PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES

• Citation: 40 CFR Part 152
• Sections: 74

§ 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 Unless specifically superseded by part 174, the regulations in part 152 apply to PIPs.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.

§ 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 LD 50 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 LC 50 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 LD 50 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.

§ 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)).

§ 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.

§ 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.

§ 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.

§ 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.

§ 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.

Table 1—Active Ingredients Permitted in Exempted Minimum Risk Pesticide Products

Label display name

Chemical name

Specifications

CAS No.

Castor oil

Castor oil

United States Pharmacopeia (U.S.P.) or equivalent

8001-79-4

Cedarwood oil

Cedarwood oil (China)

85085-29-6

Cedarwood oil

Cedarwood oil (Texas)

68990-83-0

Cedarwood oil

Cedarwood oil (Virginia)

8000-27-9

Chitosan

Poly-D-glucosamine

Includes chitosan salts (consisting solely of those salts that can be formed with the acids listed in this table or table 2 to paragraph (f)(2) of this section)

9012-76-4

Cinnamon

Cinnamon

N/A

Cinnamon oil

Cinnamon oil

8015-91-6

Citric acid

2-Hydroxypropane-1,2,3-tricarboxylic acid

77-92-9

Citronella

Citronella

N/A

Citronella oil

Citronella oil

8000-29-1

Cloves

Cloves

N/A

Clove oil

Clove oil

8000-34-8

Corn gluten meal

Corn gluten meal

66071-96-3

Corn oil

Corn oil

8001-30-7

Cornmint

Cornmint

N/A

Cornmint oil

Cornmint oil

68917-18-0

Cottonseed oil

Cottonseed oil

8001-29-4

Dried blood

Dried blood

68991-49-9

Eugenol

4-Allyl-2-methoxyphenol

97-53-0

Garlic

Garlic

N/A

Garlic oil

Garlic oil

8000-78-0

Geraniol

(2E)-3,7-Dimethylocta-2,6-dien-1-ol

106-24-1

Geranium oil

Geranium oil

8000-46-2

Lauryl sulfate

Lauryl sulfate

151-41-7

Lemongrass oil

Lemongrass oil

8007-02-1

Linseed oil

Linseed oil

8001-26-1

Malic acid

2-Hydroxybutanedioic acid

6915-15-7

Peppermint

Peppermint

N/A

Peppermint oil

Peppermint oil

8006-90-4

2-Phenylethyl propionate

2-Phenylethyl propionate

122-70-3

Potassium sorbate

Potassium (2E,4E)-hexa-2,4-dienoate

24634-61-5

Putrescent whole egg solids

Putrescent whole egg solids

51609-52-0

Rosemary

Rosemary

N/A

Rosemary oil

Rosemary oil

8000-25-7

Sesame

Sesame

Includes ground sesame plant

N/A

Sesame oil

Sesame oil

8008-74-0

Sodium chloride

Sodium chloride

7647-14-5

Sodium lauryl sulfate

Sulfuric acid monododecyl ester, sodium salt

151-21-3

Soybean oil

Soybean oil

8001-22-7

Spearmint

Spearmint

N/A

Spearmint oil

Spearmint oil

8008-79-5

Thyme

Thyme

N/A

Thyme oil

Thyme oil

8007-46-3

White pepper

White pepper

N/A

Zinc

Zinc

Zinc metal strips (consisting solely of zinc metal and impurities)

7440-66-6

(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.

Table 2—Inert Ingredients Permitted in Minimum Risk Pesticide Products

Label display name

Chemical name

CAS No.

Acetyl tributyl citrate

Citric acid, 2-(acetyloxy)-, tributyl ester

77-90-7

Agar

Agar

9002-18-0

Almond hulls

Almond hulls

N/A

Almond oil

Oils, almond

8007-69-0

Almond shells

Almond shells

N/A

alpha-Cyclodextrin

alpha-Cyclodextrin

10016-20-3

Aluminatesilicate

Aluminatesilicate

1327-36-2

Aluminum magnesium silicate

Silicic acid, aluminum magnesium salt

1327-43-1

Aluminum potassium sodium silicate

Silicic acid, aluminum potassium sodium salt

12736-96-8

Aluminum silicate

Aluminum silicate

1335-30-4

Aluminum sodium silicate

Silicic acid, aluminum sodium salt

1344-00-9

Aluminum sodium silicate

Silicic acid (H4 SiO4), aluminum sodium salt (1:1:1)

12003-51-9

Ammonium benzoate

Benzoic acid, ammonium salt

1863-63-4

Ammonium stearate

Octadecanoic acid, ammonium salt

1002-89-7

Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate

Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate

113894-85-2

Amylopectin, hydrogen 1-octadecenylbutanedioate

Amylopectin, hydrogen 1-octadecenylbutanedioate

125109-81-1

Animal glue

Animal glue

N/A

Ascorbyl palmitate

Ascorbyl palmitate

137-66-6

Attapulgite-type clay

Attapulgite-type clay

12174-11-7

Beeswax

Beeswax

8012-89-3

Bentonite

Bentonite

1302-78-9

Bentonite, sodian

Bentonite, sodian

85049-30-5

beta-Cyclodextrin

beta-Cyclodextrin

7585-39-9

Bone meal

Bone meal

68409-75-6

Bran

Bran

N/A

Bread crumbs

Bread crumbs

N/A

(+)-Butyl lactate

Lactic acid, n-butyl ester, (S)

34451-19-9

Butyl lactate

Lactic acid, n-butyl ester

138-22-7

Butyl stearate

Octadecanoic acid, butyl ester

123-95-5

Calcareous shale

Calcareous shale

N/A

Calcite

Calcite (Ca(CO 3 ))

13397-26-7

Calcium acetate

Calcium acetate

62-54-4

Calcium acetate monohydrate

Acetic acid, calcium salt, monohydrate

5743-26-0

Calcium benzoate

Benzoic acid, calcium salt

2090-05-3

Calcium carbonate

Calcium carbonate

471-34-1

Calcium citrate

Citric acid, calcium salt

7693-13-2

Calcium octanoate

Calcium octanoate

6107-56-8

Calcium oxide silicate

Calcium oxide silicate (Ca 3 O(SiO 4 ))

12168-85-3

Calcium silicate

Silicic acid, calcium salt

1344-95-2

Calcium stearate

Octadecanoic acid, calcium salt

1592-23-0

Calcium sulfate

Calcium sulfate

7778-18-9

Calcium sulfate dihydrate

Calcium sulfate dihydrate

10101-41-4

Calcium sulfate hemihydrate

Calcium sulfate hemihydrate

10034-76-1

Canary seed

Canary seed

N/A

Carbon

Carbon

7440-44-0

Carbon dioxide

Carbon dioxide

124-38-9

Carboxymethyl cellulose

Cellulose, carboxymethyl ether

9000-11-7

Cardboard

Cardboard

N/A

Carnauba wax

Carnauba wax

8015-86-9

Carob gum

Locust bean gum

9000-40-2

Carrageenan

Carrageenan

9000-07-1

Caseins

Caseins

9000-71-9

Castor oil

Castor oil

8001-79-4

Castor oil, hydrogenated

Castor oil, hydrogenated

8001-78-3

Cat food

Cat food

N/A

Cellulose

Cellulose

9004-34-6

Cellulose acetate

Cellulose acetate

9004-35-7

Cellulose, mixture with cellulose carboxymethyl ether, sodium salt

Cellulose, mixture with cellulose carboxymethyl ether, sodium salt

51395-75-6

Cellulose, pulp

Cellulose, pulp

65996-61-4

Cellulose, regenerated

Cellulose, regenerated

68442-85-3

Cheese

Cheese

N/A

Chlorophyll a

Chlorophyll a

479-61-8

Chlorophyll b

Chlorophyll b

519-62-0

Citric acid

Citric acid

77-92-9

Citric acid, monohydrate

Citric acid, monohydrate

5949-29-1

Citrus meal

Citrus meal

N/A

Citrus pectin

Citrus pectin

9000-69-5

Citrus pulp

Citrus pulp

68514-76-1

Clam shells

Clam shells

N/A

Cocoa

Cocoa

8002-31-1

Cocoa shell flour

Cocoa shell flour

N/A

Cocoa shells

Cocoa shells

N/A

Cod-liver oil

Cod-liver oil

8001-69-2

Coffee grounds

Coffee grounds

68916-18-7

Cookies

Cookies

N/A

Cork

Cork

61789-98-8

Corn cobs

Corn cobs

N/A

Cotton

Cotton

N/A

Cottonseed meal

Cottonseed meal

68424-10-2

Cracked wheat

Cracked wheat

N/A

Decanoic acid, monoester with 1,2,3-propanetriol

Decanoic acid, monoester with 1,2,3-propanetriol

26402-22-2

Dextrins

Dextrins

9004-53-9

Diglyceryl monooleate

9-Octadecenoic acid, ester with 1,2,3-propanetriol

49553-76-6

Diglyceryl monostearate

9-Octadecanoic acid, monoester with oxybis(propanediol)

12694-22-3

Dilaurin

Dodecanoic acid, diester with 1,2,3-propanetriol

27638-00-2

Dipalmitin

Hexadecanoic acid, diester with 1,2,3-propanetriol

26657-95-4

Dipotassium citrate

Citric acid, dipotassium salt

3609-96-9

Disodium citrate

Citric acid, disodium salt

144-33-2

Disodium sulfate decahydrate

Disodium sulfate decahydrate

7727-73-3

Diatomaceous earth

Kieselguhr; Diatomite (less than 1% crystalline silica)

61790-53-2

Dodecanoic acid, monoester with 1,2,3-propanetriol

Dodecanoic acid, monoester with 1,2,3-propanetriol

27215-38-9

Dolomite

Dolomite

16389-88-1

Douglas fir bark

Douglas fir bark

N/A

Egg shells

Egg shells

N/A

Eggs

Eggs

N/A

(+)-Ethyl lactate

Lactic acid, ethyl ester, (S)

687-47-8

Ethyl lactate

Lactic acid, ethyl ester

97-64-3

Feldspar

Feldspar

68476-25-5

Ferric oxide

Iron oxide (Fe 2 O 3 )

1309-37-1

Ferrous oxide

Iron oxide (FeO)

1345-25-1

Fish meal

Fish meal

N/A

Fish oil

Fish oil

8016-13-5

Fuller's earth

Fuller's earth

8031-18-3

Fumaric acid

Fumaric acid

110-17-8

gamma-Cyclodextrin

gamma-Cyclodextrin

17465-86-0

Gelatins

Gelatins

9000-70-8

Gellan gum

Gellan gum

71010-52-1

Glue

Glue (as depolymd. animal collagen)

68476-37-9

Glycerin

1,2,3-Propanetriol

56-81-5

Glycerol monooleate

9-Octadecenoic acid (Z)-, 2,3-dihydroxypropyl ester

111-03-5

Glyceryl dicaprylate

Octanoic acid, diester with 1,2,3-propanetriol

36354-80-0

Glyceryl dimyristate

Tetradecanoic acid, diester with 1,2,3-propanetriol

53563-63-6

Glyceryl dioleate

9-Octadecenoic acid (9Z)-, diester with 1,2,3-propanetriol

25637-84-7

Glyceryl distearate

Octadecanoic acid, diester with 1,2,3-propanetriol

1323-83-7

Glyceryl monomyristate

Tetradecanoic acid, monoester with 1,2,3-propanetriol

27214-38-6

Glyceryl monooctanoate

Octanoic acid, monoester with 1,2,3-propanetriol

26402-26-6

Glyceryl monooleate

9-Octadecenoic acid (9Z)-, monoester with 1,2,3-propanetriol

25496-72-4

Glyceryl monostearate

Octadecanoic acid, monoester with 1,2,3-propanetriol

31566-31-1

Glyceryl stearate

Octadecanoic acid, ester with 1,2,3-propanetriol

11099-07-3

Granite

Granite

N/A

Graphite

Graphite

7782-42-5

Guar gum

Guar gum

9000-30-0

Gum Arabic

Gum arabic

9000-01-5

Gum tragacanth

Gum tragacanth

9000-65-1

Gypsum

Gypsum

13397-24-5

Hematite

Hematite (Fe 2 O 3 )

1317-60-8

Humic acid

Humic acid

1415-93-6

Hydrogenated cottonseed oil

Hydrogenated cottonseed oil

68334-00-9

Hydrogenated rapeseed oil

Hydrogenated rapeseed oil

84681-71-0

Hydrogenated soybean oil

Hydrogenated soybean oil

8016-70-4

Hydroxyethyl cellulose

Cellulose, 2-hydroxyethyl ether

9004-62-0

Hydroxypropyl cellulose

Cellulose, 2-hydroxypropyl ether

9004-64-2

Hydroxypropyl methyl cellulose

Cellulose, 2-hydroxypropyl methyl ether

9004-65-3

Iron magnesium oxide

Iron magnesium oxide (Fe 2 MgO 4 )

12068-86-9

Iron oxide, hydrate

Iron oxide (Fe 2 O 3 ), hydrate

12259-21-1

Iron oxide

Iron oxide (Fe 3 O 4 )

1317-61-9

Isopropyl alcohol

2-Propanol

67-63-0

Isopropyl myristate

Isopropyl myristate

110-27-0

Kaolin

Kaolin

1332-58-7

Lactose

Lactose

63-42-3

Lactose monohydrate

Lactose monohydrate

64044-51-5

Lanolin

Lanolin

8006-54-0

Latex rubber

Latex rubber

N/A

Lauric acid

Lauric acid

143-07-7

Lecithins

Lecithins

8002-43-5

Licorice extract

Licorice extract

68916-91-6

Lime dolomitic

Lime (chemical) dolomitic

12001-27-3

Limestone

Limestone

1317-65-3

Linseed oil

Linseed oil

8001-26-1

Magnesium carbonate

Carbonic acid, magnesium salt (1:1)

546-93-0

Magnesium benzoate

Magnesium benzoate

553-70-8

Magnesium oxide

Magnesium oxide

1309-48-4

Magnesium oxide silicate

Magnesium oxide silicate (Mg 3 O(Si 2 O 5 ) 2 ), monohydrate

12207-97-5

Magnesium silicate

Magnesium silicate

1343-88-0

Magnesium silicate hydrate

Magnesium silicate hydrate

1343-90-4

Magnesium silicon oxide

Magnesium silicon oxide (Mg 2 Si 3 O 8 )

14987-04-3

Magnesium stearate

Octadecanoic acid, magnesium salt

557-04-0

Magnesium sulfate

Magnesium sulfate

7487-88-9

Magnesium sulfate heptahydrate

Magnesium sulfate heptahydrate

10034-99-8

Malic acid

Malic acid

6915-15-7

Malt extract

Malt extract

8002-48-0

Malt flavor

Malt flavor

N/A

Maltodextrin

Maltodextrin

9050-36-6

Methylcellulose

Cellulose, methyl ether

9004-67-5

Mica

Mica

12003-38-2

Mica-group minerals

Mica-group minerals

12001-26-2

Milk

Milk

8049-98-7

Millet seed

Millet seed

N/A

Mineral oil

Mineral oil (U.S.P.)

8012-95-1

1-Monolaurin

Dodecanoic acid, 2,3-dihydroxypropyl ester

142-18-7

1-Monomyristin

Tetradecanoic acid, 2,3-dihydroxypropyl ester

589-68-4

Monomyristin

Decanoic acid, diester with 1,2,3-propanetriol

53998-07-1

Monopalmitin

Hexadecanoic acid, monoester with 1,2,3-propanetriol

26657-96-5

Monopotassium citrate

Citric acid, monopotassium salt

866-83-1

Monosodium citrate

Citric acid, monosodium salt

18996-35-5

Montmorillonite

Montmorillonite

1318-93-0

Myristic acid

Myristic acid

544-63-8

Nepheline syenite

Nepheline syenite

37244-96-5

Nitrogen

Nitrogen

7727-37-9

Nutria meat

Nutria meat

N/A

Nylon

Nylon

N/A

Octanoic acid, potassium salt

Octanoic acid, potassium salt

764-71-6

Octanoic acid, sodium salt

Octanoic acid, sodium salt

1984-06-1

Oleic acid

Oleic acid

112-80-1

Oyster shells

Oyster shells

N/A

Palm oil

Palm oil

8002-75-3

Palm oil, hydrogenated

Palm oil, hydrogenated

68514-74-9

Palmitic acid

Hexadecanoic acid

57-10-3

Paper

Paper

N/A

Paraffin wax

Paraffin wax

8002-74-2

Peanut butter

Peanut butter

N/A

Peanut shells

Peanut shells

N/A

Peanuts

Peanuts

N/A

Peat moss

Peat moss

N/A

Pectin

Pectin

9000-69-5

Perlite

Perlite

130885-09-5

Perlite, expanded

Perlite, expanded

93763-70-3

Plaster of paris

Plaster of paris

26499-65-0

Polyethylene

Polyethylene

9002-88-4

Polyglyceryl oleate

Polyglyceryl oleate

9007-48-1

Polyglyceryl stearate

Polyglyceryl stearate

9009-32-9

Potassium acetate

Acetic acid, potassium salt

127-08-2

Potassium aluminum silicate, anhydrous

Potassium aluminum silicate, anhydrous

1327-44-2

Potassium benzoate

Benzoic acid, potassium salt

582-25-2

Potassium bicarbonate

Carbonic acid, monopotassium salt

298-14-6

Potassium chloride

Potassium chloride

7447-40-7

Potassium citrate

Citric acid, potassium salt

7778-49-6

Potassium humate

Humic acids, potassium salts

68514-28-3

Potassium myristate

Tetradecanoic acid, potassium salt

13429-27-1

Potassium oleate

9-Octadecenoic acid (9Z)-, potassium salt

143-18-0

Potassium ricinoleate

9-Octadecenoic acid, 12-hydroxy-, monopotassium salt, (9Z, 12R)-

7492-30-0

Potassium sorbate

Sorbic acid, potassium salt

24634-61-5

Potassium stearate

Octadecanoic acid, potassium salt

593-29-3

Potassium sulfate

Potassium sulfate

7778-80-5

Potassium sulfate

Sulfuric acid, monopotassium salt

7646-93-7

1,2-Propylene carbonate

1,3-Dioxolan-2-one, 4-methyl-

108-32-7

Pumice

Pumice

1332-09-8

Red cabbage color

Red cabbage color (expressed from edible red cabbage heads via a pressing process using only acidified water)

N/A

Red cedar chips

Red cedar chips

N/A

Red dog flour

Red dog flour

N/A

Rubber

Rubber

9006-04-6

Sawdust

Sawdust

N/A

Shale

Shale

N/A

Silica, amorphous, fumed

Silica, amorphous, fumed (crystalline free)

112945-52-5

Silica, amorphous, precipitate and gel

Silica, amorphous, precipitate and gel

7699-41-4

Silica

Silica (crystalline free)

7631-86-9

Silica gel

Silica gel

63231-67-4

Silica gel, precipitated, crystalline-free

Silica gel, precipitated, crystalline-free

112926-00-8

Silica, hydrate

Silica, hydrate

10279-57-9

Silica, vitreous

Silica, vitreous

60676-86-0

Silicic acid, magnesium salt

Silicic acid (H 2 SiO 3 ), magnesium salt (1:1)

13776-74-4

Soap

Soap (The water soluble sodium or potassium salts of fatty acids produced by either the saponification of fats and oils, or the neutralization of fatty acid)

N/A

Soapbark

Quillaja saponin

1393-03-9

Soapstone

Soapstone

308076-02-0

Sodium acetate

Acetic acid, sodium salt

127-09-3

Sodium alginate

Sodium alginate

9005-38-3

Sodium benzoate

Benzoic acid, sodium salt

532-32-1

Sodium bicarbonate

Sodium bicarbonate

144-55-8

Sodium carboxymethyl cellulose

Cellulose, carboxymethyl ether, sodium salt

9004-32-4

Sodium chloride

Sodium chloride

7647-14-5

Sodium citrate

Sodium citrate

994-36-5

Sodium humate

Humic acids, sodium salts

68131-04-4

Sodium oleate

Sodium oleate

143-19-1

Sodium ricinoleate

9-Octadecenoic acid, 12-hydroxy-, monosodium salt, (9Z,12R)-

5323-95-5

Sodium stearate

Octadecanoic acid, sodium salt

822-16-2

Sodium sulfate

Sodium sulfate

7757-82-6

Sorbitol

D-glucitol

50-70-4

Soy protein

Soy protein

N/A

Soya lecithins

Lecithins, soya

8030-76-0

Soybean hulls

Soybean hulls

N/A

Soybean meal

Soybean meal

68308-36-1

Soybean, flour

Soybean, flour

68513-95-1

Stearic acid

Octadecanoic acid

57-11-4

Sulfur

Sulfur

7704-34-9

Syrups, hydrolyzed starch, hydrogenated

Syrups, hydrolyzed starch, hydrogenated

68425-17-2

Tetraglyceryl monooleate

9-Octadecenoic acid (9Z)-, monoester with tetraglycerol

71012-10-7

Tricalcium citrate

Citric acid, calcium salt (2:3)

813-94-5

Triethyl citrate

Citric acid, triethyl ester

77-93-0

Tripotassium citrate

Citric acid, tripotassium salt

866-84-2

Tripotassium citrate monohydrate

Citric acid, tripotassium salt, monohydrate

6100-05-6

Trisodium citrate

Citric acid, trisodium salt

68-04-2

Trisodium citrate dihydrate

Citric acid, trisodium salt, dihydrate

6132-04-3

Trisodium citrate pentahydrate

Citric acid, trisodium salt, pentahydrate

6858-44-2

Ultramarine blue

C.I. Pigment Blue 29

57455-37-5

Urea

Urea

57-13-6

Vanillin

Benzaldehyde, 4-hydroxy-3-methoxy-

121-33-5

Vermiculite

Vermiculite

1318-00-9

Vinegar

Vinegar (maximum 8% acetic acid in solution)

8028-52-2

Vitamin C

L-Ascorbic acid

50-81-7

Vitamin E

Vitamin E

1406-18-4

Walnut flour

Walnut flour

N/A

Walnut shells

Walnut shells

N/A

Wheat

Wheat

N/A

Wheat flour

Wheat flour

N/A

Wheat germ oil

Wheat germ oil

8006-95-9

Wheat oil

Oils, wheat

68917-73-7

Whey

Whey

92129-90-3

White mineral oil

White mineral oil (petroleum)

8042-47-5

Wintergreen oil

Wintergreen oil

68917-75-9

Wollastonite

Wollastonite (Ca(SiO 3 ))

13983-17-0

Wool

Wool

N/A

Xanthan gum

Xanthan gum

11138-66-2

Yeast

Yeast

68876-77-7

Zeolites

Zeolites (excluding erionite (CAS Reg. No. 66733-21-9))

1318-02-1

Zeolites, NaA

Zeolites, NaA

68989-22-0

Zinc iron oxide

Zinc iron oxide

12063-19-3

Zinc oxide

Zinc oxide (ZnO)

1314-13-2

Zinc stearate

Octadecanoic acid, zinc salt

557-05-1

(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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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).

§ 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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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).

§ 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.

§ 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.

§ 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.

§ 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).

§ 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).

§ 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.

§ 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).

§ 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.

§ 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.

§ 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.

§ 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).

§ 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.

§ 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.

§ 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.

§ 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).

§ 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.

§ 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.