Title 40—Protection of Environment–Volume 26

Last updated on September 6th, 2024 at 12:09 am

Title 40—Protection of Environment–Volume 26

Part


chapter i—Environmental Protection Agency (Continued)

150

CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

SUBCHAPTER E—PESTICIDE PROGRAMS

PART 150—GENERAL

Authority:Reorganization Plan No. 3 of 1970 (5 U.S.C. App.).

§ 150.17 Addresses for the Office of Pesticide Programs.

The official addresses, unless otherwise noted, are as follows:

(a) Applications, correspondence, and non-docket materials—(1) United States Postal Service mailing address. Office of Pesticide Programs (7510P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

(2) Hand/courier delivery address. Office of Pesticide Programs, Environmental Protection Agency, 2777 S. Crystal Dr., Arlington, VA 22202-4501. This is not a mailing address. You must make arrangements with the person receiving your delivery.

(b) Office of Pesticide Programs Regulatory Public Docket (OPP Docket)—(1) Electronic docket address. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov. Although listed in the docket index at regulations.gov, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only at the OPP Docket.

(2) Physical location. Environmental Protection Agency Docket Center (EPA/DC), Environmental Protection Agency, EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. This is not a mailing address. For instructions on visiting the docket, go to http://www.epa.gov/dockets/contacts.htm.

(3) United States Postal Service mailing address. Office of Pesticide Programs Regulatory Public Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

(4) Hand/courier delivery. For hand/courier delivery or to make special arrangements for deliveries of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.

[77 FR 46291, Aug. 3, 2012]

PART 151 [RESERVED]

PART 152—PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES

Authority:7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Subpart A—General Provisions

Source:53 FR 15975, May 4, 1988, unless otherwise noted.

§ 152.1 Scope.

(a) Part 152 sets forth procedures, requirements and criteria concerning the registration of pesticide products under FIFRA section 3, including plant-incorporated protectants (PIPs). Unless specifically superseded by part 174, the regulations in part 152 apply to PIPs.

(b) Part 152 also describes associated regulatory activities affecting registration, as described in this paragraph.

(1) Data compensation and exclusive use of data in support of registration. Refer to subpart E of this part.

(2) Rights and obligations of registrants. Refer to subpart G of this part.

(3) Classification of pesticide uses. Refer to subpart I of this part.

(4) Fees. Refer to subpart U of this part.

(5) Requirements pertaining to pesticide devices. Refer to subpart Z of this part.

[73 FR 75594, Dec. 12, 2008]

§ 152.3 Definitions.

Terms used in this part have the same meaning as in the Act. In addition, the following terms have the meanings set forth in this section.

Act or FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136-136y).

Active ingredient means any substance (or group of structurally similar substances if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA sec. 2(a), except as provided in § 174.3 of this chapter.

Acute dermal LD50 means a statistically derived estimate of the single dermal dose of a substance that would cause 50 percent mortality to the test population under specified conditions.

Acute inhalation LC50 means a statistically derived estimate of the concentration of a substance that would cause 50 percent mortality to the test population under specified conditions.

Acute oral LD50 means a statistically derived estimate of the single oral dose of a substance that would cause 50 percent mortality to the test population under specified conditions.

Administrator means the Administrator of the United States Environmental Protection Agency or his delegate.

Agency means the United States Environmental Protection Agency (EPA), unless otherwise specified.

Applicant means a person who applies for a registration or amended registration under FIFRA sec. 3.

Biological control agent means any living organism applied to or introduced into the environment that is intended to function as a pesticide against another organism declared to be a pest by the Administrator.

Distribute or sell and other grammatical variations of the term such as “distributed or sold” and “distribution or sale,” means the acts of distributing, selling, offering for sale, holding for sale, shipping, holding for shipment, delivering for shipment, or receiving and (having so received) delivering or offering to deliver, or releasing for shipment to any person in any State.

End use product means a pesticide product whose labeling

(1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating, or regulating the growth of plants, and

(2) Does not state that the product may be used to manufacture or formulate other pesticide products.

Final printed labeling means the label or labeling of the product when distributed or sold. Final printed labeling does not include the package of the product, unless the labeling is an integral part of the package.

Inert ingredient means any substance (or group of structurally similar substances if designated by the Agency), other than an active ingredient, which is intentionally included in a pesticide product, except as provided by § 174.3 of this chapter.

Institutional use means any application of a pesticide in or around any property or facility that functions to provide a service to the general public or to public or private organizations, including but not limited to:

(1) Hospitals and nursing homes.

(2) Schools other than preschools and day care facilities.

(3) Museums and libraries.

(4) Sports facilities.

(5) Office buildings.

Living plant means a plant, plant organ, or plant part that is alive, viable, or dormant. Examples of plant parts include, but are not limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.

Manufacturing use product means any pesticide product that is not an end-use product.

New use, when used with respect to a product containing a particular active ingredient, means:

(1) Any proposed use pattern that would require the establishment of, the increase in, or the exemption from the requirement of a tolerance or food additive regulation under section 408 of the Federal Food, Drug and Cosmetic Act;

(2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or

(3) Any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure, to the active ingredient of man or other organisms.

Operated by the same producer, when used with respect to two establishments, means that each such establishment is either owned by, or leased for operation by and under the control of, the same person. The term does not include establishments owned or operated by different persons, regardless of contractural agreement between such persons.

Package or packaging means the immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution, sale, consumption, use, or storage. The term does not include any shipping or bulk container used for transporting or delivering the pesticide unless it is the only such package.

Pesticide means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, other than any article that:

(1) Is a new animal drug under FFDCA sec. 201(w), or

(2) Is an animal drug that has been determined by regulation of the Secretary of Health and Human Services not to be a new animal drug, or

(3) Is an animal feed under FFDCA sec. 201(x) that bears or contains any substances described by paragraph (s) (1) or (2) of this section.

Pesticide product means a pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold. The term includes any physical apparatus used to deliver or apply the pesticide if distributed or sold with the pesticide.

Plant-incorporated protectant means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof.

Released for shipment. A product becomes released for shipment when the producer has packaged and labeled it in the manner in which it will be distributed or sold, or has stored it in an area where finished products are ordinarily held for shipment. Products stored in an area where finished products are ordinarily held for shipment, but which are not intended to be released for shipment must be physically separated and marked as not yet released for shipment. Once a product becomes released for shipment, the product remains in the condition of being released for shipment unless subsequent activities, such as relabeling or repackaging, constitute production.

Residential use means use of a pesticide directly:

(1) On humans or pets,

(2) In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or

(3) In any preschool or day care facility.

[53 FR 15975, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 73 FR 64224, Oct. 29, 2008; 73 FR 75594, Dec. 12, 2008]

§ 152.5 Pests.

An organism is declared to be a pest under circumstances that make it deleterious to man or the environment, if it is:

(a) Any vertebrate animal other than man;

(b) Any invertebrate animal, including but not limited to, any insect, other arthropod, nematode, or mollusk such as a slug and snail, but excluding any internal parasite of living man or other living animals;

(c) Any plant growing where not wanted, including any moss, alga, liverwort, or other plant of any higher order, and any plant part such as a root; or

(d) Any fungus, bacterium, virus, prion, or other microorganism, except for those on or in living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs (as defined in FFDCA section 201(g)(1)) and cosmetics (as defined in FFDCA section 201(i)).

[53 FR 15975, May 4, 1988, as amended at 78 FR 13507, Feb. 28, 2013]

§ 152.6 Substances excluded from regulation by FIFRA.

Products and substances listed in this section are excluded from FIFRA regulation if they meet the specified conditions or criteria.

(a) Liquid chemical sterilants. A liquid chemical sterilant product is not a pesticide under section 2(u) of FIFRA if it meets all of the following criteria. Excluded products are regulated by the Food and Drug Administration (FDA). Products excluded are those meeting all of the following criteria:

(1) Composition. The product must be in liquid form as sold or distributed. Pressurized gases or products in dry or semi-solid form are not excluded by this provision. Ethylene oxide products are not liquid products and are not excluded by this provision.

(2) Claims. The product must bear a sterilant claim, or a sterilant plus subordinate level disinfection claim. Products that bear antimicrobial claims solely at a level less than “sterilant” are not excluded and are jointly regulated by EPA and FDA.

(3) Use site. (i) The product must be intended and labeled only for use on “critical or semi-critical devices.” A “critical device” is any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body. A semi-critical device is any device which contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.

(ii) Liquid chemical sterilants that bear claims solely for use on non-critical medical devices are jointly regulated by EPA and FDA.

(iii) Liquid chemical sterilants that bear claims solely for use on sites that are not medical devices, such as veterinary equipment, are not excluded and are regulated solely by EPA.

(b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from regulation under FIFRA if it is a substance (or mixture of substances), meeting all of the following criteria:

(1) The substance prevents or hinders the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria and is distributed and sold solely for those purposes and no other pesticidal purposes. For purposes of this section, living organisms are not considered to be substances, and the actions of living organisms are not relevant to whether a substance is deemed to be a nitrogen stabilizer.

(2) The substance was in “commercial agronomic use” in the United States before January 1, 1992. EPA considers a substance to be in commercial agronomic use if it is available for sale or distribution to users for direct agronomic benefit, as opposed to limited research, experimental or demonstration use.

(3) The substance was not registered under FIFRA before January 1, 1992.

(4) Since January 1, 1992, the distributor or seller has made no claim that the product prevents or hinders the process of nitrification, denitrification, ammonia volatilization or urease production. EPA considers any of the following claims (or their equivalents) to be a claim that the product prevents or hinders nitrification, denitrification, ammonia volatilization or urease production:

(i) Improves crop utilization of applied nitrogen.

(ii) Reduces leaching of applied nitrogen or reduces groundwater nitrogen contamination.

(iii) Prevents nitrogen loss.

(iv) Prolongs availability of nitrogen.

(v) Increases nitrogen uptake, availability, usage, or efficiency.

(5) A product will be considered to have met the criterion of paragraph (b)(4) of this section that no nitrogen stabilization claim has been made if:

(i) The nitrogen stabilization claim, in whatever terms expressed, is made solely in compliance with a State requirement to include the claim in materials required to be submitted to a State legislative or regulatory authority, or in the labeling or other literature accompanying the product; and

(ii) The State requirement to include the claim was in effect both before the product bearing the claim was introduced into commercial agronomic use, and before the effective date of this rule.

(6) A product that meets all of the criteria of this paragraph with respect to one State is not thereby excluded from FIFRA regulation if distributed and sold in another State whose nitrogen stabilization statement requirement does not meet the requirements of paragraph (b)(5)(ii) of this section.

(c) Human drugs. Fungi, bacteria, viruses or other microorganisms in or on living man are not “pests” as defined in section 2(t) of FIFRA. Products intended and labeled for use against such organisms are human drugs subject to regulation by the FDA under the FFDCA.

(d) Animal drugs. (1) Fungi, viruses, bacteria or other microorganisms on or in living animals are not “pests” under section 2(t) of FIFRA. Products intended for use against such organisms are “animal drugs” regulated by the FDA under the FFDCA.

(2) A “new animal drug” as defined in section 201(w) of the FFDCA, or an animal drug that FDA has determined is not a “new animal drug” is not a pesticide under section 2(u) of FIFRA. Animal drugs are regulated by the FDA under the FFDCA.

(e) Animal feeds. An animal feed containing a new animal drug is not a pesticide under section 2(u) of FIFRA. An animal feed containing a new animal drug is subject to regulation by the FDA under the FFDCA.

(f) Vitamin hormone products. A product consisting of a mixture of plant hormones, plant nutrients, inoculants, or soil amendments is not a “plant regulator” under section 2(v) of FIFRA, provided it meets the following criteria:

(1) The product, in the undiluted package concentration at which it is distributed or sold, meets the criteria of § 156.62 of this chapter for Toxicity Category III or IV; and

(2) The product is not intended for use on food crop sites, and is labeled accordingly.

(g) Products intended to aid the growth of desirable plants. A product of any of the following types, intended only to aid the growth of desirable plants, is not a “plant regulator” under section 2(v) of FIFRA, and therefore is not a pesticide:

(1) A plant nutrient product, consisting of one or more macronutrients or micronutrient trace elements necessary to normal growth of plants and in a form readily usable by plants.

(2) A plant inoculant product consisting of microorganisms to be applied to the plant or soil for the purpose of enhancing the availability or uptake of plant nutrients through the root system.

(3) A soil amendment product containing a substance or substances intended for the purpose of improving soil characteristics favorable for plant growth.

[66 FR 64763, Dec. 14, 2001, as amended at 73 FR 75594, Dec. 12, 2008]

§ 152.8 Products that are not pesticides because they are not for use against pests.

A substance or article is not a pesticide, because it is not intended for use against “pests” as defined in § 152.5, if it is:

(a) A fertilizer product not containing a pesticide.

(b) A product intended to force bees from hives for the collection of honey crops.

[53 FR 15975, May 4, 1988, as amended at 66 FR 64764, Dec. 14, 2001]

§ 152.10 Products that are not pesticides because they are not intended for a pesticidal purpose.

A product that is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or regulate the growth of plants, is not considered to be a pesticide. The following types of products or articles are not considered to be pesticides unless a pesticidal claim is made on their labeling or in connection with their sale and distribution:

(a) Deodorizers, bleaches, and cleaning agents;

(b) Products not containing toxicants, intended only to attract pests for survey or detection purposes, and labeled accordingly;

(c) Products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants, such as certain pruning paints to trees.

§ 152.15 Pesticide products required to be registered.

No person may distribute or sell any pesticide product that is not registered under the Act, except as provided in §§ 152.20, 152.25, and 152.30. A pesticide is any substance (or mixture of substances) intended for a pesticidal purpose, i.e., use for the purpose of preventing, destroying, repelling, or mitigating any pest or use as a plant regulator, defoliant, or desiccant. A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:

(a) The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise):

(1) That the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or

(2) That the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or

(b) The substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide; or

(c) The person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose.

Subpart B—Exemptions

Source:53 FR 15977, May 4, 1988, unless otherwise noted.

§ 152.20 Exemptions for pesticides adequately regulated by another Federal agency.

The pesticides or classes of pesticide listed in this section are exempt from all requirements of FIFRA. The Agency has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated by another Federal agency.

(a) Certain biological control agents. (1) Except as provided by paragraphs (a)(3) and (a)(4) of this section, all biological control agents are exempt from FIFRA requirements.

(2) If the Agency determines that an individual biological control agent or class of biological control agents is no longer adequately regulated by another Federal agency, and that it should not otherwise be exempted from the requirements of FIFRA, the Agency will revoke this exemption by amending paragraph (a)(3) of this section.

(3) The following biological control agents are not exempt from FIFRA requirements:

(i) A eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;

(ii) A procaryotic microorganism including, but not limited to, Eubacteria and Archaebacteria; or

(iii) A parasitically-replicating microscopic element, including, but not limited to, viruses.

(4) All living plants intended for use as biological control agents are exempt from the requirements of FIFRA. However, plant-incorporated protectants are not exempt pursuant to this section. Regulations, including exemptions, for plant-incorporated protectants are addressed in part 174 of this chapter.

(b) Non-liquid chemical sterilants. A non-liquid chemical sterilant, except ethylene oxide, that meets the criteria of § 152.6(a)(2) with respect to its claims and § 152.6(a)(3) with respect to its use sites is exempted from regulation under FIFRA.

[53 FR 15977, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 66 FR 64764, Dec. 14, 2001; 72 FR 61027, Oct. 26, 2007]

§ 152.25 Exemptions for pesticides of a character not requiring FIFRA regulation.

The pesticides or classes of pesticides listed in this section have been determined to be of a character not requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended for use, and used, only in the manner specified.

(a) Treated articles or substances. An article or substance treated with, or containing, a pesticide to protect the article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insect or fungus infestation), if the pesticide is registered for such use.

(b) Pheromones and pheromone traps. Pheromones and identical or substantially similar compounds labeled for use only in pheromone traps (or labeled for use in a manner which the Administrator determines poses no greater risk of adverse effects on the environment than use in pheromone traps), and pheromone traps in which those compounds are the sole active ingredient(s).

(1) For the purposes of this paragraph, a pheromone is a compound produced by an arthropod which, alone or in combination with other such compounds, modifies the behavior of other individuals of the same species.

(2) For the purposes of this paragraph, a synthetically produced compound is identical to a pheromone only when their molecular structures are identical, or when the only differences between the molecular structures are between the stereochemical isomer ratios of the two compounds, except that a synthetic compound found to have toxicological properties significantly different from a pheromone is not identical.

(3) When a compound possesses many characteristics of a pheromone but does not meet the criteria in paragraph (a)(2) of this section, it may, after review by the Agency, be deemed a substantially similar compound.

(4) For the purposes of this paragraph, a pheromone trap is a device containing a pheromone or an identical or substantially similar compound used for the sole purpose of attracting, and trapping or killing, target arthropods. Pheromone traps are intended to achieve pest control by removal of target organisms from their natural environment and do not result in increased levels of pheromones or identical or substantially similar compounds over a significant fraction of the treated area.

(c) Preservatives for biological specimens. (1) Embalming fluids.

(2) Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of learning.

(3) Products used to preserve the integrity of milk, urine, blood, or other body fluids for laboratory analysis.

(d) Foods. Products consisting of foods and containing no active ingredients, which are used to attract pests.

(e) Natural cedar. (1) Natural cedar blocks, chips, shavings, balls, chests, drawer liners, paneling, and needles that meet all of the following criteria:

(i) The product consists totally of cedarwood or natural cedar.

(ii) The product is not treated, combined, or impregnated with any additional substance(s).

(iii) The product bears claims or directions for use solely to repel arthropods other than ticks or to retard mildew, and no additional claims are made in sale or distribution. The labeling must be limited to specific arthropods, or must exclude ticks if any general term such as “arthropods,” “insects,” “bugs,” or any other broad inclusive term, is used. The exemption does not apply to natural cedar products claimed to repel ticks.

(2) The exemption does not apply to cedar oil, or formulated products which contain cedar oil, other cedar extracts, or ground cedar wood as part of a mixture.

(f) Minimum risk pesticides—(1) Exempted products. Products containing the following active ingredients, alone or in combination with other substances listed in table 1 of this paragraph, are exempt from the requirements of FIFRA provided that all of the criteria of this section are met. All listed active ingredients may be used in non-food use products. Under section 408 of the Federal Food, Drug, and Cosmetic Act and EPA (FFDCA) implementing regulations at part 180 of this chapter, food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter. Such tolerances or exemptions may be found, for example, in §§ 180.950, 180.1071, 180.1087, 180.1233, and 180.1251 of this chapter.

(2) Permitted inert ingredients. A pesticide product exempt under paragraph (f)(1) of this section may only include the inert ingredients listed in paragraphs (f)(2)(i) through (iv) of this section. All listed inert ingredients may be used in non-food use products. Under FFDCA section 408 and EPA implementing regulations at part 180 of this chapter, food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter. Such tolerances or exemptions may be found, for example, in §§ 180.910, 180.920. 180.930, 180.940, 180.950, and 180.1071 of this chapter.

(i) Commonly consumed food commodities, as described in § 180.950(a) of this chapter.

(ii) Animal feed items, as described in § 180.950(b) of this chapter.

(iii) Edible fats and oils, as described in § 180.950(c) of this chapter.

(iv) Specific chemical substances, as listed in the following table.

(3) Other conditions of exemption. All of the following conditions must be met for products to be exempted under this section:

(i) Each product containing the substance must bear a label identifying the label display name and percentage (by weight) of each active ingredient as listed in table 1 in paragraph (f)(1) of this section. Each product must also list all inert ingredients by the label display name listed in table 2 in paragraph (f)(2)(iv) of this section.

(ii) The product must not bear claims either to control or mitigate microorganisms that pose a threat to human health, including but not limited to disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.

(iii) Company name and contact information.

(A) The name of the producer or the company for whom the product was produced must appear on the product label. If the company whose name appears on the label in accordance with this paragraph is not the producer, the company name must be qualified by appropriate wording such as “Packed for [insert name],” “Distributed by [insert name], or “Sold by [insert name]” to show that the name is not that of the producer.

(B) Contact information for the company specified in accordance with paragraph (f)(3)(iii)(A) of this section must appear on the product label including the street address plus ZIP code and the telephone phone number of the location at which the company may be reached.

(C) The company name and contact information must be displayed prominently on the product label.

(iv) The product must not include any false and misleading labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) through (viii).

(4) Providing guidance. Guidance on minimum risk pesticides is available at http://www2.epa.gov/minimum-risk-pesticides or successor Web pages.

[53 FR 15977, May 4, 1988, as amended at 59 FR 2751, Jan. 19, 1994; 61 FR 8878, Mar. 6, 1996; 66 FR 64764, Dec. 14, 2001; 71 FR 35545, June 21, 2006; 80 FR 80660, Dec. 28, 2015; 87 FR 67370, Nov. 8, 2022]

§ 152.30 Pesticides that may be transferred, sold, or distributed without registration.

An unregistered pesticide, or a pesticide whose registration has been cancelled or suspended, may be dis-tributed or sold, or otherwise transferred, to the extent described by this section.

(a) A pesticide transferred between registered establishments operated by the same producer. An unregistered pesticide may be transferred between registered establishments operated by the same producer. The pesticide as transferred must be labeled in accordance with part 156 of this chapter.

(b) A pesticide transferred between registered establishments not operated by the same producer. An unregistered pesticide may be transferred between registered establishments not operated by the same producer if:

(1) The transfer is solely for the purpose of further formulation, packaging, or labeling into a product that is registered;

(2) Each active ingredient in the pesticide, at the time of transfer, is present as a result of incorporation into the pesticide of either:

(i) A registered product; or

(ii) A pesticide that is produced by the registrant of the final product; and

(3) The product as transferred is labeled in accordance with part 156 of this chapter.

(c) A pesticide distributed or sold under an experimental use permit. (1) An unregistered pesticide may be distributed or sold in accordance with the terms of an experimental use permit issued under FIFRA sec. 5, if the product is labeled in accordance with § 172.6 of this chapter.

(2) An unregistered pesticide may be distributed or sold in accordance with the provisions of § 172.3 of this chapter, pertaining to use of a pesticide for which an experimental use permit is not required, provided the product is labeled in accordance with part 156 of this chapter.

(d) A pesticide transferred solely for export. An unregistered pesticide may be transferred within the United States solely for export if it meets the following conditions:

(1) The product is prepared and packaged according to the specifications of the foreign purchaser; and

(2) The product is labeled in accordance with part 156 of this chapter.

(e) A pesticide distributed or sold under an emergency exemption. An unregistered pesticide may be distributed or sold in accordance with the terms of an emergency exemption under FIFRA sec. 18, if the product is labeled in accordance with part 156 of this chapter.

(f) A pesticide transferred for purposes of disposal. An unregistered, suspended, or cancelled pesticide may be transferred solely for disposal in accordance with FIFRA sec. 19 or an applicable Administrator’s order. The product must be labeled in accordance with part 156 of this chapter.

(g) Existing stocks of a formerly registered product. A cancelled or suspended pesticide may be distributed or sold to the extent and in the manner specified in an order issued by the Administrator concerning existing stocks of the pecticide.

Subpart C—Registration Procedures

Source:53 FR 15978, May 4, 1988, unless otherwise noted.

§ 152.40 Who may apply.

Any person may apply for new registration of a pesticide product. Any registrant may apply for amendment of the registration of his product.

§ 152.42 Application for new registration.

Any person seeking to obtain a registration for a new pesticide product must submit an application for registration, containing the information specified in § 152.50. An application for new registration must be approved by the Agency before the product may legally be distributed or sold, except as provided by § 152.30.

§ 152.43 Alternate formulations.

(a) A product proposed for registration must have a single, defined composition, except that EPA may approve a basic formulation and one or more alternate formulations for a single product.

(b) An alternate formulation must meet the criteria listed in paragraph (b) (1) through (4) of this section. The Agency may require the submission of data to determine whether the criteria have been met.

(1) The alternate formulation must have the same certified limits for each active ingredient as the basic formulation.

(2) If the alternate formulation contains an inert ingredient or impurity of toxicological significance, the formulation must have the same upper certified limit for that substance as the basic formulation;

(3) The label text of the alternate formulation product must be identical to that of the basic formulation.

(4) The analytical method required under § 158.355 of this chapter must be suitable for use on both the basic formulation and the alternate formulation.

(c) Notwithstanding the criteria in this section, the Agency may determine that an alternate formulation must be separately registered. If EPA makes this determination, the Agency will notify the applicant of its determination and its reasons. Thereafter the application for an alternate formulation will be treated as an application for new registration, and the alternate formulation will be assigned a new registration number.

[53 FR 15978, May 4, 1988, as amended at 72 FR 61027, Oct. 26, 2007]

§ 152.44 Application for amended registration.

(a) Except as provided by § 152.46, any modification in the composition, labeling, or packaging of a registered product must be submitted with an application for amended registration. The applicant must submit the information required by § 152.50, as applicable to the change requested. If an application for amended registration is required, the application must be approved by the Agency before the product, as modified, may legally be distributed or sold.

(b) In its discretion, the Agency may:

(1) Waive the requirement for submission of an application for amended registration;

(2) Require that the applicant certify to the Agency that he has complied with an Agency directive rather than submit an application for amended registration; or

(3) Permit an applicant to modify a registration by notification or non-notification in accordance with § 152.46.

(c) A registrant may at any time submit identical minor labeling amendments affecting a number of products as a single application if no data are required for EPA to approve the amendment (for example, a change in the wording of a storage statement for designated residential use products). A consolidated application must clearly identify the labeling modification(s) to be made (which must be identical for all products included in the application), list the registration number of each product for which the modification is requested, and provide required supporting materials (for example, labeling) for each affected product.

[53 FR 15978, May 4, 1988, as amended at 61 FR 33041, June 26, 1996; 66 FR 64764, Dec. 14, 2001]

§ 152.46 Notification and non-notification changes to registrations.

(a) Changes permitted by notification. (1) EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished by notification to the Agency, without requiring that the registrant obtain Agency approval. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of modifications permitted by notification and any conditions and procedures for submitting notifications.

(2) A registrant may modify a registration consistent with paragraph (a)(1) of this section and any procedures issued thereunder and distribute or sell the modified product as soon as the Agency has received the notification. Based upon the notification, the Agency may require that the registrant submit an application for amended registration. If it does so, the Agency will notify the registrant and state its reasons for requiring an application for amended registration. Thereafter, if the registrant fails to submit an application the Agency may determine that the product is not in compliance with the requirements of the Act. Notification under this paragraph is considered a report filed under the Act for the purposes of FIFRA section 12(a)(2)(M).

(b) Changes permitted without notification. EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished without notification to or approval by the Agency. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of amendments permitted without notification (also known as non-notification). A registrant may distribute or sell a product changed in a manner consistent with such procedures without notification to or approval by the Agency.

(c) Effect of non-compliance. Notwithstanding any other provision of this section, if the Agency determines that a product has been modified through notification or without notification in a manner inconsistent with paragraphs (a) or (b) of this section and any procedures issued thereunder, the Agency may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application for amended registration.

[61 FR 33041, June 26, 1996]

§ 152.50 Contents of application.

Each application for registration or amended registration must include the following information, as applicable:

(a) Application form. An application form must be completed and submitted to the Agency. Application forms are provided by the Agency, with instructions as to the number of copies required and proper completion.

(b) Identity of the applicant—(1) Name. The applicant must identify himself. An applicant not residing in the United States must also designate an agent in accordance with paragraph (b)(3) of this section to act on behalf of the applicant on all registration matters.

(2) Address of record. The applicant must provide an address in the United States for correspondence purposes. The U.S. address provided will be considered the applicant’s address of record, and EPA will send all correspondence concerning the application and any subsequent registration to that address. It is the responsibility of the applicant and any registrant under § 152.122 to ensure that the Agency has a current and accurate address.

(3) Authorized agent. An applicant may designate a person residing in the United States to act as his agent. If an applicant wishes to designate an agent, he must send the Agency a letter stating the name and United States address of his agent. The applicant must notify the Agency if he changes his designated agent. This relationship may be terminated at any time by the applicant by notifying the Agency in writing.

(4) Company number. If an applicant has been assigned a company number by the Agency, the application must reference that number.

(c) Summary of the application. Each application must include a list of the data submitted with the application, together with a brief description of the results of the studies. The list of data submitted may be the same as the list required by § 158.32 or § 161.32, as applicable, of this chapter. The summary must state that it is releasable to the public after registration in accordance with § 152.119.

(d) Identity of the product. The product for which application is being submitted must be identified. The following information is required:

(1) The product name;

(2) The trade name(s) (if different); and

(3) The EPA Registration Number, if currently registered.

(e) Draft labeling. Each application for new registration must be accompanied by five legible copies of draft labeling (typescript or mock-up). Each application for amended registration that proposes to make any changes in the product labeling must be accompanied by five legible copies of draft labeling incorporating the proposed labeling changes. If the proposed labeling change affects only a portion of the labeling, such as the use directions, the applicant may submit five copies of that portion of the label which is the subject of the amendment. Upon request, an applicant for amended registration must submit a complete label to consolidate amendments.

(f) Registration data requirements. (1) An applicant must submit materials to demonstrate that he has complied with the FIFRA sec. 3(c)(1)(F) and subpart E of this part with respect to satisfaction of data requirements, to enable the Agency to make the determination required by FIFRA sec. 3(c)(5)(B). Required items are described in subpart E of this part.

(2) An applicant must furnish any data specified in part 158 or part 161 of this chapter, as applicable, of this chapter which are required by the Agency to determine that the product meets the registration standards of FIFRA sec. 3(c)(5) or (7). Each study must comply with:

(i) Section 158.32 of this chapter, with respect to format of data submission.

(ii) Section 158.33 of this chapter, with respect to studies for which a claim of trade secret or confidential business information is made.

(iii) Section 158.34 of this chapter, with respect to flagging for potential adverse effects.

(iv) Section 160.12 of this chapter, with respect to a statement whether studies were conducted in accordance with Good Laboratory Practices of part 160.

(3) An applicant shall furnish with his application any factual information of which he is aware regarding unreasonable adverse effects of the pesticide on man or the environment, which would be required to be reported under FIFRA sec. 6(a)(2) if the product were registered.

(g) Certification relating to child-resistant packaging. If the product meets the criteria for child-resistant packaging, the applicant must submit a certification that the product will be distributed or sold only in child-resistant packaging. Refer to part 157 of this chapter for the criteria and certification requirements.

(h) Request for classification. If an applicant wishes to request a classification different from that established by the Agency, he must submit a request for such classification and information supporting the request.

(i) Statement concerning tolerances. (1) If the proposed labeling bears instructions for use of the pesticide on food or feed crops, or if the intended use of the pesticide results or may be expected to result, directly or indirectly, in pesticide chemical residues in or on food or feed (including residues of any active ingredient, inert ingredient, metabolite, or degradation product), the applicant must submit a statement indicating whether such residues are authorized by a tolerance or exemption from the requirement of a tolerance issued under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA).

(2) If such residues have not been authorized, the application must be accompanied by a petition for establishment of appropriate tolerances or exemptions from the requirement of a tolerance, in accordance with part 180 of this chapter.

(j) Fees. (1) The applicant shall identify the appropriate fee category in the schedule provided for by FIFRA sec. 33, and shall submit the fee for that category as prescribed by the latest EPA notice of section 33 fees.

(2) If FIFRA sec. 33 is not in effect, the applicant shall submit any fees required by subpart U of this part, if applicable.

[53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60 FR 32096, June 19, 1995; 72 FR 61027, Oct. 26, 2007; 73 FR 75594, Dec. 12, 2008]

§ 152.55 Where to send applications and correspondence.

Applications and correspondence relating to registration should be sent to the Office of Pesticide Programs’ Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).

[71 FR 35545, June 21, 2006]

Subpart D [Reserved]

Subpart E—Satisfaction of Data Requirements and Protection of Data Submitters’ Rights

Source:49 FR 30903, Aug. 1, 1984, unless otherwise noted.

§ 152.80 General.

This subpart E describes the information that an applicant must submit with his application for registration or amended registration to comply (and for the Agency to determine compliance) with the provisions of FIFRA sec. 3(c)(1)(F). This subpart also describes the procedures by which data submitters may challenge registration actions which allegedly failed to comply with these procedures. If the Agency determines that an applicant has failed to comply with the requirements and procedures in this subpart, the application may be denied. If the Agency determines, after registration has been issued, that an applicant failed to comply with these procedures and requirements, the Agency may issue a notice of intent to cancel the product’s registration.

[73 FR 75594, Dec. 12, 2008]

§ 152.81 Applicability.

(a) Except as provided in paragraph (b) of this section, the requirements of this subpart apply to:

(1) Each application for registration of a new product.

(2) Each application for amended registration of a currently registered product.

(3) Each submission in response to a Data Call-In under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(2)(B) for an existing registration, including but not limited to, a product subject to reregistration under FIFRA section 4 or registration review under FIFRA section 3(g). If the Data Call-In establishes procedures for protection of data submitters’ rights, recipients must comply with the specific requirements of the Data Call-In rather than the generic procedures set forth in §§ 152.85 through 152.96.

(b) This subpart does not apply to any of the following:

(1) An application for registration submitted to a State under FIFRA section 24(c).

(2) An application for an experimental use permit (EUP) under FIFRA section 5.

(3) An application for an emergency exemption under FIFRA section 18.

(4) A request for cancellation of a registration, or a request for deletion of one or more existing uses, under FIFRA section 6(f).

(5) A modification to registration of a currently registered product that may be accomplished under the notification or non-notification provisions of § 152.46 and any procedures issued thereunder. Notwithstanding the preceding sentence, compliance with this subpart is required if the Administrator has, by written notice under § 152.46, determined that the modification may not be accomplished by notification or non-notification.

(6) Any type of amendment if the Administrator determines, by written finding, that Agency consideration of data would not be necessary in order to approve the amendment under FIFRA section 3(c)(5).

(7) Compliance with Agency regulations, adjudicatory hearing decisions, notices, or other Agency announcements that unless the registration is amended in the manner the Agency proposes, the product’s registration will be suspended or canceled, or that a hearing will be held under FIFRA section 6. However, this paragraph does not apply to amendments designed to avoid cancellation or suspension threatened under FIFRA section 3(c)(2)(B) or because of failure to submit data.

[79 FR 6824, Feb. 5, 2014]

§ 152.82 Definitions.

For the purposes of this subpart, the definitions set forth in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), in § 152.3, and in this section apply. In addition, the term “exclusive use study” shall have the meaning set forth in § 152.83.

Data gap means the absence of any valid study or studies in the Agency’s files which would satisfy a specific data requirement for a particular pesticide product.

Data Submitters List means the current Agency list, entitled “Pesticide Data Submitters by Chemical,” of persons who have submitted data to the Agency.

Original data submitter means the person who possesses all rights to exclusive use or compensation under FIFRA section 3(c)(1)(F) in a study originally submitted in support of an application for registration, amended registration, reregistration, or experimental use permit, or to maintain an existing registration in effect. The term includes the person who originally submitted the study, any person to whom the rights under FIFRA section 3(c)(1)(F) have been transferred, or the authorized representative of a group of joint data developers.

Valid study means a study that has been conducted in accordance with the Good Laboratory Practice standards of 40 CFR part 160 or generally accepted scientific methodology and that EPA has not determined to be invalid.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008. Redesignated and amended at 79 FR 6825, Feb. 5, 2014]

§ 152.83 Definition of exclusive use study.

A study is an exclusive use study if it meets the conditions of either paragraph (a) or paragraph (b) of this section.

(a) Initial exclusive use period. A study submitted to support the registration of a product containing a new active ingredient (new chemical) or a new combination of active ingredients (new combination) is an exclusive use study if all the following conditions are met:

(1) The study pertains to a new active ingredient (new chemical) or new combination of active ingredients (new combination) first registered after September 30, 1978.

(2) The study was submitted in support of, or as a condition of approval of, the application resulting in the first registration of a product containing such new chemical or new combination, or an application to amend such registration to add a new use.

(3) Less than 10 years have passed (or up to 13 years, if the period of exclusive use protection has been extended under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(1)(F)(ii)) since the issuance of the registration for which the data were submitted.

(4) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B).

(b) Exclusive use period for certain minor use data. A study submitted by an applicant or registrant to support an amendment adding a new minor use to an existing registration that does not retain any period of exclusive use under paragraph (b)(1) of this section is an exclusive study under FIFRA section 3(c)(1)(F)(vi) if all the following conditions are met:

(1) The study relates solely to a minor use of a pesticide.

(2) The applicant or registrant at the time the new use is requested has notified the Administrator that any exclusive use period for the pesticide has expired and that the study is eligible for exclusive use treatment.

(3) Less than 10 years have passed since the study was submitted to EPA.

(4) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B).

(5) The minor use supported by the data has not been voluntarily canceled nor have such data been used to support a non-minor use.

[79 FR 6825, Feb. 5, 2014]

§ 152.84 When materials must be submitted to the Agency.

Information and materials required by this subpart must be submitted at the time of application, unless the application is determined not to be subject to the requirements of this subpart.

[79 FR 6825, Feb. 5, 2014]

§ 152.85 Formulators’ exemption.

(a) Statutory provision. FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or cite data pertaining to any pesticide contained in his product that is derived solely from one or more EPA-registered products which the applicant purchases from another person. This provision is commonly referred to as the formulators’ exemption.

(b) Applicability of the formulators’ exemption. (1) The formulators’ exemption applies only to data concerning the purchased product or its ingredients. These data may include, but are not limited to, product chemistry, toxicology, residue chemistry, exposure, environmental fate, and ecological effects.

(2) The data to which the formulators’ exemption applies usually will concern the safety of one or more of the product’s active ingredients, specifically, those active ingredients which are contained in the purchased product. In general, data for which the required test substance is the technical grade of the active ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product are eligible for the formulators’ exemption.

(3) The formulators’ exemption generally does not apply to data on the applicant’s product itself, including the safety or efficacy of the product, unless the composition of the product is identical to the purchased product. In general, data for which the required test substance is the product proposed for registration are not eligible for the formulators’ exemption.

(c) Limitation of the formulators’ exemption. EPA interprets FIFRA section 3(c)(2)(D) as allowing an applicant to use the formulators’ exemption with respect to data concerning an ingredient of his product only if:

(1) The application indicates that the ingredient’s presence in the product is attributable solely to the purchase from another person of an identified, registered product containing that ingredient and the use of the purchased product in formulating the product; and

(2) The purchased product is a registered manufacturing-use product whose label does not prohibit its use for making an end-use product labeled for any use for which the applicant’s product will be labeled; or

(3) The purchased product is a registered end-use product labeled for each use for which the applicant’s product will be labeled.

(d) Claiming eligibility for the exemption. (1) If the product contains one or more ingredients eligible for the formulators’ exemption, the applicant need not comply with the requirements of §§ 152.90 through 152.96 with respect to any data requirement pertaining to such ingredient, provided that he submits to the Agency a certification statement containing the following information (a form for this purpose is available from the Agency):

(i) Identification of the applicant, and of the product by EPA registration number or file symbol.

(ii) Identification of each ingredient in the pesticide that is eligible for the formulators’ exemption, and the EPA registration number of the product that is the source of that ingredient.

(iii) A statement that the listed ingredients meet the requirements for the formulators’ exemption.

(iv) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula.

(v) The name, title and signature of the applicant or his authorized representative and the date of signature.

(2) An applicant for amended registration is not required to submit a new formulators’ exemption statement, if the current statement in Agency files is complete and accurate.

(e) Approval of registration. Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve an application unless there are available to EPA for its review all data that are necessary to make the required risk/benefit finding under FIFRA section 3(c)(5) or section 3(c)(7).

[72 FR 61027, Oct. 26, 2007]

§ 152.86 The cite-all method.

An applicant may comply with this subpart by citing all data in Agency files that are pertinent to its consideration of the requested registration under FIFRA section 3(c)(5), in accordance with the procedures in this section, as applicable.

(a) Exclusive use studies. The applicant must certify to the Agency that he has obtained, from each person listed on the Data Submitters List as an exclusive use data submitter for the chemical in question, a written authorization that contains at least the following information:

(1) Identification of the applicant to whom the authorization is granted;

(2) Authorization to the applicant to use all pertinent studies in satisfaction of data requirements for the application in question; and

(3) The signature and title of the original data submitter or his authorized representative and date of the authorization.

If the Agency identifies any exclusive use data submitter not on the Data Submitters List, the applicant will be required prior to registration to obtain the necessary written authorization from such person.

(b) Other studies. The applicant must certify to the Agency that, with respect to each other person on the Data Submitters List for the chemical in question:

(1) He has obtained from that person a written authorization that contains the information required by paragraphs (a) (1) through (3) of this section; or

(2) He has furnished to that person:

(i) A notification of his intent to apply for registration, including the name of the proposed product, and a list of the product’s active ingredients;

(ii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F) for any data on which the application relies;

(iii) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of any study; and

(iv) The applicant’s name, address, and contact information, including telephone number and email address.

(c) General offer to pay statement. The applicant must submit to the Agency the following general offer to pay statement:

[Name of applicant] hereby offers and agrees to pay compensation to other persons, with regard to the approval of this application, to the extent required by FIFRA section 3(c)(1)(F) of the Federal Insecticide, Fungicide and Rodenticide Act.

(d) Acknowledgement of reliance on data. Each application filed under this section shall include an acknowledgement that for purposes of FIFRA section 3(c)(1)(F) the application relies on the following data:

(1) All data submitted with or specifically cited in the application; and

(2) Each other item of data in the Agency’s files which:

(i) Concerns the properties or effects of the applicant’s product, of any product which is identical or substantially similar to the applicant’s product, or of one or more of the active ingredients in the applicant’s product; and

(ii) Is one of the types of data that EPA would require to be submitted if the application sought the initial registration under FIFRA section 3(c)(5) of a product with composition and intended uses identical or substantially similar to the applicant’s product, under the data requirements in effect on the date EPA approves the applicant’s present application.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

§ 152.90 The selective method.

An applicant may comply with this subpart by listing the specific data requirements that apply to his product, its active ingredients, and use patterns, and demonstrating his compliance for each data requirement by submitting or citing individual studies, or by demonstrating that no study has previously been submitted to the Agency. This section summarizes the procedures that an applicant must follow if he chooses the selective method of demonstrating compliance. Sections 152.91 through 152.96 contain specific procedures for citing or submitting a study or claiming a data gap.

(a) List of data requirements. (1) Each applicant must submit a list of the data requirements that would apply to his pesticide, its active ingredients, and its use patterns, if the product were being proposed for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(5) for the first time.

(2) The applicant must list the applicable requirements, as prescribed by part 158 of this chapter, as applicable. All required (R) studies, and any studies that could be conditionally required (CR) based upon composition, use pattern, or the results of required studies, are to be listed. The applicant need not list data requirements pertaining to any ingredient which qualifies for the formulators’ exemption.

(b) Methods of demonstrating compliance. The applicant must state for each data requirement on the list required by paragraph (a) of this section which of the following methods of compliance with the requirement he is using, and shall provide the supporting documentation specified in the referenced section.

(1) Existence of or granting of a data waiver. Refer to § 152.91.

(2) Submission of a new valid study. Refer to § 152.92.

(3) Citation of a specific valid study previously submitted to the Agency by the applicant or another person, with any necessary written authorizations or offers to pay. Refer to § 152.93.

(4) Citation of a public literature study. Refer to § 152.94.

(5) Citation of all pertinent studies previously submitted to the Agency, with any necessary written authorizations or offers to pay. Refer to § 152.95.

(6) Claim of data gap. Refer to § 152.96.

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]

§ 152.91 Waiver of a data requirement.

The applicant may demonstrate compliance for a data requirement by documenting the existence of a waiver in accordance with paragraph (a) of this section, or by being granted a new waiver requested in accordance with paragraph (b) of this section.

(a) Request for an extension of an existing waiver. An applicant may claim that a waiver previously granted by the Agency also applies to a data requirement for the product. To document this claim, the applicant must provide a reference to the Agency record that describes the previously granted waiver, such as an Agency list of waivers or an applicable Reregistration Eligibility Decision (RED) document or registration review decision document, and explain why that waiver should apply to the product.

(b) Request for a new waiver. An applicant who requests a waiver to satisfy a data requirement must submit the information specified in 40 CFR 158.45 or 40 CFR 161.45.

(c) Effect of denial of waiver request. A decision by the Agency to deny a written request for a new waiver or an extension of an existing waiver is a final Agency action. Following denial, the applicant must choose another method of satisfying the data requirement.

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]

§ 152.92 Submission of a new valid study.

An applicant may demonstrate compliance for a data requirement by submitting a valid study that has not previously been submitted to the Agency. A study previously submitted to the Agency should not be resubmitted but should be cited in accordance with § 152.93.

§ 152.93 Citation of a previously submitted valid study.

An applicant may demonstrate compliance for a data requirement by citing a valid study previously submitted to the Agency. The study is not to be submitted to the Agency with the application.

(a) Study originally submitted by the applicant. If the applicant certifies that he is the original data submitter, no documentation other than the citation is necessary.

(b) Study previously submitted by another person. If the applicant is not the original data submitter, the applicant may cite the study only in accordance with paragraphs (b) (1) through (3) of this section.

(1) Citation with authorization of original data submitter. The applicant may cite any valid study for which he has obtained the written authorization of the original data submitter. The applicant must obtain written authorization to cite any study that is an exclusive use study. The applicant must certify that he has obtained from the original data submitter a written authorization that contains at least the following information:

(i) Identification of the applicant to whom the authorization is granted;

(ii) Identification by title, EPA Accession Number or Master Record Identification Number, and date of submission, of the study or studies for which the authorization is granted;

(iii) Authorization to the applicant to use the specified study in satisfaction of the data requirement for the application in question; and

(iv) The signature and title of the original data submitter or his authorized representative, and date of the authorization.

(2) Citation with offer to pay compensation to the original data submitter. The applicant may cite any valid study that is not subject to the exclusive use provisions of FIFRA section 3(c)(1)(F)(i) without written authorization from the original data submitter if the applicant certifies to the Agency that he has furnished to the original data submitter:

(i) A notification of the applicant’s intent to apply for registration, including the proposed product name and a list of the product’s active ingredients;

(ii) Identification of the specific data requirement involved and of the study for which the offer to pay is made (by title, EPA Accession Number or Master Record Identification Number, and date of submission, if possible);

(iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);

(iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of the study; and

(v) The applicant’s name, address, and contact information, including a telephone number and email address.

(3) Citation without authorization or offer to pay. The applicant may cite any valid study without written authorization from, or offer to pay to, the original data submitter if the study was originally submitted to the Agency on or before the date that is 15 years before the date of the application for which it is cited, and the study is not an exclusive use study, as defined in § 152.83(c).

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

§ 152.94 Citation of a public literature study or study generated at government expense.

(a) An applicant may demonstrate compliance for a data requirement by citing, and submitting to the Agency, one of the following:

(1) A valid study from the public literature.

(2) A valid study generated by, or at the expense of, any government (Federal, State, or local) agency.

(b) In no circumstances does submission of a public literature study or government-generated study confer any rights on the data submitter to exclusive use of data or compensation under FIFRA section 3(c)(1)(F).

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

§ 152.95 Citation of all studies in the Agency’s files pertinent to a specific data requirement.

An applicant normally may demonstrate compliance for a data requirement by citation of all studies in the Agency’s files pertinent to that data requirement. The applicant who selects this cite-all option must submit to the Agency:

(a) A general offer to pay statement having the same wording as that specified in § 152.86(c) except that the offer to pay may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected;

(b) A certification that:

(1) For each person who is included on the Data Submitters List as an original data submitter of exclusive use data for the active ingredient in question, the applicant has obtained a written authorization containing the information required by § 152.86(a) for the use the any exclusive use study that would be pertinent to the applicant’s product; and

(2) For each person included on the current Data Submitters List as an original data submitter of data that are not exclusive use for the active ingredient in question, the applicant has furnished:

(i) A notification of the applicant’s intent to apply for registration, including the name of the proposed product, and a list of the product’s active ingredients;

(ii) Identification of the specific data requirement(s) for which the offer to pay for data is being made;

(iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);

(iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for use of any study; and

(v) The applicant’s name, address, and contact information, including a telephone number and email address.

(c) An acknowledgment having the same wording as that specified in § 152.86(d), except that it may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

§ 152.96 Claim of data gap.

(a) When a data gap may be claimed. Except as provided in paragraph (b) of this section, an applicant may defer his obligation to satisfy an applicable data requirement until the Agency requires the data if no other person has previously submitted to the Agency a valid study that would satisfy the data requirement in question.

(b) When a data gap may not be claimed—(1) Product containing a new active ingredient. An applicant for registration of a product containing a new active ingredient may not defer his obligation by claiming a data gap unless he can demonstrate to the Agency’s satisfaction that the data requirement was imposed so recently that insufficient time has elapsed for the study to have been completed and that, in the public interest, the product should be registered during the limited period of time required to complete the study. Refer to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(7)(C).

(2) Product not containing a new active ingredient. An applicant for registration of a product under FIFRA sections 3(c)(7)(A) or (B) (a product not containing a new active ingredient) may not defer his obligation by claiming a data gap if the data are:

(i) Data needed to determine whether the product is identical or substantially similar to another currently registered product or differs only in ways that would substantially increase the risk of unreasonable adverse effects on the environment.

(ii) Efficacy data specific to the product, if required to be submitted to the Agency.

(iii) If a new use is proposed for a product that is identical or substantially similar to an existing product, data to demonstrate whether the new use would substantially increase the risk of unreasonable adverse effects on the environment.

(c) Approval of application with a data gap claim—(1) In accordance with § 152.115(a), any registration that is approved based upon a data gap claim shall be conditioned on the submission of the data no later than the time that the data are required to be submitted for similar products already registered.

(2) Notwithstanding paragraph (c)(1) of this section, the Agency will not approve an application if it determines that the data for which a data gap claim has been made are needed to determine if the product meets the requirements of FIFRA sections 3(c)(5) or (7).

[79 FR 6826, Feb. 5, 2014]

§ 152.97 Rights and obligations regarding the Data Submitters List.

(a) Each original data submitter shall have the right to be included on the Agency’s Data Submitters List.

(b) Each original data submitter who wishes to have his name added to the current Data Submitters List must submit to the Agency the following information:

(1) Name and current address.

(2) Chemical name, common name (if any) and Chemical Abstracts Service (CAS) number (if any) of the active ingredients(s), with respect to which he is an original data submitter.

(3) For each such active ingredient, the type(s) of study he has previously submitted (identified by reference to data/information requirements listed in part 158 of this chapter), the date of submission, and the EPA registration number, file symbol, or other identifying reference for which it was submitted.

(c) Each applicant not already included on the Data Submitters List for a particular active ingredient must inform the Agency at the time of the submission of a relevant study whether he wishes to be included on the Data Submitters List for that pesticide.

[79 FR 6826, Feb. 5, 2014]

§ 152.98 Procedures for transfer of exclusive use or compensation rights to another person.

A person who possesses rights to exclusive use or compensation under FIFRA section 3(c)(1)(F) may transfer such rights to another person in accordance with this section.

(a) The original data submitter must submit to the Agency a transfer document that contains the following information:

(1) The name, address and state of incorporation (if any) of the original data submitter (the transferor);

(2) The name, address and state of incorporation (if any) of the person to whom the data rights are being transferred (the transferee);

(3) Identification of each item of data transferred including:

(i) The name of the study or item of data;

(ii) Whether the study is an exclusive use study, and, if so, when the period of exclusive use protection expires;

(iii) The name of the person or laboratory that conducted the study;

(iv) The date the study was submitted to the Agency;

(v) The EPA document number assigned to the item of data (the Master Record Identification Number or Accession Number), if known. If not known, the EPA administrative number (such as the EPA Registration Number, petition number, file symbol, or permit number) with which the item of data was submitted, such that the Agency can identify the item of data.

(vi) A statement that the transferor transfers irrevocably to the transferee all rights, titles, and interest in the items of data named;

(vii) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and

(viii) The names, signatures and titles of the transferor and transferee, and the date signed.

(b) In addition, the original data submitter must submit to the Agency a notarized statement affirming that:

(1) The person signing the transfer agreement is authorized by the original data submitter to bind the data submitter;

(2) No court order prohibits the transfer, and any required court approvals have been obtained; and

(3) The transfer is authorized under Federal, State, and local law and relevant corporate charters, bylaws or partnership agreements.

(c) The Agency will acknowledge the transfer of the data by notifying both transferor and transferee, and will state the effective date of the transfer. Thereafter the transferee will be considered to be the original data submitter of the items of data transferred for all purposes under FIFRA section 3(c)(1)(F), unless a new transfer agreement is submitted to the Agency.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

§ 152.99 Petitions to cancel registration.

An original data submitter may petition the Agency to deny or cancel the registration of a product in accordance with this section if he has submitted to the Agency a valid study which, he claims, satisfies a data requirement that an applicant purportedly has failed to satisfy.

(a) Grounds for petition. (1) If an applicant has offered to pay compensation to an original data submitter of a study (either specifically or by filing a general offer to pay statement), the original data submitter may petition the Agency to deny or cancel the registration to which the offer related on any of the following grounds:

(i) The applicant has failed to participate in an agreed-upon procedure for reaching an agreement on the amount and terms of compensation. The petitioner shall submit a copy of the agreed-upon procedure and describe the applicant’s failure to participate in the procedure.

(ii) The applicant has failed to comply with the terms of an agreement on compensation. The petitioner shall submit a copy of the agreement, and shall describe how the applicant has failed to comply with the agreement.

(iii) The applicant has failed to participate in an arbitration proceeding. The petitioner shall submit evidence of such failure.

(iv) The applicant has failed to comply with the terms of an arbitration decision. The petitioner shall submit a copy of the arbitration decision, and describe how the applicant has failed to comply with the decision.

(2) When no offer to pay has been made, the petitioner shall state in his petition the basis for the challenge, and describe how the failure of the applicant to comply with the procedures of this subpart has deprived him of the rights accorded him under FIFRA section 3(c)(1)(F). Possible grounds for challenge include, but are not limited to, the following:

(i) The applicant has failed to list a data requirement applicable to his product, or has failed to demonstrate compliance with all applicable data requirements.

(ii) The applicant has submitted or cited a study that is not valid.

(iii) The applicant has submitted or cited a study that does not satisfy the data requirement for which it was submitted or cited.

(iv) The applicant has falsely or improperly claimed that a data gap existed at the time of his application.

(v) The applicant has submitted or cited a study originally submitted by the petitioner, without the required authorization or offer to pay.

(b) Procedure for petition to the Agency—(1) Time for filing. A petition under paragraph (a)(1) of this section may be filed at any time that the circumstances warrant. A petition under paragraph (a)(2) of this section must be filed within one year after the Agency makes public the issuance of the registration.

(2) Notice to affected registrant. At the same time that the petitioner files his petition with the Agency, the petitioner shall send a copy to the affected applicant or registrant by certified mail or by any other method that provides evidence of delivery. The affected applicant or registrant shall have 60 days from the date of receipt of the petition to submit written comments to the Agency.

(c) Disposition of petitions. The Agency will consider the material submitted by the petitioner and the response, if any, by the affected applicant or registrant.

(1) If the Agency determines that the petition is without merit, it will inform the petitioner and the affected applicant or registrant that the petition is denied. Denial of a petition is a final Agency action.

(2) If the Agency determines that an applicant has acted in any way described by paragraph (a)(1) of this section, the Agency will notify the petitioner and the affected applicant or registrant that it intends to deny or cancel the registration of the product in support of which the data were cited. The affected applicant or registrant will have 15 days from the date of delivery of this notice to respond. If the Agency determines, after considering any response, that the affected applicant or registrant has acted in the ways described by paragraph (a)(1) of this section, the Agency will deny or cancel the registration without further hearing. Refer to FIFRA section 3(c)(1)(F)(ii). Denial or cancellation of a registration is a final Agency action.

(3) Except as provided in paragraph (c)(2) of this section, if the Agency determines that an applicant for registration of a product has acted in any way that deprives an original data submitter of rights under FIFRA section 3(c)(1)(F), the Agency will take steps to deny the application or cancel the registration, as appropriate. The procedures in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or cancellation is a final Agency action.

(d) Hearing. Any hearing will be conducted in accordance with the procedures in 40 CFR part 164. The only matter for resolution at the hearing shall be whether the registrant failed to comply with the requirements and procedures of FIFRA section 3(c)(1)(F) or of this subpart, in the manner described by the petitioner. A decision following a hearing shall be final.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6826, Feb. 5, 2014]

Subpart F—Agency Review of Applications

Source:53 FR 15980, May 4, 1988, unless otherwise noted.

§ 152.100 Scope.

(a) The Agency will follow the procedures in this subpart for all applications for registration, except an application for registration of a pesticide that has been the subject of a previous Agency cancellation or suspension notice under FIFRA sec. 6.

(b) The Agency will follow the procedures of subpart D of part 164 of this chapter in evaluating any application for registration of a pesticide involving use of the pesticide in a manner that is prohibited by a suspension or cancellation order, to the extent required by subpart D of part 164.

§ 152.102 Publication.

The Agency will issue in the Federal Register a notice of receipt of each application for registration of a product that contains a new active ingredient or that proposes a new use. After registration of the product, the Agency will issue in the Federal Register a notice of issuance. The notice of issuance will describe the new chemical or new use, summarize the Agency’s regulatory conclusions, list missing data and the conditions for their submission, and respond to comments received on the notice of application.

§ 152.104 Completeness of applications.

The applicant is responsible for the accuracy and completeness of all information submitted in connection with the application. The Agency will review each application to determine whether it is complete. An application is incomplete if any pertinent item specified in § 152.50 has not been submitted, or has been incorrectly submitted (for example, data required by part 158, or part 161 of this chapter, as applicable, and not submitted in accordance with the requirements for format, claims of confidential business information, or flagging).

[72 FR 61028, Oct. 26, 2007]

§ 152.105 Incomplete applications.

The Agency will not begin or continue the review of an application that is incomplete. If the Agency determines that an application is incomplete or that further information is needed in order to complete the Agency’s review, the Agency will notify the applicant of the deficiencies and allow the applicant 75 days to make corrections or additions to complete the application. If the applicant believes that the deficiencies cannot be corrected within 75 days, he must notify the Agency within those 75 days of the date on which he expects to complete the application. If, after 75 days, the applicant has not responded, or if the applicant subsequently fails to complete the application within the time scheduled for completion, the Agency will terminate any action on such application, and will treat the application as if it had been withdrawn by the applicant. Any subsequent submission relating to the same product must be submitted as a new application.

§ 152.107 Review of data.

(a) The Agency normally will review data submitted with an application that have not previously been submitted to the Agency.

(b) The Agency normally will review other data submitted or cited by an applicant only:

(1) As part of the process of reregistering currently registered products;

(2) When acting on an application for registration of a product containing a new active ingredient;

(3) If such data have been flagged in accordance with § 158.34 or 161.34 of this chapter; or

(4) When the Agency determines that it would otherwise serve the public interest.

(c) If the Agency finds that it needs additional data in order to determine whether the product may be registered, it will notify the applicant as early as possible in the review process.

[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007]

§ 152.108 Review of labeling.

The Agency will review all draft labeling submitted with the application. If an applicant for amended registration submits only that portion of the labeling proposed for amendment, the Agency may review the entire label, as revised by the proposed changes, in deciding whether to approve the amendment. The Agency will not approve final printed labeling, but will selectively review it for compliance.

§ 152.110 Time for agency review.

The Agency will complete its review of applications as expeditiously as possible. Applications subject to specific timeframes under the fee schedule established by FIFRA section 33 will be reviewed within the timeframes established for the application or action type.

[73 FR 75595, Dec. 12, 2008]

§ 152.111 Choice of standards for review of applications.

The Agency has discretion to review applications under either the unconditional registration criteria of FIFRA sec. 3(c)(5) or the conditional registration criteria of FIFRA sec. 3(c)(7). The type of review chosen depends primarily on the extent to which the relevant data base has been reviewed for completeness and scientific validity. EPA conducts data reviews needed to support unconditional registrations on a chemical-by-chemical basis, according to an established priority list. Except for applications for registration of a new active ingredient or in special cases where it finds immediate review to be warranted, the Agency will not commence a complete review of the existing data base on a given chemical in response to receipt of an application for registration. Instead the Agency will review the application using the criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B).

§ 152.112 Approval of registration under FIFRA sec. 3(c)(5).

EPA will approve an application under the criteria of FIFRA sec. 3(c)(5) only if:

(a) The Agency has determined that the application is complete and is accompanied by all materials required by the Act and this part, including, but not limited to, evidence of compliance with subpart E of this part;

(b) The Agency has reviewed all relevant data in the possession of the Agency (see §§ 152.107 and 152.111);

(c) The Agency has determined that no additional data are necessary to make the determinations required by FIFRA sec. 3(c)(5) with respect to the pesticide product which is the subject of the application;

(d) The Agency has determined that the composition of the product is such as to warrant the proposed efficacy claims for it, if efficacy data are required to be submitted for the product by part 158 or part 161 of this chapter, as applicable.

(e) The Agency has determined that the product will perform its intended function without unreasonable adverse effects on the environment, and that, when used in accordance with widespread and commonly recognized practice, the product will not generally cause unreasonable adverse effects on the environment;

(f) The Agency has determined that the product is not misbranded as that term is defined in FIFRA sec. 2(q) and part 156 of this chapter, and its labeling and packaging comply with the applicable requirements of the Act, this part, and parts 156 and 157 of this chapter;

(g) If the proposed labeling bears directions for use on food, animal feed, or food or feed crops, or if the intended use of the pesticide results or may reasonably be expected to result, directly or indirectly, in pesticide residues (including residues of any active or inert ingredient of the product, or of any metabolite or degradation product thereof) in or on food or animal feed, all necessary tolerances, exemptions from the requirement of a tolerance, and food additive regulations have been issued under FFDCA sec. 408, and

(h) If the product, in addition to being a pesticide, is a drug within the meaning of FFDCA sec. 201(q), the Agency has been notified by the Food and Drug Administration (FDA) that the product complies with any requirements imposed by FDA.

[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007; 73 FR 75595, Dec. 12, 2008]

§ 152.113 Approval of registration under FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient.

(a) Except as provided in paragraph (b) of this section, the Agency may approve an application for registration or amended registration of a pesticide product, each of whose active ingredients is contained in one or more other registered peticide products, only if the Agency has determined that:

(1) It possesses all data necessary to make the determinations required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide product which is the subject of the application (including, at a minimum, data needed to characterize any incremental risk that would result from approval of the application);

(2) Approval of the application would not significantly increase the risk of any unreasonable adverse effect on the environment; and

(3) The criteria of § 152.112(a), (d), and (f) through (h) have been satisfied.

(b) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined that the applicant’s product and its proposed use are identical or substantially similar to a currently registered pesticide and use, or that the pesticide and its proposed use differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.

(c) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:

(1) The pesticide is the subject of a special review, based on a use of the product that results in human dietary exposure; and

(2) The proposed new use involves use on a major food or feed crop, or involves use on a minor food or feed crop for which there is available an effective alternative registered pesticide which does not meet the risk criteria associated with human dietary exposure. The determination of available and effective alternatives shall be made with the concurrence of the Secretary of Agriculture.

§ 152.114 Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new active ingredient.

An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a period of time sufficient for the generation and submission of certain of the data necessary for a finding of registrability under FIFRA sec. 3(c)(5) if the Agency determines that:

(a) Insufficient time has elapsed since the imposition of the data requirement for those data to have been developed;

(b) All other required test data and materials have been submitted to the Agency;

(c) The criteria in § 152.112(a), (b), (d), and (f) through (h) have been satisfied;

(d) The use of the pesticide product during the period of the conditional registration will not cause any unreasonable adverse effect on the environment; and

(e) The registration of the pesticide product and its subsequent use during the period of the conditional registration are in the public interest.

§ 152.115 Conditions of registration.

(a) Substantially similar products and new uses. Each registration issued under § 152.113 shall be conditioned upon the submission or citation by the registrant of all data which are required for unconditional registration of his product under FIFRA sec. 3(c)(5), but which have not yet been submitted, no later than the time such data are required to be submitted for similar pesticide products already registered. If a notice requiring submission of such data has been issued under FIFRA sec. 3(c)(2)(B) prior to the date of approval of the application, the applicant must submit or cite the data described by that notice at the time specified by that notice. The applicant must agree to these conditions before the application may be approved.

(b) New active ingredients. Each registration issued under § 152.114 shall be conditioned upon the applicant’s agreement to each of the following conditions:

(1) The applicant will submit remaining required data (and interim reports if required) in accordance with a schedule approved by the Agency.

(2) The registration will expire upon a date established by the Agency, if the registrant fails to submit data as required by the Agency. The expiration date will be established based upon the length of time necessary to generate and submit the required data. If the studies are submitted in a timely manner, the registration will be cancelled if the Agency determines, based on the data (alone, or in conjuction with other data), that the product or one or more of its uses meets or exceeds any of the risk criteria established by the Agency to initiate a special review. If the Agency so determines, it will issue to the registrant a Notice of Intent to Cancel under FIFRA sec. 6(e), and will specify any provisions for sale and distribution of existing stocks of the pesticide product.

(3) The applicant will submit an annual report of the production of the product.

(c) Other conditions. The Agency may establish, on a case-by-case basis, other conditions applicable to registrations to be issued under FIFRA sec. 3(c)(7).

(d) Cancellation if condition is not satisfied. If any condition of the registration of the product is not satisfied, or if the Agency determines that the registrant has failed to initiate or pursue appropriate action towards fulfillment of any condition, the Agency will issue a notice of intent to cancel under FIFRA sec. 6(e).

[53 FR 15980, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]

§ 152.116 Notice of intent to register to original submitters of exclusive use data.

(a) Except as provided in paragraph (c) of this section, at least 30 days before registration of a product containing an active ingredient for which a previously submitted study is eligible for exclusive use under FIFRA sec. 3(c)(1)(F)(i), the Agency will notify the original submitter of the exclusive use study of the intended registration of the product. If requested by the exclusive use data submitter within 30 days, the Agency will also provide the applicant’s list of data requirements and method of demonstrating compliance with each data requirement.

(b) Within 30 days after receipt of the Agency’s notice, or of the applicant’s list of data requirements, whichever is later, the exclusive use data submitter may challenge the issuance of the registration in accordance with the procedures in § 152.99 (b) and (c). If the Agency finds that the challenge has merit, it will issue a notice of denial of the application. The applicant may then avail himself of the hearing procedures provided by FIFRA sec. 3(c)(6). If the Agency finds that the challenge is without merit, it will deny the petition and register the applicant’s product. Denial of the petition is a final Agency action.

(c) If an applicant has submitted to the Agency a certification from an exclusive use data submitter that he is aware of the applicant’s application for registration, and does not object to the issuance of the registration, the Agency will not provide the 30-day notification described in paragraph (a) of this section to that exclusive use data submitter.

[53 FR 15980, May 4, 1988, as amended at 73 FR 75595, Dec. 12, 2008]

§ 152.117 Notification to applicant.

The Agency will notify the applicant of the approval of his application by a Notice of Registration for new registration, or by a letter in the case of an amended registration.

§ 152.118 Denial of application.

(a) Basis for denial. The Agency may deny an application for registration if the Agency determines that the pesticide product does not meet the criteria for registration under either FIFRA sec. 3(c)(5) or (7), as specified in §§ 152.112 through 152.114.

(b) Notification of applicant. If the Agency determines that an application should be denied, it will notify the applicant by certified letter. The letter will set forth the reasons and factual basis for the determination with conditions, if any, which must be fulfilled in order for the registration to be approved.

(c) Opportunity for remedy by the applicant. The applicant will have 30 days from the date of receipt of the certified letter to take the specified corrective action. During this time the applicant may request that his application be withdrawn.

(d) Notice of denial. If the applicant fails to correct the deficiencies within the 30-day period, the Agency may issue a notice of denial, which will be published in the Federal Register, and which will set forth the reasons and the factual basis for the denial.

(e) Hearing rights. Within 30 days following the publication of the notice of denial, an applicant, or any interested person with written authorization of the applicant, may request a hearing in accordance with FIFRA sec. 6(b). Hearings will be conducted in accordance with part 164 of this chapter.

§ 152.119 Availability of material in support of registration.

(a) The information submitted to support a registration application shall be part of the official Agency file for that registration.

(b) Within 30 days after registration, the Agency will make available for public inspection, upon request, the materials required by subpart E to be submitted with an application. Materials that will be publicly available include an applicant’s list of data requirements, the method used by the applicant to demonstrate compliance for each data requirement, and the applicant’s citations of specific studies in the Agency’s possession if applicable.

(c) Except as provided by FIFRA sec. 10, within 30 days after registration, the data on which the Agency based its decision to register the product will be made available for public inspection, upon request, in accordance with the procedures in 40 CFR part 2.

Subpart G—Obligations and Rights of Registrants

Source:53 FR 15983, May 4, 1988, unless otherwise noted.

§ 152.122 Currency of address of record and authorized agent.

(a) The registrant must keep the Agency informed of his current name and address of record. If the Agency’s good faith attempts to contact the registrant are not successful, the Agency will issue in the Federal Register a notice of intent to cancel all products of the registrant under FIFRA sec. 6(b). The registrant must respond within 30 days requesting that the registrations be maintained in effect, and providing his name and address of record. If no response is received, the cancellations will become effective at the end of 30 days without further notice to the registrant. The Agency may make provision for the sale and distribution of existing stocks of such products after the effective date of cancellation.

(b) The registrant must also notify the Agency if he changes his authorized agent.

§ 152.125 Submission of information pertaining to adverse effects.

If at any time the registrant receives or becomes aware of any factual information regarding unreasonable adverse effects of the pesticide on the environment that has not previously been submitted to the Agency, the registrant shall, in accordance with FIFRA section 6(a)(2) and the requirements of part 159, subpart D of this chapter, provide such information to the Agency, clearly identified as FIFRA 6(a)(2) data.

[73 FR 75595, Dec. 12, 2008]

§ 152.130 Distribution under approved labeling.

(a) A registrant may distribute or sell a registered product with the composition, packaging and labeling currently approved by the Agency.

(b) A registrant may distribute or sell a product under labeling bearing any subset of the approved directions for use, provided that in limiting the uses listed on the label, no changes would be necessary in precautionary statements, use classification, or packaging of the product.

(c) Normally, if the product labeling is amended on the initiative of the registrant, by submission of an application for amended registration, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after approval of the revision, unless an order subsequently issued by the Agency under FIFRA sec. 6 or 13 provides otherwise. However, if paragraph (d) of this section applies to the registrant’s product, the time frames established by the Agency in accordance with that paragraph shall take precedence.

(d) If a product’s labeling is required to be revised as a result of the issuance of a Registration Standard, a Label Improvement Program notice, or a notice concluding a special review process, the Agency will specify in the notice to the registrant the period of time that previously approved labeling may be used. In all cases, supplemental or sticker labeling may be used as an interim compliance measure for a reasonable period of time. The Agency may establish dates as follows governing when label changes must appear on labels:

(1) The Agency may establish a date after which all product distributed or sold by the registrant must bear revised labeling.

(2) The Agency may also establish a date after which no product may be distributed or sold by any person unless it bears revised labeling. This date will provide sufficient time for product in channels of trade to be distributed or sold to users or otherwise disposed of.

§ 152.132 Supplemental distribution.

The registrant may distribute or sell his registered product under another person’s name and address instead of (or in addition to) his own. Such distribution and sale is termed “supplemental distribution” and the product is referred to as a “distributor product.” The distributor is considered an agent of the registrant for all intents and purposes under the Act, and both the registrant and the distributor may be held liable for violations pertaining to the distributor product. Supplemental distribution is permitted upon notification to the Agency if all the following conditions are met:

(a) The registrant has submitted to the Agency for each distributor product a statement signed by both the registrant and the distributor listing the names and addresses of the registrant and the distributor, the distributor’s company number, the additional brand name(s) to be used, and the registration number of the registered product.

(b) The distributor product is produced, packaged and labeled in a registered establishment operated by the same producer (or under contract in accordance with § 152.30) who produces, packages, and labels the registered product.

(c) The distributor product is not repackaged (remains in the producer’s unopened container).

(d) The label of the distributor product is the same as that of the registered product, except that:

(1) The product name of the distributor product may be different (but may not be misleading);

(2) The name and address of the distributor may appear instead of that of the registrant;

(3) The registration number of the registered product must be followed by a dash, followed by the distributor’s company number (obtainable from the Agency upon request);

(4) The establishment number must be that of the final establishment at which the product was produced; and

(5) Specific claims may be deleted, provided that no other changes are necessary.

(e) Voluntary cancellation of a product applies to the registered product and all distributor products distributed or sold under that registration number. The registrant is responsible for ensuring that distributors under his cancelled registration are notified and comply with the terms of the cancellation.

[53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]

§ 152.135 Transfer of registration.

(a) A registrant may transfer the registration of a product to another person, and the registered product may be distributed and sold without the requirement of a new application for registration by that other person, if the parties submit to the Agency the documents listed in paragraphs (b) and (c) of this section, and receive Agency approval as described in paragraph (d) of this section.

(b) Persons seeking approval of a transfer of registration must provide a document signed by the authorized representative of the registrant (the transferor) and of the person to whom the registration is transferred (the transferee) that contains the following information:

(1) The name, address and State of incorporation (if any) of the transferor;

(2) The name, address and State of incorporation of the transferee;

(3) The name(s) and EPA registration number(s) of the product(s) being transferred;

(4) A statement that the transferor transfers irrevocably to the transferee all right, title, and interest in the EPA registration(s) listed in the document;

(5) A statement that the transferred registration(s) shall not serve as collateral or otherwise secure any loan or other payment arrangement or executory promise, and that the registration(s) shall not revert to the transferor unless a new transfer agreement is submitted to and approved by the Agency;

(6) A description of the general nature of the underlying transaction, e.g., merger, spinoff, bankruptcy transfer (no financial information need be disclosed);

(7) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and

(8) An acknowledgment by the transferee that his rights and duties concerning the registration under FIFRA and this chapter will be deemed by EPA to be the same as those of the transferor at the time the transfer is approved.

(c) In addition, the transferor must submit to the Agency a notarized statement affirming that:

(1) The person signing the transfer agreement is authorized by the registrant to bind the transferor;

(2) No court order prohibits the transfer, and that any required court approvals have been obtained; and

(3) The transfer is authorized under all relevant Federal, State and local laws and all relevant corporate charters, bylaws, partnerships, or other agreements.

(d) If the required documents are submitted, and no information available to the Agency indicates that the information is incorrect, the Agency will approve the transfer without requiring that the transferee obtain a new registration. The Agency will notify the transferor and transferee of its approval.

(e) The transfer will be effective on the date of Agency approval. Thereafter the transferee will be regarded as the registrant for all purposes under FIFRA.

(f) Rights to exclusive use of data or compensation under FIFRA section 3(c)(1)(F) are separate from the registration itself and may be retained by the transferor, or may be transferred independently in accordance with the provisions of § 152.98. If the registrant as the original data submitter wishes to transfer data rights at the same time as he transfers the registration, he may submit a single transfer document containing the information required by this section for both the registration and the data.

[53 FR 15983, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 73 FR 75595, Dec. 12, 2008]

Subpart H [Reserved]

Subpart I—Classification of Pesticides

Source:53 FR 15986, May 4, 1988, unless otherwise noted.

§ 152.160 Scope.

(a) Types of classification. A pesticide product may be unclassified, or it may be classified for restricted use or for general use. The Agency does not normally classify products for general use; products that are not restricted remain unclassified.

(b) Kinds of restrictions. The Agency may restrict a product or its uses to use by a certified applicator, or by or under the direct supervision of a certified applicator, as described in FIFRA sec. 3(d)(1)(C). The Agency may also, by regulation, prescribe restrictions relating to the product’s composition, labeling, packaging, uses, or distribution and sale, or to the status or qualifications of the user.

§ 152.161 Definitions.

In addition to the definitions in § 152.3, the following terms are defined for the purposes of this subpart:

(a) Dietary LC50 means a statistically derived estimate of the concentration of a test substance in the diet that would cause 50 percent mortality to the test population under specified conditions.

(b) Outdoor use means any pesticide application that occurs outside enclosed manmade structures or the consequences of which extend beyond enclosed manmade structures, including, but not limited to, pulp and paper mill water treatments and industrial cooling water treatments.

§ 152.164 Classification procedures.

(a) Grouping of products for classification purposes. In its discretion, the Agency may identify a group of products having common characteristics or uses and may classify for restricted use same or all of the products or uses included in that group. Such a group may be comprised of, but is not limited to, products that:

(1) Contain the same active ingredients.

(2) Contain the same active ingredients in a particular concentration range, formulation type, or combination of concentration range and formulation type.

(3) Have uses in common.

(4) Have other characteristics, such as toxicity, flammability, or physical properties, in common.

(b) Classification reviews. The Agency may conduct classification reviews and classify products at any time, if it determines that a restriction on the use of a pesticide product is necessary to avoid unreasonable adverse effects on the environment. However, classification reviews normally will be conducted and products classified only in the following circumstances:

(1) As part of the review of an application for new registration of a product containing an active ingredient not contained in any currently registered product.

(2) As part of the review of an application for a new use of a product, if existing uses of that product previously have been classified for restricted use. Review of a restricted use product at this time is for the purpose of determining whether the new use should also be classified for restricted use. Normally the Agency will not conduct initial classification reviews for existing uses of individual products in conjunction with an application for amended registration.

(3) As part of the process of developing or amending a registration standard for a pesticide. The Agency normally will conduct classification reviews of all uses of a currently registered pesticide at this time.

(4) As part of any special review of a pesticide, in accordance with the procedures of 40 CFR part 154.

(c) Classification procedures. (1) If the Agency determines that a product or one or more of its uses should be classified for restricted use, the Agency initially may classify the product by regulation. In this case, within 60 days after the effective date of a final rule, each registrant of a product subject to the rule must submit to the Agency one of the following, as directed in the final rule:

(i) A copy of the amended label and any supplemental labeling to be used as an interim compliance measure.

(ii) A statement, which the Agency considers a report under the Act, that the registrant will comply with the labeling requirements prescribed by the Agency within the timeframes prescribed by the regulation.

(iii) An application for amended registration to delete the uses which have been restricted, or to “split” the registration into two registrations, one including only restricted or all uses, and the other including only uses that have not been classified.

(2) Alternatively, EPA may notify the applicant or registrant of the classification decision and require that he submit the information required by paragraph (c)(1) of this section. The Agency may deny registration or initiate cancellation proceedings if the registrant fails to comply within the timeframes established by the Agency in its notification.

§ 152.166 Labeling of restricted use products.

(a) Products intended for end use. A product whose labeling bears directions for end use and that has been classified for restricted use must be labeled in accordance with the requirements of § 156.10 of this chapter or other Agency instructions. The Agency will permit the use of stickers or supplemental labeling as an interim alternative to the use of an approved amended label, in accordance with § 152.167.

(b) Products intended only for formulation. A product whose labeling does not bear directions for end use (a product that is intended and labeled solely for further formulation into other pesticide products) is not subject to the labeling requirements of this subpart.

§ 152.167 Distribution and sale of restricted use products.

Unless modified by the Agency, the compliance dates in this section shall apply to restricted use products.

(a) Sale by registrant or producer. (1) No product with a use classified for restricted use may be distributed or sold by the registrant or producer after the 120th day after the effective date of such classification unless the product:

(i) Bears an approved amended label which contains the terms of restricted use imposed by the Agency and otherwise complies with part 156 of this chapter;

(ii) Bears a sticker containing the product name, EPA registration number, and any terms of restricted use imposed by the Agency; or

(iii) Is accompanied by supplemental labeling bearing the information listed in paragraph (a)(1)(ii) of this section.

(2) If the registrant chooses to delete the restricted uses from his product label, that product may not be distributed or sold after the 180th day after the effective date of classification unless the product bears amended labeling with the restricted uses deleted.

(3) Notwithstanding paragraphs (a) (1) and (2) of this section, after the 270th day after the effective date of classification, no registrant or producer may distribute or sell a product that does not bear the approved amended label. After that date, stickers and supplemental labeling described in paragraph (a)(1) (ii) and (iii) are no longer acceptable.

(b) Sale by retailer. No product with a use classified for restricted use by a regulation may be distributed or sold by a retailer or other person after the 270th day after the effective date of the final rule unless the product bears a label or labeling which complies with paragraph (a)(1) of this section.

§ 152.168 Advertising of restricted use products.

(a) Any product classified for restricted use shall not be advertised unless the advertisement contains a statement of its restricted use classification.

(b) The requirement in paragraph (a) of this section applies to all advertisements of the product, including, but not limited, to:

(1) Brochures, pamphlets, circulars and similar material offered to purchasers at the point of sale or by direct mail.

(2) Newspapers, magazines, newsletters and other material in circulation or available to the public.

(3) Broadcast media such as radio and television.

(4) Telephone advertising.

(5) Billboards and posters.

(c) The requirement may be satisfied for printed material by inclusion of the statement “Restricted Use Pesticide,” or the terms of restriction, prominently in the advertisement. The requirement may be satisfied with respect to broadcast or telephone advertising by inclusion in the broadcast of the spoken words “Restricted use pesticide,” or a statement of the terms of restriction.

(d) The requirements of this section shall be effective:

(1) After 270 days after the effective date of restriction of a product that is currently registered, unless the Agency specifies a shorter time period;

(2) Upon the effective date of registration of a product not currently registered.

§ 152.170 Criteria for restriction to use by certified applicators.

(a) General criteria. An end-use product will be restricted to use by certified applicators (or persons under their direct supervision) if the Agency determines that:

(1) Its toxicity exceeds one or more of the specific hazard criteria in paragraph (b) or (c) of this section, or evidence described in paragraph (d) of this section substantiates that the product or use poses a serious hazard that may be mitigated by restricting its use;

(2) Its labeling, when considered according to the factors in paragraph (e)(2) of this section, is not adequate to mitigate these hazard(s);

(3) Restriction of the product would decrease the risk of adverse effects; and

(4) The decrease in risks of the pesticide as a result of restriction would exceed the decrease in benefits.

(b) Criteria for human hazard—(1) Residential and institutional uses. A pesticide product intended for residential or institutional use will be considered for restricted use classification if:

(i) The pesticide, as diluted for use, has an acute oral LD50 of 1.5 g/kg or less;

(ii) The pesticide, as formulated, has an acute dermal LD50 of 2000 mg/kg or less;

(iii) The pesticide, as formulated, has an acute inhalation LC50 of 0.5 mg/liter or less, based upon a 4-hour exposure period;

(iv) The pesticide, as formulated, is corrosive to the eye (causes irreversible destruction of ocular tissue) or results in corneal involvement or irritation persisting for more than 7 days;

(v) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or scarring) or causes severe irritation (severe erythema or edema) at 72 hours; or

(vi) When used in accordance with label directions, or widespread and commonly recognized practice, the pesticide may cause significant subchronic, chronic or delayed toxic effects on man as a result of single or multiple exposures to the product ingredients or residues.

(2) All other uses. A pesticide product intended for uses other than residential or institutional use will be considered for restricted use classification if:

(i) The pesticide, as formulated, has an acute oral LD50 of 50 mg/kg or less;

(ii) The pesticide, as formulated, has an acute dermal LD50 of 200 mg/kg or less;

(iii) The pesticide, as diluted for use, has an acute dermal LD50 of 16 g/kg or less;

(iv) The pesticide, as formulated, has an acute inhalation LC50 of 0.05 mg/liter or less, based upon a 4-hour exposure period;

(v) The pesticide, as formulated, is corrosive to the eye or causes corneal involvement or irritation persisting for more than 21 days;

(vi) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or scarring); or

(vii) When used in accordance with label directions, or widespread and commonly recognized practice, the pesticide may cause significant subchronic toxicity, chronic toxicity, or delayed toxic effects on man, as a result of single or multiple exposures to the product ingredients or residues.

(c) Criteria for hazard to non-target species—(1) All products. A pesticide product intended for outdoor use will be considered for restricted use classification if:

(i) When used according to label directions, application results in residues of the pesticide, its metabolites, or its degradation products, in the diet of exposed mammalian wildlife, immediately after application, such that:

(A) The level of such residues equals or exceeds one-fifth of the acute dietary LC50; or

(B) The amount of pesticide consumed in one feeding day (mg/kg/day) equals or exceeds one-fifth of the mammalian acute oral LD50;

(ii) When used according to label directions, application results, immediately after application, in residues of the pesticide, its metabolites or its degradation products, in the diet of exposed birds at levels that equal or exceed one-fifth of the avian subacute dietary LC50;

(iii) When used according to label directions, application results in residues of the pesticide, its metabolites or its degradation products, in water that equal or exceed one-tenth of the acute LC50 for non-target aquatic organisms likely to be exposed; or

(iv) Under conditions of label use or widespread and commonly recognized practice, the pesticide may cause discernible adverse effects on non-target organisms, such as significant mortality or effects on the physiology, growth, population levels or reproduction rates of such organisms, resulting from direct or indirect exposure to the pesticide, its metabolites or its degradation products.

(2) Granular products. In addition to the criteria of paragraph (c)(1) of this section, a pesticide intended for outdoor use and formulated as a granular product will be considered for restricted use classification if:

(i) The formulated product has an acute avian or mammalian oral LD50 of 50 mg/kg or less as determined by extrapolation from tests conducted with technical material or directly with the formulated product; and

(ii) It is intended to be applied in such a manner that significant exposure to birds or mammals may occur.

(d) Other evidence. The Agency may also consider evidence such as field studies, use history, accident data, monitoring data, or other pertinent evidence in deciding whether the product or use may pose a serious hazard to man or the environment that can reasonably be mitigated by restricted use classification.

(e) Alternative labeling language. (1) If the Agency determines that a product meets one or more of the criteria of paragraphs (b) or (c) of this section, or if other evidence identified in paragraph (d) of this section leads the Agency to conclude that the product should be considered for restricted use classification, the Agency will then determine if additional labeling language would be adequate to mitigate the identified hazard(s) without restricted use classification. If the labeling language meets all the criteria specified in paragraph (e)(2) of this section, the product will not be classified for restricted use.

(2) The labeling will be judged adequate if it meets all the following criteria:

(i) The user, in order to follow label directions, would not be required to perform complex operations or procedures requiring specialized training and/or experience.

(ii) The label directions do not call for specialized apparatus, protective equipment, or materials that reasonably would not be available to the general public.

(iii) Failure to follow label directions in a minor way would result in few or no significant adverse effects.

(iv) Following directions for use would result in few or no significant adverse effects of a delayed or indirect nature through bioaccumulation, persistence, or pesticide movement from the original application site.

(v) Widespread and commonly recognized practices of use would not nullify or detract from label directions such that unreasonable adverse effects on the environment might occur.

§ 152.171 Restrictions other than those relating to use by certified applicators.

The Agency may by regulation impose restrictions on a product or class of products if it determines that:

(a) Without such restrictions, the product when used in accordance with warnings, cautions and directions for use or in accordance with widespread and commonly recognized practices of use may cause unreasonable adverse effects on the environment; and

(b) The decrease in risks as a result of restricted use would exceed the decrease in benefits as a result of restricted use.

§ 152.175 Pesticides classified for restricted use.

The following uses of pesticide products containing the active ingredients specified below have been classified for restricted use and are limited to use by or under the direct supervision of a certified applicator.

[43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46 FR 5698, Jan. 19, 1981. Redesignated and amended at 53 FR 15988, May 4, 1988; 60 FR 32096, June 19, 1995]

Subparts J-T [Reserved]

Subpart U—Registration Fees

Source:53 FR 19114, May 26, 1988, unless otherwise noted.

§ 152.400 Purpose.

Subpart U prescribes fees to be charged for the pesticide regulatory activities set forth in § 152.403 as performed by the Environmental Protection Agency (as authorized by 31 U.S.C. 9701 and Pub. L. 100-202) and provisions regarding their payment.

§ 152.401 Inapplicability of fee provisions to applications filed prior to October 1, 1997.

No fee required by this subpart U shall be levied with respect to any application filed during the period beginning on October 25, 1988, and ending on September 30, 1997. See FIFRA section 4(i)(7) (added to FIFRA by Pub. L. 100-532, October 25, 1988, 102 Stat. 2654).

[53 FR 11923, Mar. 22, 1989]

§ 152.403 Definitions of fee categories.

(a) New chemical registration review means review of an application for registration of a pesticide product containing a chemical active ingredient which is not contained as an active ingredient in any other pesticide product that is registered under FIFRA at the time the application is made.

(b) New biochemical and microbial registration review means review of an application for registration of a biochemical or microbial pesticide product containing a biochemical or microbial active ingredient not contained in any other pesticide product that is registered under FIFRA at the time the application is made. For purposes of this subpart, the definitions of biochemical and microbial pesticides contained in § 158.2000 and § 158.2100, respectively, shall apply.

(c) New use pattern registration review means review of an application for registration, or for amendment of a registration entailing a major change to the use pattern of an active ingredient contained in a product registered under FIFRA or pending Agency decision on a prior application at the time of application. For purposes of this paragraph, examples of major changes include but are not limited to, changes from non-food to food use, outdoor to indoor use, ground to aerial application, terrestrial to aquatic use, and non-residential to residential use.

(d) Old chemical registration review means review of an application for registration of a new product containing active ingredients and uses which are substantially similar or identical to those currently registered or for which an application is pending Agency decision.

(e) Amendment review means review of any application requiring Agency approval to amend the registration of a currently registered product, or for which an application is pending Agency decision, not entailing a major change to the use pattern of an active ingredient.

(f) Experimental use permit review means review of an application for a permit pursuant to section 5 of FIFRA to apply a limited quantity of a pesticide in order to accumulate information necessary to register the pesticide. The application may be for a new chemical or for a new use of an old chemical. The fee applies to such experimental uses of a single unregistered active ingredient (no limit on the number of other active ingredients, in a tank mix, already registered for the crops involved) and no more than three crops. This fee does not apply to experimental use permits required for small-scale field testing of microbial pest control agents (40 CFR 172.3).

[53 FR 19114, May 26, 1988, as amended at 72 FR 61028, Oct. 26, 2007]

§ 152.404 Fee amounts.

The fee prescribed by the following table must be submitted with each application for registration, amended registration or experimental use permit. Fees will be adjusted annually in accordance with § 152.410. The Agency may waive or refund fees in accordance with § 152.412.

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]

§ 152.406 Submission of supplementary data.

Applicants may submit data to supplement pending applications without incurring additional charges if the proper fee was paid with submission of the original application and subsequent submissions of supplementary data do not constitute a change in the type of registration action requested.

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]

§ 152.408 Special considerations.

(a) If two or more applicants apply for a new chemical registration for products having the same active ingredient and each applicant provides a set of data in support of the registration developed independently of the other applicants’ data, then each applicant submitting an independent set of data shall be charged the full new chemical registration review fee.

(b) If two or more applicants apply for a new chemical registration for products having the same active ingredient and the applicants have jointly developed or paid for the joint development of a common set of data to support their applications for registration, then each applicant shall be charged an equal share of the total fee for review of the applications for all of the subject products. The total fee will include the sum of the new chemical registration review fee for one product and one old chemical registration review fee for each additional product.

(c) If an application is received for registration of a product that contains two or more new chemical active ingredients and a different set of generic data is required by the Agency for each new chemical for the purpose of registration, the applicant will be required to pay the full new chemical registration review fee for each active ingredient.

§ 152.410 Adjustment of fees.

(a) The fee schedule will be adjusted annually by the same percentage as the percent change in the Federal General Schedule (GS) pay scale. Such adjustments will be published in the Federal Register as a final rule and will be effective 30 days or more after promulgation.

(b) Processing costs and fees will be reviewed periodically and changes will be made to the schedule as necessary. Such adjustments will be published for notice and comment in the Federal Register.

§ 152.412 Waivers and refunds.

(a) Refunds. If an application is not accepted for processing because it is incomplete, the fee, less $1,200 for handling and initial review (or the amount of the fee, whichever is less), shall be returned. If an application is withdrawn by the applicant before significant Agency scientific review has begun, the fee, less $1,200, shall be returned. If an unacceptable or withdrawn petition is resubmitted, it shall be accompanied by the fee that would be required if it were submitted for the first time.

(b) Waiver of fees for activities initiated by the Agency. The Agency may waive fees for amended registrations where the amendment has been initiated solely by the Agency. The Agency retains sole discretion in determining when this fee will be waived. The announcement of the fee waiver will accompany the EPA request for an amendment. The Agency will not approve any individual requests for waivers of EPA-initiated activity fees.

(c) Waiver of fees for activities initiated by applicants. Upon request by an applicant, together with the supporting documentation or justification described in this paragraph, the Agency may waive or refund fees in whole or in part. A request for waiver must be submitted in accordance with § 152.414(a). An application for which a waiver of fees has been requested will not be accepted for review until the waiver has been granted, or until the waiver has been denied and thereafter the proper fee has been submitted.

(1) Minor use. Fees may be waived for applications limited to minor uses that lack commercial feasibility for the pesticide applicant. An applicant requesting a waiver on this basis must provide supporting information that demonstrates that anticipated revenues from the uses that are the subject of the application would be insufficient to pay back the cost of the fee. The burden of proof of the reasonableness of this estimate rests with the applicant.

(2) IR-4. Fees will be waived for registration actions that are determined to be specifically associated with tolerance petitions submitted by the Inter-Regional Research Project Number 4 (IR-4 program) when such waiver is deemed by the Agency to be in the public interest.

(3) Severe economic impact. The Agency may waive two-thirds of any cumulative registration fee payment in a 12-month period following completion of the applicant’s most recent fiscal year that exceeds 3 percent of the applicant’s pesticide sales in its most recently completed fiscal year. An applicant requesting a waiver on this basis must provide documentation (e.g. copy of an annual report, or income tax forms filed with the Internal Revenue Service, or if needed, a notarized statement signed by a corporate officer regarding annual pesticide sales) demonstrating that:

(i) The company applying had less than $40 million in gross revenue (including all revenue sources) in the most recently concluded fiscal year of operation, and a single fee would constitute more than 3 percent of the applicant’s gross revenue from pesticide sales in the most recently completed fiscal year of operation, or

(ii) The company applying had less than $40 million in gross revenue (including all revenue sources) in the most recently concluded fiscal year of operation, and the cumulative registration fees paid during the 12 months following the applicant’s most recently completed fiscal year, including any registration fees paid for the applicant for which a waiver is requested, constitute more than 3 percent of the applicant’s gross revenue from pesticide sales in the most recently concluded fiscal year of operation.

(iii) The Agency will not grant such a waiver if it determines that the entity submitting the application has been formed or manipulated to qualify for such a waiver.

(4) Public interest. The Agency, in its discretion, may waive in whole or in part any of the fees established herein in the public interest. Examples include, but are not limited to, pesticides offering unique advantages for reducing public health risks, those that significantly reduce a current environmental risk, or a product with extraordinary utility for use in Integrated Pest Management (IPM).

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]

§ 152.414 Procedures.

(a) Procedures for requesting a waiver. (1) A request for a waiver must be submitted in writing at the time the application is submitted to the Office of Pesticide Programs’ Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).

(2) A payment of $1,200 for processing the waiver or the amount of the actual fee, whichever is less, must be submitted simultaneously to the address set forth in paragraph (b) of this section. This fee will be refunded (or applied to any resulting partial fee) if the waiver is granted. Payment of fees for the registration activities, in contrast to the waiver fee, shall not be required until the Agency makes a determination on the waiver request. Since the actual fee is submitted to an address different than the one to which the waiver request is submitted, a copy of the payment document must be submitted with the waiver request that is submitted to the Office of Pesticide Programs’ Document Processing Desk as described in paragraph (a)(1) of this section. No fee is required from a person who has no financial interest in the application.

(b) Procedures for payment of fees. All fees required by this section must be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency. All payment of fees must be forwarded to the Environmental Protection Agency, Headquarters Accounting Operations Branch, Office of Pesticide Programs (Registration Fees), P.O. Box 360277M, Pittsburgh, PA 15251. The payments should be specifically labeled “Registration Fees” and should be accompanied only by a copy of the registration application form or the experimental use permit application form, as appropriate. An application will not be accepted for processing until the required fees have been submitted.

(c) Procedures for submitting application and supporting data. The application, along with supporting data, shall be forwarded within 30 days of payment to the Washington DC address set forth in paragraph (a)(1) of this section.

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993; 69 FR 39864, July 1, 2004; 71 FR 35545, June 21, 2006]

Subparts V-Y [Reserved]

Subpart Z—Devices

§ 152.500 Requirements for devices.

(a) A device is defined as any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom.

(b) A device is not required to be registered under FIFRA sec. 3. The Agency has issued a policy statement concerning its authority and activities with respect to devices, which was published in the Federal Register of November 19, 1976 (41 FR 51065). A device is subject to the requirements set forth in:

(1) FIFRA sec. 2(q)(1) and part 156 of this chapter, with respect to labeling;

(2) FIFRA sec. 7 and part 167 of this chapter, with respect to establishment registration and reporting;

(3) FIFRA sec. 8 and part 169 of this chapter, with respect to books and records;

(4) FIFRA sec. 9, with respect to inspection of establishments;

(5) FIFRA sec. 12, 13, and 14, with respect to violations, enforcement activities, and penalties;

(6) FIFRA sec. 17, with respect to import and export of devices;

(7) FIFRA sec. 25(c)(3), with respect to child-resistant packaging; and

(8) FIFRA sec. 25(c)(4), with respect to the Agency’s authority to declare devices subject to certain provisions of the Act.

[53 FR 15990, May 4, 1988. Redesignated at 60 FR 32096, June 19, 1995]

PART 153—REGISTRATION POLICIES AND INTERPRETATIONS

Authority:7 U.S.C. 136w.

Subparts A-F [Reserved]

Subpart G—Determination of Active and Inert Ingredients

Source:53 FR 15989, May 4, 1988, unless otherwise noted.

§ 153.125 Criteria for determination of pesticidal activity.

(a) An ingredient will be considered an active ingredient if it is contained in a pesticide product and:

(1) The ingredient has the capability by itself, and when used as directed at the proposed use dilution, to function as a pesticide; or

(2) The ingredient has the ability to elicit or enhance a pesticidal effect in another compound whose pesticidal activity is substantially increased due to the interaction of the compounds. Compounds which function simply to enhance or prolong the activity of an active ingredient by physical action, such as stickers and other adjuvants, are not generally considered to be active ingredients.

(b) Normally the applicant will determine and state in his application whether an ingredient is active or inert with respect to pesticidal activity. The Agency, as part of its review of an application for registration, or in conjunction with the Registration Standard or Special Review process, may require any ingredient, to be designated as an active ingredient if the Agency finds that it meets the criteria in paragraph (a) of this section. Conversely, the Agency may determine that any ingredient designated as active by an applicant is an inert ingredient if it fails to meet those criteria.

(c) If an ingredient is designated as an active ingredient, it must be identified in the label ingredients statement. If an ingredient is designated as an inert ingredient, it must be included as part of the total inert ingredients in the label ingredients statement.

(d) Designation of a substance as a pesticidally inert ingredient does not relieve the applicant or registrant of other requirements of FIFRA with respect to labeling of inert ingredients or submission of data, or from the requirements of the Federal Food, Drug, and Cosmetic Act with respect to tolerances or other clearance of ingredients.

[53 FR 15989, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]

Subpart H—Coloration and Discoloration of Pesticides

Source:53 FR 15990, May 4, 1988, unless otherwise noted.

§ 153.140 General.

Section 25(c)(5) of the Act authorizes the Administrator to prescribe regulations requiring coloration or discoloration of any pesticide if the Administrator determines that such requirements are feasible and necessary for the protection of health and the environment. This subpart describes those pesticide products which must be colored or discolored.

[60 FR 32096, June 19, 1995]

§ 153.155 Seed treatment products.

(a) Pesticide products intended for use in treating seeds must contain an EPA-approved dye to impart an unnatural color to the seed, unless appropriate tolerances or other clearances have been established under the Federal Food, Drug and Cosmetic Act for residues of the pesticide.

(b) The following products are exempt from the requirement of paragraph (a) of this section:

(1) Products intended and labeled for use solely by commercial seed treaters, provided that the label bears a statement requiring the user to add an EPA-approved dye with the pesticide during the seed treatment process.

(2) Products intended and labeled for use solely as at-planting or hopper box treatments.

(3) Products which are gaseous in form or are used as fumigants.

(c) EPA-approved dyes for seed treatment are listed in:

(1) Sections 180.910, 180.920, and 180.950 if an exemption from the requirement of a tolerance has been established.

(2) Section 180.2010 if EPA has determined that residues of the dye will be present, if at all, at levels that are below the threshold of regulation.

(3) Section 180.2020 if it has been determined that no tolerance or exemption from the requirement of a tolerance is needed as a result of a determination by EPA that the use is unlikely to result in residues in food/feed.

[53 FR 15990, May 4, 1988, as amended at 66 FR 66772, Dec. 27, 2001; 69 FR 23117, Apr. 28, 2004]

Subparts I-M [Reserved]

PART 154—SPECIAL REVIEW PROCEDURES

Authority:7 U.S.C. 136a, d, and w.


Source:50 FR 49015, Nov. 27, 1985, unless otherwise noted.

Subpart A—General Provisions

§ 154.1 Purpose and scope.

(a) Purpose. The purpose of the Special Review process is to help the Agency determine whether to initiate procedures to cancel, deny, or reclassify registration of a pesticide product because uses of that product may cause unreasonable adverse effects on the environment, in accordance with sections 3(c)(6) and 6 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The process is intended to ensure that the Agency assesses risks that may be posed by pesticides, and the benefits of use of those pesticides, in an open and responsive manner. The issuance of a Notice of Special Review means that the Agency has determined that one or more uses of a pesticide may pose significant risks and that, following completion of the Special Review process, the Agency expects to initiate formal proceedings seeking to cancel, deny, reclassify, or require modifications to the registration of the product(s) in question unless it has been shown during the Special Review that the Agency’s initial determination was erroneous, that the risks can be reduced to acceptable levels without the need for formal proceedings, or that the benefits of the pesticide’s use outweigh the risks. Following completion of the Special Review process, a pesticide in question may be returned to the registration process.

(b) Scope. This part sets forth the substantive standards for initiating a Special Review of a pesticide product and the procedures for initiating and conducting the Special Review.

§ 154.3 Definitions.

Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply:

Act or FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended.

Administrator means the Administrator of the Environmental Protection Agency or any officer or employee thereof to whom authority has been delegated to act for the Administrator.

Confidential business information means trade secrets or confidential commercial or financial information under FIFRA section 10(b) or 5 U.S.C. 552(b)(3) or (4).

Other significant evidence means factually significant information that relates to the uses of the pesticide and its adverse risk to man or to the environment but does not include evidence based only on misuse of the pesticide unless such misuse is widespread and commonly recognized practice.

Person means an applicant, registrant, manufacturer, pesticide user, environmental group, labor union, or other individual or group of individuals interested in pesticide regulation.

Pesticide use means a use of a pesticide (described in terms of the application site and other applicable identifying factors) that is included in the labeling of a pesticide product which is registered, or for which an application for registration is pending, and the terms and conditions (or proposed terms and conditions) of registration for the use.

Terms and conditions of registration means the terms and conditions governing lawful sale, distribution, and use approved in conjunction with registration, including labeling, use classification, composition, and packaging.

Validated test means a test determined by the Agency to have been conducted and evaluated in a manner consistent with accepted scientific procedures.

[73 FR 75595, Dec. 12, 2008]

§ 154.5 Burden of persuasion in determinations under this part.

In making determinations under this part the Administrator shall be guided by the principle that the burden of persuasion that a pesticide product is entitled to registration or continued registration for any particular use or under any particular set of terms and conditions of registration is always on the proponent(s) of registration.

§ 154.7 Criteria for initiation of Special Review.

(a) The Administrator may conduct a Special Review of a pesticide use if he determines, based on a validated test or other significant evidence, that the use of the pesticide (taking into account the ingredients, impurities, metabolites, and degradation products of the pesticide):

(1) May pose a risk of serious acute injury to humans or domestic animals.

(2) May pose a risk of inducing in humans an oncogenic, heritable genetic, teratogenic, fetotoxic, reproductive effect, or a chronic or delayed toxic effect, which risk is of concern in terms of either the degree of risk to individual humans or the number of humans at some risk, based upon:

(i) Effects demonstrated in humans or experimental animals.

(ii) Known or predicted levels of exposure of various groups of humans.

(iii) The use of appropriate methods of evaluating data and relating such data to human risk.

(3) May result in residues in the environment of nontarget organisms at levels which equal or exceed concentrations acutely or chronically toxic to such organisms, or at levels which produce adverse reproductive effects in such organisms, as determined from tests conducted on representative species or from other appropriate data.

(4) May pose a risk to the continued existence of any endangered or threatened species designated by the Secretary of the Interior or the Secretary of Commerce under the Endangered Species Act of 1973, as amended.

(5) May result in the destruction or other adverse modification of any habitat designated by the Secretary of the Interior or the Secretary of Commerce under the Endangered Species Act as a critical habitat for any endangered or threatened species.

(6) May otherwise pose a risk to humans or to the environment which is of sufficient magnitude to merit a determination whether the use of the pesticide product offers offsetting social, economic, and environmental benefits that justify initial or continued registration.

(b) In making any determination that a pesticide use satisfies one of the criteria for issuance of a Special Review specified by paragraph (a) of this section, the Administrator shall consider available evidence concerning both the adverse effect in question and the magnitude and scope of exposure of humans and nontarget organisms associated with use of the pesticide.

§ 154.10 Petitions to begin the Special Review process.

The Administrator may evaluate a pesticide use under the criteria of § 154.7 either on his own initiative, or at the suggestion of any interested person.

§ 154.15 Docket for the Special Review.

(a) Establishment of the docket. When the Agency first notifies registrants privately that it is considering issuance of a Notice of Special Review for a pesticide, it shall establish a docket concerning that particular pesticide.

(b) Contents of the docket. For each pre-Special Review or Special Review, the docket shall contain:

(1) The Notice of Special Review, any Notice of Preliminary Determination, and any Notice of Final Determination.

(2) Any notice issued under § 154.21 or § 154.23.

(3) Any documents (other than information claimed to be confidential business information) referred to by the Agency in those notices as relied upon by the Agency in reaching its determination.

(4) Copies of all written comments or materials (other than information claimed to be confidential business information) responding to any notice furnished under § 154.21 or § 154.23 or submitted at any time during the Special Review process by any person outside of government.

(5) Any written response to the Notice of Preliminary Determination from the Secretary of Agriculture or the Scientific Advisory Panel.

(6) A transcript of all public meetings held by the Scientific Advisory Panel or conducted by the Agency for the purpose of gathering information.

(7) A memorandum describing each meeting between Agency personnel and any person or party outside of government which concerns a pending pre-Special Review or Special Review decision. Each such memorandum shall be based on notes taken at the meeting and shall specify the date and time of the meeting, the participants and their affiliations, who requested the meeting, the subject matter of the meeting, and the person who prepared the memorandum. Except for information claimed to be confidential business information, each memorandum shall describe fully and accurately all significant positions taken, arguments made, and facts presented by each participant in the meeting, and shall identify all documents, proposals, or other materials distributed or exchanged at the meeting. Any discussion of claimed confidential business information shall be identified in meeting notes and referenced in the memorandum.

(8) All comments, correspondence, or other materials concerning a pending pre-Special Review or Special Review decision provided to the Agency by a person or party outside of government (other than information claimed to be confidential business information).

(9) All documents, proposals, or other materials concerning a pending pre-Special Review or Special Review decision, provided by the Agency to any person or party outside of government (other than information claimed to be confidential business information).

(c) Assertion of confidential business information claims. (1) Information, comments, data, or other written material submitted to the Agency concerning a Special Review may be claimed by the submitter to be confidential business information. The burden of identifying claimed confidential business information rests with the submitter, or, in meetings, with the participants who wish to assert a claim of confidentiality.

(2) To assert a claim of confidentiality for all or any part of a written submission concerning a Special Review, the submitter must furnish three copies of the material. Two copies must be complete, with claimed confidential business information clearly marked in the text. Items in the document that are claimed confidential should be numbered consecutively throughout the text. The third copy must have the claimed confidential business information excised from the text without closing up or paraphrasing the remaining text. The deletions should be consecutively numbered to correspond to the numbering of the complete copies. Each copy must be marked on the cover as to whether it contains claimed confidential business information.

(3) Any written material concerning a Special Review received by the Agency that is not marked as confidential will be deemed to be nonconfidential, and may be made available through the public docket or otherwise disclosed without prior notice to the submitter.

(d) Placement of materials in the docket. Any memorandum identified under paragraph (b)(7) of this section shall be placed in the docket within 10 working days of the subject meeting. Materials identified under paragraph (b)(8) of this section shall be placed in the docket within 10 working days of receipt by the Office of Pesticide Programs, or within 15 working days of receipt by the Office of Pesticide Programs if the submitter has asserted a confidential business information claim concerning the submittal. Materials identified under paragraph (b)(9) of this section shall be placed in the docket within 15 working days of transmittal to such person or party outside of government.

(e) Index. The Agency shall prepare and maintain a current index of all materials included in the docket. The index will include a list identifying, for each meeting between Agency personnel and a person or party outside of government for which a memorandum has been prepared, the date, the subject, participants, and person who requested the meeting. The index will also list any document included in the docket by its title, its source, its recipient, and the date it was received or provided by the Agency.

(f) Access to the docket. (1)(i) For each chemical in Special Review, the docket shall be available for public inspection and copying and its index kept current and made available to the public on request. The docket and index for any pesticide for which the Agency has issued a pre-Special Review notification under § 154.21 will only be made available for public inspection and copying following issuance of a proposed decision not to start a Special Review under § 154.23, a Notice of Special Review under § 154.25(c), or as otherwise specified in § 154.34.

(ii) The docket and index will be available at the OPP Regulatory Public Docket located as set forth in 40 CFR 150.17(c).

(2) Information contained in the docket shall not be disclosed to the public to the extent that FIFRA or any other statute or regulation (including, but not limited to, 5 U.S.C. 552(b)(3) or (4)) prohibits its disclosure.

(3) The Agency will distribute a compendium of indices for new materials in the public docket by mail, on a monthly basis, to those members of the public who have specifically requested such material. The Agency will announce the availability of docket indices both annually in the Federal Register and in each Federal Register Notice concerning pre-Special Review or Special Review for specific pesticides. The Agency may also periodically require parties on the mailing list to renew their previous request for such materials.

[50 FR 49015, Nov. 27, 1985, as amended at 69 FR 39864, July 1, 2004; 71 FR 35545, June 21, 2006]

Subpart B—Procedures

§ 154.21 Preliminary notification to registrants and applicants for registration.

(a) Preliminary notification. If the Administrator decides that he may initiate a Special Review of a pesticide use, he shall send written notice by certified mail to the affected registrant(s) and applicant(s) setting forth his decision and a general description of the information which supports it.

(b) Comment opportunity. Registrant(s) and applicant(s) will be allowed 30 days from the receipt of notification to respond in writing to dispute the validity of the Agency’s conclusions or to present information in response to the notification.

§ 154.23 Proposed decision not to initiate a Special Review.

If the Administrator proposes not to initiate a Special Review after having given notice under § 154.21, he shall issue a proposed decision for publication in the Federal Register. The proposal shall include a description of the concerns which were the original basis for placement of the pesticide in pre-Special Review status and the Agency’s rationale for its proposed decision, announce the availability of a public docket, and provide a period generally not less than 30 days for submission of comments. A notice under § 154.25(b) may not be published unless it has been preceded by a notice under this section. A proposal under this section shall not be based on the benefits of use of a pesticide product.

§ 154.25 Public announcement of final decision whether to initiate a Special Review.

(a) The Administrator shall evaluate the available information and the comments received in response to the notice under § 154.21 and any notice issued under § 154.23, and shall issue for publication in the Federal Register a notice under paragraph (b) or (c) of this section.

(b) If the Administrator determines after having given notice under § 154.21 not to initiate a Special Review, he shall issue his decision for publication in the Federal Register with a statement of reasons.

(c) If the Administrator determines after having given notice under § 154.21 that one or more of the risk criteria set forth in § 154.7 have been satisfied, the Agency shall issue a notice for publication in the Federal Register which shall include:

(1) Identification of the pesticide uses for which a Special Review has been initiated and an identification of the criteria which have been satisfied.

(2) A brief discussion of the Agency’s reasons for determining that the criteria have been satisfied.

(3) A statement indicating that EPA has established a docket for the Special Review, the contents of the docket, the location of the docket, and the times during which the docket will be available for inspection and copying.

(4) An invitation to all interested persons to submit further information concerning the risks and benefits associated with each use of the pesticide subject to the Special Review.

(5) A brief description of the Special Review process and a statement that registrants and applicants bear an affirmative burden of supporting registration of a pesticide product.

(6) A date by which information in response to the Agency’s request for further information must be submitted.

(d) In his discretion, the Administrator may request that the Scientific Advisory Panel hold a public meeting to review the scientific issues related to the Special Review.

§ 154.26 Comment opportunity.

After issuance of a Notice of Special Review that applies to a use of a pesticide product (or category of products), any person may submit to the Agency any information, argument, or both, pertinent to:

(a) Whether the use of a pesticide product satisfies any of the § 154.7 risk criteria, with respect to the composition, labeling, packaging, and restrictions on use of the product as currently registered.

(b) Whether the use of a pesticide product would satisfy any of the § 154.7 risk criteria if its composition, labeling, packaging, and restrictions on use were approved in accordance with an application for registration or amended registration pending before the Agency. For further information see § 154.27(b).

(c) Whether any risks posed by the use or proposed use of the product that satisfy the § 154.7 risk criteria are unreasonable, taking into account the economic, social, and environmental costs and benefits of the use of the product.

(d) What regulatory action, if any, the Agency should take with respect to the use of the product.

§ 154.27 Meetings with interested persons.

(a) In the Special Review process, to assure openness and responsiveness, no person or party outside of government will be afforded special or preferential access to Agency Special Review decisionmakers or to the Agency’s Special Review process. At the same time, however, Agency personnel are free to meet and otherwise communicate with persons or parties outside of government, including registrants and manufacturers, users, trade unions, environmental groups and other interested persons, to obtain information, exchange views, explore factual and substantive positions, or discuss regulatory options concerning Special Review decisions.

(b) Meetings between EPA and any person or party outside of government will not result in undue delay in reaching Special Review decisions. During such meetings, the Agency will not commit to take any particular action concerning a pending decision. The Agency may receive and consider information and recommendations from persons or parties outside of government; however, the Agency will make the final administrative decision on a wholly independent basis and in accordance with law.

(c) Any interested person may ask to meet with Agency officials to discuss factual information available to the Agency, to present any factual information, to respond to presentations by other persons, or to discuss what regulatory actions should be taken regarding a pesticide which is or may be the subject of a Special Review. If, at its discretion, the Agency holds such meetings with any person outside of government concerning a use of a pesticide product, the Agency will prepare and file in the docket a memorandum of such meeting, meeting the requirements specified in § 154.15(b)(7).

(d) Meetings described in this section may include meetings held after issuance of a Notice of Special Review with any registrant who proposes to change voluntarily the composition, packaging, and labeling, or other terms and conditions of registration of his pesticide product in a way which he believes would reduce the risks of use of the product so that it would no longer meet or exceed the risk criteria of § 154.7. Meetings for this purpose will be most helpful and productive for both registrants and the Agency if they are requested by registrants shortly after the issuance of the Notice of Special Review.

(e) If the Agency meets with any person or party outside of government concerning a pending Special Review decision, the Agency will not issue a final Special Review decision until 30 days after inclusion of a memorandum concerning that meeting in the public docket. During those 30 days, any person or party may submit written comments to the Agency regarding the subject matter of the meeting in question. The Agency may issue a final Special Review decision without allowing this 30-day period if expedited action is necessary to protect public health or the environment, or if the Agency has invited other parties with potentially opposing viewpoints to the meeting in question (e.g., registrants, users, labor, and environmental groups).

(f) The Agency may decline to meet subsequently with any person or party who asserts unreasonable confidential business information claims pursuant to § 154.15(c) for the purpose of circumventing the docketing procedures described in § 154.15(b).

§ 154.29 Informal public hearings.

(a) Timing. At any time after issuance of a Notice of Special Review and prior to issuance of a Notice of Final Determination, the Administrator may conduct an informal public hearing to gather relevant information or otherwise assist Agency decisionmaking.

(b) Federal Register notice. The Administrator shall issue a notice for publication in the Federal Register of any informal public hearing to be held under this section. The notice shall contain the following information:

(1) The time, date, and place of the hearing.

(2) A brief description of the procedures governing participation in the hearing by interested persons.

(3) The issues to be considered at the hearing.

(c) Transcript. A verbatim transcript of the hearing shall be prepared and filed in the public docket.

§ 154.31 Notices of Preliminary Determination.

The Administrator shall prepare a Notice of Preliminary Determination after the close of the comment period on a Notice of Special Review.

(a) Contents of notice. The Notice of Preliminary Determination shall respond to all significant comments submitted in response to the Notice of Special Review. For each use of a pesticide product that was the subject of the Notice of Special Review, the Notice of Preliminary Determination shall also include, as appropriate:

(1) A determination whether the use satisfies any of the risk criteria set forth in § 154.7, and a discussion of the reasons for the determination.

(2) A determination of whether any changes in the composition, packaging, labeling, or restrictions on use of a pesticide product that were proposed in an application for new or amended registration submitted after issuance of the Notice of Special Review would reduce the risk so that the use no longer would satisfy any of the risk criteria in § 154.7.

(3) If the use satisfies any of the risk criteria set forth in § 154.7, a determination of whether the adverse effects posed by the use are unreasonable, taking into account the economic, social, and environmental costs and benefits of the use of the product, and a discussion of reasons for the determination.

(4) If the use is determined to pose an unreasonable adverse effect, a statement of the regulatory action, if any, which the Agency intends to initiate with respect to the use, and a discussion of the reasons for initiating that regulatory action.

(5) A statement that the Administrator is requesting comments from the Secretary of Agriculture and the Scientific Advisory Panel on the notices and analysis specified in paragraph (b) of this section, and that the notices and analysis are available on request.

(6) Instructions to interested persons on how to submit comments (including the deadline for submission of comments).

(7) The location of the docket under § 154.15 and the times during which the docket will be available for inspection and copying.

(b) Referral to Secretary of Agriculture and Scientific Advisory Panel. If the Administrator proposes to cancel, deny, or change the classification of the registration of a pesticide product which is the subject of a Special Review, or to hold a hearing under FIFRA section 6(b)(2) on whether to take any of those actions, he shall:

(1) Prepare a proposed form of a Notice of Intent to Cancel, a Notice of Intent to Deny Registration, a Notice of Intent to Hold a Hearing, and/or a Notice of Intent to Change Classification, as appropriate.

(2) Prepare an Agricultural Impact Analysis, analyzing the impact of the proposed action on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy.

(3) Send the proposed notices and analysis to the Secretary of Agriculture and the Scientific Advisory Panel for comment, as provided by the Act.

(4) Send the Notice of Preliminary Determination and the other notices and analysis prepared under this section to all registrants and applicants for registration of products that are subject to the Special Review.

(c) Publication. The Agency shall issue the Notice of Preliminary Determination for publication in the Federal Register.

§ 154.33 Notice of Final Determination.

(a) Publication and notice to registrants and applicants. The Administrator shall prepare a Notice of Final Determination after the close of the comment period on a Notice of Preliminary Determination. As necessary, the Administrator shall also prepare Notices of Intent to Cancel, Notices of Denial, Notices of Intent to Hold a Hearing under FIFRA section 6(b)(2), or Notices of Intent to Change Classification.

(b) Contents. The Notice of Final Determination shall include:

(1) For each pesticide use subject to the Notice of Preliminary Determination, the Agency’s final determination with respect to each use, along with a discussion of the reasons for the determination.

(2) Any comments submitted by the Secretary of Agriculture or the Scientific Advisory Panel, and the responses of the Administrator to these comments.

(3) The response of the Administrator to any significant public comments submitted on the Notice of Preliminary Determination.

(4) Instructions to registrants, applicants for registration, and other interested persons concerning the procedures which will be used to implement any regulatory action which the Administrator has decided upon, including instructions concerning how to request hearings, if hearings are available as of right under the Act or have been made available by the Administrator under the Act.

(5) The location of the docket under § 154.15 and the times during which the docket will be available for inspection and copying.

(c) Publication and notification of registrants and applicants. The Notice of Final Determination and any Notice of Intent to Cancel, Notice of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to Change Classification shall be published in the Federal Register. If the Administrator issues a Notice of Intent to Cancel, Notice of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to Change Classification, such notice, along with the Notice of Final Determination, also shall be sent by certified mail to all affected registrants and applicants.

§ 154.34 Expedited procedures.

(a) The Agency may elect to issue a Notice of Special Review and a Notice of Preliminary Determination simultaneously; or, to initiate cancellation, suspension, or denial proceedings concerning a pesticide or any of its uses without first conducting a Special Review or issuing a Notice of Preliminary Determination.

(b) If the Agency elects to issue a simultaneous Notice of Special Review and Notice of Preliminary Determination, the Agency will make the docket for that decision available for public inspection no more than 3 months after the Agency privately notifies the registrant of its risk concerns pursuant to § 154.21(a).

§ 154.35 Finality of determinations.

(a) The Administrator will not approve an application for registration or amended registration of a pesticide product except by use of the procedures specified in paragraph (c) of this section, if:

(1) The application proposes registration of a product for a use which earlier had been the subject of a notice under § 154.21(a);

(2) After the Administrator issued the notice, he determined not to initiate a Special Review, because of a proposal by an applicant for registration or amended registration to change the terms and conditions of registration of the product in a way which would reduce the risk sufficiently to eliminate the need for a Special Review; and

(3) The application for registration or amended registration now proposes that the terms and conditions which served as the basis of the earlier determination be eliminated, or be modified in a way which might increase the risk which was the subject of the notice under § 154.21(a).

(b) The Administrator will not approve an application for registration or amended registration of a pesticide product except by use of the procedures specified in paragraph (c) of this section, if:

(1) The application proposed registration of a product for a use which earlier had been the subject of a Notice of Special Review issued under § 154.25;

(2) After the Administrator issued that Notice, he determined not to issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal by an applicant for registration or amended registration to change the terms and conditions of registration of the product in a way which would reduce the risk sufficiently to eliminate the need for issuance of a notice under FIFRA section 3(c)(6) or 6(b); and

(3) The application for registration or amended registration now proposes that the terms and conditions of registration which served as the basis for the earlier determination now be eliminated or be modified in a way which might increase the risk which was the subject of the Notice of Special Review.

(c) An application to which paragraph (a) or (b) of this section applies may not be approved until:

(1) The Administrator issues a notice for publication in the Federal Register which describes why the application is subject to the provisions of this section, states that the Administrator proposes to approve the application and his reasons, solicits public comment on whether the application should be approved, and provides a period not less than 30 days for comments to be submitted; and

(2) If any substantive comments are submitted in response to the notice, the Administrator issues a second notice for publication in the Federal Register responding to the comments.

PART 155—REGISTRATION STANDARDS AND REGISTRATION REVIEW

Authority:7 U.S.C. 136a and 136w.


Source:50 FR 49001, Nov. 27, 1985, unless otherwise noted.

Subpart A [Reserved]

Subpart B—Docketing and Public Participation Procedures

§ 155.23 Definitions.

For the purposes of this part, confidential business information means trade secrets or confidential commercial or financial information under FIFRA sec. 10(b) or 5 U.S.C. 552(b) (3) or (4).

§ 155.25 Schedule.

EPA will issue annually in the Federal Register a notice listing the pesticides (or groups of pesticides) for which Registration Standards are currently being developed. The list will include pesticides for which a Registration Standard is scheduled for issuance within the next year, and the approximate sequence of issuance. The list may also include pesticides for which a Registration Standard will be under development during the upcoming year, but which are not scheduled for issuance until the succeeding year. The notice will invite comment and submission of information on the individual pesticides on the list.

§ 155.27 Agency review of data.

EPA will independently (or using the services of disinterested contractors or consultants) review available data in preparation for the development of a Registration Standard, and will be responsible for the drafting of the Registration Standard based on such data reviews. The Agency will not permit registrants to prepare, or assist in the preparation of, data reviews or other Registration Standard documents. The Agency may, however, meet with registrants to discuss its pending reviews, decisions, or documents, in accordance with the meeting procedures in § 155.30, and the docketing procedures in § 155.32.

§ 155.30 Meetings and communications.

EPA personnel may, upon their own initiative or upon request of any interested person or party, meet or communicate with persons or parties outside of government concerning a Registration Standard under development. Such meetings or communications will conform to the following policies and procedures:

(a) Purpose. Meetings and communications may be for the purpose of receiving and considering information, exchanging views, exploring factual and substantive positions, discussing regulatory options or for any other purpose deemed appropriate by the Agency in its deliberations concerning development of a Registration Standard. The Agency will not commit to take any particular action concerning a Registration Standard under development during discussions with any person or party outside of government. The Agency will make its final administrative decision on a wholly independent basis, and in accordance with law.

(b) Meetings with persons or parties outside of government. Requests by responsible persons or parties outside of government to meet with Agency personnel concerning a Registration Standard under development should be directed in writing to the Registration Division. Reasonable requests will ordinarily be granted on a timely basis. EPA will decide the time and place of such meetings, and the Agency personnel who will attend. EPA may decline to meet with persons or parties who assert unreasonable claims of confidential business information for the purpose of circumventing the docketing procedures in § 155.32. EPA may also decline to meet if the number or frequency of meetings would delay unduly the issuance of the Registration Standard. Further, no person or party outside government will be accorded special or preferential access to Agency pesticide decisionmaking or to the Agency’s decisional process.

(c) Information submitted to the Agency concerning a Registration Standard under development. (1) Information, comments, data, or other written material submitted to the Agency at any time concerning a Registration Standard under development may be claimed by the submitter to be confidential business information. The burden of identifying claimed confidential business information rests with the submitter, or, in meetings, with the participants from outside of government who wish to assert a claim of confidentiality.

(2) To assert a claim of confidentiality for all or any part of a written submission concerning a Registration Standard under development, the submitter must furnish three copies of the material. Two copies must be complete, with claimed confidential business information clearly marked in the text. Items in the document that are claimed confidential should be numbered consecutively throughout the document. The third copy must have the claimed confidential business information excised from the text without closing up or paraphrasing the remaining text. The deletions should be consecutively numbered to correspond to the numbering of the complete copies. Each copy must be marked on the cover as to whether it contains claimed confidential business information.

(3) Any written material received by the Agency that is not marked as confidential will be deemed to be nonconfidential, and may be made available through the public docket or otherwise disclosed without prior notice to the submitter.

(d) Memorandum of meeting. For each meeting with a person or party outside of government, the Agency will prepare, based on notes taken at the meeting, a memorandum of the meeting. The memorandum will be prepared within 10 working days of the meeting and will include all of the following information:

(1) The date and time of the meeting.

(2) The name of the person who requested the meeting.

(3) The names and affiliations of the participants.

(4) The subject matter of the meeting.

(5) A full and accurate description of all significant positions taken, facts presented, and arguments made by each participant (except that any discussion of claimed confidential business information will be identified in meeting notes, and referenced in the memorandum).

(6) Identification of all documents, proposals, or other materials (other than information claimed to be confidential business information) distributed or exchanged at the meeting.

(7) The name of the person who prepared the memorandum.

[50 FR 49001, Nov. 27, 1985, as amended at 58 FR 34203, June 23, 1993]

§ 155.32 Public docket.

(a) When created. (1) A docket will be created for each Registration Standard under development when the Agency begins review of data for the Registration Standard or upon publication of the notice described in § 155.25 setting out the list and sequence of Registration Standards, whichever is earlier. The Agency will announce in its annual schedule notice the dockets that are available for Registration Standards under development.

(2) If the Agency notifies registrants privately in accordance with 40 CFR 154.21 that one or more risk criteria set forth in 40 CFR 154.7 (leading to a special review) may have been exceeded, that notification and any subsequent communications concerning that notification will be placed in a separate docket pertaining to possible special review in accordance with the provisions of § 154.15.

(b) Contents of docket. The docket will contain, within the time frames indicated, all of the following documents and information (except that information claimed to be confidential business information will not be included):

(1) An index of its contents (refer to paragraph (c) of this section).

(2) A copy of each comment received in response to the notice described in § 155.25 that pertains to a pesticide for which the notice indicated a Registration Standard was under development (within 10 working days after receipt by the Agency, or 15 working days if the submitter has asserted a confidential business information claim concerning the material).

(3) A copy of each memorandum of a meeting between the Agency and persons or parties outside of government, prepared in accordance with § 155.30(d) (within 10 working days after the meeting).

(4) A copy of each document, comment, item of correspondence or other written material concerning the Registration Standard submitted to the Agency by any person or party outside of government, whether in a meeting or separately (within 10 working days after receipt, or 15 working days if the submitter has asserted a confidential business information claim concerning the material).

(5) A copy of each document, proposal, or other item of written material concerning the Registration Standard provided by the Agency to any person or party outside of government (within 15 working days after the item is made available to such person or party).

(6) A copy of the Registration Standard;

(7) With respect to a Registration Standard for which the Agency has determined that a substantially complete chronic health and teratology data base exists, a copy of the Federal Register notice concerning availability of a proposed Registration Standard, and a copy of each comment received in response to that notice (within 10 working days after receipt by the Agency, or 15 working days if the submitter has asserted a confidential business information claim concerning the material).

(8) A copy of the Federal Register notice announcing the issuance of the Registration Standard (within 10 working days after the publication of the notice).

(c) Index of the docket. The Agency will establish and keep current an index to the docket for each Registration Standard. The index will include, but is not limited to:

(1) A list of each meeting between the Agency and any person or party outside of government, containing the date and subject of the meeting, the names of participants and the name of the person requesting the meeting.

(2) A list of each document in the docket by title, source or recipient(s), and the date the document was received or provided by the Agency.

(d) Availability of docket and indices. (1) The Agency will make available to the public for inspection and copying the docket and index for any Registration Standard.

(2) The Agency will establish and maintain a mailing list of persons who have specifically requested that they receive indices for Registration Standard dockets. On a quarterly basis, EPA will distribute the indices of new materials placed in the public docket to these persons. Annually, EPA will require that persons on the list renew their requests for inclusion on the list.

(3) The Agency will issue annually in the Federal Register (in conjunction with the annual schedule notice specified in § 155.25) a notice announcing the availability of docket indices.

(4) Each Federal Register notice of availability of a Registration Standard will announce the availability of the docket index for that Standard.

§ 155.34 Notice of availability.

(a) The Agency will issue in the Federal Register a notice announcing the issuance and availability of Registration Standard which:

(1) Concerns a previously unregistered active ingredient; or

(2) Concerns a previously registered active ingredient, and the Registration Standard states that registrants will be required (under FIFRA section 3(c)(2)(B)) to submit chronic health (including, but not limited to, chronic feeding, oncogenicity and reproduction) or teratology studies.

(b) Interested persons may submit comments concerning any Registration Standard described by paragraph (a) of this section at any time.

(c) The Agency will issue in the Federal Register a notice announcing the availability of, and providing opportunity for comment on, each proposed Registration Standard which concerns a previously registered active ingredient for which the Agency has determined that a substantially complete chronic health and teratology data base exists. Following the comment period and issuance of the Registration Standard, the Agency will issue in the Federal Register a notice of availability of the Registration Standard.

Subpart C—Registration Review Procedures

Source:71 FR 45732, Aug. 9, 2006, unless otherwise noted.

§ 155.40 General.

(a) Purpose. These regulations establish procedures for the registration review program required in FIFRA section 3(g). Registration review is the periodic review of a pesticide’s registration to ensure that each pesticide registration continues to satisfy the FIFRA standard for registration. Under FIFRA section 3(g), each pesticide is required to be reviewed every 15 years.

(1) Among other things, FIFRA requires that a pesticide generally will not cause unreasonable adverse effects on the environment. Registration review is intended to ensure that each pesticide’s registration is based on current scientific and other knowledge regarding the pesticide, including its effects on human health and the environment.

(2) If a product fails to satisfy the FIFRA standard for registration, the product’s registration may be subject to cancellation or other remedies under FIFRA.

(b) Applicability. This subpart applies to every pesticide product registered under FIFRA section 3 as well as all pesticide products registered under FIFRA section 24(c). It does not apply to products whose sale or distribution is authorized under FIFRA section 5 or section 18.

(c) Limitations. (1) At any time, the Agency may undertake any other review of a pesticide under FIFRA, irrespective of the pesticide’s past, ongoing, scheduled, or not yet scheduled registration review.

(2) When the Agency determines that new data or information are necessary for a pesticide’s registration review, it will require such data under FIFRA section 3(c)(2)(B).

[71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75595, Dec. 12, 2008]

§ 155.42 Registration review cases.

(a) Establishing registration review cases. A registration review case will be composed of one or more active ingredients and all the products containing such ingredient(s). The Agency may group related active ingredients into a registration review case when the active ingredients are so closely related in chemical structure and toxicological profile as to allow common use of some or all required data for hazard assessment.

(1) Existing pesticides. The Agency will assign each pesticide registered on or before the effective date of this regulation to a registration review case.

(2) New pesticides. The Agency will assign each pesticide registered after the effective date of this regulation to an existing registration review case or to a new registration review case.

(3) A pesticide product that contains multiple active ingredients will belong to the registration review cases for each of its active ingredients.

(b) Modifying registration review cases. New data or information may suggest that a registration review case should be modified. The Agency may modify a registration review case in the following ways:

(1) Add a new active ingredient to a registration review case. The Agency may determine that a new active ingredient is chemically and toxicologically similar to active ingredients in an existing registration review case and should be grouped with the ingredients in the existing registration review case.

(2) Split a registration review case into two or more registration review cases. For example, new data or information may suggest that active ingredients in a registration review case are not as similar as previously believed and that they belong in two or more separate registration review cases.

(3) Move an ingredient from one registration review case to another. For example, new data or information might suggest that an ingredient should not be grouped with the other ingredients in the registration review case and that it belongs in a different registration review case.

(4) Merge two or more registration review cases into a single registration review case. For example, new data or information might suggest that the active ingredients in two or more registration review cases should be grouped together for registration review.

(5) Delete an active ingredient from a registration review case. For example, the Agency will remove the ingredient from the case if the registrations of all products containing an active ingredient in a registration review case are canceled.

(c) Closing a registration review case. The Agency will close a registration review case if all products in the case are canceled.

(d) Establishing a baseline date for a registration review case. For the purpose of scheduling registration reviews, the Agency will establish a baseline date for each registration review case. In general, the baseline date will be the date of initial registration of the oldest pesticide product in the case or the date of reregistration, whichever is later. For the purpose of these procedures, the date of reregistration is the date on which the Reregistration Eligibility Decision or Interim Reregistration Decision was signed, whichever date the Agency determines to be more appropriate based on the comprehensiveness of the review.

(1) The Agency generally will not change the baseline date for a registration review case when it modifies a case by adding or deleting ingredients or products.

(2) When the Agency splits a registration review case into two or more cases, the new case(s) generally will have the baseline date of the original registration review case.

(3) When the Agency merges two or more registration review cases into a single case, the Agency generally will use the earliest baseline date as the baseline date for the new case.

(e) Announcing registration review cases and baseline dates. The Agency will maintain a list of registration review cases, including baseline dates, on its website.

§ 155.44 Establish schedules for registration review.

The Agency will develop schedules for registration review that are generally based on the baseline date of the registration review case or on the date of the latest registration review of the registration review case. The Agency may also take into account other factors, such as achieving process efficiencies by reviewing related cases together, when developing schedules for registration review. The Agency will maintain schedules for the current year and at least two subsequent years on its website.

§ 155.46 Deciding that a registration review is complete and additional review is not needed.

The Agency may determine that there is no need to reconsider a previous decision that a pesticide satisfies the standard of registration in FIFRA. In such cases, instead of establishing a pesticide registration review case docket as described in § 155.50, the Agency may propose that, based on its determination that a pesticide meets the FIFRA standard for registration, no further review will be necessary. In such circumstances, the Agency will publish a notice in the Federal Register announcing the availability of the proposed decision and provide a comment period of at least 60 calendar days. The Agency will publish a notice in the Federal Register announcing the availability of a final version of the decision, an explanation of any changes to the proposed decision and its response to any comments. The date of the final notice of availability would be used as the date of the latest registration review for the purpose of scheduling subsequent registration reviews.

§ 155.48 Data Call-In.

The Agency may issue a Data Call-In notice under FIFRA section 3(c)(2)(B) at any time if the Agency believes that the data are needed to conduct the registration review. The provisions in FIFRA section 3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission, compensation, and exemption of data required to conduct a registration review.

§ 155.50 Initiate a pesticide’s registration review.

The Agency will initiate a pesticide’s registration review by establishing a docket for each registration review case, except for cases covered under § 155.46, and opening it for public review.

(a) Contents of the registration review case docket. The Agency will place in this docket information that will assist the public in understanding the types of information and issues that the Agency may consider in the course of the registration review. The Agency may include information from its files including, but not limited to, the following information:

(1) An overview of registration review case status;

(2) A list of current registrations and registrants, any Federal Register notices regarding pending registration actions, and current or pending tolerances;

(3) Risk assessment documents;

(4) Bibliographies concerning current registrations;

(5) Summaries of incident data; and

(6) Any other pertinent data or information.

(b) Public review of the registration review case docket. The Agency will publish a notice in the Federal Register announcing the availability for public review of the information described in paragraph (a) of this section and establishing a comment period of at least 60 days. During this comment period, interested persons may identify any additional information they believe the Agency should consider in the course of the registration review.

(c) Submission of data and other information during the comment period. The Agency may identify, either in the notice published under paragraph (b) of this section, or at any other time, data or information that it does not have but which may be useful, if available, for consideration in the registration review. Any person may submit data or information in response to such identification. In order to be considered during a pesticide’s registration review, the submitted data or information must meet the requirements listed below.

(1) In order to ensure that the Agency will consider data or information in the conduct of a registration review, interested persons must submit the data or information during the comment period established in the notice described in paragraph (b) of this section. The Agency may, at its discretion, consider data or information submitted at a later date.

(2) The data or information must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.

(3) Submitters must clearly identify the source of any submitted data or information.

(4) Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide’s registration review.

(d) For the purposes of this subpart, the provisions of subpart B do not apply.

§ 155.52 Stakeholder engagement.

In addition to the public participation opportunities described in § 155.50 and § 155.53(c), the Agency may meet with stakeholders regarding a forthcoming or ongoing registration review. For example, before conducting a pesticide’s registration review, the Agency may consult with registrants or pesticide users regarding the use and usage of the pesticide. The Agency may consult with registrants, pesticide users, or other persons during a pesticide’s registration review with regard to developing risk management options for a pesticide. The Agency may informally consult with officials of Federal, State or Tribal agencies regarding a forthcoming or ongoing registration review.

(a) Minutes of meetings with persons outside of government. Subject to paragraph (c) of this section, if the Agency meets with one or more individuals that are not government employees to discuss matters relating to a registration review, the Agency will place in the docket a list of meeting attendees, minutes of the meeting, and any documents exchanged at the meeting, not later than the earlier of:

(1) 45 days after the meeting; or

(2) The date of issuance of the registration review decision.

(b) Exchange of documents or other written material. In the course of a meeting with a person outside of government, the Agency or that person may provide the other with a copy of a document or other written material that has not yet been released to the public. The Agency will place a copy of any such document or other written material in the docket along with the minutes of the meeting where the materials were exchanged.

(c) Confidential business information. The Agency will identify, but not include in the docket, any confidential business information whose disclosure is prohibited by FIFRA section 10.

[71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75596, Dec. 12, 2008]

§ 155.53 Conduct of a pesticide’s registration review.

The Agency will review data and information described in § 155.50(a), (b), and (c) or submitted in response to a Data Call-In notice that it believes should be considered in the pesticide’s registration review.

(a) Assess changes since a pesticide’s last review. The Agency will assess any changes that may have occurred since the Agency’s last registration decision in order to determine the significance of such changes and whether the pesticide still satisfies the FIFRA standard for registration. The Agency will consider whether to conduct a new risk assessment to take into account, among other things, any changes in statutes or regulations, policy, risk assessment procedures or methods, or data requirements. The Agency will consider whether any new data or information on the pesticide, including any data or information submitted under § 155.50 or in response to a Data Call-In notice, warrant conducting a new risk assessment or a new risk/benefit assessment. The Agency will also consider whether any new data or information regarding an individual pesticide product, including any data or information submitted under § 155.50 or in response to a Data Call-In notice, such as data or information about an inert ingredient in the pesticide product or other information or data relating to the composition, labeling or use of the pesticide product, warrant additional review of a pesticide product’s registration.

(b) Conduct new assessments as needed. (1) Active ingredient(s) in the registration review case. If the Agency finds that a new assessment of the pesticide is needed, it will determine whether it can base the new assessment on available data or information, including data or information submitted under § 155.50 or in response to a Data Call-In notice. If sufficient data or information are available, the Agency will conduct the new risk assessment or risk/benefit assessment. If the Agency determines that additional data or information are needed to conduct the review, the Agency will issue a Data Call-In notice under FIFRA section 3(c)(2)(B).

(2) Individual product registrations. If the Agency finds that additional review of an individual product’s registration is needed, it will review the pesticide product label, confidential statement of formula, product-specific data, or other pertinent data or information, as appropriate, to determine whether the registration of the individual product meets the FIFRA standard for registration. If the Agency determines that additional data or information are needed to conduct the review, the Agency will issue a Data Call-In notice under FIFRA section 3(c)(2)(B).

(c) Public participation during a pesticide’s registration review. The Agency will generally make available for public review and comment a draft risk assessment for a pesticide if a new risk assessment has been conducted. The Agency will publish a notice in the Federal Register announcing the availability of the draft risk assessment and provide a comment period of at least 30 calendar days. The Agency will publish a notice in the Federal Register announcing the availability of a revised risk assessment, an explanation of any changes to the proposed document, and its response to comments. If the revised risk assessment indicates risks of concern, the Agency may, in the notice announcing the availability of the revised risk assessment, provide a comment period of at least 30 calendar days for the public to submit suggestions for mitigating the risk identified in the revised risk assessment.

(1) The Agency might not request comments on a draft risk assessment in cases where the Agency’s initial screening of a pesticide indicates that it has low use/usage, affects few if any stakeholders or members of the public, poses low risk, and/or requires little or no risk mitigation. In such cases, the Agency will make a draft risk assessment available for public review and comment when it issues a proposed decision on the registration review case.

(2) If the Agency finds that it is not necessary to conduct a new risk assessment, it will issue a proposed decision on the registration review case as described in § 155.58.

§ 155.56 Interim registration review decision.

The Agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. A FIFRA 3(c)(2)(B) notice requiring the needed data or information may precede, accompany, or follow issuance of the interim registration review decision. The Agency will follow procedures in § 155.58 when issuing an interim registration review decision.

§ 155.57 Registration review decision.

A registration review decision is the Agency’s determination whether a pesticide meets, or does not meet, the standard for registration in FIFRA.

§ 155.58 Procedures for issuing a decision on a registration review case.

(a) The Agency will publish a notice in the Federal Register announcing the availability of a proposed registration review decision or a proposed interim registration review decision. At that time, the Agency will place in the pesticide’s registration review docket the Agency’s proposed decision and the bases for the decision. There will be a comment period of at least 60 calendar days on the proposed decision.

(b) In its proposed decision, the Agency will, among other things:

(1) State its proposed findings with respect to the FIFRA standard for registration and describe the basis for such proposed findings.

(2) Identify proposed risk mitigation measures or other remedies as needed and describe the basis for such proposed requirements.

(3) State whether it believes that additional data are needed and, if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring such data may be issued in conjunction with a proposed or final decision on the registration review case or a proposed or final interim decision on a registration review case.

(4) Specify proposed labeling changes; and

(5) Identify deadlines that it intends to set for completing any required actions.

(c) After considering any comments on the proposed decision, the Agency will issue a registration review decision or interim registration review decision. This decision will include an explanation of any changes to the proposed decision and the Agency’s response to significant comments. The Agency will publish a notice in the Federal Register announcing the availability of a registration review decision or interim registration review decision. The registration review case docket will remain open until all actions required in the final decision on the registration review case have been completed.

(d) If the registrant fails to take the action required in a registration review decision or interim registration review decision, the Agency may take appropriate action under FIFRA.

PART 156—LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES

Authority:7 U.S.C. 136-136y.

Subpart A—General Provisions

§ 156.3 Definitions.

Terms used in this part have the same meaning as in the Act and part 152 of this chapter. In addition, as used in this part, the following terms shall have the meanings set forth below.

Dilutable means that the pesticide product’s labeling allows or requires the pesticide product to be mixed with a liquid diluent prior to application or use.

Transport vehicle means a cargo-carrying vehicle such as an automobile, van, tractor, truck, semitrailer, tank car or rail car used for the transportation of cargo by any mode.

[73 FR 64224, Oct. 29, 2008]

§ 156.10 Labeling requirements.

(a) General—(1) Contents of the label. Every pesticide product shall bear a label containing the information specified by the Act and the regulations in this part. The contents of a label must show clearly and prominently the following:

(i) The name, brand, or trademark under which the product is sold as prescribed in paragraph (b) of this section;

(ii) The name and address of the producer, registrant, or person for whom produced as prescribed in paragraph (c) of this section;

(iii) The net contents as prescribed in paragraph (d) of this section;

(iv) The product registration number as prescribed in paragraph (e) of this section;

(v) The producing establishment number as prescribed in paragraph (f) of this section;

(vi) An ingredient statement as prescribed in paragraph (g) of this section;

(vii) Hazard and precautionary statements as prescribed in subpart D of this part for human and domestic animal hazards and subpart E of this part for environmental hazards.

(viii) The directions for use as prescribed in paragraph (i) of this section; and

(ix) The use classification(s) as prescribed in paragraph (j) of this section.

(2) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information required on the labeling by the Act or the regulations in this part must be clearly legible to a person with normal vision, and must be placed with such conspicuousness (as compared with other words, statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(ii) All required label text must:

(A) Be set in 6-point or larger type;

(B) Appear on a clear contrasting background; and

(C) Not be obscured or crowded.

(3) Language to be used. All required label or labeling text shall appear in the English language. However, the Agency may require or the applicant may propose additional text in other languages as is considered necessary to protect the public. When additional text in another language is necessary, all labeling requirements will be applied equally to both the English and other-language versions of the labeling.

(4) Placement of Label—(i) General. The label shall appear on or be securely attached to the immediate container of the pesticide product. For purposes of this section, and the misbranding provisions of the Act, “securely attached” shall mean that a label can reasonably be expected to remain affixed during the foreseeable conditions and period of use. If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold.

(ii) Tank cars and other bulk containers—(A) Transportation. While a pesticide product is in transit, the appropriate provisions of 49 CFR parts 170-189, concerning the transportation of hazardous materials, and specifically those provisions concerning the labeling, marking and placarding of hazardous materials and the vehicles carrying them, define the basic Federal requirements. In addition, when any registered pesticide product is transported in a tank car, tank truck or other mobile or portable bulk container, a copy of the accepted label must be attached to the shipping papers, and left with the consignee at the time of delivery.

(B) Storage. When pesticide products are stored in bulk containers, whether mobile or stationary, which remain in the custody of the user, a copy of the label of labeling, including all appropriate directions for use, shall be securely attached to the container in the immediate vicinity of the discharge control valve.

(5) False or misleading statements. Pursuant to section 2(q)(1)(A) of the Act, a pesticide or a device declared subject to the Act pursuant to § 152.500, is misbranded if its labeling is false or misleading in any particular including both pesticidal and non-pesticidal claims. Examples of statements or representations in the labeling which constitute misbranding include:

(i) A false or misleading statement concerning the composition of the product;

(ii) A false or misleading statement concerning the effectiveness of the product as a pesticide or device;

(iii) A false or misleading statement about the value of the product for purposes other than as a pesticide or device;

(iv) A false or misleading comparison with other pesticides or devices;

(v) Any statement directly or indirectly implying that the pesticide or device is recommended or endorsed by any agency of the Federal Government;

(vi) The name of a pesticide which contains two or more principal active ingredients if the name suggests one or more but not all such principal active ingredients even though the names of the other ingredients are stated elsewhere in the labeling;

(vii) A true statement used in such a way as to give a false or misleading impression to the purchaser;

(viii) Label disclaimers which negate or detract from labeling statements required under the Act and these regulations;

(ix) Claims as to the safety of the pesticide or its ingredients, including statements such as “safe,” “nonpoisonous,” “noninjurious,” “harmless” or “nontoxic to humans and pets” with or without such a qualifying phrase as “when used as directed”; and

(x) Non-numerical and/or comparative statements on the safety of the product, including but not limited to:

(A) “Contains all natural ingredients”;

(B) “Among the least toxic chemicals known”

(C) “Pollution approved”

(6) Final printed labeling. (i) Except as provided in paragraph (a)(6)(ii) of this section, final printed labeling must be submitted and accepted prior to registration. However, final printed labeling need not be submitted until draft label texts have been provisionally accepted by the Agency.

(ii) Clearly legible reproductions or photo reductions will be accepted for unusual labels such as those silk-screened directly onto glass or metal containers or large bag or drum labels. Such reproductions must be of microfilm reproduction quality.

(b) Name, brand, or trademark. (1) The name, brand, or trademark under which the pesticide product is sold shall appear on the front panel of the label.

(2) No name, brand, or trademark may appear on the label which:

(i) Is false or misleading, or

(ii) Has not been approved by the Administrator through registration or supplemental registration as an additional name pursuant to § 152.132.

(c) Name and address of producer, registrant, or person for whom produced. An unqualified name and address given on the label shall be considered as the name and address of the producer. If the registrant’s name appears on the label and the registrant is not the producer, or if the name of the person for whom the pesticide was produced appears on the label, it must be qualified by appropriate wording such as “Packed for * * *,” “Distributed by * * *,” or “Sold by * * *” to show that the name is not that of the producer.

(d) Net weight or measure of contents. (1) The net weight or measure of content shall be exclusive of wrappers or other materials and shall be the average content unless explicitly stated as a minimum quantity.

(2) If the pesticide is a liquid, the net content statement shall be in terms of liquid measure at 68 °F (20 °C) and shall be expressed in conventional American units of fluid ounces, pints, quarts, and gallons.

(3) If the pesticide is solid or semisolid, viscous or pressurized, or is a mixture of liquid and solid, the net content statement shall be in terms of weight expressed as avoirdupois pounds and ounces.

(4) In all cases, net content shall be stated in terms of the largest suitable units, i.e., “1 pound 10 ounces” rather than “26 ounces.”

(5) In addition to the required units specified, net content may be expressed in metric units.

(6) Variation above minimum content or around an average is permissible only to the extent that it represents deviation unavoidable in good manufacturing practice. Variation below a stated minimum is not permitted. In no case shall the average content of the packages in a shipment fall below the stated average content.

(7) For a pesticide product packaged in a refillable container, an appropriately sized area on the label may be left blank to allow the net weight or measure of content to be marked in by the refiller according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale of the pesticide. As required in paragraph (a)(1)(iii) of this section, the net contents must be shown clearly and prominently on the label.

(e) Product registration number. The registration number assigned to the pesticide product at the time of registration shall appear on the label, preceded by the phrase “EPA Registration No.,” or the phrase “EPA Reg. No.” The registration number shall be set in type of a size and style similar to other print on that part of the label on which it appears and shall run parallel to it. The registration number and the required identifying phrase shall not appear in such a manner as to suggest or imply recommendation or endorsement of the product by the Agency.

(f) Producing establishment’s registration number. The producing establishment registration number preceded by the phrase “EPA Est.”, of the final establishment at which the product was produced may appear in any suitable location on the label or immediate container. It must appear on the wrapper or outside container of the package if the EPA establishment registration number on the immediate container cannot be clearly read through such wrapper or container. For a pesticide product packaged in a refillable container, an appropriately sized area on the label may be left blank after the phrase “EPA Est.” to allow the EPA establishment registration number to be marked in by the refiller according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale of the pesticide.

(g) Ingredient statement—(1) General. The label of each pesticide product must bear a statement which contains the name and percentage by weight of each active ingredient, the total percentage by weight of all inert ingredients; and if the pesticide contains arsenic in any form, a statement of the percentages of total and water-soluble arsenic calculated as elemental arsenic. The active ingredients must be designated by the term “active ingredients” and the inert ingredients by the term “inert ingredients,” or the singular forms of these terms when appropriate. Both terms shall be in the same type size, be aligned to the same margin and be equally prominent. The statement “Inert Ingredients, none” is not required for pesticides which contain 100 percent active ingredients. Unless the ingredient statement is a complete analysis of the pesticide, the term “analysis” shall not be used as a heading for the ingredient statement.

(2) Position of ingredient statement. (i) The ingredient statement is normally required on the front panel of the label. If there is an outside container or wrapper through which the ingredient statement cannot be clearly read, the ingredient statement must also appear on such outside container or wrapper. If the size or form of the package makes it impracticable to place the ingredient statement on the front panel of the label, permission may be granted for the ingredient statement to appear elsewhere.

(ii) The text of the ingredient statement must run parallel with other text on the panel on which it appears, and must be clearly distinguishable from and must not be placed in the body of other text.

(3) Names to be used in ingredient statement. The name used for each ingredient shall be the accepted common name, if there is one, followed by the chemical name. The common name may be used alone only if it is well known. If no common name has been established, the chemical name alone shall be used. In no case will the use of a trademark or proprietary name be permitted unless such name has been accepted as a common name by the Administrator under the authority of section 25(c)(6).

(4) Statements of percentages. The percentages of ingredients shall be stated in terms of weight-to-weight. The sum of percentages of the active and the inert ingredients shall be 100. Percentages shall not be expressed by a range of values such as “22-25%.” If the uses of the pesticide product are expressed as weight of active ingredient per unit area, a statement of the weight of active ingredient per unit volume of the pesticide formulation shall also appear in the ingredient statement.

(5) Accuracy of stated percentages. The percentages given shall be as precise as possible reflecting good manufacturing practice. If there may be unavoidable variation between manufacturing batches, the value stated for each active ingredient shall be the lowest percentage which may be present.

(6) Deterioration. Pesticides which change in chemical composition significantly must meet the following labeling requirements:

(i) In cases where it is determined that a pesticide formulation changes chemical composition significantly, the product must bear the following statement in a prominent position on the label: “Not for sale or use after [date].”

(ii) The product must meet all label claims up to the expiration time indicated on the label.

(7) Inert ingredients. The Administrator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment.

(h) [Reserved]

(i) Directions for Use—(1) General requirements—(i) Adequacy and clarity of directions. Directions for use must be stated in terms which can be easily read and understood by the average person likely to use or to supervise the use of the pesticide. When followed, directions must be adequate to protect the public from fraud and from personal injury and to prevent unreasonable adverse effects on the environment.

(ii) Placement of directions for use. Directions may appear on any portion of the label provided that they are conspicuous enough to be easily read by the user of the pesticide product. Directions for use may appear on printed or graphic matter which accompanies the pesticide provided that:

(A) If required by the Agency, such printed or graphic matter is securely attached to each package of the pesticide, or placed within the outside wrapper or bag;

(B) The label bears a reference to the directions for use in accompanying leaflets or circulars, such as “See directions in the enclosed circular:” and

(C) The Administrator determines that it is not necessary for such directions to appear on the label.

(iii) Exceptions to requirement for direction for use. (A) Detailed directions for use may be omitted from labeling of pesticides which are intended for use only by manufacturers of products other than pesticide products in their regular manufacturing processes, provided that:

(1) The label clearly shows that the product is intended for use only in manufacturing processes and specifies the type(s) of products involved.

(2) Adequate information such as technical data sheets or bulletins, is available to the trade specifying the type of product involved and its proper use in manufacturing processes;

(3) The product will not come into the hands of the general public except after incorporation into finished products; and

(4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment.

(B) Detailed directions for use may be omitted from the labeling of pesticide products for which sale is limited to physicians, veterinarians, or druggists, provided that:

(1) The label clearly states that the product is for use only by physicians or veterinarians;

(2) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment; and

(3) The product is also a drug and regulated under the provisions of the Federal Food, Drug and Cosmetic Act.

(C) Detailed directions for use may be omitted from the labeling of pesticide products which are intended for use only by formulators in preparing pesticides for sale to the public, provided that:

(1) There is information readily available to the formulators on the composition, toxicity, methods of use, applicable restrictions or limitations, and effectiveness of the product for pesticide purposes;

(2) The label clearly states that the product is intended for use only in manufacturing, formulating, mixing, or repacking for use as a pesticide and specifies the type(s) of pesticide products involved;

(3) The product as finally manufactured, formulated, mixed, or repackaged is registered; and

(4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment.

(2) Contents of Directions for Use. The directions for use shall include the following, under the headings “Directions for Use”:

(i) The statement of use classification as prescribed in paragraph (j) of this section immediately under the heading “Directions for Use.”

(ii) Immediately below the statement of use classification, the statement “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”

(iii) The site(s) of application, as for example the crops, animals, areas, or objects to be treated.

(iv) The target pest(s) associated with each site.

(v) The dosage rate associated with each site and pest.

(vi) The method of application, including instructions for dilution, if required, and type(s) of application apparatus or equipment required.

(vii) The frequency and timing of applications necessary to obtain effective results without causing unreasonable adverse effects on the environment.

(viii) Worker protection statements meeting the requirements of subpart K of this part.

(ix) Specific directions concerning the storage, residue removal and disposal of the pesticide and its container, in accordance with subpart H of this part. These instructions must be grouped and appear under the heading, “Storage and Disposal.” This heading must be set in type of the same minimum sizes as required for the child hazard warning. (See table in § 156.60(b))

(x) Any limitations or restrictions on use required to prevent unreasonable adverse effects, such as:

(A) Required intervals between application and harvest of food or feed crops.

(B) Rotational crop restrictions.

(C) Warnings as required against use on certain crops, animals, objects, or in or adjacent to certain areas.

(D) For total release foggers as defined in § 156.78(d)(1), the following statements must be included in the “Directions for Use.”

DO NOT use more than one fogger per room. DO NOT use in small, enclosed spaces such as closets, cabinets, or under counters or tables. Do not use in a room 5 ft. × 5 ft. or smaller; instead, allow fog to enter from other rooms. Turn off ALL ignition sources such as pilot lights (shut off gas valves), other open flames, or running electrical appliances that cycle off and on (i.e., refrigerators, thermostats, etc.). Call your gas utility or management company if you need assistance with your pilot lights.”

(E) For restricted use pesticides, a statement that the pesticide may be applied under the direct supervision of a certified applicator who is not physically present at the site of application but nonetheless available to the person applying the pesticide, unless the Agency has determined that the pesticide may only be applied under the direct supervision of a certified applicator who is physically present.

(F) Other pertinent information which the Administrator determines to be necessary for the protection of man and the environment.

(j) Statement of use classification. Any pesticide product for which some uses are classified for general use and others for restricted use shall be separately labeled according to the labeling standards set forth in this subsection, and shall be marketed as separate products with different registration numbers, one bearing directions only for general use(s) and the other bearing directions for restricted use(s) except that, if a product has both restricted use(s) and general use(s), both of these uses may appear on a product labeled for restricted use. Such products shall be subject to the provisions of paragraph (j)(2) of this section.

(1) General Use Classification. Pesticide products bearing directions for use(s) classified general shall be labeled with the exact words “General Classification” immediately below the heading “Directions for Use.” And reference to the general classification that suggests or implies that the general utility of the pesticide extends beyond those purposes and uses contained in the Directions for Use will be considered a false or misleading statement under the statutory definitions of misbranding.

(2) Restricted Use Classification. Pesticide products bearing direction for use(s) classified restricted shall bear statements of restricted use classification on the front panel as described below:

(i) Front panel statement of restricted use classification. (A) At the top of the front panel of the label, set in type of the same minimum sizes as required for human hazard signal words (see table in paragraph (h)(1)(iv) of this section), and appearing with sufficient prominence relative to other text and graphic material on the front panel to make it unlikely to be overlooked under customary conditions of purchase and use, the statement “Restricted Use Pesticide” shall appear.

(B) Directly below this statement on the front panel, a summary statement of the terms of restriction imposed as a precondition to registration shall appear. If use is restricted to certified applicators, the following statement is required: “For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator’s certification.” If, however, other regulatory restrictions are imposed, the Administrator will define the appropriate wording for the terms of restriction by regulation.

[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR 36571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978. Redesignated and amended at 53 FR 15991, 15999, May 4, 1988; 57 FR 38146, Aug. 21, 1992; 60 FR 32096, June 19, 1995; 63 FR 9082, Feb. 23, 1998; 66 FR 64764, Dec. 14, 2001; 71 FR 47420, Aug. 16, 2006; 73 FR 75596, Dec. 12, 2008]

Subparts B-C [Reserved]

Subpart D—Human Hazard and Precautionary Statements

Source:66 FR 64764, Dec. 14, 2001, unless otherwise noted.

§ 156.60 General.

Each product label is required to bear hazard and precautionary statements for humans and domestic animals (if applicable) as prescribed in this subpart. Hazard statements describe the type of hazard that may occur, while precautionary statements will either direct or inform the user of actions to take to avoid the hazard or mitigate its effects.

(a) Location of statements—(1) Front panel statements. The signal word, child hazard warning, and, in certain cases, the first aid statement are required to appear on the front panel of the label, and also in any supplemental labeling intended to accompany the product in distribution or sale.

(2) Statements elsewhere on label. Hazard and precautionary statements not required on the front panel may appear on other panels of the label, and may be required also in supplemental labeling. These include, but are not limited to, the human hazard and precautionary statements, domestic animal statements if applicable, a Note to Physician, and physical or chemical hazard statements.

(b) Placement and prominence—(1) Front panel statements. All required front panel warning statements shall be grouped together on the label, and shall appear with sufficient prominence relative to other front panel text and graphic material to make them unlikely to be overlooked under customary conditions of purchase and use. The table below shows the minimum type size requirements for the front panel warning statements for various front panel sizes.

(2) Other required statements. All other hazard and precautionary statements must be at least 6 point type.

§ 156.62 Toxicity Category.

This section establishes four Toxicity Categories for acute hazards of pesticide products, Category I being the highest toxicity category. Most human hazard, precautionary statements, and human personal protective equipment statements are based upon the Toxicity Category of the pesticide product as sold or distributed. In addition, toxicity categories may be used for regulatory purposes other than labeling, such as classification for restricted use and requirements for child-resistant packaging. In certain cases, statements based upon the Toxicity Category of the product as diluted for use are also permitted. A Toxicity Category is assigned for each of five types of acute exposure, as specified in the table in this paragraph.

§ 156.64 Signal word.

(a) Requirement. Except as provided in paragraph (a)(4), each pesticide product must bear on the front panel a signal word, reflecting the highest Toxicity Category (Category I is the highest toxicity category) to which the product is assigned by any of the five routes of exposure in § 156.62. The signal word must also appear together with the heading for the human precautionary statement section of the labeling (see § 156.70).

(1) Toxicity Category I. Any pesticide product meeting the criteria of Toxicity Category I for any route of exposure must bear on the front panel the signal word “DANGER.” In addition, if the product is assigned to Toxicity Category I on the basis of its oral, inhalation or dermal toxicity (as distinct from skin and eye irritation), the word “Poison” must appear in red on a background of distinctly contrasting color, and the skull and crossbones symbol must appear in immediate proximity to the word “Poison.”

(2) Toxicity Category II. Any pesticide product meeting the criteria of Toxicity Category II as the highest category by any route of exposure must bear on the front panel the signal word “WARNING.”

(3) Toxicity Category III. Any pesticide product meeting the criteria of Toxicity Category III as the highest category by any route of exposure must bear on the front panel the signal word “CAUTION.”

(4) Toxicity Category IV. A pesticide product meeting the criteria of Toxicity Category IV by all routes of exposure is not required to bear a signal word. If a signal word is used, it must be “CAUTION.”

(b) Use of signal words. In no case may a product:

(1) Bear a signal word reflecting a higher Toxicity Category than indicated by the route of exposure of highest toxicity, unless the Agency determines that such labeling is necessary to prevent unreasonable adverse effects on man or the environment;

(2) Bear a signal word reflecting a lesser Toxicity Category associated with a diluted product. Although precautionary statements for use dilutions may be included on label, the signal word must reflect the toxicity of the product as distributed or sold; or

(3) Bear different signal words on different parts of the label.

§ 156.66 Child hazard warning.

(a) Each pesticide product must bear on the front panel of the label the statement “Keep Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear on a separate line in close proximity to the signal word, if required. The statement is required on Toxicity Category IV products that do not otherwise require a signal word.

(b) In its discretion, EPA may waive the requirement, or require or permit an alternative child hazard warning, if:

(1) The applicant can demonstrate that the likelihood of exposure of children to the pesticide during distribution, marketing, storage or use is remote (for example, an industrial use product); or

(2) The pesticide is approved for use on children (for example, an insect repellent).

(c) EPA may approve an alternative child hazard warning that more appropriately reflects the nature of the pesticide product to which children may be exposed (for example, an impregnated pet collar). In this case, EPA may also approve placement on other than the front panel.

§ 156.68 First aid statement.

(a) Product as sold and distributed. Each product must bear a first aid statement if the product has systemic effects in Category I, II, or III, or skin or eye irritation effects in Category I or II.

(b) Product as diluted for use. If the product labeling bears directions for dilution with water prior to use, the label may also include a statement describing how the first aid measures may be modified for the diluted product. Such a statement must reflect the Toxicity Category(ies) of the diluted product, based upon data for the route of exposure (or calculations if appropriate). If the labeling provides for a range of use dilutions, only that use dilution representing the highest concentration allowed by labeling may be used as the basis for a statement pertaining to the diluted product. The statement for a diluted product may not substitute for the statement for the concentrate, but augments the information provided for the concentrate.

(c) Heading. The heading of the statement may be “First Aid” or “Statement of Practical Treatment.”

(d) Location of first aid statement. The first aid statement must appear on the front panel of the label of all products assigned to Toxicity Category I by any route of exposure. Upon review, the Agency may permit reasonable variations in the placement of the first aid statement if a reference such as “See first aid statement on back panel” appears on the front panel. The first aid statement for products assigned to Toxicity Categories II or III may appear on any panel of the label.

§ 156.70 Precautionary statements for human hazards.

(a) Requirement. Human hazard and precautionary statements as required must appear together on the label or labeling under the general heading “Precautionary Statements” and under appropriate subheadings similar to “Humans and Domestic Animals,” “Environmental Hazards” (see subpart E of this part) and “Physical or Chemical Hazards.” The phrase “and Domestic Animals” may be omitted from the heading if domestic animals will not be exposed to the product.

(b) Content of statements. When data or other information show that an acute hazard may exist to humans or domestic animals, the label must bear precautionary statements describing the particular hazard, the route(s) of exposure and the precautions to be taken to avoid accident, injury or toxic effect or to mitigate the effect. The precautionary paragraph must be immediately preceded by the appropriate signal word.

(c) Typical precautionary statements. The table below presents typical hazard and precautionary statements. Specific statements pertaining to the hazards of the product and its uses must be approved by the Agency. With Agency approval, statements may be augmented to reflect the hazards and precautions associated with the product as diluted for use. Refer to § 156.68(b) for requirements for use dilution statements.

§ 156.78 Precautionary statements for physical or chemical hazards.

(a) Requirement. Warning statements on the flammability or explosive characteristics of the pesticide product are required if a product meets the criteria in this section. Warning statements pertaining to other physical/chemical hazards (e.g., oxidizing potential, conductivity, chemical reactions leading to production of toxic substances) may be required on a case-by-case basis.

(b) Pressurized products. The table below sets out the required flammability label statements for pressurized products.

(c) Non-pressurized products. The table below sets out the required flammability label statements for non-pressurized products.

(d) Total release fogger products. (1) A total release fogger is defined as a pesticide product in a pressurized container designed to automatically release the total contents in one operation, for the purpose of creating a permeating fog within a confined space to deliver the pesticide throughout the space.

(2) If a pesticide product is a total release fogger containing a propellant with a flash point at or below 20 °F, then the following special instructions must be added to the “Physical and Chemical Hazards” warning statement, in addition to any flammability statement required by paragraph (b) of this section:

This product contains a highly flammable ingredient. It may cause a fire or explosion if not used properly. Follow the Directions for Use on this label very carefully.

(3) A graphic symbol depicting fire, such as illustrated in this paragraph, or an equivalent symbol, must be displayed along with the required language adjoining the “Physical and Chemical Hazards” warning statement. The graphic symbol must be no smaller than twice the size of the first character of the human hazard signal word.

Highly Flammable Ingredient

Ingrediente Altamente Inflamable

Subpart E—Environmental Hazard and Precautionary Statements

Source:66 FR 64767, Dec. 14, 2001, unless otherwise noted.

§ 156.80 General.

(a) Requirement. Each product is required to bear hazard and precautionary statements for environmental hazards, including hazards to non-target organisms, as prescribed in this subpart. Hazard statements describe the type of hazard that may be present, while precautionary statements direct or inform the user of actions to take to avoid the hazard or mitigate its effects.

(b) Location of statements. Environmental hazard and precautionary statements may appear on any panel of the label and may be required also in supplemental labeling. The environmental hazard statements must appear together under the heading “Environmental Hazards.” Typically the statements are grouped as a sub-category within the “Precautionary Statements” section of the labeling.

(c) Type size. All environmental hazard and precautionary statements must be at least 6 point type.

§ 156.85 Non-target organisms.

(a) Requirement. Where a hazard exists to non-target organisms, EPA may require precautionary statements of the nature of the hazard and the appropriate precautions to avoid potential accident, injury, or damage.

(b) Examples. The statements in this paragraph illustrate the types of hazard statements that EPA may require and the circumstances under which they are typically required. These statements are not comprehensive; other statements may be required if more appropriate to the formulation or use.

(1) If a pesticide intended for outdoor use contains an active ingredient with a mammalian acute oral LD50 of 100 mg/kg or less, the statement, “This pesticide is toxic to wildlife” is required.

(2) If a pesticide intended for outdoor use contains an active ingredient with a fish acute LC50 of 1 ppm or less, the statement, “This pesticide is toxic to fish” is required.

(3) If a pesticide intended for outdoor use contains an active ingredient with an avian acute oral LD50 of 100 mg/kg or less, or a subacute dietary LC50 of 500 ppm or less, the statement, “This pesticide is toxic to wildlife” is required.

(4) If either accident history or field studies demonstrate that the use of the pesticide may result in fatality to birds, fish or mammals, the statement, “This pesticide is extremely toxic to wildlife (fish)” is required.

(5) If a product is intended for or involves foliar application to agricultural crops, forests or shade trees, or mosquito abatement treatments, and contains a pesticide toxic to pollinating insects, the label must bear appropriate label cautions.

(6) If a product is intended for outdoor use other than aquatic applications, the label must bear the caution, “Keep out of lakes, ponds or streams. Do not contaminate water by cleaning of equipment or disposal of wastes.”

Subparts F-G [Reserved]

Subpart H—Container Labeling

Source:71 FR 47420, Aug. 16, 2006, unless otherwise noted.

§ 156.140 Identification of container types.

For products other than plant-incorporated protectants, the following statements, as applicable, must be placed on the label or container. The information may be located on any part of the container except the closure. If the statements are placed on the container, they must be durably marked on the container. Durable marking includes, but is not limited to etching, embossing, ink jetting, stamping, heat stamping, mechanically attaching a plate, molding, or marking with durable ink.

(a) Nonrefillable container. For nonrefillable containers, the statements in paragraphs (a)(1) through (a)(4) of this section are required except as provided in paragraphs (a)(5), (c), (d), and (e) of this section. If placed on the label, the statements in paragraphs (a)(1) through (a)(3) of this section must be under an appropriate heading under the heading “Storage and Disposal.” If any of the statements in paragraphs (a)(1) through (a)(3) of this section are placed on the container, an appropriate referral statement such as “See container for recycling [or other descriptive word] information.” must be placed on the label under the heading “Storage and Disposal.”

(1) Statement identifying a nonrefillable container. The following phrase is required: “Nonrefillable container.”

(2) Reuse statement. One of the following statements is required. Products with labels that allow household/residential use must use the statement in paragraph (a)(2)(i) or (a)(2)(iii) of this section. All other products must use the statement in paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of this section.

(i) “Do not reuse or refill this container.”

(ii) “Do not reuse this container to hold materials other than pesticides or dilute pesticides (rinsate). After emptying and cleaning, it may be allowable to temporarily hold rinsate or other pesticide-related materials in the container. Contact your state regulatory agency to determine allowable practices in your state.”

(iii) The following statement may be used if a product is “ready-to-use” and its directions for use allow a different product (that is a similar, but concentrated formulation) to be poured into the container and diluted by the end user: “Do not reuse or refill this container unless the directions for use allow a different (concentrated) product to be diluted in the container.”

(3) Recycling or reconditioning statement. One of the following statements is required:

(i) “Offer for recycling if available.”

(ii) “Once cleaned, some agricultural plastic pesticide containers can be taken to a container collection site or picked up for recycling. To find the nearest site, contact your chemical dealer or manufacturer or contact [a pesticide container recycling organization] at [phone number] or [web site]. For example, this statement could be “Once cleaned, some agricultural plastic pesticide containers can be taken to a container collection site or picked up for recycling. To find the nearest site, contact your chemical dealer or manufacturer or contact the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free) or www.acrecycle.org.”

(iii) A recycling statement approved by EPA and published in an EPA document, such as a Pesticide Registration Notice.

(iv) An alternative recycling statement that has been reviewed and approved by EPA.

(v) “Offer for reconditioning if appropriate.”

(4) Batch code. A lot number, or other code used by the registrant or producer to identify the batch of the pesticide product which is distributed and sold is required.

(5) Exemptions. Pesticide products in the following types of nonrefillable containers, and their packaging, are exempt from the requirements in paragraphs (a)(1) and (a)(2) of this section:

(i) Aerosol cans.

(ii) Devices as defined in § 152.500 of this chapter.

(iii) One-time use caulking tubes and other one-time use squeezable tube containers for paste, gel, or other similar substances.

(iv) Foil packets for water soluble packaging, repellent wipes, and other one-time use products.

(v) One-time use portion control packets, such as polyethylene sleeve packages, or rodenticide placepacks.

(vi) One-time use bait stations.

(vii) One-time use cages for repellent or trapping strips.

(viii) Pet collars or animal ear tags, such as cattle ear tags.

(ix) One-time use semiochemical dispersion devices.

(x) Any container that is destroyed by the use of the product contained.

(xi) Any container that would be destroyed if reuse of the container were attempted.

(b) Refillable container. For refillable containers, one of the following statements is required, except as provided in paragraphs (c), (d), and (e) of this section. If placed on the label, the statement must be under the heading “Storage and Disposal.” If the statement is placed on the container, an appropriate referral statement, such as “Refilling limitations are on the container.” must be placed under the heading “Storage and Disposal.”

(1) “Refillable Container. Refill this container with pesticide only. Do not reuse this container for any other purpose.”

(2) “Refillable Container. Refill this container with [common chemical name] only. Do not reuse this container for any other purpose.”

(c) Modification. EPA may, on its own initiative or based on data or information submitted by any person, modify or waive the requirements of this section or permit or require alternative labeling statements.

(d) Exemption for articles. Pesticidal articles that are not exempted from FIFRA regulation by § 152.25(a) of this chapter are exempt from the requirements of this section.

(e) Exemption for transport vehicles. Transport vehicles are exempt from the requirements of this section.

[71 FR 47420, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]

§ 156.144 Residue removal instructions—general.

(a) General. Except as provided by paragraphs (c) through (g) of this section, the label of each pesticide product must include the applicable instructions for removing pesticide residues from the container prior to container disposal that are specified in § 156.146 and § 156.156. The residue removal instructions are required for both nonrefillable and refillable containers.

(b) Placement of residue removal statements. All residue removal instructions must be placed under the heading “Storage and Disposal.”

(c) Exemption for residential/household use products. Residential/household use pesticide products are exempt from the residue removal instruction requirements in this section through § 156.156.

(d) Modification. EPA may, on its own initiative or based on data submitted by any person, modify or waive the requirements of this section through § 156.156, or permit or require alternative labeling statements.

(e) Exemption for gases. Pesticide products that are gaseous at atmospheric temperature and pressure are exempt from the residue removal instruction requirements in this section through § 156.156.

(f) Exemption for articles. Pesticidal articles that are not exempted from FIFRA regulation by § 152.25(a) of this chapter are exempt from the residue removal instruction requirements in this section through § 156.156.

(g) Exemption for transport vehicles. Transport vehicles are exempt from the requirements in this section through § 156.156.

[71 FR 47420, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]

§ 156.146 Residue removal instructions for nonrefillable containers—rigid containers with dilutable pesticides.

The label of each dilutable (liquid or solid) pesticide product packaged in a rigid nonrefillable container must include the following residue removal instructions as appropriate.

(a) Timing of the residue removal procedure. One of the following statements must immediately precede the instructions required in paragraph (b) of this section and must be consistent with the instructions in paragraphs (b) and (c) of this section:

(1) “Clean container promptly after emptying.”

(2) “Triple rinse or pressure rinse container (or equivalent) promptly after emptying.”

(3) “Triple rinse container (or equivalent) promptly after emptying.”

(b) Triple rinse instructions. The label of each dilutable pesticide product packaged in rigid nonrefillable containers must include one of the following sets of instructions.

(1) For liquid dilutable pesticide products in containers small enough to shake, use the following instructions: “Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container 1/4 full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times.”

(2) For solid dilutable pesticide products in containers small enough to shake, use the following instructions: “Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank. Fill the container 1/4 full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times.”

(3) For containers that are too large to shake, use the following instructions: “Triple rinse as follows: Empty remaining contents into application equipment or a mix tank. Fill the container 1/4 full with water. Replace and tighten closures. Tip container on its side and roll it back and forth, ensuring at least one complete revolution, for 30 seconds. Stand the container on its end and tip it back and forth several times. Turn the container over onto its other end and tip it back and forth several times. Empty the rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Repeat this procedure two more times.”

(c) Pressure rinse instructions. The label of each dilutable pesticide product packaged in rigid nonrefillable containers may include one of the following sets of instructions, and one of them must be used if the statement in paragraph (a)(2) of this section is used. If one of these statements is included on the label, it must immediately follow the triple rinse instructions specified in paragraph (b) of this section.

(1) For liquid dilutable pesticide products, use the following label instruction: “Pressure rinse as follows: Empty the remaining contents into application equipment or a mix tank and continue to drain for 10 seconds after the flow begins to drip. Hold container upside down over application equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container, and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the flow begins to drip.”

(2) For solid dilutable pesticide products, use the following label instruction: “Pressure rinse as follows: Empty the remaining contents into application equipment or a mix tank. Hold container upside down over application equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container, and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the flow begins to drip.”

(d) Non-water diluent. (1) A registrant who wishes to require users to clean a container with a diluent other than water (e.g., solvents) must submit to EPA a written request to modify the residue removal instructions of this section. The registrant may not distribute or sell the pesticide with the modified residue removal instructions until EPA approves the request in writing.

(2) The registrant must indicate why a non-water diluent is necessary for efficient residue removal, and must propose residue removal instructions and disposal instructions that are appropriate for the characteristics and formulation of the pesticide product and non-water diluent. The proposed residue removal instructions must identify the diluent. If the Directions for Use permit the application of a mixture of the pesticide and the non-water diluent, the instructions may allow the rinsate to be added to the application equipment or mix tank. If the Directions for Use do not identify the non-water diluent as an allowable addition to the pesticide, the instructions must require collection and storage of the rinsate in a rinsate collection system.

(3) EPA may approve the request if EPA finds that the proposed instructions are necessary and appropriate.

§ 156.156 Residue removal instructions for refillable containers.

The label of each pesticide product packaged in a refillable container must include the residue removal instructions in this section. Instructions must be given for all pesticide products that are distributed or sold in refillable containers, including those that do not require dilution prior to application.

(a) Timing of the residue removal procedure. One of the following statements must immediately precede the instructions required in paragraph (b) of this section and must be consistent with the instructions in paragraph (b) of this section:

(1) “Cleaning the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller.”

(2) “Pressure rinsing the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller.”

(b) Residue removal instructions prior to container disposal. (1) Instructions for cleaning each refillable container prior to disposal are required. The residue removal instructions must be appropriate for the characteristics and formulation of the pesticide product and must be adequate to protect human health and the environment.

(2) Subject to meeting the standard in paragraph (b)(1) of this section, the statement on residue removal instructions could include any one of the following:

(i) The refilling residue removal procedure developed by the registrant for the pesticide product.

(ii) Standard industry practices for cleaning refillable containers.

(iii) For pesticides that require dilution prior to application, the following statement: “To clean the container before final disposal, empty the remaining contents from this container into application equipment or a mix tank. Fill the container about 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. Pour or pump rinsate into application equipment or rinsate collection system. Repeat this rinsing procedure two more times.”

(iv) Any other statement the registrant considers appropriate.

§ 156.159 Compliance date.

Any pesticide product released for shipment by a registrant after August 16, 2011 must bear a label that complies with §§ 156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146 and 156.156.

[75 FR 62326, Oct. 8, 2010]

Subparts I-J [Reserved]

Subpart K—Worker Protection Statements

Source:57 FR 38146, Aug. 21, 1992, unless otherwise noted.

§ 156.200 Scope and applicability.

(a) Scope. (1) This subpart prescribes statements that must be placed on the pesticide label and in pesticide labeling. These statements incorporate by reference the Worker Protection Standard, part 170 of this chapter. The requirements addressed in these statements are designed to reduce the risk of illness or injury resulting from workers’ and pesticide handlers’ occupational exposures to pesticides used in the production of agricultural plants on agricultural establishments as defined in § 170.3 of this chapter. These statements refer to specific workplace practices designed to reduce or eliminate exposure and to respond to emergencies that may arise from the exposures that may occur.

(2) This subpart prescribes interim requirements that must be placed on the pesticide label and in pesticide labeling. These interim requirements pertain to restricted-entry intervals, personal protective equipment, and notification. On a case-by-case basis, these interim requirements will be reviewed and may be revised during reregistration or other agency review processes.

(b) Applicability. (1) The requirements of this subpart apply to each pesticide product that bears directions for use in the production of any agricultural plant on any agricultural establishment as defined in § 170.3 of this chapter, or whose labeling reasonably permits such use.

(2) The requirements of this subpart do not apply to a product that bears directions solely for uses excepted by § 170.202(b) of this chapter.

(c) Effective dates. No product to which this subpart applies shall be distributed or sold without amended labeling by any registrant after April 21, 1994, or by any person after October 23, 1995.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]

§ 156.203 Definitions.

Terms in this subpart have the same meanings as they do in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, the following terms, as used in this subpart, shall have the meanings stated below:

Fumigant means any pesticide product that is a vapor or gas or forms a vapor or gas on application and whose method of pesticidal action is through the gaseous state.

Restricted-entry interval or REI means the time after the end of a pesticide application during which entry to the treated area is restricted.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]

§ 156.204 Modification and waiver of requirements.

(a) Modification on Special Review. If the Agency concludes in accordance with § 154.25(c) of this chapter that a pesticide should be placed in Special Review because the pesticide meets or exceeds the criteria for human health effects of § 154.7(a)(1)(2) or (6) of this chapter, the Agency may modify the personal protective equipment required for handlers or early-entry workers or both, the restricted-entry intervals, or the notification to workers requirements.

(b) Other modifications. The Agency, pursuant to this subpart and authorities granted in FIFRA sections 3, 6, and 12, may, on its initiative or based on data submitted by any person, modify or waive the requirements of this subpart, or permit or require alternative labeling statements. Supporting data may be either data conducted according to Subdivisions U or K of the Pesticide Assessments guidelines or data from medical, epidemiological, or health effects studies. A registrant who wishes to modify any of the statements required in § 156.206, § 156.208, § 156.210, or § 156.212 must submit an application for amended registration unless specifically directed otherwise by the Agency.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]

§ 156.206 General statements.

(a) Application restrictions. Each product shall bear the statement: “Do not apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application.” This statement shall be near the beginning of the DIRECTIONS FOR USE section of the labeling under the heading AGRICULTURAL USE REQUIREMENTS.

(b) 40 CFR part 170 reference statement. (1) Each product shall bear the reference statement: “Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR part 170.” This statement shall be placed on the product label under the heading AGRICULTURAL USE REQUIREMENTS.

(2) Each product shall bear the statement: “This standard contains requirements for the protection of agricultural workers on farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains requirements for training, decontamination, notification, and emergency assistance. It also contains specific instructions and exceptions pertaining to the statements on this label [in this labeling] about [use any of the following that are applicable] personal protective equipment, restricted-entry interval, and notification to workers.” These statements shall be placed immediately following the reference statement required by paragraph (b)(1) of this section, or they shall be placed in the supplemental product labeling under the heading AGRICULTURAL USE REQUIREMENTS.

(3) If the statements in paragraph (b)(2) of this section are included in supplemental labeling rather than on the label of the pesticide container, the container label must contain this statement immediately following the statement required in paragraph (b)(1) of this section: “Refer to supplemental labeling entitled AGRICULTURAL USE REQUIREMENTS in the DIRECTIONS FOR USE section of the labeling for information about this standard.”

(4) If the statements in paragraph (b)(2) of this section are included in supplemental labeling, they must be preceded immediately by the statement in paragraph (b)(1) of this section under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.

(c) Product-type identification. (1) If the product contains an organophosphate (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall be associated with the product name or product-type identification or shall be in the STATEMENT OF PRACTICAL TREATMENT or FIRST AID section of the label.

(2) If the product is a fumigant, the label shall so state. The identification shall appear:

(i) As part of the product name; or

(ii) Close to the product name, as part of the product-type identification or as a separate phrase or sentence.

(d) State restrictions. Each product shall bear the statement: “For any requirements specific to your State, consult the agency in your State responsible for pesticide regulation.” This statement shall be under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.

(e) Spanish warning statements. If the product is classified as toxicity category I or toxicity category II according to the criteria in § 156.62, the signal word shall appear in Spanish in addition to English followed by the statement, “Si Usted no entiende la etiqueta, busque a alguien para que se la explique a Usted en detalle. (If you do not understand the label, find some one to explain it to you in detail.)” The Spanish signal word “PELIGRO” shall be used for products in toxicity category I, and the Spanish signal word “AVISO” shall be used for products in toxicity category II. These statements shall appear on the label close to the English signal word.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 73 FR 75596, Dec. 12, 2008]

§ 156.208 Restricted-entry statements.

(a) Requirement. Each product with a restricted-entry interval shall bear the following statement: “Do not enter or allow worker entry into treated areas during the restricted-entry interval (REI).” This statement shall be under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.

(b) Location of specific restricted-entry interval statements. (1) If a product has one specific restricted-entry interval applicable to all registered uses of the product on agricultural plants, the restricted-entry interval for the product shall appear as a continuation of the statement required in paragraph (a) of this section and shall appear as follows: “of X hours” or “of X days” or “until the acceptable exposure level of X ppm or mg/m
3 is reached.”

(2) If different restricted-entry intervals have been established for some crops or some uses of a product, the restricted-entry statement in paragraph (b)(1) of this section shall be associated on the labeling of the product with the directions for use for each crop each use to which it applies, immediately preceded or immediately followed by the words “Restricted-entry interval” (or the letters “REI”).

(c) Restricted-entry interval based on toxicity of active ingredient—(1) Determination of toxicity category. A restricted-entry interval shall be established based on the acute toxicity of the active ingredients in the product. For the purpose of setting the restricted-entry interval, the toxicity category of each active ingredient in the product shall be determined by comparing the obtainable data on the acute dermal toxicity, eye irritation effects, and skin irritation effects of the ingredient to the criteria of § 156.62. The most toxic of the applicable toxicity categories that are obtainable for each active ingredient shall be used to determine the restricted-entry interval for that product. If no acute dermal toxicity data are obtainable, data on acute oral toxicity also shall be considered in this comparison. If no applicable acute toxicity data are obtainable on the active ingredient, the toxicity category corresponding to the signal word of any registered manufacturing-use product that is the source of the active ingredient in the end-use product shall be used. If no acute toxicity data are obtainable on the active ingredients and no toxicity category of a registered manufacturing-use product is obtainable, the toxicity category of the end-use product (corresponding to the signal word on its labeling) shall be used.

(2) Restricted-entry interval for sole active ingredient products. (i) If the product contains only one active ingredient and it is in toxicity category I by the criteria in paragraph (c)(1) of this section, the restricted-entry interval shall be 48 hours. If, in addition, the active ingredient is an organophosphorus ester that inhibits cholinesterase and that may be applied outdoors in an area where the average annual rainfall for the application site is less than 25 inches per year, the following statement shall be added to the restricted-entry interval statement: “(72 hours in outdoor areas where average annual rainfall is less than 25 inches a year).”

(ii) If the product contains only one active ingredient and it is in toxicity category II by the criteria in paragraph (c)(1) of this section, the restricted-entry interval shall be 24 hours.

(iii) If the product contains only active ingredients that are in toxicity category III or IV by the criteria in paragraph (c)(1) of this section, the restricted-entry interval shall be 12 hours.

(3) Restricted-entry interval for multiple active ingredient products. If the product contains more than one active ingredient, the restricted-entry interval (including any associated statement concerning use in arid areas under paragraph (c)(2)(i) of this section) shall be based on the active ingredient that requires the longest restricted-entry interval as determined by the criteria in this section.

(d) Exception for fumigants. The criteria for determining restricted-entry intervals in paragraph (c) of this section shall not apply to any product that is a fumigant. For fumigants, any existing restricted-entry interval (hours, days, or acceptable exposure level) shall be retained. Entry restrictions for fumigants have been or shall be established on a case-by-case basis at the time of registration, reregistration, or other Agency review process.

(e) Existing product-specific restricted-entry intervals. (1) A product-specific restricted-entry interval, based on data collected in accordance with § 158.1070 or § 161.390 of this chapter and Subdivision K of the Pesticide Assessment Guidelines, shall supersede any restricted-entry interval applicable to the product under paragraph (c) of this section.

(2) Product-specific restricted-entry intervals established for pesticide products or pesticide uses that are not covered by part 170 of this chapter shall remain in effect and shall not be placed under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.

(f) Existing interim restricted-entry intervals. (1) An interim restricted-entry interval established by the Agency before the effective date of this subpart will continue to apply unless a longer restricted-entry interval is required by paragraph (c) of this section.

(2) Existing interim restricted-entry intervals established by the Agency for pesticide products or pesticide uses not covered by part 170 of this chapter shall remain in effect and shall not be placed under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 72 FR 61028, Oct. 26, 2007; 73 FR 75596, Dec. 12, 2008]

§ 156.210 Notification-to-workers statements.

(a) Requirement. Each product that meets the requirements of paragraph (b) of this section shall bear the posting and oral notification statements prescribed below. The statements shall be in the DIRECTIONS FOR USE section of the labeling under the heading AGRICULTURAL USE REQUIREMENTS.

(b) Notification to workers of pesticide application. (1) Each product that contains any active ingredient classified as toxicity category I for either acute dermal toxicity or skin irritation potential under the criteria in § 156.62 shall bear the statement: “Notify workers of the application by warning them orally and by posting warning signs at entrances to treated areas.” If no acute dermal toxicity data are obtainable, data on acute oral toxicity of the active ingredient shall be considered instead. If no data on acute dermal toxicity, skin irritation potential, or acute oral toxicity are obtainable on the active ingredient, the toxicity category corresponding to the signal word of any registered manufacturing-use product that is the source of the active ingredient in the end-use product shall be used. If none of the applicable acute toxicity data are obtainable on the active ingredient and no toxicity category of the registered manufacturing-use product is obtainable, the toxicity category of the end-use product corresponding to the product’s signal word shall be used.

(2) Each product that is a fumigant and is registered for use in a greenhouse (or whose labeling allows use in a greenhouse) shall bear the statement: “For greenhouse applications, notify workers of the application by warning them orally and by posting warning signs outside all entrances to the greenhouse.”

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 73 FR 75596, Dec. 12, 2008]

§ 156.212 Personal protective equipment statements.

(a) Requirement. Each product shall bear the personal protective equipment statements prescribed in paragraphs (d) through (j) of this section.

(b) Exceptions. (1) If personal protective equipment were required for a product before the effective date of this subpart, the existing requirements shall be retained on the labeling wherever they are more specific or more protective (as specified in EPA guidance materials) than the requirements in the table in paragraph (e) of this section.

(2) Any existing labeling statement that prohibits the use of gloves or boots overrides the corresponding requirement in paragraph (e) of this section and must be retained on the labeling.

(3) If the product labeling contains uses that are not covered by part 170 of this chapter, the registrant may adopt the personal protective equipment required in this section for those uses. However, if the personal protective equipment required in this section would not be sufficiently protective or would be onerously overprotective for uses not covered by part 170 of this chapter, the registrant must continue to apply the existing personal protective equipment requirements to those uses. The labeling must indicate which personal protective equipment requirements apply to uses covered by part 170 of this chapter and which personal protective equipment requirements apply to other uses.

(c) Location of personal protective equipment statements—(1) Personal protective equipment statements for pesticide handlers. Personal protective equipment statements for pesticide handlers shall be in the HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) section of the labeling. The required statements may be combined to avoid redundancy as long as the requirements and conditions under which they apply are identified.

(2) Personal protective equipment statements for early-entry workers. Personal protective equipment statements for early-entry workers shall be placed in the DIRECTIONS FOR USE section of the labeling under the heading AGRICULTURAL USE REQUIREMENTS and immediately after the restricted-entry statement required in § 156.208(a).

(d) Personal protective equipment statements for pesticide handlers. (1) The table in paragraph (e) of this section specifies minimum requirements for personal protective equipment (as defined in § 170.240 of this chapter) and work clothing for pesticide handlers. This personal protective equipment requirement applies to any product that presents a hazard through any route of exposure identified in the table (acute dermal toxicity, skin irritation potential, acute inhalation toxicity, and eye irritation potential).

(2) The requirement for personal protective equipment is based on the acute toxicity category of the end-use product for each route of exposure as defined by § 156.62. If data to determine the acute dermal toxicity or the acute inhalation toxicity are not obtainable, the acute oral toxicity shall be used as a surrogate to determine the personal protective equipment requirements for that route of exposure. If data to determine the acute toxicity of the product by a specific route of exposure (including acute oral toxicity in lieu of acute dermal or acute inhalation toxicity) are not obtainable, the toxicity category corresponding to the signal word of the end-use product shall be used to determine personal protective equipment requirements for that route of exposure. If the signal word is “CAUTION,” toxicity category III will be used.

(3) The minimum personal protective equipment and work clothing requirements specified in this section shall be included in a statement such as the following: “Applicators and other handlers must wear: (body protection statement); (glove statement, if applicable); (footwear statement, if applicable); (protective eyewear statement, if applicable); (respirator statement, if applicable).” The format of statements given in this paragraph is optional, but it is recommended for clarity.

(e) Summary of personal protective equipment requirements. The following table 1 summarizes the personal protective equipment requirements by route of exposure and toxicity category:

(f) Chemical-resistant gloves labeling statements for pesticide handlers. If the table in paragraph (e) of this section indicates that chemical-resistant gloves are required, the glove statement shall be as specified in paragraph (f)(2), (3), (4), or (5) of this section.

(1) Exception. The registrant shall specify a glove type other than that selected through the criteria in paragraphs (f)(2) through (5) of this section if information available to the registrant indicates that such a glove type is more appropriate or more protective than the glove type specified in this section. The statement must specify the particular types of chemical-resistant glove (such as nitrile, butyl, neoprene, and/or barrier-laminate).

(2) Solid formulations. For products formulated and applied as solids or formulated as solids and diluted solely with water for application, the glove statement shall specify: “waterproof gloves.”

(3) Aqueous-based formulations. For products formulated and applied as a water-based liquid or formulated as a water-based liquid and diluted solely with water for application, the glove statement may specify: “waterproof gloves” instead of the statement in paragraph (f)(4) of this section.

(4) Other liquid formulations. For products formulated or diluted with liquids other than water, the glove statement shall specify: “chemical-resistant (such as nitrile or butyl) gloves.”

(5) Gaseous formulations and applications. For products formulated or applied as gases, any existing glove statement established before the effective date of this subpart, including any glove prohibition statement, will continue to apply. If no glove statement or glove prohibition now exists, the glove statement shall specify “chemical-resistant (such as nitrile or butyl) gloves.”

(g) Existing respirator requirement for pesticide handlers on product labeling—(1) General requirement. If a statement placed on a product’s labeling before the effective date of this subpart indicates that respiratory protection is required, that requirement for protection shall be retained. The statement must specify, or be amended to specify, one of the following respirator types and the appropriate MSHA/NIOSH approval number prefix:

(i) Dust/mist filtering respirator with MSHA/NIOSH/ approval number prefix TC-21C; or

(ii) Respirator with an organic-vapor-removing cartridge and a prefilter approved for pesticides with MSHA/NIOSH approval number prefix TC-23C or with a canister approved for pesticides with MSHA/NIOSH approval number prefix TC-14G; or

(iii) Supplied-air respirator with MSHA/NIOSH approval number prefix TC-19C or self-contained breathing apparatus (SCBA) with MSHA/NIOSH approval number TC-13F.

(2) Respirator type already specified on labeling. If the existing respiratory protection requirement specifies a respirator type, it shall be retained. The respirator statement must be revised, if necessary, to conform to the wording in paragraph (g)(1) of this section.

(3) Respirator type not already specified on labeling. If the existing respiratory protection requirement on product labeling does not specify a respirator type as listed in paragraph (g)(1) of this section, the specific respirator type shall be that required in the criteria in paragraphs (g)(3)(ii) through (vi) of this section.

(i) Exception. The registrant shall specify a different type of respiratory protection device if information, such as vapor pressure value, is available to the registrant to indicate that the type of respiratory protection device selected through the criteria in paragraphs (g)(3)(ii) through (vi) of this section would not be adequately protective, or might increase risks to the user unnecessarily.

(ii) Gases applied outdoors. For products that are formulated or applied as a gas (space and soil fumigants) and that may be used outdoors, the respiratory protection statement shall be: “For handling activities outdoors, use either a respirator with an organic-vapor-removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G).”

(iii) Gases used in enclosed areas. For products that are formulated or applied as a gas (space and soil fumigants) and that may be used in greenhouses or other enclosed areas, the respiratory protection statement shall specify: “For handling activities in enclosed areas, use either a supplied-air respirator with MSHA/NIOSH approval number prefix TC-19C, or a self-contained breathing apparatus (SCBA) with MSHA/NIOSH approval number TC-13F.”

(iv) Solids. For products that are formulated and applied as solids, the respiratory protection statement shall specify: “dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).”

(v) Liquids in toxicity category I. For products that are formulated or applied as liquids, and, as formulated, have an acute inhalation toxicity (or its surrogate as specified in paragraph (d)(2) of this section) in category I, the respiratory protection statement shall specify: “either a respirator with an organic-vapor-removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix 14G).”

(vi) Liquids in toxicity category II. For products that are formulated or applied as liquids, and, as formulated, have an acute inhalation toxicity (or its surrogate as specified in paragraph (d)(2) of this section) in category II, the respiratory protection statement shall specify: “For handling activities during (select uses applicable to the product: airblast, mistblower, pressure greater than 40 p.s.i. with fine droplets, smoke, mist, fog, aerosol or direct overhead) exposures, wear either a respirator with an organic-vapor-removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix 14G). For all other exposures, wear a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).”

(h) New respirator requirement established for pesticide handlers in this part—(1) General requirement. If the table in paragraph (e) of this section indicates a respiratory protection device is required, and existing product labeling has no respiratory protection requirement, the registrant shall add a respiratory protection statement that specifies a: “dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).”

(2) Exception. The registrant shall specify a different type of respiratory protection device if information, such as vapor pressure value, is available to the registrant to indicate that the type of respiratory protection device required in paragraph (h)(1) of this section would not be adequately protective or might increase risks to the user unnecessarily.

(i) Additional personal protective equipment requirements for pesticide handlers. In addition to the minimum personal protective equipment and work clothing requirements given in the table in paragraph (e) of this section, the labeling statement for any product in toxicity category I or II on the basis of dermal toxicity or skin irritation potential (or their surrogate as specified in paragraph (d)(2) of this section), shall include the following personal protective equipment instructions, additions, or substitutions as applicable:

(1) If the product is not ready-to-use and there is no existing requirement for a chemical-resistant suit, the following statement shall be included: “Mixers/Loaders: add a chemical-resistant apron.”

(2) If the application of the product may result in overhead exposure to any handler (for example, applicator exposure during airblast spraying of orchards or flagger exposure during aerial application), the following statement shall be included: “Overhead Exposure: wear chemical-resistant headgear.”

(3) If any type of equipment other than the product container may be used to mix, load, or apply the product, and there is no requirement for a chemical-resistant protective suit, the following statement shall be included: “For Cleaning Equipment: add a chemical-resistant apron.”

(j) Personal protective equipment for early-entry workers. This paragraph specifies minimum requirements for personal protective equipment (as defined in § 170.240 of this chapter) and work clothing for early-entry workers.

(1) For all pesticide products, add the statement: “For early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, wear: (list the body protection, glove, footwear, protective eyewear, and protective headgear, if applicable, statements specified for applicators and other handlers, but omit any respiratory protection statement).”

(2) If the body protection statement in the personal protective equipment requirement for handlers specifies a long-sleeved shirt and long pants, “coveralls” must be specified in the statement of personal protective equipment for early-entry workers.

(3) If there is no statement requiring gloves and no prohibition against gloves for applicators and other handlers under the heading HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) in the labeling, add a requirement for “waterproof gloves” in the statement of personal protective equipment for early-entry workers.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 73 FR 75596, Dec. 12, 2008]

PART 157—PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES

Authority:7 U.S.C. 136w.


Source:51 FR 21286, June 11, 1986; 51 FR 36692, Oct. 15, 1986, unless otherwise noted.

Subpart A [Reserved]

Subpart B—Child-Resistant Packaging

§ 157.20 General.

This subpart prescribes requirements for child-resistant packaging of pesticide products and devices. The requirements are established under the authority of FIFRA section 25(a)(1), which authorizes the Administrator to issue regulations to carry out the purposes of the Act, and FIFRA section 25(c)(3), which authorizes the Administrator to establish standards with respect to the package, container or wrapping in which a pesticide or device is enclosed in order to protect children and adults from serious injury or illness resulting from accidental ingestion or contact with pesticides or devices regulated under the Act.

§ 157.21 Definitions.

Terms used in this subpart shall have the following meanings:

Appropriate, when used with respect to child-resistant packaging, means that the packaging is chemically compatible with the pesticide contained therein.

Child-resistant packaging means packaging that is designed and constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time, and that is not difficult for normal adults to use properly.

Package or packaging means the immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution, sale, consumption, use or storage. The term does not include any shipping or bulk container used for transporting or delivering the pesticide unless it is the only such package.

Practicable, when used with respect to child-resistant packaging, means that the packaging can be mass produced and can be used in assembly line production.

Residential use means use of a pesticide or device:

(1) Directly on humans or pets;

(2) In, on, or around any structure, vehicle, article, surface or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles; or

(3) In or around any preschool or day care facility.

Technically feasible, when applied to child-resistant packaging, means that the technology exists to produce the child-resistant packaging for a particular pesticide.

Unit packaging means a package that is labeled with directions to use the entire contents of the package in a single application.

[51 FR 21286, June 11, 1986, as amended at 73 FR 75596, Dec. 12, 2008]

§ 157.22 When required.

Unless exempted under § 157.24, a pesticide product must be distributed and sold in child-resistant packaging complying with § 157.32 if it meets both of the following criteria:

(a) Toxicity criterion. Based upon testing with an appropriate test species, the product meets any of the following toxicity criteria:

(1) The pesticide has an acute oral LD50 of 1.5 g/kg or less;

(2) The pesticide has an acute dermal LD50 of 2000 mg/kg or less;

(3) The pesticide has an acute inhalation LC50 of 2 mg/liter or less;

(4) The pesticide is corrosive to the eye (causes irreversible destruction of ocular tissue) or causes corneal involvement or irritation persisting for 21 days or more;

(5) The pesticide is corrosive to the skin (causes tissue destruction into the dermis and/or scarring) or causes severe skin irritation (severe erythema or edema) at 72 hours; or

(6) The pesticide or device has such characteristics that, based upon human toxicological data, use history, accident data or such other evidence as is available, the Agency determines there is serious hazard of accidental injury or illness which child-resistant packaging could reduce; and

(b) Use criterion. The product’s labeling either directly recommends residential use or reasonably can be interpreted to permit residential use.

§ 157.24 Exemptions.

(a) General exemptions. The Agency hereby exempts from the requirement for child-resistant packaging the following classes of products:

(1) Products classified for restricted use. (i) A product restricted to use by or under the supervision of a certified applicator is not required to be distributed and sold in child-resistant packaging.

(ii) Notwithstanding the exemption in paragraph (a)(1)(i) of this section, the Agency may require the use of child-resistant packaging for a product classified for restricted use by or under the direct supervision of a certified applicator if the Agency determines that the product poses a risk of serious accidental injury or illness which child-resistant packaging could reduce. If the Agency makes such a determination, it will notify the registrant in writing and provide a short statement of the basis of its determination. The registrant will then have 30 days to request a hearing on the Agency’s determination. Thereafter the Agency will decide whether to require the product to be distributed only in child-resistant packaging and will notify the registrant of its decision.

(2) Products packaged in large sizes. (i) Except as provided by paragraph (a)(2)(ii) of this section, a product is not required to be in child-resistant packaging if distributed and sold in the following sizes:

(A) If the product is a solid product, regardless of pesticide type, a size of 50 pounds or greater;

(B) If the product is a liquid product intended for use in swimming pools, a size greater than 7.5 gallons by volume;

(C) If the product is a liquid product intended for any other pesticide use, a size of 5 gallons or greater by volume;

(D) If the product is packaged as an aerosol (measured by weight), regardless of pesticide type, a weight of 2 pounds or greater.

(ii) The Agency may require that a product packaged in a size exceeding that listed in paragraphs (a)(2)(i) (A) through (D) of this section be distributed and sold only in child-resistant packaging if the Agency determines that the product is, or is intended to be, distributed or sold to homeowners or other members of the general public. If the Agency makes such a determination, it will notify the registrant in writing and provide a short statement of the basis of its determination. The registrant will then have 30 days to request a hearing on the Agency’s determination. Thereafter the Agency will decide whether to require the product to be distributed only in child-resistant packaging and will notify the registrant of its decision.

(b) Exemptions requiring Agency approval. The Agency may, in accordance with paragraphs (b) (1) through (3) of this section, grant an exemption from the requirements of this subpart. An exemption may be withdrawn in accordance with paragraph (b)(4) of this section.

(1) Requesting an exemption. A request for an exemption must be submitted to the Agency, and must be accompanied by two copies of the following information:

(i) The name, address, and telephone number of the requester;

(ii) The name and registration number (or file symbol) of the product(s) for which the exemption is requested;

(iii) A description of the package and the size(s) for which the exemption is requested; and

(iv) Documentation supporting the request for exemption, including the length of time for which the exemption is requested.

(2) Exemption based upon lack of toxicity. The Agency may grant an exemption from the requirements of this subpart if the registrant or applicant demonstrates to the Agency’s satisfaction that the hazards indicated by the toxicity criteria in § 157.22(a) are not indicative of the hazards to man. If granted, an exemption shall apply to other products of substantially similar composition. A notice will be issued in the Federal Register stating the nature of and reasons for the exemption.

(3) Exemption based upon technical factors. The Agency may grant an exemption from the requirements of this subpart based upon technical considerations. If granted, the exemption will be for a specified length of time, and will apply to other products of substantially similar composition and intended uses. A notice of the granting of an exemption will be issued in the Federal Register. In considering whether to grant an exemption, the Agency will consider, among other things, the following:

(i) Whether the toxicity of the product is such that it should not be allowed to be distributed or sold except in child-resistant packaging.

(ii) Whether child-resistant packaging is technically feasible, practicable, or appropriate. An exemption may be granted if the Agency determines that any one of these criteria has not been met.

(iii) Whether the composition or use pattern of the product necessitates a particular form of packaging for proper use.

(iv) Whether child-resistant packaging that is technically feasible, practicable, and appropriate is available for the product or can reasonably be made available to the registrant in sufficient quantities to meet his packaging needs. This determination does not include a consideration of whether the packaging would be adaptable to a registrant’s existing package type or packaging equipment.

(v) Whether the registrant has made a timely and good faith effort to obtain child-resistant packaging for the product.

(vi) If child-resistant packaging which is technically feasible, practicable, and appropriate is not yet available, when such packaging is likely to be available.

(4) An exemption may be withdrawn by the Agency at any time if the lack of child-resistant packaging results in serious illnesses or injuries to children. If the Agency determines that an exemption should be withdrawn, it will notify the registrant, stating the basis for its determination. The registrant will then have 30 days to request a hearing on the Agency’s determination. Thereafter the Agency will decide whether to withdraw the exemption, and will notify the registrant of its decision.

§ 157.27 Unit packaging.

Pesticide products distributed or sold as an aggregate of one or more unit packages and meeting the criteria of § 157.22 must be distributed or sold in child-resistant packaging either for each unit package or for the outer retail container which contains the unit packages. Child-resistant packaging is not required for both the outer package and the unit packages unless the Agency determines, on a case-by-case basis, that it is necessary for risk reduction.

§ 157.30 Voluntary use of child-resistant packaging.

A registrant whose product is not required to be in child-resistant packaging may distribute or sell his pesticide product in child-resistant packaging. If he does so, that packaging must meet the standards for child-resistant packaging stated in § 157.32. The registrant must certify to this effect in accordance with § 157.34, and must retain the records required by § 157.36.

§ 157.32 Standards.

(a) Effectiveness standard. The child-resistant packaging, when tested by the protocol specified in 16 CFR 1700.20, shall meet the effectiveness specifications in 16 CFR 1700.15(b).

(b) Compatibility standard. The child-resistant packaging must continue to meet the effectiveness specifications of paragraph (a) of this section when in actual use as a pesticide container. This requirement may be satisfied by appropriate scientific evaluation of the compatibility of the substance with the child-resistant packaging to determine that the chemical and physical characteristics of the pesticide will not compromise or interfere with the proper functioning of the child-resistant packaging and that the packaging will not be detrimental to the integrity of the product during storage and use.

(c) Durability standard. The child-resistant packaging must continue to meet the effectiveness and compatibility standards of paragraphs (a) and (b) of this section for the reasonably expected lifetime of the package, taking into account the number of times the package is customarily opened and closed. This requirement may be satisfied by appropriate technical evaluation based on physical wear and stress factors of packaging, the force required for activation, and other relevant factors.

§ 157.34 Certification.

(a) General. (1) The registrant of a pesticide product required to be in child-resistant packaging shall certify to the Agency that the package meets the standards of § 157.32.

(2) Certification must be submitted with each application for new registration, if applicable. If the Agency determines, in accordance with § 157.24(a)(1)(ii), (2)(ii), or (b)(4), that a currently registered product is required to be packaged in child-resistant packaging, a certification must be submitted within 6 months after the Agency finally notifies the registrant of the requirement.

(b) Contents of certification. The certification must contain the following information:

(1) The name and EPA registration number of the product to which the certification applies, the registrant’s name and address, the date, and the name, title and signature of the company official making the certification.

(2) A statement that the packaging that is being used for the product will meet the standards of § 157.32. The statement, “I certify that the packaging that will be used for this product meets the standards of 40 CFR 157.32,” will suffice for this purpose.

§ 157.36 Recordkeeping.

For as long as the registration of a pesticide product required to be in child-resistant packaging is in effect, the registrant must retain the records listed in this section. The registrant must, upon request by the Agency, make them available to Agency representatives for inspection and copying, or must submit them to the Agency.

(a) A description of the package, including a description of:

(1) The container and its dimensions and composition.

(2) The closure or child-resistant mechanism, including the name of its manufacturer and the manufacturer’s designation for the closure or the physical working of the child-resistant packaging mechanism.

(b) A copy of the certification statement required by § 157.34.

(c) One of the following types of records verifying that each package for the product is child-resistant:

(1) Test data on the package based on the Consumer Product Safety Commission protocol in 16 CFR 1700.20.

(2) Test data, not conforming to the protocol in 16 CFR 1700.20, or a set of measurements on the package, together with an explanation as to why such data or measurements demonstrate that the package is child-resistant.

(3) Test data, whether or not conforming to the protocol in 16 CFR 1700.20, on a different package, together with an explanation of why such data demonstrate that the package being used is child-resistant.

(4) Written evidence that verifies that testing on the package has been conducted according to the protocol in 16 CFR 1700.20. Written evidence may be one of the following:

(i) A letter or literature from the packaging supplier;

(ii) A letter from the facility that conducted the testing; or

(iii) A specification in the contract between the registrant or applicant and the packaging supplier;

(5) When the container and closure are purchased separately by the registrant:

(i) Information of the kinds described in paragraphs (c) (1) through (4) of this section showing that the closure is child-resistant; and

(ii) A written explanation of why the container is child-resistant; and

(iii) Information showing that the closure and container are compatible with each other, and a written explanation of why the resulting package is child-resistant.

(6) A combination of the records listed in paragraphs (c) (1) through (5).

(d) Records verifying that the package meets the compatibility and durability standards of § 157.32(b) and (c).

[51 FR 21286, June 11, 1986; 51 FR 36692, Oct. 15, 1986, as amended at 65 FR 39304, June 26, 2000]

PART 158—DATA REQUIREMENTS FOR PESTICIDES

Authority:7 U.S.C. 136-136y; 21 U.S.C. 346a.


Source:72 FR 60957, Oct. 26, 2007, unless otherwise noted.

Subpart A—General Provisions

§ 158.1 Purpose and scope.

(a) Purpose. The purpose of this part is to specify the kinds of data and information EPA requires in order to make regulatory judgments under FIFRA secs. 3, 4, and 5 about the risks and benefits of pesticide products. Further, this part specifies the data and information needed to determine the safety of pesticide chemical residues under FFDCA sec. 408.

(b) Scope. (1) This part describes the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the reregistration of a pesticide product; support the maintenance of a pesticide registration by means of the data call-in process, e.g., as used in the registration review program; or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue.

(2) This part establishes general policies and procedures associated with the submission of data in support of a pesticide regulatory action.

(3) This part does not include study protocols, methodology, or standards for conducting or reporting test results; nor does this part describe how the Agency uses or evaluates the data and information in its risk assessment and risk management decisions, or the regulatory determinations that may be based upon the data.

(c) Scope of individual subparts. (1) Conventional pesticides. Subparts A, B, C, D, E, F, G, K, L, N, O, and R apply to conventional pesticides.

(2) Biochemical pesticides. Subparts A, B, E, R, and U apply to biochemical pesticides.

(3) Microbial pesticides. Subparts A, B, E, R, and V apply to microbial pesticides.

(4) Antimicrobial pesticides. Subparts A, B, C, D, E, R, and W of this part apply to antimicrobial pesticides.

[72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013; 87 FR 22474, Apr. 15, 2022]

§ 158.3 Definitions.

All terms defined in sec. 2 of the Federal Insecticide, Fungicide, and Rodenticide Act apply to this part and are used with the meaning given in the Act. Applicable terms from the Federal Food, Drug, and Cosmetic Act also apply to this part. Individual subparts may contain definitions that pertain solely to that subpart. The following additional terms apply to this part:

Applicant means any person or entity, including for the purposes of this part a registrant, who submits, or is required to submit, to the Agency any application, petition, or submission intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following:

(1) An application for registration or amended registration of a pesticide product under FIFRA sec. 3 or 24.

(2) A submission of data required in conjunction with reregistration of a currently registered product under FIFRA sec. 4.

(3) An application for an experimental use permit under FIFRA sec. 5.

(4) A submission of data in response to a notice issued by EPA under FIFRA sec. 3(c)(2)(B).

(5) A petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under FFDCA sec. 408.

Registration includes a new registration, amended registration and reregistration, unless stated otherwise.

§ 158.5 Applicability.

(a) The requirements of this part apply to the following submissions:

(1) An application for new or amended registration under FIFRA sec. 3 or 24.

(2) An application for experimental use permit under FIFRA sec. 5.

(3) A submission of data or information to support the continuation of a registration under FIFRA sec. 3, 4, or 24.

(4) A petition to establish, modify or revoke a tolerance or exemption from a tolerance under FFDCA sec. 408.

(b) The information specified in this part must be furnished with each submission described in paragraph (a) of this section if it has not been submitted previously, or if any previous submission is not accurate or complete.

§ 158.30 Flexibility.

(a) FIFRA provides EPA flexibility to require, or not require, data and information for the purposes of making regulatory judgments for pesticide products. EPA has the authority to establish or modify data needs for individual pesticide chemicals. The actual data required may be modified on an individual basis to fully characterize the use and properties, characteristics, or effects of specific pesticide products under review. The Agency encourages each applicant to consult with EPA to discuss the data requirements particular to its product prior to and during the registration process.

(b) The Agency cautions applicants that the data routinely required in this part may not be sufficient to permit EPA to evaluate the potential of the product to cause unreasonable adverse effects to man or the environment. EPA may require the submission of additional data or information beyond that specified in this part if such data or information are needed to appropriately evaluate a pesticide product.

(c) This part will be updated as needed to reflect evolving program needs and advances in science.

§ 158.32 Format of data submissions.

(a) General. (1) All data submitted under this part must be formatted in accordance with this section.

(2) The requirements of this section do not apply to administrative materials accompanying a data submission, including forms, labeling, and correspondence.

(b) Transmittal document. Each submission in support of a regulatory action must be accompanied by a transmittal document, which includes:

(1) Identity of the submitter.

(2) The transmittal date.

(3) Identification of the regulatory action with which the submission is associated, e.g., the registration or petition number.

(4) A list of the individual documents included in the submission.

(c) Individual documents. Unless otherwise specified by the Agency, each submission must be in the form of individual documents or studies. Previously submitted documents should not be resubmitted unless specifically requested by the Agency, but should be cited with adequate information to identify the previously submitted document. Each study or document should include the following:

(1) A title page including the following information:

(i) The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed.

(ii) The author(s) of the study.

(iii) The date the study was completed.

(iv) If the study was performed in a laboratory, the name and address of the laboratory, project numbers or other identifying codes.

(v) If the study is a commentary on or supplement to another previously submitted study, full identification of the other study with which it should be associated in review.

(vi) If the study is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and date of publication.

(2) The appropriate statement(s) regarding any data confidentiality claims as described in § 158.33.

(3) A statement of compliance or non-compliance with respect to Good Laboratory Practice Standards as required by 40 CFR 160.12, if applicable.

(4) A complete and accurate English translation must be included for any information that is not in English.

(5) A flagging statement as prescribed by § 158.34, if applicable.

§ 158.33 Confidential data.

(a) Definitions. For the purposes of this section:

(1) Registered or previously registered pesticide means any pesticide containing an active ingredient contained in a product that is, or has ever been, an active ingredient in a product registered under sec. 3 of FIFRA. A registered pesticide that is the subject of an application for a new use falls within the category of “registered or previously registered pesticide.”

(2) Safety and efficacy information means information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered or previously registered pesticide or its separate ingredients, impurities, or degradation products, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment, including, but not limited to, data on safety to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persistence, translocation and fate in the environment, and metabolism.

(b) Applicability. (1) This section applies to information submitted pursuant to this part. It supplements the general confidentiality procedures in 40 CFR part 2, subpart B, including FIFRA confidentiality procedures at 40 CFR 2.307. To the extent that provisions in this section conflict with those in 40 CFR part 2, subpart B, the provisions in this section take precedence. The provisions of 40 CFR 2.308 do not apply to information to which this section applies. In addition to complying with the requirements of this section, any confidentiality claims for information subject to 40 CFR part 174 (plant-incorporated protectants) must be substantiated at the time of submission as described in § 174.9 of this chapter.

(2) FFDCA sec. 408(i) protects confidential information submitted in connection with an application for a tolerance or exemption to the same extent as FIFRA sec. 10. References in this section to FIFRA sec. 10 are deemed to apply equally to information submitted pursuant to FFDCA sec. 408, pursuant to the authority in sec. 408(i).

(c) Method of asserting business confidentiality claims—(1) Claim required. Information to which this section applies (and which is submitted on or after the effective date of this regulation) will be deemed as not subject to a confidentiality claim unless a claim for that information is made in accordance with the procedures specified in this paragraph. Information not subject to a confidentiality claim may be made available to the public without further notice, subject to the requirements of FIFRA sec. 10(g).

(2) Statement required. Upon submission to EPA, each document must be accompanied by a signed and dated document containing either the statements in paragraph (c)(2)(i) or (ii) of this section. No claims or markings on the document or any attachments, other than these statements and attachments submitted in accordance with paragraph (c)(3) of this section, will be recognized as asserting a claim of confidentiality. The format of data submissions is set forth in § 158.32.

(i) No claim of confidentiality.

No claim of confidentiality, on any basis whatsoever, is made for any information contained in this document. I acknowledge that information not designated as within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) and which pertains to a registered or previously registered pesticide is not entitled to confidential treatment and may be released to the public, subject to the provisions regarding disclosure to multinational entities under FIFRA sec. 10(g).

(ii) Claim of confidentiality.

Information claimed as confidential has been removed to a confidential attachment.

(3) Confidential attachment. (i) All information claimed as confidential must be submitted in a separate confidential attachment to the document and cross referenced to the specific location in the document from which it was removed. The confidential attachment must have its own title page and be paginated separately from the non-confidential document.

(ii) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) manufacturing or quality control processes must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(A).

(iii) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) the details of any methods for testing, detecting, or measuring the quantity of any deliberately added inert ingredient of a pesticide, must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(B).

(iv) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) the identity or percentage quantity of any deliberately added inert ingredient of a pesticide must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(C).

(v) Information in the confidential attachment that is designated in accordance with paragraphs (c)(3)(ii) – (iv) of this section must be on a separate page from information that is not so designated.

(4) Voluntary release of information to States and foreign governments. (i) Submitters are encouraged to include with the statement required under paragraph (c)(2) of this section an additional statement to allow EPA to share information with State and foreign governments. EPA will not consider such a statement to be a waiver of confidentiality or proprietary claims for the information. The statement is as follows:

I authorize the Environmental Protection Agency to release any information contained in this document to State or foreign governments, without relinquishing proprietary rights or any confidentiality claims asserted above.

(ii) Information designated as releasable to state or foreign governments in accordance with this section may be released to such a government without further notice to the submitter. EPA will inform the State or foreign government of any of the confidentiality claims associated with the information.

(d) Release of information. (1) Safety and efficacy information that was submitted to EPA on or after May 4, 1988 and that has not been designated by the submitter as FIFRA sec. 10(d)(1)(A), (B), or (C) information in accordance with the applicable requirements of this section is not entitled to confidential treatment and may be disclosed to the public without further notice to the submitter, in accordance with paragraph (d)(2) of this section. Safety and efficacy information which has been designated by the submitter as FIFRA sec. 10(d)(1) (A), (B), or (C) information is entitled to confidential treatment only to the extent provided by FIFRA sec. 10(b), this section, and 40 CFR 2.208.

(2) Information that is not entitled to be protected as confidential in accordance with FIFRA sec. 10(b), this section and with EPA confidentiality regulations at 40 CFR part 2, subpart B, may be released to the public without the affirmation of non-multinational status provided under FIFRA sec. 10(g), provided that the information does not contain or consist of any complete unpublished report submitted to EPA, or excerpts or restatements of any such report which reveal the full methodology and complete results of the study, test, or experiment, and all explanatory information necessary to understand the methodology or interpret the results.

§ 158.34 Flagging of studies for potential adverse effects.

(a) Any applicant who submits a study of a type listed in paragraph (b) of this section must submit with the study a statement in accordance with paragraph (c) of this section.

(b) The following table indicates the study types and the criteria to be applied to each. Column 1 lists the study types by name. Column 2 lists the associated Pesticide Assessment Guideline number. Column 3 lists the criteria applicable to each type of study. Column 4 lists the reporting code to be included in the statement specified in paragraph (c) of this section when any criterion is met or exceeded.

(c) Identification of studies. For each study of a type identified in paragraph (b) of this section, the applicant shall include the appropriate one of the following two statements, together with the signature of the authorized representative of the company, and the date of signature:

(1) Study does not meet or exceed criteria.

I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study neither meets nor exceeds any of the applicable criteria.

(2) Study meets or exceeds criteria.

I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study meets or exceeds the criteria numbered [insert all applicable reporting codes].

§ 158.45 Waivers.

(a) The data requirements specified in this part as applicable to a category of products will not always be appropriate for every product in that category. Some products may have unusual physical, chemical, or biological properties or atypical use patterns which would make particular data requirements inappropriate, either because it would not be possible to generate the required data or because the data would not be useful in the Agency’s evaluation of the risks or benefits of the product. The Agency will waive data requirements it finds are inappropriate, but will ensure that sufficient data are available to make the determinations required by the applicable statutory standards.

(b)(1) Applicants are encouraged to discuss a data waiver request with the Agency before developing and submitting supporting data, information, or other materials.

(2) All waiver requests must be submitted to the Agency in writing. The request must clearly identify the data requirement(s) for which a waiver is sought along with an explanation and supporting rationale why the applicant believes the data requirement should be waived. In addition, the applicant must describe any unsuccessful attempts to generate the required data, furnish any other information which the applicant(s) believe(s) would support the request, and when appropriate, suggest alternative means of obtaining data to address the concern which underlies the data requirement.

(c) The Agency will review each waiver request and subsequently inform the applicant in writing of its decision. If the decision could apply to more than the requested product, the Agency, in its discretion, may choose to send a notice to all registrants or publish a notice in the Federal Register announcing the decision. An Agency decision denying a written request to waive a data requirement is a final Agency action.

§ 158.60 Minor use data policies.

FIFRA sec. 2(ll) defines the term “minor use”and FIFRA provides a number of statutory provisions concerning minor uses. In addition, EPA has established policies with respect to minor uses of pesticides, including, but not limited to, the following:

(a) A new data requirement pertinent to both an unregistered minor use and a registered major use will not be applied to a minor use applicant until it is applied to the major use registration.

(b) EPA will accept appropriate and adequate extrapolations and regional data to support establishment of individual minor use tolerances.

§ 158.70 Satisfying data requirements.

(a) General policy. The Agency will determine whether the data submitted or cited to fulfill the data requirements specified in this part are acceptable. This determination will be based on the design and conduct of the experiment from which the data were derived, and an evaluation of whether the data fulfill the purpose(s) of the data requirement. In evaluating experimental design, the Agency will consider whether generally accepted methods were used, sufficient numbers of measurements were made to achieve statistical reliability, and sufficient controls were built into all phases of the experiment. The Agency will evaluate the conduct of each experiment in terms of whether the study was conducted in conformance with the design, good laboratory practices were observed, and results were reproducible. The Agency will not reject data merely because they were derived from studies which, when initiated, were in accordance with an Agency-recommended protocol, even if the Agency subsequently recommends a different protocol, as long as the data fulfill the purposes of the requirements as described in this paragraph.

(1) The provisions in this part 158 should be read in conjunction with the provisions in § 152.85 to claim eligibility for the formulators’ exemption.

(2) [Reserved]

(b) Good laboratory practices. Applicants must adhere to the good laboratory practice (GLP) standards described in 40 CFR part 160 when conducting studies. Applicants must also adhere to GLP standards when conducting a study in support of a waiver request of any data requirement which is within the scope of the GLP requirements.

(c) Agency guidelines. EPA has published Test Guidelines that contain standards for conducting acceptable tests, guidance on the evaluation and reporting of data, definition of terms, and suggested study protocols. Copies of the Test Guidelines may be obtained by visiting the agency’s website at www.epa.gov/pesticides.

(d) Study protocols—(1) General. Any appropriate protocol may be used to generate the data required by this part, provided that it meets the purpose of the test standards specified in the pesticide assessment guidelines, and provides data of suitable quality and completeness as typified by the protocols cited in the guidelines. Applicants should use the test procedure which is most suitable for evaluation of the particular ingredient, mixture, or product. Accordingly, failure to follow a suggested protocol will not invalidate a test if another appropriate methodology is used.

(2) Organization for Economic Co-Operation and Development (OECD) protocols. Tests conducted in accordance with the requirements and recommendations of the applicable OECD protocols can be used to develop data necessary to meet the requirements specified in this part. Applicants should note, however, that certain of the OECD recommended test standards, such as test duration and selection of test species, are less restrictive than those recommended by EPA. Therefore, when using OECD protocols, care should be taken to observe the test standards in a manner such that the data generated by the study will satisfy the requirements of this part.

(e) Combining studies. Certain toxicology studies may be combined to satisfy data requirements. For example, carcinogenicity studies in rats may be combined with the rat chronic toxicity study. Combining appropriate studies may be expected to reduce usage of test animals as well as reduce the cost of studies. EPA encourages this practice by including standards for acceptable combined tests in the Pesticide Assessment Guidelines. Registrants and applicants are encouraged to consider combining other tests when practical and likely to produce scientifically acceptable results. Registrants and applicants, however, must consult with the EPA before initiating combined studies.

§ 158.75 Requirements for additional data.

The data routinely required by this part may not be sufficient to permit EPA to evaluate every pesticide product. If the information required under this part is not sufficient to evaluate the potential of the product to cause unreasonable adverse effects on man or the environment, additional data requirements will be imposed. However, EPA expects that the information required by this part will be adequate in most cases for an assessment of the properties and effects of the pesticide.

§ 158.80 Use of other data.

(a) Data developed in foreign countries. With certain exceptions, laboratory and field study data developed outside the United States may be submitted in support of a pesticide registration. Data generated in a foreign country which the Agency will not consider include, but are not limited to, data from tests which involved field test sites or a test material, such as a native soil, plant, or animal, that is not characteristic of the United States. Applicants submitting foreign data must take steps to ensure that U.S. materials are used, or be prepared to supply data or information to demonstrate the lack of substantial or relevant differences between the selected material or test site and the U.S. material or test site. Once submitted, the Agency will determine whether or not the data meet the data requirements.

(b) Data generated for other purposes. Data developed for purposes other than satisfaction of FIFRA data requirements, such as monitoring studies, may also satisfy data requirements in this part. Consultation with the Agency should be arranged if applicants are unsure about suitability of such data.

Subpart B—How To Use Data Tables

§ 158.100 Pesticide use patterns.

(a) General use patterns for conventional, biochemical, and microbial pesticides. There are six broad use categories used in the data tables. The six broad categories include terrestrial outdoor uses, aquatic outdoor uses, greenhouse uses, forestry uses, residential outdoor uses, and indoor uses of all types. The 6 broad use categories are further subdivided into 12 general use patterns which are the bases for data requirements established by use pattern. Within the data tables, general use patterns have been combined into single columns when the data requirements are the same for the combined uses. If there are no data requirements for a specific use, the column for that use is not included in the table. The 12 general use pattern groups used in the data table in this part are:

(1) Terrestrial food crop use.

(2) Terrestrial feed crop use.

(3) Terrestrial nonfood crop use.

(4) Aquatic food crop use.

(5) Aquatic nonfood use.

(6) Greenhouse food crop use.

(7) Greenhouse nonfood crop use.

(8) Forestry use.

(9) Residential outdoor use.

(10) Residential indoor use.

(11) Indoor food use.

(12) Indoor nonfood use.

(b) Pesticide use site index for conventional, biochemical, and microbial pesticides. The Pesticide Use Site Index for Conventional, Biochemical, and Microbial Pesticides is a comprehensive list of specific pesticide use sites. The index is alphabetized separately by site for all agricultural and all nonagricultural uses. The Pesticide Use Site Index associates each pesticide use site with one or more of the 12 general use patterns. It may be used in conjunction with the data tables to determine the applicability of data requirements to specific uses. The Pesticide Use Site Index for Conventional, Biochemical, and Microbial Pesticides will be updated periodically, and is available from the Agency or may be obtained from the Agency’s Web site at http://www.epa.gov/pesticides.

(c) Antimicrobial pesticide use patterns. The general use patterns for antimicrobial pesticides are described in § 158.2201.

(d) Pesticide use site index for antimicrobial pesticides. The Pesticide Use Site Index for Antimicrobial Pesticides is a comprehensive list of specific antimicrobial use sites. The index is alphabetized by antimicrobial use sites, and associates each antimicrobial use site with one or more of the antimicrobial use patterns. It may be used in conjunction with the data tables to determine the applicability of data requirements to specific uses. The Pesticide Use Site Index for Antimicrobial Pesticides will be updated periodically, and is available from the Agency or may be obtained from the Agency’s Web site at http://www.epa.gov/pesticides.

(e) Determination of use pattern. Applicants unsure of the correct use pattern for their particular product should consult the Agency.

[72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013]

§ 158.110 Required and conditionally required data.

The tables in this part use the descriptors R (required), CR (conditionally required), and NR (not required) as a general indication of the applicability of a data requirement. In all cases, the test notes referred to in the table must be consulted to determine the actual applicability of the data requirement.

(a) EPA requires data designated as “required”(R) for products with a given use pattern in order to evaluate the risks or benefits of a product having that use pattern under any conditions established by the test notes.

(b) Data designated as “conditionally required” (CR) for products with a given use pattern are required by EPA to evaluate the risks or benefits of a product having that use pattern if the product meets the conditions specified in the notes accompanying the requirement. The determination of whether the data must be submitted is based on the product’s use pattern, physical or chemical properties, expected exposure of nontarget organisms, and/or results of previous testing (for example, tier testing). Applicants must evaluate each applicable test note for the conditions and criteria to be considered in determining whether conditionally required data must be submitted.

(c) Data not required for the Agency’s assessment of the risks and benefits of a particular use pattern are designated “not required” (NR) in data tables.

§ 158.120 Determining data requirements.

As with current practice, the actual data and studies required may be modified on an individual basis to fully characterize the use and properties of specific pesticide products under review. While EPA is attempting to assist the applicant in this subpart, it is important to emphasize that it is the applicant’s obligation under FIFRA to demonstrate that an individual product meets the standard under FIFRA and/or FFDCA. Accordingly, applicants are encouraged to consult with the Agency on the appropriate data requirements as set forth here as they relate to their specific product prior to and during the registration process.

(a) Finding the appropriate data table. (1) Pesticide data requirements for conventional chemical active ingredients and related substances are presented in subparts D, E, F, G, K, L, N, and O of this part in the form of a series of data tables, each addressing a particular scientific discipline or data topic. Data requirements for biochemical and microbial pest control agents are contained and are described separately within subparts U and V of this part, respectively.

(2) Key to table notations. R = required data; CR = conditionally required data; NR = Not required; MP = manufacturing-use product; EP = end-use product; TEP = typical end-use product; TGAI = technical grade of the active ingredient; PAI = pure active ingredient; PAIRA = pure active ingredient, radiolabeled; Choice = choice of several test substances depending on studies required.

(b) Identifying required studies. To determine the specific kinds of data needed to support the registration use of each pesticide product, the applicant may:

(1) Refer to the applicable subpart(s) of this part. These subparts describe the data requirements including data tables for each subject area.

(2) Select the general use pattern(s) that best cover the use pattern(s) specified on the pesticide product label as explained in § 158.100. All applicable use patterns must be included.

(3) Proceed down the appropriate general use pattern column in the table and note which tests are required (R), conditionally required (CR), or not required (NR). Required and conditionally required studies are described in § 158.110.

(4) Review the notes for each requirement to determine its applicability to the specific product proposed for registration.

(5)(i) Proceed down the Test substance columns and determine the appropriate test substance needed for that study. If the data are intended to support a manufacturing-use product, use the MP column. If the data are intended to support an end-use product, use the EP column.

(ii) The test substances columns specify which substance is to be used for testing. Applicants should note that the substance that must be used when performing the study may or may not be the product itself. For example, the data from a certain study may be required to support the registration of an end-use product, but the test substance column may state that the particular test shall be performed using the technical grade of the active ingredient(s) in the end-use product.

(iii) Manufacturing-use products (MP) and end-use products (EP) containing a single active ingredient and no intentionally added inert ingredients are considered identical in composition to each other, and to the technical grade of the active ingredient (TGAI) from which they were derived. Therefore, the data from a test conducted using any one of these as the test substance is also suitable to meet the requirement (if any) for the same test to be conducted using either of the other substances.

(6) Refer to the Pesticide Assessment Guideline reference number for each study located in the first column. See § 158.70(c) for information pertaining to the guidelines and how to obtain copies.

§ 158.130 Purposes of the registration data requirements.

(a) General. The data requirements for registration are intended to generate data and information necessary to address concerns pertaining to the identity, composition, potential adverse effects and environmental fate of each pesticide.

(b) Product chemistry—(1) Product composition. Data on product composition are needed:

(i) To support the conclusions expressed in the statement of formula;

(ii) To compare to the composition of materials used in required testing under this part; and

(iii) To determine whether a product is “identical or substantially similar”to another product, a determination that involves the comparison of product composition.

(2) Nominal concentration and certified limits. The nominal concentration of a product, defined as that concentration that is expected to be present in a product as a result of the production or formulation process, is used to gauge the acceptability of the certified limits, which define the outer limits of the range of the product’s ingredients. The certified limits are used to enforce the composition of the product and to ensure the accuracy of hazard assessments.

(3) Physical and chemical characteristics. The physical and chemical characteristics of an active ingredient or product are used:

(i) To confirm or provide supportive information on the identity and composition of the product;

(ii) To assess the hazards of the ingredient or product; and

(iii) To trigger or evaluate certain other studies required by this part.

(c) Product performance. Requirements to develop data on product performance provide a mechanism to ensure that pesticide products will perform as intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. Specific performance standards are used to validate the efficacy data in the public health areas, including disinfectants used to control microorganisms infectious to man in any area of the inanimate environment and those pesticides used to control vertebrates (such as rodents, birds, bats and skunks) that may directly or indirectly transmit diseases to humans.

(d) Toxicology-humans and domestic animals. Data required to assess hazards to humans and domestic animals are derived from a variety of acute, subchronic and chronic toxicity tests, and tests to assess mutagenicity and pesticide metabolism.

(1) Acute studies. Determination of acute oral, dermal and inhalation toxicity is usually the initial step in the assessment and evaluation of the toxic characteristics of a pesticide. These data provide information on health hazards likely to arise soon after, and as a result of, short-term exposure. Data from acute studies serve as a basis for classification and precautionary labeling. For example, acute toxicity data are used to calculate farmworker reentry intervals and to develop precautionary label statements pertaining to protective clothing requirements for applicators. They also provide information used in establishing the appropriate dose levels in subchronic and other studies; provide initial information on the mode of toxic action(s) of a substance; and determine the need for child resistant packaging. Information derived from primary eye and primary dermal irritation studies serves to identify possible hazards from exposure of the eyes, associated mucous membranes and skin.

(2) Subchronic studies. Subchronic tests provide information on health hazards that may arise from repeated exposures over a limited period of time. They provide information on target organs and accumulation potential. The resulting data are also useful in selecting dose levels for chronic studies and for establishing safety criteria for human exposure. These tests are not capable of detecting those effects that have a long latency period for expression (e.g., carcinogenicity).

(3) Chronic studies. Chronic toxicity studies (usually conducted by feeding the test substance to the test species) are intended to determine the effects of a substance in a mammalian species following prolonged and repeated exposure. Under the conditions of this test, effects which have a long latency period or are cumulative should be detected. The purpose of long-term carcinogenicity studies is to observe test animals over most of their life span for the development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of administration.

(4) Developmental toxicity and reproduction studies. The developmental toxicity study is designed to determine the potential of the test substance to induce structural and/or other abnormalities to the fetus as the result of exposure of the mother during pregnancy. Two-generation reproduction testing is designed to provide information concerning the general effects of a test substance on gonadal function, estrus cycles, mating behavior, conception, parturition, lactation, weaning, and the growth and development of the offspring. The study may also provide information about the effects of the test substance on neonatal morbidity, mortality, and preliminary data on prenatal developmental toxicity and serve as a guide for subsequent tests.

(5) Mutagenicity studies. For each test substance a battery of tests is required to assess the potential to affect the mammalian cell’s genetic components. The objectives underlying the selection of a battery of tests for mutagenicity assessment are:

(i) To detect, with sensitive assay methods, the capacity of a chemical to alter genetic material in cells.

(ii) To determine the relevance of these mutagenic changes to mammals.

(iii) When mutagenic potential is demonstrated, to incorporate these findings in the assessment of heritable effects, carcinogenicity, and, possibly, other health effects.

(6) Metabolism studies. Data from studies on the absorption, distribution, metabolism, and excretion of a pesticide aid in the valuation of test results from other toxicity studies and in the extrapolation of data from animals to man. The main purpose of metabolism studies is to produce data which increases the Agency’s understanding of the behavior of the chemical when considering the human exposure anticipated from intended uses of the pesticide.

(e) Hazards to nontarget organisms—(1) General. The information required to assess hazards to nontarget organisms is derived from tests to determine pesticidal effects on birds, mammals, fish, terrestrial and aquatic invertebrates and plants. These tests include short-term acute, subacute, reproduction, simulated field, and full field studies arranged in a hierarchical or tier system which progresses from the basic laboratory tests to the applied field tests. The results of each tier of testing must be evaluated to determine the potential of the pesticide to cause adverse effects, and to determine whether further testing is required. A purpose common to all data requirements is to provide data which determine the need for (and appropriate wording for) precautionary label statements to minimize the potential adverse effects to nontarget organisms.

(2) Short-term studies. The short-term acute and subchronic laboratory studies provide basic toxicity information which serves as a starting point for the hazard assessment. These data are used: To establish acute toxicity levels of the active ingredient to the test organisms; to compare toxicity information with measured or estimated pesticide residues in the environment in order to assess potential impacts on fish, wildlife and other nontarget organisms; and to indicate whether further laboratory and/or field studies are needed.

(3) Long-term and field studies. Additional studies (i.e., avian, fish, and invertebrate reproduction, life cycle studies and plant field studies) may be required when basic data and environmental conditions suggest possible problems. Data from these studies are used to: Estimate the potential for chronic effects, taking into account the measured or estimated residues in the environment; and to determine if additional field or laboratory data are necessary to further evaluate hazards. Simulated field and/or field data are used to examine acute and chronic adverse effects on captive or monitored fish and wildlife populations under natural or near-natural environments. Such studies are required only when predictions as to possible adverse effects in less extensive studies cannot be made, or when the potential for adverse effects is high.

(f) Applicator and post-application exposure. Data are used to evaluate exposures to persons in occupational and non-occupational settings, including agricultural, residential, commercial, institutional and recreational sites. Data include oral, dermal and inhalation exposure data, post-application residue data, post-application monitoring data, use information, and human activity information. These data, together with toxicology data, are used to determine whether application or post-application risks are of concern, and, where appropriate, to develop post-application restrictions such as reentry restrictions.

(g) Pesticide spray drift evaluation. Data required to evaluate pesticide spray drift are derived from studies of droplet size spectrum and spray drift field evaluations. These data contribute to the development of the overall exposure estimate and, along with data on toxicity for humans, fish and wildlife, or plants, are used to assess the potential hazard of pesticides to these organisms. A purpose common to all these tests is to provide data which will be used to determine the need for (and appropriate wording for) precautionary labeling to minimize the potential adverse effect to nontarget organisms.

(h) Environmental fate—(1) General. The data generated by environmental fate studies are used to: Assess the toxicity to man through exposure of humans to pesticide residues remaining after application, either upon reentering treated areas or from consuming inadvertantly-contaminated food; assess the presence of widely distributed and persistent pesticides in the environment which may result in loss of usable land, surface water, ground water, and wildlife resources; and, assess the potential environmental exposure of other nontarget organisms, such as fish and wildlife, to pesticides. Another specific purpose of the environmental fate data requirements is to help applicants and the Agency estimate expected environmental concentrations of pesticides in specific habitats where threatened or endangered species or other wildlife populations at risk are found.

(2) Degradation studies. The data from hydrolysis and photolysis studies are used to determine the rate of pesticide degradation and to identify pesticides that may adversely affect nontarget organisms.

(3) Metabolism studies. Data generated from aerobic and anaerobic metabolism studies are used to determine the nature and availability of pesticides to rotational crops and to aid in the evaluation of the persistence of a pesticide.

(4) Mobility studies. These data requirements pertain to leaching, adsorption/desorption, and volatility of pesticides. They provide information on the mode of transport and eventual destination of the pesticide in the environment. This information is used to assess potential environmental hazards related to: Contamination of human and animal food; loss of usable land and water resources to man through contamination of water (including ground water); and habitat loss of wildlife resulting from pesticide residue movement or transport in the environment.

(5) Dissipation studies. The data generated from dissipation studies are used to assess potential environmental hazards (under actual field use conditions) related to: Reentry into treated areas; hazards from residues in rotational crops and other food sources; and the loss of land as well as surface and ground water resources.

(i) Residue chemistry. (1) Residue chemistry data are used by the Agency to estimate the exposure of the general population to pesticide residues in food and for setting and enforcing tolerances for pesticide residues in food or feed.

(2) Information on the chemical identity and composition of the pesticide product, the amounts, frequency and time of the pesticide application, and results of tests on the amount of residues remaining on or in the treated food or feed, are needed to support a finding as to the magnitude and identity of residues which result in food or animal feed as a consequence of a proposed pesticide usage.

(3) Residue chemistry data are also needed to support the adequacy of one or more methods for the enforcement of the tolerance, and to support practicable methods for removing residues that exceed any proposed tolerance.

(4) Accumulation studies. Accumulation studies indicate pesticide residue levels in food supplies that originate from wild sources or from rotational crops. Rotational crop studies are necessary to establish realistic crop rotation restrictions and to determine if tolerances may be needed for residues on rotational crops. Data from irrigated crop studies are used to determine the amount of pesticide residues that could be taken up by representative crops irrigated with water containing pesticide residues. These studies allow the Agency to establish label restrictions regarding application of pesticides on sites where the residues can be taken up by irrigated crops. These data also provide information that aids the Agency in establishing any corresponding tolerances that would be needed for residues on such crops. Data from pesticide accumulation studies in fish are used to establish label restrictions to prevent applications in certain sites so that there will be minimal residues entering edible fish or shellfish. These residue data are also used to determine if a tolerance or action level is needed for residues in aquatic animals eaten by humans.

Subpart C—Experimental Use Permits

§ 158.200 Experimental use permit data requirements tables.

Sections 158.200 through 158.270 describe how to use these tables to determine the experimental use permit data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed at the end of each table. Refer to 40 CFR part 172 for further information on experimental use permits.

§ 158.210 Experimental use permit data requirements for product chemistry.

All product chemistry data, as described in § 158.310, must be submitted to support a request for an experimental use permit.

§ 158.220 Experimental use permit data requirements for product performance.

All product performance data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.

(a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use.

(2) Data are also required for forestry and residential outdoor uses.

(b) Key. CR = Conditionally required; NR = Not required; R = Required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product.

(c) Table. The following table shows the experimental use data requirements for product performance. The test notes are shown in paragraph (d) of this section.

(d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

1. The Agency has waived the requirement to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment, or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.

2. [Reserved]

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

§ 158.230 Experimental use permit data requirements for toxicology.

All toxicology data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.

(a) Use patterns. (1) Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use.

(2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use, aquatic nonfood crop use, aquatic nonfood outdoor use, greenhouse nonfood crop use, forestry use, residential outdoor use, indoor nonfood use, and indoor residential use.

(b) Key. CR = Conditionally required; NR = Not required; R = Required; EP = End-use product; MP = Manufacturing-use product; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient.

(c) Table. The following table shows the experimental use data requirements for toxicology. The test notes are shown in paragraph (d) of this section.

(d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

1. Not required if test material is a gas or a highly volatile liquid.

2. Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.

3. Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).

4. Required if repeated dermal exposure is likely to occur under conditions of use.

5. Required if the test material is an organophosphorus substance, which includes uncharged organophosphorus esters, thioesters, or anhydrides of organophosphoric, organophosphonic, or organophosphoramidic acids, or of related phosphorothioic, phosponothioic, or phosphorothioamidic acids, or is structurally related to other substances that may cause the delayed neurotoxicity sometimes seen in this class of chemicals.

6. These studies are seldom required to support EUPs. They may be required if the dietary exposure for these EUPs occupies a large part, e.g., greater than 50%, of the reference dose.

7. The oral route, by oral intubation, is preferred unless the chemical or physical properties of the test substance or the pattern of exposure suggests a more appropriate route of exposure.

8. May be combined with the 2-generation reproduction study in rodents by utilizing a second mating of the parental animals in either generation.

9. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must also be submitted.

10. Choice of assay using either:

i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;

ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate in vitro test for clastogenicity; or

iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.

11. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

§ 158.240 Experimental use permit data requirements for ecological effects.

All data for terrestrial nontarget organisms and aquatic nontarget organisms as described in § 158.243 must be submitted to support a request for an experimental use permit. No data for nontarget plant protection must be submitted to support a request for an experimental use permit.

§ 158.243 Experimental use permit data requirements for terrestrial and aquatic nontarget organisms.

All terrestrial and aquatic nontarget organism data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.

(a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use.

(2) Data are also required for the general use patterns of forestry and residential outdoor use.

(b) Key. CR = Conditionally required; NR = Not required; R = Required; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; commas between the test substances (e.g. TGAI, TEP) indicate that data may be required on the TGAI or TEP depending on the conditions set forth in the test note.

(c) Table. The following table shows the experimental use data requirements for terrestrial and aquatic nontarget organisms. The test notes are shown in paragraph (d) of this section.

(d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to, turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.

2. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support end-use products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if there is no potential for environmental exposure.

3. Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses.

4. Data are required on waterfowl and upland game bird species.

5. Data are required on one coldwater fish and one warmwater fish for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required.

6. EP or TEP testing is required for any product which meets any of the following conditions:

i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.

ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is ≥one-half the LC50 or EC50 of the TGAI when the EP is used as directed.

iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.

7. Data are required on one freshwater aquatic invertebrate species.

8. Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.

9. Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96 hour LC50 on that species must also be provided.

10. Not required when:

i. The octanol/water partition coefficients of the pesticide and its major degradates are

ii. There are no potential exposures to fish and other nontarget aquatic organisms; or

iii. The hydrolytic half-life is

11. The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. A freshwater invertebrate must also be tested with the EP or TEP using the same species tested with the TGAI.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

§ 158.250 Experimental use permit data requirements for human exposure.

No data for applicator exposure and post-application exposure must be submitted to support a request for an experimental use permit.

§ 158.260 Experimental use permit data requirements for environmental fate.

All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.

(a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes the general use patterns of aquatic food crop, aquatic nonfood residential, and aquatic nonfood outdoors. The greenhouse use pattern includes both food and nonfood uses. The indoor use pattern includes food, nonfood, and residential indoor uses.

(2) Data are also required for the general use patterns of forestry use and residential outdoor use.

(b) Key. CR = Conditionally required; NR = Not required; R = Required; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient.

(c) Table. The following table shows the experimental use data requirements for environmental fate. The test notes are shown in paragraph (d) of this section.

(d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives.

2. Required for aquatic uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to cranberry bogs and rice paddies.

3. Adsorption and desorption using a batch equilibrium method is preferred. However, in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

§ 158.270 Experimental use permit data requirements for residue chemistry.

All residue chemistry data, as described in § 158.1410, are required for an experimental use permit for which a temporary tolerance under FFDCA section 408(r) is sought. Residue chemistry data are not required for an experimental use permit issued on a crop-destruct basis.

§§ 158.280-158.290 [Reserved]

Subpart D—Product Chemistry

§ 158.300 Definitions.

The following terms are defined for the purposes of this subpart:

Active ingredient means any substance (or group of structurally similar substances, if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, defoliant, or nitrogen stabilizer, within the meaning of FIFRA sec. 2(b).

End-use product means a pesticide product whose labeling:

(1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating or regulating growth of plants, or as a nitrogen stabilizer, and

(2) does not state that the product may be used to manufacture or formulate other pesticide products.

Formulation means:

(1) The process of mixing, blending, or dilution of one or more active ingredients with one or more other active or inert ingredients, without an intended chemical reaction, to obtain a manufacturing-use product or an end-use product, or

(2) The repackaging of any registered product.

Impurity means any substance (or group of structurally similar substances if specified by the Agency), in a pesticide product other than an active ingredient or an inert ingredient, including unreacted starting materials, side reaction products, contaminants, and degradation products.

Impurity associated with an active ingredient means:

(1) Any impurity present in the technical grade of active ingredient; and

(2) Any impurity which forms in the pesticide product through reactions between the active ingredient and any other component of the product or packaging of the product.

Inert ingredient means any substance (or group of structurally similar substances if designated by the Agency), other than the active ingredient, which is intentionally included in a pesticide product.

Integrated system means a process for producing a pesticide product that:

(1) Contains any active ingredient derived from a source that is not an EPA-registered product; or

(2) Contains any active ingredient that was produced or acquired in a manner that does not permit its inspection by the Agency under FIFRA sec. 9(a) prior to its use in the process.

Manufacturing-use product means any pesticide product other than an end-use product. A product may consist of the technical grade of active ingredient only, or may contain inert ingredients, such as stabilizers or solvents.

Nominal concentration means the amount of an ingredient which is expected to be present in a typical sample of a pesticide product at the time the product is produced, expressed as a percentage by weight.

Starting material means a substance used to synthesize or purify a technical grade of active ingredient (or the practical equivalent of the technical grade ingredient if the technical grade cannot be isolated) by chemical reaction.

Technical grade of active ingredient means a material containing an active ingredient:

(1) Which contains no inert ingredient, other than one used for purification of the active ingredient; and

(2) Which is produced on a commercial or pilot plant production scale (whether or not it is ever held for sale).

§ 158.310 Product chemistry data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (f) of the section.

(b) Use patterns. Product chemistry data are required for all pesticide products and are not use-specific.

(c) Test substance. Data requirements that list only the manufacturing-use product as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added.

(d) Key. R = Required; CR = Conditionally required; MP = Manufacturing-use product; NR = Not required; EP = End-use product; TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient.

(e) Table. The following table shows the data requirements for product chemistry. The table notes are shown in paragraph (f) of this section.

(f) Test notes. The following test notes are applicable to the product chemistry data requirements in the table to paragraph (e) of this section:

1. Data must be provided in accordance with § 158.320.

2. Data must be provided in accordance with § 158.325.

3. Data must be provided in accordance with § 158.330.

4. Data must be provided in accordance with § 158.335.

5. Data must be provided in accordance with § 158.340.

6. Data must be provided in accordance with § 158.345.

7. Data must be provided in accordance with § 158.350.

8. Data must be provided in accordance with § 158.355.

9. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI.

10. Data are required if the product is produced by an integrated system.

11. Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a product produced by an integrated system when the new TGAI is first used as a formulating ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time. Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis.

12. Data on the stability to metals and metal ions are required only if the TGAI is expected to come into contact with either material.

13. Required when the product contains an oxidizing or reducing agent.

14. Required when the product contains combustible liquids.

15. Required when the product is potentially explosive.

16. Required when the product is an emulsifiable liquid and is to be diluted with petroleum solvent.

17. Required when the EP is a liquid and is to be used around electrical equipment.

18. Required when the test substance is soluble or dispersible in water.

19. Required when the product is a liquid.

20. Required when the TGAI is solid at room temperature.

21. Required when the TGAI is liquid at room temperature.

22. Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).

23. Required for water insoluble test substances (>10−6 g/l) and fibrous test substances with diameter of ≥0.1 µm.

24. Required if technical chemical is organic and non-polar.

25. Not required for salts.

26. Data on stability of the MP and TGAI to storage at normal temperatures are required. Data on the stability of the TGAI to high temperatures are required if the TGAI is expected to be subjected to temperatures >50 °C (122 °F) during production or storage.

§ 158.320 Product identity and composition.

Information on the composition of the pesticide product must be furnished. The information required by paragraphs (a), (b), and (f) of this section must be provided for each product. In addition, if the product is produced by an integrated system, the information on impurities required by paragraphs (c) and (d) of this section must be provided.

(a) Active ingredient. The following information is required for each active ingredient in the product:

(1) If the source of any active ingredient in the product is an EPA-registered product:

(i) The chemical and common name (if any) of the active ingredient, as listed on the source product.

(ii) The nominal concentration of the active ingredient in the product, based upon the nominal concentration of active ingredient in the source product.

(iii) Upper and lower certified limits of the active ingredient in the product, in accordance with § 158.350.

(2) If the source of any active ingredient in the product is not an EPA-registered product:

(i) The chemical name according to Chemical Abstracts Society (CAS) nomenclature, the CAS Registry Number, and any common names.

(ii) The molecular, structural, and empirical formulae and the molecular weight or weight range.

(iii) The nominal concentration.

(iv) Upper and lower certified limits of the active ingredient in accordance with § 158.350.

(v) The purpose of the ingredient in the formulation.

(b) Inert ingredients. The following information is required for each inert ingredient (if any) in the product:

(1) The chemical name of the ingredient according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names (if known). If the chemical identity or chemical composition of an ingredient is not known to the applicant because it is proprietary or trade secret information, the applicant must ensure that the supplier or producer of the ingredient submits to the Agency (or has on file with the Agency) information on the identity or chemical composition of the ingredient. Generally, it is not required that an applicant know the identity of each ingredient in a mixture that he uses in his product. However, in certain circumstances, the Agency may require that the applicant know the identity of a specific ingredient in such a mixture. If the Agency requires specific knowledge of an ingredient, it will notify the applicant in writing.

(2) The nominal concentration.

(3) Upper and lower certified limits in accordance with § 158.350.

(4) The purpose of the ingredient in the formulation.

(c) Impurities of toxicological significance associated with the active ingredient. For each impurity associated with the active ingredient that is determined by EPA to be toxicologically significant, the following information is required:

(1) Identification of the ingredient as an impurity.

(2) The chemical name of the impurity.

(3) The nominal concentration of the impurity in the product.

(4) A certified upper limit, in accordance with § 158.350.

(d) Other impurities associated with the active ingredient. For each other impurity associated with an active ingredient that was found to be present in any sample at a level ≥0.1 percent by weight of the technical grade active ingredient the following information is required:

(1) Identification of the ingredient as an impurity.

(2) The chemical name of the impurity.

(3) The nominal concentration of the impurity in the final product.

(e) Impurities associated with an inert ingredient. [Reserved]

(f) Ingredients that cannot be characterized. If the identity of any ingredient or impurity cannot be specified as a discrete chemical substance (such as mixtures that cannot be characterized or isomer mixtures), the applicant must provide sufficient information to enable EPA to identify its source and qualitative composition.

§ 158.325 Description of materials used to produce the product.

The following information must be submitted on the materials used to produce the product:

(a) Products not produced by an integrated system. (1) For each active ingredient that is derived from an EPA-registered product:

(i) The name of the EPA-registered product.

(ii) The EPA registration number of that product.

(2) For each inert ingredient:

(i) Each brand name, trade name, common name, or other commercial designation of the ingredient.

(ii) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and, if requested by the Agency, chemical and physical properties) of the ingredient, including a copy of technical specifications, data sheets, or other documents describing the ingredient.

(iii) If requested by the Agency, the name and address of the producer of the ingredient or, if that information is not known to the applicant, the name and address of the supplier of the ingredient.

(b) Products produced by an integrated system. (1) The information required by paragraph (a)(1) of this section concerning each active ingredient that is derived from an EPA-registered product (if any).

(2) The following information concerning each active ingredient that is not derived from an EPA-registered product:

(i) The name and address of the producer of the ingredient (if different from the applicant).

(ii) Information about each starting material used to produce the active ingredient, as follows:

(A) Each brand name, trade name, or other commercial designation of the starting material.

(B) The name and address of the person who produces the starting material or, if that information is not known to the applicant, the name and address of each person who supplies the starting material.

(C) All information that the applicant knows (or that is reasonably available to him), concerning the composition (and if requested by the Agency, chemical or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing it.

(3) The information required by paragraph (a)(2) of this section concerning each inert ingredient.

(c) Additional information. On a case-by-case basis, the Agency may require additional information on substances used in the production of the product.

§ 158.330 Description of production process.

If the product is produced by an integrated system, the applicant must submit information on the production (reaction) processes used to produce the active ingredients in the product. The applicant must also submit information about the formulation process, in accordance with § 158.335.

(a) Information must be submitted for the current production process for each active ingredient that is not derived from an EPA-registered product. If the production process is not continuous (a single reaction process from starting materials to active ingredient), but is accomplished in stages or by different producers, the information must be provided for each such production process.

(b) The following information must be provided for each process resulting in a separately isolated substance:

(1) The name and address of the producer who uses the process, if not the same as the applicant.

(2) A general characterization of the process (e.g., whether it is a batch or continuous process).

(3) A flow chart of the chemical equations of each intended reaction occurring at each step of the process, and of the duration of each step and of the entire process.

(4) The identity of the materials used to produce the product, their relative amounts, and the order in which they are added.

(5) A description of the equipment used that may influence the composition of the substance produced.

(6) A description of the conditions (e.g., temperature, pressure, pH, humidity) that are controlled during each step of the process to affect the composition of the substance produced, and the limits that are maintained.

(7) A description of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced).

(8) A description of the procedures used to assure consistent composition of the substance produced, e.g., calibration of equipment, sampling regimens, analytical methods, and other quality control methods.

§ 158.335 Description of formulation process.

The applicant must provide information on the formulation process of the product (unless the product consists solely of a technical grade of active ingredient) as required by the following sections:

(a) Section 158.330(b)(2), pertaining to characterization of the process.

(b) Section 158.330(b)(4), pertaining to ingredients used in the process.

(c) Section 158.330(b)(5), pertaining to process equipment.

(d) Section 158.330(b)(6), pertaining to the conditions of the process.

(e) Section 158.330(b)(8), pertaining to quality control measures.

§ 158.340 Discussion of formation of impurities.

The applicant must provide a discussion of the impurities that may be present in the product, and why they may be present. The discussion should be based on established chemical theory and on what the applicant knows about the starting materials, technical grade of active ingredient, inert ingredients, and production or formulation process. If the applicant has reason to believe that an impurity that EPA would consider toxicologically significant may be present, the discussion must include an expanded discussion of the possible formation of the impurity and the amounts at which it might be present. The impurities which must also be discussed are the following, as applicable:

(a) Technical grade active ingredients and products produced by an integrated system. (1) Each impurity associated with the active ingredient which was found to be present in any analysis of the product conducted by or for the applicant.

(2) Each other impurity which the registrant or applicant has reason to believe may be present in his product at any time before use at a level ≥0.1 percent (1,000 ppm) by weight of the technical grade of the active ingredient, based on what he knows about the following:

(i) The composition (or composition range) of each starting material used to produce his product.

(ii) The impurities which the applicant knows are present (or believes are likely to be present) in the starting materials, and the known or presumed level (or range of levels) of these impurities.

(iii) The intended reactions and side reactions which may occur in the production of the product, and the relative amounts of byproduct impurities produced by such reactions.

(iv) The possible degradation of the ingredients in the product after its production but prior to its use.

(v) Post-production reactions between the ingredients in the product.

(vi) The possible migration of components of packaging materials into the pesticide.

(vii) The possible carryover of contaminants from use of production equipment previously used to produce other products or substances.

(viii) The process control, purification and quality control measures used to produce the product.

(b) Products not produced by an integrated system. Each impurity associated with the active ingredient which the applicant has reason to believe may be present in the product at any time before use at a level ≥0.1 percent (1,000 ppm) by weight of the product based on what he knows about the following:

(1) The possible carryover of impurities present in any registered product which serves as the source of any of the product’s active ingredients. The identity and level of impurities in the registered source need not be discussed or quantified unless known to the formulator.

(2) The possible carryover of impurities present in the inert ingredients in the product.

(3) Possible reactions occurring during the formulation of the product between any of its active ingredients, between the active ingredients and inert ingredients, or between the active ingredient and the production equipment.

(4) Post-production reactions between any of the product’s active ingredients and any other component of the product or its packaging.

(5) Possible migration of packaging materials into the product.

(6) Possible contaminants resulting from earlier use of equipment to produce other products.

(c) Expanded discussion. On a case-by-case basis, the Agency may require an expanded discussion of information on impurities:

(1) From other possible chemical reactions.

(2) Involving other ingredients.

(3) At additional points in the production or formulation process.

§ 158.345 Preliminary analysis.

(a) If the product is produced by an integrated system, the applicant must provide a preliminary analysis of each technical grade of active ingredient contained in the product to identify all impurities present at 0. 1 percent or greater of the technical grade of the active ingredient. The preliminary analysis should be conducted at the point in the production process after which no further chemical reactions designed to produce or purify the substances are intended.

(b) Based on the preliminary analysis, a statement of the composition of the technical grade of the active ingredient must be provided. If the technical grade of the active ingredient cannot be isolated, a statement of the composition of the practical equivalent of the technical grade of the active ingredient must be submitted.

§ 158.350 Certified limits.

The applicant must propose certified limits for the ingredients in the product. Certified limits become legally binding limits upon approval of the application. Certified limits will apply to the product from the date of production to date of use. If the product label bears a statement prohibiting use after a certain date, the certified limits will apply only until that date.

(a) Ingredients for which certified limits are required. Certified limits are required on the following ingredients of a pesticide product:

(1) An upper and lower limit for each active ingredient.

(2) An upper and lower limit for each inert ingredient.

(3) If the product is a technical grade of active ingredient or is produced by an integrated system, an upper limit for each impurity of toxicological significance associated with the active ingredient and found to be present in any sample of the product.

(4) On a case-by-case basis, certified limits for other ingredients or impurities as specified by EPA.

(b) EPA determination of standard certified limits for active and inert ingredients. (1) Unless the applicant proposes different limits as provided in paragraph (c) of this section, the upper and lower certified limits for active and inert ingredients will be determined by EPA. EPA will calculate the certified limits on the basis of the nominal concentration of the ingredient in the product, according to the table in paragraph (b)(2) of this section.

(2) Table of standard certified limits.

(c) Applicant proposed limits. (1) The applicant may propose a certified limit for an active or inert ingredient that differs from the standard certified limit calculated according to paragraph (b)(2) of this section.

(2) If certified limits are required for impurities, the applicants must propose a certified limit. The standard certified limits may not be used for such substances.

(3) Certified limits should:

(i) Be based on a consideration of the variability of the concentration of the ingredient in the product when good manufacturing practices and normal quality control procedures are used.

(ii) Allow for all sources of variability likely to be encountered in the production process.

(iii) Take into account the stability of the ingredient in the product and the possible formation of impurities between production and sale or distribution.

(4) The applicant may include an explanation of the basis of his proposed certified limits, including how the certified limits were arrived at (e.g., sample analysis, quantitative estimate based on production process), and its accuracy and precision. This will be particularly useful if the range of the certified limit for an active or inert ingredient is greater than the standard certified limits.

(d) Special cases. If the Agency finds unacceptable any certified limit (either standard, or applicant proposed), the Agency will inform the registrant or applicant of its determination and will provide supporting reasons. The Agency may also recommend alternative limits to the applicant. The Agency may require, on a case-by-case basis, any or all of the following:

(1) More precise limits.

(2) More thorough explanation of how the certified limits were determined.

(3) A narrower range between the upper and lower certified limits than that proposed.

(e) Certification statement. The applicant must certify the accuracy of the information presented, and that the certified limits of the ingredients will be maintained. The following statement, signed by the authorized representative of the company, is acceptable:

I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the description of the composition of [insert product name], EPA Reg. No. [insert registration number], refers to the composition set forth on the Statement of Formula and supporting materials. This description includes the representations that: (1) no ingredient will be present in the product in an amount greater than the upper certified limit or in an amount less than the lower certified limit (if required) specified for that ingredient in a currently approved Statement of Formula (or as calculated by the Agency); and (2) if the Agency requires that the source of supply of an ingredient be specified, that all quantities of such ingredient will be obtained from the source specified in the Statement of Formula.

§ 158.355 Enforcement analytical method.

An analytical method suitable for enforcement purposes must be provided for each active ingredient in the product and for each other ingredient or impurity that the Agency determines to be toxicologically significant.

Subpart E—Product Performance for Products Claiming Effectiveness Against Vertebrate Pests, Products With Prion-Related Claims, and Products for Control of Organisms Producing Mycotoxins

§ 158.400 Product performance data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product performance data requirements for a particular pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. Data are also required for the general use patterns of forestry use, residential outdoor use, and indoor use, which includes both food and nonfood uses.

(c) Key. CR = Conditionally required; NR = Not required; R = Required; EP = End-use product; MP = Manufacturing-use product; TEP = Typical end-use product.

(d) Table. The following table lists the data requirements that pertain to product performance. The table notes are shown in paragraph (e) of this section.

(e) Test notes. The following notes appy to the data requirements table in paragraph (d) of this section.

1. The Agency has waived the requirement to submit product performance data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment, or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration.

2. [Reserved]

[72 FR 60957, Oct. 26, 2007, as amended at 78 FR 13507, Feb. 28, 2013; 78 FR 26978, May 8, 2013]

Subpart F—Toxicology

§ 158.500 Toxicology data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use the data table in paragraph (d) of this section to determine the toxicology data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test in the table are listed in paragraph (e) of this section.

(b) Use patterns. (1) Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use.

(2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use, aquatic nonfood use, greenhouse nonfood crop use, forestry use, residential outdoor use, and indoor nonfood use.

(c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active ingredient radio-labeled; Choice = Choice of several test substances depending on study required.

(d) Table. The following table lists the toxicology data requirements. The table notes are shown in paragraph (e) of this section.

(e) Test notes. The following test notes apply to the requirements in the table to paragraph (d) of this section:

1. Not required if test material is a gas or a highly volatile liquid.

2. Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under § 152.170(b) or special review consideration under § 154.7(a)(1).

3. Not required if the test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.

4. Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).

5. Required if repeated dermal exposure is likely to occur under conditions of use.

6. Required if the test material is an organophosphorus substance, which includes uncharged organophosphorus esters; thioesters or anhydrides of organophosphoric, organophosphonic, or organophosphoramidic acids; or of related phosphorothioic, phosponothioic, or phosphorothioamidic acids; or is structurally related to other substances that may cause the delayed neurotoxicity sometimes seen in this class of chemicals.

7. As determined by the Agency, additional measurements may also be required, such as cholinesterase activity for certain pesticides, e.g., organophosphates and some carbamates. The route of exposure must correspond with the primary route of exposure.

8. Required for nonfood use pesticides if oral exposure could occur.

9. The 90-day study is required in the rat for hazard characterization (possibly endpoint selection) and dose-setting for the chronic/carcinogenicity study. It is not required in the mouse, but the Agency would strongly encourage the registrant to conduct a 90-day range finding for the purposes of dose selection for the mouse carcinogenicity study to achieve adequate dosing and an acceptable study. The registrant is also encouraged to consult with the Agency on the results of the 90-day mouse study prior to conducting the carcinogenicity study.

10. Required for agricultural uses or if repeated human dermal exposure may occur. Not required if an acceptable 90-day dermal toxicity study is performed and submitted.

11. EP testing is required if the product, or any component of it, may increase dermal absorption of the active ingredient(s) as determined by testing using the TGAI, or increase toxic or pharmacologic effects.

12. Required for food uses if either of the following criteria is met:

(i) The use pattern is such that the dermal route would be the primary route of exposure; or

(ii) The active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite is the toxic moiety.

13. Required if there is the likelihood of significant repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.

14. Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., 21- or 28-days, may be sufficient to satisfy this requirement. Registrants should consult with the Agency to determine whether studies of shorter duration would meet this requirement.

15. Required if results of acute neurotoxicity study indicate significant statistical or biological effects, or if other available data indicate the potential for this type of delayed neurotoxicity, as determined by the Agency.

16. All 90-day subchronic studies in rats can be designed to simultaneously fulfill the requirements of the 90-day neurotoxicity study using separate groups of animals for testing. Although the subchronic guidelines include the measurement of neurological endpoints, they do not meet the requirement of the 90-day neurotoxicity study.

17. Required if either of the following are met:

(i) The use of the pesticide is likely to result in repeated human exposure over a considerable portion of the human lifespan, as determined by the Agency;

(ii) The use requires a tolerance or an exemption from the requirement of a tolerance.

18. Based on the results of the acute and subchronic neurotoxicity studies, or other available data, a combined chronic toxicity and neurotoxicity study may be required.

19. Studies which are designed to simultaneously fulfill the requirements of both the chronic oral and carcinogenicity studies (i.e., a combined study) may be conducted. Minimum acceptable study durations are:

(i) Chronic rodent feeding study (food use) – 24 months.

(ii) Chronic rodent feeding study (nonfood use) – 12 months.

(iii) Mouse carcinogenicity study – 18 months.

(iv) Rat carcinogenicity study – 24 months.

20. Required if any of the following, as determined by the Agency, are met:

(i) The use of the pesticide is likely to result in significant human exposure over a considerable portion of the human life span which is significant in terms of either frequency, duration, or magnitude of exposure;

(ii) The use requires a tolerance or an exemption from the requirement of a tolerance; or

(iii) The active ingredient, metabolite, degradate, or impurity (a) is structurally related to a recognized carcinogen, (b) causes mutagenic effects as demonstrated by in vitro or in vivo testing, or (c) produces a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchronic studies that may lead to a neoplastic change.

21. If this study is modified or waived, a subchronic 90-day oral study conducted in the same species may be required.

22. Testing in two species is required for all uses.

23. The oral route, by oral intubation, is preferred unless the chemical or physical properties of the test substance or the pattern of exposure suggests a more appropriate route of exposure.

24. Additional testing by other routes may be required if the pesticide is determined to be a prenatal developmental toxicant after oral dosing.

25. May be combined with the 2-generation reproduction study in rodents by utilizing a second mating of the parental animals in either generation.

26. Required to support products intended for food uses and to support products intended for nonfood uses if use of the product is likely to result in significant human exposure over a portion of the human life span in terms of frequency, magnitude or duration of exposure.

27. An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, pharmacokinetic, or mechanistic data) to determine whether a standard guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing animal, or in some cases to support a waiver for such testing. Registrants should submit any alternative proposed testing protocols and supporting scientific rationale to the Agency prior to study initiation.

28. Study required using a weight-of-evidence approach considering:

(i) The pesticide causes treatment-related neurological effects in adult animal studies (i.e., clinical signs of neurotoxicity, neuropathology, functional or behavioral effects).

(ii) The pesticide causes treatment-related neurological effects in developing animals, following pre- and postnatal exposure (i.e., nervous system malformations or neuropathy, brain weight changes in offspring, functional or behavioral changes in the offspring).

(iii) The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological studies.

(iv) The pesticide evokes a mechanism that is associated with adverse effects on the development of the nervous system (e.g., SAR relationship to known neurotoxicants, altered neuroreceptor or neurotransmitter responses).

29. The use of a combined study that utilizes the 2-generation reproduction study in rodents as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is encouraged.

30. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must also be submitted.

31. Choice of assay using either:

(i) Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;

(ii) Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate in vitro test for clastogenicity; or

(iii) CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.

32. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.

33. Required when chronic or carcinogenicity studies are required. May be required if significant adverse effects are seen in available toxicology studies and these effects can be further elucidated by metabolism studies.

34. May be required if the product’s use will result in exposure to domestic animals through, but not limited to, direct application.

35. A risk assessment assuming that dermal absorption is equal to oral absorption must be performed to determine if the study is required, and to identify the doses and duration of exposure for which dermal absorption is to be quantified.

36. A 1-year non-rodent study (i.e., 1-year dog study) would be required if the Agency finds that a pesticide chemical is highly bioaccumulating and is eliminated so slowly that it does not achieve steady state or sufficient tissue concentrations to elicit an effect during a 90-day study. EPA would require the appropriate tier II metabolism and pharmacokinetic studies to evaluate more precisely bioavailability, half-life, and steady state to determine if a longer duration dog toxicity study is needed.

§ 158.510 Tiered testing options for nonfood pesticides.

For nonfood use pesticides only, applicants have two options for generating and submitting required toxicology (§ 158.500) and human exposure (§ 158.1020, § 158.1070, and § 158.1410) studies. Applicants are to select one of the following:

(a) Acute, subchronic, chronic, and other toxicological studies on the active ingredient must be submitted together. The specific makeup of the set of toxicology study requirements is based on the anticipated exposure to the pesticide as determined by the Agency. If hazards are identified based upon review of these studies, specific exposure data will be required to evaluate risk.

(b) Certain toxicological and exposure studies must be submitted simultaneously with the toxicology data submitted in a tiered system. Exposure data must be submitted along with first tier toxicology data. The requirement for additional second and third level toxicology testing will be determined by the Agency based on the results of the first tiered studies.

(1) The required first-tier toxicology studies consist of:

(i) Battery of acute studies.

(ii) A subchronic 90-day dermal study or a subchronic 90-day inhalation study.

(iii) An acute and subchronic neurotoxicity screening battery in the rat.

(iv) Prenatal developmental toxicity studies in both the rat and rabbit.

(v) Reproduction and fertility studies in rats.

(vi) Battery of mutagenicity studies.

(vii) Immunotoxicity study.

(2) The conditionally required second-tier studies include:

(i) Subchronic 90-day feeding studies in both the rodent and nonrodent.

(ii) Dermal penetration study.

(3) The conditionally required third-tier studies include:

(i) Chronic feeding studies in the rodent.

(ii) Carcinogenicity.

(iii) Metabolism study.

(iv) Additional mutagenicity testing.

Subpart G— Ecological Effects

§ 158.630 Terrestrial and aquatic nontarget organisms data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget data requirements for a particular pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood use patterns. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use.

(2) Data are also required for the general use patterns of forestry and residential outdoor use.

(3) In general, for all outdoor end-uses, including turf, the following studies are required: Two avian oral LD50, two avian dietary LC50, two avian reproduction studies, two freshwater fish LC50, one freshwater invertebrate EC50, one honeybee acute contact LD50, one freshwater fish early-life stage, one freshwater invertebrate life cycle, and three estuarine acute LC50/EC50 studies — fish, mollusk and invertebrate. All other outdoor residential uses, i.e., gardens and ornamental will not usually require the freshwater fish early-life stage, the freshwater invertebrate life-cycle, and the acute estuarine tests.

(c) Key. R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; PAI = Pure active ingredient; EP = end-use product. Commas between the test substances (i.e., TGAI, TEP) indicate that data may be required on the TGAI or the TEP depending on the conditions set forth in the test note.

(d) Table. The following table shows the data requirements for nontarget terrestrial and aquatic organism. The table notes are shown in paragraph (e) of this section.

(e) Test notes. The following test notes apply to terrestrial and aquatic nontarget organisms data requirements in the table to paragraph (d) of this section:

1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.

2. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support end-use products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if there is no potential for environmental exposure.

3. Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses.

4. Data are required on waterfowl and upland game bird species.

5. Tests are required based on the results of lower tier toxicology studies, such as the acute and subacute testing, intended use pattern, and environmental fate characteristics that indicate potential exposure.

6. Higher tier testing may be required for a specific use pattern when a refined risk assessment indicates a concern based on laboratory toxicity endpoints and refined exposure assessments.

7. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.

8. Data are required on one coldwater fish and one warmwater fish for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required.

9. EP or TEP testing is required for any product which meets any of the following conditions:

i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.

ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is ≥one-half the LC50 or EC50 of the TGAI when the EP is used as directed.

iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.

10. Data are required on one freshwater aquatic invertebrate species.

11. Data are required on one estuarine/marine mollusk, one estuarine/marine invertebrate and one estuarine/marine fish species.

12. Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.

13. Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96-hour LC50 on that species must also be provided.

14. Data are required on one estuarine/marine invertebrate species.

15. Data are required on estuarine/marine species if the product meets any of the following conditions:

i. Intended for direct application to the estuarine or marine environment.

ii. Expected to enter this environment in significant concentrations because of its expected use or mobility patterns.

iii. If the acute LC50 or EC50

iv. If the estimated environmental concentration (EEC) in water is ≥0.01 of the acute EC50 or LC50 or if any of the following conditions exist:

A. Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected.

B. Physicochemical properties indicate bioaccumulation of the pesticide.

C. The pesticide is persistent in water (e.g., half-life in water >4 days).

16. Data are required on one estuarine/marine fish species.

17. Data are required on estuarine/marine species if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations because of its expected use or mobility patterns.

18. Data are required on freshwater species if the end-use product is intended to be applied directly to water, or is expected to be transported to water from the intended use site, and when any of the following conditions apply:

i. If the estimated environmental concentration (EEC) is ≥0.1 of the no-observed-effect level in the fish early-life stage or invertebrate life cycle test;

ii. If studies of other organisms indicate that the reproductive physiology of fish may be affected.

19. Not required when:

i. The octanol/water partition coefficients of the pesticide and its major degradates are

ii. There are no potential exposures to fish and other nontarget aquatic organisms; or

iii. The hydrolytic half-life is

20. Data are required based on the results of lower tier studies such as acute and chronic aquatic organism testing, intended use pattern, and environmental fate characteristics that indicate significant potential exposure.

21. Data are required if:

i. The half-life of the pesticide in the sediment is ≤10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist:

A. The soil partition coefficient (Kd) is ≥50.

B. The log Kow is ≥3.

C. The Koc ≥1,000.

ii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.

22. Data are required if:

i. The estimated environmental concentration (EEC) in sediment is >0.1 of the acute LC50/EC50 values and

ii. The half-life of the pesticide in the sediment is >10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist:

A. The soil partition coefficient (Kd) is ≥50.

B. The log Kow is ≥3.

C. The Koc ≥1,000.

iii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.

23. Sediment testing with estuarine/marine test species is required if the product is intended for direct application to the estuarine or marine environment or the product is expected to enter this environment in concentrations which the Agency believes to be significant, either by runoff or erosion, because of its expected use or mobility pattern.

24. Data are required only when the formulation contains one or more active ingredients having an acute LD50 of

25. Required if any of the following conditions are met:

i. Data from other sources (Experimental Use Permit program, university research, registrant submittals, etc.) indicate potential adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.);

ii. Data from residual toxicity studies indicate extended residual toxicity.

iii. Data derived from studies with terrestrial arthropods other than bees indicate potential chronic, reproductive or behavioral effects.

26. The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. Freshwater invertebrate and acute estuarine and marine organisms must also be tested with the EP or TEP using the same species tested with the TGAI.

§ 158.660 Nontarget plant protection data requirements table.

(a) General. Sections 158.100 through158.130 describe how to use this table to determine the nontarget plant data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes only the general use patterns of aquatic food crops and aquatic nonfood.

(2) Data are also required for the general use patterns of forestry use and residential outdoor use.

(c) Key. R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.

(d) Table. The following table shows the nontarget plant protection data requirements. The table notes are shown in paragraph (e) of this section.

(e) Test notes. The following test notes apply to the table in paragraph (d) of this section.

1. Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.

2. Not required for known phytotoxicants.

3. Generally not required for granular formulations. May be requested on a case-by-case basis.

4. Required for known phytotoxicants such as herbicides, desiccants and defoliants.

5. Required if a tested terrestrial species exhibits a 25 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the Tier I testing.

6. Required if the tested aquatic species exhibits a 50 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the tier I testing.

7. Not required for aquatic residential uses.

8. Environmental chemistry methods used to generate data must include the results of a successful confirmatory method trial by an independent laboratory.

9. Tests are required on a case-by-case basis based on the results of lower tier phytotoxicity studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.

10. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.

Subparts H-J [Reserved]

§§ 158.700-158.900 [Reserved]

Subpart K—Human Exposure

§ 158.1000 Applicator exposure—general requirements.

(a) If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration (OSHA), provide adequate protection from risk under FIFRA for a particular pesticide use pattern, exposure data may not be required for that use pattern. Applicants should consult with the Agency on appropriate testing prior to the initiation of studies.

(b) The Agency may accept surrogate exposure data estimations from other sources to satisfy applicator exposure data requirements if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. In order to be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address applicator exposure data requirements and contain adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the applicator activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. The Agency will consider using such surrogate data for evaluating human exposure on a case-by-case basis.

§ 158.1010 Applicator exposure—criteria for testing.

Applicator exposure data described in paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, at least one of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.

(a) Toxicity criteria. (1) Evidence of potentially significant adverse effects have been observed in any applicable toxicity study.

(2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from handling of the pesticide.

(b) Exposure criteria. (1) Dermal exposure may occur during the prescribed use.

(2) Respiratory exposure may occur during the prescribed use.

§ 158.1020 Applicator exposure data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the applicator exposure data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. (1) Occupational use patterns include products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, terrestrial nonfood crop, aquatic food, aquatic nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food use, and indoor nonfood use. Occupational use patterns also include commercial (“for hire”) applications to residential outdoor and indoor sites.

(2) Residential use patterns include residential outdoor use and residential indoor use. These use patterns are limited to nonoccupational, i.e., nonprofessional, pesticide applications.

(c) Key. R = Required; CR = Conditionally required; TEP = Typical end-use product.

(d) Table. The data requirements listed pertain to pesticide products that meet the testing criteria outlined in § 158.1010. The table notes are shown in paragraph (e) of this section.

(e) Test notes. The following notes apply to the data requirements in the table to paragraph (d) of this section:

1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.

2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data, provided the human pharmacokinetics of the pesticide and/or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for the back calculation to actual dose.

3. Data are required if the product is applied outdoors.

4. Data are required if the product is applied indoors.

5. Data reporting and calculations are required when handler exposure data are submitted.

§ 158.1050 Post-application exposure—general requirements.

(a) If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants should consult with the Agency on appropriate testing before the initiation of studies.

(b) The Agency may accept surrogate exposure data from other sources to satisfy post-application exposure data requirements if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific needs of EPA. In order to be acceptable, among other things, the Agency must find that the surrogate exposure data have adequate information to address post-application exposure data requirements and contain adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the post-application activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. The Agency will consider using such surrogate data for evaluating human exposure on a case-by-case basis.

§ 158.1060 Post-application exposure—criteria for testing.

Exposure data described in § 158.1070(d) are required based upon toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, either or both of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.

(a) Toxicity criteria. (1) Evidence of potentially significant adverse health effects have been observed in any applicable toxicity study.

(2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from post-application exposure to the pesticide.

(b) Exposure criteria. The need for data from potential exposure resulting from situations not covered by this paragraph should be discussed with the Agency.

(1) For outdoor uses. (i) Occupational human post-application exposure to pesticide residues on plants or in soil could occur as the result of cultivation, pruning, harvesting, mowing or other work-related activity. Such uses include agricultural food, feed, and fiber commodities, forest trees, ornamental plants, and turf grass.

(ii) Residential human post-application exposure to pesticide residues on plants or in soil could occur. Such uses may include turf grass, fruits, vegetables, and ornamentals grown at sites, including, but not limited to, homes, parks, and recreation areas.

(2) For indoor uses. (i) Occupational human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at agricultural or commercial sites, such as, but not limited to, agricultural animal facilities and industrial or manufacturing facilities.

(ii) Residential human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at residential sites, such as, but not limited to homes, daycare centers, hospitals, schools, and other public buildings.

§ 158.1070 Post-application exposure data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the post-application data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. (1) Occupational use patterns include products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, terrestrial nonfood use, aquatic food, aquatic nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food, and indoor nonfood. Occupational use patterns also include commercial (“for hire”) applications to residential outdoor and indoor sites.

(2) Residential use patterns include residential outdoor use and indoor residential use. These use patterns are limited to nonoccupational, i.e., nonprofessional, pesticide applications.

(c) Key. R = Required; CR = Conditionally required; NR = Not required; TEP = Typical end-use product.

(d) Table. The data requirements listed in the following table pertain to pesticide products that meet the testing criteria outlined in § 158.1060. The table notes are shown in paragraph (e) of this section.

(e) Test notes. The following test notes apply to the data requirements in the table to paragraph (d) of this section:

1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.

2. Bridging applicable residue dissipation data to dermal exposure data is required.

3. Turf grass transferable residue dissipation data are required when pesticides are applied to turf grass. Dislodgeable foliar residue dissipation data are required when pesticides are applied to the foliage of plants other than turf grass.

4. Data are required for occupational sites if (i) there are uses on turf grass or other plant foliage, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated foliage while participating in typical activities.

5. Data are required for residential sites if there are uses on turf grass or other plant foliage.

6. Data are required for occupational sites, if (i) there are outdoor or greenhouse uses to or around soil or other planting media, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated soil or planting media while participating in typical activities.

7. Data are required for residential sites if the pesticide is applied to or around soil or other planting media both outdoors and indoors, e.g., residential greenhouse or houseplant uses.

8. Data are required for occupational sites if the pesticide is applied to or around on non-plant surfaces, e.g., flooring or countertops, and if the human activity data indicate that workers are likely to have post-application dermal contact with treated indoor surfaces while participating in typical activities.

9. Data are required for residential sites if the pesticide is applied to or around non-plant surfaces, e.g., flooring and countertops.

10. Data are required for occupational sites if the human activity data indicate that workers are likely to have post-application exposures while participating in typical activities.

11. Data are required for residential sites if post-application exposures are likely.

12. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data provided the human pharmocokinetics of the pesticide and/or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for a back-calculation to the total internal dose.

13. Data are required when passive dosimetry techniques are not applicable for a particular exposure scenario, such as a swimmer exposure to pesticides.

14. Data reporting and calculations are required when any post-application exposure monitoring data are submitted.

15. The selection of a sampling method will depend on the nondietary pathway(s) of interest. Data must be generated to consider all potential pathways of nondietary ingestion exposure that are applicable (e.g., soil ingestion, hand-to-mouth transfer, and object-to-mouth transfer of surface residues).

Subpart L—Spray Drift

§ 158.1100 Spray drift data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the spray drift data requirements for a particular pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. Data are also required for the general use patterns of forestry use, residential outdoor use, and indoor use.

(c) Key. CR = Conditionally required; NR = Not required; TEP = Typical end-use product; MP = Manufacturing use product; EP = End-use product.

(d) Table. The following table lists the data requirements that pertain to spray drift. The table notes are shown in paragraph (e) of this section.

(e) Test notes. The following notes apply to the requirements in the table to paragraph (d) of this section:

1. This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants.

2. [Reserved]

Subpart M [Reserved]

§§ 158.1200-158.1299 [Reserved]

Subpart N—Environmental Fate

§ 158.1300 Environmental fate data requirements table.

(a) General. All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for registration.

(b) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes the general use patterns of aquatic food crop, and aquatic nonfood. The greenhouse use pattern includes both food and nonfood uses. The indoor use pattern includes food, nonfood, and residential indoor uses.

(2) Data are also required for the general use patterns of forestry use and residential outdoor use.

(c) Key. CR = Conditionally required; NR = Not required; R = Required; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.

(d) Table. The following table shows the data requirements for environmental fate. The test notes are shown in paragraph (e) of this section.