exhibits has been stipulated.
3.2 The following exhibits were offered by Complaint Counsel and marked for identification. There was reserved to the respondent(s) (and party intervenors) the right to object to their receipt in evidence on the grounds stated:
4. Respondent’s Evidence. 4.1 The following exhibits were offered by the respondent(s), received in evidence, and marked as herein indicated:
The authenticity of these exhibits has been stipulated.
4.2 The following exhibits were offered by the respondent(s) and marked for identification. There was reserved to Complaint Counsel (and party intervenors) the right to object to their receipt in evidence on the grounds stated:
5. Party Intervenor’s Evidence. 5.1 The following exhibits were offered by the party intervenor(s), received in evidence, and marked as herein indicated:
The authenticity of these exhibits has been stipulated.
5.2 The following exhibits were offered by the party intervenor(s) and marked for identification. There was reserved to Complaint Counsel and respondent(s) the right to object to their receipt in evidence on the grounds stated:
If any other exhibits are to be offered by any party, such exhibits will be submitted to opposing counsel at least ten (10) days prior to hearing, and a supplemental note of evidence filed into this record.
6. Additional Actions. The following additional action(s) were taken:
7. Limitations and Reservations. 7.1 Each of the parties has the right to further supplement the list of witnesses not later than ten (10) days prior to commencement of the hearing by furnishing opposing counsel with the name and address of the witness and general subject matter of his/her testimony and by filing a supplement to this pretrial order. Thereafter, additional witnesses may be added only after application to the Presiding Officer, for good cause shown.
7.2 Rebuttal witnesses not listed in the exhibits to this order may be called only if the necessity of their testimony could not reasonably be foreseen ten (10) days prior to trial. If it appears to counsel at any time before trial that such rebuttal witnesses will be called, notice will immediately be given to opposing counsel and the Presiding Officer.
7.3 The probable length of hearing is __ days. The hearing will commence on the ______ day of ______, 19__, at __ o’clock _ m. at ____.
7.4 Prehearing briefs will be filed not later than 5:00 p.m. on __________ (Insert date not later than ten (10) days prior to the hearing.) All anticipated legal questions, including those relating to the admissibility of evidence, must be covered by prehearing briefs.
This prehearing order has been formulated after a conference at which counsel for the respective parties appeared. Reasonable opportunity has been afforded counsel for corrections or additions prior to signing. It will control the course of the hearing, and it may not be amended except by consent of the parties and the Presiding Officer, or by order of the Presiding Officer to prevent manifest injustice.
Where intervenors appear pursuant to § 1025.17 of these Rules, the prehearing order may be suitably modified; the initial page may be modified to reflect the intervention.
PART 1027—SALARY OFFSET
§ 1027.1 Purpose and scope.
(a) This regulation provides procedures for the collection by administrative offset of a Federal employee’s salary without his/her consent to satisfy certain debts owed to the Federal government. These regulations apply to all Federal employees who owe debts to the Consumer Product Safety Commission (CPSC) and to current employees of CPSC who owe debts to other Federal agencies. This regulation does not apply when the employee consents to recovery from his/her current pay account.
(b) This regulation does not apply to debts or claims arising under:
(1) The Internal Revenue Code of 1954, as amended, 26 U.S.C. 1 et seq.;
(2) The Social Security Act, 42 U.S.C. 301 et seq.;
(3) The tariff laws of the United States; or
(4) Any case where a collection of a debt by salary offset is explicitly provided for or prohibited by another statute.
(c) This regulation does not apply to any adjustment to pay arising out of an employee’s selection of coverage or a change in coverage under a Federal benefits program requiring periodic deductions from pay if the amount to be recovered was accumulated over four pay periods or less.
(d) This regulation does not preclude the compromise, suspension, or termination of collection action where appropriate under the standards implementing the Federal Claims Collection Act, 31 U.S.C. 3711 et seq, and 4 CFR parts 101 through 105.
(e) This regulation does not preclude an employee from requesting waiver of an overpayment under 5 U.S.C. 5584, 10 U.S.C. 2774, or 32 U.S.C. 716, or in any way questioning the amount or validity of the debt by submitting a subsequent claim to the General Accounting Office. This regulation does not preclude an employee from requesting a waiver pursuant to other statutory provisions applicable to the particular debt being collected.
(f) Matters not addressed in these regulations should be reviewed in accordance with the Federal Claims Collection Standards at 4 CFR 101.1 et seq.
§ 1027.2 Definitions.
For the purposes of this part the following definitions will apply:
Agency means an executive agency as defined at 5 U.S.C. 105, including the U.S. Postal Service and the U.S. Postal Rate Commission; a military department as defined at 5 U.S.C. 102; an agency or court in the judicial branch; an agency of the legislative branch, including the U.S. Senate and House of Representatives; and other independent establishments that are entities of the Federal government.
Certification means a written debt claim received from a creditor agency which requests the paying agency to offset the salary of an employee.
CPSC or Commission means the Consumer Product Safety Commission.
Creditor agency means an agency of the Federal Government to which the debt is owed.
Debt means an amount owed by a Federal employee to the United States from sources which include loans insured or guaranteed by the United States and all other amounts due the United States from fees, leases, rents, royalties, services, sales of real or personal property, overpayments, penalties, damages, interests, fines, forfeitures (except those arising under the Uniform Code of Military Justice), and all other similar sources.
Disposable pay means the amount that remains from an employee’s Federal pay after required deductions for social security, Federal, State or local income tax, health insurance premiums, retirement contributions, life insurance premiums, Federal employment taxes, and any other deductions that are required to be withheld by law.
Executive Director means the Executive Director of the Consumer Product Safety Commission, who is the person designated by the Chairman to determine whether an employee is indebted to the United States and to take action to collect such debts.
Hearing official means an individual responsible for conducting a hearing with respect to the existence or amount of a debt claimed, or the repayment schedule of a debt, and who renders a decision on the basis of such hearing. A hearing official may not be under the supervision or control of the Chairman of the Commission.
Paying agency means the agency that employs the individual who owes the debt and authorizes the payments of his/her current pay.
Salary offset means an administrative offset to collect a debt pursuant to 5 U.S.C. 5514 by deduction(s) at one or more officially established pay intervals from the current pay account of an employee without his/her consent.
§ 1027.3 Applicability.
(a) These regulations are to be followed when:
(1) The Commission is owed a debt by an individual who is a current employee of the CPSC; or
(2) The Commission is owed a debt by an individual currently employed by another Federal agency; or
(3) The Commission employs an individual who owes a debt to another federal agency.
§ 1027.4 Notice requirements before offset.
(a) Salary offset shall not be made against an employee’s pay unless the employee is provided with written notice signed by the Executive Director of the debt at least 30 days before salary offset commences.
(b) The written notice shall contain:
(1) A statement that the debt is owed and an explanation of its nature and amount;
(2) The agency’s intention to collect the debt by deducting from the employee’s current disposable pay account;
(3) The amount, frequency, proposed beginning date, and duration of the intended deduction(s);
(4) An explanation of interest, penalties, and administrative charges, including a statement that such charges will be assessed unless excused in accordance with the Federal Claims Collections Standards at 4 CFR 101.1 et seq;
(5) The employee’s right to inspect, request, and receive a copy of government records relating to the debt;
(6) The employee’s opportunity to establish a written schedule for the voluntary repayment of the debt in lieu of offset;
(7) The employee’s right to an oral hearing or a determination based on a review of the written record (“paper hearing”) conducted by an impartial hearing official concerning the existence or the amount of the debt, or the terms of the repayment schedule;
(8) The procedures and time period for petitioning for a hearing;
(9) A statement that a timely filing of a petition for a hearing will stay the commencement of collection proceedings;
(10) A statement that a final decision on the hearing (if requested) will be issued by the hearing official not later than 60 days after the filing of the petition requesting the hearing unless the employee requests and the hearing official grants a delay in the proceedings;
(11) A statement that knowingly false or frivolous statements, representations, or evidence may subject the employee to appropriate disciplinary procedures and/or statutory penalties;
(12) A statement of other rights and remedies available to the employee under statutes or regulations governing the program for which the collection is being made;
(13) Unless there are contractual or statutory provisions to the contrary, a statement that amounts paid on or deducted for the debt which are later waived or found not owed to the United States will be promptly refunded to the employee; and
(14) A statement that the proceedings regarding such debt are governed by section 5 of the Debt Collection Act of 1982 (5 U.S.C. 5514).
§ 1027.5 Hearing.
(a) Request for hearing. (1) An employee may file a petition for an oral or paper hearing in accordance with the instructions outlined in the agency’s notice to offset.
(2) A hearing may be requested by filing a written petition addressed to the Executive Director stating why the employee disputes the existence or amount of the debt or, in the case of an individual whose repayment schedule has been established other than by a written agreement, concerning the terms of the repayment schedule. The petition for a hearing must be received by the Executive Director not later than fifteen (15) calendar days after the employee’s receipt of the offset notice, or notice of the terms of the payment schedule, unless the employee can show good cause for failing to meet the filing deadline.
(b) Hearing procedures. (1) The hearing will be presided over by an impartial hearing official.
(2) The hearing shall conform to procedures contained in the Federal Claims Collection Standards, 4 CFR 102.3(c). The burden shall be on the employee to demonstrate that the existence or the amount of the debt is in error.
§ 1027.6 Written decision.
(a) The hearing official shall issue a final written opinion no later than 60 days after the filing of the petition.
(b) The written opinion will include: A statement of the facts presented to demonstrate the nature and origin of the alleged debt; the hearing official’s analysis, findings, and conclusions; the amount and validity of the debt; and the repayment schedule.
§ 1027.7 Coordinating offset with another Federal agency.
(a) The CPSC as the creditor agency. (1) When the Executive Director determines that an employee of another agency (i.e., the paying agency) owes a debt to the CPSC, the Executive Director shall, as appropriate:
(i) Certify in writing to the paying agency that the employee owes the debt, the amount and basis of the debt, the date on which payment was due, and the date the Government’s right to collect the debt accrued, and that this part 1027 has been approved by the Office of Personnel Management.
(ii) Unless the employee has consented to salary offset in writing or signed a statement acknowledging receipt of the required procedures, and the written consent is sent to the paying agency, the Executive Director must advise the paying agency of the action(s) taken under this part 1027, and the date(s) they were taken.
(iii) Request the paying agency to collect the debt by salary offset. If deductions must be made in installments, the Executive Director may recommend to the paying agency the amount or percentage of disposable pay to be collected in each installment;
(iv) Arrange for a hearing upon the proper petitioning by the employee;
(v) If the employee is in the process of separating from the Federal service, the CPSC must submit its debt claim to the paying agency as provided in this part. The paying agency must certify the total amount collected, give a copy of the certification to the employee, and send a copy of the certification and notice of the employee’s separation to the CPSC. If the paying agency is aware that the employee is entitled to Civil Service Retirement and Disability Fund or other similar payments, it must certify to the agency responsible for making such payments that the debtor owes a debt, including the amount of the debt, and that the provisions of 5 CFR 550.1108 have been followed; and
(vi) If the employee has already separated from federal service and all payments due from the paying agency have been paid, the Executive Director may request, unless otherwise prohibited, that money payable to the employee from the Civil Service Retirement and Disability Fund or other similar funds be collected by administrative offset.
(2) [Reserved]
(b) The CPSC as the paying agency. (1) Upon receipt of a properly certified debt claim from another agency, deductions will be scheduled to begin at the next established pay interval. The employee must receive written notice that CPSC has received a certified debt claim from the creditor agency, the amount of the debt, the date salary offset will begin, and the amount of the deduction(s). CPSC shall not review the merits of the creditor agency’s determination of the validity or the amount of the certified claim.
(2) If the employee transfers to another agency after the creditor agency has submitted its debt claim to CPSC and before the debt is collected completely, CPSC must certify the amount collected. One copy of the certification must be furnished to the employee. A copy must be furnished to the creditor agency with notice of the employee’s transfer.
§ 1027.8 Procedures for salary offset.
(a) Deductions to liquidate an employee’s debt will be by the method and in the amount stated in the Executive Director’s notice of intention to offset as provided in § 1027.4. Debts will be collected in one lump sum where possible. If the employee is financially unable to pay in one lump sum, collection must be made in installments.
(b) Debts will be collected by deduction at officially established pay intervals from an employee’s current pay account unless alternative arrangements for repayment are made.
(c) Installment deductions will be made over a period not greater than the anticipated period of employment. The size of installment deductions must bear a reasonable relationship to the size of the debt and the employee’s ability to pay. The deduction for the pay intervals for any period must not exceed 15% of disposable pay unless the employee has agreed in writing to a deduction of a greater amount.
(d) Unliquidated debts may be offset against any financial payment due to a separated employee including but not limited to final salary or leave payment in accordance with 31 U.S.C. 3716.
§ 1027.9 Refunds.
(a) CPSC will promptly refund to an employee any amounts deducted to satisfy debts owed to CPSC when the debt is waived, found not owed to CPSC, or when directed by an administrative or judicial order.
(b) Another creditor agency will promptly return to CPSC any amounts deducted by CPSC to satisfy debts owed to the creditor agency when the debt is waived, found not owed, or when directed by an administrative or judicial order.
(c) Unless required by law, refunds under this paragraph shall not bear interest.
§ 1027.10 Statute of limitations.
(a) If a debt has been outstanding for more than 10 years after CPSC’s right to collect the debt first accrued, the agency may not collect by salary offset unless facts material to the Government’s right to collect were not known and could not reasonably have been known by the official or officials who were charged with the responsibility for discovery and collection of such debts.
(b) [Reserved]
§ 1027.11 Non-waiver of rights.
An employee’s involuntary payment of all or any part of a debt collected under these regulations will not be construed as a waiver of any rights that the employee may have under 5 U.S.C. 5514 or any other provision of law.
§ 1027.12 Interest, penalties, and administrative costs.
Charges may be assessed on a debt for interest, penalties, and administrative costs in accordance with 31 U.S.C. 3717 and the Federal Claims Collection Standards, 4 CFR 101.1 et seq.
PART 1028—PROTECTION OF HUMAN SUBJECTS
§ 1028.101 To what does this policy apply?
(a) Except as detailed in § 1028.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States. Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy.
(b) [Reserved]
(c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.
(d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise covered by this policy comply with some or all of the requirements of this policy.
(e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide additional protections for human subjects.
(f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects.
(g) This policy does not affect any foreign laws or regulations that may otherwise be applicable and that provide additional protections to human subjects of research.
(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the
(i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy, provided the alternative procedures to be followed are consistent with the principles of the Belmont Report.
(j) Federal guidance on the requirements of this policy shall be issued only after consultation, for the purpose of harmonization (to the extent appropriate), with other Federal departments and agencies that have adopted this policy, unless such consultation is not feasible.
(k) [Reserved]
(l) Pre-2018 Requirements. Compliance dates and transition provisions:
(1) For purposes of this section, the pre-2018 Requirements means this subpart as published in the 2016 edition of the Code of Federal Regulations.
(2) 2018 Requirements. For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this part. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for § 1028.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section:
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 1028.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 1028.101(b) of the pre-2018 Requirements before January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an institution planning or engaged in research otherwise covered by paragraph (l)(3) of this section determines that such research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination.
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(1) Section 1028.102(l) of the 2018 Requirements (definition of research) (instead of § 1028.102(d) of the pre-2018 Requirements);
(2) Section 1028.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of § 1028.103(f) of the pre-2018 Requirements); and
(3) Section 1028.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of § 1028.103(b), as related to the requirement for continuing review, and in addition to § 1028.109, of the pre-2018 Requirements); and
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research:
(i) Research initially approved by an IRB on or after January 21, 2019;
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019; and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
(m) Severability: Any provision of this part held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this part and shall not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other dissimilar circumstances.
§ 1028.102 Definitions for purposes of this policy.
(a) Certification means the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
(b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
(c) Department or agency head means the head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated.
(d) Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency).
(e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
(2) Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
(3) Interaction includes communication or interpersonal contact between investigator and subject.
(4) Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
(5) Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
(6) An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
(7) Federal departments or agencies implementing this policy shall:
(i) Upon consultation with appropriate experts (including experts in data matching and re-identification), reexamine the meaning of “identifiable private information,” as defined in paragraph (e)(5) of this section, and “identifiable biospecimen,” as defined in paragraph (e)(6) of this section. This reexamination shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. If appropriate and permitted by law, such Federal departments and agencies may alter the interpretation of these terms, including through the use of guidance.
(ii) Upon consultation with appropriate experts, assess whether there are analytic technologies or techniques that should be considered by investigators to generate “identifiable private information,” as defined in paragraph (e)(5) of this section, or an “identifiable biospecimen,” as defined in paragraph (e)(6) of this section. This assessment shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. Any such technologies or techniques will be included on a list of technologies or techniques that produce identifiable private information or identifiable biospecimens. This list will be published in the
(f) Institution means any public or private entity, or department or agency (including federal, state, and other agencies).
(g) IRB means an institutional review board established in accord with and for the purposes expressed in this policy.
(h) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
(i) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research.
(j) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
(k) Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.
(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
(m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format.
§ 1028.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
(a) Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under § 1028.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for Federal-wide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal departments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance that it will comply with the requirements of this policy, as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB (if such certification is required by paragraph (d) of this section).
(b) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes.
(c) The department or agency head may limit the period during which any assurance shall remain effective or otherwise condition or restrict the assurance.
(d) Certification is required when the research is supported by a Federal department or agency and not otherwise waived under § 1028.101(i) or exempted under § 1028.104. For such research, institutions shall certify that each proposed research study covered by the assurance and this section has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB.
(e) For nonexempt research involving human subjects covered by this policy (or exempt research for which limited IRB review takes place pursuant to § 1028.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)) that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, the institution and the organization operating the IRB shall document the institution’s reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (e.g., in a written agreement between the institution and the IRB, by implementation of an institution-wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a research protocol).
§ 1028.104 Exempt research.
(a) Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category.
(b) Use of the exemption categories for research subject to the requirements of 45 CFR part 46, subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows:
(1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met.
(2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners.
(3) Subpart D. The exemptions at paragraphs (d)(1) and (d)(4) through (8) of this section may be applied to research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D.
(c) [Reserved]
(d) Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:
(1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 1028.111(a)(7).
(3)(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 1028.111(a)(7).
(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
(4) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable biospecimens are publicly available;
(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
(5) Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
(ii) [Reserved]
(6) Taste and food quality evaluation and consumer acceptance studies:
(i) If wholesome foods without additives are consumed, or
(ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
(7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by § 1028.111(a)(8).
(8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with § 1028.116(a)(1) through (4), (a)(6), and (d);
(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with § 1028.117;
(iii) An IRB conducts a limited IRB review and makes the determination required by § 1028.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
(iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.
§ 1028.105-1028.106 [Reserved]
§ 1028.107 IRB membership.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.
(b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
(c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(d) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
§ 1028.108 IRB functions and operations.
(a) In order to fulfill the requirements of this policy each IRB shall:
(1) Have access to meeting space and sufficient staff to support the IRB’s review and recordkeeping duties;
(2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant;
(3) Establish and follow written procedures for:
(i) Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
(ii) Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and
(iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.
(4) Establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of
(i) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) Any suspension or termination of IRB approval.
(b) Except when an expedited review procedure is used (as described in § 1028.110), an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
§ 1028.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under § 1028.104 for which limited IRB review is a condition of exemption (under § 1028.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)).
(b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with § 1028.116. The IRB may require that information, in addition to that specifically mentioned in § 1028.116, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 1028.117.
(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
(e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in paragraph (f) of this section.
(f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:
(i) Research eligible for expedited review in accordance with § 1028.110;
(ii) Research reviewed by the IRB in accordance with the limited IRB review described in § 1028.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8);
(iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
(A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
(2) [Reserved]
(g) An IRB shall have authority to observe or have a third party observe the consent process and the research.
§ 1028.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
(a) The Secretary of HHS has established, and published as a Notice in the
(b)(1) An IRB may use the expedited review procedure to review the following:
(i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer determines that the study involves more than minimal risk;
(ii) Minor changes in previously approved research during the period for which approval is authorized; or
(iii) Research for which limited IRB review is a condition of exemption under § 1028.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).
(2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in § 1028.108(b).
(c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure.
(d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution’s or IRB’s use of the expedited review procedure.
§ 1028.111 Criteria for IRB approval of research.
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized:
(i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
(ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, § 1028.116.
(5) Informed consent will be appropriately documented or appropriately waived in accordance with § 1028.117.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(i) The Secretary of HHS will, after consultation with the Office of Management and Budget’s privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of data.
(ii) [Reserved]
(8) For purposes of conducting the limited IRB review required by § 1028.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
(i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of § 1028.116(a)(1)-(4), (a)(6), and (d);
(ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with § 1028.117; and
(iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
§ 1028.112 Review by institution.
Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.
§ 1028.113 Suspension or termination of IRB approval of research.
An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
§ 1028.114 Cooperative research.
(a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.
(b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.
(2) The following research is not subject to this provision:
(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
(c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.
§ 1028.115 IRB Records.
(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in § 1028.109(f)(1).
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in § 1028.108(a)(2).
(6) Written procedures for the IRB in the same detail as described in § 1028.108(a)(3) and (4).
(7) Statements of significant new findings provided to subjects, as required by § 1028.116(c)(5).
(8) The rationale for an expedited reviewer’s determination under § 1028.110(b)(1)(i) that research appearing on the expedited review list described in § 1028.110(a) is more than minimal risk.
(9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in § 1028.103(e).
(b) The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by authorized representatives of the Federal department or agency at reasonable times and in a reasonable manner.
§ 1028.116 General requirements for informed consent.
(a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is described in paragraph (f) of this section. Except as provided elsewhere in this policy:
(1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.
(2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
(3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.
(4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
(5) Except for broad consent obtained in accordance with paragraph (d) of this section:
(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
(6) No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
(b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized representative:
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others that may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
(i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
(c) Additional elements of informed consent. Except as provided in paragraphs (d), (e), or (f) of this section, one or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative:
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s consent;
(3) Any additional costs to the subject that may result from participation in the research;
(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject;
(6) The approximate number of subjects involved in the study;
(7) A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
(8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
(9) For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
(d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements in paragraphs (b) and (c) of this paragraph. If the subject or the legally authorized representative is asked to provide broad consent, the following shall be provided to each subject or the subject’s legally authorized representative:
(1) The information required in paragraphs (b)(2), (3), (5), and (8) and, when appropriate, (c)(7) and (9) of this section;
(2) A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
(3) A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
(4) A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);
(5) Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
(6) Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and
(7) An explanation of whom to contact for answers to questions about the subject’s rights and about storage and use of the subject’s identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.
(e) Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials—(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a), (b), and (c) of this section, provided the IRB satisfies the requirements of paragraph (e)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
(2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (e)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section.
(3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:
(i) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
(A) Public benefit or service programs;
(B) Procedures for obtaining benefits or services under those programs;
(C) Possible changes in or alternatives to those programs or procedures; or
(D) Possible changes in methods or levels of payment for benefits or services under those programs; and
(ii) The research could not practicably be carried out without the waiver or alteration.
(f) General waiver or alteration of consent—(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a), (b), and (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
(2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section.
(3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:
(i) The research involves no more than minimal risk to the subjects;
(ii) The research could not practicably be carried out without the requested waiver or alteration;
(iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
(v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
(g) Screening, recruiting, or determining eligibility. An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, if either of the following conditions are met:
(1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
(2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
(h) Posting of clinical trial consent form. (1) For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms.
(2) If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
(3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
(i) Preemption. The informed consent requirements in this policy are not intended to preempt any applicable Federal, state, or local laws (including tribal laws passed by the official governing body of an American Indian or Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be legally effective.
(j) Emergency medical care. Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or local law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe).
§ 1028.117 Documentation of informed consent.
(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy shall be given to the person signing the informed consent form.
(b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the following:
(1) A written informed consent form that meets the requirements of § 1028.116. The investigator shall give either the subject or the subject’s legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject’s legally authorized representative.
(2) A short form written informed consent form stating that the elements of informed consent required by § 1028.116 have been presented orally to the subject or the subject’s legally authorized representative, and that the key information required by § 1028.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject’s legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject’s legally authorized representative, in addition to a copy of the short form.
(c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
(i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;
(ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
(iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
§ 1028.118 Applications and proposals lacking definite plans for involvement of human subjects.
Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution’s responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under § 1028.101(i) or exempted under § 1028.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research.
§ 1028.119 Research undertaken without the intention of involving human subjects.
Except for research waived under § 1028.101(i) or exempted under § 1028.104, in the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component.
§ 1028.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
(a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the Federal department or agency through such officers and employees of the Federal department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
(b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.
§ 1028.121 [Reserved]
§ 1028.122 Use of Federal funds.
Federal funds administered by a Federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.
§ 1028.123 Early termination of research support: Evaluation of applications and proposals.
(a) The department or agency head may require that Federal department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy.
(b) In making decisions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).
§ 1028.124 Conditions
With respect to any research project or any class of research projects the department or agency head of either the conducting or the supporting Federal department or agency may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects.
PART 1031—COMMISSION PARTICIPATION AND COMMISSION EMPLOYEE INVOLVEMENT IN VOLUNTARY STANDARDS ACTIVITIES
Subpart A—General Policies
§ 1031.1 Purpose and scope.
(a) This part 1031 sets forth the Consumer Product Safety Commission’s guidelines and requirements on participating in the activities of voluntary standards bodies. Subpart A sets forth general policies on Commission involvement, and subpart B sets forth policies and guidelines on employee involvement in voluntary standards activities. Subpart C sets forth the criteria governing public review and comment on staff involvement in voluntary standards activities.
(b) For purposes of both subpart A and subpart B of this part 1031, voluntary standards bodies are private sector domestic or multinational organizations or groups, or combinations thereof, such as, but not limited to, all non-profit organizations, industry associations, professional and technical societies, institutes, and test laboratories, that are involved in the planning, development, establishment, revision, review or coordination of voluntary standards. Voluntary standards development bodies are voluntary standards bodies, or their sub-groups, that are devoted to developing or establishing voluntary standards.
§ 1031.2 Background.
(a) Congress enacted the Consumer Product Safety Act in 1972 to protect consumers against unreasonable risks of injury associated with consumer products. In order to achieve that goal, Congress established the Consumer Product Safety Commission as an independent regulatory agency and granted it broad authority to promulgate mandatory safety standards for consumer products as a necessary alternative to industry self regulation.
(b) In 1981, the Congress amended the Consumer Product Safety Act, the Federal Hazardous Substances Act, and the Flammable Fabrics Act, to require the Commission to rely on voluntary standards rather than promulgate a mandatory standard when voluntary standards would eliminate or adequately reduce the risk of injury addressed and it is likely that there will be substantial compliance with the voluntary standards. (15 U.S.C. 2056(b), 15 U.S.C. 1262(g)(2), 15 U.S.C. 1193(h)(2)). The 1981 Amendments also require the Commission, after any notice or advance notice of proposed rulemaking, to provide technical and administrative assistance to persons or groups who propose to develop or modify an appropriate voluntary standard. (15 U.S.C. 2054(a)(3)). Additionally, the amendments encourage the Commission to provide technical and administrative assistance to groups developing product safety standards and test methods, taking into account Commission resources and priorities (15 U.S.C. 2054(a)(4)). Although the Commission is required to provide assistance to such groups, it may determine the level of assistance in accordance with the level of its own administrative and technical resources and in accordance with its assessment of the likelihood that the groups being assisted will successfully develop a voluntary standard that will preclude the need for a mandatory standard.
(c) In 1990, Congress passed the Consumer Product Safety Improvement Act (CPSIA), amending section 15(b) of the CPSA to require that manufacturers, distributors, and retailers notify the Commission about products that fail to comply with an applicable voluntary standard upon which the Commission has relied under section 9 of the CPSA. CPSIA also amended section 9(b)(2) of the CPSA to require that the CPSC afford interested persons the opportunity to comment regarding any voluntary standard prior to CPSC termination and reliance.
§ 1031.3 Consumer Product Safety Act amendments.
The Consumer Product Safety Act, as amended, contains several sections pertaining to the Commission’s participation in the development and use of voluntary standards.
(a) Section 7(b) provides that the Commission shall rely on voluntary consumer product safety standards prescribing requirements described in subsection (a) whenever compliance with such voluntary standards would eliminate or adequately reduce the risk of injury addressed and it is likely that there will be substantial compliance with such voluntary standards. (15 U.S.C. 2056(b)).
(b) Section 5(a)(3) provides that the Commission shall, following publication of an advance notice of proposed rulemaking or a notice of proposed rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist public and private organizations or groups of manufacturers, administratively and technically, in the development of safety standards addressing the risk of injury identified in such notice. (15 U.S.C. 2054(a)(3)).
(c) Section 5(a)(4) provides that the Commission shall, to the extent practicable and appropriate (taking into account the resources and priorities of the Commission), assist public and private organizations or groups of manufacturers, administratively and technically, in the development of product safety standards and test methods. (15 U.S.C. 2054(a)(4)).
§ 1031.4 Effect of voluntary standards activities on Commission activities.
(a)(1) The Commission, in determining whether to begin proceedings to develop mandatory standards under the acts it administers, considers whether mandatory regulation is necessary or whether there is an existing voluntary standard that adequately addresses the problem and the extent to which that voluntary standard is complied with by the affected industry.
(2) The Commission acknowledges that there are situations in which adequate voluntary standards, in combination with appropriate certification programs, may be appropriate to support a conclusion that a mandatory standard is not necessary. The Commission may find that a mandatory standard is not necessary where compliance with an existing voluntary standard would eliminate or adequately reduce the risk of injury associated with the product, contains requirements and test methods that have been evaluated and found acceptable by the Commission, and it is likely that there will be substantial and timely compliance with the voluntary standard. Under such circumstances, the Commission may agree to encourage industry compliance with the voluntary standard and subsequently evaluate the effectiveness of the standard in terms of accident and injury reduction for products produced in compliance with the standard.
(3) In evaluating voluntary standards, the Commission will relate the requirements of the standard to the identified risks of injury and evaluate the requirements in terms of their effectiveness in eliminating or reducing the risks of injury. The evaluation of voluntary standards will be conducted by Commission staff members, including representatives of legal, economics, engineering, epidemiological, health sciences, human factors, other appropriate interests, and the Voluntary Standards Coordinator. The staff evaluation will be conducted in a manner similar to evaluations of standards being considered for promulgation as mandatory standards.
(4) In the event that the Commission has evaluated an existing voluntary standard and found it to be adequate in all but a few areas, the Commission may defer the initiation of a mandatory rulemaking proceeding and request the voluntary standards organization to revise the standard to address the identified inadequacies expeditiously.
(b) In the event the Commission determines that there is no existing voluntary standard that will eliminate or adequately reduce a risk of injury the Commission may commence a proceeding for the development of a consumer product safety rule or a regulation in accordance with section 9 of the Consumer Product Safety Act, 15 U.S.C. 2058, section 3(f) of the Federal Hazardous Substances Act, 15 U.S.C. 1262(f), or section 4(a) of the Flammable Fabrics Act, 15 U.S.C. 1193(g), as may be applicable. In commencing such a proceeding, the Commission will publish an advance notice of proposed rulemaking which shall, among other things, invite any person to submit to the Commission an existing standard or portion of an existing standard, or to submit a statement of intention to modify or develop, within a reasonable period of time, a voluntary standard to address the risk of injury.
(c) The Commission will consider those provisions of a voluntary standard that have been reviewed, evaluated, and deemed to be adequate in addressing the specified risks of injury when initiating a mandatory consumer product safety rule or regulation under the Consumer Product Safety Act, the Federal Hazardous Substances Act, or the Flammable Fabrics Act, as may be applicable. Comments will be requested in the advance notice of proposed rulemaking on the adequacy of such voluntary standard provisions.
§ 1031.5 Criteria for Commission involvement in voluntary standards activities.
The Commission will consider the extent to which the following criteria are met in considering Commission involvement in the development of voluntary safety standards for consumer products:
(a) The likelihood the voluntary standard will eliminate or adequately reduce the risk of injury addressed and that there will be substantial and timely compliance with the voluntary standard.
(b) The likelihood that the voluntary standard will be developed within a reasonable period of time.
(c) Exclusion, to the maximum extent possible, from the voluntary standard being developed, of requirements which will create anticompetitive effects or promote restraint of trade.
(d) Provisions for periodic and timely review of the standard, including review for anticompetitive effects, and revision or amendment as the need arises.
(e) Performance-oriented and not design-restrictive requirements, to the maximum practical extent, in any standard developed.
(f) Industry arrangements for achieving substantial and timely industry compliance with the voluntary standard once it is issued, and the means of ascertaining such compliance based on overall market share of product production.
(g) Provisions in the standard for marking products conforming to the standard so that future Commission investigation can indicate the involvement of such products in accidents and patterns of injury.
(h) Provisions for insuring that products identified as conforming to such standards will be subjected to a testing and certification (including self-certification) procedure, which will provide assurance that the products comply with the standard.
(i) The openness to all interested parties, and the establishment of procedures which will provide for meaningful participation in the development of such standards by representatives of producers, suppliers, distributors, retailers, consumers, small business, public interests and other individuals having knowledge or expertise in the areas under consideration, and procedures for affording other due process considerations.
§ 1031.6 Extent and form of Commission involvement in the development of voluntary standards.
(a) The extent of Commission involvement will be dependent upon the Commission’s interest in the particular standards development activity and the Commission’s priorities and resources.
(b) The Commission’s interest in a specific voluntary standards activity will be based in part on the frequency and severity of injuries associated with the product, the involvement of the product in accidents, the susceptibility of the hazard to correction through standards, and the overall resources and priorities of the Commission. Commission involvement in voluntary standards activities generally will be guided by the Commission’s operating plan and performance budget.
(c) Commission involvement in voluntary standards activities varies.
(1) The Commission staff may maintain an awareness of the voluntary standards development process through oral or written inquiries, receiving and reviewing minutes of meetings and copies of draft standards, or attending meetings for the purpose of observing and commenting during the standards development process in accordance with subpart B of this part. For example, Commission staff may respond to requests from voluntary standards organizations, standards development committees, trade associations and consumer organizations; by providing information concerning the risks of injury associated with particular products, National Electronic Injury Surveillance System (NEISS) data, death, injury, and incident data, summaries and analyses of in-depth investigation reports; discussing Commission goals and objectives with regard to voluntary standards and improved consumer product safety; responding to requests for information concerning Commission programs; and initiating contacts with voluntary standards organizations to discuss cooperative voluntary standards activities.
(2) Employee involvement may include membership as defined in § 1031.10(a). Commission staff may regularly attend meetings of a standard development committee or group and take an active part in the discussions of the committee and in developing the standard, in accordance with subpart B of this part. The Commission may contribute to the deliberations of the committee by expending resources to provide technical assistance (e.g., research, engineering support, and information and education programs) and administrative assistance (e.g., travel costs, hosting meetings, and secretarial functions) in support of the development and implementation of those voluntary standards referenced in the Commission’s operating plan, performance budget, mid-year review, or other official Commission document. The Commission may also support voluntary standards activities as described in § 1031.7. Employee involvement may include observation as defined in § 1031.10(c).
(d) Normally, the total amount of Commission support given to a voluntary standards activity shall be no greater than that of all non-Federal participants in that activity, except where it is in the public interest to do so.
(e) In the event of duplication of effort by two or more groups (either inside or outside the Commission) in developing a voluntary standard for the same product or class of products, the Commission shall encourage the several groups to cooperate in the development of a single voluntary standard.
§ 1031.7 Commission support of voluntary standards activities.
(a) The Commission’s support of voluntary safety standards development activities may include any one or a combination of the following actions:
(1) Providing epidemiological and health science information and explanations of hazards for consumer products.
(2) Encouraging the initiation of the development of voluntary standards for specific consumer products.
(3) Identifying specific risks of injury to be addressed in a voluntary standard.
(4) Performing or subsidizing technical assistance, including research, health science data, and engineering support, in the development of a voluntary standard activity in which the Commission staff is participating.
(5) Providing assistance on methods of disseminating information and education about the voluntary standard or its use.
(6) Performing a staff evaluation of a voluntary standard to determine its adequacy and efficacy in reducing the risks of injury that have been identified by the Commission as being associated with the use of the product.
(7) Encouraging state and local governments to reference or incorporate the provisions of a voluntary standard in their regulations or ordinances and to participate in government or industrial model code development activities, so as to develop uniformity and minimize conflicting State and local regulations.
(8) Monitoring the number and market share of products conforming to a voluntary safety standard.
(9) Providing for the involvement of agency personnel in voluntary standards activities as described in subpart B of this part.
(10) Providing administrative assistance, such as hosting meetings and secretarial assistance.
(11) Providing funding support for voluntary standards development, as permitted by the operating plan, performance budget, mid-year review, or other official Commission document.
(12) Taking other actions that the Commission believes appropriate in a particular situation.
(b) [Reserved]
§ 1031.8 Voluntary Standards Coordinator.
(a) The Executive Director shall appoint a Voluntary Standards Coordinator to coordinate agency participation in voluntary standards bodies so that:
(1) The most effective use is made of agency personnel and resources, and
(2) The views expressed by such personnel are in the public interest and, at a minimum, do not conflict with the interests and established views of the agency.
(b) The Voluntary Standards Coordinator is responsible for managing the Commission’s voluntary standards program, as well as preparing and submitting to the Commission a semiannual summary of staff’s voluntary standards activities. The summary shall set forth, among other things, the goals of each voluntary standard under development, the extent of CPSC staff activity, the current status of standards development and implementation, and, if any, recommendations for additional Commission action. The Voluntary Standards Coordinator shall also compile information on the Commission’s voluntary standards activities for the Commission’s annual report.
Subpart B—Employee Involvement
§ 1031.9 Purpose and scope.
(a) This subpart sets forth the Consumer Product Safety Commission’s criteria and requirements governing membership and involvement by Commission officials and employees in the activities of voluntary standards development bodies.
(b) The Commission realizes there are advantages and benefits afforded by greater involvement of Commission personnel in the standards activities of domestic and international voluntary standards organizations. However, such involvement might present an appearance or possibility of the Commission giving preferential treatment to an organization or group or of the Commission losing its independence or impartiality. Also, such involvement may present real or apparent conflict of interest situations.
(c) The purpose of this subpart is to further the objectives and programs of the Commission and to do so in a manner that ensures that such involvement:
(1) Is consistent with the intent of the Consumer Product Safety Act and the other acts administered by the Commission;
(2) Is not contrary to the public interest;
(3) Presents no real or apparent conflict of interest, and does not result in or create the appearance of the Commission giving preferential treatment to an organization or group or the Commission compromising its independence or impartiality; and
(4) Takes into account Commission resources and priorities.
(d) Commission employees must obtain approval from their supervisor and the Office of the Executive Director to be involved in voluntary standards activities. They must regularly report to the Voluntary Standards Coordinator regarding their involvement in standards activities, and provide copies of all official correspondence and other communications between the CPSC and the standards developing entities.
(e) All Commission employees involved in voluntary standards activities are subject to any restrictions for avoiding conflicts of interest and for avoiding situations that would present an appearance of bias.
§ 1031.10 Definitions.
For purposes of describing the level of involvement in voluntary standards activities for which Commission employees may be authorized, the following definitions apply:
(a) Membership. Membership is the status of an employee who joins a voluntary standards development or advisory organization or subgroup and is listed as a member. It includes all oral and written communications which are incidental to such membership.
(b) Employee involvement. Employee involvement may include the active, ongoing involvement of an official or employee in the development of a new or revised voluntary standard pertaining to a particular consumer product or to a group of products that is the subject of a Commission voluntary standards project. These projects should be those that are approved by the Commission, either by virtue of the agency’s annual budget or operating plan, or by other specific agency authorization or decision, and are in accord with subpart A. Employee involvement may include regularly attending meetings of a standards development committee or group, taking an active part in discussions and technical debates, expressing opinions, expending other resources in support of a voluntary standard development activity, and participating as a voting member of, or in a leadership position on, a voluntary standard development group, when authorized. It includes all oral and written communications which are part of the process. Employee involvement may also involve maintaining an awareness related to general voluntary standards projects set forth in the agency’s annual budget or operating plan or otherwise approved by the agency.
(c) Observation. Observation is the attendance by an official or employee at a meeting of a voluntary standards development group for the purpose of observing and gathering information.
§ 1031.11 Procedural safeguards.
(a) Subject to the provisions of this subpart and budgetary and time constraints, Commission employees may be involved in voluntary standards activities that will further the objectives and programs of the Commission, are consistent with ongoing and anticipated Commission regulatory programs as set forth in the agency’s operating plan, and are in accord with the Commission’s policy statement on involvement in voluntary standards activities set forth in subpart A of this part.
(b) Commission employees who are involved in the development of a voluntary standard and who later participate in an official evaluation of that standard for the Commission shall describe in any information, oral or written, presented to the Commission, the extent of their involvement in the development of the standard. Any evaluation or recommendation for Commission actions by such employee shall strive to be as objective as possible and be reviewed by higher-level Commission officials or employees prior to submission to the Commission.
(c) Commission officials or employees who are authorized to participate as a voting member of a voluntary standard development group represent the position of CPSC staff. Such votes or opinions do not bind the Commission in any way or necessarily represent the opinions or views of the Commission, but rather, solely represent the views of the CPSC staff.
(d) Commission employees and officials who are involved in the development of voluntary standards may accept leadership positions in voluntary standard development groups (e.g., committee chairman or secretary) or leadership positions with the governing bodies of standard-making entities, when authorized with the prior approval of the Office of the Executive Director.
(e) Attendance of Commission personnel at voluntary standards meetings shall be noted in the public calendar, and meeting summaries shall be submitted to the Office of the Secretary, as required by the Commission’s meetings policy, 16 CFR part 1012.
§ 1031.12 Membership criteria.
(a) The Commissioners, their special assistants, and Commission officials and employees holding the positions listed below, may not become members of a voluntary standards group because they either have the responsibility for making final decisions, or advise those who make final decisions, on whether to rely on a voluntary standard, promulgate a consumer product safety standard, or to take other action to prevent or reduce an unreasonable risk of injury associated with a product.
(1) The Commissioners;
(2) The Commissioners’ Special Assistants;
(3) The General Counsel and General Counsel Staff;
(4) The Executive Director, the Deputy Executive Director, and Special Assistants to the Executive Director;
(5) The Associate Executive Directors and Office Directors;
(6) The Assistant Executive Director of the Office of Hazard Identification and Reduction, the Deputy Assistant Executive Director of the Office of Hazard Identification and Reduction and any Special Assistants to the Assistant Executive Director of that office.
(b) All other officials and employees not covered under § 1031.12(a) may participate as voting members or accept leadership positions in voluntary standard development groups, when authorized with the prior approval of the Office of the Executive Director.
(c) Commission employees or officials who have the approval of the Office of the Executive Director to accept membership in a voluntary standards organization or group pursuant to paragraph (b) of this section shall apprise the General Counsel and the Voluntary Standards Coordinator prior to their acceptance.
(d) Commission officials or employees who desire to become a member of a voluntary standards body or group in their individual capacity must obtain prior approval of the Commission’s Ethics Counselor for an outside activity pursuant to the Commission’s Employee Standards of Conduct, 16 CFR part 1030.
§ 1031.13 Criteria for employee involvement.
(a) Commission officials, other than those positions listed in § 1031.12(a), may be involved in the development of voluntary safety standards for consumer products, but only in their official capacity as employees of the Commission and if permitted to do so by their supervisor and any other person designated by agency management procedures. Such involvement shall be in accordance with Commission procedures.
(b) Employees in positions listed in § 1031.12(a)(4), (5), and (6) may be involved, on a case-by-case basis, in the development of a voluntary standard provided that they have the specific advance approval of the Commission.
(c) Except in extraordinary circumstances and when approved in advance by the Executive Director in accordance with the provisions of the Commission’s meetings policy, 16 CFR part 1012, Commission personnel shall not become involved in meetings concerning the development of voluntary standards that are not open to the public for attendance and observation. Attendance of Commission personnel at a voluntary standard meeting shall be noted in the public calendar and meeting logs filed with the Office of the Secretary in accordance with the Commission’s meetings policy.
(d) Generally, Commission employees may become involved in the development of voluntary standards only if they are made available for comment by all interested parties prior to their use or adoption.
(e) Involvement by Commission officials and employees in voluntary standards bodies or standards-developing groups does not, of itself, connote Commission agreement with, or endorsement of, decisions reached, approved or published by such bodies or groups.
§ 1031.14 Observation criteria.
A Commission official or employee may, on occasion, attend voluntary standards meetings for the sole purpose of observation, with the advance approval of his or her supervisor and any other person designated by agency management procedures. Commission officials and employees shall notify the Voluntary Standard Coordinator, for information purposes, prior to observing a voluntary standards meeting.
§ 1031.15 Communication criteria.
(a) Commission officials and employees, who are not in the positions listed in § 1031.12(a), or who are not already authorized to communicate with a voluntary standards group or representative incidental to their approved membership in a voluntary standard organization or group or as part of a voluntary standard, may:
(1) Communicate, within the scope of their duties, with a voluntary standard group, representative, or other committee member, on voluntary standards matters which are substantive in nature, i.e., matters that pertain to the formulation of the technical aspects of a specific voluntary standard or the course of conduct for developing the standard, only with the specific advance approval from the person or persons to whom they apply to obtain approval for involvement pursuant to § 1031.13. The approval may indicate the duration of the approval and any other conditions.
(2) Communicate, within the scope of their duties, with a voluntary standard group, representative, or other committee member, concerning voluntary standards activities which are not substantive in nature.
(b) Commission employees may communicate with voluntary standards organizations only in accordance with Commission procedures.
(c) Commissioners can engage in substantive and non-substantive written communications with voluntary standards bodies or representatives, provided a disclaimer in such communications indicates that any substantive views expressed are only their individual views and are not necessarily those of the Commission. Where a previous official Commission vote has taken place, that vote should also be noted in any such communication. Copies of such communications shall thereafter be provided to the other Commissioners, the Office of the Secretary, and the Voluntary Standards Coordinator.
(d) The Voluntary Standards Coordinator shall be furnished a copy of each written communication of a substantive nature and a report of each oral communication of a substantive nature between a Commission official or employee and a voluntary standards organization or representative which pertains to a voluntary standards activity. The information shall be provided to the Voluntary Standards Coordinator as soon as practicable after the communication has taken place.
Subpart C—Public Participation and Comment
§ 1031.16 Purpose and scope.
(a) This subpart sets forth the Consumer Product Safety Commission’s criteria and requirements governing public review and comment on staff involvement in the activities of voluntary standards development bodies.
(b) The Commission realizes there are advantages and benefits afforded by greater public awareness of staff involvement in standards development activities. Furthermore, the Commission recognizes public comment and input as an important part of the voluntary standards development process.
(c) The purpose of this subpart is to further the objectives and programs of the Commission and to do so in a manner that ensures openness and transparency.
§ 1031.17 Background.
(a) In a
(b) The pilot program ended on April 18, 2005, after a 6-month period. CPSC invited general comments on whether to continue the programs beyond the pilot period and solicited suggestions for improving the program.
(c) On July 28, 2005, the CPSC staff submitted to the Commission an assessment of the pilot program’s results, including data that indicated the voluntary standards site ranked among the top 20 directories visited on the CPSC Web site. Further, the report included the staff’s recommendation that the voluntary standards Web site be expanded to include information on all standards activities.
(d) On August 4, 2005, in accordance with the staff’s recommendation, the Commission voted unanimously to continue the voluntary standards program and expand it to include all voluntary standards activities.
§ 1031.18 Method of review and comment.
(a) Each of the voluntary standards activities in which Commission staff is involved shall have a unique Web link on the Commission Web site with relevant information regarding CPSC activity, including:
(1) The name(s) of CPSC staff working on the activity; and
(2) The e-mail and mailing addresses of the CPSC Office of the Secretary, to which any interested party may communicate their particular interest.
(b) E-mail and written comments on voluntary standards from the public to the CPSC shall be managed by the Office of the Secretary. Such communication shall be forwarded to appropriate staff for consideration and/or response.
(c) On the voluntary standards Web site, consumers shall have the opportunity to register for periodic e-mail notices from the Commission with respect to their standard of interest. Such notices shall be issued by the CPSC each time a voluntary standard site has been updated and no less than once every calendar year.
PART 1033—DISPLAY OF CONTROL NUMBERS FOR COLLECTION OF INFORMATION REQUIREMENTS UNDER THE PAPERWORK REDUCTION ACT
§ 1033.1 Purpose.
The purpose of this part 1033 is to display all control numbers assigned by the Office of Management and Budget (OMB) to collection of information requirements contained in rules enforced by the Consumer Product Safety Commission. Display of OMB control numbers is required by provisions of the Paperwork Reduction Act at 44 U.S.C. 3507(f) and by regulations issued by OMB to implement that act at 5 CFR 1320.7(f)(2), 1320.12(d), 1320.13(j), and 1320.14(e).
§ 1033.2 Display of control numbers.
The following rules enforced by the Consumer Product Safety Commission containing collections of information are listed with the control numbers assigned by the Office of Management and Budget:
| Part or section of title 16 Code of Federal Regulations | Currently assigned OMB control No. |
|---|---|
| Part 1019 | 3041-0003 |
| Part 1204 | 3041-0006 |
| Part 1509 | 3041-0012 |
| Part 1508 | 3041-0013 |
| Part 1632 | 3041-0014 |
| Part 1210 | 3041-0016 |
| Part 1630, 1631 | 3041-0017 |
| Sections 1500.18(a)(6), 1500.86(a)(4) | 3041-0019 |
| Part 1209 | 3041-0022 |
| Parts 1610, 1611 | 3041-0024 |
| Parts 1615, 1616 | 3041-0027 |
| Part 1505 | 3041-0035 |
| Part 1406 | 3041-0040 |
| Part 1205 | 3041-0091 |
| Part 1211 | 3041-0125 |
PART 1034—ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE CONSUMER PRODUCT SAFETY COMMISSION
§ 1034.101 Purpose.
This part effectuates section 119 of the Rehabilitation, Comprehensive Services, and Developmental Disabilities Amendments of 1978, which amended section 504 of the Rehabilitation Act of 1973 to prohibit discrimination on the basis of handicap in programs or activities conducted by Executive agencies or the United States Postal Service.
§ 1034.102 Application.
This part applies to all programs or activities conducted by the agency.
§ 1034.103 Definitions.
For purposes of this part, the term—
Assistant Attorney General means the Assistant Attorney General, Civil Rights Division, United States Department of Justice.
Auxiliary aids means services or devices that enable persons with impaired sensory, manual, or speaking skills to have an equal opportunity to participate in, and enjoy the benefits of, programs or activities conducted by the agency. For example, auxiliary aids useful for persons with impaired vision include readers, Brailled materials, audio recordings, telecommunications devices and other similar services and devices. Auxiliary aids useful for persons with impaired hearing include telephone handset amplifiers, telephones compatible with hearing aids, telecommunication devices for deaf persons (TDD’s), interpreters, notetakers, written materials, and other similar services and devices.
Complete complaint means a written statement that contains the complainant’s name and address and describes the agency’s alleged discriminatory action in sufficient detail to inform the agency of the nature and date of the alleged violation of section 504. It shall be signed by the complainant or by someone authorized to do so on his or her behalf. Complaints filed on behalf of classes or third parties shall describe or identify (by name, if possible) the alleged victims of discrimination.
Facility means all or any portion of buildings, structures, equipment, roads, walks, parking lots, rolling stock or other conveyances, or other real or personal property.
Handicapped person means any person who has a physical or mental impairment that substantially limits one or more major life activities, has a record of such an impairment, or is regarded as having such an impairment.
As used in this definition, the phrase:
(1) Physical or mental impairment includes—
(i) Any physiological disorder or condition, cosmetic disfigurement, or anatomical loss affecting one of more of the following body systems: Neurological; musculoskeletal; special sense organs; respiratory, including speech organs; cardiovascular; reproductive; digestive; genitourinary; hemic and lymphatic; skin; and endocrine; or
(ii) Any mental or psychological disorder, such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities. The term physical or mental impairment includes, but is not limited to, such diseases and conditions as orthopedic, visual, speech, and hearing impairments, cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, diabetes, mental retardation, emotional illness, and drug addition and alcholism.
(2) Major life activities includes functions such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, and working.
(3) Has a record of such an impairment means has a history of, or has been misclassified as having, a mental or physical impairment that substantially limits one or more major life activities.
(4) Is regarded as having an impairment means—
(i) Has a physical or mental impairment that does not substantially limit major life activities but is treated by the agency as constituting such a limitation;
(ii) Has a physical or mental impairment that substantially limits major life activities only as a result of the attitudes of others toward such impairment; or
(iii) Has none of the impairments defined in subparagraph (1) of this definition but is treated by the agency as having such an impairment.
Qualified handicapped person means—
(1) With respect to any agency program or activity under which a person is required to perform services or to achieve a level of accomplishment, a handicapped person who meets the essential eligibility requirements and who can achieve the purpose of the program or activity without modifications in the program or activity that the agency can demonstrate would result in a fundamental alteration in its nature; or
(2) With respect to any other program or activity, a handicapped person who meets the essential eligibility requirements for participation in, or receipt of benefits from, that program or activity.
(3) Qualified handicapped person is defined for purposes of employment in 29 CFR 1613.702(f), which is made applicable to this part by § 1034.140.
Section 504 means section 504 of the Rehabilitation Act of 1973 (Pub. L. 93-112, 87 Stat. 394 (29 U.S.C. 794)), as amended by the Rehabilitation Act Amendments of 1974 (Pub. L. 93-516, 88 Stat. 1617), and the Rehabilitation, Comprehensive Services, and Developmental Disabilities Amendments of 1978 (Pub. L. 95-602, 92 Stat. 2955). As used in this part, section 504 applies only to programs or activities conducted by Executive agencies and not to federally assisted programs.
§§ 1034.104-1034.109 [Reserved]
§ 1034.110 Self-evaluation.
(a) The agency shall, by April 9, 1987, evaluate its current policies and practices, and the effects thereof, that do not or may not meet the requirements of this part, and, to the extent modification of any such policies and practices is required, the agency shall proceed to make the necessary modifications.
(b) The agency shall provide an opportunity to interested persons, including handicapped persons or organizations representing handicapped persons, to participate in the self-evaluation process by submitting comments (both oral and written).
(c) The agency shall, until three years following the completion of the self-evaluation, maintain on file and make available for public inspections:
(1) A description of areas examined and any problems identified, and
(2) A description of any modifications made.
§ 1034.111 Notice.
The agency shall make available to employees, applicants, participants, beneficiaries, and other interested persons such information regarding the provisions of this part and its applicability to the programs or activities conducted by the agency, and make such information available to them in such manner as the head of the agency finds necessary to apprise such persons of the protections against discrimination assured them by section 504 and this regulation.
§§ 1034.112-1034.129 [Reserved]
§ 1034.130 General prohibitions against discrimination.
(a) No qualified handicapped person shall, on the basis of handicap, be excluded from participation in, be denied the benefits of, or otherwise be subjected to discrimination under any program or activity conducted by the agency.
(b)(1) The agency, in providing any aid, benefit, or service, may not, directly or through contractual, licensing, or other arrangements, on the basis of handicap—
(i) Deny a qualified handicapped person the opportunity to participate in or benefit from the aid, benefit, or service;
(ii) Afford a qualified handicapped person an opportunity to participate in or benefit from the aid, benefit, or service that is not equal to that afforded others;
(iii) Provide a qualified handicapped person with an aid, benefit, or service that is not as effective in affording equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement as that provided to others;
(iv) Provide different or separate aid, benefits, or services to handicapped persons or to any class of handicapped persons than is provided to others unless such action is necessary to provide qualified handicapped persons with aid, benefits, or services that are as effective as those provided to others;
(v) Deny a qualified handicapped person the opportunity to participate as a member of planning or advisory boards; or
(vi) Otherwise limit a qualified handicapped person in the enjoyment of any right, privilege, advantage, or opportunity enjoyed by others receiving the aid, benefit, or service.
(2) The agency may not deny a qualified handicapped person the opportunity to participate in programs or activities that are not separate or different, despite the existence of permissibly separate or different programs or activities.
(3) The agency may not, directly or through contractual or other arrangements, utilize criteria or methods of administration the purpose or effect of which would—
(i) Subject qualified handicapped persons to discrimination on the basis of handicap; or
(ii) Defeat or substantially impair accomplishment of the objectives of a program or activity with respect to handicapped persons.
(4) The agency may not, in determining the site or location of a facility, make selections the purpose or effect of which would—
(i) Exclude handicapped persons from, deny them the benefits of, or otherwise subject them to discrimination under any program or activity conducted by the agency; or
(ii) Defeat or substantially impair the accomplishment of the objectives of a program or activity with respect to handicapped persons.
(5) The agency, in the selection of procurement contractors, may not use criteria that subject qualified handicapped persons to discrimination on the basis of handicap.
(c) The exclusion of nonhandicapped persons from the benefits of a program limited by Federal statute or Executive order to handicapped persons or the exclusion of a specific class of handicapped persons from a program limited by Federal statute or Executive order to a different class of handicapped persons is not prohibited by this part.
(d) The agency shall administer programs and activities in the most integrated setting appropriate to the needs of qualified handicapped persons.
§§ 1034.131-1034.139 [Reserved]
§ 1034.140 Employment.
No qualified handicapped person shall, on the basis of handicap, be subjected to discrimination in employment under any program or activity conducted by the agency. The definitions, requirements, and procedures of section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 791), as established by the Equal Employment Opportunity Commission in 29 CFR part 1613, shall apply to employment in federally conducted programs or activities.
§§ 1034.141-1034.148 [Reserved]
§ 1034.149 Program accessibility: Discrimination prohibited.
Except as otherwise provided in § 1034.150, no qualified handicapped person shall, because the agency’s facilities are inaccessible to or unusable by handicapped persons, be denied the benefits of, be excluded from participation in, or otherwise be subjected to discrimination under any program or activity conducted by the agency.
§ 1034.150 Program accessibility: Existing facilities.
(a) General. The agency shall operate each program or activity so that the program or activity, when viewed in its entirety, is readily accessible to and usable by handicapped persons. This paragraph does not—
(1) Necessarily require the agency to make each of its existing facilities accessible to and usable by handicapped persons; or
(2) Require the agency to take any action that it can demonstrate would result in a fundamental alteration in the nature of a program or activity or in undue financial and administrative burdens. In those circumstances where agency personnel believe that the proposed action would fundamentally alter the program or activity or would result in undue financial and administrative burdens, the agency has the burden of proving that compliance with § 1034.150(a) would result in such alteration or burdens. The decision that compliance would result in such alteration or burdens must be made by the agency head or his or her designee after considering all agency resources available for use in the funding and operation of the conducted program or activity, and must be accompanied by a written statement of the reasons for reaching that conclusion. If an action would result in such an alteration or such burdens, the agency shall take any other action that would not result in such an alteration or such burdens but would nevertheless ensure that handicapped persons receive the benefits and services of the program or activity.
(b) Methods. The agency may comply with the requirements of this section through such means as redesign of equipment, reassignment of services to accessible buildings, assignment of aides to beneficiaries, home visits, delivery of services at alternate accessible sites, alteration of existing facilities and construction of new facilities, use of accessible rolling stock, or any other methods that result in making its programs or activities readily accessible to and usable by handicapped persons. The agency is not required to make structural changes in existing facilities where other methods are effective in achieving compliance with this section. The agency, in making alterations to existing buildings, shall meet accessibility requirements to the extent compelled by the Architectural Barriers Act of 1968, as amended (42 U.S.C. 4151-4157), and any regulations implementing it. In choosing among available methods for meeting the requirements of this section, the agency shall give priority to those methods that offer programs and activities to qualified handicapped persons in the most integrated setting appropriate.
(c) Time period for compliance. The agency shall comply with the obligations established under this section by June 6, 1986, except that where structural changes in facilities are undertaken, such changes shall be made by April 7, 1989, but in any event as expeditiously as possible.
(d) Transition plan. In the event that structural changes to facilities will be undertaken to achieve program accessibility, the agency shall develop, by October 7, 1986, a transition plan setting forth the steps necessary to complete such changes. The agency shall provide an opportunity to interested persons, including handicapped persons or organizations representing handicapped persons, to participate in the development of the transition plan by submitting comments (both oral and written). A copy of the transition plan shall be made available for public inspection. The plan shall, at a minimum—
(1) Identify physical obstacles in the agency’s facilities that limit the accessibility of its programs or activities to handicapped persons;
(2) Describe in detail the methods that will be used to make the facilities accessible;
(3) Specify the schedule for taking the steps necessary to achieve compliance with this section and, if the time period of the transition plan is longer than one year, identify steps that will be taken during each year of the transition period; and
(4) Indicate the official responsible for implementation of the plan.
§ 1034.151 Program accessibility: New construction and alterations.
Each building or part of a building that is constructed or altered by, on behalf of, or for the use of the agency shall be designed, constructed, or altered so as to be readily accessible to and usable by handicapped persons. The definitions, requirements, and standards of the Architectural Barriers Act (42 U.S.C. 4151-4157), as established in 41 CFR 101-19.600 to 101-19.607, apply to buildings covered by this section.
§§ 1034.152-1034.159 [Reserved]
§ 1034.160 Communications.
(a) The agency shall take appropriate steps to ensure effective communication with applicants, participants, personnel of other Federal entities, and members of the public.
(1) The agency shall furnish appropriate auxiliary aids where necessary to afford a handicapped person an equal opportunity to participate in, and enjoy the benefits of, a program or activity conducted by the agency.
(i) In determining what type of auxiliary aid is necessary, the agency shall give primary consideration to the requests of the handicapped person.
(ii) The agency need not provide individually prescribed devices, readers for personal use or study, or other devices of a personal nature.
(2) Where the agency communicates with applicants and beneficiaries by telephone, telecommunication devices for deaf persons (TDD’s) or equally effective telecommunication systems shall be used.
(b) The agency shall ensure that interested persons, including persons with impaired vision or hearing, can obtain information as to the existence and location of accessible services, activities, and facilities.
(c) The agency shall provide signage at a primary entrance to each of its inaccessible facilities, directing users to a location at which they can obtain information about accessible facilities. The international symbol for accessibility shall be used at each primary entrance of an accessible facility.
(d) This section does not require the agency to take any action that it can demonstrate would result in a fundamental alteration in the nature of a program or activity or in undue financial and administrative burdens. In those circumstances where agency personnel believe that the proposed action would fundamentally alter the program or activity or would result in undue financial and administrative burdens, the agency has the burden of proving that compliance with § 1034.160 would result in such alteration or burdens. The decision that compliance would result in such alteration or burdens must be made by the agency head or his or her designee after considering all agency resources available for use in the funding and operation of the conducted program or activity, and must be accompanied by a written statement of the reasons for reaching that conclusion. If an action required to comply with this section would result in such an alteration or such burdens, the agency shall take any other action that would not result in such an alteration or such burdens but would nevertheless ensure that, to the maximum extent possible, handicapped persons receive the benefits and services of the program or activity.
§§ 1034.161-1034.169 [Reserved]
§ 1034.170 Compliance procedures.
(a) Except as provided in paragraph (b) of this section, this section applies to all allegations of discrimination on the basis of handicap in programs or activities conducted by the agency.
(b) The agency shall process complaints alleging violations of section 504 with respect to employment according to the procedures established by the Equal Employment Opportunity Commission in 29 CFR part 1613 pursuant to section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 791).
(c) The Office of Equal Employment Opportunity and Minority Enterprise shall be responsible for coordinating implementation of this section. Complaints may be sent to the Director, Office of Equal Employment Opportunity and Minority Enterprise, Consumer Product Safety Commission, Washington, D.C. 20207.
(d) The agency shall accept and investigate all complete complaints for which it has jurisdiction. All complete complaints must be filed within 180 days of the alleged act of discrimination. The agency may extend this time period for good cause.
(e) If the agency receives a complaint over which it does not have jurisdiction, it shall promptly notify the complainant and shall make reasonable efforts to refer the complaint to the appropriate government entity.
(f) The agency shall notify the Architectural and Transportation Barriers Compliance Board upon receipt of any complaint alleging that a building or facility that is subject to the Architectural Barriers Act of 1968, as amended (42 U.S.C. 4151-4157), or section 502 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 792), is not readily accessible to and usable by handicapped persons.
(g) Within 180 days of the receipt of a complete complaint for which it has jurisdiction, the agency shall notify the complainant of the results of the investigation in a letter containing—
(1) Findings of fact and conclusions of law;
(2) A description of a remedy for each violation found; and
(3) A notice of the right to appeal.
(h) Appeals of the findings of fact and conclusions of law or remedies must be filed by the complainant within 90 days of receipt from the agency of the letter required by § 1034.170(g). The agency may extend this time for good cause.
(i) Timely appeals shall be accepted and processed by the head of the agency.
(j) The head of the agency shall notify the complainant of the results of the appeal within 60 days of the receipt of the request. If the head of the agency determines that additional information is needed from the complainant, he or she shall have 60 days from the date of receipt of the additional information to make his or her determination on the appeal.
(k) The time limits cited in paragraphs (g) and (j) of this section may be extended with the permission of the Assistant Attorney General.
(l) The agency may delegate its authority for conducting complaint investigations to other Federal agencies, except that the authority for making the final determination may not be delegated to another agency.
§§ 1034.171-1034.999 [Reserved]
PART 1051—PROCEDURE FOR PETITIONING FOR RULEMAKING
§ 1051.1 Scope.
(a) This part establishes procedures for the submission and disposition of petitions for the issuance, amendment or revocation of rules under the Consumer Product Safety Act (CPSA) (15 U.S.C. 2051 et seq.) or other statutes administered by the Consumer Product Safety Commission.
(b) Persons filing petitions for rulemaking shall follow as closely as possible the requirements and are encouraged to follow as closely as possible the recommendations for filing petitions under § 1051.5.
(c) Petitions regarding products regulated under the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261 et seq.) are governed by existing Commission procedures at 16 CFR 1500.82. Petitions regarding the exemption of products regulated under the Poison Prevention Packaging Act of 1970 (PPPA) (15 U.S.C. 1471 et seq.) are governed by existing Commission procedures at 16 CFR part 1702. In addition, however, persons filing such petitions shall follow the requirements and are encouraged to follow the recommendations for filing petitions as set forth in § 1051.5.
§ 1051.2 General.
(a) Any person may file with the Commission a petition requesting the Commission to begin a proceeding to issue, amend or revoke a regulation under any of the statutes it administers.
(b) A petition which addresses a risk of injury associated with a product which could be eliminated or reduced to a sufficient extent by action taken under the Federal Hazardous Substances Act, the Poison Prevention Packaging Act of 1970, or the Flammable Fabrics Act may be considered by the Commission under those Acts. However, if the Commission finds by rule, in accordance with section 30(d) of the CPSA, as amended by Public Law 94-284, that it is in the public interest to regulate such risk of injury under the CPSA, it may do so. Upon determination by the Office of the General Counsel that a petition should be considered under one of these acts rather than the CPSA, the Office of the Secretary shall docket and process the petition under the appropriate act and inform the petitioner of this determination. Such docketing, however, shall not preclude the Commission from proceeding to regulate the product under the CPSA after making the necessary findings.
§ 1051.3 Place of filing.
A petition should be mailed to: Office of the Secretary, Consumer Product Safety Commission, Washington, DC 20207. Persons wishing to file a petition in person may do so in the Office of the Secretary, at 4330 East West Highway, Bethesda, Maryland.
§ 1051.4 Time of filing.
For purposes of computing time periods under this part, a petition shall be considered filed when time-date stamped by the Office of the Secretary. A document is time-date stamped when it is received in the Office of the Secretary.
§ 1051.5 Requirements and recommendations for petitions.
(a) Requirements. To be considered a petition under this part, any request to issue, amend or revoke a rule shall meet the requirements of this paragraph (a). A petition shall:
(1) Be written in the English language;
(2) Contain the name and address of the petitioner;
(3) Indicate the product (or products) regulated under the Consumer Product Safety Act or other statute the Commission administers for which a rule is sought or for which there is an existing rule sought to be modified or revoked. (If the petition regards a procedural or other rule not involving a specific product, the type of rule involved must be indicated.)
(4) Set forth facts which establish the claim that the issuance, amendment, or revocation of the rule is necessary (for example, such facts may include personal experience; medical, engineering or injury data; or a research study); and
(5) Contain an explicit request to initiate Commission rulemaking and set forth a brief description of the substance of the proposed rule or amendment or revocation thereof which it is claimed should be issued by the Commission. (A general request for regulatory action which does not reasonably specify the type of action requested shall not be sufficient for purposes of this subsection.)
(b) Recommendations. The Commission encourages the submission of as much information as possible related to the petition. Thus, to assist the Commission in its evaluation of a petition, to the extent the information is known and available to the petitioner, the petitioner is encouraged to supply the following information or any other information relating to the petition. The petition will be considered by the Commission even if the petitioner is unable to supply the information recommended in this paragraph (b). However, as applicable, and to the extent possible, the petitioner is encouraged to:
(1) Describe the specific risk(s) of injury to which the petition is addressed, including the degree (severity) and the nature of the risk(s) of injury associated with the product and possible reasons for the existence of the risk of injury (for example, product defect, poor design, faulty workmanship, or intentional or unintentional misuse);
(2) State why a consumer product safety standard would not be feasible if the petition requests the issuance of a rule declaring the product to be a banned hazardous product; and
(3) Supply or reference any known documentation, engineering studies, technical studies, reports of injuries, medical findings, legal analyses, economic analyses and environmental impact analyses relating to the petition.
(c) Procedural recommendations. The following are procedural recommendations to help the Commission in its consideration of petitions. The Commission requests, but does not require, that a petition filed under this part:
(1) Be typewritten,
(2) Include the word “petition” in a heading preceding the text,
(3) Specify what section of the statute administered by the Commission authorizes the requested rulemaking,
(4) Include the telephone number of the petitioner, and
(5) Be accompanied by at least five (5) copies of the petition.
§ 1051.6 Documents not considered petitions.
(a) A document filed with the Commission which addresses a topic or involves a product outside the jurisdiction of the Commission will not be considered to be a petition. After consultation with the Office of the General Counsel, the Office of the Secretary, if appropriate, will forward to the appropriate agency documents which address products or topics within the jurisdiction of other agencies. The Office of the Secretary shall notify the sender of the document that it has been forwarded to the appropriate agency.
(b) Any other documents filed with the Office of the Secretary that are determined by the Office of the General Counsel not to be petitions shall be evaluated for possible staff action. The Office of the General Counsel shall notify the writer of the manner in which the Commission staff is treating the document. If the writer has indicated an intention to petition the Commission, the Office of the General Counsel shall inform the writer of the procedure to be followed for petitioning.
§ 1051.7 Statement in support of or in opposition to petitions; Duty of petitioners to remain apprised of developments regarding petitions.
(a) Any person may file a statement with the Office of the Secretary in support of or in opposition to a petition prior to Commission action on the petition. Persons submitting statements in opposition to a petition are encouraged to provide copies of such statements to the petitioner.
(b) It is the duty of the petitioner, or any person submitting a statement in support of or in opposition to a petition, to keep himself or herself apprised of developments regarding the petition. Information regarding the status of petitions is available from the Office of the Secretary of the Commission.
(c) The Office of the Secretary shall send to the petitioner a copy of the staff briefing package on his or her petition at the same time the package is transmitted to the Commissioners for decision.
§ 1051.8 Public hearings on petitions.
(a) The Commission may hold a public hearing or may conduct such investigation or proceeding, including a public meeting, as it deems appropriate to determine whether a petition should be granted.
(b) If the Commission decides that a public hearing on a petition, or any portion thereof, would contribute to its determination of whether to grant or deny the petition, it shall publish in the
§ 1051.9 Factors the Commission considers in granting or denying petitions.
(a) The major factors the Commission considers in deciding whether to grant or deny a petition regarding a product include the following items:
(1) Whether the product involved presents an unreasonable risk of injury.
(2) Whether a rule is reasonably necessary to eliminate or reduce the risk of injury.
(3) Whether failure of the Commission to initiate the rulemaking proceeding requested would unreasonably expose the petitioner or other consumers to the risk of injury which the petitioner alleges is presented by the product.
(4) Whether, in the case of a petition to declare a consumer product a “banned hazardous product” under section 8 of the CPSA, the product is being or will be distributed in commerce and whether a feasible consumer product safety standard would adequately protect the public from the unreasonable risk of injury associated with such product.
(b) In considering these factors, the Commission will treat as an important component of each one the relative priority of the risk of injury associated with the product about which the petition has been filed and the Commission’s resources available for rulemaking activities with respect to that risk of injury. The CPSC Policy on Establishing Priorities for Commission Action, 16 CFR 1009.8, sets forth the criteria upon which Commission priorities are based.
§ 1051.10 Granting petitions.
(a) The Commission shall either grant or deny a petition within a reasonable time after it is filed, taking into account the resources available for processing the petition. The Commission may also grant a petition in part or deny it in part. If the Commission grants a petition, it shall begin proceedings to issue, amend or revoke the rule under the appropriate provisions of the statutes under its administration. Beginning a proceeding means taking the first step in the rulemaking process (issuance of an advance notice of proposed rulemaking or a notice of proposed rulemaking, whichever is applicable).
(b) Granting a petition and beginning a proceeding does not necessarily mean that the Commission will issue, amend or revoke the rule as requested in the petition. The Commission must make a final decision as to the issuance, amendment, or revocation of a rule on the basis of all available relevant information developed in the course of the rulemaking proceeding. Should later information indicate that the action is unwarranted or not necessary, the Commission may terminate the proceeding.
§ 1051.11 Denial of petitions.
(a) If the Commission denies a petition it shall promptly notify the petitioner in writing of its reasons for such denial as required by the Administrative Procedure Act, 5 U.S.C. 555(e).
(b) If the Commission denies a petition, the petitioner (or another party) can refile the petition if the party can demonstrate that new or changed circumstances or additional information justify reconsideration by the Commission.
(c) A Commission denial of a petition shall not preclude the Commission from continuing to consider matters raised in the petition.
PART 1052—PROCEDURAL REGULATIONS FOR INFORMAL ORAL PRESENTATIONS IN PROCEEDINGS BEFORE THE CONSUMER PRODUCT SAFETY COMMISSION
§ 1052.1 Scope and purpose.
(a) Section 9(d)(2) of the Consumer Product Safety Act, 15 U.S.C. 2058(d)(2), and section 4(d) of the Flammable Fabrics Act, 15 U.S.C. 1193(d), provide that certain rules under those statutes shall be promulgated pursuant to section 4 of the Administrative Procedure Act, 5 U.S.C. 553, except that the Commission shall give interested persons an opportunity for the oral presentation of data, views or arguments in addition to the opportunity to make written submissions. Several rulemaking provisions of the statutes administered by the Commission are subject only to the rulemaking procedures of the Administrative Procedure Act. Section 4(c) of the Administrative Procedure Act provides that the opportunity for oral presentations may or may not be granted in rulemaking under that section. In addition, section 27(a) of the Consumer Product Safety Act, 15 U.S.C. 2076(a), authorizes informal proceedings that can be conducted in non-rulemaking investigatory situations.
(b) This part sets forth rules of procedure for the oral presentation of data, views or arguments in the informal rulemaking or investigatory situations described in subsection (a) of this section. In situations where the opportunity for an oral presentation is not required by statute, the Commission will determine whether to provide the opportunity on a case-by-case basis.
§ 1052.2 Notice of opportunity for oral presentation.
The Commission will publish in the
§ 1052.3 Conduct of oral presentation.
(a) The purpose of the oral presentation is to afford interested persons an opportunity to participate in person in the Commission’s rulemaking or other proceedings and to help inform the Commission of relevant data, views and arguments.
(b) The oral presentation, which shall be taped or transcribed, shall be an informal, non-adversarial legislative-type proceeding at which there will be no formal pleadings or adverse parties.
(c) The proceedings for the oral presentation shall be conducted impartially, thoroughly, and expeditiously to allow interested persons an opportunity for oral presentation of data, views or arguments.
§ 1052.4 Presiding officer; appointment, duties, powers.
(a) For oral presentations, the presiding officer shall either be the Chairman of the Commission or a presiding officer shall be appointed by the Chairman with the concurrence of the Commission.
(b) The presiding officer shall chair the proceedings, shall make appropriate provision for testimony, comments and questions, and shall be responsible for the orderly conduct of the proceedings. The presiding officer shall have all the powers necessary or appropriate to contribute to the equitable and efficient conduct of the oral proceedings including the following:
(1) The right to apportion the time of persons making presentations in an equitable manner in order to complete the presentations within the time period allotted for the proceedings.
(2) The right to terminate or shorten the presentation of any party when, in the view of the presiding officer, such presentation is repetitive or is not relevant to the purpose of the proceedings.
(3) The right to confine the presentations to the issues specified in the notice of oral proceeding or, where no issues are specified, to matters pertinent to the proposed rule or other proceeding.
(4) The right to require a single representative to present the views of two or more persons or groups who have the same or similar interests. The presiding officer shall have the authority to identify groups or persons with the same or similar interests in the proceedings.
(c) The presiding officer and Commission representatives shall have the right to question persons making an oral presentation as to their testimony and any other relevant matter.
PART 1061—APPLICATIONS FOR EXEMPTION FROM PREEMPTION
§ 1061.1 Scope and purpose.
(a) This part applies to the submission and consideration of applications by State and local governments for exemption from preemption by statutes, standards, and regulations of the Consumer Product Safety Commission.
(b) This part implements section 26 of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2075), section 18 of the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261n), section 16 of the Flammable Fabrics Act (FFA) (15 U.S.C. 1203), and section 7 of the Poison Prevention Packaging Act (PPPA) (15 U.S.C. 1476), all as amended.
§ 1061.2 Definitions.
For the purposes of this part:
(a) Commission means the Consumer Product Safety Commission.
(b) Commission’s statutory preemption provisions and statutory preemption provisions means section 26 of the CPSA (15 U.S.C. 2075), section 18 of the FHSA (15 U.S.C. 1261n), section 16 of the FFA (15 U.S.C. 1203) and section 7 of the PPPA (15 U.S.C. 1476).
(c) Commission statute, standard, or regulation means a statute, standard, regulation, or requirement that is designated as having a preemptive effect by the Commission’s statutory preemption provisions.
(d) State means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, Wake Island, Midway Island, Kingman Reef, Johnston Island, the Canal Zone, American Samoa, or the Trust Territory of the Pacific Islands.
(e) Local government means any political subdivision of a State having the authority to establish or continue in effect any standard, regulation, or requirement that has the force of law and is applicable to a consumer product.
(f) State or local requirement means any statute, standard, regulation, ordinance, or other requirement that applies to a product regulated by the Commission, that is issued by a State or local government, and that is intended to have the force of law when in effect.
§ 1061.3 Statutory considerations.
(a) The Commission’s statutory preemption provisions provide, generally, that whenever consumer products are subject to certain Commission statutes, standards, or regulations, a State or local requirement applicable to the same product is preempted, i.e., superseded and made unenforceable, if both are designed to protect against the same risk of injury or illness, unless the State or local requirement is identical to the Commission’s statutory requirement, standard, or regulation. A State or local requirement is not preempted if the product it is applicable to is for the State or local government’s own use and the requirement provides a higher degree of protection than the Commission’s statutory requirement, standard, or regulation.
(b) The Commission’s statutory preemption provisions provide, generally, that if a State or local government wants to enforce its own requirement that is preempted, the State or local government must seek an exemption from the Commission before any such enforcement. The Commission may, by regulation, exempt a State or local requirement from preemption if it finds that the State or local requirement affords a significantly higher degree of protection than the Commission’s statute, standard, or regulation, and that it does not unduly burden interstate commerce. Such findings must be included in any exemption regulation.
§ 1061.4 Threshold requirements for applications for exemption.
(a) The Commission will consider an application for preemption on its merits, only if the application demonstrates all of the following:
(1) The State or local requirement has been enacted or issued in final form by an authorized official or instrumentality of the State or local government. For purposes of this section, a State or local requirement may be considered to have been enacted or issued in final form even though it is preempted by a Commission standard or regulation.
(2) The applicant is an official or instrumentality of a State or local government having authority to act for, or on behalf of, that government in applying for an exemption from preemption for the safety requirement referred to in the application.
(3) The State or local requirement is preempted under a Commission statutory preemption provision by a Commission statute, standard, or regulation. A State or local requirement is preempted if the following tests are met:
(i) There is a Commission statute, standard, or regulation in effect that is applicable to the product covered by the State or local requirement.
(ii) The Commission statute, standard, or regulation is designated as having a preemptive effect under a statutory preemption provision.
(iii) The State or local requirement is designed to protect against the same risk of injury or illness as that addressed by the Commission statute, standard, or regulation.
(iv) The State or local requirement is not identical to the Commission statute, standard, or regulation.
(b) State and local governments may contact the Commission’s Office of the General Counsel to obtain informal advice on whether a State or local requirement meets the threshold requirements of paragraph (a) of this section.
§ 1061.5 Form of applications for exemption.
An application for exemption shall:
(a) Be written in the English language.
(b) Clearly indicate that it is an application for an exemption from preemption by a Commission statute, standard, or regulation.
(c) Identify the State or local requirement that is the subject of the application and give the date it was enacted or issued in final form.
(d) Identify the specific Commission statute, standard, or regulation that is believed to preempt the State or local requirement.
(e) Contain the name and address of the person, branch, department, agency, or other instrumentality of the State or local government that should be notified of the Commission’s actions concerning the application.
(f) Document the applicant’s authority to act for, or on behalf of, the State or local government in applying for an exemption from preemption for the particular safety requirement in question.
(g) Be signed by an individual having authority to apply for the exemption from federal preemption on behalf of the applicant.
(h) Be submitted, in five copies, to the Secretary, Consumer Product Safety Commission, Washington, DC 20207.
§ 1061.6 Contents of applications for exemption.
Applications for exemption shall include the information specified in §§ 1061.7 through 1061.10. More generally, a State or local government seeking an exemption should provide the Commission with the most complete information possible in support of the findings the Commission is required to make in issuing an exemption regulation. If any of the specified information is omitted because it is unavailable or not relevent, such omission should be explained in the application.
§ 1061.7 Documentation of the State or local requirement.
An application for an exemption from preemption shall contain the following information:
(a) A copy of the State or local requirement that is the subject of the application. Where available, the application shall also include copies of any legislative history or background materials used in issuing the requirement, including hearing reports or studies concerning the development or consideration of the requirement.
(b) A written explanation of why compliance with the State or local requirement would not cause the product to be in violation of the applicable Commission statute, standard, or regulation.
§ 1061.8 Information on the heightened degree of protection afforded.
An application for an exemption from preemption shall also contain information demonstrating that the State or local requirement provides a significantly higher degree of protection from the risk of injury or illness than the preempting Commission statute, standard, or regulation. More specifically, an application shall contain:
(a) A description of the risk of injury or illness addressed by the State or local requirement.
(b) A detailed explanation of the State or local requirement and its rationale.
(c) An analysis of differences between the State or local requirement and the Commission statute, standard, or regulation.
(d) A detailed explanation of the State or local test method and its rationale.
(e) Information comparing available test results for the Commission statute, standard, or regulation and the State or local requirement.
(f) Information to show hazard reduction as a result of the State or local requirement, including injury data and results of accident simulation.
(g) Any other information that is relevant to applicant’s contention that the State or local requirement provides a significantly higher degree of protection than does the Commission statute, standard, or regulation.
(h) Information regarding enforcement of the State or local requirement and sanctions that could be imposed for noncompliance.
§ 1061.9 Information about the effect on interstate commerce.
An application for exemption from preemption shall provide information on the effect on interstate commerce a granting of the requested exemption would be expected to cause, including the extent of the burden and the benefit to public health and safety that would be provided by the State or local requirement. More specifically, applications for exemption shall include, where available, information showing:
(a) That it is technologically feasible to comply with the State or local requirement. Evidence of technological feasibility could take the form of:
(1) Statements by affected persons indicating ability to comply with the State or local government requirement.
(2) Statements indicating that other jurisdictions have established similar requirements that have been, or could be, met by persons affected by the requirement that is the subject of the application.
(3) Information as to technological product or process modifications necessary to achieve compliance with the State or local requirement.
(4) Any other information indicating the technological feasibility of compliance with the State or local requirement.
(b) That it is economically feasible to comply with the State or local requirement, i.e., that there would not be significant adverse effects on the production and distribution of the regulated products. Evidence of economic feasibility could take the form of:
(1) Information showing that the State or local requirement would not result in the unavailability (or result in a significant decline in the availability) of the product, either in the interstate market or within the geographic boundary of the State or local government imposing the requirement.
(2) Statements from persons likely to be affected by the State or local requirement concerning the anticipated effect of the requirement on the availability or continued marketing of the product.
(3) Any other information indicating the economic impact of compliance with the State or local requirement, such as projections of the anticipated effect of the State or local requirement on the sales and prices of the product, both in interstate commerce and within the geographic area of the State or local government.
(c) The present geographic distribution of the product to which the State or local requirement would apply, and projections of future geographic distribution. Evidence of the geographic distribution could take the form of governmental or private information or data (including statements from manufacturers, distributors, or retailers of the product) showing advertising in the interstate market, interstate retailing, or interstate distribution.
(d) The probability of other States or local governments applying for an exemption for a similar requirement. Evidence of the probability that other States or local governments would apply for an exemption could take the form of statements from other States or local governments indicating their intentions.
(e) That specified local conditions require the State or local government to apply with the exemption in order to adequately protect the public health or safety of the State or local area.
§ 1061.10 Information on affected parties.
An application for an exemption from preemption shall include a statement which identifies in general terms, parties potentially affected by the State or local requirement, especially small businesses, including manufacturers, distributors, retailers, consumers, and consumer groups.
§ 1061.11 Incomplete or insufficient applications.
(a) If an application fails to meet the threshold requirements of § 1061.4(a) of this part, the Office of General Counsel will inform the applicant and return the application without prejudice to its being resubmitted.
(b) If an application fails to provide all the information specified in §§ 1061.5 through 1061.10 of this part, and fails to fully explain why it has not been provided, the Office of General Counsel will either:
(1) Return it to the applicant without prejudice to its being resubmitted,
(2) Notify the applicant and allow it to provide the missing information, or
(3) If the deficiencies are minor and the applicant concurs, forward it to the Commission for consideration on its merits.
(c) If the Commission or the Commission staff believes that additional information is necessary or useful for a proper evaluation of the application, the Commission or Commission staff will promptly request the applicant to furnish such additional information.
(d) If an application is not returned under paragraphs (a) or (b) of this section, the Commission will consider it on its merits.
§ 1061.12 Commission consideration on merits.
(a) If the Commission proposes to grant an application for exemption it will, in accordance with 5 U.S.C. 553, publish a notice of that fact in the
(b) The Commission will evaluate all timely written and oral submissions received from interested parties, as well as any other available and relevant information on the proposal.
(c) The Commission’s evaluation will focus on:
(1) Whether the State or local requirement provides a significantly higher degree of protection than the Commission statute or regulation from the risk of injury or illness that they both address.
(2) Whether the State or local requirement would unduly burden interstate commerce if the grant of the exemption from preemption allows it to go into effect. The Commission will evaluate these factors in accordance with the Commission’s statutory preemption provisions and their legislative history.
(3) Whether compliance with the State or local requirements would not cause the product to be in violation of the applicable Commission statute, standard, or regulation.
(d) If, after evaluating the record, the Commission determines to grant an exemption, it will publish a final exemption regulation, including the findings required by the statutory preemption provisions, in the
(e) If the Commission denies an application, whether or not published for comment, it will publish its reasons for doing so in the
SUBCHAPTER B—CONSUMER PRODUCT SAFETY ACT REGULATIONS
PART 1101—INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT
Subpart A—Background
§ 1101.1 General background.
(a) Basic purpose. This rule sets forth the Consumer Product Safety Commission’s policy and procedure under sections 6(b)(1)-(5) of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2055(b)(1)-(5)) which relate to public disclosure of information from which the identity of a manufacturer or private labeler of a product can be readily ascertained. In addition, these rules provide for retraction of inaccurate or misleading information the Commission has disclosed that reflects adversely on the safety of a consumer product or class of products or on the practices of any manufacturer, private labeler, distributor or retailer of consumer products as required by section 6(b)(7) of the CPSA (15 U.S.C. 2055(b)(7)).
(b) Statutory requirements. Section 6(b) establishes procedures that the Commission must follow when it releases certain firm specific information to the public and when it retracts certain information it has released.
(1) Generally, section 6(b)(1) requires the Commission to provide manufacturers or private labelers with advance notice and opportunity to comment on information the Commission proposes to release, if the public can readily ascertain the identity of the firm from the information. Section 6(b)(1) also requires the Commission to take reasonable steps to assure that the information is accurate and that disclosure is fair in the circumstances and reasonably related to effectuating the purposes of the Acts administered by the Commission. Disclosure of information may not occur in fewer than 15 days after notice to the manufacturer or private labeler unless the Commission publishes a finding that the public health and safety requires a lesser period of notice. Exceptions to these requirements are established in section 6(b)(4). Additional limitations on the disclosure of information reported to the Commission under section 15(b) of the CPSA are established in section 6(b)(5).
(2) Section 6(b)(2) requires the Commission to provide further notice to manufacturers or private labelers where the Commission proposes to disclose product-specific information the firms have claimed to be inaccurate.
(3) Section 6(b)(3) authorizes manufacturers and private labelers to bring lawsuits against the Commission to prevent disclosure of product-specific information after the firms have received the notice specified.
(c) Internal clearance procedures. Section 6(b)(6) requires the Commission to establish internal clearance procedures for Commission initiated disclosures of information that reflect on the safety of a consumer product or class of products, even if the information is not product specific. This rule does not address section 6(b)(6) because the Commission has internal clearance procedures in its directives system. (Directive 1450.2 “Clearance Procedures for Commission Staff to Use in Providing Information to the Public.” April 27, 1983.
§ 1101.2. Scope.
Section 6(b) and these rules apply to information concerning products subject to the CPSA (15 U.S.C. 2051-2085), and to the four other acts the Commission administers (transferred acts). These transferred acts are the Flammable Fabrics Act, 15 U.S.C. 1191-1204 (FFA); the Poison Prevention Packaging Act of 1970, 15 U.S.C. 1471-1476 (PPPA); the Federal Hazardous Substances Act, 15 U.S.C. 1261-1276 (FHSA); and the Refrigerator Safety Act, 15 U.S.C. 1211-1214 (RSA). These provisions are now applicable to the Virginia Graeme Baker Pool and Spa Safety Act, 15 U.S.C. 8003(a); and the Children’s Gasoline Burn Prevention Act § 2(a), Public Law 110-278, 122 Stat. 2602 (July 17, 2008).
Subpart B—Information Subject to Notice and Analysis Provisions of Section 6(b)(1)
§ 1101.11 General application of provisions of section 6(b)(1).
(a) Information subject to section 6(b)(1). To be subject to the notice and analysis provisions of section 6(b)(1), information must meet all the following criteria:
(1) The information must pertain to a specific product which is either designated or described in a manner which permits its identity to be ascertained readily by the public.
(2) The information must be obtained, generated or received by the Commission as an entity or by individual members, employees, agents, contractors or representatives of the Commission acting in their official capacities.
(3) The Commission or its members, employees, agents or representatives must propose to disclose the information to the public (see § 1101.12).
(4) The manner in which the product is designated or described in the information must permit the public to ascertain readily the identity of the manufacturer or private labeler. [See § 1101.13.]
(b) Information not subject to section 6(b)(1). The requirements of section 6(b)(1) do not apply to:
(1) Information described in the exclusions contained in section 6(b)(4) of the CPSA (see subpart E of this rule).
(2) Information the Commission is required by law to make publicly available. This information includes, for example, Commission notifications to foreign governments regarding certain products to be exported, as required by section 18(b) of the CPSA, 15 U.S.C. 2068(b); section 14(d) of the FHSA, 15 U.S.C. 1273(d); and section 15(c) of the FFA, 15 U.S.C. 1202(c). (See the Commission’s Export Policy Statement, 16 CFR part 1017.)
(3) Information required to be disclosed to the President and Congress pursuant to section 27(j) of the CPSA, 15 U.S.C. 2076(j).
(4) Press releases issued by firms.
(5) Information filed or presented in administrative proceedings or litigation to which the Commission is a party and which is not expressly subject to the section 6(b)(4) exceptions.
§ 1101.12 Commission must disclose information to the public.
Public. For the purposes of section 6(b)(1), the public includes any person except:
(a) Members, employees, agents, representatives and contractors of the Commission, in their official capacity.
(b) State officials who are commissioned officers under section 29(a)(2) of the CPSA, 15 U.S.C. 2078(a)(2), to the extent that the Commission furnishes them information necessary for them to perform their duties under that section. Such officials may not release to the public copies of such information unless the Commission has complied with section 6(b) or the information falls within an exception to section 6(b).
(c) Members of a Commission Chronic Hazard Advisory Panel established under section 28 of the CPSA (15 U.S.C. 2077). However, disclosures of information by such a Panel are subject to section 6(b).
(d) The persons or firms to whom the information to be disclosed pertains, or their legal representatives.
(e) The persons or firms who provided the information to the Commission, or their legal representatives.
(f) Other Federal agencies or state or local governments to whom accident and investigation reports are provided pursuant to section 29(e) of the CPSA (15 U.S.C. 2078(e)). However, as required by that section, employees of Federal agencies or state or local governments may not release to the public copies of any accident or investigation report made under the CPSA by an officer, employee or agent of the Commission unless CPSC has complied with the applicable requirements of section 6(b).
(g) The Chairman or ranking minority member of a committee or subcommittee of Congress acting pursuant to committee business and having jurisdiction over the matter which is the subject of the information requested.
(h) Any federal, state, local, or foreign government agency pursuant to, and in accordance with, section 29(f) of the Consumer Product Safety Improvement Act of 2008 (Pub. L. 110-314, 122 Stat. 3016 (August 14, 2008)).
§ 1101.13 Public ability to ascertain readily identity of manufacturer or private labeler.
The advance notice and analysis provisions of section 6(b)(1) apply only when a reasonable person receiving the information in the form in which it is to be disclosed and lacking specialized expertise can readily ascertain from the information itself the identity of the manufacturer or private labeler of a particular product. The Commission will provide the advance notice and opportunity to comment if there is a question whether the public could readily ascertain the identity of a manufacturer or private labeler.
Subpart C—Procedure for Providing Notice and Opportunity To Comment Under Section 6(b)(1)
§ 1101.21 Form of notice and opportunity to comment.
(a) Notice may be oral or written. The Commission will generally provide to manufacturers or private labelers written notice and opportunity to comment on information subject to section 6(b)(1). However, when the Commission publishes a finding that the public health and safety requires a lesser period of notice pursuant to section 6(b)(1) of the CPSA, the Commission may determine that it is necessary to provide the notice and opportunity to comment orally, either in person or by telephone.
(b) Content of notice. The Commission will provide the manufacturer or private labeler with:
(1) Either the actual text of the information to be disclosed or, if appropriate, a summary of the information.
(2) A general description of the manner in which the Commission will disclose the information, including any other relevant information the Commission intends to include with the disclosure. If the Commission advises that the form of disclosure will be by press release, for example, the Commission need not provide further notice to disclose a summary of the press release.
(3) A request for comment with respect to the information, including a request for explanatory data or other relevant information for the Commission’s consideration.
(4) A statement that, in the absence of a specific request by a firm that its comments be withheld from disclosure, the Commission will release to the public the firm’s comments (or a summary thereof prepared by the firm or, if the firm declines to do so, by the Commission).
(5) A statement that a request that comments be withheld from disclosure will be honored.
(6) Notice that the firm may request confidential treatment for the information, in accordance with section 6(a)(3) of the Consumer Product Safety Act, 15 U.S.C. 2055(a)(3) (see § 1101.24(b)).
(7) A statement that no further request for comment will be sought by the Commission if it intends to disclose the identical information in the same format, unless the firm specifically requests the opportunity to comment on subsequent information disclosures.
(8) The name, address, and telephone number of the person to whom comments should be sent and the time when any comments are due (see § 1101.22).
§ 1101.22 Timing: request for time extensions.
(a) Time for comment. (1) Generally firms will receive ten (10) calendar days from the date of the letter in which the Commission transmits the notice to furnish comments to the Commission. Firms that receive requests for comments by mail will receive an additional three (3) days to comment to account for time in the mail.
(2) Upon his or her own initiative or upon request, the Freedom of Information Officer may provide a different amount of time for comment, particularly for firms that receive voluminous or complex material. In addition, the Commission may publish a finding that the public health and safety requires a lesser period of notice and may require a response in a shorter period of time (see § 1101.24).
(b) No response submitted. (1) If the Commission has not received a response within the time specified and if it has received no request for extension of time, the Commission will analyze the information as provided in subpart D. If no comments are submitted the Commission will not give the further notice provided in section 6(b)(2).
(2) Unless the Commission publishes a finding that the public health and safety requires a lesser period of notice (see § 1101.23), the Commission will not disclose the information in fewer than 15 days after providing a manufacturer or private labeler notice and opportunity to comment.
(c) Requests for time extension. (1) Requests for extension of time to comment on information to be disclosed must be made to the person who provided the Commission’s notice and opportunity to comment. The request for time extension may be either oral or written. An oral request for a time extension must be promptly confirmed in writing.
(2) Requests for extension of time must explain with specificity why the extension is needed and how much additional time is required.
(3) The Commission will promptly respond to requests for extension of time.
§ 1101.23 Providing less than 15 days notice before disclosing information.
There are two circumstances in which the Commission may disclose to the public information subject to section 6(b)(1) in a time less than 15 days after providing notice to the manufacturer or private labeler.
(a) Firm agrees to lesser period or does not object to disclosure. The Commission may disclose to the public information subject to section 6(b)(1) before the 15-day period expires when, after receiving the Commission’s notice and opportunity to comment, the firm involved agrees to the earlier disclosure; notifies the Commission that it has no comment; or notifies the Commission that it does not object to disclosure.
(b) Commission finding a lesser period is required. Section 6(b)(1) provides that the Commission may publish a finding that the public health and safety requires a lesser period of notice than the 15 days advance notice that section 6(b)(1) generally requires. The Commission may find that the public health and safety requires less than 15 days advance notice, for example, to warn the public quickly because individuals may be in danger from a product hazard or a potential hazard, or to correct product safety information released by third persons, which mischaracterizes statements made by the Commission about the product or which attributes to the Commission statements about the product which the Commission did not make.
(c) Notice of finding. The Commission will inform a manufacturer or private labeler of a product which is the subject of a public health and safety finding that the public health and safety requires less than 15 days advance notice either orally or in writing, depending on the immediacy of the need for quick action. Where applicable, before releasing information, the Commission will comply with the requirements of section 6(b) (1) and (2) by giving the firm the opportunity to comment on the information, either orally or in writing depending on the immediacy of the need for quick action, and by giving the firm advance notice before disclosing information claimed by a manufacturer or private labeler to be inaccurate (see § 1101.25).
§ 1101.24 Scope of comments Commission seeks.
(a) Comment in regard to the information. The section 6(b) opportunity to comment on information is intended to permit firms to furnish information and data to the Commission to assist the agency in its evaluation of the accuracy of the information. A firm’s submission, therefore, must be specific and should be accompanied by documentation, where available, if the comments are to assist the Commission in its evaluation of the information. Comments of a general nature, such as general suggestions or allegations that a document is inaccurate or that the Commission has not taken reasonable steps to assure accuracy, are not sufficient to assist the Commission in its evaluation of the information or to justify a claim of inaccuracy. The weight accorded a firm’s comments on the accuracy of information and the degree of scrutiny which the Commission will exercise in evaluating the information will depend on the specificity and completeness of the firm’s comments and of the accompanying documentation. In general, specific comments which are accompanied by documentation will be given more weight than those which are undocumented and general in nature.
(b) Claims of confidentiality. If the manufacturer or private labeler believes the information involved cannot be disclosed because of section 6(a)(2) of the CPSA (15 U.S.C. 2055(a)(2)), which pertains to trade secret or other confidential material, the firm may make claims of confidentiality at the time it submits its comments to the Commission under this section. Such claims must identify the specific information which the firm believes to be confidential or trade secret material and must state with specificity the grounds on which the firm bases it claims. (See Commission’s Freedom of Information Act regulation, 16 CFR part 1015, particularly 16 CFR 1015.18.)
(c) Requests for nondisclosure of comments. If a firm objects to disclosure of its comments or a portion thereof, it must notify the Commission at the time it submits its comments. If the firm objects to the disclosure of a portion of its comments, it must identify those portions which should be withheld.
§ 1101.25 Notice of intent to disclose.
(a) Notice to manufacturer or private labeler. In accordance with section 6(b)(2) of the CPSA, if the Commission, after following the notice provisions of section 6(b)(1), determines that information claimed to be inaccurate by a manufacturer or private labeler in comments submitted under section 6(b)(1) should be disclosed because the Commission believes it has complied with section 6(b)(1), the Commission shall notify the manufacturer or private labeler that it intends to disclose the information not less than 5 days after the date of the receipt of notification by the firm. The notice of intent to disclose will include an explanation of the reason for the Commission’s decision, copies of any additional materials, such as explanatory statements and letters to Freedom of Information Act requesters, which were not previously sent to the firm.
(b) Commission finding a lesser period is required. The Commission may determine that the public health and safety requires less than 5 days advance notice of its intent to disclose information claimed to be inaccurate. For example, the Commission may determine it is necessary to warn the public quickly because individuals may be in danger from a product hazard or a potential hazard, or to correct product safety information released by third persons, which mischaracterized statements made by the Commission about the product or which attributes to the Commission statements about the product which the Commission did not make.
(c) Notice of findings. The Commission will inform a manufacturer or private labeler of a product which is the subject of a public health and safety finding that the public health and safety requires less than 5 days advance notice either orally or in writing, depending on the immediacy of the need for quick action.
§ 1101.26 Circumstances when the Commission does not provide notice and opportunity to comment.
(a) Notice to the extent practicable. Section 6(b)(1) requires that “to the extent practicable” the Commission must provide manufacturers and private labelers notice and opportunity to comment before disclosing information from which the public can ascertain readily their identity.
(b) Circumstances when notice and opportunity to comment is not practicable. The Commission has determined that there are various circumstances when notice and opportunity to comment is not practicable. Examples include the following:
(1) When the Commission has taken reasonable steps to assure that the company to which the information pertains is out of business and has no identifiable successor.
(2) When the information is disclosed in testimony in response to an order of the court during litigation to which the Commission is not a party.
Subpart D—Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate, and That Disclosure Is Fair in the Circumstances and Reasonably Related to Effectuating the Purposes of the Acts It Administers
§ 1101.31 General requirements.
(a) Timing of decisions. The Commission will attempt to make its decision on disclosure so that it can disclose information in accordance with section 6(b) as soon as is reasonably possible after expiration of the statutory fifteen day moratorium on disclosure.
(b) Inclusion of comments. In disclosing any information under this section, the Commission will include any comments or other information submitted by the manufacturer or private labeler unless the manufacturer or private labeler at the time it submits its section 6(b) comments specifically requests the Commission not to include the comments or to include only a designated portion of the comments and disclosure of the comments on such a designated portion is not necessary to assure that the disclosure of the information which is the subject of the comments is fair in the circumstances.
(c) Explanatory statements. Where appropriate, the Commission will accompany the disclosure of information subject to this subpart with an explanatory statement that makes the nature of the information disclosed clear to the public. Inclusion of an explanatory statement is in addition to, and not a substitute for, taking reasonable steps to assure the accuracy of information. To the extent it is practical the Commission will also accompany the disclosure with any other relevant information in its possession that places the released information in context.
(d) Information previously disclosed. If the Commission has previously disclosed, in accordance with section 6(b)(1), the identical information it intends to disclose again in the same format, it will not customarily take any additional steps to assure accuracy unless the Commission has some reason to question its accuracy or unless the firm, in its comments responding to the Commission’s initial section 6(b) notice, specifically requests the opportunity to comment on subsequent disclosures, or unless the Commission determines that sufficient time has passed to warrant seeking section 6(b) comment again. Before disclosing the information the Commission will again review the information to see if accuracy is called into question and will further look to whether disclosure is fair in the circumstances and reasonably related to effectuating the purposes of the Acts the Commission administers.
§ 1101.32 Reasonable steps to assure information is accurate.
(a) The Commission considers that the following types of actions are reasonable steps to assure the accuracy of information it proposes to release to the public:
(1) The Commission staff or a qualified person or entity outside the Commission (e.g., someone with requisite training or experience, such as a fire marshal, a fire investigator, an electrical engineer, or an attending physician) conducts an investigation or an inspection which yields or corroborates the product information to be disclosed; or
(2) The Commission staff conducts a technical, scientific, or other evaluation which yields or corroborates the product information to be disclosed or the staff obtains a copy of such an evaluation conducted by a qualified person or entity; or
(3) The Commission staff provides the information to be disclosed to the person who submitted it to the Commission for review and, if necessary, correction, and the submitter confirms the information as accurate to the best of the submitter’s knowledge and belief, provided that:
(i) The confirmation is made by the person injured or nearly injured in an incident involving the product; or
(ii) The confirmation is made by a person who, on the basis of his or her own observation or experience, identifies an alleged safety-related defect in or problem with such a product even though no incident or injury associated with the defect or problem may have occurred; or
(iii) The confirmation is made by an eyewitness to an injury or safety-related incident involving such a product; or
(iv) The confirmation is made by an individual with requisite training or experience who has investigated and/or determined the cause of deaths, injuries or safety-related incidents involving such a product. Such persons would include, for example, a fire marshal, a fire investigator, an electrical engineer, an ambulance attendant, or an attending physician; or
(v) The confirmation is made by a parent or guardian of a child involved in an incident involving such a product, or by a person to whom a child is entrusted on a temporary basis.
(b) The steps set forth below are the steps the Commission will take to analyze the accuracy of information which it proposes to release to the public.
(1) The Commission will review each proposed disclosure of information which is susceptible of factual verification to assure that reasonable steps have been taken to assure accuracy in accordance with § 1101.32(a).
(2) As described in subpart C, the Commission will provide a manufacturer or private labeler with a summary or text of the information the Commission proposes to disclose and will invite comment with respect to that information.
(3) If the Commission receives no comments or only general, undocumented comments claiming inaccuracy, the Commission will review the information in accordance with § 1101.32(a) and release it, generally without further investigating its accuracy if there is nothing on the face of the information that calls its accuracy into question.
(4) If a firm comments on the accuracy of the information the Commission proposes to disclose, the Commission will review the information in light of the comments. The degree of review by the Commission and the weight accorded a firm’s comments will be directly related to the specificity and completeness of the firm’s comments on accuracy and the accompanying documentation. Documented comments will be given more weight than undocumented comments. Specific comments will be given more weight than general comments. Further steps may be taken to determine the accuracy of the information if the Commission determines such action appropriate.
§ 1101.33 Reasonable steps to assure information release is fair in the circumstances.
(a) The steps set forth below are the steps the Commission has determined are reasonable to take to assure disclosure of information to the public is fair in the circumstances:
(1) The Commission will accompany information disclosed to the public with the manufacturer’s or private labeler’s comments unless the manufacturer or private labeler asks in its section 6(b) comments that its comments or a designated portion thereof not accompany the information.
(2) The Commission generally will accompany the disclosure of information with an explanatory statement that makes the nature of the information disclosed clear to the public. The Commission will also take reasonable steps to disclose any other relevant information it its possession that will assure disclosure is fair in the circumstances.
(3) The Commission will limit the form of disclosure to that which it considers appropriate in the circumstances. For example, the Commission may determine it is not appropriate to issue a nationwide press release in a particular situation and rather will issue a press release directed at certain localities, regions, or user populations.
(4) The Commission may delay disclosure of information in some circumstances. For example, the Commission may elect to postpone an information release until an investigation, analysis or test of a product is complete, rather than releasing information piecemeal.
(b) The Commission will not disclose information when it determines that disclosure would not be fair in the circumstances. The following are examples of disclosures which generally would not be fair in the circumstances.
(1) Disclosure of information furnished by a firm to facilitate prompt remedial action or settlement of a case when the firm has a reasonable expectation that the information will be maintained by the Commission in concidence.
(2) Disclosure of notes or minutes of meetings to discuss or negotiate settlement agreements and of drafts of documents prepared during settlement negotiations, where the firm has a reasonable expectation that such written materials will be maintained by the Commission in confidence.
(3) Disclosure of the work-product of attorneys employed by a firm and information subject to an attorney/client privilege, if the Commission has obtained the information from the client or the attorney, the attorney or client advises the Commission of the confidential nature of the information at the time it is submitted to the Commission, and the information has been maintained in confidence by the client and the attorney.
(4) Disclosure of a firm’s comments (or a portion thereof) submitted under section 6(b)(1) over the firm’s objection.
(a) The steps set forth below are the steps the Commission has determined are reasonable to take to assure that the disclosure of information to the public effectuates the purposes of the Acts it administers.
(1) Purposes of the CPSA. The Commission will review information to determine whether disclosure would be reasonably related to effectuating one or more of the specific purposes of the CPSA, as set forth in sections 2(b) and 5, 15 U.S.C. 2051(b) and 2054.
(2) Purposes of the FHSA, FFA, PPPA and RSA. The Commission will also review information concerning products subject to the transferred acts it administers and to the Commission’s specific functions under those acts to determine whether disclosure of information would be reasonably related to effectuating the purposes of those acts.
(3) Purposes of the FOIA. FOIA requests will be reviewed to determine whether disclosure of the information is reasonably related to effectuating one or more of the purposes of the acts administered by the Commission. In the event of a close question on this issue, the Commission will defer to the purposes of the FOIA. The FOIA establishes a general right of the public to have access to information in the Commission’s possession, particularly information that reveals whether the Commission is meeting its statutory responsibilities or information upon which the Commission bases a decision that affects the public health and safety.
(b) In reviewing proposed information disclosures, the Commission will consider disclosing the material on the basis of whether release of the information, when taken as a whole, was prepared or is maintained in the course of or to support an activity of the Commission designed to accomplish one or more of the statutory purposes.
Subpart E—Statutory Exceptions of Section 6(b)(4)
§ 1101.41 Generally.
(a) Scope. This subpart describes and interprets the exceptions to the requirements of section 6(b)(1)-(b)(3) that are set forth in section 6(b)(4). These exceptions apply to:
(1) Information about a product reasonably related to the subject matter of an imminent hazard action in federal court;
(2) Information about a product which the Commission has reasonable cause to believe is in violation of any consumer product safety rule or provision under the Consumer Product Safety Act (15 U.S.C. 2051, et seq.) or similar rule or provision of any other act enforced by the Commission;
(3) Information in the course of or concerning a rulemaking proceeding; or
(4) information in the course of or concerning an adjudicatory, administrative or judicial proceeding.
(b) Application to transferred act. The Commission will apply the exceptions contained in section 6(b)(4) to those provisions in the transferred acts, comparable to the specific provisions in the CPSA to which section 6(b)(4) applies.
§ 1101.42 Imminent hazard exception.
(a) Statutory provision. Section 6(b)(4)(A) provides that the requirements of section 6(b)(1) do not apply to public disclosure of “information about any consumer product with respect to which product the Commission has filed an action under section 12 (relating to imminently hazardous products).”
(b) Scope of exception. This exception applies once the Commission has filed an action under section 12 of the CPSA (15 U.S.C. 2061), in a United States district court. Once the exception applies, information may be disclosed to the public while the proceeding is pending without following the requirements of section 6(b)(1) if the information concerns or relates to the product alleged to be imminently hazardous. Upon termination of the proceeding, information filed with the court or otherwise made public is not subject to section 6(b). Information in the Commission’s possession which has not been made public is subject to section 6(b).
§ 1101.43 Section 6(b)(4)(A) exception.
(a) Statutory provision. Section (6)(b)(4)(A) provides that the requirements of section 6(b)(1) do not apply to public disclosure of information about any consumer product which the Commission has reasonable cause to believe is in violation of any consumer product safety rule or provision under the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) or similar rule or provision of any other act enforced by the Commission.
(b) Scope of exception. This exception applies once the Commission has “reasonable cause to believe” there has occurred a violation of any consumer product safety rule or provision under the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) or similar rule or provision of any other act enforced by the Commission. Once the exception applies, the Commission may disclose information to the public without following the requirements of section 6(b)(1) if the information concerning the product is reasonably related to the violation.
§ 1101.44 Rulemaking proceeding exception.
(a) Statutory provision. Section 6(b)(4)(B) provides that the requirements of section 6(b)(1) do not apply to public disclosure of information “in the course of or concerning a rulemaking proceeding (which shall commence upon the publication of an advance notice of proposed rulemaking or a notice of proposed rulemaking) * * * under this Act.”
(b) Scope of exception. This exception applies upon publication in the
(c) The phrase “in the course of” refers to information disclosed as part of the proceeding and may, therefore, include information generated before the proceeding began and later presented as part of the proceeding. A rulemaking proceeding ends once the Commission has published the final rule or a notice of termination of the rulemaking in the
(d) The phrase “concerning” refers to information about the proceeding itself both after the proceeding has begun and indefinitely thereafter. Therefore, the Commission may publicly disclose information that describes the substance, process and outcome of the proceeding. By issuing opinions and public statements, the Commissioners, and the presiding official, who act as decisionmakers, may also publicly explain their individual votes and any decision rendered.
§ 1101.45 Adjudicatory proceeding exception.
(a) Statutory provision. Section 6(b)(4)(B) provides that the requirements of section 6(b)(1) do not apply to public disclosure of “information in the course of or concerning * * * [an] adjudicatory proceeding * * * under this Act.”
(b) Scope of exception. This exception applies once the Commission begins an administrative adjudication under the CPSA. The Commission will also apply the exception to any administrative adjudicatory proceeding under FHSA, FAA, or PPPA. An adjudicatory proceeding begins with the filing of a complaint under section 15(c) or (d), 17(a)(1) or (3), or 20 of the CPSA (15 U.S.C. 2064(c) or (d), 2066(a)(1), or (3), or 2069); section 15 of the FHSA (15 U.S.C. 1274); section 5(b) of the FFA, (15 U.S.C. 1194(b)); or section 4(c) of the PPPA (15 U.S.C. 1473(c)). An adjudicatory proceeding ends when the Commission issues a final order, 16 CFR 1025.51-1025.58.
(c) The phrase “in the course of” refers to information disclosed as part of the adjudication, whether in documents filed or exchanged during discovery, or in testimony given in such proceedings, and may therefore, include information generated before the adjudication began.
(d) The phrase “concerning” refers to information about the administrative adjudication itself, both once it begins and indefinitely thereafter. Therefore, the Commission may publicly disclose information that describes the substance, process and outcome of the proceeding including, for example, the effectiveness of any corrective action such as information on the number of products corrected as a result of a remedial action. By issuing opinions and public statements, the Commissioners and the presiding official, who act as decisionmakers, may publicly explain their individual votes and any decision rendered.
§ 1101.46 Other administrative or judicial proceeding exception.
(a) Statutory provision. Section 6(b)(4)(B) provides that the requirements of section 6(b)(1) do not apply to public disclosure of “information in the course of or concerning any * * * other administrative or judicial proceeding under this Act.”
(b) Scope of exception. This exception applies to an administrative or judicial proceeding, other than a rulemaking or administrative adjudicatory proceeding, under the CPSA, FHSA, FFA, or PPPA. Proceedings within this exception include:
(1) A proceeding to act on a petition to start a rulemaking proceeding. This proceeding begins with the filing of a petition and ends when the petition is denied or, if granted, when the rulemaking proceeding begins. Information subject to the exception for petition proceedings is the petition itself and the supporting documentation, and information subsequently compiled by the staff and incorporated or referenced in the staff briefing papers for and recommendation to the Commission.
(2) A proceeding to act on a request for exemption from a rule or regulation. This proceeding begins with the filing of a request for exemption and ends when the request is denied or, if granted, when the Commission takes the first step to implement the exemption, e.g., when an amendment to the rule or regulation is proposed.
(3) A proceeding to issue a subpoena or general or special order. This proceeding begins with a staff request to the Commission to issue a subpoena or general or special order and ends once the request is granted or denied.
(4) A proceeding to act on a motion to quash or to limit a subpoena or general or special order. This proceeding begins with the filing with the Commission of a motion to quash or to limit and ends when the motion is granted or denied.
(5) Any judicial proceeding to which the Commission is a party. This proceeding begins when a complaint is filed and ends when a final decision (including appeal) is rendered with respect to the Commission.
(6) Any administrative proceeding to which the Commission is a party, such as an administrative proceeding before the Merit Systems Protection Board or the Federal Labor Relations Authority. This proceeding begins and ends in accordance with the applicable regulations or procedures of the administrative body before which the proceeding is heard.
(7) A proceeding to obtain a retraction from the Commission pursuant to subpart F of these rules. This proceeding begins with the filing with the Secretary of the Commission of a request for retraction and ends when the request is denied or, if granted, when the information is retracted.
(c) In the course of or concerning. The phrase “in the course of or concerning” shall have the same meaning as set forth in either § 1101.44 (c) and (d) or § 1101.45 (c) and (d), whichever is applicable.
Subpart F—Retraction
§ 1101.51 Commission interpretation.
(a) Statutory provisions. Section 6(b)(7) of the CPSA provides: If the Commission finds that, in the administration of this Act, it has made public disclosure of inaccurate or misleading information which reflects adversely upon the safety of any consumer product or class of consumer products, or the practices of any manufacturer, private labeler, distributor, or retailer of consumer products, it shall, in a manner equivalent to that in which such disclosure was made, take reasonable steps to publish a retraction of such inaccurate or misleading information.
(b) Scope. Section 6(b)(7) applies to inaccurate or misleading information only if it is adverse—i.e., if it reflects adversely either on the safety of a consumer product or on the practices of a manufacturer, private labeler, distributor or retailer. In addition, the Commission will apply section 6(b)(7) to information about products, and about manufacturers and private labelers of products, the Commission may regulate under any of the statutes it administers. Section 6(b)(7) applies to information already disclosed by the Commission, members of the Commission, or the Commission employees, agents, contractors or representatives in their official capacities.
§ 1101.52 Procedure for retraction.
(a) Initiative. The Commission may retract information under section 6(b)(7) on the initiative of the Commission, upon the request of a manufacturer, private labeler, distributor, or retailer of a consumer product, or upon the request of any other person in accordance with the procedures provided in this section.
(b) Request for retraction. Any manufacturer, private labeler, distributor or retailer of a consumer product or any other person may request a retraction if he/she believes the Commission or an individual member, employee, agent, contractor or representative of the Commission has made public disclosure of inaccurate or misleading information, which reflects adversely either on the safety of a product with which the firm deals or on the practices of the firm. The request must be in writing and addressed to the Secretary, CPSC. Washington, D.C. 20207.
(c) Content of request. A request for retraction must include the following information to the extent it is reasonably available:
(1) The information disclosed for which retraction is requested, the date on which the information was disclosed, the manner in which it was disclosed, who disclosed it, the type of document (e.g., letter, memorandum, news release) and any other relevant information the firm has to assist the Commission in identifying the information. A photocopy of the disclosure should accompany the request.
(2) A statement of the specific aspects of the information the firm believes are inaccurate or misleading and reflect adversely either on the safety of a consumer product with which the firm deals or on the firm’s practices.
(3) A statement of the reasons the firm believes the information is inaccurate or misleading and reflects adversely either on the safety of a consumer product with which the firm deals or on the firm’s practices.
(4) A statement of the action the firm requests the Commission to take in publishing a retraction in a manner equivalent to that in which disclosure was made.
(5) Any additional data or information the firm believes is relevant.
(d) Commission action on request. The Commission will act expeditiously on any request for retraction within 30 working days unless the Commission determines, for good cause, that a longer time period is appropriate. If the Commission finds that the Commission or any individual member, employee, agent contractor or representative of the Commission has made public disclosure of inaccurate or misleading information that reflects adversely either on the safety of the firm’s product or the practices of the firm, the Commission will publish a retraction of information in a manner equivalent to that in which the disclosure was made. If the Commission finds that fuller disclosure is necessary, it will publish a retraction in the manner it determines appropriate under the circumstances.
(e) Notification to requester. The Commission will promptly notify the requester in writing of its decision on request for retraction. Notification shall set forth the reasons for the Commission’s decision.
Subpart G—Information Submitted Pursuant to Section 15(b) of the CPSA
§ 1101.61 Generally.
(a) Generally. In addition to the requirements of section 6(b)(1), section 6(b)(5) of the CPSA imposes further limitations on the disclosure of information submitted to the Commission pursuant to section 15(b) of the CPSA, 15 U.S.C. 2064(b).
(b) Criteria for disclosure. Under section 6(b)(5) the Commission shall not disclose to the public information which is identified as being submitted pursuant to section 15(b) or which is treated by the Commission staff as being submitted pursuant to section 15(b). Section 6(b)(5) also applies to information voluntarily submitted after a firm’s initial report to assist the Commission in its evaluation of the section 15 report. However, the Commission may disclose information submitted pursuant to section 15(b) in accordance with section 6(b)(1)-(3) if:
(1) The Commission has issued a complaint under section 15 (c) or (d) of the CPSA alleging that such product presents a substantial product hazard; or
(2) In lieu of proceeding against such product under section 15 (c) or (d), the Commission has accepted in writing a remedial settlement agreement dealing with such product; or
(3) The person who submitted the information under section 15(b) agrees to its public disclosure.
(4) The Commission publishes a finding that the public health and safety requires public disclosure with a lesser period of notice than is required by section 6(b)(1).
§ 1101.62 Statutory exceptions to section 6(b)(5) requirements.
(a) Scope. The limitations established by section 6(b)(5) do not apply to the public disclosure of:
(1) Information with respect to a consumer product which is the subject of an action brought under section 12 (see § 1101.42);
(2) Information with respect to a consumer product which the Commission has reasonable cause to believe is in violation of any consumer product safety rule or provision under the Consumer Product Safety Act (Pub. L. 92-573, 86 Stat. 1207, as amended (15 U.S.C. 2051, et seq.)) or similar rule or provision of any other act enforced by the Commission; or
(3) Information in the course of or concerning a judicial proceeding (see § 1101.45).
§ 1101.63 Information submitted pursuant to section 15(b) of the CPSA.
(a) Section 6(b)(5) applies only to information provided to the Commission by a manufacturer, distributor, or retailer which is identified by the manufacturer, distributor or retailer, or treated by the Commission staff as being submitted pursuant to section 15(b).
(b) Section 6(b)(5)’s limitation also applies to the portions of staff generated documents that contain, summarize or analyze such information submitted pursuant to section 15(b).
(c) Section 6(b)(5) does not apply to information independently obtained or prepared by the Commission staff.
Subpart H—Delegation of Authority to Information Group
(a) Delegation. Pursuant to section 27(b)(9) of the CPSA 15 U.S.C. 2076(b)(9) the Commission delegates to the General Counsel or his or her senior staff designees, the authority to render all decisions under this part concerning the release of information subject to section 6(b) when firms have furnished section 6(b) comment except as provided in paragraph (b). The Commission also delegates to the Secretary of the Commission, or his or her senior staff designee, authority to make all decisions under this part concerning the release of information under section 6(b) when firms have failed to furnish section 6(b) comment or have consented to disclosure except as provided in paragraph (b) of this section. The General Counsel shall have authority to establish an Information Group composed of the General Counsel and the Secretary of the Commission or their designees who shall be senior staff members.
(b) Findings not deleted. The Commission does not delegate its authority—
(1) To find, pursuant to section 6(b)(1) and § 1101.23(b) of this part, that the public health and safety requires less than 15 days advance notice of proposed disclosures of information.
(2) To find, pursuant to section 6(b)(2) and § 1101.25(b) of this part, that the public health and safety requires less than five (5) days advance notice of its intent to disclose information claimed to be inaccurate;
(3) To decide whether it should take reasonable steps to publish a retraction of information in accordance with section 6(b)(7) and § 1101.52 of this part.
(c) Final agency action; Commission decision. A decision of the General Counsel or the Secretary or their designees shall be a final agency decision and shall not be appealable as of right to the Commission. However, the General Counsel or the Secretary may in his or her discretion refer an issue to the Commission for decision.
PART 1102—PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE
Subpart A—Background and Definitions
§ 1102.2 Purpose.
This part sets forth the Commission’s interpretation, policy, and procedures with regard to the establishment and maintenance of a Publicly Available Consumer Product Safety Information Database (also referred to as the “Database”) on the safety of consumer products and other products or substances regulated by the Commission.
§ 1102.4 Scope.
This part applies to the content, procedure, notice, and disclosure requirements of the Publicly Available Consumer Product Safety Information Database, including all information published therein.
§ 1102.6 Definitions.
(a) Except as specified in paragraph (b) of this section, the definitions in section 3 of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2052) apply to this part.
(b) For purposes of this part, the following definitions apply:
(1) Additional information means any information that the Commission determines is in the public interest to include in the Publicly Available Consumer Product Safety Information Database.
(2) Commission or CPSC means the Consumer Product Safety Commission.
(3) Consumer product means a consumer product as defined in section 3(a)(5) of the CPSA, and also includes any other products or substances regulated by the Commission under any other act it administers.
(4) Harm means injury, illness, or death; or risk of injury, illness, or death, as determined by the Commission.
(5) Mandatory recall notice means any notice to the public required of a firm pursuant to an order issued by the Commission under section 15(c) of the CPSA.
(6) Manufacturer comment means a comment made by a manufacturer or private labeler of a consumer product in response to a report of harm transmitted to such manufacturer or private labeler.
(7) Publicly Available Consumer Product Safety Information Database, also referred to as the Database, means the database on the safety of consumer products established and maintained by the CPSC as described in section 6A of the CPSA.
(8) Report of harm means any information submitted to the Commission through the manner described in § 1102.10(b), regarding any injury, illness, or death; or any risk of injury, illness, or death, as determined by the Commission, relating to the use of a consumer product.
(9) Submitter of a report of harm means any person or entity that submits a report of harm.
(10) Voluntary recall notice means any notice to the public by the Commission relating to a voluntary corrective action, including a voluntary recall of a consumer product, taken by a manufacturer in consultation with the Commission.
Subpart B—Content Requirements
§ 1102.10 Reports of harm.
(a) Who may submit. The following persons or entities may submit reports of harm:
(1) Consumers including, but not limited to, users of consumer products, family members, relatives, parents, guardians, friends, attorneys, investigators, professional engineers, agents of a user of a consumer product, and observers of the consumer products being used;
(2) Local, state, or federal government agencies including, but not limited to, local government agencies, school systems, social services, child protective services, state attorneys general, state agencies, and all executive and independent federal agencies as defined in Title 5 of the United States Code;
(3) Health care professionals including, but not limited to, medical examiners, coroners, physicians, nurses, physician’s assistants, hospitals, chiropractors, and acupuncturists;
(4) Child service providers including, but not limited to, child care centers, child care providers, and prekindergarten schools; and
(5) Public safety entities including, but not limited to, police, fire, ambulance, emergency medical services, federal, state, and local law enforcement entities, and other public safety officials and professionals, including consumer advocates or individuals who work for nongovernmental organizations, consumer advocacy organizations, and trade associations, so long as they have a public safety purpose.
(b) Manner of submission. To be entered into the Database, reports of harm must be submitted to the CPSC using one of the following methods:
(1) Internet submissions through the CPSC’s Internet Web site on an electronic incident report form specifically developed to collect such information.
(2) Telephonic submissions through a CPSC call center, where the information is entered on the electronic incident form.
(3) Electronic mail directed to the Office of the Secretary at [email protected], or by facsimile at 301-504-0127, provided that the submitter completes the incident report form available for download on the CPSC’s Internet Web site specifically developed to collect such information.
(4) Written submissions to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814-4408. The Commission will accept only those written reports of harm that use the incident report form developed for the CPSC’s Internet Web site; or
(5) Other means the Commission subsequently makes available.
(c) Size limit of reports of harm. The Commission may, in its discretion, limit the data size of reports of harm, which may include attachments submitted, where such reports of harm and attachments may negatively impact the technological or operational performance of the system.
(d) Minimum requirements for publication. Subject to §§ 1102.24 and 1102.26, the Commission will publish in the Publicly Available Consumer Product Safety Information Database reports of harm containing all of the following information:
(1) Description of the consumer product. The description of the consumer product must, at a minimum, include a word or phrase sufficient to distinguish the product as a consumer product, a component part of a consumer product, or a product or substance regulated by the Commission. In addition to a word or phrase sufficient to distinguish the product as a consumer product, a description of a consumer product may include, but is not limited to, the name, including the brand name of the consumer product, model, serial number, date of manufacture (if known) or date code, date of purchase, price paid, retailer, or any other descriptive information about the product.
(2) Identity of the manufacturer or private labeler. The name of one or more manufacturers or private labelers of the consumer product. In addition to a firm name, identification of a manufacturer or private labeler may include, but is not limited to, a mailing address, phone number, or electronic mail address.
(3) Description of the harm. A brief narrative description of illness, injury, or death; or risk of illness, injury, or death related to use of the consumer product. Examples of a description of harm or risk of harm include, but are not limited to: Death, asphyxiation, lacerations, burns, abrasions, contusions, fractures, choking, poisoning, suffocation, amputation, or any other narrative description relating to a bodily harm or risk of bodily harm. Incident reports that relate solely to the cost or quality of a consumer product, with no discernable bodily harm or risk of bodily harm, do not constitute “harm” for purposes of this part. A description of harm may, but need not, include the severity of any injury and whether any medical treatment was received.
(4) Incident date. The date, or an approximate date, on which the incident occurred.
(5) Category of submitter. Indication of which category the submitter is in (i.e., consumers, government agencies, etc.) from § 1102.10(a).
(6) Contact information. The submitter’s first name, last name, and complete mailing address. Although this information will not be published in the Database, it is required information for the report of harm. Submitters also may, but are not required to, provide an electronic mail address and a phone number to allow for efficient and timely contact regarding a report of harm, when necessary.
(7) Verification. A submitter of a report of harm must affirmatively verify that he or she has reviewed the report of harm, and that the information contained therein is true and accurate to the best of the submitter’s knowledge, information, and belief. Verification procedures for each method of submission will be specified.
(8) Consent. A submitter of a report of harm must consent to publication of the report of harm in the Database if he or she wants the information to be included in the Database.
(e) Additional information requested on report of harm. The minimum requirements (at § 1102.10(d)) for publication of a report of harm in the Database do not restrict the Commission from choosing to seek other categories of voluntary information in the future.
(f) Information not published. The Commission will exclude the following information provided on a report of harm from publication in the Database:
(1) Name and contact information of the submitter of a report of harm;
(2) Victim’s name and contact information, if the victim or the victim’s parent, guardian, or appropriate legally authorized representative, has not provided appropriate legal consent;
(3) Photographs that in the determination of the Commission are not in the public interest, including photographs that could be used to identify a person or photographs that would constitute an invasion of personal privacy based on the Privacy Act of 1974, Public Law 93-579 as amended;
(4) Medical records without the consent of the person about whom such records pertain or without the consent of his or her parent, guardian, or appropriate legally authorized representative;
(5) Confidential information as set forth in § 1102.24;
(6) Information determined to be materially inaccurate as set forth in § 1102.26;
(7) Reports of harm retracted at any time by the submitters of those reports, if they indicate in writing to the Commission that they supplied materially inaccurate information;
(8) Consents and verifications associated with a report of harm; and
(9) Any other information submitted on or with a report of harm, the inclusion of which in the Database, the Commission determines is not in the public interest. The Commission shall consider whether the information is related to a product safety purpose served by the Database, including whether or not the information helps Database users to:
(i) Identify a consumer product;
(ii) Identify a manufacturer or private labeler of a consumer product;
(iii) Understand a harm or risk of harm related to the use of a consumer product; or
(iv) Understand the relationship between a submitter of a report of harm and the victim.
(g) Reports of harm from persons under the age of 18. The Commission will not accept any report of harm when the report of harm is or was submitted by anyone under the age of 18 without consent of the parent or guardian of that person.
(h) Incomplete reports of harm. Any information received by the Commission related to a report of harm that does not meet the requirements for submission or publication will not be published, but will be maintained for internal use.
(i) Official records of the Commission. All reports of harm that are submitted to the Commission become official records of the Commission in accordance with 16 CFR 1015.1. Alteration (or disposition) of any such records will only be in accordance with the procedures specified in this part.
§ 1102.12 Manufacturer comments.
(a) Who may submit. A manufacturer or private labeler may submit a comment related to a report of harm if the report of harm identifies such manufacturer or private labeler.
(b) How to submit. A manufacturer or private labeler may submit comments to the CPSC using one of the following methods:
(1) A manufacturer or private labeler who registers with the Commission as described in § 1102.20(f) may submit comments through a manufacturer portal maintained on the CPSC’s Internet Web site;
(2) A manufacturer or private labeler may submit comments by electronic mail, directed to the Office of the Secretary at [email protected]; or
(3) A manufacturer or private labeler may submit written comments directed to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814-4408.
(c) What must be submitted. Subject to §§ 1102.24 and 1102.26, the Commission will publish manufacturer comments related to a report of harm transmitted to a manufacturer or private labeler in the Database if such manufacturer comment meets the following requirements:
(1) Manufacturer comment relates to report of harm. The manufacturer or private labeler’s comment must relate to information contained in a specific report of harm that identifies such manufacturer or private labeler and that is submitted for publication in the Database.
(2) Unique identifier. A manufacturer comment must state the unique identifier provided by the CPSC.
(3) Verification. A manufacturer or private labeler must verify that it has reviewed the report of harm and the comment related to the report of harm and that the information contained in the comment is true and accurate to the best of the firm’s knowledge, information, and belief.
(4) Request for publication. When a manufacturer or private labeler submits a comment regarding a report of harm, it may request that the Commission publish such comment in the Database. A manufacturer or private labeler must affirmatively request publication of the comment, and consent to such publication in the Database, for each comment submitted to the CPSC.
(d) Information published. Subject to §§ 1102.24 and 1102.26, the Commission will publish a manufacturer comment and the date of its submission to the CPSC in the Database if the comment meets the minimum requirements for publication as described in paragraph (c) of this section.
(e) Information not published. The Commission will not publish in the Database consents and verifications associated with a manufacturer comment.
§ 1102.14 Recall notices.
All information presented in a voluntary or mandatory recall notice that has been made available to the public shall be accessible and searchable in the Database.
§ 1102.16 Additional information.
In addition to reports of harm, manufacturer comments, and recall notices, the CPSC shall include in the Database any additional information it determines to be in the public interest, consistent with the requirements of section 6(a) and (b) of the CPSA.
Subpart C—Procedural Requirements
§ 1102.20 Transmission of reports of harm to the identified manufacturer or private labeler.
(a) Information transmitted. Except as provided in paragraphs (a)(1) through (a)(3) of this section, the Commission will transmit all information provided in a report of harm, provided such report meets the minimum requirements for publication in the Database, to the manufacturer or private labeler identified in a report of harm. The following information will not be transmitted to a manufacturer or private labeler:
(1) Name and contact information for the submitter of the report of harm, unless such submitter provides express written consent (for example, by checking a box on the report of harm) to provide such information to the manufacturer or private labeler;
(2) Photographs that could be used to identify a person; and
(3) Medical records, unless the person about whom such records pertain, or his or her parent, guardian, or appropriate legally authorized representative, consents to providing such records to the manufacturer or private labeler.
(b) Limitation on use of contact information. A manufacturer or private labeler who receives name and contact information for the submitter of a report of harm and/or a victim must not use or disseminate such information to any other party for any other purpose other than verification of information contained in a report of harm. Verification of information contained in a report of harm must not include activities such as sales, promotion, marketing, warranty, or any other commercial purpose. Verification of information contained in a report of harm may include verification of the:
(1) Identity of the submitter and/or the victim, including name, location, age, and gender;
(2) Consumer product, including serial or model number, date code, color, or size;
(3) Harm or risk of harm related to the use of the consumer product;
(4) Description of the incident related to use of the consumer product;
(5) Date or approximate date of the incident; and/or
(6) Category of submitter.
(c) Timing. To the extent practicable, the Commission will transmit a report of harm to the manufacturer or private labeler within five business days of submission of the completed report of harm. If the Commission cannot determine whom the manufacturer or private labeler is from the report of harm, or otherwise, then it will not post the report of harm on the Database but will maintain the report for internal agency use. Examples of circumstances that may arise that may make transmission of the report of harm impracticable within five business days include, but are not limited to:
(1) The manufacturer or private labeler is out of business with no identifiable successor;
(2) The submitter misidentified a manufacturer or private labeler;
(3) The report of harm contained inaccurate or insufficient contact information for a manufacturer or private labeler; or
(4) The Commission cannot locate valid contact information for a manufacturer or private labeler.
(d) Method of transmission. The Commission will use the method of transmission and contact information provided by the manufacturer or private labeler. The Commission will transmit reports of harm to a manufacturer or private labeler who has registered with the Commission as described in paragraph (f) of this section. If a manufacturer or private labeler has not registered with the Commission, the Commission will send reports of harm through the United States mail to the firm’s principal place of business, unless the Commission selects another equally effective method of transmission.
(e) Size limits of manufacturer comments. The Commission may, in its discretion, limit the data size of comments, which may include attachments submitted, where such comments and attachments may negatively impact the technological or operational performance of the system.
(f) Manufacturer registration. Manufacturers and private labelers may register with the Commission to select a preferred method for receiving reports of harm that identify such firm as the manufacturer or private labeler. Manufacturers and private labelers that choose to register with the Commission must:
(1) Register with the Commission through a process identified for such registration;
(2) Provide and maintain updated contact information for the firm, including the name of the firm, title of a person to whom reports of harm should be directed, complete mailing address, telephone number, electronic mail address, and Web site address (if any); and
(3) Select a specified method to receive reports of harm that identify the firm as the manufacturer or private labeler of a consumer product.
(g) Manufacturer comments. A manufacturer or private labeler who receives a report of harm from the CPSC may comment on the information contained in such report of harm. The Commission, in its discretion, where it determines it is in the public interest, may choose not to publish a manufacturer comment in the Database. For example, it may not be in the public interest for the Commission to publish comments that, in the unlikely event, contain language reasonably described as lewd, lascivious, or obscene.
§ 1102.24 Designation of confidential information.
(a) For purposes of this section, “confidential information” is considered to be information that contains or relates to a trade secret or other matter referred to in 18 U.S.C. 1905 or that is subject to 5 U.S.C. 552(b)(4).
(b) A manufacturer or private labeler identified in a report of harm and who receives a report of harm from the CPSC may review such report of harm for confidential information and request that portions of the report of harm be designated as confidential information. Each requester seeking such a designation of confidential information bears the burden of proof and must:
(1) Specifically identify the exact portion(s) of the report of harm claimed to be confidential;
(2) State whether the information claimed to be confidential has ever been released in any manner to a person who was not an employee or in a confidential relationship with the company;
(3) State whether the information so specified is commonly known within the industry or is readily ascertainable by outside persons with a minimum of time and effort;
(4) If known, state the company’s relationship with the victim and/or submitter of the report of harm and how the victim and/or submitter of the report of harm came to be in possession of such allegedly confidential information;
(5) State how the release of the information would be likely to cause substantial harm to the company’s competitive position; and
(6) State whether the person submitting the request for treatment as confidential information is authorized to make claims of confidentiality on behalf of the person or organization concerned.
(c) Manner of submission. Requests for designation of confidential information may be submitted in the same manner as manufacturer comments as described in § 1102.12(b). A request for designation of confidential treatment must be conspicuously marked.
(d) Timing of submission. In order to ensure that the allegedly confidential information is not placed in the database, a request for designation of confidential information must be received by the Commission in a timely manner prior to the 10th business day after the date on which the Commission transmits the report to the manufacturer or private labeler. If a request for confidential treatment is submitted in a timely fashion, the Commission will either make a determination on the claim prior to posting on the 10th business day after transmittal to the manufacturer or, as a matter of policy, redact the allegedly confidential information from a report of harm before publication in the Database until it makes a determination regarding confidential treatment.
(e) Assistance with defense. No request to redact confidential information from a report of harm pursuant to 5 U.S.C. 552(b)(4) should be made by any person who does not intend in good faith, and so certifies in writing, to assist the Commission in the defense of any judicial proceeding that thereafter might be brought to compel the disclosure of information that the Commission has determined to be a trade secret or privileged or confidential commercial or financial information.
(f) Commission determination of confidentiality. If the Commission determines that information in a report of harm is confidential, the Commission shall:
(1) Notify the manufacturer or private labeler;
(2) Redact such confidential information in the report of harm; and
(3) Publish the report of harm in the Database without such confidential information.
(g) Commission determination of no confidentiality. If the Commission determines that a report of harm does not contain confidential information, the Commission shall:
(1) Notify the manufacturer or private labeler; and
(2) Publish the report of harm, if not already published, in the Database.
(h) Removal of confidential information. As stated at 6A(c)(1)(C)(iii) of the CPSA, to seek removal of alleged confidential information that has been published in the Database, a manufacturer or private labeler may bring an action in the district court of the United States in the district in which the complainant resides, or has its principal place of business, or in the U.S. District Court for the District of Columbia.
§ 1102.26 Determination of materially inaccurate information.
(a) For purposes of this section, the following definitions apply:
(1) Materially inaccurate information in a report of harm means information that is false or misleading, and which is so substantial and important as to affect a reasonable consumer’s decision making about the product, including:
(i) The identification of a consumer product;
(ii) The identification of a manufacturer or private labeler;
(iii) The harm or risk of harm related to use of the consumer product; or
(iv) The date, or approximate date on which the incident occurred.
(2) Materially inaccurate information in a manufacturer comment means information that is false or misleading, and which is so substantial and important as to affect a reasonable consumer’s decision making about the product, including:
(i) The description of the consumer product;
(ii) The identity of the firm or firms responsible for the importation, manufacture, distribution, sale, or holding for sale of a consumer product;
(iii) The harm or risk of harm related to the use of a consumer product;
(iv) The status of a Commission, manufacturer, or private labeler investigation;
(v) Whether the manufacturer or private labeler is engaging in a corrective action and whether such action has not been approved by the Commission; or
(vi) Whether the manufacturer has taken, or promised to take, any other action with regard to the product.
(b) Request for determination of materially inaccurate information. Any person or entity reviewing a report of harm or manufacturer comment, either before or after publication in the Database, may request that the report of harm or manufacturer comment, or portions of such report of harm or manufacturer comment, be excluded from the Database or corrected by the Commission because it contains materially inaccurate information. Each requester seeking an exclusion or correction bears the burden of proof and must:
(1) State the unique identifier of the report of harm or manufacturer comment to which the request for a determination of materially inaccurate information pertains;
(2) Specifically identify the exact portion(s) of the report of harm or the manufacturer comment claimed to be materially inaccurate;
(3) State the basis for the allegation that such information is materially inaccurate;
(4) Provide evidence, which may include documents, statements, electronic mail, Internet links, photographs, or any other evidence, sufficient for the Commission to make a determination that the designated information is materially inaccurate;
(5) State what relief the requester is seeking: Exclusion of the entire report of harm or manufacturer comment; redaction of specific information; correction of specific information; or the addition of information to correct the material inaccuracy;
(6) State whether and how an alleged material inaccuracy may be corrected without removing or excluding an entire report of harm or manufacturer comment; and
(7) State whether the person submitting the allegation of material inaccuracy is authorized to make claims of material inaccuracy on behalf of the person or organization concerned.
(c) Manner of submission—(1) Length of request and expedited review. The Commission strongly recommends requesters seeking an expedited review of claims of materially inaccurate information to limit the length of the request described in § 1102.26(b) to no more than five pages, including attachments, to allow for the expedited review of the request. Regardless of length, all submissions will be reviewed.
(2) Manufacturers and private labelers. A manufacturer or private labeler may request a Commission determination of materially inaccurate information related to a report of harm in the same manner as described in § 1102.12(b). Such requests should be conspicuously marked.
(3) All other requests. All other requests for a Commission determination of materially inaccurate information contained in a report of harm or manufacturer comment made by any other person or firm must be submitted to the CPSC using one of the methods listed below. The request seeking a Commission determination of materially inaccurate information may be made through:
(i) Electronic mail. By electronic mail directed to the Office of the Secretary at [email protected]; or
(ii) Paper-based. Written submission directed to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814-4408.
(d) Timing of submission. A request for a Commission determination regarding materially inaccurate information may be submitted at any time. If a request for determination of materially inaccurate information is submitted prior to publication of a report of harm in the Database, the Commission cannot withhold the report of harm from publication in the Database until it makes a determination. Absent a determination, the Commission will publish reports of harm on the tenth business day after transmitting a report of harm to the manufacturer or private labeler.
(e) Assistance with defense. No request for a determination of materially inaccurate information should be made by any person who does not intend in good faith, and so certifies in writing, to assist the Commission in the defense of any judicial proceeding that thereafter might be brought to compel the disclosure of information that the Commission has determined to be materially inaccurate information.
(f) Notice. The Commission shall notify the person or firm requesting a determination regarding materially inaccurate information of its determination and method of resolution after resolving such request.
(g) Commission determination of material inaccuracy before publication. If the Commission determines that information in a report of harm or manufacturer comment is materially inaccurate information before it is published in the Database, the Commission shall:
(1) Decline to add the materially inaccurate information to the Database;
(2) Correct the materially inaccurate information, and, if the minimum requirements for publication as set forth in §§ 1102.10(d) and 1102.12(c) are met, publish the report of harm or manufacturer comment in the Database; or
(3) Add information to the report of harm or the manufacturer comment to correct the materially inaccurate information, and, if the minimum requirements for publication as set forth in §§ 1102.10(d) and 1102.12(c) are met, publish the report of harm or manufacturer comment in the Database.
(h) Commission determination of material inaccuracy after publication. If the Commission determines, after an investigation, that the requested designated information in a report of harm or manufacturer comment contains materially inaccurate information after the report of harm or manufacturer comment has been published in the Database, the Commission shall, no later than seven business days after such determination:
(1) Remove the information determined to be materially inaccurate from the Database, including any associated documents, photographs, or comments;
(2) Correct the information, and, if the minimum requirements for publication as set forth in §§ 1102.10(d) and 1102.12(c) are met, maintain the report of harm or manufacturer comment in the Database; or
(3) Add information to the report of harm or the manufacturer comment to correct the materially inaccurate information, and, if the minimum requirements for publication as set forth in §§ 1102.10(d) and 1102.12(c) are met, maintain the report of harm or manufacturer comment in the Database.
(i) Commission discretion. (1) In exercising its discretion to remove, correct, or add information to correct materially inaccurate information contained in a report of harm or manufacturer comment, the Commission shall preserve the integrity of information received for publication in the Database whenever possible. Subject to §§ 1102.10(d) and 1102.12(c), the Commission shall favor correction, and the addition of information to correct, over exclusion of entire reports of harm and manufacturer comments, where possible.
(2) Expedited determinations. Where a manufacturer has filed a request for a correction or exclusion within the recommended page limit in § 1102.26(c)(1), the Commission shall attempt, where practicable, to make an expedited determination of a claim of material inaccuracy. Given the requirement of section 6A of the CPSA that reports of harm be published, the Commission will publish reports of harm on the tenth business day after transmitting a report of harm, where the Commission has been unable to make a determination regarding a claim of material inaccuracy prior to the statutorily mandated publication date. In such instances, the Commission will make any necessary correction, exclusion, or addition not later than seven business days after making a determination that there is materially inaccurate information in the report of harm. Manufacturer comments will be published at the same time as the report of harm is published, or as soon thereafter as practicable.
(j) Commission determination of no material inaccuracy. If the Commission determines that the requested information in a report of harm or manufacturer comment does not contain materially inaccurate information, the Commission will:
(1) Notify the requester of its determination; and
(2) Publish the report of harm or manufacturer comment, if not already published, in the Database if it meets the minimum requirements set forth in §§ 1102.10(d) and 1102.12(c).
(k) Commission action in absence of request. The Commission may review a report of harm or manufacturer comment for materially inaccurate information on its own initiative, following the same notice and procedural requirements set forth in paragraphs (g) through (j) of this section.
§ 1102.28 Publication of reports of harm.
(a) Timing. Subject to §§ 1102.10, 1102.24, and 1102.26, the Commission will publish reports of harm that meet the requirements for publication in the Database. The Commission will publish reports of harm as soon as practicable, but not later than the tenth business day after such report of harm is transmitted to the manufacturer or private labeler by the CPSC.
(b) Exceptions. The Commission may publish a report of harm that meets the requirements of § 1102.10(d) in the Database beyond the 10-business-day time frame set forth in paragraph (a) of this section if the Commission determines that a report of harm misidentifies or fails to identify all manufacturers or private labelers. Such information must be corrected through the procedures set forth in § 1102.26 for materially inaccurate information in a report of harm. Once a manufacturer or a private labeler has been identified correctly, the time frame set forth in paragraph (a) of this section shall apply.
§ 1102.30 Publication of manufacturer comments.
Timing. Subject to §§ 1102.12, 1102.24, and 1102.26, the Commission will publish in the Database manufacturer comments submitted in response to a report of harm that meet the minimum requirements set forth in § 1102.12(c). This publication will occur at the same time as the report of harm is published or as soon thereafter as practicable. An example of a circumstance that may make it impracticable to publish a manufacturer comment at the same time as a report of harm includes when the Commission did not receive the comment until on or after the publication date of the report of harm.
Subpart D—Notice and Disclosure Requirements
§ 1102.42 Disclaimers.
The Commission does not guarantee the accuracy, completeness, or adequacy of the contents of the Consumer Product Safety Information Database, particularly with respect to the accuracy, completeness, or adequacy of information submitted by persons outside of the CPSC. The Database will contain a notice to this effect that will be prominently and conspicuously displayed on the Database and on any documents that are printed from the Database.
§ 1102.44 Applicability of sections 6(a) and (b) of the CPSA.
(a) Generally. Sections 6(a) and 6(b) of the CPSA shall not apply to the submission, disclosure, and publication of information provided in a report of harm that meets the minimum requirements for publication in § 1102.10(d) in the Database.
(b) Limitation on construction. Section 1102.44(a) shall not be construed to exempt from the requirements of sections 6(a) and 6(b) of the CPSA information received by the Commission pursuant to:
(1) Section 15(b) of the CPSA; or
(2) Any other mandatory or voluntary reporting program established between a retailer, manufacturer, or private labeler and the Commission.
PART 1105—CONTRIBUTIONS TO COSTS OF PARTICIPANTS IN DEVELOPMENT OF CONSUMER PRODUCT SAFETY STANDARDS
§ 1105.1 Purpose.
The purpose of this part is to describe the factors the Commission considers when determining whether or not to contribute to the cost of an individual, a group of individuals, a public or private organization or association, partnership or corporation (hereinafter “participant”) who participates with the Commission in developing standards. The provisions of this part do not apply to and do not affect the Commission’s ability and authority to contract with persons or groups outside the Commission to aid the Commission in developing proposed standards.
§ 1105.2 Factors.
The Commission may agree to contribute to the cost of a participant who participates with the Commission in developing a standard in any case in which the Commission determines:
(a) That a contribution is likely to result in a more satisfactory standard than would be developed without a contribution; and
(b) That the participant to whom a contribution is made is financially responsible.
§ 1105.3 A more satisfactory standard.
In considering whether a contribution is likely to result in a more satisfactory standard, the Commission shall consider:
(a) The need for representation of one or more particular interests, expertise, or points of view in the development proceeding; and
(b) The extent to which particular interests, points of view, or expertise can reasonably be expected to be represented if the Commission does not provide any financial contribution.
§ 1105.4 Eligibility.
In order to be eligible to receive a financial contribution, a participant must request in advance a specific contribution with an explanation as to why the contribution is likely to result in a more satisfactory standard than would be developed without a contribution. The request for a contribution shall contain, to the fullest extent possible and appropriate, the following information:
(a) A description of the point of view, interest and/or expertise that the participant intends to bring to the proceeding;
(b) The reason(s) that representation of the participant’s interest, point of view, or expertise can reasonably be expected to contribute substantially to a full and fair determination of the issues involved in the proceeding;
(c) An explanation of the economic interest, if any, that the participant has (and individuals or groups comprising the participant have) in any Commission determination related to the proceeding;
(d) A discussion, with supporting documentation, of the reason(s) a participant is unable to participate effectively in the proceeding without a financial contribution;
(e) A description of the participant’s employment or organization, as appropriate; and
(f) A specific and itemized estimate of the costs for which the contribution is sought.
§ 1105.5 Applications.
Applications must be submitted to the Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207, within the time specified by the Commission in its
§ 1105.6 Criteria.
The Commission may authorize a financial contribution only for participants who meet all of the following criteria:
(a) The participant represents particular interest, expertise or point of view that can reasonably be expected to contribute substantially to a full and fair determination of the issues involved in the proceeding;
(b) The economic interest of the participant in any Commission determination related to the proceeding is small in comparison to the participant’s costs of effective participation in the proceeding. If the participant consists of more than one individual or group, the economic interest of each of the individuals or groups comprising the participant shall also be considered, if practicable and appropriate; and
(c) The participant does not have sufficient financial resources available for effective participation in the proceeding, in the absence of a financial contribution.
§ 1105.7 Limits on compensation.
The Commission may establish a limit on the total amount of financial compensation to be made to all participants in a particular proceeding and may establish a limit on the total amount of compensation to be made to any one participant in a particular proceeding.
The Commission shall compensate participants only for costs that have been authorized and only for such costs actually incurred for participation in a proceeding.
§ 1105.9 Itemized vouchers.
The participant shall be paid upon submission of an itemized voucher listing each item of expense. Each item of expense exceeding $15 must be substantiated by a copy of a receipt, invoice, or appropriate document evidencing the fact that the cost was incurred.
§ 1105.10 Reasonable costs.
The Commission shall compensate participants only for costs that it determines are reasonable. As guidelines in these determinations, the Commission shall consider market rates and rates normally paid by the Commission for comparable goods and services, as appropriate.
§ 1105.11 Compensable costs.
The Commission may compensate participants for any or all of the following costs:
(a) Salaries for participants or employees of participants;
(b) Fees for consultants, experts, contractural services, and attorneys that are incurred by participants;
(c) Transportation costs;
(d) Travel-related costs such as lodging, meals, tipping, telephone calls; and
(e) All other reasonable costs incurred, such as document reproduction, postage, baby-sitting, and the like.
§ 1105.12 Advance contributions.
The Commission may make its contribution in advance upon specific request, and the contribution may be made without regard to section 3648 of the Revised States of the United States (31 U.S.C. 529).
§ 1105.13 Noncompensable costs.
The items of cost toward which the Commission will not contribute include:
(a) Costs for the acquisition of any interest in land or buildings;
(b) Costs for the payment of items in excess of the participant’s actual cost; and
(c) Costs determined not to be allowable under generally accepted accounting principles and practices or part 1-15, Federal Procurement Regulations (41 CFR part 1-15).
§ 1105.14 Audit and examination.
The Commission and the Comptroller General of the United States, or their duly authorized representatives, shall have access for the purpose of audit and examination to any pertinent books, documents, papers and records of a participant receiving compensation under this section. The Commission may establish additional guidelines for accounting, recordkeeping, and other administrative procedures with which participants must comply as a condition of receiving a contribution.
PART 1107—TESTING AND LABELING PERTAINING TO PRODUCT CERTIFICATION
Subpart A—General Provisions
§ 1107.1 Purpose.
This part establishes the protocols and standards for ensuring continued testing of children’s products periodically and when there has been a material change in the product’s design or manufacturing process and safeguarding against the exercise of undue influence by a manufacturer on a third party conformity assessment body. It also establishes a program for labeling of consumer products to indicate that the certification requirements have been met pursuant to sections 14(a)(2) and (i)(2)(B) of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2063(a)(2) and (i)(2)(B)).
§ 1107.2 Definitions.
Unless otherwise stated, the definitions of the Consumer Product Safety Act and the Consumer Product Safety Improvement Act of 2008 apply to this part. The following definitions apply for purposes of this part:
CPSA means the Consumer Product Safety Act.
CPSC means the Consumer Product Safety Commission.
Due care means the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances. Due care does not permit willful ignorance.
High degree of assurance means an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.
Identical in all material respects means there is no difference with respect to compliance to the applicable rules, bans, standards, or regulations between the samples to be tested for compliance and the finished product distributed in commerce.
Manufacturer means the parties responsible for certification of a consumer product pursuant to 16 CFR part 1110.
Manufacturing process means the techniques, fixtures, tools, materials, and personnel used to create the component parts and assemble a finished product.
Material change means any change in the product’s design, manufacturing process, or sourcing of component parts that a manufacturer exercising due care knows, or should know, could affect the product’s ability to comply with the applicable rules, bans, standards, or regulations.
Third party conformity assessment body means a testing laboratory whose accreditation has been accepted by the CPSC to conduct certification testing on children’s products. Only third party conformity assessment bodies whose scope of accreditation includes the applicable required tests can be used for children’s product certification or periodic testing purposes.
Subpart B [Reserved]
Subpart C—Certification of Children’s Products
§ 1107.20 General requirements.
(a) Manufacturers must submit a sufficient number of samples of a children’s product, or samples that are identical in all material respects to the children’s product, to a third party conformity assessment body for testing to support certification. The number of samples selected must be sufficient to provide a high degree of assurance that the tests conducted for certification purposes accurately demonstrate the ability of the children’s product to meet all applicable children’s product safety rules.
(b) If the manufacturing process for a children’s product consistently creates finished products that are uniform in composition and quality, a manufacturer may submit fewer samples to provide a high degree of assurance that the finished product complies with the applicable children’s product safety rules. If the manufacturing process for a children’s product results in variability in the composition or quality of children’s products, a manufacturer may need to submit more samples to provide a high degree of assurance that the finished product complies with the applicable children’s product safety rules.
(c) Except where otherwise specified by a children’s product safety rule, component part testing pursuant to 16 CFR part 1109 may be used to support the certification testing requirements of this section.
(d) If a product sample fails certification testing to the applicable children’s product safety rule(s), even if other samples have passed the same certification test, the manufacturer must investigate the reasons for the failure and take the necessary steps to address the reasons for the failure. A manufacturer cannot certify the children’s product until the manufacturer establishes, with a high degree of assurance that the finished product does comply with all applicable children’s product safety rules.
§ 1107.21 Periodic testing.
(a) General requirements for all manufacturers. All manufacturers of children’s products must conduct periodic testing. All periodic testing must be conducted by a third party conformity assessment body. Periodic testing must be conducted pursuant to either paragraph (b), (c), or (d) of this section or as provided in regulations under this title. The testing interval selected for periodic testing may be based on a fixed production interval, a set number of units produced, or another method chosen by the manufacturer based on the product produced and its manufacturing process, so long as the applicable maximum testing interval specified in paragraph (b), (c), or (d) of this section is not exceeded. Component part testing pursuant to 16 CFR part 1109 may be used to support the periodic testing requirements of this section.
(b) A manufacturer must conduct periodic testing to ensure compliance with the applicable children’s product safety rules at least once a year, except as otherwise provided in paragraphs (c), and (d) of this section or as provided in regulations under this title. If a manufacturer does not conduct production testing under paragraph (c) of this section, or testing by a testing laboratory under paragraph (d) of this section, the manufacturer must conduct periodic testing as follows:
(1) Periodic Testing Plan. Manufacturers must develop a periodic testing plan to ensure with a high degree of assurance that children’s products manufactured after the issuance of a Children’s Product Certificate, or since the previous periodic testing was conducted, continue to comply with all applicable children’s product safety rules. The periodic testing plan must include the tests to be conducted, the intervals at which the tests will be conducted, and the number of samples tested. At each manufacturing site, the manufacturer must have a periodic testing plan specific to each children’s product manufactured at that site.
(2) Testing Interval. The testing interval selected must be short enough to ensure that, if the samples selected for testing pass the test, there is a high degree of assurance that the other untested children’s products manufactured during the testing interval comply with the applicable children’s product safety rules. The testing interval may vary depending upon the specific children’s product safety rules that apply to the children’s product, but may not exceed one year. Factors to be considered when determining the testing interval include, but are not limited to, the following:
(i) High variability in test results, as indicated by a relatively large sample standard deviation in quantitative tests;
(ii) Measurements that are close to the allowable numerical limit for quantitative tests;
(iii) Known manufacturing process factors which could affect compliance with a rule. For example, if the manufacturer knows that a casting die wears down as the die nears the end of its useful life, the manufacturer may wish to test more often as the casting die wears down;
(iv) Consumer complaints or warranty claims;
(v) Introduction of a new set of component parts into the assembly process;
(vi) The manufacture of a fixed number of products;
(vii) Potential for serious injury or death resulting from a noncompliant children’s product;
(viii) The number of children’s products produced annually, such that a manufacturer should consider testing a children’s product more frequently if the product is produced in very large numbers or distributed widely throughout the United States;
(ix) The children’s product’s similarity to other children’s products with which the manufacturer is familiar and/or whether the children’s product has many different component parts compared to other children’s products of a similar type; or
(x) Inability to determine the children’s product’s noncompliance easily through means such as visual inspection.
(c)(1) If a manufacturer implements a production testing plan as described in paragraph (c)(2) of this section to ensure continued compliance of the children’s product with a high degree of assurance to the applicable children’s product safety rules, the manufacturer must submit samples of its children’s product to a third party conformity assessment body for periodic testing to the applicable children’s product safety rules at least once every two years. A manufacturer may consider the information obtained from production testing when determining the appropriate testing interval and the number of samples needed for periodic testing to ensure that there is a high degree of assurance that the other untested children’s products manufactured during the testing interval comply with the applicable children’s product safety rules.
(2) Production Testing Plan. A production testing plan describes the production management techniques and tests that must be performed to provide a high degree of assurance that the products manufactured after certification continue to meet all the applicable children’s product safety rules. A production testing plan may include recurring testing or the use of process management techniques, such as control charts, statistical process control programs, or failure modes and effects analyses (FMEAs) designed to control potential variations in product manufacturing that could affect the product’s ability to comply with the applicable children’s product safety rules. A manufacturer may use measurement techniques that are nondestructive and tailored to the needs of an individual product to ensure that a product complies with all applicable children’s product safety rules. Any production test method used to conduct production testing must be effective in determining compliance. Production testing cannot consist solely of mathematical methods (such as an FMEA, with no additional components, or computer simulations). Production testing must include some testing, although it is not required that the test methods employed be the test methods used for certification. A manufacturer must document the production testing methods used to ensure continuing compliance and the basis for determining that the production testing plan provides a high degree of assurance that the product being manufactured continues to comply with all applicable children’s product safety rules. A production testing plan must contain the following elements:
(i) A description of the production testing plan, including, but not limited to, a description of the process management techniques used, the tests to be conducted, or the measurements to be taken; the intervals at which the tests or measurements will be made; the number of samples tested; and the basis for determining that the combination of process management techniques and tests provide a high degree of assurance of compliance if they are not the tests prescribed for the applicable children’s product safety rule;
(ii) At each manufacturing site, the manufacturer must have a production testing plan specific to each children’s product manufactured at that site;
(iii) The production testing interval selected for tests must ensure that, if the samples selected for production testing comply with an applicable children’s product safety rule, there is a high degree of assurance that the untested products manufactured during that testing interval also will comply with the applicable children’s product safety rule. Production testing intervals should be appropriate for the specific testing or alternative measurements being conducted.
(3) If a production testing plan as described in this paragraph (c) fails to provide a high degree of assurance of compliance with all applicable children’s product safety rules, the CPSC may require the manufacturer to meet the requirements of paragraph (b) of this section or modify its production testing plan to ensure a high degree of assurance of compliance.
(d)(1) For manufacturers conducting testing to ensure continued compliance with the applicable children’s product safety rules using a testing laboratory accredited to ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories,” periodic tests by a third party conformity assessment body must be conducted at least once every three years. Any ISO/IEC 17025 -accredited testing laboratory used for ensuring continued compliance must be accredited by an accreditation body that is accredited to ISO/IEC 17011, “Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies.” The test method(s) used by an ISO/IEC 17025-accredited testing laboratory when conducting testing to ensure continued compliance must be the same test method(s) used for certification to the applicable children’s product safety rules. Manufacturers must conduct testing using the ISO/IEC 17025-accredited testing laboratory frequently enough to provide a high degree of assurance that the children’s product continues to comply with the applicable children’s product safety rules. A manufacturer may consider the information obtained from testing conducted by an ISO/IEC 17025-accredited testing laboratory when determining the appropriate testing interval and the number of samples for periodic testing that are needed to ensure that there is a high degree of assurance that the other untested children’s products manufactured during the testing interval comply with the applicable children’s product safety rules.
(2) If the continued testing described in paragraph (d)(1) of this section fails to provide a high degree of assurance of compliance with all applicable children’s product safety rules, the CPSC may require the manufacturer to meet the requirements of paragraph (b) of this section or modify the testing frequency or number of samples required to ensure a high degree of assurance of continued compliance.
(e) [Reserved]
(f) A manufacturer must select representative product samples to be submitted to the third party conformity assessment body for periodic testing. The procedure used to select representative product samples for periodic testing must provide a basis for inferring compliance about the population of untested products produced during the applicable periodic testing interval. The number of samples selected for the sampling procedure must be sufficient to ensure continuing compliance with all applicable children’s product safety rules. The manufacturer must document the procedure used to select the product samples for periodic testing and the basis for inferring the compliance of the product manufactured during the periodic testing interval from the results of the tested samples.
(g) Incorporation by reference. The Director of the Federal Register approves the incorporation by reference of the standards in this section in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy at the Division of the Secretariat, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone (301) 504-7479, email: [email protected], or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) International Organization for Standardization (ISO), ISO Central Secretariat Chemin de Blandonnet 8 CP 401—1214 Vernier, Geneva, Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 30; http://www.iso.org/iso/home.htm.
(i) ISO/IEC 17011:2017(E) (ISO/IEC 17011), “Conformity assessment—Requirements for accreditation bodies accrediting conformity assessment bodies,” November 10, 2017; and
(ii) ISO/IEC 17025:2017(E) (ISO/IEC 17025), “General requirements for the competence of testing and calibration laboratories,” November 10, 2017.
(2) [Reserved]
§ 1107.23 Material change.
(a) General Requirements. If a children’s product undergoes a material change in product design or manufacturing process, including the sourcing of component parts, which a manufacturer exercising due care knows, or should know, could affect the product’s ability to comply with the applicable children’s product safety rules, the manufacturer must submit a sufficient number of samples of the materially changed children’s product for testing by a third party conformity assessment body and issue a new Children’s Product Certificate. The number of samples submitted must be sufficient to provide a high degree of assurance that the materially changed component part or finished product complies with the applicable children’s product safety rules. A manufacturer of a children’s product that undergoes a material change cannot issue a new Children’s Product Certificate for the product until the product meets the requirements of the applicable children’s product safety rules. The extent of such testing may depend on the nature of the material change. When a material change is limited to a component part of the finished children’s product and does not affect the ability of other component parts of the children’s product or the finished children’s product to comply with other applicable children’s product safety rules, a manufacturer may issue a new Children’s Product Certificate based on the earlier third party certification tests and on test results of the changed component part conducted by a third party conformity assessment body. A manufacturer must exercise due care to ensure that any component part undergoing component part-level testing is identical in all material respects to the component part on the finished children’s product. Changes that cause a children’s product safety rule to no longer apply to a children’s product are not considered to be material changes.
(b) Product Design. For purposes of this subpart, the term “product design” includes all component parts, their composition, and their interaction and functionality when assembled. To determine which children’s product safety rules apply to a children’s product, a manufacturer should examine the product design for the children’s product as received or assembled by the consumer.
(c) Manufacturing Process. A material change in the manufacturing process is a change in how the children’s product is made that could affect the finished children’s product’s ability to comply with the applicable children’s product safety rules. For each change in the manufacturing process, a manufacturer should exercise due care to determine if compliance to an existing applicable children’s product safety rule could be affected, or if the change results in a newly applicable children’s product safety rule.
(d) Sourcing of Component Parts. A material change in the sourcing of component parts results when the replacement of one component part of a children’s product with another component part could affect compliance with the applicable children’s product safety rule. This includes, but is not limited to, changes in component part composition, component part supplier, or the use of a different component part from the same supplier who provided the initial component part.
§ 1107.24 Undue influence.
(a) Each manufacturer must establish procedures to safeguard against the exercise of undue influence by a manufacturer on a third party conformity assessment body.
(b) The procedures required in paragraph (a) of this section, at a minimum, must include:
(1) Safeguards to prevent attempts by the manufacturer to exercise undue influence on a third party conformity assessment body, including a written policy statement from company officials that the exercise of undue influence is not acceptable, and directing that every appropriate staff member receive training on avoiding undue influence, and sign a statement attesting to participation in such training;
(2) A requirement that upon substantive changes to the requirements in this section regarding avoiding undue influence, the appropriate staff must be retrained regarding those changed requirements.
(3) A requirement to notify the CPSC immediately of any attempt by the manufacturer to hide or exert undue influence over test results; and
(4) A requirement to inform employees that allegations of undue influence may be reported confidentially to the CPSC and a description of the manner in which such a report can be made.
§ 1107.26 Recordkeeping.
(a) A manufacturer of a children’s product subject to an applicable children’s product safety rule must maintain the following records:
(1) A copy of the Children’s Product Certificate for each product. The children’s product covered by the certificate must be clearly identifiable and distinguishable from other products;
(2) Records of each third party certification test. The manufacturer must have separate certification tests records for each manufacturing site;
(3) Records of one of the following for periodic tests of a children’s product:
(i) A periodic test plan and periodic test results;
(ii) A production testing plan, production test results, and periodic test results; or
(iii) Testing results of tests conducted by a testing laboratory accredited to ISO/IEC 17025 (see § 1107.21 for availability) and periodic test results.
(4) Records documenting the testing of representative samples, as set forth in § 1107.21(f), including the number of representative samples selected and the procedure used to select representative samples. Records also must include the basis for inferring compliance of the product manufactured during the periodic testing interval from the results of the tested samples;
(5) Records of descriptions of all material changes in product design, manufacturing process, and sourcing of component parts, and the certification tests run and the test values; and
(6) Records of the undue influence procedures, including training materials and training records of all employees trained on these procedures, including attestations described at § 1107.24(b)(1).
(b) A manufacturer must maintain the records specified in paragraph (a) of this section for five years. The manufacturer must make these records available, either in hard copy or electronically, such as through an Internet Web site, for inspection by the CPSC upon request. Records may be maintained in languages other than English if they can be:
(1) Provided immediately by the manufacturer to the CPSC; and
(2) Translated accurately into English by the manufacturer within 48 hours of a request by the CPSC, or any longer period negotiated with CPSC staff.
Subpart D—Consumer Product Labeling Program
§ 1107.30 Labeling consumer products to indicate that the certification requirements of section 14 of the CPSA have been met.
(a) Manufacturers and private labelers of a consumer product may indicate, by a uniform label on, or provided with the product, that the product complies with any consumer product safety rule under the CPSA, or with any similar rule, ban, standard or regulation under any other act enforced by the CPSC.
(b) The label must be visible and legible, and consist of the following statement:
(c) A consumer product may bear the label if the manufacturer or private labeler has certified, pursuant to section 14 of the CPSA, that the consumer product complies with all applicable consumer product safety rules under the CPSA and with all rules, bans, standards, or regulations applicable to the product under any other act enforced by the Consumer Product Safety Commission.
(d) A manufacturer or private labeler may use a label in addition to the label described in paragraph (b) on the consumer product, as long as such label does not alter or mislead consumers as to the meaning of the label described in paragraph (b) of this section. A manufacturer or private labeler must not imply that the CPSC has tested, approved, or endorsed the product.
PART 1109—CONDITIONS AND REQUIREMENTS FOR RELYING ON COMPONENT PART TESTING OR CERTIFICATION, OR ANOTHER PARTY’S FINISHED PRODUCT TESTING OR CERTIFICATION, TO MEET TESTING AND CERTIFICATION REQUIREMENTS
Subpart A—General Conditions and Requirements
§ 1109.1 Scope.
(a) This part applies to tests or certifications of the following when such testing or certification is used to support a certificate of compliance pursuant to section 14(a) of the Consumer Product Safety Act (CPSA) or to meet continued testing requirements pursuant to section 14(i) of the CPSA:
(1) Component parts of consumer products; and
(2) Finished products when conducted by a party that is not required to test or certify products pursuant to part 1110 of this chapter.
(b) Component part manufacturers and suppliers may certify or test their component parts, but are not required to do so. Also, parties that are not required to test finished products, or to issue finished product certificates pursuant to part 1110 of this chapter, may do so voluntarily.
(c) Subpart A establishes general requirements for component part testing and certification, and relying on component part testing or certification, or another party’s finished product certification or testing, to support a certificate of compliance issued pursuant to section 14(a) of the Consumer Product Safety Act (CPSA) or to meet continued testing requirements pursuant to section 14(i) of the CPSA. Subpart B sets forth additional requirements for component part testing for specific consumer products, component parts, and chemicals. Subpart B is applicable only to those products or requirements expressly included in subpart B. Subpart C describes the conditions and requirements for composite testing.
§ 1109.2 Purpose.
The purpose of this part is to set forth the conditions and requirements under which passing component part test reports, certification of component parts of consumer products, or finished product testing or certification procured or issued by another party, can be used to meet, in whole or in part, the testing and certification requirements of sections 14(a) and 14(i) of the CPSA.
§ 1109.3 Applicability.
The provisions of this part apply to all manufacturers and importers who are required to issue finished product certifications pursuant to section 14(a) of the CPSA and part 1110 of this chapter and to procure tests to ensure continued compliance pursuant to section 14(i) of the CPSA. This part also applies to manufacturers and suppliers of component parts or finished products who are not required to test or certify consumer products pursuant to part 1110 of this chapter, but who voluntarily choose to undertake testing or certification.
§ 1109.4 Definitions.
The following definitions apply to this part:
(a) Certifier means a party that is either a finished product certifier or a component part certifier as defined in this section.
(b) Component part means any part of a consumer product, including a children’s product that either must or may be tested separately from a finished consumer product to assess the consumer product’s ability to comply with a specific rule, ban, standard, or regulation enforced by the CPSC. Within the same consumer product, the component parts to be tested and the tests to be conducted may vary, depending on the applicable regulations and required test methods, if any.
(c) Component part certifier means a party who, although not required to do so pursuant to part 1110 of this chapter, voluntarily certifies the following as complying with one or more rules, bans, standards, or regulations enforced by the CPSC, consistent with the content requirements for certifications in part 1110 of this chapter:
(1) Component parts to be used in consumer products; or
(2) Finished products.
(d) CPSA means the Consumer Product Safety Act.
(e) CPSC means the Consumer Product Safety Commission.
(f) CPSIA means the Consumer Product Safety Improvement Act of 2008.
(g) Due care means the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances. Due care does not permit willful ignorance.
(h) Finished product certifier means a party responsible for certifying compliance of a finished consumer product pursuant to part 1110 of this chapter with all applicable rules, bans, standards, and regulations enforced by the CPSC.
(i) Identical in all material respects means there is no difference with respect to compliance to the applicable rules, bans, standards, or regulations, between the samples to be tested for compliance and the component part or finished product distributed in commerce.
(j) Paint means any type of surface coating that is subject to part 1303 of this chapter or section 4.3.5.2 of ASTM F 963-08 (or any successor standard of section 4.3.5.2 of ASTM F 963-08 accepted by the Commission).
(k) Testing party means a party (including, but not limited to, domestic manufacturers, foreign manufacturers, importers, private labelers, or component part suppliers) who procures tests (either by conducting the tests themselves, when this is allowed, or by arranging for another party to conduct the tests), of a consumer product, or any component part thereof, for compliance, in whole or in part, with any applicable rule, ban, standard, or regulation enforced by the CPSC. Testing laboratories and third party conformity assessment bodies are not testing parties under this definition.
(l) Third party conformity assessment body means a testing laboratory whose accreditation has been accepted by the CPSC to conduct certification testing on children’s products. Only third party conformity assessment bodies whose scope of accreditation includes the applicable required tests can be used to test children’s products for purposes of supporting certification pursuant to section 14(a) of the CPSA and testing to ensure continued compliance pursuant to section 14(i) of the CPSA.
(m) Traceable means the ability of a certifier to identify all testing parties of a component part of a consumer product or a finished product, including the name and address of each testing party and any party that conducted testing on the component part or finished product. Parties that conduct testing may include a manufacturer, a supplier, a testing laboratory, or a third party conformity assessment body. Traceability extends to the component part of the product that was tested for compliance, such that if a subassembly is tested, that subassembly must be traceable, not each component part of the subassembly, if those parts were not individually tested for other rules, bans, standards, or regulations.
§ 1109.5 Conditions, requirements, and effects generally.
(a) Component part testing allowed. Any party, including a component part manufacturer, a component part supplier, a component part certifier, or a finished product certifier, may procure component part testing as long as it complies with the requirements in this section, and with the requirements of subparts B and C of this part, if applicable in the circumstanced identified in subparts B and C. A finished product certifier may certify compliance of a consumer product with all applicable rules, bans, standards, and regulations as required by section 14(a) of the CPSA, and may ensure continued compliance of children’s products pursuant to section 14(i) of the CPSA, based, in whole or in part, on passing component part test reports or certification of one or more component parts of a consumer product if the following requirements are met:
(1) Testing of the component part is required or sufficient to assess compliance, in whole or in part, of the consumer product with the applicable rule, ban, standard, or regulation. Any doubts about whether testing one or more component parts of a consumer product is sufficient to assess whether the finished product complies with applicable rules, bans, standards, and regulations should be resolved in favor of testing the finished product; and
(2) The component part tested is identical in all material respects to the component parts used in the finished consumer product. To be identical in all material respects to a component part for purposes of supporting a certification of a children’s product, a sample need not necessarily be of the same size, shape, or finish condition as the component part of the finished product; rather, it may consist of any quantity that is sufficient for testing purposes and be in any form that has the same content as the component part of the finished product.
(b) Test Result Integrity. A certifier or testing party must exercise due care to ensure that while a component part or finished product is in its custody:
(1) Proper management and control of all raw materials, component parts, subassemblies, and finished products is established and maintained for any factor that could affect the finished product’s compliance with all applicable rules;
(2) The manufacturing process does not add or result in a prohibited level of a chemical from any source, such as the material hopper, regrind equipment, or other equipment used in the assembly of the finished product; and
(3) No action or inaction subsequent to testing and before distribution in commerce has occurred that would affect compliance, including contamination or degradation.
(c) Limitation. A certifier must not use tests of a component part of a consumer product for any rule, ban, standard, or regulation that requires testing the finished product to assess compliance with that rule, ban, standard, or regulation.
(d) Test method and sampling protocol. Each certifier and testing party must exercise due care to ensure that when it procures a test for use in meeting the requirements of sections 14(a) or 14(i) of the CPSA:
(1) All testing is done using required test methods, if any;
(2) Required sampling protocols are followed, if any; and
(3) Testing and certification follows the applicable requirements in sections 14(a) and 14(i) of the CPSA, and part 1107 of this chapter or any more specific rules, bans, standards, or regulations, used to assess compliance of the component part or finished product.
(e) Timing. Subject to any more specific rule, ban, standard, or regulation, component part testing may occur before final assembly of a consumer product, provided that nothing in the final assembly of the consumer product can cause the component part or the final consumer product to become noncompliant.
(f) Traceability. A certifier must not rely on component part or finished product testing procured by a testing party or another certifier unless such component parts or finished products are traceable.
(g) Documentation by certifiers and testing parties. Each certifier and testing party must provide the following documentation, either in hard copy or electronically, to a certifier relying on such documentation as a basis for issuing a certificate:
(1) Identification of the component part or the finished product tested;
(2) Identification of a lot or batch number, or other information sufficient to identify the component parts or finished products to which the testing applies;
(3) Identification of the applicable rules, bans, standards, and regulations for which each component part or finished product was tested;
(4) Identification of the testing method(s) and sampling protocol(s) used;
(5) The date or date range when the component part or finished product was tested;
(6) Test reports that provide the results of each test on a component part or finished product, and the test values, if any;
(7) Identification of the party that conducted each test (including testing conducted by a manufacturer, testing laboratory, or third party conformity assessment body), and an attestation by the party conducting the testing that all testing of a component part or finished product by that party was performed in compliance with applicable provisions of section 14 of the CPSA, part 1107 of this chapter, or any more specific rules, bans, standards, or regulations;
(8) Component part certificate(s) or finished product certificate(s), if any;
(9) Records to support traceability as defined in § 1109.4(m); and
(10) An attestation by each certifier and testing party that while the component part or finished product was in its custody, it exercised due care to ensure compliance with the requirements set forth in subparagraph (b) of this section.
(h) Effect of voluntary certification. (1) The Commission will consider any certificate issued by a component part certifier in accordance with this part to be a certificate issued in accordance with section 14(a) of the CPSA. All certificates must contain all of the information required by part 1110 of this chapter.
(2) Any party who elects to certify compliance of a component part or a finished product with applicable rules, standards, bans, or regulations, must assume all responsibilities of a manufacturer under sections 14(a) and 14(i) of the CPSA and part 1107 of this chapter with respect to that component part or finished product’s compliance to the applicable rules, standards, bans, or regulations.
(i) Certification by finished product certifiers. (1) A finished product certifier must exercise due care in order to rely, in whole or in part, on one or more of the following as a basis for issuing a finished product certificate:
(i) Finished product certificate(s) issued by another party;
(ii) Finished product test report(s) provided by another party;
(iii) Component part certificate(s); or
(iv) Component part test report(s).
(2) If a finished product certifier fails to exercise due care in its reliance on another party’s certifications or test reports, then the Commission will not consider the finished product certifier to hold a certificate issued in accordance with section 14(a) of the CPSA. Exercising due care in this context means taking the steps that a prudent and competent person in the same line of business would take to conduct a reasonable review of another party’s certification or test reports, and to address any concern over their validity, before relying on such documents to issue a finished product certificate. Due care does not permit willful ignorance. Such steps may vary according to the circumstances.
(3) A finished product certifier must not rely on another party’s certifications or test reports unless the finished product certifier receives the documentation under paragraph (g) of this section from the certifier or testing party. The finished product certifier may receive such documentation either in hard copy or electronically, or access the documentation through an Internet Web site. The Commission may consider a finished product certifier who does not obtain such documentation before certifying a consumer product to have failed to exercise due care.
(j) Recordkeeping requirements. Each certifier or testing party must maintain the documentation required in paragraph (g) of this section for five years, and must make such documentation available for inspection by the CPSC upon request, either in hard copy or electronically, such as through an Internet Web site. Records may be maintained in languages other than English if they can be:
(1) Provided immediately by the certifier or testing party to the CPSC; and
(2) Translated accurately into English by the certifier or testing party within 48 hours of a request by the CPSC or any longer period negotiated with CPSC staff.
Subpart B—Conditions and Requirements for Specific Consumer Products, Component Parts, and Chemicals
§ 1109.11 Component part testing for paint.
(a) Generally. The Commission will permit certification of a consumer product, or a component part of a consumer product, as being in compliance with the lead paint limit of part 1303 of this chapter or the content limits for paint on toys of section 4.3 of ASTM F 963-11 or any successor standard of section 4.3 of ASTM F 963-11 accepted by the Commission if, for each paint used on the product, the requirements in § 1109.5 and paragraph (b) of this section are met.
(b) Requirement. For each paint used on the product:
(1) Unless using the test method ASTM F 2853-10 to test for lead in paint, all testing must be performed on dry paint that is scraped off of a substrate for testing. The substrate used need not be of the same material as the material used in the finished product or have the same shape or other characteristics as the part of the finished product to which the paint will be applied; and
(2) The tested paint is identical in all material respects to that used in production of the consumer product. The paint samples to be tested must have the same composition as the paint used on the finished product. However, a larger quantity of the paint may be tested than is used on the consumer product in order to generate a sufficient sample size. The paint may be supplied to the testing laboratory for testing either in liquid form or in the form of a dried film of the paint on any suitable substrate.
§ 1109.12 Component part testing for lead content of children’s products.
A certifier may rely on component part testing of each accessible component part of a children’s product for lead content, where such component part testing is performed by a third party conformity assessment body, provided that the requirements in § 1109.5 are met, and the determination of which, if any, parts are inaccessible pursuant to section 101(b)(2) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) and part 1500.87 of this chapter is based on an evaluation of the finished product.
§ 1109.13 Component part testing for phthalates in children’s toys and child care articles.
A certifier may rely on component part testing of appropriate component parts of a children’s toy or child care article for phthalate content provided that the requirements in § 1109.5 are met, and the determination of which, if any, parts are inaccessible pursuant to section 108(d) of the CPSIA and part 1199 of this chapter is based on an evaluation of the finished product.
Subpart C—Conditions and Requirements for Composite Testing
§ 1109.21 Composite testing.
(a) Paint. In testing paint for compliance with chemical content limits, certifiers and testing parties may procure tests conducted on a combination of different paint samples so long as test procedures are followed to ensure that no failure to comply with the lead limits will go undetected (see paragraph (c) of this section). A certificate may be based on testing each component part of the paint according to the requirements of § 1109.11 and certifying that each component part in the mixture individually complies with the lead in paint limit or other paint limit. Testing and certification of composite paints must also comply with §§ 1109.5 and 1109.11.
(b) Component parts. A certifier or testing party may procure tests conducted on a combination of component parts for compliance with chemical content limits so long as test procedures are followed to ensure that no failure to comply with the content limits will go undetected (see paragraph (c) of this section). Testing and certification of composite component parts for lead content must also comply with §§ 1109.5 and 1109.12. Testing and certification of composite component parts for phthalate content must also comply with §§ 1109.5 and 1109.13.
(c) How to evaluate composite testing. When using composite testing, only the total amount or percentage of the target chemical is determined, not how much was in each individual paint or component part. Therefore, to determine that each paint or component part is within the applicable limit, the entire amount of the target chemical in the composite is attributed to each paint or component part. If this method yields an amount of the target chemical that exceeds the limit applicable to any paint or component part in the composite sample, additional testing would be required to determine which of the paints or component parts, if any, fail to meet the applicable limit.
PART 1110—CERTIFICATES OF COMPLIANCE
§ 1110.1 Purpose and scope.
(a) This part 1110:
(1) Limits the entities required to provide certificates in accordance with section 14(a) of the Consumer Product Safety Act, as amended (CPSA), 15 U.S.C. 2063(a), to importers and U.S. domestic manufacturers;
(2) Specifies the content, form, and availability requirements of the CPSA that must be met for a certificate to satisfy the certificate requirements of section 14(a); and
(3) Specifies means by which an electronic certificate shall meet those requirements.
(b) This part 1110 does not address issues related to type or frequency of testing necessary to satisfy the certification requirements of CPSA section 14(a). It does not address issues related to CPSA section 14(g)(4) concerning advance filing of electronic certificates of compliance with the Commission and/or the Commissioner of Customs.
§ 1110.3 Definitions.
The following definitions apply for purposes of this part 1110.
(a) Electronic certificate means, for purposes of this part 1110, a set of information available in, and accessible by, electronic means that sets forth the information required by CPSA section 14(a) and section 14(g) and that meets the availability requirements of CPSA section 14(g)(3).
(b) Unless otherwise stated, the definitions of section 3 of the CPSA and additional definitions in the Consumer Product Safety Improvement Act of 2008 (CPSIA), Pub. L. 110-314, apply for purposes of this part 1110.
§ 1110.5 Acceptable certificates.
A certificate that is in hard copy or electronic form and complies with all applicable requirements of this part 1110 meets the certificate requirements of section 14 of the CPSA. This does not relieve the importer or domestic manufacturer from the underlying statutory requirements concerning the supporting testing and/or other bases to support certification and issuance of certificates.
§ 1110.7 Who must certify and provide a certificate.
(a) Imports. Except as otherwise provided in a specific standard, in the case of a product manufactured outside the United States, only the importer must certify in accordance with, and provide the certificate required by, CPSA section 14(a) as applicable, that the product or shipment in question complies with all applicable CPSA rules and all similar rules, bans, standards, and regulations applicable to the product or shipment under any other Act enforced by the Commission.
(b) Domestic products. Except as otherwise provided in a specific standard, in the case of a product manufactured in the United States, only the manufacturer must certify in accordance with, and provide the certificate required by, CPSA section 14(a) as applicable, that the product or shipment in question complies with all applicable CPSA rules and all similar rules, bans, standards, and regulations applicable to the product or shipment under any other Act enforced by the Commission.
(c) Availability of certificates—(1) Imports. In the case of imports, the certificate required by CPSA section 14(a) must be available to the Commission from the importer as soon as the product or shipment itself is available for inspection in the United States.
(2) Domestic products. In the case of domestic products, the certificate required by CPSA section 14(a) must be available to the Commission from the manufacturer prior to introduction of the product or shipment in question into domestic commerce.
§ 1110.9 Form of certificate.
As required by CPSA section 14(g)(2), the information on a hard copy or electronic certificate must be provided in English and may be provided in any other language.
§ 1110.11 Content of certificate.
As required by CPSA sections 14(a) and 14(g), a certificate must contain the following information:
(a) Identification of the product covered by the certificate.
(b) Citation to each CPSC product safety regulation or statutory requirement to which the product is being certified. Specifically, the certificate shall identify separately each applicable consumer product safety rule under the Consumer Product Safety Act and any similar rule, ban, standard or regulation under any other Act enforced by the Commission that is applicable to the product.
(c) Identification of the importer or domestic manufacturer certifying compliance of the product, including the importer or domestic manufacturer’s name, full mailing address, and telephone number.
(d) Contact information for the individual maintaining records of test results, including the custodian’s name, e-mail address, full mailing address, and telephone number. (CPSC suggests that each issuer maintain test records supporting the certification for at least three years as is currently required by certain consumer product specific CPSC standards, for example at 16 CFR 1508.10 for full-size baby cribs.)
(e) Date (month and year at a minimum) and place (including city and state, country, or administrative region) where the product was manufactured. If the same manufacturer operates more than one location in the same city, the street address of the factory in question should be provided.
(f) Date and place (including city and state, country or administrative region) where the product was tested for compliance with the regulation(s) cited above in subsection (b).
(g) Identification of any third-party laboratory on whose testing the certificate depends, including name, full mailing address and telephone number of the laboratory.
§ 1110.13 Availability of electronic certificate.
(a) CPSA section 14(g)(3) requires that the certificates required by section 14(a) “accompany” each product or product shipment and be “furnished” to each distributor and retailer of the product in question.
(1) An electronic certificate satisfies the “accompany” requirement if the certificate is identified by a unique identifier and can be accessed via a World Wide Web URL or other electronic means, provided the URL or other electronic means and the unique identifier are created in advance and are available, along with access to the electronic certificate itself, to the Commission or to the Customs authorities as soon as the product or shipment itself is available for inspection.
(2) An electronic certificate satisfies the “furnish” requirement if the distributor(s) and retailer(s) of the product are provided a reasonable means to access the certificate.
(b) An electronic certificate shall have a means to verify the date of its creation or last modification.
§ 1110.15 Legal responsibility for certificate information.
Any entity or entities may maintain an electronic certificate platform and may enter the requisite data. However, the entity or entities required by CPSA section 14(a) to issue the certificate remain legally responsible for the accuracy and completeness of the certificate information required by statute and its availability in timely fashion.
PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES
Subpart A—Purpose and Definitions
§ 1112.1 Purpose.
This part defines the term “third party conformity assessment body” and describes the types of third party conformity assessment bodies whose accreditations are accepted by the CPSC to test children’s products under section 14 of the CPSA. It describes the requirements and procedures for becoming a CPSC-accepted third party conformity assessment body; the audit requirement applicable to CPSC-accepted third party conformity assessment bodies; how a third party conformity assessment body may voluntarily discontinue participation as a CPSC-accepted third party conformity assessment body; the grounds and procedures for withdrawal or suspension of CPSC acceptance of the accreditation of a third party conformity assessment body; and how an individual may submit information alleging grounds for adverse action.
§ 1112.3 Definitions.
Unless otherwise stated, the definitions of section 3 of the CPSA and additional definitions in the Consumer Product Safety Improvement Act of 2008, Public Law 110-314, apply for purposes of this part. The following definitions apply for purposes of this subpart:
Accept accreditation means that the CPSC has positively disposed of an application by a third party conformity assessment body to test children’s products pursuant to a particular children’s product safety rule, for purposes of the testing required in section 14 of the CPSA.
Accreditation means a procedure by which an authoritative body gives formal recognition that a third party conformity assessment body meets competence requirements to perform specific tasks. Accreditation recognizes a third party conformity assessment body’s technical capability and is usually specific for tests of the systems, products, components, or materials for which the third party conformity assessment body claims proficiency.
Accreditation body means an entity that:
(1) Accredits or has accredited a third party conformity assessment body as meeting, at a minimum, the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Standard ISO/IEC 17025 (see § 1107.21 of this chapter for availability), “General Requirements for the Competence of Testing and Calibration Laboratories,” and any test methods or consumer product safety requirements specified in the relevant notice of requirements issued by the Commission; and
(2) Is a signatory to the International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement.
Audit means a systematic, independent, documented process for obtaining records, statements of fact, or other relevant information, and assessing them objectively to determine the extent to which specified requirements are fulfilled. An audit, for purposes of this part, consists of two parts:
(1) An examination by an accreditation body to determine whether the third party conformity assessment body meets or continues to meet the conditions for accreditation (a process known more commonly as a “reassessment”); and
(2) The resubmission of the “Consumer Product Conformity Assessment Body Acceptance Registration Form” (CPSC Form 223) and accompanying documentation by the third party conformity assessment body and the Consumer Product Safety Commission’s (CPSC’s) examination of the resubmitted CPSC Form 223 and accompanying documentation. Accompanying documentation includes the baseline documents required of all applicants in § 1112.13(a), the documents required of firewalled applicants in § 1112.13(b)(2), and/or the documents required of governmental applicants in § 1112.13(c)(2).
Commission means the body of Commissioners appointed to the Consumer Product Safety Commission.
CPSA means the Consumer Product Safety Act, 15 U.S.C. 2051-2089.
CPSC means the Consumer Product Safety Commission as an agency.
Notice of requirements means a publication that provides the minimum qualifications necessary for a third party conformity assessment body to have its accreditation accepted to test children’s products for conformity with a particular children’s product safety rule.
Quality manager means an individual (however named) who, irrespective of other duties and responsibilities, has defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times and has direct access to the highest level of management at which decisions are made on the conformity assessment body’s policy or resources.
Scope means the range of particular CPSC safety rules and/or test methods to which a third party conformity assessment body has been accredited and for which it may apply for CPSC acceptance.
Suspend means the CPSC has removed its acceptance, for purposes of the testing of children’s products required in section 14 of the CPSA, of a third party conformity assessment body’s accreditation for failure to cooperate in an investigation under this part.
Third party conformity assessment body means a laboratory.
Undue influence means that a manufacturer, private labeler, governmental entity, or other interested party affects a third party conformity assessment body, such that commercial, financial, or other pressures compromise the integrity of its testing processes or results.
Withdraw means the CPSC removes its prior acceptance of a third party conformity assessment body’s accreditation pursuant to a particular children’s product safety rule for purposes of the testing of children’s products required in section 14 of the CPSA.
Subpart B—General Requirements Pertaining to Third Party Conformity Assessment Bodies
§ 1112.11 What are the types of third party conformity assessment bodies?
(a) Independent. Independent third party conformity assessment bodies are third party conformity assessment bodies that are neither owned, managed, or controlled by a manufacturer or private labeler of a children’s product to be tested by the third party conformity assessment body, nor owned or controlled, in whole or in part, by a government;
(b) Firewalled. A third party conformity assessment body must apply for firewalled status if:
(1) It is owned, managed, or controlled by a manufacturer or private labeler of a children’s product;
(i) For purposes of determining whether a third party conformity assessment body is firewalled, “manufacturer” includes a trade association.
(ii) A manufacturer or private labeler is considered to own, manage, or control a third party conformity assessment body if any one of the following characteristics applies:
(A) The manufacturer or private labeler of the children’s product holds a 10 percent or greater ownership interest, whether direct or indirect, in the third party conformity assessment body. Indirect ownership interest is calculated by successive multiplication of the ownership percentages for each link in the ownership chain;
(B) The third party conformity assessment body and a manufacturer or private labeler of the children’s product are owned by a common “parent” entity; or
(C) A manufacturer or private labeler of the children’s product has the ability to appoint any of the third party conformity assessment body’s senior internal governing body (such as, but not limited to, a board of directors), the ability to appoint the presiding official (such as, but not limited to, the chair or president) of the third party conformity assessment body’s senior internal governing body, the ability to hire, dismiss, or set the compensation level for third party conformity assessment body personnel, regardless of whether this ability is ever exercised;
(2) The children’s product is subject to a CPSC children’s product safety rule that the third party conformity assessment body requests CPSC acceptance to test; and
(3) The third party conformity assessment body intends to test such children’s product made by the owning, managing, or controlling entity for the purpose of supporting a Children’s Product Certificate.
(c) Governmental. Governmental third party conformity assessment bodies are owned or controlled, in whole or in part, by a government. For purposes of this part, “government” includes any unit of a national, territorial, provincial, regional, state, tribal, or local government, and a union or association of sovereign states. “Government” also includes domestic, as well as foreign entities. A third party conformity assessment body is “owned or controlled, in whole or in part, by a government” if any one of the following characteristics applies:
(1) A governmental entity holds a 1 percent or greater ownership interest, whether direct or indirect, in the third party conformity assessment body. Indirect ownership interest is calculated by successive multiplication of the ownership percentages for each link in the ownership chain;
(2) A governmental entity provides any direct financial investment or funding (other than fee for work);
(3) A governmental entity has the ability to appoint a majority of the third party conformity assessment body’s senior internal governing body (such as, but not limited to, a board of directors); the ability to appoint the presiding official of the third party conformity assessment body’s senior internal governing body (such as, but not limited to, chair or president); and/or the ability to hire, dismiss, or set the compensation level for third party conformity assessment body personnel;
(4) Third party conformity assessment body management or technical personnel include any government employees;
(5) The third party conformity assessment body has a subordinate position to a governmental entity in its external organizational structure (not including its relationship as a regulated entity to a government regulator); or
(6) Apart from its role as regulator, the government can determine, establish, alter, or otherwise affect:
(i) The third party conformity assessment body’s testing outcomes;
(ii) The third party conformity assessment body’s budget or financial decisions;
(iii) Whether the third party conformity assessment body may accept particular offers of work; or
(iv) The third party conformity assessment body’s organizational structure or continued existence.
§ 1112.13 How does a third party conformity assessment body apply for CPSC acceptance?
(a) Baseline Requirements. Each third party conformity assessment body seeking CPSC acceptance must:
(1) Submit a completed Consumer Product Conformity Assessment Body Registration Form (CPSC Form 223 or Application). In submitting a CPSC Form 223, the third party conformity assessment body must attest to facts and characteristics about its business that will determine whether the third party conformity assessment body is independent, firewalled, or governmental. The third party conformity assessment body also must attest that it has read, understood, and agrees to the regulations in this part. The third party conformity assessment body must update its CPSC Form 223 whenever any information previously supplied on the form changes.
(2) Submit the following documentation.
(i) Accreditation certificate. (A) The third party conformity assessment body must be accredited to the ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories.”
(B) The accreditation must be by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement (ILAC-MRA).
(ii) Statement of scope. The third party conformity assessment body’s accreditation must include a statement of scope that clearly identifies each CPSC rule and/or test method for which CPSC acceptance is sought. Although a third party conformity assessment body may include more than one CPSC rule and/or test method in its scope in one application, it must submit a new application if the CPSC has already accepted the third party conformity assessment body for a particular scope, and the third party conformity assessment body wishes to expand its acceptance to include additional CPSC rules and/or test methods.
(b) Additional Requirements for Firewalled Third Party Conformity Assessment Bodies. (1) A third party conformity assessment body may be accepted as a firewalled third party conformity assessment body if the Commission, by order, makes the findings described in § 1112.17(b).
(2) For the Commission to evaluate whether an applicant firewalled third party conformity assessment body satisfies the criteria listed in § 1112.17(b), and in addition to the baseline accreditation requirements in paragraph (a) of this section, a firewalled third party conformity assessment body applying for acceptance of its accreditation must submit copies of:
(i) The third party conformity assessment body’s established policies and procedures that explain:
(A) How the third party conformity assessment body will protect its test results from undue influence by the manufacturer, private labeler, or other interested party;
(B) That the CPSC will be notified immediately of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over the third party conformity assessment body’s test results; and
(C) That allegations of undue influence may be reported confidentially to the CPSC;
(ii) Training documents, including a description of the training program content, showing how employees are trained annually on the policies and procedures described in paragraph (b)(2)(i) of this section;
(iii) Training records, including a list and corresponding signatures, of the staff members who received the training identified in paragraph (b)(2)(ii) of this section. The records must include training dates, location, and the name and title of the individual providing the training;
(iv) An organizational chart(s) of the third party conformity assessment body that includes the names of all third party conformity assessment body personnel, both temporary and permanent, and their reporting relationship within the third party conformity assessment body;
(v) An organizational chart(s) of the broader organization that identifies the reporting relationships of the third party conformity assessment body within the broader organization (using both position titles and staff names); and
(vi) A list of all third party conformity assessment body personnel with reporting relationships outside of the third party conformity assessment body. The list must identify the name and title of the relevant third party conformity assessment body employee(s) and the names, titles, and employer(s) of all individuals outside of the third party conformity assessment body to whom they report;
(c) Additional Requirements for Governmental Third Party Conformity Assessment Bodies. (1) The CPSC may accept a governmental third party conformity assessment body if the CPSC determines that:
(i) To the extent practicable, manufacturers or private labelers located in any nation are permitted to choose third party conformity assessment bodies that are not owned or controlled by the government of that nation;
(ii) The third party conformity assessment body’s testing results are not subject to undue influence by any other person, including another governmental entity;
(iii) The third party conformity assessment body is not accorded more favorable treatment than other third party conformity assessment bodies in the same nation who have been accredited;
(iv) The third party conformity assessment body’s testing results are accorded no greater weight by other governmental authorities than those of other accredited third party conformity assessment bodies; and
(v) The third party conformity assessment body does not exercise undue influence over other governmental authorities on matters affecting its operations or on decisions by other governmental authorities controlling distribution of products based on outcomes of the third party conformity assessment body’s conformity assessments.
(2) For the CPSC to evaluate whether a governmental third party conformity assessment body satisfies the criteria listed in paragraph (c)(1) of this section, and in addition to the baseline accreditation requirements in paragraph (a) of this section, a governmental third party conformity assessment body seeking CPSC-accepted status must submit:
(i) Description. A description illustrating the relationships with other entities, such as government agencies and joint ventures partners. The description may be in the form of a diagram;
(ii) Responses to questionnaires. The CPSC will provide a governmental third party conformity assessment body applicant with a questionnaire and will provide a separate questionnaire to the affiliated governmental entity;
(iii) Executed memorandum. A copy of an executed memorandum addressing undue influence;
(A) The memorandum must be:
(1) Addressed to all staff of the third party conformity assessment body;
(2) On company letterhead;
(3) From senior management of the third party conformity assessment body;
(4) In the primary written language used for business communication in the area where the third party conformity assessment body is located; if that language is different than English, an English translation of the executed memorandum must also be provided to the CPSC;
(5) Displayed prominently for staff reference for as long as the accreditation of the third party conformity assessment body whose accreditation is accepted by the CPSC; and
(B) The memorandum must state that:
(1) The policy of the laboratory is to reject undue influence by any manufacturer, private labeler, governmental entity, or other interested party, regardless of that person or entity’s affiliation with any organization;
(2) Employees are required to report immediately to their supervisor or any other official designated by the third party conformity assessment body about any attempts to gain undue influence; and
(3) The third party conformity assessment body will not tolerate violations of the undue influence policy.
(iv) Attestation. A senior officer of the governmental third party conformity assessment body, who has the authority to make binding statements of policy on behalf of the third party conformity assessment body, must attest to the following:
(A) The third party conformity assessment body seeks acceptance as a governmental third party conformity assessment body under the CPSC’s program of requirements for the testing of children’s products;
(B) The official intends the attestation to be considered in support of any and all applications made by this third party conformity assessment body for acceptance of its accreditation by the CPSC, including future applications related to additional CPSC rules and/or test methods;
(C) The attestation, and any other document submitted in support of the application, is accurate in its representation of current conditions or policies at the third party conformity assessment body, to the best of the official’s knowledge, information, and/or belief. The information in the attestation, and any other document submitted in support of the application, will be understood by the CPSC as continuing in its accuracy in every respect, until and unless notice of its revocation by an authorized officer of the third party conformity assessment body is received by the CPSC. The official understands that acceptance by the CPSC carries with it the obligation to comply with this part, in order to remain on the CPSC’s list of accepted third party conformity assessment bodies. The attestation is submitted as a condition of acceptance of this laboratory as a governmental third party conformity assessment body by the CPSC.
(D) The word “government” in the attestation refers to any government (central, provincial, municipal, or other) in this third party conformity assessment body’s country or administrative area and includes state-owned entities, even if those entities do not carry out governmental functions.
(E) With regard to consumer products to be distributed in commerce in the United States and subject to CPSC third party testing requirements, the third party conformity assessment body does not receive, and will not accept from any governmental entity, treatment that is more favorable than that received by other third party conformity assessment bodies in the same country or administrative area, which have been accepted as accredited for third party testing by the CPSC. More favorable treatment for a governmental third party conformity assessment body includes, but is not limited to, authorization to perform essential export-related functions, while competing CPSC-accepted laboratories in the same country or administrative area are not permitted to perform those same functions.
(F) With regard to consumer products to be sold in the United States and subject to CPSC third party testing requirements, the third party conformity assessment body’s testing results are not accorded greater weight by any governmental entity that may be evaluating such results for export control purposes, compared to other third party conformity assessment bodies in the same country or administrative area, which have been accepted as accredited for third party testing by the CPSC.
(G) The third party conformity assessment body has an expressed policy, known to its employees, that forbids attempts at undue influence over any government authorities on matters affecting its operations.
(H) When a governmental third party conformity assessment body is owned or controlled by a governmental entity that also has any ownership or control over consumer product production, the senior officer of the applicant third party conformity assessment body must attest that the third party conformity assessment body will not conduct CPSC tests in support of a Children’s Product Certificate for products for export to the United States that have been produced by an entity in which that governmental entity holds such ownership or control until it has applied for and been accepted by the Commission as, a dual governmental-firewalled third party conformity assessment body.
(v) Governmental entity attestation. In the event that the CPSC determines that its ability to accept a governmental third party conformity assessment body’s application is dependent upon a recently changed circumstance in the relationship between the third party conformity assessment body and a governmental entity, and/or a recently changed policy of the related governmental entity, the CPSC may require the relevant governmental entity to attest to the details of the new relationship or policy.
(d) Dual firewalled and governmental status. A third party conformity assessment body that meets both the firewalled and the governmental criteria must submit applications under both firewalled and governmental categories.
(e) English language. All application materials must be in English.
(f) Electronic submission. The CPSC Form 223 and all accompanying documentation must be submitted electronically via the CPSC Web site.
(g) Clarification and verification. The CPSC may require additional information to determine whether the third party conformity assessment body meets the relevant criteria. In addition, the CPSC may verify accreditation certificate and scope information directly from the accreditation body before approving an application.
(h) Retraction of application. A third party conformity assessment body may retract a submitted CPSC Form 223 any time before the CPSC has acted on the submission. A retraction will not end or nullify any enforcement action that the CPSC is otherwise authorized by law to pursue.
(i) Incorporation by reference. The Director of the Federal Register approves the incorporation by reference in paragraph (a)(2)(i) of this section in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of ISO/IEC 17025:2017(E), “Requirements for the competence of testing and calibration laboratories,” approved November 10, 2021 from the International Organization for Standardization (ISO), ISO Central Secretariat Chemin de Blandonnet 8 CP 401-1214 Vernier, Geneva, Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 30; http://www.iso.org/iso/home.htm. You may inspect a copy at the Division of the Secretariat, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone (301) 504-7479, email: [email protected], or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
§ 1112.15 When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule or test method?
(a) Once the CPSC publishes the requirements for accreditation to a particular CPSC rule or test method, a third party conformity assessment body may apply to the CPSC for acceptance to that scope of accreditation. An application may be made for acceptance of accreditation to more than one CPSC rule or test method. Once accepted by the CPSC, a third party conformity assessment body may apply at any time to expand the scope of its acceptance to include additional CPSC rules or test methods. A third party conformity assessment body may only issue test results for purposes of section 14 of the CPSA that fall within a scope for which the CPSC has accepted the third party conformity assessment body’s accreditation.
(b) The CPSC has published the requirements for accreditation for third party conformity assessment bodies to assess conformity for the following CPSC rules or test methods:
(1) 16 CFR part 1203, Safety Standard for Bicycle Helmets;
(2) 16 CFR part 1215, Safety Standard for Infant Bath Seats;
(3) 16 CFR part 1216, Safety Standard for Infant Walkers;
(4) 16 CFR part 1217, Safety Standard for Toddler Beds;
(5) 16 CFR part 1219, Safety Standard for Full-Size Baby Cribs;
(6) 16 CFR part 1220, Safety Standard for Non-Full-Size Baby Cribs;
(7) 16 CFR part 1221, Safety Standard for Play Yards;
(8) 16 CFR part 1223, Safety Standard for Infant Swings;
(9) 16 CFR part 1224, Safety Standard for Portable Bed Rails;
(10) 16 CFR part 1303, Ban of Lead-Containing Paint and Certain Consumer Products Bearing Lead-Containing Paint. For its accreditation to be accepted by the Commission to test to 16 CFR part 1303, a third party conformity assessment body must have one or more of the following test methods referenced in its statement of scope:
(i) CPSC Standard Operating Procedure for Determining Lead (Pb) in Paint and Other Similar Surface Coatings, CPSC-CH-E1003-09;
(ii) CPSC Standard Operating Procedure for Determining Lead (Pb) in Paint and Other Similar Surface Coatings, CPSC-CH-E1003-09.1;
(iii) ASTM F2853-10, “Standard Test Method for Determination of Lead in Paint Layers and Similar Coatings or in Substrates and Homogenous Materials by Energy Dispersive X-Ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams.”
(11) 16 CFR part 1420, Safety Standard for All-Terrain Vehicles;
(12) 16 CFR 1500.86(a)(5), Exceptions from Classification as a Banned Toy or Other Banned Article for Use by Children (Clacker Balls);
(13) 16 CFR 1500.86(a)(7) and (8), Exceptions from Classification as a Banned Toy or Other Banned Article for Use by Children (Dive Sticks and Similar Articles);
(14) 16 CFR part 1501, Method for Identifying Toys and Other Articles Intended for Use by Children Under 3 Years of Age Which Present Choking, Aspiration, or Ingestion Hazards Because of Small Parts;
(15) 16 CFR part 1505, Requirements for Electrically Operated Toys or Other Electrically Operated Articles Intended for Use by Children;
(16) 16 CFR part 1510, Requirements for Rattles;
(17) 16 CFR part 1511, Requirements for Pacifiers;
(18) 16 CFR part 1512, Requirements for Bicycles;
(19) 16 CFR part 1513, Requirements for Bunk Beds;
(20) 16 CFR part 1610, Standard for the Flammability of Clothing Textiles;
(21) 16 CFR part 1611, Standard for the Flammability of Vinyl Plastic Film;
(22) 16 CFR part 1615, Standard for the Flammability of Children’s Sleepwear: Sizes 0 Through 6X (FF 3-71);
(23) 16 CFR part 1616, Standard for the Flammability of Children’s Sleepwear: Sizes 7 Through 14 (FF 5-74);
(24) 16 CFR part 1630, Standard for the Surface Flammability of Carpets and Rugs (FF 1-70);
(25) 16 CFR part 1631, Standard for the Surface Flammability of Small Carpets and Rugs (FF 2-70);
(26) 16 CFR part 1632, Standard for the Flammability of Mattresses and Mattress Pads (FF 4-72, amended);
(27) 16 CFR part 1633, Standard for the Flammability (Open Flame) of Mattress Sets;
(28) Lead Content in Children’s Metal Jewelry. For its accreditation to be accepted by the Commission to test for lead content in children’s metal jewelry, a third party conformity assessment body must have one or more of the following test methods referenced in its statement of scope:
(i) CPSC Test Method CPSC-CH-E1001-08, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”;
(ii) CPSC Test Method CPSC-CH-E1001-08.1, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”;
(iii) CPSC Test Method CPSC-CH-E1001-08.2, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”;
(iv) CPSC Test Method CPSC-CH-E1001-08.3, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”;
(v) Section I, “Screening Test for Total Pb Analysis,” from CPSC “Standard Operating Procedure for Determining Lead (Pb) and its Availability in Children’s Metal Jewelry,” February 3, 2005;
(29) Limits on Total Lead in Children’s Products: Children’s Metal Products. For its accreditation to be accepted by the Commission to test for total lead content in children’s metal products, a third party conformity assessment body must have one or more of the following test methods referenced in its statement of scope:
(i) CPSC Test Method CPSC-CH-E1001-08, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”;
(ii) CPSC Test Method CPSC-CH-E1001-08.1, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”;
(iii) CPSC Test Method CPSC-CH-E1001-08.2, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”;
(iv) CPSC Test Method CPSC-CH-E1001-08.3, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”;
(30) Limits on Total Lead in Children’s Products: Nonmetal Children’s Products. For its accreditation to be accepted by the Commission to test for lead content in nonmetal children’s products, a third party conformity assessment body must have one or more of the following test methods referenced in its statement of scope:
(i) CPSC Test Method CPSC-CH-E1002-08, “Standard Operating Procedure for Determining Total Lead (Pb) in Nonmetal Children’s Products”;
(ii) CPSC Test Method CPSC-CH-E1002-08.1, “Standard Operating Procedure for Determining Total Lead (Pb) in Nonmetal Children’s Products”;
(iii) CPSC Test Method CPSC-CH-E1002-08.2, “Standard Operating Procedure for Determining Total Lead (Pb) in Nonmetal Children’s Products”;
(iv) CPSC Test Method CPSC-CH-E1002-08.3, “Standard Operating Procedure for Determining Total Lead (Pb) in Nonmetal Children’s Products”;
(31) 16 CFR part 1307, Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates. For its accreditation to be accepted by the Commission to test for phthalates in children’s toys and child care articles, a third party conformity assessment body must have one or more of the following test methods referenced in its statement of scope:
(i) CPSC Test Method CPSC-CH-C1001-09.4, “Standard Operating Procedure for Determination of Phthalates”;
(ii) GB/T 22048-2008, “Toys and Children’s Products—Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic”;
(32) 16 CFR part 1250, safety standard for toys. CPSC only requires certain provisions of ASTM F963-23 to be subject to third party testing; therefore, CPSC only accepts the accreditation of third-party conformity assessment bodies for testing under the following toy safety standards:
(i) [Reserved]
(ii) ASTM F963-23:
(A) Section 4.3.5.1(2), Surface Coating Materials—Soluble Test for Metals
(B) Section 4.3.5.2, Toy Substrate Materials
(C) Section 4.3.6, Cleanliness of Liquids, Pastes, Putties, Gels, and Powders, and Items of Avian Feather Origin (except for cosmetics and tests on formulations used to prevent microbial degradation).
(D) Section 4.3.7, Stuffing Materials
(E) Section 4.5, Sound Producing Toys
(F) Section 4.6, Small Objects (except labeling and/or instructional literature requirements)
(G) Section 4.7, Accessible Edges (except labeling and/or instructional literature equirements)
(H) Section 4.8, Projections (except bath toy projections)
(I) Section 4.9, Accessible Points (except labeling and/or instructional literature requirements)
(J) Section 4.10, Wires or Rods
(K) Section 4.11, Nails and Fasteners
(L) Section 4.12, Plastic Film
(M) Section 4.13, Folding Mechanisms and Hinges
(N) Section 4.14, Cords, Straps, and Elastics
(O) Section 4.15, Stability and Overload Requirements
(P) Section 4.16, Confined Spaces
(Q) Section 4.17, Wheels, Tires, and Axles
(R) Section 4.18, Holes, Clearances, and Accessibility of Mechanisms
(S) Section 4.19, Simulated Protective Devices (except labeling and/or instructional literature requirements)
(T) Section 4.20.1, Pacifiers with Rubber Nipples/Nitrosamine Test
(U) Section 4.20.2, Toy Pacifiers
(V) Section 4.21, Projectile Toys
(W) Section 4.22, Teethers and Teething Toys
(X) Section 4.23.1, Rattles with Nearly Spherical, Hemispherical, or Circular Flared Ends
(Y) Section 4.24, Squeeze Toys
(Z) Section 4.25, Battery-Operated Toys (except labeling and/or instructional literature requirements)
(AA) Section 4.26, Toys Intended to Be Attached to a Crib or Playpen (except labeling and/or instructional literature requirements)
(BB) Section 4.27, Stuffed and Beanbag-Type Toys
(CC) Section 4.30, Toy Gun Marking
(DD) Section 4.32, Certain Toys with Nearly Spherical Ends
(EE) Section 4.35, Pompoms
(FF) Section 4.36, Hemispheric-Shaped Objects
(GG) Section 4.37, Yo-Yo Elastic Tether Toys
(HH) Section 4.38, Magnets (except labeling and/or instructional literature requirements)
(II) Section 4.39, Jaw Entrapment in Handles and Steering Wheels
(JJ) Section 4.40, Expanding Materials
(KK) Section 4.41, Toy Chests (except labeling and/or instructional literature requirements)
(33) 16 CFR part 1218, Safety Standard for Bassinets and Cradles.
(34) 16 CFR part 1225, Safety Standard for Hand-Held Infant Carriers.
(35) 16 CFR part 1222, Safety Standard for Bedside Sleepers.
(36) 16 CFR part 1227, Safety Standard for Carriages and Strollers.
(37) 16 CFR part 1226, Safety Standard for Soft Infant and Toddler Carriers.
(38) 16 CFR part 1230, Safety Standard for Frame Child Carriers.
(39) 16 CFR part 1228, Safety Standard for Sling Carriers.
(40) 16 CFR part 1233, Safety Standard for Portable Hook-On Chairs.
(41) 16 CFR part 1234, Safety Standard for Infant Bath Tubs.
(42) 16 CFR part 1229, Safety Standard for Infant Bouncer Seats.
(43) 16 CFR part 1232, Safety Standard for Children’s Folding Chairs and Children’s Folding Stools.
(44) 16 CFR part 1231, Safety Standard for High Chairs.
(45) 16 CFR part 1235, Safety Standard for Baby Changing Products.
(46) 16 CFR part 1236, Safety Standard for Infant Sleep Products.
(47) 16 CFR part 1237, Safety Standard for Booster Seats.
(48) 16 CFR part 1238, Safety Standard for Stationary Activity Centers.
(49) 16 CFR part 1239, Safety Standard for Gates and Enclosures.
(50) 16 CFR part 1241, Safety Standard for Crib Mattresses.
(51) [Reserved]
(52) 16 CFR part 1262, Safety Standard for Magnets.
(53) 16 CFR part 1260, Safety Standard for Operating Cords on Custom Window Coverings.
(54) 16 CFR part 1261, Safety Standard for Clothing Storage Units.
(55) 16 CFR part 1263, Safety Standard for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries.
(c) The Director of the Federal Register approves the incorporations by reference in paragraph (b) of this section in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy of the standards incorporated in this section at the Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(1) ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428: http://www.astm.org.
(i) ASTM F2853-10, “Standard Test Method for Determination of Lead in Paint Layers and Similar Coatings or in Substrates and Homogenous Materials by Energy Dispersive X-Ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams,” July 1, 2010;
(ii) ASTM F963-23, “Standard Consumer Safety Specification for Toy Safety,” August 1, 2023.
(2) Code of China, Room 2118, New Fortune International Plaza, No.71 Chaoyang Road, Chaoyang District, Beijing, 100123, China: http://www.codeofchina.com/.
(i) GB/T 22048-2008, National Standard of the People’s Republic of China, “Toys and Children’s Products—Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic,” June 18, 2008;
(ii) [Reserved]
(3) CPSC National Product Testing and Evaluation Center, 5 Research Place, Rockville, MD 20850; www.cpsc.gov.
(i) CPSC-CH-C1001-9.4, “Standard Operating Procedure for Determination of Phthalates”, January 17, 2018;
(ii) CPSC-CH-E1001-08, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry)”, December 4, 2008;
(iii) CPSC-CH-E1001-08.1, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry), Revision”, June 21, 2010;
(iv) CPSC-CH-E1001-08.2, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry), Revision”, April 10, 2012;
(v) CPSC-CH-E1001-08.3, “Standard Operating Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including Children’s Metal Jewelry) Revision”, November 15, 2012;
(vi) CPSC-CH-E1002-08, “Standard Operating Procedure for Determining Total Lead (Pb) in Non-metal Children’s Products”, February 1, 2009;
(vii) CPSC-CH-E1002-08.1, “Standard Operating Procedure for Determining Total Lead (Pb) in Non-metal Children’s Products, Revised”, June 21, 2010;
(viii) CPSC-CH-E1002-08.2, “Standard Operating Procedure for Determining Total Lead (Pb) in Nonmetal Children’s Products, Revision”, April 10, 2012;
(ix) CPSC-CH-E1002-08.3, “Standard Operating Procedure for Determining Total Lead (Pb) in Non-metal Children’s Products, Revision”, November 15, 2012;
(x) CPSC-CH-E1003-09, “Standard Operating Procedure for Determining Lead (Pb) in Paint and Other Similar Surface Coatings”, April 26, 2009;
(xi) CPSC-CH-E1003-09.1, “Standard Operating Procedure for Determining Lead (Pb) in Paint and Other Similar Surface Coatings”, February 25, 2011;
(xii) CPSC “Standard Operating Procedure for Determining Lead (Pb) and its Availability in Children’s Metal Jewelry”, February 3, 2005.
§ 1112.17 How will the CPSC respond to each application?
(a) The CPSC staff will review each application and may contact the third party conformity assessment body with questions or to request submission of missing information.
(b) The application of a firewalled third party conformity assessment body will be accepted by order of the Commission, if the Commission finds that:
(1) Acceptance of the accreditation of the third party conformity assessment body would provide equal or greater consumer safety protection than the manufacturer’s or private labeler’s use of an independent third party third party conformity assessment body; and
(2) The third party conformity assessment body has established procedures to ensure that:
(i) Its test results are protected from undue influence by the manufacturer, private labeler, or other interested party;
(ii) The CPSC is notified immediately of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over test results; and
(iii) Allegations of undue influence may be reported confidentially to the CPSC.
(c) The CPSC will communicate its decision on each application in writing to the applicant, which may be by electronic mail.
§ 1112.19 How does the CPSC publish information identifying third party conformity assessment bodies that have been accepted?
The CPSC will maintain on its Web site an up-to-date listing of third party conformity assessment bodies whose accreditations it has accepted and the scope of each acceptance. The CPSC will update the listing regularly to account for changes, such as the addition of new CPSC rules and/or test methods to its scope of accreditation, changes to accreditation certificates, new addresses, as well as changes to the status of a third party conformity assessment body due to voluntary discontinuance, suspension, and/or withdrawal. The CPSC will also list the firewalled or governmental status of accepted laboratories on the CPSC Web site.
§ 1112.21 May a third party conformity assessment body use testing methods other than those specified in the relevant CPSC rule or test method?
If the CPSC has specified a test method, a third party conformity assessment body must use that test method for any tests conducted for purposes of section 14 of the CPSA.
§ 1112.23 May a CSPC-accepted third party conformity assessment body subcontract work conducted for purposes of section 14 of the CPSA?
(a) A CPSC-accepted third party conformity assessment body (which, for purposes of this section, also will be referred to as the prime contractor) may only subcontract work conducted for purposes of section 14 of the CPSA to other third party conformity assessment bodies whose accreditation has been accepted by the CPSC for the scope necessary for the subcontracted work. Violation of this provision constitutes compromising the integrity of the testing process and may be grounds for withdrawal of the CPSC’s acceptance of the accreditation of the prime and/or subcontracting third party conformity assessment body.
(b) The provisions of this part apply to all CPSC-accepted third party conformity assessment bodies, even if they are a prime contractor and/or a subcontractor.
§ 1112.25 What are a third party conformity assessment body’s recordkeeping responsibilities?
(a) The third party conformity assessment body must maintain the following records, which must be legible:
(1) All test reports and technical records related to tests conducted for purposes of section 14 of the CPSA must be maintained for a period of at least five years from the date the test was conducted;
(2) In the case of a test report for a test conducted by a CPSC-accepted third party conformity assessment body acting as a subcontractor, the prime contractor’s test report must clearly identify which test(s) was performed by a CPSC-accepted third party conformity assessment body acting as a subcontractor(s), and the test report from the CPSC-accepted third party conformity assessment body acting as a subcontractor must be available upon request by CPSC.
(3) Where a report, for purposes of section 14 of the CPSA, provided by the third party conformity assessment body to a customer is different from the test record, the third party conformity assessment body also must retain the report provided to the customer for a period of at least five years from the date the test was conducted.
(4) Any and all third party conformity assessment body internal documents describing testing protocols and procedures (such as instructions, standards, manuals, guides, and reference data) that have applied to a test conducted for purposes of section 14 of the CPSA must be retained for a period of at least five years from the date such test was conducted.
(b) Upon request by the CPSC, the third party conformity assessment body must make any and all of the records required by this section available for inspection, either in hard copy or electronically, such as through an Internet Web site. If the records are not in the English language, the third party conformity assessment body must make copies of the original (non-English language) available to the CPSC within 48 hours, and they must make an English translation of the records available to the CPSC within 30 calendar days of the date the CPSC requested an English translation.
A third party conformity assessment body, as a condition of the continued CPSC-acceptance of its accreditation, must allow an officer or employee duly designated by the CPSC to enter and inspect the third party conformity assessment body for purposes of an investigation under this part. The CPSC will conduct such inspections in accordance with 16 CFR 1118.2. Failure to cooperate with such an inspection constitutes failure to cooperate with an investigation and is grounds for suspension under § 1112.45.
§ 1112.29 How does a third party conformity assessment body voluntarily discontinue its participation with the CPSC?
(a) A third party conformity assessment body may voluntarily discontinue participation as a CPSC-accepted third party conformity assessment body at any time and for any portion of its scope that is accepted by the CPSC. The third party conformity assessment body must notify the CPSC, in writing, which may be electronic. The notice must include:
(1) Name, address, phone number, electronic mail address for the third party conformity assessment body and the person responsible for submitting the request;
(2) Scope of the discontinuance;
(3) Beginning date for the discontinuance;
(4) Statement that the third party conformity assessment body understands that it must reapply for acceptance of the accreditation scope for which it is requesting discontinuance; and
(5) Verification that the person requesting the discontinuance has the authority to make such a request on behalf of the third party conformity assessment body.
(b) The CPSC may verify the information submitted in a notice of voluntary discontinuance.
(c) Upon receipt of a notice from a third party conformity assessment body that it wishes to discontinue voluntarily as a CPSC-accepted third party conformity assessment body, or after verifying the information in a notice, the CPSC will update its Web site to indicate that the CPSC no longer accepts the accreditation of the third party conformity assessment body for the scope indicated, as of the date provided in the notice.
(d) Notwithstanding a third party conformity assessment body’s voluntary discontinuance as a CPSC-accepted third party conformity assessment body, the CPSC may begin or continue an investigation related to an adverse action under this part, or other legal action.
Subpart C—Audit Requirements for Third Party Conformity Assessment Bodies
§ 1112.30 What is the purpose of this subpart?
This subpart establishes the audit requirements for third party conformity assessment bodies pursuant to section 14(i)(1) of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2063(i)(1)). Compliance with these requirements is a condition of the continuing accreditation of such third party conformity assessment bodies pursuant to section 14(a)(3)(C) of the CPSA. However, this subpart does not apply to certifying organizations under the Labeling of Hazardous Art Materials Act, even if such organizations are third party conformity assessment bodies.
§ 1112.31 Who is subject to these audit requirements?
Except for certifying organizations described in 16 CFR 1500.14(b)(8), these audit requirements apply to third party conformity assessment bodies operating pursuant to section 14(a)(2) of the CPSA. Third party conformity assessment bodies must comply with the audit requirements as a continuing condition of the CPSC’s acceptance of their accreditation.
§ 1112.33 What must an audit address or cover and who conducts the audit?
(a) The reassessment portion of an audit must cover management requirements and technical requirements. Each reassessment portion of an audit also must examine the third party conformity assessment body’s management systems to ensure that the third party conformity assessment body is free from any undue influence regarding its technical judgment.
(b) The third party conformity assessment body must have the reassessment portion of the audit conducted by the same accreditation body that accredited the third party conformity assessment body. For example, if a third party conformity assessment body was accredited by an accreditation body named AB-1, then AB-1 would conduct the reassessment. If, however, the same third party conformity assessment body changes its accreditation so that it becomes accredited by a different accreditation body named AB-2, then AB-2 would conduct the reassessment.
(c) The third party conformity assessment body must have the examination portion of the audit conducted by the CPSC. The examination portion of the audit will consist of resubmission of the “Consumer Product Conformity Assessment Body Acceptance Registration Form” (CPSC Form 223) by the third party conformity assessment body and the CPSC’s examination of the resubmitted CPSC Form 223.
(1) For “firewalled” conformity assessment bodies, the CPSC’s examination may include verification to ensure that the “firewalled” conformity assessment body continues to meet the criteria set forth in section 14(f)(2)(D) of the CPSA.
(2) For government-owned or government-controlled conformity assessment bodies, the CPSC’s examination may include verification to ensure that the government-owned or government-controlled conformity assessment body continues to meet the criteria set forth in section 14(f)(2)(B) of the CPSA.
§ 1112.35 When must an audit be conducted?
(a) At a minimum, each third party conformity assessment body must be reassessed at the frequency established by its accreditation body.
(b) For the examination portion of the audit, which is conducted by the CPSC:
(1) Each third party conformity assessment body must submit a CPSC Form 223 for audit purposes no less than every two years. When a CPSC Form 223 is submitted for audit purposes, the third party conformity assessment body must submit any accompanying documentation that would be required if it were a new application.
(2) Under § 1112.13(a)(1), a third party conformity assessment body must submit a new CPSC Form 223 whenever the information supplied on the form changes. In the event that the third party conformity assessment body submits a new CPSC Form 223 to provide updated information, the third party conformity assessment body may elect to have the new CPSC Form 223 satisfy the requirement of paragraph (b)(1) of this section. If the third party conformity assessment body intends to have the new CPSC Form 223 treated as its submission for audit purposes, the third party conformity assessment body must make that intention clear upon submission, and it must submit any accompanying documentation that would be required if it were a new application.
(3) At least 30 days prior to the date by which a third party conformity assessment body must submit a CPSC Form 223 for audit purposes, the CPSC will notify the body in writing, which may be electronic, of the impending audit deadline. A third party conformity assessment body may request an extension of the deadline for the examination portion of the audit, but it must indicate how much additional time is requested and explain why such an extension is warranted. The CPSC will notify the third party conformity assessment body whether its request for an extension has been granted.
§ 1112.37 What must a third party conformity assessment body do after an audit?
(a) When the accreditation body presents its findings to the third party conformity assessment body, the third party conformity assessment body’s quality manager must receive the findings and, if necessary, initiate corrective action in response to the findings.
(b) The quality manager must prepare a resolution report identifying the corrective actions taken and any follow-up activities. If findings indicate that immediate corrective action is necessary, the quality manager must document that they notified the relevant parties within the third party conformity assessment body to take immediate corrective action and also document the action(s) taken.
(c) If the accreditation body decides to reduce, suspend, or withdraw the third party conformity assessment body’s accreditation, and the reduction, suspension, or withdrawal of accreditation is relevant to the third party conformity assessment body’s activities pertaining to a CPSC regulation or test method, the quality manager must notify the CPSC. Such notification must be sent to the Assistant Executive Director, Office of Hazard Identification and Reduction, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, within five business days of the accreditation body’s notification to the third party conformity assessment body.
(d) If the CPSC finds that the third party conformity assessment body no longer meets the conditions specified in CPSC Form 223, or in the relevant statutory provisions applicable to that third party conformity assessment body, the CPSC will notify the third party conformity assessment body, identify the condition or statutory provision that is no longer met, and specify a time by which the third party conformity assessment body shall notify the CPSC of the steps it intends to take to correct the deficiency, and indicate when it will complete such steps. The quality manager must document that they notified the relevant parties within the third party conformity assessment body to take corrective action and also document the action(s) taken.
(e) If the third party conformity assessment body fails to remedy the deficiency in a timely fashion, the CPSC shall take whatever action it deems appropriate under the circumstances, up to and including withdrawing the CPSC’s accreditation of the third party conformity assessment body or the CPSC’s acceptance of the third party conformity assessment body’s accreditation.
§ 1112.39 What records should a third party conformity assessment body retain regarding an audit?
A third party conformity assessment body must retain all records related to an audit that it receives from an accreditation body regarding a reassessment and all records pertaining to the third party conformity assessment body’s resolution of, or plans for, resolving nonconformities identified through a reassessment by an accreditation body or through an examination by the CPSC. A third party conformity assessment body also must retain such records related to the last three reassessments (or however many reassessments have been conducted, if the third party conformity assessment body has been reassessed less than three times) and make such records available to the CPSC, upon request.
Subpart D—Adverse Actions: Types, Grounds, Allegations, Procedural Requirements, and Publication
§ 1112.41 What are the possible adverse actions the CPSC may take against a third party conformity assessment body?
(a) Potential adverse actions against a third party conformity assessment body include:
(1) Denial of Acceptance of Accreditation;
(2) Suspension of Acceptance of Accreditation; or
(3) Withdrawal of Acceptance of Accreditation.
(b) Withdrawal of acceptance of accreditation can be on a temporary or permanent basis, and the CPSC may immediately withdraw its acceptance in accordance with § 1112.53.
§ 1112.43 What are the grounds for denial of an application?
(a) The CPSC may deny an application for any of the following reasons:
(1) Failure to complete all information, and/or attestations, and/or failure to provide accompanying documentation, required in connection with an application within 30 days after notice of a deficiency by the CPSC;
(2) Submission of false or misleading information concerning a material fact(s) on an application, any materials accompanying an application, or on any other information provided to the CPSC related to a third party conformity assessment body’s ability to become or to remain a CPSC-accepted third party conformity assessment body; or
(3) Failure to satisfy necessary requirements described in § 1112.13, such as ISO/IEC 17025:2017(E) accreditation by a ILAC-MRA signatory accreditation body for the CPSC scope for which acceptance of accreditation is being sought.
(b) The CPSC’s denial of an application will follow the process described in § 1112.51.
§ 1112.45 What are the grounds for suspension of CPSC acceptance?
(a) The CPSC may suspend its acceptance of a third party conformity assessment body’s accreditation for any portion of its scope when the third party conformity assessment body fails to cooperate with an investigation under section 14 of the CPSA. A third party conformity assessment body “fails to cooperate” when it does not respond to CPSC inquiries or requests, or it responds in a manner that is unresponsive, evasive, deceptive, or substantially incomplete, or when it fails to cooperate with an investigatory inspection under § 1112.27.
(b) Suspension lasts until the third party conformity assessment body complies, to the satisfaction of the CPSC, with required actions, as outlined in the notice described in § 1112.51(b), or until the CPSC withdraws its acceptance of the third party conformity assessment body.
(c) If the CPSC determines that the third party conformity assessment body is cooperating sufficiently with the CPSC’s investigation, the CPSC will lift the suspension. The suspension will lift as of the date of the CPSC’s written notification to the third party conformity assessment body that the CPSC is lifting the suspension. The written notification may be by electronic mail.
§ 1112.47 What are the grounds for withdrawal of CPSC acceptance?
(a) A manufacturer, private labeler, governmental entity, or other interested party has exerted undue influence on such third party conformity assessment body or otherwise interfered with or compromised the integrity of the testing process.
(b) The third party conformity assessment body failed to comply with an applicable protocol, standard, or requirement under subpart C of this part.
(c) The third party conformity assessment body failed to comply with any provision in subpart B of this part.
§ 1112.49 How may a person submit information alleging grounds for adverse action, and what information should be submitted?
(a) Initiating information. Any person may submit information to the Commission, such as by writing to the U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, or by sending electronic mail to: [email protected]. The submission must allege that one or more of the grounds for adverse action set forth in this part exists. Any request for confidentiality must be indicated clearly in the submission. The submission should include:
(1) Contact information, including a name and/or a method by which the CPSC may contact the person providing the information;
(2) Identification of the third party conformity assessment body against whom the allegation is being made, identification of any officials or employees of the third party conformity assessment body relevant to the allegation, and contact information for such individuals.
(3) Identification of any manufacturers, distributors, importers, private labelers, and/or governmental entities relevant to the allegation. The submission also should identify any officials or employees of the manufacturers, distributors, importers, private labelers, or governmental entities relevant to the allegation, and contact information for such individuals.
(4) Description of acts and/or omissions to support each asserted ground for adverse action. Generally, the submission should describe, in detail, the basis for the allegation that grounds for adverse action against a third party conformity assessment body exists. In addition to a description of the acts and omissions and their significance, a description may include: dates, times, persons, companies, governmental entities, locations, products, tests, test results, equipment, supplies, frequency of occurrence, and negative outcomes. When possible, the submission should attach documents, records, photographs, correspondence, notes, electronic mails, or any other information that supports the basis for the allegations;
(5) Description of the impact of the acts and/or omissions, where known.
(b) Review of initiating information. Upon receiving the information, the CPSC will review the information to determine if it is sufficient to warrant an investigation. The CPSC may deem the information insufficient to warrant an investigation if the information fails to address adequately the categories of information outlined in paragraph (a) of this section.
§ 1112.51 What are the procedures relevant to adverse actions?
(a) Investigation. (1) Investigations under this part are investigations into grounds for an adverse action against a third party conformity assessment body.
(2) The Commission will use its Procedures for Investigations, Inspections, and Inquiries, 16 CFR part 1118, subpart A, to investigate under this part.
(3) An investigation under this part may include any act the CPSC takes to verify the accuracy, veracity, and/or completeness of information received in connection with an application for acceptance of accreditation, a submission alleging grounds for an adverse action, or any other information received by the CPSC that relates to a third party conformity assessment body’s ability to become or remain a CPSC-accepted third party conformity assessment body.
(4) The CPSC will begin an investigation under this part by providing written notice, which may be electronic, to the third party conformity assessment body. The notice will inform the third party conformity assessment body that the CPSC has received information sufficient to warrant an investigation, and it will describe the information received by the CPSC and the CPSC’s investigative process. The notice also will inform the third party conformity assessment body that failure to cooperate with a CPSC investigation is grounds for suspension under § 1112.45.
(5) The notice sent by the CPSC under § 1112.35(b)(3) informing the third party conformity assessment body that it must submit a CPSC Form 223 for audit purposes, which may be electronic, constitutes notice of investigation for purposes of this section. The examination portion of an audit under § 1112.33(c) constitutes an investigation for purposes of this section.
(b) Initial notice. If, after investigation, the CPSC determines that grounds for adverse action exist and proposes to take an adverse action against a third party conformity assessment body, the CPSC will notify the third party conformity assessment body, in writing, which may be electronic, about the proposed adverse action. If the proposed adverse action is suspension or withdrawal, the notice formally begins a proceeding to suspend or withdraw, as described in section 14(e) of the CPSA. The notice will contain:
(1) The proposed adverse action;
(2) Specific grounds on which the proposed adverse action is based;
(3) Findings of fact to support the proposed adverse action;
(4) When appropriate, specific actions a third party conformity assessment body must take to avoid an adverse action;
(5) When the proposed adverse action is withdrawal, consideration of the criteria set forth in paragraph (d)(1) of this section;
(6) The time period by which a third party conformity assessment body has to respond to the notice. In general, the notice will inform the third party conformity assessment body that it has 30 calendar days to respond. A third party conformity assessment body may request an extension of the response time, but they must explain why such an extension is warranted and the amount of additional time needed for a response; and
(7) Except under § 1112.53, a CPSC-accepted third party conformity assessment body may continue to conduct tests for purposes of section 14 of the CPSA until a Final Notice of adverse action is issued.
(c) Third party conformity assessment body response to initial notice. A third party conformity assessment body’s response must be submitted in writing, in English, and may be in the form of electronic mail. The response may include, but is not limited to, an explanation or refutation of material facts upon which the Commission’s proposed action is based, supported by documents or sworn affidavit; results of any internal review of the matter and action(s) taken as a result; or a detailed plan and schedule for an internal review. The written response must state the third party conformity assessment body’s reasons why the ground(s) for adverse action does not exist, or why the CPSC should not pursue the proposed adverse action, or any portion of the proposed adverse action. If a third party conformity assessment body responds to the notice in a timely manner, the CPSC will review the response, and, if necessary, investigate further to explore or resolve issues bearing on whether grounds exist for adverse action and the nature of the proposed adverse action. If a third party conformity assessment body does not respond to the notice in a timely manner, the CPSC may proceed without further delay to a Final Notice, as described in paragraph (e) of this section.
(d) Proceeding. (1) In any proceeding to withdraw the CPSC’s acceptance of a third party conformity assessment body’s accreditation, the CPSC will consider the gravity of the third party conformity assessment body’s action or failure to act, including:
(i) Whether the action or failure to act resulted in injury, death, or the risk of injury or death;
(ii) Whether the action or failure to act constitutes an isolated incident or represents a pattern or practice; and
(iii) Whether and when the third party conformity assessment body initiated remedial action.
(2) In all cases, the CPSC will review and take under advisement the response provided by the third party conformity assessment body. Except for cases under paragraph (d)(3) of this section, the CPSC will determine what action is appropriate under the circumstances.
(3) If, after reviewing and taking under advisement the response provided by a CPSC-accepted firewalled third party conformity assessment body, the CPSC staff concludes that suspension or withdrawal of CPSC acceptance of accreditation is appropriate, staff will transmit its recommendation to the Commission for consideration. Any suspension or withdrawal of CPSC acceptance of accreditation of a firewalled third party conformity assessment body (including immediate and temporary withdrawal under § 1112.53) will be by order of the Commission.
(4) The CPSC may withdraw its acceptance of the accreditation of a third party conformity assessment body on a permanent or temporary basis.
(5) If the CPSC withdraws its acceptance of the accreditation of a third party conformity assessment body, the CPSC may establish conditions for the reacceptance of the accreditation of the third party conformity assessment body, under section 14(e)(2)(B)(ii) of the CPSA. Any such conditions would be related to the reason(s) for the withdrawal.
(e) Final notice. If, after reviewing a third party conformity assessment body’s response to a notice and conducting additional investigation, where necessary, the CPSC determines that grounds for adverse action exist, it will send a Final Notice to the third party conformity assessment body, in writing, which may be electronic. The Final Notice will state:
(1) The adverse action that the CPSC is taking;
(2) Specific grounds on which the adverse action is based;
(3) Findings of fact that support the adverse action;
(4) When the adverse action is withdrawal, consideration of the criteria as set forth in paragraph (d)(1) of this section;
(5) When the adverse action is withdrawal, whether the withdrawal is temporary or permanent, and if temporary, the duration of the withdrawal;
(6) The third party conformity assessment body’s accreditation is not accepted by the Commission as of the date of the Final Notice of denial, suspension, or withdrawal, for specified portion(s) of its CPSC scope. The CPSC Web site will be updated to reflect adverse actions to any previously CPSC-accepted third party conformity assessment bodies; and
(7) Whether the third party conformity assessment body may submit a new application.
(f) Possible actions after final notice. Upon receipt of a Final Notice, a third party conformity assessment body, as applicable, may:
(1) If the Final Notice indicates such, the third party conformity assessment body may submit a new application; or
(2) File an Administrative Appeal.
(g) Administrative appeal. (1) Except for paragraph (g)(2) of this section, the third party conformity assessment body may file an Administrative Appeal with the Office of the Executive Director.
(i) The Administrative Appeal must be sent, by mail, within 30 calendar days of the date on the Final Notice to: the Office of the Executive Director, Room 812, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, or by electronic mail to: [email protected].
(ii) All appeals must be in writing, and must be in English.
(iii) All appeals must explain the nature and scope of the issues appealed from in the Final Decision, and must describe in detail the reasons why the third party conformity assessment body believes that no ground(s) for adverse action exist.
(iv) If an Administrative Appeal is timely filed, the Executive Director will issue a Final Decision within 60 calendar days of receipt. If the Executive Director’s Final Decision requires more than 60 calendar days, he or she will notify the third party conformity assessment body that more time is required, state the reason(s) why more time is required, and, if feasible, include an estimated date for a Final Decision to be issued.
(2) In the case that the Commission has suspended or withdrawn its acceptance of the accreditation of a firewalled third party conformity assessment body, the firewalled third party conformity assessment body may file an Administrative Appeal with the Commission.
(i) The Administrative Appeal must be sent, by mail, within 30 calendar days of the date on the Final Notice to: the Office of the Secretary, Room 820, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, or by electronic mail to: [email protected].
(ii) All appeals must be in writing, and must be in English.
(iii) All appeals must explain the nature of the issues appealed from in the Final Decision, and must describe in detail the reasons why the third party conformity assessment body believes that no ground(s) for adverse action exist.
§ 1112.53 Can the CPSC immediately withdraw its acceptance of the accreditation of a third party conformity assessment body?
(a) When it is in the public interest to protect health and safety, and notwithstanding any other provision of this part, the CPSC may withdraw immediately and temporarily its acceptance of a third party conformity assessment body’s accreditation for any portion of its CPSC scope while the CPSC pursues an investigation and potential adverse action under § 1112.51.
(1) For purposes of this part, “in the public interest to protect health and safety” means that the CPSC has credible evidence that:
(i) The integrity of test(s) being conducted under a scope for which the CPSC has accepted the third party conformity assessment body’s accreditation, have been affected by undue influence or otherwise interfered with or compromised; and
(ii) The scope for which the CPSC has accepted the third party conformity assessment body’s accreditation involve a product(s) which, if noncompliant with CPSC rules, bans, standards, and/or regulations, constitutes an imminently hazardous consumer product under section 12 of the CPSA.
(2) When presented with an allegation that, if credible, would result in immediate and temporary withdrawal of CPSC acceptance of a third party conformity assessment body’s accreditation, the investigation and adverse action procedures described in § 1112.51 apply, except that instead of the timeframes described in § 1112.51, the following timeframes will apply when the CPSC pursues immediate and temporary withdrawal:
(i) The Initial Notice will generally inform the third party conformity assessment body that it has 7 calendar days to respond.
(ii) An administrative appeal of a Final Notice of immediate and temporary withdrawal will be timely if filed within 7 calendar days of the date of the Final Notice.
(b) If the third party conformity assessment body is already the subject of an investigation or adverse action process under § 1112.51, the immediate and temporary withdrawal will remain in effect until: the agency communicates in writing that the immediate and temporary withdrawal has been lifted; the investigation concludes and the agency does not propose an adverse action; or the adverse action process concludes with denial, suspension, or withdrawal.
(c) If the third party conformity assessment body is not already the subject of an investigation or adverse action process under § 1112.51, an investigation under § 1112.51(a) will be launched based on the same information that justified the immediate and temporary withdrawal.
§ 1112.55 Will the CPSC publish adverse actions?
Immediately following a final adverse action, the CPSC may publish the fact of a final adverse action, the text of a final adverse action, or a summary of the substance of a final adverse action. After issuance of a final adverse action, the CPSC will amend its Web site listing of CPSC-accepted third party conformity assessment bodies to reflect the nature and scope of such adverse action.
PART 1115—SUBSTANTIAL PRODUCT HAZARD REPORTS
Subpart A—General Interpretation
§ 1115.1 Purpose.
The purpose of this part 1115 is to set forth the Consumer Product Safety Commission’s (Commission’s) interpretation of the reporting requirements imposed on manufacturers (including importers), distributors, and retailers by section 15(b) of the Consumer Product Safety Act, as amended (CPSA) (15 U.S.C. 2064(b)) and to indicate the actions and sanctions which the Commission may require or impose to protect the public from substantial product hazards, as that term is defined in section 15(a) of the CPSA.
§ 1115.2 Scope and finding.
(a) Section 15(a) of the CPSA (15 U.S.C. 2064(a)) defines substantial product hazard as either:
(1) A failure to comply with an applicable consumer product safety rule, which failure creates a substantial risk of injury to the public, or
(2) A product defect which (because of the pattern of defect, the number of defective products distributed in commerce, the severity of the risk, or otherwise) creates a substantial risk of injury to the public.
(b) Section 15(b) of the CPSA requires every manufacturer (including an importer), distributor, and retailer of a consumer product distributed in commerce who obtains information which reasonably supports the conclusion that the product fails to comply with an applicable consumer product safety rule, fails to comply with a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA, contains a defect which could create a substantial product hazard described in subsection 15(a)(2) of the CPSA, or creates an unreasonable risk of serious injury or death, immediately to inform the Commission, unless the manufacturer (including an importer), distributor or retailer has actual knowledge that the Commission has been adequately informed of such failure to comply, defect, or risk. This provision indicates that a broad spectrum of safety related information should be reported under section 15(b) of the CPSA.
(c) Sections 15 (c) and (d) of the CPSA, (15 U.S.C. 2064(c) and (d)), empower the Commission to order a manufacturer (including an importer), distributor, or retailer of a consumer product distributed in commerce that presents a substantial product hazard to give various forms of notice to the public of the defect or the failure to comply and/or to order the subject firm to elect either to repair, to replace, or to refund the purchase price of such product. However, information which should be reported under section 15(b) of the CPSA does not automatically indicate the presence of a substantial product hazard, because what must be reported under section 15(b) are failures to comply with consumer product safety rules or voluntary standards upon which the Commission has relied under section 9, defects that could create a substantial product hazard, and products which create an unreasonable risk of serious injury or death. (See § 1115.12.)
(d) The provisions of this part 1115 deal with all consumer products (including imports) subject to regulation under the Consumer Product Safety Act, as amended (15 U.S.C. 2051-2081) (CPSA), and the Refrigerator Safety Act (15 U.S.C. 1211-1214) (RSA). In addition, the Commission has found that risks of injury to the public from consumer products subject to regulation under the Flammable Fabrics Act (15 U.S.C. 1191-1204) (FFA), the Federal Hazardous Substances Act (15 U.S.C. 1261-1274) (FHSA), and the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471-1476) (PPPA) cannot be eliminated or reduced to a sufficient extent in a timely fashion under those acts. Therefore, pursuant to section 30(d) of the CPSA (15 U.S.C. 2079(d)), manufacturers (including importers), distributors, and retailers of consumer products which are subject to regulation under provisions of the FFA, FHSA, and PPPA must comply with the reporting requirements of section 15(b).
§ 1115.3 Definitions.
In addition to the definitions given in section 3 of the CPSA (15 U.S.C. 2052), the following definitions apply:
(a) Adequately informed under section 15(b) of the CPSA means that the Commission staff has received the information requested under §§ 1115.12 and/or 1115.13 of this part insofar as it is reasonably available and applicable or that the staff has informed the subject firm that the staff is adequately informed.
(b) Commission meeting means the joint deliberations of at least a majority of the Commission where such deliberations determine or result in the conduct or disposition of official Commission business. This term is synonymous with “Commission meeting” as defined in the Commission’s regulation issued under the Government in the Sunshine Act, 16 CFR part 1012.
(c) Noncompliance means the failure of a consumer product to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA.
(d) A person means a corporation, company, association, firm, partnership, society, joint stock company, or individual.
(e) Staff means the staff of the Consumer Product Safety Commission unless otherwise stated.
(f) Subject firm means any manufacturer (including an importer), distributor, or retailer of a consumer product.
§ 1115.4 Defect.
Section 15(b)(2) of the CPSA requires every manufacturer (including an importer), distributor, and retailer of a consumer product who obtains information which reasonably supports the conclusion that the product contains a defect which could create a substantial product hazard to inform the Commission of such defect. Thus, whether the information available reasonably suggests a defect is the first determination which a subject firm must make in deciding whether it has obtained information which must be reported to the Commission. In determining whether it has obtained information which reasonably supports the conclusion that its consumer product contains a defect, a subject firm may be guided by the criteria the Commission and staff use in determining whether a defect exists. At a minimum, defect includes the dictionary or commonly accepted meaning of the word. Thus, a defect is a fault, flaw, or irregularity that causes weakness, failure, or inadequacy in form or function. A defect, for example, may be the result of a manufacturing or production error; that is, the consumer product as manufactured is not in the form intended by, or fails to perform in accordance with, its design. In addition, the design of and the materials used in a consumer product may also result in a defect. Thus, a product may contain a defect even if the product is manufactured exactly in accordance with its design and specifications, if the design presents a risk of injury to the public. A design defect may also be present if the risk of injury occurs as a result of the operation or use of the product or the failure of the product to operate as intended. A defect can also occur in a product’s contents, construction, finish, packaging, warnings, and/or instructions. With respect to instructions, a consumer product may contain a defect if the instructions for assembly or use could allow the product, otherwise safely designed and manufactured, to present a risk of injury. To assist subject firms in understanding the concept of defect as used in the CPSA, the following examples are offered:
(a) An electric appliance presents a shock hazard because, through a manufacturing error, its casing can be electrically charged by full-line voltage. This product contains a defect as a result of manufacturing or production error.
(b) Shoes labeled and marketed for long-distance running are so designed that they might cause or contribute to the causing of muscle or tendon injury if used for long-distance running. The shoes are defective due to the labeling and marketing.
(c) A kite made of electrically conductive material presents a risk of electrocution if it is long enough to become entangled in power lines and be within reach from the ground. The electrically conductive material contributes both to the beauty of the kite and the hazard it presents. The kite contains a design defect.
(d) A power tool is not accompanied by adequate instructions and safety warnings. Reasonably foreseeable consumer use or misuse, based in part on the lack of adequate instructions and safety warnings, could result in injury. Although there are no reports of injury, the product contains a defect because of the inadequate warnings and instructions.
(e) An exhaust fan for home garages is advertised as activating when carbon monoxide fumes reach a dangerous level but does not exhaust when fumes have reached the dangerous level. Although the cause of the failure to exhaust is not known, the exhaust fan is defective because users rely on the fan to remove the fumes and the fan does not do so.
§ 1115.5 Reporting of failures to comply with a voluntary consumer product safety standard relied upon by the Commission under section 9 of the CPSA.
(a) General provision. Under the CPSA, the Commission may rely on voluntary standards in lieu of developing mandatory ones. In recognition of the role of voluntary standards under the CPSA, section 15(b)(1) requires reports if a product fails to comply with a voluntary standard “upon which the Commission has relied under section 9” of the CPSA. The Commission has relied upon a voluntary consumer product safety standard under section 9 of the CPSA if, since August 13, 1981 it has terminated a rulemaking proceeding or withdrawn an existing consumer product safety rule because it explicitly determined that an existing voluntary standard, or portion(s) thereof, is likely to result in an adequate reduction of the risk of injury and it is likely there will be substantial compliance with that voluntary standard. (See appendix to this part 1115 for a list of such voluntary standards.) This provision applies only when the Commission relies upon a voluntary standard in a rulemaking proceeding under section 9 of the CPSA. In evaluating whether or not to rely upon an existing voluntary standard, the Commission shall adhere to all the procedural safeguards currently required under the provisions of the CPSA, including publication in the
(b) Reporting requirement. A firm must report under this section if it has distributed in commerce, subsequent to the effective date of the Consumer Product Safety Improvement Act of 1990 (November 16, 1990), a product that does not conform to a voluntary standard or portion(s) of a voluntary standard relied upon by the Commission since August 13, 1981. If the Commission relied upon only a portion(s) of a voluntary standard, a firm must report under this section only nonconformance with the portion(s) of the voluntary standard relied upon by the Commission. Pursuant to section 7(b)(2) of the CPSA, the Commission shall monitor any modifications of a voluntary standard upon which it has relied and determine, as a matter of policy, at the time any substantive safety related modification is adopted, whether it shall continue to rely upon the former standard or whether it shall rely, subsequently, upon the modified standard. The Commission shall publish such decisions in the
§ 1115.6 Reporting of unreasonable risk of serious injury or death.
(a) General provision. Every manufacturer, distributor, and retailer of a consumer product distributed in commerce who obtains information which reasonably supports the conclusion that its product creates an unreasonable risk of serious injury or death is required to notify the Commission immediately. 15 U.S.C. 2064(b)(3). The requirement that notification occur when a responsible party “obtains information which reasonably supports the conclusion that” its product creates an unreasonable risk of serious injury or death is intended to require firms to report even when no final determination of the risk is possible. Firms must carefully analyze the information they obtain to determine whether such information “reasonably supports” a determination that the product creates an unreasonable risk of serious injury or death. (See § 1115.12(f) for a discussion of the kinds of information that firms must study and evaluate to determine whether they have an obligation to report.) Firms that obtain information indicating that their products present an unreasonable risk of serious injury or death should not wait for such serious injury or death to actually occur before reporting. Such information can include reports from experts, test reports, product liability lawsuits or claims, consumer or customer complaints, quality control data, scientific or epidemiological studies, reports of injury, information from other firms or governmental entities, and other relevant information. While such information shall not trigger a per se reporting requirement, in its evaluation of whether a subject firm is required to file a report under the provisions of section 15 of the CPSA, the Commission shall attach considerable significance if such firm learns that a court or jury has determined that one of its products has caused a serious injury or death and a reasonable person could conclude based on the lawsuit and other information obtained by the firm that the product creates an unreasonable risk of serious injury or death.
(b) Unreasonable risk. The use of the term “unreasonable risk” suggests that the risk of injury presented by a product should be evaluated to determine if that risk is a reasonable one. In determining whether a product presents an unreasonable risk, the firm should examine the utility of the product, or the utility of the aspect of the product that causes the risk, the level of exposure of consumers to the risk, the nature and severity of the hazard presented, and the likelihood of resulting serious injury or death. In its analysis, the firm should also evaluate the state of the manufacturing or scientific art, the availability of alternative designs or products, and the feasibility of eliminating the risk. The Commission expects firms to report if a reasonable person could conclude given the information available that a product creates an unreasonable risk of serious injury or death. In its evaluation of whether a subject firm is required to file a report under the provisions of section 15 of the CPSA the Commission shall, as a practical matter, attach considerable significance if such firm obtains information which reasonably supports the conclusion that its product violates a standard or ban promulgated under the FHSA, FFA, PPPA or RSA and the violation could result in serious injury or death.
(c) Serious injury or death. The term “serious injury” is not defined in the CPSA. The Commission believes that the term includes not only the concept of “grievous bodily injury,” defined at § 1115.12(d), but also any other significant injury. Injuries necessitating hospitalization which require actual medical or surgical treatment, fractures, lacerations requiring sutures, concussions, injuries to the eye, ear, or internal organs requiring medical treatment, and injuries necessitating absence from school or work of more than one day are examples of situations in which the Commission shall presume that such a serious injury has occurred. To determine whether an unreasonable risk of serious injury or death exists, the firm should evaluate chronic or long term health effects as well as immediate injuries.
§ 1115.7 Relation to other provisions.
The reporting requirements of section 37 of the CPSA (15 U.S.C. 2084) are in addition to the requirement in section 15 of the CPSA. Section 37 requires a product manufacturer to report certain kinds of lawsuit information. It is intended as a supplement to, not a substitute for, the requirements of section 15(b) of the CPSA. Whether or not a firm has an obligation to provide information under section 37, it must consider whether it has obtained information which reasonably supports the conclusion that its product violates a consumer product safety rule, does not comply with a voluntary safety standard upon which the Commission has relied under section 9, contains a defect which could create a substantial product hazard, or creates an unreasonable risk of serious injury or death. If a firm has obtained such information, it must report under section 15(b) of the CPSA, whether or not it is required to report under section 37. Further, in many cases the Commission would expect to receive reports under section 15(b) long before the obligation to report under section 37 arises since firms have frequently obtained reportable information before settlements or judgments in their product liability lawsuits.
§ 1115.8 Compliance with product safety standards.
(a) Voluntary standards. The CPSA and other federal statutes administered by the Commission generally encourage the private sector development of, and compliance with voluntary consumer product safety standards to help protect the public from unreasonable risks of injury associated with consumer products. To support the development of such consensus standards, Commission staff participates in many voluntary standards committees and other activities. The Commission also strongly encourages all firms to comply with voluntary consumer product safety standards and considers, where appropriate, compliance or non-compliance with such standards in exercising its authorities under the CPSA and other federal statutes, including when making determinations under section 15 of the CPSA. Thus, for example, whether a product is in compliance with applicable voluntary safety standards may be relevant to the Commission staff’s preliminary determination of whether that product presents a substantial product hazard under section 15 of the CPSA.
(b) Mandatory standards. The CPSA requires that firms comply with all applicable mandatory consumer product safety standards and to report to the Commission any products which do not comply with either mandatory standards or voluntary standards upon which the Commission has relied. As is the case with voluntary consumer product safety standards, compliance or non-compliance with applicable mandatory safety standards may be considered by the Commission and staff in making relevant determinations and exercising relevant authorities under the CPSA and other federal statutes. Thus, for example, while compliance with a relevant mandatory product safety standard does not, of itself, relieve a firm from the need to report to the Commission a product defect that creates a substantial product hazard under section 15 of the CPSA, it will be considered by staff in making the determination of whether and what type of corrective action may be required.
§ 1115.9 [Reserved]
§ 1115.10 Persons who must report and where to report.
(a) Every manufacturer (including importer), distributor, or retailer of a consumer product that has been distributed in commerce who obtains information that such consumer product contains a defect which could create a substantial risk of injury to the public shall immediately notify the Office of Compliance, Division of Corrective Actions, Consumer Product Safety Commission, Washington, DC 20207 (telephone: 301-504-0608), or such other persons as may be designated. Manufacturers (including importers), distributors, and retailers of consumer products subject to regulation by the Commission under provisions of the FFA, FHSA, PPPA, as well as consumer products subject to regulation under the CPSA and RSA, must comply with this requirement.
(b) Every manufacturer (including importer), distributor, or retailer of a consumer product that has been distributed in commerce who obtains information that such consumer product fails to comply with an applicable consumer product safety standard or ban issued under the CPSA shall immediately notify the Commission’s Office of Compliance and Enforcement, Division of Corrective Actions or such other persons as may be designated. A subject firm need not report a failure to comply with a standard or regulation issued under the provisions of the RSA, FFA, FHSA, or PPPA unless it can be reasonably concluded that the failure to comply results in a defect which could create a substantial product hazard. (See paragraph (a) of this section.)
(c) Every manufacturer (including importer), distributor, and retailer of a consumer product that has been distributed in commerce who obtains information that such consumer product fails to comply with a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA, shall immediately notify the Commission’s Office of Compliance and Enforcement, Division of Corrective Actions or such other persons as may be designated.
(d) Every manufacturer (including importer), distributor, and retailer of a consumer product that has been distributed in commerce who obtains information that such consumer product creates an unreasonable risk of serious injury or death shall immediately notify the Commission’s Office of Compliance and Enforcement, Division of Corrective Actions or such other persons as may be designated. This obligation applies to manufacturers, distributors and retailers of consumer products subject to regulation by the Commission under the Flammable Fabrics Act, Federal Hazardous Substances Act, Poison Prevention Packaging Act, and Refrigerator Safety Act as well as products subject to regulation under the CPSA.
(e) A distributor or retailer of a consumer product (who is neither a manufacturer nor an importer of that product) is subject to the reporting requirements of section 15(b) of the CPSA but may satisfy them by following the procedure detailed in § 1115.13(b).
(f) A manufacturer (including an importer), distributor, or retailer need not inform the Commission under section 15(b) of the CPSA if that person has actual knowledge that the Commission has been adequately informed of the defect or failure to comply. (See section 15(b) of the CPSA.)
§ 1115.11 Imputed knowledge.
(a) In evaluating whether or when a subject firm should have reported, the Commission will deem a subject firm to have obtained reportable information when the information has been received by an official or employee who may reasonably be expected to be capable of appreciating the significance of the information. (See § 1115.14(b).)
(b) In evaluating whether or when a subject firm should have reported, the Commission will deem a subject firm to know what a reasonable person acting in the circumstances in which the firm finds itself would know. Thus, the subject firm shall be deemed to know what it would have known if it had exercised due care to ascertain the truth of complaints or other representations. This includes the knowledge a firm would have if it conducted a reasonably expeditious investigation in order to evaluate the reportability of a death or grievous bodily injury or other information. (See § 1115.14.)
§ 1115.12 Information which should be reported; evaluating substantial product hazard.
(a) General. Subject firms should not delay reporting in order to determine to a certainty the existence of a reportable noncompliance, defect or unreasonable risk. The obligation to report arises upon receipt of information from which one could reasonably conclude the existence of a reportable noncompliance, defect which could create a substantial product hazard, or unreasonable risk of serious injury or death. Thus, an obligation to report may arise when a subject firm received the first information regarding a potential hazard, noncompliance or risk. (See § 1115.14(c).) A subject firm in its report to the Commission need not admit, or may specifically deny, that the information it submits reasonably supports the conclusion that its consumer product is noncomplying, contains a defect which could create a substantial product hazard within the meaning of section 15(b) of the CPSA, or creates an unreasonable risk of serious injury or death. After receiving the report, the staff may conduct further investigation and will preliminarily determine whether the product reported upon presents a substantial product hazard. This determination can be based on information supplied by a subject firm or from any other source. If the matter is adjudicated, the Commission will ultimately make the decision as to substantial product hazard or will seek to have a court make the decision as to imminent product hazard.
(b) Failure to comply. A subject firm must report information indicating that a consumer product which it has distributed in commerce does not comply with an applicable consumer product safety standard or ban issued under the CPSA, or a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA.
(c) Unreasonable risk of serious injury or death. A subject firm must report when it obtains information indicating that a consumer product which it has distributed in commerce creates an unreasonable risk of serious injury or death.
(d) Death or grievous bodily injury. Information indicating that a noncompliance or a defect in a consumer product has caused, may have caused, or contributed to the causing, or could cause or contribute to the causing of a death or grievous bodily injury (e.g., mutilation, amputation/dismemberment, disfigurement, loss of important bodily functions, debilitating internal disorders, severe burns, severe electrical shocks, and injuries likely to require extended hospitalization) must be reported, unless the subject firm has investigated and determined that the information is not reportable.
(e) Other information indicating a defect or noncompliance. Even if there are no reports of a potential for or an actual death or grievous bodily injury, other information may indicate a reportable defect or noncompliance. In evaluating whether or when a subject firm should have reported, the Commission will deem a subject firm to know what a reasonable and prudent manufacturer (including an importer), distributor, or retailer would know. (See § 1115.11.)
(f) Information which should be studied and evaluated. Paragraphs (f)(1) through (7) of this section are examples of information which a subject firm should study and evaluate in order to determine whether it is obligated to report under section 15(b) of the CPSA. Such information may include information that a firm has obtained, or reasonably should have obtained in accordance with § 1115.11, about product use, experience, performance, design, or manufacture outside the United States that is relevant to products sold or distributed in the United States. All information should be evaluated to determine whether it suggests the existence of a noncompliance, a defect, or an unreasonable risk of serious injury or death:
(1) Information about engineering, quality control, or production data.
(2) Information about safety-related production or design change(s).
(3) Product liability suits and/or claims for personal injury or damage.
(4) Information from an independent testing laboratory.
(5) Complaints from a consumer or consumer group.
(6) Information received from the Commission or other governmental agency.
(7) Information received from other firms, including requests to return a product or for replacement or credit. This includes both requests made by distributors and retailers to the manufacturer and requests from the manufacturer that products be returned.
(g) Evaluating substantial risk of injury. Information which should be or has been reported under section 15(b) of the CPSA does not automatically indicate the presence of a substantial product hazard. On a case-by-case basis the Commission and the staff will determine whether a defect or noncompliance exists and whether it results in a substantial risk of injury to the public. In deciding whether to report, subject firms may be guided by the following criteria the staff and the Commission use in determining whether a substantial product hazard exists:
(1) Hazard created by defect. Section 15(a)(2) of the CPSA lists factors to be considered in determining whether a defect creates a substantial risk of injury. These factors are set forth in the disjunctive. Therefore, the exist- ence of any one of the factors could create a substantial product hazard. The Commission and the staff will consider some or all of the following factors, as appropriate, in determining the substantiality of a hazard created by a product defect:
(i) Pattern of defect. The Commission and the staff will consider whether the defect arises from the design, composition, contents, construction, finish, packaging, warnings, or instructions of the product or from some other cause and will consider the conditions under which the defect manifests itself.
(ii) Number of defective products distributed in commerce. Even one defective product can present a substantial risk of injury and provide a basis for a substantial product hazard determination under section 15 of the CPSA if the injury which might occur is serious and/or if the injury is likely to occur. However, a few defective products with no potential for causing serious injury and little likelihood of injuring even in a minor way will not ordinarily provide a proper basis for a substantial product hazard determination. The Commission also recognizes that the number of products remaining with consumers is a relevant consideration.
(iii) Severity of the risk. A risk is severe if the injury which might occur is serious and/or if the injury is likely to occur. In considering the likelihood of any injury the Commission and the staff will consider the number of injuries reported to have occurred, the intended or reasonably foreseeable use or misuse of the product, and the population group exposed to the product (e.g., children, elderly, handicapped).
(iv) Other considerations. The Commission and the staff will consider all other relevant factors.
(2) Hazard presented by noncompliance. Section 15(a)(1) of the CPSA states that a substantial product hazard exists when a failure to comply with an applicable consumer product safety rule creates a substantial risk of injury to the public. Therefore, the Commission and staff will consider whether the noncompliance is likely to result in injury when determining whether the noncompliance creates a substantial product hazard. As appropriate, the Commission and staff may consider some or all of the factors set forth in paragraph (f)(1) of this section in reaching the substantial product hazard determination.
(a) Written reports. The chief executive officer of the subject firm should sign any written reports to the Commission under section 15(b) of the CPSA unless this responsibility has been delegated by filing a written delegation of authority with the Commission’s Office of Compliance and Enforcement, Division of Corrective Actions. Delegations of authority filed with the Commission under § 1115.9 of the previous regulations interpreting section 15 of the CPSA will remain in effect until revoked by the chief executive officer of the subject firm. The delegation may be in the following form:
(Name of company) _________.
I ________ hereby certify that I am Chief Executive Officer of the above-named company and that as such I am authorized to sign documents and to certify on behalf of said company the accuracy and completeness of information in such documents.
Pursuant to the power vested in me, I hereby delegate all or, to the extent indicated below, a portion of that authority to the person listed below.
This delegation is effective until revoked in writing. Authority delegated to:
Extent of authority: ___________
Signed:
(b) Distributors and retailers. A distributor or retailer of a product (who is neither a manufacturer nor an importer of that product) satisfies the initial reporting requirements either by telephoning or writing the Office of Compliance and Enforcement, Division of Corrective Actions, Consumer Product Safety Commission, Washington, DC 20207, phone 301-504-0608; by sending a letter describing the noncompliance, defect or risk of injury to the manufacturer (or importer) of the product and sending a copy of the letter to the Commission’s Division of Corrective Actions; or by forwarding to the Commission’s Division of Corrective Actions reportable information received from another firm. A distributor or retailer who receives reportable information from a manufacturer (or importer) shall report to the Commission unless the manufacturer (or importer) informs the distributor or retailer that a report has been made to the Commission. A report under this paragraph should contain the information detailed in paragraph (c) of this section insofar as it is known to the distributor or retailer. Unless further information is requested by the staff, this action will constitute a sufficient report insofar as the distributor or retailer is concerned.
(c) Initial report. Immediately after a subject firm has obtained information which reasonably supports the conclusion that a product fails to comply with an applicable consumer product safety rule or a voluntary standard, contains a defecat which could create a substantial risk of serious injury or death, the subject firm should provide the Division of Corrective Actions, Office of Compliance, Consumer Product Safety Commission, Washington, DC 20207 (telephone: 301-504-0608), with an initial report containing the information listed in paragraphs (c) (1) through (6) of this section. This initial report may be made by any means, but if it is not in writing, it should be confirmed in writing within 48 hours of the initial report. (See § 1115.14 for time computations.) The initial report should contain, insofar as is reasonably available and/or applicable:
(1) An identification and description of the product.
(2) The name and address of the manufacturer (or importer) or, if the manufacturer or importer is not known, the names and addresses of all known distributors and retailers of the product.
(3) The nature and extent of the possible defect, the failure to comply, or the risk.
(4) The nature and extent of the injury or risk of injury associated with the product.
(5) The name and address of the person informing the Commission.
(6) To the extent such information is then reasonably available, the data specified in § 1115.13(d).
(d) Full report. Subject firms which file initial reports are required to file full reports in accordance with this paragraph. Retailers and distributors may satisfy their reporting obligations in accordance with § 1115.13(b). At any time after an initial report, the staff may modify the requirements detailed in this section with respect to any subject firm. If the staff preliminarily determines that there is no substantial product hazard, it may inform the firm that its reporting obligation has been fulfilled. However, a subject firm would be required to report if it later became aware of new information indicating a reportable defect, noncompliance, or risk, whether the new information related to the same or another consumer product. Unless modified by staff action, the following information, to the extent that it is reasonably available and/or applicable, constitutes a “full report,” must be submitted to the staff, and must be supplemented or corrected as new or different information becomes known:
(1) The name, address, and title of the person submitting the “full report” to the Commission.
(2) The name and address of the manufacturer (or importer) of the product and the addresses of the manufacturing plants for that product.
(3) An identification and description of the product(s). Give retail prices, model numbers, serial numbers, and date codes. Describe any identifying marks and their location on the product. Provide a picture or a sample of the product.
(4) A description of the nature of the defect, failure to comply, or risk. If technical drawings, test results, schematics, diagrams, blueprints, or other graphic depictions are available, attach copies.
(5) The nature of the injury or the possible injury associated with the product defect, failure to comply, or risk.
(6) The manner in which and the date when the information about the defect, noncompliance, or risk (e.g., complaints, reported injuries, quality control testing) was obtained. If any complaints related to the safety of the product or any allegations or reports of injuries associated with the product have been received, copies of such complaints or reports (or a summary thereof) shall be attached. Give a chronological account of facts or events leading to the report under section 15(b) of the CPSA, beginning with receipt of the first information which ultimately led to the report. Also included may be an analysis of these facts or events.
(7) The total number of products and units involved.
(8) The dates when products and units were manufactured, imported, distributed, and sold at retail.
(9) The number of products and units in each of the following: in the possession of the manufacturer or importer, in the possession of private labelers, in the possession of distributors, in the possession of retailers, and in the possession of consumers.
(10) An explanation of any changes (e.g., designs, adjustments, and additional parts, quality control, testing) that have been or will be effected to correct the defect, failure to comply, or risk and of the steps that have been or will be taken to prevent similar occurrences in the future together with the timetable for implementing such changes and steps.
(11) Information that has been or will be given to purchasers, including consumers, about the defect, noncompliance, or risk with a description of how this information has been or will be communicated. This shall include copies or drafts of any letters, press releases, warning labels, or other written information that has been or will be given to purchasers, including consumers.
(12) The details of and schedule for any contemplated refund, replacement, or repair actions, including plans for disposing of returned products (e.g., repair, destroy, return to foreign manufacturer).
(13) A detailed explanation and description of the marketing and distribution of the product from the manufacturer (including importer) to the consumer (e.g., use of sales representatives, independent contractors, and/or jobbers; installation of the product, if any, and by whom).
(14) Upon request, the names and addresses of all distributors, retailers, and purchasers, including consumers.
(15) Such further information necessary or appropriate to the functions of the Commission as is requested by the staff.
§ 1115.14 Time computations.
(a) General. Weekends and holidays are excluded from the computation of the time periods in this part.
(b) Imputing knowledge. In evaluating whether or when a firm should have reported, the Commission shall impute to the subject firm knowledge of product safety related information received by an official or employee of a subject firm capable of appreciating the significance of the information. Under ordinary circumstances, 5 days should be the maximum reasonable time for information to reach the Chief Executive Officer or the official or employee responsible for complying with the reporting requirements of section 15(b) of the CPSA. The Commission will impute knowledge possessed by the Chief Executive Officer or by the official or employee responsible for complying with the reporting requirements of section 15(b) of the CPSA simultaneously to the subject firm.
(c) Time when obligation to report arises. The obligation to report under section 15(b) of the CPSA may arise upon receipt by a subject firm of the first information regarding a noncompliance, or a potential hazard presented by a product defect, or an unreasonable risk. Information giving rise to a reporting obligation may include, but is not limited to, complaints, injury reports, quality control and engineering data. A subject firm should not await complete or accurate risk estimates before reporting under section 15(b) of CPSA. However, if information is not clearly reportable, a subject firm may spend a reasonable time for investigation and evaluation. (See § 1115.14(d).)
(d) Time for investigation and evaluation. A subject firm may conduct a reasonably expeditious investigation in order to evaluate the reportability of a death or grievous bodily injury or other information. This investigation and evaluation should not exceed 10 days unless a firm can demonstrate that a longer period is reasonable. The Commission will deem that, at the end of 10 days, a subject firm has received and considered all information which would have been available to it had a reasonable, expeditious, and diligent investigation been undertaken.
(e) Time to report. Immediately, that is, within 24 hours, after a subject firm has obtained information which reasonably supports the conclusion that its consumer product fails to comply with an applicable consumer product safety rule or voluntary consumer product safety standard, contains a defect which could create a substantial risk of injury to the public, or creates an unreasonable risk of serious injury or death, the firm should report. (See § 1115.13.) If a firm elects to conduct an investigation in order to evaluate the existence of reportable information, the 24-hour period begins when the firm has information which reasonably supports the conclusion that its consumer product fails to comply with an applicable consumer product safety rule or voluntary consumer product safety standard upon which the Commission has relied under section 9, contains a defect which could create a substantial product hazard, or creates an unreasonable risk of serious injury or death. Thus, a firm could report to the Commission before the conclusion of a reasonably expeditious investigation and evaluation if the reportable information becomes known during the course of the investigation. In lieu of the investigation, the firm may report the information immediately.
§ 1115.15 Confidentiality and disclosure of data.
(a) General. The Commission does not routinely make reports available to the public until the staff has made a preliminary hazard determination. Copies of reports will not be available to the public in the Commission’s public reading room, and information contained in reports will not ordinarily be disclosed to the public in the absence of a formal request.
(b) Freedom of Information Act. Any person who submits information to the Commission who believes that any portion of the information is entitled to exemption from public disclosure under the provisions of the Freedom of Information Act, as amended (15 U.S.C. 552(b)), of the CPSA, as amended, or of another Federal statute must accompany the submission with a written request that the information be considered exempt from disclosure or indicate that a written request will be submitted within 10 working days of the submission. The request shall (1) identify the portions of the information for which exemption is claimed, which may include the identity of the reporting firm and the fact that it is making a report, and (2) state the facts and reasons which support the claimed exemption. After the staff has made its preliminary hazard determination, and regardless of whether or not the staff preliminarily determines that a product presents a substantial product hazard, the Commission will no longer honor requests for exempt status for the identity of the reporting firm, the identity of the consumer product, and the nature of the reported alleged defect or noncompliance. This information, together with the staff’s preliminary hazard determination, will be made available to the public in the Commission’s public reading room. Information for which exempt status is claimed (such as alleged trade secrets, confidential commercial or financial information, or information the disclosure of which would constitute an unwarranted invasion of personal privacy) shall not be released to the public except in accordance with the applicable statute or the Commission’s Freedom of Information Act regulations (16 CFR part 1015).
(c) Section 6(b) of the CPSA. The Commission believes that the first two sentences in section 6(b)(1) of the CPSA (15 U.S.C. 2055(b)(1)) apply to affirmative dissemination of information by the Commission (such as press releases or fact sheets distributed to the public) from which the public may ascertain readily the identity of the product’s manufacturer and/or private labeler. Manufacturers and private labelers will ordinarily be given 30 days’ notice before the Commission makes such affirmative disseminations. However, this 30-day notice will not apply if the Commission finds that a lesser notice period is required in the interest of public health and safety.
Subpart B—Remedial Actions and Sanctions
§ 1115.20 Voluntary remedial actions.
As appropriate, the Commission will attempt to protect the public from substantial product hazards by seeking one or more of the following voluntary remedies:
(a) Corrective action plans. A corrective action plan is a document, signed by a subject firm, which sets forth the remedial action which the firm will voluntarily undertake to protect the public, but which has no legally binding effect. The Commission reserves the right to seek broader corrective action if it becomes aware of new facts or if the corrective action plan does not sufficiently protect the public.
(1) Corrective action plans shall include, as appropriate:
(i) A statement of the nature of the alleged hazard associated with the product, including the nature of the alleged defect or noncompliance and type(s) of injury or potential injury presented.
(ii) A detailed statement of the means to be employed to notify the public of the alleged product hazard (e.g., letter, press release, advertising), including an identification of the classes of persons who will receive such notice and a copy or copies of the notice or notices to be used.
(iii) A specification of model number and/or other appropriate descriptions of the product.
(iv) Any necessary instructions regarding use or handling of the product pending correction.
(v) An explanation of the specific cause of the alleged substantial product hazard, if known.
(vi) A statement of the corrective action which will be or has been taken to eliminate the alleged substantial product hazard. The firm should indicate whether it is repairing or replacing the product or refunding its purchase price. If products are to be returned to a subject firm, the corrective action plan should indicate their disposition (e.g., reworked, destroyed, returned to foreign manufacturer). Samples of replacement products and relevant drawings and test data for repairs or replacements should be available.
(vii) A statement of the steps that will be, or have been, taken to reasonably prevent recurrence of the alleged substantial product hazard in the future.
(viii) A statement of the action which will be undertaken to correct product units in the distribution chain, including a timetable and specific information about the number and location of such units.
(ix) The signatures of representatives of the subject firm.
(x) An acknowledgment by the subject firm that the Commission may monitor the corrective action and that the firm will furnish necessary information, including customer lists.
(xi) An agreement that the Commission may publicize the terms of the plan to the extent necessary to inform the public of the nature and extent of the alleged substantial product hazard and of the actions being undertaken to correct the alleged hazard presented.
(xii) Additional points of agreement, as appropriate.
(xiii) If desired by the subject firm, the following statement or its equivalent: “The submission of this corrective action plan does not constitute an admission by (the subject firm) that either reportable information or a substantial product hazard exists.”
(xiv) An acknowledgment that the corrective action plan becomes effective only upon its final acceptance by the Commission.
(2) In determining whether to recommend to the Commission acceptance of a corrective action plan, the staff shall consider favorably both the promptness of the subject firm’s reporting and any remedial actions taken by the subject firm in the interest of public safety. The staff also shall consider, insofar as possible, prior involvement by the subject firm in corrective action plans and Commission orders if such involvement bears on the likelihood that the firm will comply fully with the terms of the corrective action plan.
(3) Upon receipt of a corrective action plan and staff recommendation, the Commission may:
(i) Approve the plan;
(ii) Reject the plan and issue a complaint (in which case an administrative and/or judicial proceeding will be commenced); or
(iii) Take any other action necessary to insure that the plan is adequate.
(4) When time permits and where practicable in the interest of protecting the public, a summary of the plan shall be published in the Commission’s Public Calendar. Those portions of the plan that are not restricted will be made available to the public in the Commission’s public reading room as much in advance of the Commission meeting as practicable. Any interested person wishing to comment on the plan must file a Notice of Intent to Comment at least forty-eight (48) hours prior to the commencement of the Commission meeting during which the plan will be discussed. If no notices of intent are received, the Commission may take final action on the plan. If such notice is received within the time limits detailed above, the plan will, if practicable, be docketed for the following week’s agenda. All comments must be in writing, and final written comments must be submitted at least forty-eight (48) hours before that session.
(b) Consent order agreements under section 15 of CPSA. The consent order agreement (agreement) is a document executed by a subject firm (Consenting Party) and a Commission staff representative which incorporates both a proposed complaint setting forth the staff’s charges and a proposed order by which such charges are resolved.
(1) Consent order agreements shall include, as appropriate:
(i) An admission of all jurisdictional facts by the Consenting Party.
(ii) A waiver of any rights to an administrative or judicial hearing and of any other procedural steps, including any rights to seek judicial review or otherwise challenge or contest the validity of the Commission’s Order.
(iii) A statement that the agreement is in settlement of the staff’s charges.
(iv) A statement that the Commission’s Order is issued under section 15 of the CPSA (15 U.S.C. 2064) and that a violation is a prohibited act within the meaning of section 19(a)(5) of the CPSA (15 U.S.C. 2068(a)(5)) and may subject a violator to civil and/or criminal penalties under sections 20 and 21 of the CPSA (15 U.S.C. 2069 and 2070).
(v) An acknowledgment that the Commission reserves its right to seek sanctions for any violations of the reporting obligations of section 15(b) of CPSA (15 U.S.C. 2064(b)) and its right to take other appropriate legal action.
(vi) An acknowledgment that the agreement becomes effective only upon its final acceptance by the Commission and its service upon the Consenting Party.
(vii) An acknowledgment that the Commission may disclose terms of the consent order agreement to the public.
(viii) A listing of the acts or practices from which the Consenting Party will refrain.
(ix) A statement that the Consenting Party shall perform certain acts and practices pursuant to the agreement.
(x) An acknowledgment that any interested person may bring an action pursuant to section 24 of the CPSA (15 U.S.C. 2073) in any U.S. district court for the district in which the Consenting Party is found or transacts business to enforce the order and to obtain appropriate injunctive relief.
(xi) A description of the alleged substantial product hazard.
(xii) If desired by the Consenting Party, the following statement or its equivalent: “The signing of this consent order agreement does not constitute an admission by (the Consenting Party) that either reportable information or a substantial product hazard exists.”
(xiii) The elements of a corrective action plan as set forth in § 1115.20(a).
(2) At any time in the course of an investigation, the staff may propose to a subject firm which is being investigated that some or all of the allegations be resolved by a consent order agreement. Additionally, such a proposal may be made to the staff by a subject firm.
(3) Upon receiving an executed agreement, the Commission may:
(i) Provisionally accept it;
(ii) Reject it and issue a complaint (in which case an administrative and/or judicial proceeding will be commenced); or
(iii) Take such other action as it may deem appropriate.
(4) If the consent order agreement is provisionally accepted, the Commission shall place the agreement on the public record and shall announce provisional acceptance of the agreement in the Commission’s public calendar and in the
(5) If the Commission does not receive any requests not to accept the agreement within the time period specified above, the consent order agreement shall be deemed finally accepted by the Commission on the twentieth (20th) calendar day after the date of announcement in the
(6) If the Commission does not accept the consent order agreement on a final basis, it shall so notify the Consenting Party. Such notification constitutes withdrawal of the Commission’s provisional acceptance unless the Commission orders otherwise. The Commission then may:
(i) Issue a complaint, in which case an administrative and/or judicial proceeding will be commenced;
(ii) Order further investigation; or
(iii) Take such other action as it may deem appropriate.
§ 1115.21 Compulsory remedial actions.
As appropriate, the Commission will attempt to protect the public from hazards presented by consumer products by seeking one or more of the following:
(a) Adjudicated Commission Order. An adjudicated Commission Order under section 15 (c) or (d) of the CPSA may be issued after parties and interested persons have had an opportunity for a hearing in accordance with section 554 of title 5, United States Code, and with section 15(f) of the CPSA. This hearing is governed by the Commission’s Rules of Practice for Adjudicative Proceedings (16 CFR part 1025).
(b) Injunctive relief. The Commission may apply to a U.S. district court in accordance with the provisions of section 15(g) of the CPSA for a preliminary injunction to restrain the distribution in commerce of a product it has reason to believe presents a substantial product hazard. The Commission may seek enforcement of its orders issued under sections 15 (c) and (d) of the CPSA in accordance with provisions of sections 22 and 27(b)(7) of the CPSA (15 U.S.C. 2071 and 2076(b)(7)).
(c) Judicial determination of imminent hazard. The Commission may file a complaint in a U.S. district court in accordance with the provisions of section 12 of the CPSA (15 U.S.C. 2061).
(d) Orders of the Secretary of the Treasury. The Commission staff may inform the Secretary of the Treasury that a consumer product offered for importation into the customs territory of the United States fails to comply with an applicable consumer product safety rule and/or has a product defect which constitutes a substantial product hazard. The Commission may request the Secretary of the Treasury under section 17 of the CPSA (15 U.S.C. 2066) to refuse admission to any such consumer product.
§ 1115.22 Prohibited acts and sanctions.
(a) Statements generally. Whoever knowingly and willfully falsifies, or conceals a material fact in a report under the CPSA and rules thereunder, is subject to criminal penalties under 18 U.S.C. 1001.
(b) Timeliness and adequacy of reporting. A failure to inform the Commission immediately and adequately, as required by section 15(b) of the CPSA, is a prohibited act within section 19(a)(4) of the CPSA (15 U.S.C. 2068(a)(4)).
(c) Failure to make reports. The failure or refusal to make reports or provide information as required under the CPSA is a prohibited act within the meaning of section 19(a)(3) of the CPSA (15 U.S.C. 2068(a)(3)).
(d) Noncomplying products. The manufacture for sale, offering for sale, distribution in commerce, and/or importation into the United States of a consumer product which is not in conformity with an applicable consumer product safety rule under CPSA is a prohibited act within the meaning of sections 19 (a)(1) and (a)(2) of the CPSA (15 U.S.C. 2068 (a)(1) and (a)(2)).
(e) Orders issued under section 15 (c) and/or (d). The failure to comply with an order issued under section 15 (c) and/or (d) of the CPSA is a prohibited act within the meaning of section 19(a)(5) of the CPSA (15 U.S.C. 2068(a)(5)).
(f) Consequences of engaging in prohibited acts. A knowing violation of section 19(a) of the CPSA subjects the violator to a civil penalty in accordance with section 20 of the CPSA (15 U.S.C. 2069). “Knowing,” as defined in section 20(c) of the CPSA (15 U.S.C. 2069(c)), means the having of actual knowledge or the presumed having of knowledge deemed to be possessed by a reasonable person who acts in the circumstances, including knowledge obtainable upon the exercise of due care to ascertain the truth of representations. A knowing and willful violation of section 19(a), after the violator has received notice of noncompliance, subjects the violator to criminal penalties in accordance with section 21 of the CPSA (15 U.S.C. 2070).
Subpart C—Guidelines and Requirements for Mandatory Recall Notices
§ 1115.23 Purpose.
(a) The Commission establishes these guidelines and requirements for recall notices as required by section 15(i) of the Consumer Product Safety Act, as amended (CPSA) (15 U.S.C. 2064(i)). The guidelines and requirements set forth the information to be included in a notice required by an order under sections 12, 15(c), or 15(d) of the CPSA (15 U.S.C. 2061, 2064(c), or 2064(d)). Unless otherwise ordered by the Commission under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or by a United States district court under section 12 of the CPSA (15 U.S.C. 2061), the content information required in this subpart must be included in every such notice.
(b) The Commission establishes these guidelines and requirements to ensure that every recall notice effectively helps consumers and other persons to:
(1) Identify the specific product to which the recall notice pertains;
(2) Understand the product’s actual or potential hazards to which the recall notice pertains, and information relating to such hazards; and
(3) Understand all remedies available to consumers concerning the product to which the recall notice pertains.
§ 1115.24 Applicability.
This subpart applies to manufacturers (including importers), retailers, and distributors of consumer products as those terms are defined herein and in the CPSA.
§ 1115.25 Definitions.
In addition to the definitions given in section 3 of the CPSA (15 U.S.C. 2052), the following definitions apply:
(a) Recall means any one or more of the actions required by an order under sections 12, 15(c), or 15(d) of the CPSA (15 U.S.C. 2061, 2064(c), or 2064(d)).
(b) Recall notice means a notification required by an order under sections 12, 15(c), or 15(d) of the CPSA (15 U.S.C. 2061, 2064(c), or 2064(d)).
(c) Direct recall notice means a notification required by an order under sections 12, 15(c), or 15(d) of the CPSA (15 U.S.C. 2061, 2064(c), or 2064(d)), that is sent directly to specifically-identified consumers.
(d) Firm means a manufacturer (including an importer), retailer, or distributor as those terms are defined in the CPSA.
(e) Other persons means, but is not limited to, consumer safety advocacy organizations, public interest groups, trade associations, industry advocacy organizations, other State, local, and Federal government agencies, and the media.
§ 1115.26 Guidelines and policies.
(a) General. (1) A recall notice should provide sufficient information and motivation for consumers and other persons to identify the product and its actual or potential hazards, and to respond and take the stated action. A recall notice should clearly and concisely state the potential for injury or death.
(2) A recall notice should be written in language designed for, and readily understood by, the targeted consumers or other persons. The language should be simple and should avoid or minimize the use of highly technical or legal terminology.
(3) A recall notice should be targeted and tailored to the specific product and circumstances. In determining the form and content of a recall notice, the manner in which the product was advertised and marketed should be considered.
(4) A direct recall notice is the most effective form of a recall notice.
(5) At least two of the recall notice forms listed in subsection (b) should be used.
(b) Form of recall notice—(1) Possible forms. A recall notice may be written, electronic, audio, visual, or in any other form ordered by the Commission in an order under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or by a United States district court under section 12 of the CPSA (15 U.S.C. 2061). The forms of, and means for communicating, recall notices include, but are not limited to:
(i) Letter, Web site posting, electronic mail, RSS feed, or text message;
(ii) Computer, radio, television, or other electronic transmission or medium;
(iii) Video news release, press release, recall alert, Web stream, or other form of news release;
(iv) Newspaper, magazine, catalog, or other publication; and
(v) Advertisement, newsletter, and service bulletin.
(2) Direct recall notice. A direct recall notice should be used for each consumer for whom a firm has direct contact information, or when such information is obtainable, regardless of whether the information was collected for product registration, sales records, catalog orders, billing records, marketing purposes, warranty information, loyal purchaser clubs, or other such purposes. Direct contact information includes, but is not limited to, name and address, telephone number, and electronic mail address. Forms of direct recall notice include, but are not limited to, United States mail, electronic mail, and telephone calls. A direct recall notice should prominently show its importance over other consumer notices or mail by including “Safety Recall” or other appropriate terms in an electronic mail subject line, and, in large bold red typeface, on the front of an envelope and in the body of a recall notice.
(3) Web site recall notice. A Web site recall notice should be on a Web site’s first entry point such as a home page, should be clear and prominent, and should be interactive by permitting consumers and other persons to obtain recall information and request a remedy directly on the Web site.
(c) Languages. Where the Commission for purposes of an order under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or a United States district court for purposes of an order under section 12 of the CPSA (15 U.S.C. 2061), determines that it is necessary or appropriate to adequately inform and protect the public, a recall notice may be required to be in languages in addition to English. For example, it may be necessary or appropriate to require a recall notice be in a language in addition to English when a product label is in a language in addition to English, when a product is marketed in a language in addition to English, or when a product is marketed or available in a geographic location where English is not the predominant language.
§ 1115.27 Recall notice content requirements.
Except as provided in § 1115.29, every recall notice must include the information set forth below:
(a) Terms. A recall notice must include the word “recall” in the heading and text.
(b) Date. A recall notice must include its date of release, issuance, posting, or publication.
(c) Description of product. A recall notice must include a clear and concise statement of the information that will enable consumers and other persons to readily and accurately identify the specific product and distinguish it from similar products. The information must enable consumers to readily determine whether or not they have, or may be exposed to, the product. To the extent applicable to a product, descriptive information that must appear on a recall notice includes, but is not limited to:
(1) The product’s names, including informal and abbreviated names, by which consumers and other persons should know or recognize the product;
(2) The product’s intended or targeted use population (e.g., infants, children, or adults);
(3) The product’s colors and sizes;
(4) The product’s model numbers, serial numbers, date codes, stock keeping unit (SKU) numbers, and tracking labels, including their exact locations on the product;
(5) Identification and exact locations of product tags, labels, and other identifying parts, and a statement of the specific identifying information found on each part; and
(6) Product photographs. A firm must provide photographs. Each photograph must be electronic or digital, in color, of high resolution and quality, and in a format readily transferable with high quality to a Web site or other appropriate medium. As needed for effective notification, multiple photographs and photograph angles may be required.
(d) Description of action being taken. A recall notice must contain a clear and concise statement of the actions that a firm is taking concerning the product. These actions may include, but are not limited to, one or more of the following: Stop sale and distribution in commerce; recall to the distributor, retailer, or consumer level; repair; request return and provide a replacement; and request return and provide a refund.
(e) Statement of number of product units. A recall notice must state the approximate number of product units covered by the recall, including all product units manufactured, imported, and/or distributed in commerce.
(f) Description of substantial product hazard. A recall notice must contain a clear and concise description of the product’s actual or potential hazards that result from the product condition or circumstances giving rise to the recall. The description must enable consumers and other persons to readily identify the reasons that a firm is conducting a recall. The description must also enable consumers and other persons to readily identify and understand the risks and potential injuries or deaths associated with the product conditions and circumstances giving rise to the recall. The description must include:
(1) The product defect, fault, failure, flaw, and/or problem giving rise to the recall; and
(2) The type of hazard or risk, including, by way of example only, burn, fall, choking, laceration, entrapment, and/or death.
(g) Identification of recalling firm. A recall notice must identify the firm conducting the recall by stating the firm’s legal name and commonly known trade name, and the city and state of its headquarters. The notice must state whether the recalling firm is a manufacturer (including importer), retailer, or distributor.
(h) Identification of manufacturers. A recall notice must identify each manufacturer (including importer) of the product and the country of manufacture. Under the definition in section 3(a)(11) of the CPSA (15 U.S.C. 2052(a)(11)), a manufacturer means “any person who manufactures or imports a consumer product.” If a product has been manufactured outside of the United States, a recall notice must identify the foreign manufacturer and the United States importer. A recall notice must identify the manufacturer by stating the manufacturer’s legal name and the city and state of its headquarters, or, if a foreign manufacturer, the foreign manufacturer’s legal name and the city and country of its headquarters.
(i) Identification of significant retailers. A recall notice must identify each significant retailer of the product. A recall notice must identify such a retailer by stating the retailer’s commonly known trade name. Under the definition in section 3(a)(13) of the CPSA (15 U.S.C. 2052(a)(13)), a retailer means “a person to whom a consumer product is delivered or sold for purposes of sale or distribution by such person to a consumer.” A product’s retailer is “significant” if, upon the Commission’s information and belief, and in the sole discretion of the Commission for purposes of an order under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or in the sole discretion of a United States district court for purposes of an order under section 12 of the CPSA (15 U.S.C. 2061), any one or more of the circumstances set forth below is present (the Commission may require manufacturers (including importers), retailers, and distributors to provide information relating to these circumstances):
(1) The retailer was the exclusive retailer of the product;
(2) The retailer was an importer of the product;
(3) The retailer has stores nationwide or regionally-located;
(4) The retailer sold, or held for purposes of sale or distribution in commerce, a significant number of the total manufactured, imported, or distributed units of the product; or
(5) Identification of the retailer is in the public interest.
(j) Region. Where necessary or appropriate to assist consumers in determining whether they have the product at issue, a description of the region where the product was sold, or held for purposes of sale or distribution in commerce, must be provided.
(k) Dates of manufacture and sale. A recall notice must state the month and year in which the manufacture of the product began and ended, and the month and year in which the retail sales of the product began and ended. These dates must be included for each make and model of the product.
(l) Price. A recall notice must state the approximate retail price or price range of the product.
(m) Description of incidents, injuries, and deaths. A recall notice must contain a clear and concise summary description of all incidents (including, but not limited to, property damage), injuries, and deaths associated with the product conditions or circumstances giving rise to the recall, as well as a statement of the number of such incidents, injuries, and deaths. The description must enable consumers and other persons to readily understand the nature and extent of the incidents and injuries. A recall notice must state the ages of all persons injured and killed. A recall notice must state the dates or range of dates on which the Commission received information about injuries and deaths.
(n) Description of remedy. A recall notice must contain a clear and concise statement, readily understandable by consumers and other persons, of:
(1) Each remedy available to a consumer for the product conditions or circumstances giving rise to the recall. Remedies include, but are not limited to, refunds, product repairs, product replacements, rebates, coupons, gifts, premiums, and other incentives.
(2) All specific actions that a consumer must take to obtain each remedy, including, but not limited to, instructions on how to participate in the recall. These actions may include, but are not limited to, contacting a firm, removing the product from use, discarding the product, returning part or all of the product, or removing or disabling part of the product.
(3) All specific information that a consumer needs in order to obtain each remedy and to obtain all information about each remedy. This information may include, but is not limited to, the following: Manufacturer, retailer, and distributor contact information (such as name, address, telephone and facsimile numbers, e-mail address, and Web site address); whether telephone calls will be toll-free or collect; and telephone number days and hours of operation including time zone.
(o) Other information. A recall notice must contain such other information as the Commission for purposes of an order under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or a United States district court for purposes of an order under section 12 of the CPSA (15 U.S.C. 2061), deems appropriate and orders.
§ 1115.28 Multiple products or models.
For each product or model covered by a recall notice, the notice must meet the requirements of this subpart.
§ 1115.29 Final determination regarding form and content.
(a) Commission or court discretion. The recall notice content required by this subpart must be included in a recall notice whether or not the firm admits the existence of a defect or of an actual or potential hazard, and whether or not the firm concedes the accuracy or applicability of all of the information contained in the recall notice. The Commission will make the final determination as to the form and content of the recall notice for purposes of an order under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), and a United States district court will make the final determination as to the form and content of a recall notice for purposes of an order under section 12 of the CPSA (15 U.S.C. 2061).
(b) Recall notice exceptions. The Commission for purposes of an order under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or a United States district court for purposes of an order under section 12 of the CPSA (15 U.S.C. 2061), may determine that one or more of the recall notice requirements set forth in this subpart is not required, and will not be included, in a recall notice.
(c) Commission approval. Before a firm may publish, broadcast, or otherwise disseminate a recall notice to be issued pursuant to an order under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), the Commission must review and agree in writing to all aspects of the notice.
Appendix to Part 1115—Voluntary Standards on Which the Commission Has Relied Under Section 9 of the Consumer Product Safety Act
The following are the voluntary standards on which the Commission has relied under section 9 of the Consumer Product Safety Act:
1. American National Standard for Power Tools—Gasoline-Powered Chain Saws—Safety Regulations, ANSI B175.1-1985 sections 4.9.4, 4.12, 4.15, 7 and 8, or the current version: ANSI B175.1-1991 sections 5.9.4, 5.12, 5.15, 8 and 9.
2. American National Standard for Gas-Fired Room Heaters, Volume II, Unvented Room Heaters, ANSI Z21.11.2-1989 and addenda ANSI Z21.11.2 a and b- 1991), sections 1.8, 1.20.9, and 2.9.
PART 1116—REPORTS SUBMITTED PURSUANT TO SECTION 37 OF THE CONSUMER PRODUCT SAFETY ACT
§ 1116.1 Purpose.
The purpose of this part 1116 is to establish procedures for filing with the Consumer Product Safety Commission (“the Commission”) reports required by section 37 of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2084) and to set forth the Commission’s interpretation of the provisions of section 37.
§ 1116.2 Definitions.
(a) A 24-month period(s) means the 24-month period beginning on January 1, 1991, and each subsequent 24-month period beginning on January 1 of the calendar year that is two years following the beginning of the previous 24-month period. The first statutory two year period ends on December 31, 1992. The second begins on January 1, 1993 and ends on December 31, 1994, and so forth.
(b) Grievous bodily injury includes, but is not limited to, any of the following categories of injury:
(1) Mutilation or disfigurement. Disfigurement includes permanent facial disfigurement or non-facial scarring that results in permanent restriction of motion;
(2) Dismemberment or amputation, including the removal of a limb or other appendage of the body;
(3) The loss of important bodily functions or debilitating internal disorder. These terms include:
(i) Permanent injury to a vital organ, in any degree;
(ii) The total loss or loss of use of any internal organ,
(iii) Injury, temporary or permanent, to more than one internal organ;
(iv) Permanent brain injury to any degree or with any residual disorder (e.g. epilepsy), and brain or brain stem injury including coma and spinal cord injuries;
(v) Paraplegia, quadriplegia, or permanent paralysis or paresis, to any degree;
(vi) Blindness or permanent loss, to any degree, of vision, hearing, or sense of smell, touch, or taste;
(vii) Any back or neck injury requiring surgery, or any injury requiring joint replacement or any form of prosthesis, or;
(viii) Compound fracture of any long bone, or multiple fractures that result in permanent or significant temporary loss of the function of an important part of the body;
(4) Injuries likely to require extended hospitalization, including any injury requiring 30 or more consecutive days of in-patient care in an acute care facility, or 60 or more consecutive days of in-patient care in a rehabilitation facility;
(5) Severe burns, including any third degree burn over ten percent of the body or more, or any second degree burn over thirty percent of the body or more;
(6) Severe electric shock, including ventricular fibrillation, neurological damage, or thermal damage to internal tissue caused by electric shock.
(7) Other grievous injuries, including any allegation of traumatically induced disease.
(c) A particular model of a consumer product is one that is distinctive in functional design, construction, warnings or instructions related to safety, function, user population, or other characteristics which could affect the product’s safety related performance. (15 U.S.C. 2084(e)(2))
(1) The functional design of a product refers to those design features that directly affect the ability of the product to perform its intended use or purpose.
(2) The construction of a product refers to its finished assembly or fabrication, its materials, and its components.
(3) Warnings or instructions related to safety include statements of the principal hazards associated with a product, and statements of precautionary or affirmative measures to take during the use, handling, or storage of a product, to the extent that a reasonable person would understand such statements to be related to the safety of the product. Warnings or instructions may be written or graphically depicted and may be attached to the product or appear on the product itself, in operating manuals, or in other literature that accompanies or describes the product.
(4) The function of a product refers to its intended use or purpose.
(5) User population refers to the group or class of people by whom a product is principally used. While the manufacturer’s stated intent may be relevant to an inquiry concerning the nature of the user population, the method of distribution, the availability of the product to the public and to specific groups, and the identity of purchasers or users of the product should be considered.
(6) Other characteristics which could affect a product’s safety related performance include safety features incorporated into the product to protect against foreseeable risks that might arise during the use, handling, or storage of a product.
(d) The term manufacturer means any person who manufactures or imports a consumer product. (15 U.S.C. 2052(a)(4)).
§ 1116.3 Persons who must report under section 37.
A manufacturer of a consumer product must report if:
(a) A particular model of the product is the subject of at least 3 civil actions filed in Federal or State Court;
(b) Each suit alleges the involvement of that particular model in death or grievous bodily injury;
(c) The manufacturer is—
(1) A party to, or
(2) Is involved in the defense of or has notice of each action prior to entry of a final order, and is involved in the discharge of any obligation owed to plaintiff under the settlement of or in satisfaction of the judgment after adjudication in each of the suits; and
(d) During one of the 24-month periods defined in § 1116.2(a), each of the three actions results in either a final settlement involving the manufacturer or in a court judgment in favor of the plaintiff.
§ 1116.4 Where to report.
Reports must be sent in writing to the Commission’s Office of Compliance and Enforcement, Division of Corrective Actions, Washington, DC 20207, telephone (301) 504-0608).
§ 1116.5 When must a report be made.
(a) A manufacturer must report to the Commission within 30 days after the final settlement or court judgment in the last of the three civil actions referenced in § 1116.3.
(b) If a manufacturer has filed a section 37 report within one of the 24-month periods defined in § 1116.2(a), the manufacturer must also report the information required by section 37(c)(1) for any subsequent settlement or judgment in a civil action that alleges that the same particular model of the product was involved in death or grievous bodily injury and that takes place during the same 24-month period. Each such supplemental report must be filed within 30 days of the settlement or final judgment in the reportable civil action.
§ 1116.6 Contents of section 37 reports.
(a) Required information. With respect to each of the civil actions that is the subject of a report under section 37, the report must contain the following information:
(1) The name and address of the manufacturer of the product that was the subject of each civil action;
(2) The model and model number or designation of the consumer product subject to each action;
(3) A statement as to whether the civil action alleged death or grievous bodily injury, and, in the case of an allegation of grievous bodily injury, a statement of the category of such injury;
(4) A statement as to whether the civil action resulted in a final settlement or a judgment in favor of the plaintiff; and
(5) In the case of a judgment in favor of the plaintiff, the name of the civil action, the number assigned to the civil action, and the court in which the civil action was filed.
(b) Optional information. A manufacturer furnishing a report may include:
(1) A statement as to whether any judgment in favor of the plaintiff is under appeal or is expected to be appealed (section 15 U.S.C. 2084(c)(2)(A));
(2) Any other information that the manufacturer chooses to provide (15 U.S.C. 2084(c)(2)(B)), including the dates on which final orders were entered in the reported lawsuits, and, where appropriate, an explanation why the manufacturer has not previously filed a report under section 15(b) of the CPSA covering the same particular product model that is the subject of the section 37 report; and
(3) A specific denial that the information it submits reasonably supports the conclusion that its consumer product caused a death or grievous bodily injury.
(c) Statement of amount not required. A manufacturer submitting a section 37 report is not required by section 37 or any other provision of the Consumer Product Safety Act to provide a statement of any amount paid in final settlement of any civil action that is the subject of the report.
(d) Admission of liability not required. A manufacturer reporting to the Commission under section 37 need not admit that the information it reports supports the conclusion that its consumer product caused a death or grievous bodily injury.
§ 1116.7 Scope of section 37 and its relationship to section 15(b) of the CPSA.
(a) According to the legislative history of the Consumer Product Safety Improvement Act of 1990, the purpose of section 37 is to increase the reporting of information to the Commission that will assist it in carrying out its responsibilities.
(b) Section 37(c)(1) requires a manufacturer or importer (hereinafter “manufacturer”) to include in a section 37 report a statement as to whether a civil action that is the subject of the report alleged death or grievous bodily injury. Furthermore, under section 37(c)(2), a manufacturer may specifically deny that the information it submits pursuant to section 37 reasonably supports the conclusion that its consumer product caused a death or grievous bodily injury, and may also include any additional information that it chooses to provide. In view of the foregoing, the reporting obligation is not limited to those cases in which a product has been adjudicated as the cause of death or grievous injury or to those settled or adjudicated cases in which the manufacturer has satisfied itself that the product was the cause of such trauma. Rather, when the specific injury alleged by the plaintiff meets the definition of “grievous bodily injury” contained in § 1116.2(b) of this part, the lawsuit falls within the scope of section 37 after settlement or adjudication. The manufacturer’s opinion as to the validity of the allegation is irrelevant for reporting purposes. The category of injury alleged may be clear from the face of an original or amended complaint in a case or may reasonably be determined during pre-complaint investigation, post-complaint discovery, or informal settlement negotiation. Conclusory language in a complaint that the plaintiff suffered grievous bodily injury without further elaboration raises a presumption that the injury falls within one of the statutory categories, but is insufficient in itself to bring the suit within the ambit of the statute, unless the defendant manufacturer elects to settle such a matter without any investigation of the underlying facts. A case alleging the occurrence of grievous bodily injury in which a litigated verdict contains express findings that the injury suffered by the plaintiff did not meet the statutory criteria is also not reportable. Should a manufacturer believe that its product is wrongly implicated in an action, the statute expressly incorporates the mechanism for the manufacturer to communicate that belief to the Commission by denying in the report the involvement of the product or that the injury in fact suffered by the plaintiff was not grievous bodily injury, despite the plaintiff’s allegations to the contrary. In addition, the statute imposes stringent confidentiality requirements on the disclosure by the Commission or the Department of Justice of information submitted pursuant to sections 37(c)(1) and 37(c)(2)(A). Moreover, it specifies that the reporting of a civil action shall not constitute an admission of liability under any statute or common law or under the relevant provisions of the Consumer Product Safety Act. In view of these safeguards, the reporting of lawsuits alleging the occurrence of death or grievous injury should have little adverse effect on manufacturers.
(c) Section 37 applies to judgments and “final settlements”. Accordingly, the date on which a civil action is filed or the date on which the product that is the subject of such an action was manufactured is irrelevant to the obligation to report. A settlement is final upon the entry by a court of an order disposing of a civil action with respect to the manufacturer of the product that is the subject of the action, even through the case may continue with respect to other defendants.
(d) A judgment becomes reportable upon the entry of a final order by the trial court disposing of the matter in favor of the plaintiff and from which an appeal lies. Because section 37(c)(2) specifies that a reporting manufacturer may include a statement that a judgment in favor of a plaintiff is under appeal or is expected to be appealed, Congress clearly intended section 37 to apply prior to the exhaustion of or even the initiation of action to seek appellate remedies.
(e) No language in section 37 limits the reporting obligation to those litigated cases in which the plaintiff prevails completely. Therefore, if a court enters a partial judgment in favor of the plaintiff, the judgment is reportable, unless it is unrelated to the product that is the subject of the suit. For example, if a manufacturer’s product is exonerated during a suit, but liability is assessed against another defendant, the manufacturer need not report under section 37.
(f)(1) Section 37 applies to civil actions that allege the involvement of a particular model of a consumer product in death or grievous bodily injury. Section 3(a) of the Consumer Product Safety Act (15 U.S.C. 2052(a)) defines a “consumer product” as any article, or component part thereof, produced or distributed for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or for the personal use, consumption, or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise. The term “consumer product” does not include any article which is not customarily produced or distributed for sale to, or use or consumption by, or enjoyment of, a consumer.
(2) Since section 37 focuses on consumer products, it is the responsibility of the manufacturer of a product implicated in a civil action to determine whether the production or distribution of the product satisfies the statutory criteria of section 3(a). If it does, the action falls within the ambit of section 37. True industrial products are beyond the scope of section 37. However, if a lawsuit is based on an allegation of injury involving a consumer product, that suit falls within the scope of section 37, even though the injury may have occurred during the use of the product in employment. By the same token, occupational injuries arising during the fabrication of a consumer product are not reportable if the entity involved in the injury is not a consumer product at the time the injury occurs. In determining whether a product meets the statutory definition, manufacturers may wish to consult the relevant case law and the advisory opinions issued by the Commission’s Office of the General Counsel. The unique circumstances surrounding litigation involving asbestos-containing products warrant one exception to this analysis. The Commission, as a matter of agency discretion, will require manufacturers of such products to report under section 37 only those lawsuits that allege the occurrence of death or grievous bodily injury as the result of exposure to asbestos from a particular model of a consumer product purchased by a consumer for personal use. Such lawsuits would include not only injury to the purchaser, but also to other consumers including family, subsequent property owners, and visitors. The Commission may consider granting similar relief to manufacturers of other products that present a risk of chronic injury similar to that presented by asbestos. Any such request must contain documented evidence demonstrating that compliance with the reporting requirements will be unduly burdensome and will be unlikely to produce information that will assist the Commission in carrying out its obligations under the statutes it administers.
(g) The definition of “consumer product” also encompasses a variety of products that are subject to regulation under the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.), the Poison Prevention Packaging Act (15 U.S.C. 1471 et seq.), the Flammable Fabrics Act (15 U.S.C. 1191 et seq.), and the Refrigerator Safety Act (15 U.S.C. 1211 et seq.). Lawsuits involving such products are also subject to section 37, notwithstanding the fact that the products may be regulated or subject to regulation under one of the other statutes.
(h) Relationship of Section 37 to Section 15 of the CPSA. (1) Section 37 plays a complementary role to the reporting requirements of section 15(b) of the CPSA (15 U.S.C. 2064(b)). Section 15(b) establishes a substantial obligation for firms to review information as it becomes available to determine whether an obligation to report exists. Accordingly, the responsibility to report under section 15(b) may arise long before enough lawsuits involving a product are resolved to create the obligation to report under section 37. The enactment of section 15(b)(3) in the Consumer Product Safety Improvement Act of 1990 reinforces this expectation. Under this amendment, manufacturers must report to the Commission when they obtain information that reasonably supports the conclusion that a product creates an unreasonable risk of serious injury or death. Previously, the reporting obligation for unregulated products only arose when available information indicated that the product in question was defective and created a substantial product hazard because of the pattern of the defect, the severity of the risk of injury, the number of products distributed in commerce, etc. The effect of the 1990 amendment is discussed in detail in the Commission’s interpretative rule relating to the reporting of substantial product hazards at 16 CFR part 1115.
(2) The new substantive reporting requirements of section 15(b)(3) support the conclusion that Congress intended section 37 to capture product-related accident information that has not been reported under section 15(b). Between the time a firm learns of an incident or problem involving a product that raises safety-related concerns and the time that a lawsuit involving that product is resolved by settlement or adjudication, the firm generally has numerous opportunities to evaluate whether a section 15 report is appropriate. Such evaluation might be appropriate, for example, after an analysis of product returns, the receipt of an insurance investigator’s report, a physical examination of the product, the interview or deposition of an injured party or an eyewitness to the event that gave rise to the lawsuit, or even preparation of the firm’s responses to plaintiff’s discovery requests. Even if a manufacturer does not believe that a report is required prior to the resolution of a single lawsuit, an obligation to investigate whether a report is appropriate may arise if, for example, a verdict in favor of the plaintiff raises the issue of whether the product in question creates an unreasonable risk of death or serious injury.
(3) In contrast, the application of section 37 does not involve the discretionary judgment and subjective analyses of hazard and causation associated with section 15 reports. Once the statutory criteria of three settled or adjudicated civil actions alleging grievous injury or death in a two year period are met, the obligation to report under section 37 is automatic. For this reason, the Commission regards section 37 as a “safety net” to surface product hazards that remain unreported either intentionally or by inadvertence. The provisions in the law limiting such reports to cases in which three or more lawsuits alleging grievous injury or death are settled or adjudicated in favor of plaintiffs during a two year period provide assurance that the product involved presents a sufficiently grave risk of injury to warrant consideration by the Commission. Indeed, once the obligation to report under section 37 arises, the obligation to file a section 15 report concurrently may exist if the information available to the manufacturer meets the criteria established in section 15(b) for reporting.
(4) Section 37 contains no specific record keeping requirements. However, to track and catalog lawsuits to determine whether they are reportable, prudent manufacturers will develop and maintain information systems to index and retain lawsuit data. In the absence of a prior section 15 report, once such systems are in place, such manufacturers will be in a position to perform a two-fold analysis to determine whether the information contained in such systems is reportable under either section 15(b) or 37. A manufacturer might conclude, for example, that the differences between products that are the subject of different lawsuits make them different models or that the type of injury alleged in one or more of the suits is not grievous bodily injury. Based on this analysis, the manufacturer might also conclude that the suits are thus not reportable under section 37. However, a reporting obligation under section 15 may exist in any event if the same information reasonably supports the conclusion that the product(s) contain a defect which could create a substantial product hazard or create an unreasonable risk of serious injury or death.
§ 1116.8 Determination of particular model.
(a) The obligation rests with the manufacturer of a product to determine whether a reasonable basis exists to conclude that a product that is the subject of a settled or adjudicated lawsuit is sufficiently different from other similar products to be regarded as a “particular model” under section 37 because it is “distinctive.” To determine whether a product is “distinctive”, the proper inquiry should be directed toward the degree to which a product differs from other comparable products in one or more of the characteristics enumerated in section 37(e)(2) and § 1116.2(c) of this part. A product is “distinctive” if, after an analysis of information relating to one or more of the statutory characteristics, a manufacturer, acting in accordance with the customs and practices of the trade of which it is a member, could reasonably conclude that the difference between that product and other items of the same product class manufactured or imported by the same manufacturer is substantial and material. Information relevant to the determination of whether a product is a “particular model” includes:
(1) The description of the features and uses of the products in question in written material such as instruction manuals, description brochures, marketing or promotional programs, reports of certification of products, specification sheets, and product drawings.
(2) The differences or similarities between products in their observable physical characteristics and in components or features that are not readily observable and that are incorporated in those products for safety-related purposes;
(3) The customs and practices of the trade of which the manufacturer is a member in marketing, designating, or evaluating similar products.
(4) Information on how consumers use the products and on consumer need or demand for different products, such as products of different size. In analyzing whether products are different models, differences in size or calibration afford the basis for distinguishing between products only if those differences make the products distinctive in functional design or function.
(5) The history of the manufacturer’s model identification and marketing of the products in question;
(6) Whether variations between products relate solely to appearance, ornamentation, color, or other cosmetic features; such variations are not ordinarily sufficient to differentiate between models.
(7) Whether component parts used in a product are interchangeable with or perform substantially the same function as comparable components in other units; if they are, the use of such components does not afford a basis for distinguishing between models.
(8) Retail price. Substantial variations in price arising directly from the characteristics enumerated in section 37(e)(2) for evaluating product models may be evidence that products are different models because their differences are distinctive. Price variations imposed to accommodate different markets or vendors are not sufficient to draw such a distinction.
(9) Manufacturer’s designation, model number, or private label designation. These factors are not controlling in identifying “particular models”.
(10) Expert evaluation of the characteristics of the products in question, and surveys of consumer users or a manufacturer’s retail customers.
(b) The definition of “consumer product” expressly applies to components of consumer products. Should a component manufacturer be joined in a civil action against a manufacturer of a consumer product, the section 37 reporting requirements may apply to that manufacturer after a combination of three judgments or settlements involving the same component model during a two year period, even though the manufacturer of the finished product is exempt from such reporting because the lawsuits do not involve the same particular model of the finished consumer product. The same proposition holds true for common components used in different consumer products. If the manufacturer of such a component is a defendant in three suits and the requisite statutory criteria are met, the reporting obligations apply.
(c) Section 37 expressly defines the reporting obligation in terms of the particular model of a product rather than the manner in which a product was involved in an accident. Accordingly, even if the characteristic of a product that caused or resulted in the deaths of grievous injuries alleged in three or more civil actions is the same in all of the suits, the requirement to report under section 37 would arise only if the same particular model was involved in at least three of the suits. However, the existence of such a pattern would strongly suggest that the obligation to file a report under section 15(b) (2) or (3) (15 U.S.C. 2064(b) (2) or (3)) exists because the information reasonably supports the conclusion that the product contains a defect that could present a substantial risk of injury to the public or creates an unreasonable risk of serious injury or death.
(d) Section 37 does not require that the same category of injury be involved in multiple lawsuits for the reporting obligation to arise. As long as a particular model of a consumer product is the subject of at least three civil actions that are settled or adjudicated in favor of the plaintiff in one of the statutory two year periods, the manufacturer must report, even though the alleged category of injury and the alleged causal relationship of the product to the injury in each suit may differ.
§ 1116.9 Confidentiality of reports.
(a) Pursuant to section 6(e) of the Consumer Product Safety Act (15 U.S.C. 2055(e)) no member of the Commission, no officer or employee of the Commission, and no officer or employee of the Department of Justice may publicly disclose information furnished to the Commission under section 37(c)(1) and section 37(c)(2)(A) of the Act, except that:
(1) An authenticated copy of a section 37 report furnished to the Commission by or on behalf of a manufacturer may, upon written request, be furnished to the manufacturer or its authorized agent after payment of the actual or estimated cost of searching the records and furnishing such copies; or
(2) Any information furnished to the Commission under section 37 shall, upon written request of the Chairman or Ranking Minority Member of the Committee on Commerce, Science, and Transportation of the Senate or the Committee on Energy and Commerce of the House of Representatives or any subcommittee of such committee, be provided to the Chairman or Ranking Minority Member for purposes that are related to the jurisdiction of such committee or subcommittee.
(b) The prohibition contained in section 6(e) (15 U.S.C. 2055(e)) against the disclosure of information submitted pursuant to section 37 only applies to the specific items of information that a manufacturer is required to submit under section 37(c)(1) and to statements under section 37(c)(2)(A) relating to the possibility or existence of an appeal of a reported judgment adverse to a manufacturer. Section 6(e)(1) does not, by its terms, apply to information that the manufacturer voluntarily chooses to submit pursuant to section 37(c)(2)(B). Thus, disclosure of such information is governed by the other provisions of section 6 of the CPSA (15 U.S.C. 2055) and by the interpretative rules issued by the Commission (16 CFR parts 1101 and 1015). For example, if a manufacturer includes information otherwise reportable under section 15 as part of a section 37 report, the Commission will treat the information reported pursuant to section 15 as “additional information” submitted pursuant to section 37(c)(2)(B). Generally, any issue of the public disclosure of that information will be controlled by the relevant provisions of section 6(b), including section 6(b)(5) relating to the disclosure of substantial product hazard reports, and section 6(a) relating to the disclosure of confidential or trade secret information. However, to the extent the section 15 report reiterates or references information reported under section 37, the confidentiality provisions of section 6(e) still apply to the reiteration or reference. In addition, interpretative regulations issued under section 6(b) of the Act establish that disclosure of certain information may be barred if the disclosure would not be fair in the circumstances. 16 CFR 1101.33. Accordingly, issues of releasing additional information submitted pursuant to section 37 will also be evaluated under the fairness provisions of section 6(b). Should the Commission receive a request for such information or contemplate disclosure on its own initiative, the manufacturer will be given an opportunity to present arguments to the Commission why the information should not be disclosed, including, if appropriate, why disclosure of the information would be unfair in the circumstances. Among the factors the Commission will consider in evaluating the fairness of releasing the information are the nature of the information, the fact that it is an adjunct to a Congressional protected report, and whether the information in question supports the conclusion that a section 37 or 15(b), CPSA, report should have been filed earlier.
(c) Section 6(e) imposes no confidentiality requirements on information obtained by the Commission independently of a report pursuant to section 37. The provisions of section 6(b) govern the disclosure of such information.
§ 1116.10 Restrictions on use of reports.
No member of the Commission, no officer or employee of the Commission, and no officer or employee of the Department of Justice may use information provided to the Commission under section 37 for any purpose other than to carry out the responsibilities of the Commission.
§ 1116.11 Reports of civil actions under section 37 not admissions.
Pursuant to section 37(d), 15 U.S.C. 2084(d), the reporting of a civil action under section 37 shall not constitute an admission of—
(a) An unreasonable risk of injury;
(b) A defect in the consumer product which was the subject of the civil action;
(c) A substantial product hazard;
(d) An imminent hazard; or
(e) Any other liability under any statute or any common law.
§ 1116.12 Commission response to section 37 reports.
Upon receipt of a section 37 report, the Commission will evaluate the information contained in the report and any relevant information contained in its files or data bases to determine what, if any, follow-up or remedial action by the Commission is appropriate. If the Commission requires additional information, it will notify the manufacturer in writing of the specific information to provide. In addition, the Commission will routinely review section 37 reports to determine whether the reporting manufacturers have fulfilled their obligations under both sections 37 and 15(b) in a timely manner. Such a review may also engender a request for additional information, including the dates on which final orders were entered in each of the lawsuits reported under section 37. The Commission will treat any subsequent submission of information by the manufacturer as a submission under section 37(c)(2)(B) subject to the restrictions on public disclosure contained in sections 6(a) and (b) of the Consumer Product Safety Act.
PART 1117—REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL BALLS, LATEX BALLOONS AND OTHER SMALL PARTS
§ 1117.1 Purpose.
The purpose of this part is to set forth the Commission’s interpretative regulations for reporting of choking incidents required by the Child Safety Protection Act. The statute requires that each manufacturer, distributor, retailer, and importer of a marble, small ball, or latex balloon, or a toy or a game that contains a marble, small ball, latex balloon, or other small part, shall report to the Commission any information obtained by such manufacturer, distributor, retailer, or importer which reasonably supports the conclusion that an incident occurred in which a child (regardless of age) choked on such a marble, small ball, or latex balloon or on a marble, small ball, latex balloon, or other small part contained in such toy or game and, as a result of that incident the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional.
§ 1117.2 Definitions.
(a) Small part means any part, component, or piece of a toy or game, which, when tested in accordance with the procedures in 16 CFR 1501.4(a) and 1501.4(b)(1), fits entirely within the cylinder shown in Figure 1 appended to 16 CFR 1501.
(b) Small ball means any ball that under the influence of its own weight, passes, in any orientation, entirely through a circular hole with a diameter of 1.75 inches (4.445 cm) in a rigid template .25 inches (6 mm.) thick. For purposes of this designation, the term “ball” includes any spherical, ovoid, or ellipsoidal object that is designed or intended to be thrown, hit, kicked, rolled, or bounced, and is either not permanently attached to another toy or article, or is attached to such a toy or article by means of a string, elastic cord, or similar tether. The term ball includes any multi-sided object formed by connecting planes into a generally spherical, ovoid, or ellipsoidal shape that is designated or intended to be used as a ball, and any novelty item of a generally spherical, ovoid, or ellipsoidal shape that is designated or intended to be used as a ball.
(c) Choked means suffered an obstruction of the airways.
(d) A latex balloon is a toy or decorative item consisting of a latex bag that is designed to be inflated by air or gas. The term does not include inflatable children’s toys that are used in aquatic activities, such as rafts, water wings, life rings, etc.
(e) A marble is a ball made of a hard material, such as glass, agate, marble or plastic, that is used in various children’s games, generally as a playing piece or marker.
(f) Serious injury includes not only the concept of “grievous bodily injury” defined in the Commission’s rule for Substantial Hazard Reports at 16 CFR 1115.12(d), but also any other significant injury. Injuries necessitating hospitalization which require actual medical or surgical treatment and injuries necessitating absence from school or work of more than one day are examples of situations in which the Commission shall presume that such a serious injury has occurred.
(g) Subject firm means any manufacturer, distributor, retailer or importer of marbles, small balls, latex balloons, or a toy or game that contains a marble, small ball, latex balloon, or other small part.
(h) Toy or game includes any toy or game, including those exempt under 16 CFR 1501.3 from the small parts banning provisions of 16 CFR 1500.18(a)(9).
§ 1117.3 Reportable information.
A subject firm shall report any information it obtains which reasonably supports the conclusion that a reportable incident occurred. Generally, firms should report any information provided to the company, orally or in writing, which states that a child choked on a marble, small ball, latex balloon, or on a marble, small ball, latex balloon or other small part contained in a toy or game and, as a result of that incident the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional. Subject firms must not wait until they have investigated the incident or conclusively resolved whether the information is accurate or whether their product was involved in the incident. Firms shall not wait to determine conclusively the cause of the death, injury, cessation of breathing or necessity for treatment. An allegation that such a result followed the choking incident is sufficient to require a report.
§ 1117.4 Time for filing a report.
(a) A subject firm must report within 24 hours of obtaining information which reasonably supports the conclusion that an incident occurred in which a child (regardless of age) choked on a marble, small ball, or latex balloon or on a marble, small ball, latex balloon, or other small part contained in a toy or game and, as a result of that incident the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional. Section 1117.5 of this part sets forth the information that must be reported.
(b) The Commission will deem a subject firm to have obtained reportable information when the information has been received by an official or employee who may reasonably be expected to be capable of appreciating the significance of the information. Under ordinary circumstances, 5 days shall be the maximum reasonable time for information to reach such an employee, the Chief Executive Officer or the official or employee responsible for complying with the reporting requirements of section 102 of the Child Safety Protection Act.
§ 1117.5 Information that must be reported and to whom.
(a) Reports shall be directed to the Division of Corrective Actions, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20815 (Mailing Address: Washington, D.C. 20207) (Phone: 301-504-0608, facsimile: 301-504-0359).
(b) Subject firms must report as much of the following information as is known when the report is made:
(1) The name, address, and title of the person submitting the report to the Commission,
(2) The name and address of the subject firm,
(3) The name and address of the child who choked and the person(s) who notified the subject firm of the choking incident,
(4) Identification of the product involved including the date(s) of distribution, model or style number, a description of the product (including any labeling and warnings), a description of the marble, small ball, latex balloon or other small part involved, and pictures or sample if available,
(5) A description of the choking incident and any injuries that resulted or medical treatment that was necessary,
(6) Copies of any information obtained about the choking incident,
(7) Any information about changes made to the product or its labeling or warnings with the intention of avoiding such choking incidents, including, but not limited to, the date(s) of the change and its implementation, and a description of the change. Copies of any engineering drawings or product and label samples that depict the change(s).
(8) The details of any public notice or other corrective action planned by the firm,
(9) Such other information as appropriate.
(c) Retailers or distributors should supply as much of the information required in paragraph (b) of this section as is available to them but are not required to obtain information about product design changes or recall activities from the product manufacturer.
(d) Within ten days of their initial report, subject firms must supplement their reports to supply any of the information required by paragraph (b) of this section that was not available at the time of the initial report.
§ 1117.6 Relation to section 15(b) of the CPSA.
Section 15(b) of the CPSA requires subject firms to report when they obtain information which reasonably supports the conclusion that products they distributed in commerce fail to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA, contain a defect which could create a substantial product hazard, or create an unreasonable risk of serious injury or death. The Commission’s rules interpreting this provision are set forth at 16 CFR part 1115. The requirements of section 102 of the CSPA and this part are in addition to, but not to the exclusion of, the requirements in section 15(b) and part 1115. To comply with section 15(b), subject firms must continue to evaluate safety information they obtain about their products. Subject firms may have an obligation to report under section 15(b) of the CPSA whether or not they obtain information about choking incidents. Firms must also comply with the lawsuit-reporting provisions of section 37 of the CPSA, interpreted at 16 CFR part 1116.
§ 1117.7 Confidentiality of reports.
The confidentiality provisions of section 6 of the CPSA, 15 U.S.C. 2055, apply to reports submitted under this part. The Commission shall afford information submitted under this part the protection afforded to information submitted under section 15(b), in accordance with section 6(b)(5) of the CPSA and subpart G of part 1101 of title 16 of the CFR.
§ 1117.8 Effect of reports on liability.
A report by a manufacturer, distributor, retailer, or importer under this part shall not be interpreted, for any purpose, as an admission of liability or of the truth of the information contained in the report.
§ 1117.9 Prohibited acts and sanctions.
(a) Whoever knowingly and willfully falsifies or conceals a material fact in a report submitted under this part is subject to criminal penalties under 18 U.S.C. 1001.
(b) A failure to report to the Commission in a timely fashion as required by this part is a prohibited act under section 19(a)(3) of the CPSA, 15 U.S.C. 2068(a)(3).
(c) A subject firm that knowingly fails to report is subject to civil penalties under section 20 of the CPSA, 15 U.S.C. 2069. Knowing means the having of actual knowledge or the presumed having of knowledge deemed to be possessed by a reasonable person who acts in the circumstances, including knowledge obtainable upon the exercise of due care to ascertain the truth of representations. Section 20(d) of the CPSA, 15 U.S.C. 2069(d).
(d) Any person who knowingly and willfully violates section 19 of this Act after having received notice of noncompliance from the Commission may be subject to criminal penalties under section 21 of the CPSA, 15 U.S.C. 2070.
PART 1118—INVESTIGATIONS, INSPECTIONS AND INQUIRIES UNDER THE CONSUMER PRODUCT SAFETY ACT
Subpart A—Procedures for Investigations, Inspections, and Inquiries
§ 1118.1 Definitions, initiation of investigations, inspections, and inquiries and delegations.
(a) Definitions. For the purpose of these rules, the following definitions apply:
(1) Act means the Consumer Product Safety Act (15 U.S.C. 2051, et seq.).
(2) Commission means the Consumer Product Safety Commission.
(3) Firm means a manufacturer, private labeler, distributor, or retailer of a consumer product, except as otherwise provided by section 16(b) of the Act.
(4) Investigation is an undertaking by the Commission to obtain information for implementing, enforcing, or determining compliance with the Consumer Product Safety Act and the regulations, rules, and orders issued under the Act. The term investigation includes, but is not limited to, inspections (§ 1118.2), investigational hearings (§ 1118.5), and inquiries; employing subpoenas (§ 1118.4), depositions (§ 1118.6), and general or special orders (§ 1118.9).
(5) The definition of the terms set forth in section 3 of the Consumer Product Safety Act (15 U.S.C. 2052) shall apply to this part 1118.
(b) Initiation of Investigations and Inquiries. Investigations and inquiries will be initiated by the Commission in any manner authorized by law.
(c) Initiation of Inspections. An inspection as described in § 1118.2 is initiated when the Commission or its delegate authorizes the issuance of a written notice of inspection, described in § 1118.2(c).
(d) Delegations of Authority. The Commission hereby delegates to the Associate Executive Director for Compliance and Enforcement; the Solicitor, the Directors of the Divisions of Enforcement; the Solicitor, the Directors of the Divisions of Enforcement, Product Defect Correction, and Regulatory Management; and the directors of area offices, the power to initiate inspections in the same manner as the Commission.
§ 1118.2 Conduct and scope of inspections.
(a) After an inspection is initiated as set forth in § 1118.1, an officer or employee duly designated by the Commission shall issue the notice of inspection (hereinafter referred to as “notice”). Upon presenting the notice, along with appropriate credentials, to the person or agent in charge of the firm to be inspected, the Commission officer or employee is authorized for the purposes set forth in § 1118.1(a):
(1) To enter, at reasonable times, any factory, warehouse, firewalled third party conformity assessment body, or establishment in which products are manufactured, tested, or held, in connection with distribution in commerce, or any conveyance being used to transport products in connection with distribution in commerce; and
(2) To inspect, at reasonable times and in a reasonable manner, any conveyance or those areas of the factory, warehouse, firewalled third party conformity assessment body, or establishment where products are manufactured, tested, held, or transported and that may relate to the safety of those products; and
(3) To have access to and to copy all relevant records, books, documents, papers, packaging, or labeling which:
(i) Are required by the Commission to be established, made or maintained, or
(ii) Show or relate to the production, inventory, testing, distribution, sale, transportation, importation, or receipt of any product, or that are otherwise relevant to determining whether any person or firm has acted or is acting in compliance with the Act and regulations, rules, and orders promulgated under the Act, and
(4) To obtain:
(i) Information, both oral and written, concerning the production, inventory, testing, distribution, sale, transportation, importation, or receipt of any product, and the organization, business, conduct, practices, and management of any person or firm being inspected and its relation to any other person or firm;
(ii) Samples of items, materials, substances, products, containers, packages and packaging, and labels and labeling, or any component at manufacturer’s, distributor’s, third party conformity assessment body’s, or retailer’s cost, unless voluntarily provided; and
(iii) Information, both oral and written, concerning any matter referred to in the Act and these rules.
(b) A separate notice shall be given for each inspection, but a notice is not required for each entry made during the course of the same inspection. Each inspection shall be commenced at and completed within a reasonable period of time.
(c) The notice of inspection shall include the name and address of the person or firm being inspected; the name and title of the Commission officer or employee; the date and time of the anticipated entry; pertinent extracts from the statutory provisions upon which the right to access is based; pertinent extracts from § 1118.2 of these rules setting forth the authority of Commission officers or employees and the types of information and items they are authorized to obtain; a statement that the inspection will be conducted and the information will be provided with the cooperation of the person or firm being inspected; a statement which sets forth the purposes of the inspection and the nature of the information and items to be obtained and/or copied; and a statement that those from whom information is requested should state in writing whether any of the information submitted is believed to contain or relate to a trade secret or other matter which should be considered by the Commission to be confidential in accordance with section 6(a)(2) of the Act (15 U.S.C. 2055(a)(2)) and whether any of the information is believed to be entitled to exemption from disclosure by the Commission under the provisions of the Freedom of Information Act (5 U.S.C. 552) and the Commission’s regulations under that Act, 16 CFR part 1015 (42 FR 10496, February 22, 1977) or as amended. Any statement asserting this claim of confidentiality must be in writing, and any request for exemption of the information from disclosure must be made in accordance with the Commission’s Freedom of Information Act regulations, 16 CFR part 1015 (42 FR 10490, February 22, 1977) or as amended.
(d) If upon being presented with a notice by an officer or employee duly designated by the Commission, the person or agent-in-charge of the firm being inspected refuses to allow entry or inspection, the Commission may then seek a search warrant or take other appropriate legal action. If the person refuses to provide information, to allow access to or the copying of records, or to supply samples as provided in these rules, the officer or employee of the Commission shall complete the investigation to the extent that voluntary cooperation is provided. The Commission may take such additional action, including but not limited to seeking an ex parte search warrant, employing the compulsory process provided for in these rules, and/or taking other suitable legal action. If the person or agent in charge refuses to accept the notice upon its presentation, the officer or employee may affix the notice to a public entrance way on the premises and this shall constitute presentation of the notice.
§ 1118.3 Compulsory processes and service.
(a) In addition to or in lieu of authorizing the issuance of a notice, the Commission may elect either to seek an ex parte search warrant and/or use any other reasonable means authorized by law to initiate investigations, inspections, or inquires to obtain information for the purposes set forth in § 1118.1(a), including but not limited to the following compulsory processes:
(1) Subpoenas;
(2) Investigational hearings;
(3) Depositions; and
(4) General or special orders.
(b) Service in connection with any of the compulsory processes in § 1118.3(a) shall be effected:
(1) By personal service upon the person or agent in charge of the firm being investigated, inspected or inquired of; or
(2) By certified mail or delivery to the last known residence or business address of anyone being investigated, inspected or inquired of; or
(3) In the case of general or special orders where personal service, mailing or delivery has been unsuccessful, service may also be effected by publication in the
(c) The date of service of any form of compulsory process shall be the date on which the document is received by mail, delivered in person or published in the
(d) These rules shall be referred to in any notice of compulsory process served upon a person or firm.
(e) Anyone submitting information in response to any of the compulsory processes referred to in § 1118.3(a) should state whether any of the information submitted is believed to contain or relate to a trade secret or other matter which should be considered by the Commission to be confidential in accordance with section 6(a)(2) of the Consumer Product Safety Act (15 U.S.C. 2055(a)(2)) and whether any of the information is believed to be exempt from disclosure by the Commission under the provisions of the Freedom of Information Act (5 U.S.C. 552) and the Commission’s regulations under that Act, 16 CFR part 1015 (42 FR 10490, February 22, 1977) or as amended. Any claim of confidentiality must be in writing, and any request for exemption from disclosure must be made in accordance with the Commission’s Freedom of Information Act regulations, 16 CFR part 1015 (42 FR 10490, February 22, 1977), or as amended.
§ 1118.4 Subpoenas.
The Commission may issue to any person or firm a subpoena requiring the production of documentary evidence (subpoena duces tecum) and/or attendance and testimony of witnesses (subpoena ad testificandum) relating to any matter under investigation. Procedures regarding compliance with subpoenas and motions to limit or quash subpoenas are provided for in § 1118.9.
§ 1118.5 Investigational hearings.
(a) The Commission by subpoena may require any person or firm to provide information at an investigational hearing. These hearings shall be for the purpose of taking the testimony, under oath, of witnesses and receiving documents and other data relating to any subject under investigation. The hearings shall be presided over by the Commission, by one or more of the Commissioners, by an administrative law judge, or by a duly designated officer or employee, who shall be referred to as the presiding official. The hearings shall be stenographically reported, and the transcript shall be made a part of the record.
(b) A Commissioner who participates in a hearing or other investigation, inspection, or inquiry shall not be disqualified solely by reason of that participation from subsequently participating in a Commission decision in the same matter.
(c) Investigational hearings shall be closed to the public, unless otherwise ordered by the Commission.
(d) The release of the record of the hearing shall be governed by the Freedom of Information Act (5 U.S.C. 552), the Commission’s regulations under that Act, 16 CFR part 1015 (42 FR 10490, February 22, 1977) or as amended and/or other applicable laws or regulations, except that a person required to give testimony or a deposition may, in accordance with § 1118.7(d), obtain a copy of his or her testimony or deposition.
§ 1118.6 Depositions.
(a) The Commission by subpoena may require testimony to be taken by deposition at any stage of any investigation. Depositions may be taken before any person who is designated by the Commission and has the power to administer oaths. The person before whom the deposition is taken shall put the deponent under oath. The testimony given shall be reduced to writing by the person taking the deposition or under that person’s direction and shall then be submitted to the deponent for signature unless the deponent waives the right to sign the deposition. All depositions shall be closed to the public, unless otherwise ordered by the Commission. The release of the record of such depositions shall be governed by the Freedom of Information Act (5 U.S.C. 552), the Commission’s regulations under that Act, 16 CFR part 1015 (42 FR 10490, February 22, 1977) or as amended and/or other applicable laws or regulations, except that the deponent may, in accordance with § 1118.7(d), obtain a copy of his or her deposition.
(b) Any changes which the deponent desires to make shall be entered on the face of the deposition and shall state the reasons for such changes. The deposition shall then be signed by the deponent, unless the deponent waives the right to sign, cannot be found, or is unable or refuses to sign. The deponent must sign the deposition within 30 days of its submission to him or her, or within such shorter time period as the Commission may designate. Whenever a deponent is required to sign in less than ten days, the Commission shall notify the deponent of the reasons for such shorter time period.
§ 1118.7 Rights of witnesses at investigational hearings and of deponents at depositions.
(a) Any person, agent, or officer of a firm, who is required to produce documentary evidence or give testimony as a witness at an investigational hearing conducted under provisions of § 1118.5 or as a deponent at a deposition taken under provisions of § 1118.6 may be accompanied by an attorney, or an officer or partner of the firm, who may act as representative for the witness or the deponent. However, a person who is subpoenaed to produce documentary evidence or give testimony at an investigational hearing or deposition cannot act as attorney or representative for another witness or deponent at the same proceeding. The term attorney refers to members of the bar of a Federal court or the courts of any State or Territory of the United States, the Commonwealth of Puerto Rico, or the District of Columbia. The witness or deponent and his or her attorney or representative may act as follows during the course of an investigational hearing or deposition:
(1) A witness or deponent may confer, in confidence, with his or her attorney or representative concerning any questions asked of the witness or deponent. If the witness, deponent, or his or her attorney or representative objects to a question or any other matter relevant to the investigational hearing or deposition, the objection and basis for it shall be stated on the record. In the case of an objection based upon self-incrimination, the privilege must be asserted by the witness or deponent. If a witness at an investigational hearing refuses to answer a question or provide other information, the presiding official shall have the authority to immediately order the witness to answer the question or provide the information requested, except in circumstances where, in the discretion of the presiding official an immediate ruling would be unwarranted and except where a refusal is based upon the privilege against self-incrimination. Otherwise all objections shall be ruled upon by presiding official at the time the objection is made.
(2) Objections timely made under the provisions of § 1118.7(a) shall be noted on the record, shall be treated as continuing, and shall be preserved throughout the proceeding without the necessity of repetition during similar lines of inquiry.
(3) Except as provided by § 1118.7(a), counsel for a witness or deponent may not interrupt the examination of the witness or the deponent by making objections or statements on the record.
(4) Upon completion of the examination, any witness at an investigational hearing may clarify on the record any of his or her answers, or, if the witness is accompanied by an attorney or representative, the attorney or representative may examine the witness on the record as to answers previously given. In addition, the witness or his or her attorney or representative may make a brief statement at the conclusion of the hearing giving his, her or the firm’s position with regard to matters under investigation. In order to prevent abuse of the investigational process, the presiding official shall have the authority to impose reasonable limitations on the period of time allowed for objections, clarification of answers, and statements of position.
(5) Upon completion of all testimony, a deponent may clarify on the record any of his or her answers. The attorney or representative for a deponent may examine that deponent on the record to clarify answers previously given.
(b) Any person, agent, or officer who is required to appear in person at an investigational hearing or at a deposition shall testify as to matters and information known and/or reasonably available to the person or firm involved.
(c) Any person, agent or officer who is compelled by subpoena to appear in person at an investigational hearing or at a deposition shall receive the same fees and mileage allowances as are paid witnesses in the courts of the United States.
(d) Any person, agent, or officer who is required to appear at an investigational hearing or at a deposition shall be entitled to retain a copy of any document submitted by him or her and, upon payment of lawfully prescribed costs, in accordance with the Commission’s regulations under the Freedom of Information Act, shall be entitled to procure a copy of his or her own testimony as recorded.
(e) The presiding official shall take all necessary action to regulate the course of the hearing, to avoid delay and to assure that reasonable standards of orderly and ethical conduct are maintained. The presiding official, for reasons stated on the record, shall immediately report to the Commission any instance in which a witness or his or her attorney or representative has refused to comply with the presiding official’s directions or to adhere to reasonable standards of orderly and ethical conduct in the course of the hearing. The Commission shall take whatever action is appropriate under the circumstances.
§ 1118.8 General or special orders seeking information.
The Commission may require by the issuance of general or special orders any person or firm to submit in writing any reports and answers to questions as the Commission may prescribe. The reports or answers shall be made under oath, and shall be filed within the time prescribed by the Commission. Procedures regarding compliance with general or special orders and motions to limit or quash such orders are provided for in § 1118.9.
§ 1118.9 Motions to limit or quash subpoenas and general or special orders and delegation to modify terms for compliance.
(a) The Commission hereby delegates to the Associate Executive Director for Compliance and Enforcement; the Solicitor; the Directors of Divisions of Enforcement, Product Defect Correction, and Regulatory Management; and the General Counsel the authority:
(1) To negotiate and approve the terms of satisfactory compliance with subpoenas and general or special orders;
(2) To impose conditions upon compliance with such compulsory processes; and
(3) To extend the time for compliance and the time for filing motions to limit or quash.
(b) The person or firm served with a subpoena or general or special order may file a motion to limit or quash the subpoena or order. Any motion to limit or quash shall set forth the reasons why the subpoena or order should be limited or quashed and may be accompanied by memoranda, affidavits, or other documents submitted in support of the motion. The motion must be received in the Office of the Secretary of the Commission within 10 calendar days of receipt of the subpoena or order unless:
(1) The subpoena or order provides for a different time; or
(2) The Commission, for good cause shown, grants an extension of time to file a motion.
(c) Upon receipt of a motion to limit or quash, the Office of the Secretary shall immediately notify and transmit a copy to the appropriate staff member. Unless a different period of time is specified in the subpoena or order, the staff shall file an answer with the Office of the Secretary within 10 calendar days after receipt of the motion. A copy of the answer shall be served upon the moving party or the counsel of the moving party. No reply to the answer will be permitted.
(d) All motions to limit or quash shall be ruled upon by the Commission. The Office of the Secretary shall serve the decision on a motion to limit or quash upon the moving party or the counsel for the moving party and shall furnish a copy of the decision to the appropriate staff member. The Commission’s decision is a final decision. Motions for reconsideration will not be received.
In the event a person or firm fails to comply with any investigative process authorized by these rules, the Commission may seek appropriate action within its authority under the Consumer Product Safety Act (15 U.S.C. 2051, et seq.)
§ 1118.11 Nonexclusive delegation of power.
No provision contained herein delegating any of the Commission’s powers shall be construed as limiting the authority of the Commission to exercise the same powers.
Subpart B—Consent Order Agreements
§ 1118.20 Procedures for consent order agreements.
(a) For the procedure to be followed regarding consent order agreements involving section 15 of the Act (15 U.S.C. 2064), refer to the Commission’s regulations relating to substantial product hazards (16 CFR part 1115). For all other consent order agreements under the Consumer Product Safety Act, the provisions set forth below are applicable.
(b) The consent order agreement is a document executed by a person, or firm (consenting party) and a Commission staff representative which incorporates both a proposed complaint setting forth the staff’s charges and a proposed order by which such charges are resolved. A consent order agreement shall contain the following provisions, as appropriate:
(1) An admission of all jurisdictional facts by the consenting parties;
(2) A waiver of any rights to an administrative or judicial hearing and of any other procedural steps including any rights to seek judicial review or otherwise challenge or contest the validity of the Commission’s order;
(3) A statement that the agreement is in settlement of the staff’s charges and does not constitute an admission by the consenting party that the law has been violated;
(4) A statement describing the alleged hazard, non-compliance or violation.
(5) A statement that the Commission’s order is issued under the provisions of the Act (15 U.S.C. 2051, et seq.); and that a violation of such order may subject the consenting party to appropriate legal action.
(6) An acknowledgment that the consent order agreement only becomes effective upon its final acceptance by the Commission and its service upon the consenting party;
(7) An acknowledgment that the Commission may disclose terms of the consent order agreement to the public;
(8) A statement that the consenting party shall comply with the provisions of the agreement and order;
(9) A statement that the requirements of the order are in addition to and not to the exclusion of other remedies under the Act.
(c) At any time in the course of an investigation, the staff, with the approval of the Commission, may propose to the person or firm being investigated that any alleged violation be resolved by an agreement containing a consent order. Additionally, such a proposal may be made to the Commission staff by such person or firm.
(d) Upon receiving an executed agreement, the Commission may:
(1) Provisionally accept it;
(2) Reject it and issue the complaint (in which case the matter will be scheduled for hearing in accordance with the Commission’s Rules of Practice for Adjudicative Proceedings, 16 CFR part 1025, June 21, 1977 or as amended) and/or
(3) Take such other action as it may deem appropriate.
(e) If the agreement is provisionally accepted, the Commission shall place the agreement on the public record and shall announce provisional acceptance of the agreement in the
(f) If no requests are received, the agreement shall be deemed finally accepted by the Commission on the 16th calendar day after the date of the announcement in the
(g) If the Commission receives one or more requests that it not finally accept an agreement, it shall, within a reasonable time, either finally accept or reject the agreement after considering the requests. The Commission shall promptly issue and serve an order indicating its decision.
(1) If the agreement is accepted, the Commission shall issue the complaint and order. The order is a final order in disposition of the proceeding and is effective immediately upon its service on the consenting party under these rules. The consenting party shall thereafter be bound by and take immediate action in accordance with the final order.
(2) If the agreement is rejected, the order so notifying the consenting party shall constitute withdrawal of the Commission’s provisional acceptance. The Commission may then issue its complaint, may order further investigation, or may take any action it considers appropriate.
(h) An agreement that has been finally accepted may be vacated or modified upon petition of any party or the Commission’s own initiative. The petition shall state the proposed changes in the agreement and the reasons for granting the petition. The Commission may modify or vacate where (1) false statements were relied upon in accepting the agreement or (2) there are changed conditions of fact or law. In deciding whether to grant a petition, the Commission shall consider the public interest. A petitioner, or the Commission when acting on its own initiative, shall serve a copy of the petition or notice of reconsideration, respectively, on all parties. Parties affected by the petition or notice of reconsideration may file a response within 10 calendar days. No replies shall be accepted. The Commission shall decide the petition or notice of reconsideration within a reasonable time and, by order, shall indicate its decision and its reasons.
PART 1119—CIVIL PENALTY FACTORS
§ 1119.1 Purpose.
This part sets forth the Consumer Product Safety Commission’s (Commission) interpretation of the statutory factors considered in determining the amount of civil penalties that the Commission may seek or compromise. The policies behind, and purposes of, civil penalties include the following: Deterring violations; providing just punishment; promoting respect for the law; promoting full compliance with the law; reflecting the seriousness of the violation; and protecting the public.
§ 1119.2 Applicability.
This part applies to all civil penalty determinations the Commission may seek or compromise under the Consumer Product Safety Act (CPSA) (15 U.S.C. 2051-2089), the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261-1278), and the Flammable Fabrics Act (FFA) (15 U.S.C. 1191-1204). Any person who knowingly violates section 19 of the CPSA, section 4 of the FHSA, or section 5(e) of the FFA, is subject to a civil penalty.
§ 1119.3 Definitions.
For purposes of this rule, the following definitions apply:
(a) Product defect means a defect as referenced in the CPSA and defined in Commission regulations at 16 CFR 1115.4.
(b) Violation means a violation committed knowingly, as the term “knowingly” is defined in section 19 of the CPSA, section 4 of the FHSA, or section 5 of the FFA.
(c) Person means any manufacturer (including importer), distributor, or retailer, as those terms are defined in the CPSA, FHSA, or FFA, and any other legally responsible party.
§ 1119.4 Factors considered in determining civil penalties.
(a) Statutory Factors. (1) Section 20(b) of the CPSA, section 5(c)(3) of the FHSA, and section 5(e)(2) of the FFA, specify factors considered by the Commission in determining the amount of a civil penalty to be sought upon commencing an action for knowing violations of each act. These factors are:
(i) CPSA (15 U.S.C. 2069(b)). The nature, circumstances, extent, and gravity of the violation, including:
(A) The nature of the product defect;
(B) The severity of the risk of injury;
(C) The occurrence or absence of injury;
(D) The number of defective products distributed;
(E) The appropriateness of such penalty in relation to the size of the business of the person charged, including how to mitigate undue adverse economic impacts on small businesses; and
(F) Such other factors as appropriate.
(ii) FHSA (15 U.S.C. 1264 (c)(3)). The nature, circumstances, extent, and gravity of the violation, including:
(A) The nature of the substance;
(B) Severity of the risk of injury;
(C) The occurrence or absence of injury;
(D) The amount of substance distributed;
(E) The appropriateness of such penalty in relation to the size of the business of the person charged, including how to mitigate undue adverse economic impacts on small businesses; and
(F) Such other factors as appropriate.
(iii) FFA (15 U.S.C. 1194 (e)(2)). The nature, circumstances, extent, and gravity of the violations:
(A) The severity of the risk of injury;
(B) The occurrence or absence of injury;
(C) The appropriateness of such penalty in relation to the size of the business of the person charged; and
(D) Such other factors as appropriate.
(2) The nature, circumstances, extent, and gravity of the violation. Under this factor, the Commission will consider the totality of the circumstances and all other facts concerning a violation. The Commission will consider the enumerated statutory factors, as well as the factors described in paragraph (b) of this section.
(3) Nature of the product defect. The Commission will consider the nature of the product defect associated with a CPSA violation. This consideration will include, for example, whether the defect arises from the product’s design, composition, contents, construction, manufacture, packaging, warnings, or instructions, and will include consideration of conditions or circumstances in which the defect arises. The Commission will also consider the nature of the substance associated with an FHSA violation. Two of the statutory factors in the CPSA civil penalty factors include the terms “product defect” or “defective products.” However, certain violations of the CPSA, for example, failing to supply a required certificate that the product complies with an applicable consumer product safety rule, do not necessarily require that there be a product defect or defective product. The terms “product defect” or “defective products” would not apply to such situation. In such cases, however, the other civil penalty factors would still be considered.
(4) Severity of the risk of injury. Consistent with its discussion of severity of the risk at 16 CFR 1115.12, the Commission will consider, among other factors, the potential for serious injury, illness, or death (and whether any injury or illness required medical treatment including hospitalization or surgery); the likelihood of injury; the intended or reasonably foreseeable use or misuse of the product; and the population at risk (including vulnerable populations such as children, the elderly, or those with disabilities).
(5) The occurrence or absence of injury. The Commission will consider whether injuries, illnesses, or deaths have or have not occurred with respect to any product or substance associated with a violation, and, if so, the number and nature of injuries, illnesses, or deaths. Both acute illnesses and the likelihood of chronic illnesses will be considered.
(6) The number of defective products distributed. The Commission will consider the number of defective products or amount of substance distributed in commerce. The statutory language makes no distinction between those defective products distributed in commerce that consumers received and those defective products distributed in commerce that consumers have not received. Therefore both could be considered in appropriate cases. This factor will not be used to penalize a person’s decision to conduct a wider-than-necessary recall out of an abundance of caution. This would not include situations where such a recall is conducted due to a person’s uncertainty concerning how many or which products may need to be recalled.
(7) The appropriateness of such penalty in relation to the size of the business of the person charged, including how to mitigate undue adverse economic impacts on small businesses.
(i) The Commission is required to consider the size of the business of the person charged in relation to the amount of the penalty. This factor reflects the relationship between the size of a business and the policies behind, and purposes of, a penalty (as noted above in § 1119.1). In considering business size, the Commission may look to several factors including, but not limited to, the number of employees, net worth, and annual sales. A business’s size and a business’s ability to pay a penalty are separate considerations. In some cases for small businesses, however, these two considerations may relate to each other. The Commission will be guided, where appropriate, by relevant financial factors to determine a small business’s ability to pay a penalty, including, but not limited to, liquidity, solvency, and profitability. The burden to present clear, reliable, relevant, and sufficient evidence relating to a business’s size and ability to pay rests on the business.
(ii) The statute requires the Commission to consider how to mitigate the adverse economic impacts on small businesses only if those impacts would be undue. What the Commission considers in determining what is undue may include, but is not limited to, the business’s size and financial factors relating to its ability to pay. When considering how to mitigate undue adverse economic impacts, the Commission will, as appropriate, also follow its Small Business Enforcement Policy set forth at § 1020.5.
(b) Other factors as appropriate. In determining the amount of any civil penalty to be sought for a violation of the CPSA, FHSA, or FFA, the Commission may consider, as appropriate, such other factors in addition to those listed in the statutes. Both the Commission and a person may raise any factors they believe are relevant in determining an appropriate penalty amount. A person will be notified of any factors beyond those enumerated in the statutes that the Commission relies on as aggravating factors for purposes of determining a civil penalty amount. Additional factors that may be considered in a case include, but are not limited to, the following:
(1) Safety/compliance program and/or system relating to a violation. The Commission may consider, when a safety/compliance program and/or system as established is relevant to a violation, whether a person had at the time of the violation a reasonable and effective program or system for collecting and analyzing information related to safety issues. Examples of such information would include incident reports, lawsuits, warranty claims, and safety-related issues related to repairs or returns. The Commission may also consider whether a person conducted adequate and relevant premarket and production testing of the product at issue; had a program in place for continued compliance with all relevant mandatory and voluntary safety standards; and other factors as the Commission deems appropriate. The burden to present clear, reliable, relevant, and sufficient evidence of such program, system, or testing rests on the person seeking consideration of this factor.
(2) History of noncompliance. The Commission may consider whether or not a person’s history of noncompliance with the CPSA, FHSA, FFA, and other laws that the CPSC enforces, and the regulations thereunder, should increase the amount of the penalty. A person’s history of noncompliance may be indicated by, for example, multiple violations of one or more laws or regulations that the CPSC enforces, including repeated violations of the same law or regulation. History of noncompliance may include the number of previous violations or how recently a previous violation occurred.
(3) Economic gain from noncompliance. The Commission may consider whether a person benefitted economically from a failure to comply, including a delay in complying, with the CPSA, FHSA, FFA, and other laws that the CPSC enforces, and the regulations thereunder.
(4) Failure to respond in a timely and complete fashion to the Commission’s requests for information or remedial action. The Commission may consider whether a person’s failure to respond in a timely and complete fashion to requests from the Commission for information or for remedial action should increase a penalty. This factor is intended to address a person’s dilatory and egregious conduct in responding to written requests for information or remedial action sought by the Commission, but not to impede any person’s lawful rights.
§ 1119.5 Enforcement notification.
A person will be informed in writing if it is believed that the person has violated the law and if the Commission intends to seek a civil penalty. Any person who receives such a writing will have an opportunity to submit evidence and arguments that it should not pay a penalty or should not pay a penalty in the amount sought by the Commission.
PART 1120—SUBSTANTIAL PRODUCT HAZARD LIST
§ 1120.1 Authority.
Under the authority of section 15(j) of the Consumer Product Safety Act (CPSA), the Commission determines that consumer products or classes of consumer products listed in § 1120.3 of this part have characteristics whose existence or absence present a substantial product hazard under section 15(a)(2) of the CPSA. The Commission has determined that the listed products have characteristics that are readily observable and have been addressed by a voluntary standard, that the voluntary standard has been effective, and that there is substantial compliance with the voluntary standard. The listed products are subject to the reporting requirements of section 15(b) of the CPSA and to the recall provisions of section 15(c) and (d) of the CPSA, and shall be refused entry into the United States under section 17(a)(4) of the CPSA.
§ 1120.2 Definitions.
The definitions in section 3 of the Consumer Product Safety Act (15 U.S.C. 2052) apply to this part 1120.
(a) Substantial product hazard means a product defect which (because of the pattern of defect, the number of defective products distributed in commerce, the severity of the risk, or otherwise) creates a substantial risk of injury to the public.
(b) Hand-supported hair dryer means an electrical appliance, intended to be held with one hand during use, which creates a flow of air over or through a self-contained heating element for the purpose of drying hair.
(c) Drawstring means a non-retractable cord, ribbon, or tape of any material to pull together parts of upper outerwear to provide for closure.
(d) Seasonal and decorative lighting product means portable, plug-connected, temporary-use lighting products and accessories that have a nominal 120 volt input voltage rating. Lighting products within the scope of the rule are factory-assembled with push-in, midget- or miniature-screw base lampholders connected in series or with candelabra- or intermediate-screw base lampholders connected in parallel, directly across the 120 volt input. Such lighting products include lighted decorative outfits, such as stars, wreathes, candles without shades, light sculptures, blow-molded (plastic) figures, and animated figures. Lighting products outside the scope of the rule include: Battery-operated products; solar-powered products; products that operate from a transformer or low-voltage power supply; flexible lighting products incorporating non-replaceable series and series/parallel connected lamps enclosed within a flexible polymeric tube or extrusion; and portable electric lamps that are used to illuminate seasonal decorations.
(e) Extension cord (also known as a cord set) means a length of factory-assembled flexible cord with an attachment plug or current tap as a line fitting and with a cord connector as a load fitting. Extension cords are used for extending a branch circuit supply of an electrical outlet to the power-supply cord of a portable appliance, in accordance with the National Electrical Code.® For purposes of this rule, the term applies to extension cords that are equipped with National Electrical Manufacturer Association (“NEMA”) 1-15, 5-15 and 5-20 fittings, and that are intended for indoor use only, or for both indoor and outdoor use. The term “extension cord” does not include detachable power supply cords, appliance cords, power strips and taps, and adaptor cords supplied with outdoor tools and yard equipment.
(f) Stock window covering (also known as a stock blind, shade, or shading) has the same meaning as defined in section 3, definition 5.02, of ANSI/WCMA A100.1—2018 (incorporated by reference; see § 1120.4), as a window covering that is completely or substantially fabricated prior to being distributed in commerce and is a specific stock-keeping unit (SKU). Even when the seller, manufacturer, or distributor modifies a pre-assembled product by adjusting to size, attaching the top rail or bottom rail, or tying cords to secure the bottom rail, the product is still considered stock. Online sales of the product or the size of the order such as multi-family housing do not make the product a non-stock product. These examples are provided in ANSI/WCMA A100.1—2018 (incorporated by reference; see § 1120.4) to clarify that as long as the product is “substantially fabricated” prior to distribution in commerce, subsequent changes to the product do not change its categorization.
(g) Custom window covering (also known as a custom blind, shade, or shading) has the same meaning as defined in section 3, definition 5.01, of ANSI/WCMA A100.1—2018 (incorporated by reference; see § 1120.4), as a window covering that does not meet the definition of a stock window covering.
§ 1120.3 Products deemed to be substantial product hazards.
The following products or class of products shall be deemed to be substantial product hazards under section 15(a)(2) of the CPSA:
(a) Hand-supported hair dryers that do not provide integral immersion protection in compliance with the requirements of section 5 of UL 859, or section 6 of UL 1727 (incorporated by reference, see § 1120.4).
(b)(1) Children’s upper outerwear in sizes 2T to 16 or the equivalent, and having one or more drawstrings, that is subject to, but not in conformance with, the requirements of ASTM F 1816-97 (incorporated by reference, see § 1120.4).
(2) At its option, the Commission may use one or more of the following methods to determine what sizes of children’s upper outerwear are equivalent to sizes 2T to 16:
(i) Garments in girls’ size Large (L) and boys’ size Large (L) are equivalent to girls’ or boys’ size 12, respectively. Garments in girls’ and boys’ sizes smaller than Large (L), including Extra-Small (XS), Small (S), and Medium (M), are equivalent to sizes smaller than size 12. The fact that an item of children’s upper outerwear with a hood and neck drawstring is labeled as being larger than a size Large (L) does not necessarily mean that the item is not equivalent to a size in the range of 2T to 12.
(ii) Garments in girls’ size Extra-Large (XL) and boys’ size Extra-Large (XL) are equivalent to size 16. The fact that an item of children’s upper outerwear with a waist or bottom drawstring is labeled as being larger than size Extra-Large (XL) does not necessarily mean that the item is not equivalent to a size in the range of 2T to 16.
(iii) In cases where garment labels give a range of sizes, if the range includes any size that is subject to a requirement in ASTM F 1816-97, the garment will be considered subject, even if other sizes in the stated range, taken alone, would not be subject to the requirement. For example, a coat sized 12 through 14 remains subject to the prohibition of hood and neck area drawstrings, even though this requirement of ASTM F 1816-97 only applies to garments up to size 12. A coat size 13 through 15 would not be considered within the scope of ASTM F 1816-97’s prohibition of neck and hood drawstrings, but would be subject to the requirements for waist or bottom drawstrings.
(iv) To fall within the scope of paragraphs (b)(2)(i) through (2)(iii) of this section, a garment need not state anywhere on it, or on its tags, labels, package, or any other materials accompanying it, the term “girls,” the term “boys,” or whether the garment is designed or intended for girls or boys.
(v) The Commission may use any other evidence that would tend to show that an item of children’s upper outerwear is a size that is equivalent to sizes 2T to 16.
(c) Seasonal and decorative lighting products that lack one or more of the following characteristics in conformance with requirements in sections 6, 7, 15, 71, 79, and SB15 of UL 588 (incorporated by reference, see § 1120.4):
(1) Minimum wire size requirements in section 6 of UL 588;
(2) Sufficient strain relief requirements in sections 15, 71, 79, and SB15 of UL 588; or
(3) Overcurrent protection requirements in section 7 of UL 588.
(d) Extension cords that lack one or more of the following specified characteristics in conformance with requirements in sections 2, 9, 16, 19, 20, 21, 26, 30, 31, 32, 84, and 105 of UL 817 (incorporated by reference, see § 1120.4):
(1) Minimum wire size requirement in sections 2, 20, 21, and 30 of UL 817;
(2) Sufficient strain relief requirement in sections 20, 30, and 84 of UL 817;
(3) Proper polarization requirement in sections 9, 19, 20, 30, 31, and 32 of UL 817;
(4) Proper continuity requirement in sections 16, 20, 30, and 105 of UL 817;
(5) Outlet cover requirement (for indoor 2-wire parallel extension cords with polarized parallel-blade and -slot fittings) in sections 20 and 26 of UL 817; or
(6) Jacketed cord requirement (for outdoor use extension cords) in section 30 of UL 817.
(e) Stock window coverings that fail to comply with one or more of the following requirements of ANSI/WCMA A100.1—2018 (incorporated by reference; see § 1120.4):
(1) Operating cord requirements in section 4.3.1: section 4.3.1.1 (cordless operating system), 4.3.1.2 (short static or access cord), or 4.3.1.3 (inaccessible operating cord);
(2) Inner cord requirements in sections 4.5, 6.3, 6.7, and Appendices C and D; and
(3) On-product manufacturer label requirement in section 5.3.
(f) Custom window coverings that fail to comply with one or more of the following requirements of ANSI/WCMA A100.1—2018 (incorporated by reference; see § 1120.4):
(1) Inner cord requirements in sections 4.5, 6.3, 6.7, and Appendices C and D; and
(2) On-product manufacturer label in section 5.3.
§ 1120.4 Standards incorporated by reference.
(a) The standards required in this part are incorporated by reference (“IBR”) into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect all approved material at the Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at the National Archives and Records Administration (“NARA”). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959 USA, telephone: 610-832-9585; http://www2.astm.org/.
(1) ASTM F 1816-97, Standard Safety Specification for Drawstrings on Children’s Upper Outerwear, approved June 10, 1997, published August 1998 (“ASTM F 1816-97”), IBR approved for § 1120.3(b).
(2) [Reserved]
(c) Underwriters Laboratories, Inc (“UL”), 333 Pfingsten Road, Northbrook, IL 60062 or through UL’s Web site: www.UL.com.
(1) UL 588, Standard for Safety for Seasonal and Holiday Decorative Products, 18th Edition, approved August 21, 2000 (“UL 588”), IBR approved for § 1120.3(c).
(2) UL 859, Standard for Safety for Household Electric Personal Grooming Appliances, 10th Edition, approved August 30, 2002, and revised through June 3, 2010 (“UL 859”), IBR approved for § 1120.3(a).
(3) UL 1727, Standard for Safety for Commercial Electric Personal Grooming Appliances, 4th Edition, approved March 25, 1999, and revised through June 25, 2010 (“UL 1727”), IBR approved for § 1120.3(a).
(4) UL 817, Standard for Cord Sets and Power-Supply Cords, 11th Edition, dated March 16, 2001, as revised through February 3, 2014 (“UL 817”), IBR approved for § 1120.3(d).
(d) Window Covering Manufacturers Association, Inc., 355 Lexington Avenue, New York, New York 10017. Telephone: 212.297.2122. http://wcmanet.com.
(1) ANSI/WCMA A100.1—2018. American National Standard For Safety Of Corded Window Covering Products, approved January 8, 2018. IBR approved for §§ 1120.2 and 1120.3.
(2) [Reserved]
PART 1130—REQUIREMENTS FOR CONSUMER REGISTRATION OF DURABLE INFANT OR TODDLER PRODUCTS
§ 1130.1 Purpose, scope, and effective date.
(a) Purpose. This part prescribes a consumer product safety rule establishing requirements for consumer registration of durable infant or toddler products. These requirements are intended to improve the effectiveness of recalls of, and safety alerts regarding, such products.
(b) Scope. Part 1130 applies to manufacturers, including importers, of durable infant or toddler products, as defined in § 1130.2(a). It does not apply to infant or child restraint systems intended for use in automobiles that are covered by the registration program of the National Highway Traffic and Safety Administration (NHTSA) at 49 CFR 571.213, or to products that comprise a travel system, and are sold with a child restraint system that is covered by the NHTSA registration program at 49 CFR 571.213.
(c) Compliance Date. Compliance with this part 1130 shall be required on June 28, 2010 for the following products: full-size cribs and nonfull-size cribs; toddler beds; high chairs, booster chairs, and hook-on chairs; bath seats; gates and other enclosures for confining a child; play yards; stationary activity centers; infant carriers; strollers; walkers; swings; and bassinets and cradles. Compliance with this part 1130 shall be required on December 29, 2010 for the following products: Children’s folding chairs, changing tables, infant bouncers, infant bath tubs, bed rails and infant slings. Compliance with this part 1130 shall be required on September 24, 2020 for contoured changing pads (a type of baby changing product). The rule shall apply to durable infant or toddler products, as defined in § 1130.2(a), that are manufactured on or after those dates.
§ 1130.2 Definitions.
In addition to the definitions given in section 3 of the Consumer Product Safety Act (15 U.S.C. 2052), the following definitions apply:
(a) Definition of durable infant or toddler product means the following products intended for use, or that may be reasonably expected to be used, by children under the age of 5 years. The listed product categories are further defined in the applicable standards that the Commission issues under section 104(b) of the Consumer Product Safety Improvement Act of 2008, and include products that are combinations of the following product categories:
(1) Full-size cribs and non-full-size cribs;
(2) Toddler beds;
(3) High chairs, booster seats, and hook-on chairs;
(4) Bath seats;
(5) Gates and other enclosures for confining a child;
(6) Play yards;
(7) Stationary activity centers;
(8) Infant carrier, including soft infant and toddler carriers, hand-held infant carriers, sling carriers, and frame child carriers;
(9) Strollers;
(10) Walkers;
(11) Swings;
(12) Bassinets and cradles, including bedside sleepers and infant sleep products;
(13) Children’s folding chairs and children’s folding stools;
(14) Baby changing products;
(15) Infant bouncers;
(16) Infant bathtubs;
(17) Bed rails; and
(18) Crib mattresses.
(b) Manufacturer, for purposes of this part, in the case of a product produced within the United States, means the domestic manufacturer of the product, and in the case of an imported product, means the importer of the product.
(c) Product recall means action taken pursuant to sections 12, 15(c) or 15(d) of the CPSA (15 U.S.C. 2061, 2054(c), or 2064(d)), and action taken pursuant to a corrective action plan implemented by a company in cooperation with the Commission, where the firm is conducting one or more of the following: repair of the product; replacement of the product; or refund of the purchase price of the product.
(d) Safety alert means notice or warning of a potential problem with an individual product or class of products so that consumers and other users of the affected products respond accordingly to reduce or eliminate the potential for injury.
§ 1130.3 General requirements.
(a) Each manufacturer of a durable infant or toddler product shall:
(1) Provide consumers with a postage-paid consumer registration form that meets the requirements of this part 1130 with each such product;
(2) Maintain a record in accordance with the requirements set forth in § 1130.8 of the contact information (names, addresses, e-mail addresses, and telephone numbers) of consumers who register their products with the manufacturer under this part 1130;
(3) Permanently place the manufacturer name and contact information, model name and number, and the date of manufacture on each durable infant or toddler product in accordance with the requirements set forth in § 1130.4.
(b) Consumer information collected by a manufacturer pursuant to the requirements of this part 1130 shall not be used by the manufacturer, nor disseminated by the manufacturer to any other party, for any purpose other than notification to such consumer in the event of a product recall or safety alert.
§ 1130.4 Identification on the product.
(a) Each durable infant or toddler product shall be permanently marked with the manufacturer name, and contact information (U.S. address and telephone number, toll free if available) model name and number, and date of manufacture.
(1) If the manufacturer regularly uses only a model name or a model number, but not both, to identify the product, he/she may provide only the model name or number rather than creating a model name or number for the sole purpose of this part 1130.
(2) If the manufacturer regularly identifies the product by a product identification number (“PIN”) or other similar identifying number rather than a model number, he/she may provide that identifying number instead of a model number.
(3) The date referred to in paragraph (a) of this section shall include the month and year of manufacture and can be stated in code.
(4) A permanent mark is one that can reasonably be expected to remain on the product during the useful life of the product.
(b) The information required by this section shall be in English, legible, and in a location that is conspicuous to the consumer.
(c) The information required by this section may be combined with other information marked on the product.
§ 1130.5 Requirements for registration forms.
The registration form required under § 1130.3(a)(1) shall:
(a) Comply with the format and text requirements set forth in § 1130.6 as shown in figures 1 and 2 of this part;
(b) State all information required by this part 1130 in the English language;
(c) Be attached to the surface of each durable infant or toddler product so that, as a practical matter, the consumer must notice and handle the form after purchasing the product;
(d) Include the manufacturer’s name, model name and number for the product, and the date of manufacture;
(e) Include an option for consumers to register through the Internet;
(f) Include the statement required in § 1130.6(c)(1) that information provided by the consumer shall not be used for any purpose other than to facilitate a recall of or safety alert regarding that product.
§ 1130.6 Requirements for format and text of registration forms.
(a) Size of form. The form shall be at least the size of two standard post cards, connected with perforation for later separation, so that each of the two portions is at least 3
(b) Layout of form—(1) General. The form shall consist of four parts: top and bottom, divided by perforations for easy separation, and front and back.
(2) Font size and typeface. The registration form shall use bold black typeface. The size of the type shall be at least 0.12 in (3.0 mm) for the purpose statement required in paragraph (c)(1) of this section, and no less than 0.10 in (2.5 mm) for the other information in the registration form. The title of the purpose statement and the retention statement required in paragraph (d)(2) of this section shall be in all capitals. All other information shall be in capital and lowercase type.
(c) Front of form—(1) Top front of form: Purpose statement. The top portion of the front of each form shall state: “PRODUCT REGISTRATION FOR SAFETY ALERT OR RECALL ONLY. We will use the information provided on this card to contact you only if there is a safety alert or recall for this product. We will not sell, rent, or share your personal information. To register your product, please complete and mail the bottom part of this card, or visit our online registration at: www.Web sitename.com.” Manufacturers that do not have a Web site may provide an email address and state at the end of the purpose statement: “To register your product, please complete and mail the bottom part of this card, or email your contact information, the model name and number, and date of manufacture of the product, as provided on this card, to: [email protected].”
(2) Bottom front of form: Manufacturer’s mailing address. The bottom portion of the front of each form shall be pre-addressed and postage-paid with the manufacturer’s name and mailing address where registration information is to be collected. A manufacturer may list a brand name in addition to the manufacturer’s name. If a manufacturer uses a third party to process registration forms, the third party’s name may be included as a “c/o” (“in care of”) in the address on the form.
(d) Back of the form—(1) Top back of form—(i) Product information and manufacturer’s identification. The top portion of the back of each form shall state: “Manufacturer’s Contact Information” and provide the manufacturer’s name and contact information (a U.S. mailing address displayed in sentence format, Web site address, a telephone number, toll-free, if available); product model name and number (or other identifier as described in § 1130.4(a)(1) and (2)); and manufacture date of the product. A rectangular box shall be placed around the model name, model number, and manufacture date. A manufacturer may list the brand name in addition to the manufacturer’s name.
(ii) Retention statement. On the back of each form, just above the perforation line, the form shall state: “KEEP THIS TOP PART FOR YOUR RECORDS. FILL OUT AND RETURN BOTTOM PART.”
(2) Bottom back of form—(i) Consumer information. The bottom portion of the back of each form shall have blocks for the consumer to provide his/her name, address, telephone number, and email address. These blocks shall be 5 mm wide and 7 mm high, with as many blocks as possible to fill the width of the card allowing for normal printing practices.
(ii) Product information. The following product information shall be provided on the bottom portion of the back of each form below the blocks for consumer information printed directly on the form or on a pre-printed label that is applied to the form: the model name and number (or other identifier as described in § 1130.4(a)(1) and (2)), and the date of manufacture of the product. A rectangular box shall be placed around the model name, model number, and manufacture date. A manufacturer may include its name on the bottom portion of the back of the form if they choose to do so.
§ 1130.7 Requirements for Web site registration or alternative e-mail registration.
(a) Link to registration page. The manufacturer’s Web site, or other Web site established for the purpose of registration under this part 1130, shall be designed with a link clearly identified on the main web page that goes directly to “Product Registration.”
(b) Purpose statement. The registration page shall have the following statement at the top of the page: “PRODUCT REGISTRATION FOR SAFETY ALERT OR RECALL ONLY. We will use the information provided on this page only to contact you if there is a safety alert or recall for this product. We will not sell, rent, or share your personal information. If you register on this Web site you do not need to fill out the card that came with your product.”
(c) Content of registration page. The Web site registration page shall request only the consumer’s name, address, telephone number, e-mail address, product model name and number, and the date of manufacture. The consumer’s telephone number and e-mail address shall not be required for the consumer to submit the registration form. No other information shall appear on the electronic registration form, except for identification of the manufacturer or a link to the manufacturer’s home page, a field to confirm submission, and a prompt to indicate any incomplete or invalid fields before submission. Accessing the electronic registration form shall not cause additional screens or electronic banners to appear.
(d) Alternative for manufacturers without a Web site. A manufacturer that lacks a Web site shall provide for consumers to register their product through e-mail. Such e-mail addresses shall be set up to provide an automatic reply to confirm receipt of the consumer’s registration information.
§ 1130.8 Recordkeeping and notification requirements.
(a) Each manufacturer of a durable infant or toddler product shall maintain a record of registrants for each product manufactured that includes all of the information provided by each consumer registered.
(b) Each manufacturer of a durable infant or toddler product shall use the information provided by the registrant to notify the registrant in the event of a voluntary or involuntary recall of, or safety alert regarding, such product.
(c) Each manufacturer of a durable infant or toddler product shall maintain a record of the information provided by the registrant for a period of not less than 6 years after the date of manufacture of the product.
(d) Records required under this section shall be made available within 24 hours, upon the request of any officer, employee, or agent acting on behalf of the U.S. Consumer Product Safety Commission.
(e) Optional barcode. (1) A manufacturer may include a barcode, or other machine readable data, that when scanned would provide a direct link for the consumer to register the product.
(2) Such a link must comply with all the requirements of this part 1130, including those in § 1130.7 and the restriction that the manufacturer shall not use or disseminate the consumer registration information for any purpose other than notifying the consumer of a safety alert or recall.
Figure 1 to Part 1130—Front of Registration Form
Figure 2 to Part 1130—Back of Registration Form
PART 1145—REGULATION OF PRODUCTS SUBJECT TO OTHER ACTS UNDER THE CONSUMER PRODUCT SAFETY ACT
§ 1145.1 Scope.
In this part 1145, the Commission establishes rules which provide that risks of injury associated with consumer products that could be eliminated or reduced to a sufficient extent by action under the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261-1274), the Poison Prevention Packaging Act of 1970 (PPPA) (15 U.S.C. 1471-1476), or the Flammable Fabrics Act (FFA) (15 U.S.C. 1191-1204) will be regulated under the Consumer Product Safety Act (CPSA) (15 U.S.C. 2051-2081). Section 30(d) of the CPSA, as amended, provides that a risk of injury which is associated with a consumer product and which could be eliminated or reduced to a sufficient extent by action under the FHSA, PPPA, or the FFA may be regulated under this act only if the Commission by rule finds it is in the public interest to regulate such risk of injury under this act.
§ 1145.2 Paint (and other similar surface-coating materials) containing lead; toys, children’s articles, and articles of furniture bearing such paint (or similar surface-coating materials); risk of lead poisoning.
(a) The Commission finds that it is in the public interest to reduce the risk of lead poisoning to young children from the ingestion of paint and other similar surface-coating materials by action under the Consumer Product Safety Act rather than under the Federal Hazardous Substances Act because of the desirability of consolidating the public procedures related to such regulation with the proceeding to determine a safe level of lead under the Lead-Based Paint Poisoning Prevention Act (42 U.S.C. 4801-4846), as amended by the National Consumer Health Information and Health Promotion Act of 1976 (Pub. L. 94-317; 90 Stat. 705-706). Consolidation of these proceedings facilitates greater public participation and a more expeditious resolution of the issues.
(b) Paint and other similar surface-coating materials containing lead and toys, children’s articles, and articles of furniture bearing such paint or other similar surface-coating materials that present a risk of lead poisoning to young children by ingestion shall therefore be regulated under the Consumer Product Safety Act. Such regulation shall include all directly related pending and future rulemaking, as well as all directly related pending and future action on petitions.
§ 1145.3 Extremely flammable contact adhesives; risk of burns from explosive vapor ignition and flashback fire.
(a) The Commission finds that it is in the public interest to regulate the risk of burns from explosive vapor ignition and flashback fire associated with certain extremely flammable contact adhesives under the Consumer Product Safety Act rather than under the Federal Hazardous Substances Act because of the desirability of avoiding possibly lengthy, resource consuming, and inefficient rulemaking proceedings under the Federal Hazardous Substances Act and because of the availability of civil penalties under the CPSA. The Commission also believes that the complexity and formality of the rulemaking proceedings under the FHSA, in contrast to rulemaking proceedings under the CPSA may make it difficult for interested persons to participate.
(b) Extremely flammable contact adhesives and other similar liquid or semi-liquid products in containers over one-half pint that present a risk of burns from explosive vapor ignition and flashback fire shall therefore be regulated under the Consumer Product Safety Act. Such regulation shall include all directly related pending and future rulemaking, as well as all directly related future action on petitions. However, such action shall not include labeling that may be required under the Federal Hazardous Substances Act to address flammability hazards associated with other adhesives not subject to the ban.
§ 1145.4 Consumer patching compounds containing respirable free-form asbestos; risk of cancer associated with inhalation of asbestos fibers.
(a) The Commission finds that it is in the public interest to regulate the risk of cancer associated with inhalation of asbestos fibers from consumer patching compounds containing respirable free-form asbestos under the Consumer Product Safety Act (CPSA) rather than under the Federal Hazardous Substances Act (FHSA) because of the desirability of avoiding possibly lengthy resource-consuming, inefficient rulemaking proceedings under the FHSA and because of the availability of civil penalties under the CPSA for knowing noncompliance.
(b) Therefore, consumer patching compounds containing respirable free-form asbestos are regulated under CPSA.
§ 1145.5 Emberizing materials (embers and ash) containing respirable free-form asbestos; risk of cancer associated with inhalation of asbestos fibers.
(a) The Commission finds that it is in the public interest to regulate the risk of cancer associated with inhalation of asbestos fibers from artificial emberizing materials (embers and ash) containing respirable free-form asbestos under the Consumer Product Safety Act (CPSA) rather than under the Federal Hazardous Substances Act (FHSA) because of the desirability of avoiding possibly lengthy, resource-consuming, inefficient rulemaking proceedings under the FHSA, and because of the availability of civil penalties under the CPSA for knowing noncompliance.
(b) Therefore, artificial emberizing materials (embers and ash) containing respirable free-form asbestos are regulated under the CPSA.
§§ 1145.9-1145.15 [Reserved]
§ 1145.16 Lighters that are intended for igniting smoking materials and that can be operated by children; risks of death or injury.
(a) The Commission finds that it is in the public interest to regulate under the Consumer Product Safety Act any risks of injury associated with the fact that lighters intended for igniting smoking materials can be operated by young children, rather than regulate such risks under the Federal Hazardous Substances Act or the Poison Prevention Packaging Act of 1970.
(b) Therefore, if the Commission finds regulation to be necessary, risks of death or injury that are associated with lighters that are intended for igniting smoking materials, where such risks exist because the lighters can be operated by young children, shall be regulated under one or more provisions of the Consumer Product Safety Act. Other risks associated with such lighters, and that are based solely on the fact that the lighters contain a hazardous substance, shall continue to be regulated under the Federal Hazardous Substances Act.
§ 1145.17 Multi-purpose lighters that can be operated by children; risks of death or injury.
(a) The Commission finds that it is in the public interest to regulate under the Consumer Product Safety Act any risks of injury associated with the fact that multi-purpose lighters can be operated by young children, rather than to regulate such risks under the Federal Hazardous Substances Act or the Poison Prevention Packaging Act of 1970.
(b) Therefore, if the Commission finds regulation to be necessary, risks of death or injury that are associated with multi-purpose lighters because the lighters can be operated by young children shall be regulated under one or more provisions of the Consumer Product Safety Act. Other risks that are associated with such lighters, and that are based solely on the fact that the lighters contain a hazardous substance, shall continue to be regulated under the Federal Hazardous Substances Act.
PART 1199— CHILDREN’S TOYS AND CHILD CARE ARTICLES CONTAINING PHTHALATES: GUIDANCE ON INACCESSIBLE COMPONENT PARTS
§ 1199.1 Children’s toys and child care articles: Phthalate-containing inaccessible component parts.
(a) Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) permanently prohibits the sale of any “children’s toy or child care article” containing more than 0.1 percent of three specified phthalates (di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP)). Section 108 of the CPSIA also prohibits, on an interim basis, “toys that can be placed in a child’s mouth” or “child care article” containing more than 0.1 percent of three additional phthalates (diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DnOP)). A “children’s toy” is defined as a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays. A toy can be placed in a child’s mouth if any part of the toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the children’s product can only be licked, it is not regarded as able to be placed in the mouth. If a toy or part of a toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth. The term “child care article” means a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 years and younger, or to help such children with sucking or teething.
(b) Section 108(d) of the CPSIA provides that the prohibitions in paragraph (a) of this section do not apply to component parts of a children’s toy or child care article that are not accessible to children through normal and reasonably foreseeable use and abuse of such product, as determined by the Commission. A component part is not accessible if it is not physically exposed, by reason of a sealed covering or casing, and does not become physically exposed through reasonably foreseeable use and abuse of the product, including swallowing, mouthing, breaking, or other children’s activities, and the aging of the product.
(c) Section 108(d)(3) of the CPSIA directs the Commission to promulgate a rule to provide guidance with respect to what product components or classes of components will be considered to be inaccessible for a children’s toy or child care article that contains phthalates or adopt the same guidance with respect to inaccessibility that was adopted by the Commission with regard to accessibility of lead under section 101(b)(2)(B) (15 U.S.C. 1278a(b)(2)(B)), with additional consideration, as appropriate, of whether such component can be placed in a child’s mouth. 15 U.S.C. 2057c(d)(3). The Commission adopts the same guidance with respect to inaccessibility for the phthalates that was adopted by the Commission with regard to accessibility of lead, however, vinyl (or other plasticized material) covered mattresses/sleep surfaces, that contain phthalates that are designed or intended by the manufacturer to facilitate sleep of children age 3 and younger, are considered accessible and would not be considered inaccessible through the use of fabric coverings, including sheets and mattress pads.
(d) The accessibility probes specified for sharp points or edges under the Commission’s regulations at 16 CFR 1500.48-1500.49 should be used to assess the accessibility of phthalate-containing component parts of a children’s toy or child care article. A phthalate-containing component part would be considered accessible if it can be contacted by any portion of the specified segment of the accessibility probe. A phthalate-containing component part would be considered inaccessible if it cannot be contacted by any portion of the specified segment of the accessibility probe.
(e) For children’s toys or child care articles intended for children that are 18 months of age or younger, the use and abuse tests set forth under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.51 (excluding the bite test of § 1500.51(c)), should be used to evaluate accessibility of phthalate-containing component parts of a children’s toy or child care article as a result of normal and reasonably foreseeable use and abuse of the product.
(f) For children’s toys or child care articles intended for children that are over 18 months, but not over 36 months of age, the use and abuse tests set forth under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.52 (excluding the bite test of § 1500.52(c)), should be used to evaluate accessibility of phthalate-containing component parts of a children’s toy or child care article as a result of normal and reasonably foreseeable use and abuse of the product.
(g) For children’s toys intended for children that are over 36 months, but not over 96 months of age, the use and abuse tests set forth under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite test of § 1500.53(c)), should be used to evaluate accessibility of phthalate-containing component parts of a children’s toy as a result of normal and reasonably foreseeable use and abuse of the product.
(h) For children’s toys intended for children over 96 months through 12 years of age, the use and abuse tests set forth under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite test of § 1500.53(c)) intended for children ages 37-96 months should be used to evaluate accessibility of phthalate-containing component parts of a children’s toy as a result of normal and reasonably foreseeable use and abuse of the product.
(i) Because the Commission adopts the same guidance with respect to inaccessibility for phthalates that was adopted by the Commission with regard to inaccessibility of lead, paint, coatings, and electroplating may not be considered a barrier that would render phthalate-containing component parts of toys and child care articles inaccessible. A children’s toy or child care article that is or contains a phthalate-containing part that is enclosed, encased, or covered by fabric and passes the appropriate use and abuse tests on such covers, is considered inaccessible to a child, unless the product or part of the product, in one dimension, is smaller than 5 centimeters. However, vinyl (or other plasticized material) covered mattresses/sleep surfaces that contain phthalates that are designed or intended by the manufacturer to facilitate sleep of children age 3 and younger, are considered accessible and would not be considered inaccessible through the use of fabric coverings, including sheets and mattress pads.
(j) The intentional disassembly or destruction of products by children older than age 8 years, by means or knowledge not generally available to younger children, including use of tools, will not be considered in evaluating products for accessibility of phthalate-containing components.
PART 1200—DEFINITION OF CHILDREN’S PRODUCT UNDER THE CONSUMER PRODUCT SAFETY ACT
§ 1200.1 Purpose.
This part provides guidance on the definition of children’s product and the factors the Commission will consider when making determinations regarding children’s products as set forth under 15 U.S.C. 2052(2).
§ 1200.2 Definition of children’s product.
(a) Definition of “Children’s Product”—(1) Under section 3(a)(2) of the Consumer Product Safety Act (CPSA), a children’s product means a consumer product designed or intended primarily for children 12 years of age or younger. The term “designed or intended primarily” applies to those consumer products mainly for children 12 years old or younger. Whether a product is primarily intended for children 12 years of age or younger is determined by considering the four specified statutory factors. These factors are:
(i) A statement by a manufacturer about the intended use of such product, including a label on such product if such statement is reasonable.
(ii) Whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by children 12 years of age or younger.
(iii) Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger.
(iv) The Age Determination Guidelines issued by the Commission staff in September 2002 and any successor to such guidelines.
(2) The examples discussed herein may also be illustrative in making such determinations; however, the determination of whether a product meets the definition of a children’s product depends on factual information that may be unique to each product and, therefore, would need to be made on a case-by-case basis. The term “for use” by children 12 years or younger generally means that children will physically interact with such products based on the reasonably foreseeable use of such product. Toys and articles that are subject to the small parts regulations at 16 CFR Part 1501 and in ASTM F963 would fall within the definition of children’s product since they are intended for children 12 years of age or younger. Toys and other articles intended for children up to 96 months (8 years old) that are subject to the requirements at 16 CFR 1500.48 through 1500.49 and 16 CFR 1500.50 through 1500.53 would similarly fall within the definition of children’s product given their age grading for these other regulations. Therefore, a manufacturer could reasonably conclude on the basis of the age grading for these other regulations that its product also must comply with all requirements applicable to children’s products including, but not limited to, those under the Federal Hazardous Substances Act, ASTM F963, “Standard Consumer Safety Specification for Toy Safety,” and the Consumer Product Safety Improvement Act of 2008.
(b) Definition of “General Use Product”—(1) A general use product means a consumer product that is not designed or intended primarily for use by children 12 years old or younger. General use products are those consumer products designed or intended primarily for consumers older than age 12. Some products may be designed or intended for use by consumers of all ages, including children 12 years old or younger, but are intended mainly for consumers older than 12 years of age. Examples of general use products may include products with which a child would not likely interact, or products with which consumers older than 12 would be as likely, or more likely to interact. Products used by children 12 years of age or younger that have a declining appeal for teenagers are likely to be considered children’s products.
(2) Other products are specifically not intended for children 12 years of age or younger. These products, such as cigarette lighters, candles, and fireworks, which the Commission has traditionally warned adults to keep away from children, are not subject to the CPSIA’s lead limits, tracking label requirement, and third-party testing and certification provisions. Similarly, products that incorporate performance requirements for child resistance are not children’s products as they are designed specifically to ensure that children cannot access the contents. This would include products such as portable gasoline containers and special packaging under the Poison Prevention Packaging Act.
(c) Factors Considered—To determine whether a consumer product is primarily intended for a child 12 years of age or younger the four specified statutory factors must be considered together as a whole. The following four factors must be considered:
(1) A statement by a manufacturer about the intended use of such product, including a label on such product if such statement is reasonable. A manufacturer’s statement about the product’s intended use, including the product’s label, should be reasonably consistent with the expected use patterns for a product. A manufacturer’s statement that the product is not intended for children does not preclude a product from being regulated as a children’s product if the primary appeal of the product is to children 12 years of age or younger, as indicated, for example, by decorations or embellishments that invite use by the child, being sized for a child or being marketed to appeal primarily to children. Similarly, a label indicating that a product is for ages 9 and up does not necessarily make it a children’s product if it is a general use product. Such a label may recommend 9 years old as the earliest age for a prospective user, but may or may not indicate the age for which the product is primarily intended. The manufacturer’s label, in and of itself, is not considered to be determinative.
(2) Whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by children 12 years of age or younger.
(i) These representations may be express or implied. For example, advertising by the manufacturer expressly declaring that the product is intended for children 12 years of age or younger will support a determination that a product is a children’s product. While, for example advertising by the manufacturer showing children 12 years of age or younger using the product may support a determination that the product is a children’s product. These representations may be found in packaging, text, illustrations and/or photographs depicting consumers using the product, instructions, assembly manuals, or advertising media used to market the product.
(ii) The product’s physical location near, or visual association with, children’s products may be a factor in making an age determination, but is not determinative. For example, a product displayed in a children’s toy section of a store may support a determination that the product is a children’s product. However, where that same product is also sold in department stores and marketed for general use, further evaluation would be necessary. The Commission recognizes that manufacturers do not necessarily control where a product will be placed in a retail establishment and such lack of control will be considered. The Commission evaluates products more broadly than on a shelf-by-shelf or store-by-store basis.
(iii) The product’s association or marketing in conjunction with nonchildren’s products may not be determinative as to whether the product is a children’s product. For example, packaging and selling a stuffed animal with a candle would not preclude a determination that the stuffed animal is a children’s product since stuffed animals are commonly recognized as being primarily intended for children.
(3) Whether the product is commonly recognized by consumers as being intended for use by children 12 years of age or younger. Consumer perception of the product’s use by children, including its reasonably foreseeable use, will be evaluated. Sales data, market analyses, focus group testing, and other marketing studies may help support an analysis regarding this factor.
(i) Features and Characteristics—additional considerations that may help distinguish children’s products from nonchildren’s products include:
(A) Small sizes that would not be comfortable for the average adult;
(B) Exaggerated features (large buttons, bright indicators) that simplify the product’s use;
(C) Safety features that are not found on similar products intended for adults;
(D) Colors commonly associated with childhood (pinks, blues, bright primary colors);
(E) Decorative motifs commonly associated with childhood (such as animals, insects, small vehicles, alphabets, dolls, clowns, and puppets);
(F) Features that do not enhance the product’s utility (such as cartoons) but contribute to its attractiveness to children 12 years of age or younger; and
(G) Play value, i.e., features primarily attractive to children 12 years of age or younger that promote interactive exploration and imagination for fanciful purposes (whimsical activities lacking utility for accomplishing mundane tasks; actions performed for entertainment and amusement).
(ii) Principal use of the product—the principal uses of a product take precedence over other actions that are less likely to be performed with a product. For example, when a child pretends that a broom is a horse, that does not mean the item is a children’s product because the broom’s principal use is for sweeping;
(iii) Cost—the cost of a given product may influence the determination of the age of intended users; and
(iv) Children’s interactions, if any, with the product—products for use in a child’s environment by the caregiver but not for use by the child would not be considered to be primarily intended for a child 12 years of age or younger.
(4) The Age Determination Guidelines issued by the Consumer Product Safety Commission staff in September 2002, and any successor to such guidelines. The product’s appeal to different age groups and the capabilities of those age groups may be considered when making determinations about the appropriate user groups for products.
(d) Examples—To help manufacturers understand what constitutes a children’s product under the CPSA, the following additional examples regarding specific product categories are offered:
(1) Furnishings and Fixtures—General home furnishings and fixtures (including, but not limited to: Rocking chairs, shelving units, televisions, digital music players, ceiling fans, humidifiers, air purifiers, window curtains, tissue boxes, rugs, carpets, lamps, clothing hooks and racks) that often are found in children’s rooms or schools would not be considered children’s products unless they are decorated or embellished with a childish theme and invite use by a child 12 years of age or younger, are sized for a child, or are marketed to appeal primarily to children. Examples of home or school furnishings that are designed or intended primarily for use by children and considered children’s products include: Infant tubs, bath seats, small bean bag chairs with childish decorations, beds with children’s themes, child-sized desks, and child-sized chairs. Decorative items, such as holiday decorations and household seasonal items that are intended only for display, with which children are not likely to interact, are generally not considered children’s products, since they are intended to be used by adults.
(2) Collectibles—Adult collectibles may be distinguished from children’s collectibles by themes that are inappropriate for children 12 years of age or younger, have features that preclude use by children during play, such as high cost, limited production, fragile features, display features (such as hooks or pedestals), and are not marketed alongside children’s products (for example, in a children’s department) in ways that make them indistinguishable from children’s products. For example, collectible plush bears have high cost, are highly detailed, with fragile accessories, display cases, and platforms on which to pose and hold the bears. Children’s bears have lower costs and simple accessories that can be handled without fear of damage to the product. Another example of collectible items includes model railways and trains made for hobbyists.
(3) Jewelry—Jewelry intended for children is generally sized, themed, and marketed to children. The following characteristics may cause a piece of jewelry to be considered a children’s product: Size; very low cost; play value; childish themes on the jewelry; sale with children’s products (such as a child’s dress); sale with a child’s book, a toy, or party favors; sale with children’s cereal or snacks; sale at an entertainment or educational event attended primarily by children; sale in a store that contains mostly children’s products; and sale in a vending machine. In addition, many aspects of an item’s design and marketing are considered when determining the age of consumers for whom the product is intended and will be purchased including: Advertising; promotional materials; packaging graphics and text; dexterity requirements for wearing; appearance (coloring, textures, materials, design themes, licensing, and level of realism); and cost. These characteristics will help jewelry manufacturers and consumers determine whether a particular piece of jewelry is designed or intended primarily for children 12 years of age or younger.
(4) DVDs, Video Games, and Computer Products—Most computer products and electronic media, such as CDs, DVDs, and video games, are considered general use products. However, CDs and DVDs with encoded content that is intended for and marketed to children, such as children’s movies, games, or educational software may be determined to be children’s products. CPSC st