40 CFR Part 152 — Pesticide Registration and Classification Procedures

PART 152—PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701. Subpart A—General Provisions Source: 53 FR 15975, May 4, 1988, unless otherwise noted. § 152.1 Scope. (a) Part 152 sets forth procedures, requirements and criteria concerning the registration of pesticide products under FIFRA section 3, including plant-incorporated protectants (PIPs). Unless specifically superseded by part 174, the regulations in part 152 apply to PIPs. (b) Part 152 also describes associated regulatory activities affecting registration, as described in this paragraph. (1) Data compensation and exclusive use of data in support of registration. (2) Rights and obligations of registrants. (3) Classification of pesticide uses. (4) Fees. (5) Requirements pertaining to pesticide devices. [73 FR 75594, Dec. 12, 2008] § 152.3 Definitions. Terms used in this part have the same meaning as in the Act. In addition, the following terms have the meanings set forth in this section. Act FIFRA Active ingredient Acute dermal LD 50 Acute inhalation LC 50 Acute oral LD 50 Administrator Agency Applicant Biological control agent Distribute or sell End use product (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 Inert ingredient Institutional use (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 Manufacturing use product New use, (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, Package packaging Pesticide (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 Plant-incorporated protectant Released for shipment. Residential use (1) On humans or pets, (2) In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or (3) In any preschool or day care facility. [53 FR 15975, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 73 FR 64224, Oct. 29, 2008; 73 FR 75594, Dec. 12, 2008] § 152.5 Pests. An organism is declared to be a pest under circumstances that make it deleterious to man or the environment, if it is: (a) Any vertebrate animal other than man; (b) Any invertebrate animal, including but not limited to, any insect, other arthropod, nematode, or mollusk such as a slug and snail, but excluding any internal parasite of living man or other living animals; (c) Any plant growing where not wanted, including any moss, alga, liverwort, or other plant of any higher order, and any plant part such as a root; or (d) Any fungus, bacterium, virus, prion, or other microorganism, except for those on or in living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs (as defined in FFDCA section 201(g)(1)) and cosmetics (as defined in FFDCA section 201(i)). [53 FR 15975, May 4, 1988, as amended at 78 FR 13507, Feb. 28, 2013] § 152.6 Substances excluded from regulation by FIFRA. Products and substances listed in this section are excluded from FIFRA regulation if they meet the specified conditions or criteria. (a) Liquid chemical sterilants. (1) Composition. (2) Claims. (3) Use site. semi-critical device (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. (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. (d) Animal drugs. (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. (f) Vitamin hormone products. (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. (1) A plant nutrient product, consisting of one or more macronutrients or micronutrient trace elements necessary to normal growth of plants and in a form readily usable by plants. (2) A plant inoculant product consisting of microorganisms to be applied to the plant or soil for the purpose of enhancing the availability or uptake of plant nutrients through the root system. (3) A soil amendment product containing a substance or substances intended for the purpose of improving soil characteristics favorable for plant growth. [66 FR 64763, Dec. 14, 2001, as amended at 73 FR 75594, Dec. 12, 2008] § 152.8 Products that are not pesticides because they are not for use against pests. A substance or article is not a pesticide, because it is not intended for use against “pests” as defined in § 152.5, if it is: (a) A fertilizer product not containing a pesticide. (b) A product intended to force bees from hives for the collection of honey crops. [53 FR 15975, May 4, 1988, as amended at 66 FR 64764, Dec. 14, 2001] § 152.10 Products that are not pesticides because they are not intended for a pesticidal purpose. A product that is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or regulate the growth of plants, is not considered to be a pesticide. The following types of products or articles are not considered to be pesticides unless a pesticidal claim is made on their labeling or in connection with their sale and distribution: (a) Deodorizers, bleaches, and cleaning agents; (b) Products not containing toxicants, intended only to attract pests for survey or detection purposes, and labeled accordingly; (c) Products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants, such as certain pruning paints to trees. § 152.15 Pesticide products required to be registered. No person may distribute or sell any pesticide product that is not registered under the Act, except as provided in §§ 152.20, 152.25, and 152.30. A pesticide is any substance (or mixture of substances) intended for a pesticidal purpose, i.e. (a) The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise): (1) That the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or (2) That the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or (b) The substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide; or (c) The person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose. Subpart B—Exemptions Source: 53 FR 15977, May 4, 1988, unless otherwise noted. § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The pesticides or classes of pesticide listed in this section are exempt from all requirements of FIFRA. The Agency has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated by another Federal agency. (a) Certain biological control agents. (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. [53 FR 15977, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 66 FR 64764, Dec. 14, 2001; 72 FR 61027, Oct. 26, 2007] § 152.25 Exemptions for pesticides of a character not requiring FIFRA regulation. The pesticides or classes of pesticides listed in this section have been determined to be of a character not requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended for use, and used, only in the manner specified. (a) Treated articles or substances. (b) Pheromones and pheromone traps. (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. (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. (e) Natural cedar. (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 Exempted products. 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. (i) Commonly consumed food commodities, (ii) Animal feed items, (iii) Edible fats and oils, (iv) Specific chemical substances, 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 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 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 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 4 12068-86-9 Iron oxide, hydrate Iron oxide (Fe 2 3 12259-21-1 Iron oxide Iron oxide (Fe 3 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 2 5 2 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 3 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 3 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. (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. http://www2.epa.gov/minimum-risk-pesticides [53 FR 15977, May 4, 1988, as amended at 59 FR 2751, Jan. 19, 1994; 61 FR 8878, Mar. 6, 1996; 66 FR 64764, Dec. 14, 2001; 71 FR 35545, June 21, 2006; 80 FR 80660, Dec. 28, 2015; 87 FR 67370, Nov. 8, 2022] § 152.30 Pesticides that may be transferred, sold, or distributed without registration. An unregistered pesticide, or a pesticide whose registration has been cancelled or suspended, may be dis-tributed or sold, or otherwise transferred, to the extent described by this section. (a) A pesticide transferred between registered establishments operated by the same producer. (b) A pesticide transferred between registered establishments not operated by the same producer. (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. (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. (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. (f) A pesticide transferred for purposes of disposal. (g) Existing stocks of a formerly registered product. Subpart C—Registration Procedures Source: 53 FR 15978, May 4, 1988, unless otherwise noted. § 152.40 Who may apply. Any person may apply for new registration of a pesticide product. Any registrant may apply for amendment of the registration of his product. § 152.42 Application for new registration. Any person seeking to obtain a registration for a new pesticide product must submit an application for registration, containing the information specified in § 152.50. An application for new registration must be approved by the Agency before the product may legally be distributed or sold, except as provided by § 152.30. § 152.43 Alternate formulations. (a) A product proposed for registration must have a single, defined composition, except that EPA may approve a basic formulation and one or more alternate formulations for a single product. (b) An alternate formulation must meet the criteria listed in paragraph (b) (1) through (4) of this section. The Agency may require the submission of data to determine whether the criteria have been met. (1) The alternate formulation must have the same certified limits for each active ingredient as the basic formulation. (2) If the alternate formulation contains an inert ingredient or impurity of toxicological significance, the formulation must have the same upper certified limit for that substance as the basic formulation; (3) The label text of the alternate formulation product must be identical to that of the basic formulation. (4) The analytical method required under § 158.355 of this chapter must be suitable for use on both the basic formulation and the alternate formulation. (c) Notwithstanding the criteria in this section, the Agency may determine that an alternate formulation must be separately registered. If EPA makes this determination, the Agency will notify the applicant of its determination and its reasons. Thereafter the application for an alternate formulation will be treated as an application for new registration, and the alternate formulation will be assigned a new registration number. [53 FR 15978, May 4, 1988, as amended at 72 FR 61027, Oct. 26, 2007] § 152.44 Application for amended registration. (a) Except as provided by § 152.46, any modification in the composition, labeling, or packaging of a registered product must be submitted with an application for amended registration. The applicant must submit the information required by § 152.50, as applicable to the change requested. If an application for amended registration is required, the application must be approved by the Agency before the product, as modified, may legally be distributed or sold. (b) In its discretion, the Agency may: (1) Waive the requirement for submission of an application for amended registration; (2) Require that the applicant certify to the Agency that he has complied with an Agency directive rather than submit an application for amended registration; or (3) Permit an applicant to modify a registration by notification or non-notification in accordance with § 152.46. (c) A registrant may at any time submit identical minor labeling amendments affecting a number of products as a single application if no data are required for EPA to approve the amendment (for example, a change in the wording of a storage statement for designated residential use products). A consolidated application must clearly identify the labeling modification(s) to be made (which must be identical for all products included in the application), list the registration number of each product for which the modification is requested, and provide required supporting materials (for example, labeling) for each affected product. [53 FR 15978, May 4, 1988, as amended at 61 FR 33041, June 26, 1996; 66 FR 64764, Dec. 14, 2001] § 152.46 Notification and non-notification changes to registrations. (a) Changes permitted by notification. (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. (c) Effect of non-compliance. [61 FR 33041, June 26, 1996] § 152.50 Contents of application. Each application for registration or amended registration must include the following information, as applicable: (a) Application form. (b) Identity of the applicant Name. (2) Address of record. (3) Authorized agent. (4) Company number. (c) Summary of the application. (d) Identity of the product. (1) The product name; (2) The trade name(s) (if different); and (3) The EPA Registration Number, if currently registered. (e) Draft labeling. (f) Registration data requirements. (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. (h) Request for classification. (i) Statement concerning tolerances. (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. (2) If FIFRA sec. 33 is not in effect, the applicant shall submit any fees required by subpart U of this part, if applicable. [53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60 FR 32096, June 19, 1995; 72 FR 61027, Oct. 26, 2007; 73 FR 75594, Dec. 12, 2008] § 152.55 Where to send applications and correspondence. Applications and correspondence relating to registration should be sent to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). [71 FR 35545, June 21, 2006] Subpart D [Reserved] Subpart E—Satisfaction of Data Requirements and Protection of Data Submitters' Rights Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted. § 152.80 General. This subpart E describes the information that an applicant must submit with his application for registration or amended registration to comply (and for the Agency to determine compliance) with the provisions of FIFRA sec. 3(c)(1)(F). This subpart also describes the procedures by which data submitters may challenge registration actions which allegedly failed to comply with these procedures. If the Agency determines that an applicant has failed to comply with the requirements and procedures in this subpart, the application may be denied. If the Agency determines, after registration has been issued, that an applicant failed to comply with these procedures and requirements, the Agency may issue a notice of intent to cancel the product's registration. [73 FR 75594, Dec. 12, 2008] § 152.81 Applicability. (a) Except as provided in paragraph (b) of this section, the requirements of this subpart apply to: (1) Each application for registration of a new product. (2) Each application for amended registration of a currently registered product. (3) Each submission in response to a Data Call-In under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(2)(B) for an existing registration, including but not limited to, a product subject to reregistration under FIFRA section 4 or registration review under FIFRA section 3(g). If the Data Call-In establishes procedures for protection of data submitters' rights, recipients must comply with the specific requirements of the Data Call-In rather than the generic procedures set forth in §§ 152.85 through 152.96. (b) This subpart does not apply to any of the following: (1) An application for registration submitted to a State under FIFRA section 24(c). (2) An application for an experimental use permit (EUP) under FIFRA section 5. (3) An application for an emergency exemption under FIFRA section 18. (4) A request for cancellation of a registration, or a request for deletion of one or more existing uses, under FIFRA section 6(f). (5) A modification to registration of a currently registered product that may be accomplished under the notification or non-notification provisions of § 152.46 and any procedures issued thereunder. Notwithstanding the preceding sentence, compliance with this subpart is required if the Administrator has, by written notice under § 152.46, determined that the modification may not be accomplished by notification or non-notification. (6) Any type of amendment if the Administrator determines, by written finding, that Agency consideration of data would not be necessary in order to approve the amendment under FIFRA section 3(c)(5). (7) Compliance with Agency regulations, adjudicatory hearing decisions, notices, or other Agency announcements that unless the registration is amended in the manner the Agency proposes, the product's registration will be suspended or canceled, or that a hearing will be held under FIFRA section 6. However, this paragraph does not apply to amendments designed to avoid cancellation or suspension threatened under FIFRA section 3(c)(2)(B) or because of failure to submit data. [79 FR 6824, Feb. 5, 2014] § 152.82 Definitions. For the purposes of this subpart, the definitions set forth in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), in § 152.3, and in this section apply. In addition, the term “exclusive use study” shall have the meaning set forth in § 152.83. Data gap Data Submitters List Original data submitter Valid study [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008. Redesignated and amended at 79 FR 6825, Feb. 5, 2014] § 152.83 Definition of exclusive use study. A study is an exclusive use study if it meets the conditions of either paragraph (a) or paragraph (b) of this section. (a) Initial exclusive use period. (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. (1) The study relates solely to a minor use of a pesticide. (2) The applicant or registrant at the time the new use is requested has notified the Administrator that any exclusive use period for the pesticide has expired and that the study is eligible for exclusive use treatment. (3) Less than 10 years have passed since the study was submitted to EPA. (4) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B). (5) The minor use supported by the data has not been voluntarily canceled nor have such data been used to support a non-minor use. [79 FR 6825, Feb. 5, 2014] § 152.84 When materials must be submitted to the Agency. Information and materials required by this subpart must be submitted at the time of application, unless the application is determined not to be subject to the requirements of this subpart. [79 FR 6825, Feb. 5, 2014] § 152.85 Formulators' exemption. (a) Statutory provision. (b) Applicability of the formulators' exemption. (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. (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. (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. [72 FR 61027, Oct. 26, 2007] § 152.86 The cite-all method. An applicant may comply with this subpart by citing all data in Agency files that are pertinent to its consideration of the requested registration under FIFRA section 3(c)(5), in accordance with the procedures in this section, as applicable. (a) Exclusive use studies. (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. (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. [ Name of applicant (d) Acknowledgement of reliance on data. (1) All data submitted with or specifically cited in the application; and (2) Each other item of data in the Agency's files which: (i) Concerns the properties or effects of the applicant's product, of any product which is identical or substantially similar to the applicant's product, or of one or more of the active ingredients in the applicant's product; and (ii) Is one of the types of data that EPA would require to be submitted if the application sought the initial registration under FIFRA section 3(c)(5) of a product with composition and intended uses identical or substantially similar to the applicant's product, under the data requirements in effect on the date EPA approves the applicant's present application. [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014] § 152.90 The selective method. An applicant may comply with this subpart by listing the specific data requirements that apply to his product, its active ingredients, and use patterns, and demonstrating his compliance for each data requirement by submitting or citing individual studies, or by demonstrating that no study has previously been submitted to the Agency. This section summarizes the procedures that an applicant must follow if he chooses the selective method of demonstrating compliance. Sections 152.91 through 152.96 contain specific procedures for citing or submitting a study or claiming a data gap. (a) List of data requirements. (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. (1) Existence of or granting of a data waiver. Refer to § 152.91. (2) Submission of a new valid study. Refer to § 152.92. (3) Citation of a specific valid study previously submitted to the Agency by the applicant or another person, with any necessary written authorizations or offers to pay. Refer to § 152.93. (4) Citation of a public literature study. Refer to § 152.94. (5) Citation of all pertinent studies previously submitted to the Agency, with any necessary written authorizations or offers to pay. Refer to § 152.95. (6) Claim of data gap. Refer to § 152.96. [49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014] § 152.91 Waiver of a data requirement. The applicant may demonstrate compliance for a data requirement by documenting the existence of a waiver in accordance with paragraph (a) of this section, or by being granted a new waiver requested in accordance with paragraph (b) of this section. (a) Request for an extension of an existing waiver. (b) Request for a new waiver. (c) Effect of denial of waiver request. [49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014] § 152.92 Submission of a new valid study. An applicant may demonstrate compliance for a data requirement by submitting a valid study that has not previously been submitted to the Agency. A study previously submitted to the Agency should not be resubmitted but should be cited in accordance with § 152.93. § 152.93 Citation of a previously submitted valid study. An applicant may demonstrate compliance for a data requirement by citing a valid study previously submitted to the Agency. The study is not to be submitted to the Agency with the application. (a) Study originally submitted by the applicant. (b) Study previously submitted by another person. (1) Citation with authorization of original data submitter. (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. (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. [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014] § 152.94 Citation of a public literature study or study generated at government expense. (a) An applicant may demonstrate compliance for a data requirement by citing, and submitting to the Agency, one of the following: (1) A valid study from the public literature. (2) A valid study generated by, or at the expense of, any government (Federal, State, or local) agency. (b) In no circumstances does submission of a public literature study or government-generated study confer any rights on the data submitter to exclusive use of data or compensation under FIFRA section 3(c)(1)(F). [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008] § 152.95 Citation of all studies in the Agency's files pertinent to a specific data requirement. An applicant normally may demonstrate compliance for a data requirement by citation of all studies in the Agency's files pertinent to that data requirement. The applicant who selects this cite-all option must submit to the Agency: (a) A general offer to pay statement having the same wording as that specified in § 152.86(c) except that the offer to pay may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected; (b) A certification that: (1) For each person who is included on the Data Submitters List as an original data submitter of exclusive use data for the active ingredient in question, the applicant has obtained a written authorization containing the information required by § 152.86(a) for the use the any exclusive use study that would be pertinent to the applicant's product; and (2) For each person included on the current Data Submitters List as an original data submitter of data that are not exclusive use for the active ingredient in question, the applicant has furnished: (i) A notification of the applicant's intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients; (ii) Identification of the specific data requirement(s) for which the offer to pay for data is being made; (iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F); (iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for use of any study; and (v) The applicant's name, address, and contact information, including a telephone number and email address. (c) An acknowledgment having the same wording as that specified in § 152.86(d), except that it may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected. [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014] § 152.96 Claim of data gap. (a) When a data gap may be claimed. (b) When a data gap may not be claimed Product containing a new active ingredient. (2) Product not containing a new active ingredient. (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. (2) Notwithstanding paragraph (c)(1) of this section, the Agency will not approve an application if it determines that the data for which a data gap claim has been made are needed to determine if the product meets the requirements of FIFRA sections 3(c)(5) or (7). [79 FR 6826, Feb. 5, 2014] § 152.97 Rights and obligations regarding the Data Submitters List. (a) Each original data submitter shall have the right to be included on the Agency's Data Submitters List. (b) Each original data submitter who wishes to have his name added to the current Data Submitters List must submit to the Agency the following information: (1) Name and current address. (2) Chemical name, common name (if any) and Chemical Abstracts Service (CAS) number (if any) of the active ingredients(s), with respect to which he is an original data submitter. (3) For each such active ingredient, the type(s) of study he has previously submitted (identified by reference to data/information requirements listed in part 158 of this chapter), the date of submission, and the EPA registration number, file symbol, or other identifying reference for which it was submitted. (c) Each applicant not already included on the Data Submitters List for a particular active ingredient must inform the Agency at the time of the submission of a relevant study whether he wishes to be included on the Data Submitters List for that pesticide. [79 FR 6826, Feb. 5, 2014] § 152.98 Procedures for transfer of exclusive use or compensation rights to another person. A person who possesses rights to exclusive use or compensation under FIFRA section 3(c)(1)(F) may transfer such rights to another person in accordance with this section. (a) The original data submitter must submit to the Agency a transfer document that contains the following information: (1) The name, address and state of incorporation (if any) of the original data submitter (the transferor); (2) The name, address and state of incorporation (if any) of the person to whom the data rights are being transferred (the transferee); (3) Identification of each item of data transferred including: (i) The name of the study or item of data; (ii) Whether the study is an exclusive use study, and, if so, when the period of exclusive use protection expires; (iii) The name of the person or laboratory that conducted the study; (iv) The date the study was submitted to the Agency; (v) The EPA document number assigned to the item of data (the Master Record Identification Number or Accession Number), if known. If not known, the EPA administrative number (such as the EPA Registration Number, petition number, file symbol, or permit number) with which the item of data was submitted, such that the Agency can identify the item of data. (vi) A statement that the transferor transfers irrevocably to the transferee all rights, titles, and interest in the items of data named; (vii) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and (viii) The names, signatures and titles of the transferor and transferee, and the date signed. (b) In addition, the original data submitter must submit to the Agency a notarized statement affirming that: (1) The person signing the transfer agreement is authorized by the original data submitter to bind the data submitter; (2) No court order prohibits the transfer, and any required court approvals have been obtained; and (3) The transfer is authorized under Federal, State, and local law and relevant corporate charters, bylaws or partnership agreements. (c) The Agency will acknowledge the transfer of the data by notifying both transferor and transferee, and will state the effective date of the transfer. Thereafter the transferee will be considered to be the original data submitter of the items of data transferred for all purposes under FIFRA section 3(c)(1)(F), unless a new transfer agreement is submitted to the Agency. [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008] § 152.99 Petitions to cancel registration. An original data submitter may petition the Agency to deny or cancel the registration of a product in accordance with this section if he has submitted to the Agency a valid study which, he claims, satisfies a data requirement that an applicant purportedly has failed to satisfy. (a) Grounds for petition. (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 Time for filing. (2) Notice to affected registrant. (c) Disposition of petitions. (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. [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6826, Feb. 5, 2014] Subpart F—Agency Review of Applications Source: 53 FR 15980, May 4, 1988, unless otherwise noted. § 152.100 Scope. (a) The Agency will follow the procedures in this subpart for all applications for registration, except an application for registration of a pesticide that has been the subject of a previous Agency cancellation or suspension notice under FIFRA sec. 6. (b) The Agency will follow the procedures of subpart D of part 164 of this chapter in evaluating any application for registration of a pesticide involving use of the pesticide in a manner that is prohibited by a suspension or cancellation order, to the extent required by subpart D of part 164. § 152.102 Publication. The Agency will issue in the Federal Register Federal Register § 152.104 Completeness of applications. The applicant is responsible for the accuracy and completeness of all information submitted in connection with the application. The Agency will review each application to determine whether it is complete. An application is incomplete if any pertinent item specified in § 152.50 has not been submitted, or has been incorrectly submitted (for example, data required by part 158, or part 161 of this chapter, as applicable, and not submitted in accordance with the requirements for format, claims of confidential business information, or flagging). [72 FR 61028, Oct. 26, 2007] § 152.105 Incomplete applications. The Agency will not begin or continue the review of an application that is incomplete. If the Agency determines that an application is incomplete or that further information is needed in order to complete the Agency's review, the Agency will notify the applicant of the deficiencies and allow the applicant 75 days to make corrections or additions to complete the application. If the applicant believes that the deficiencies cannot be corrected within 75 days, he must notify the Agency within those 75 days of the date on which he expects to complete the application. If, after 75 days, the applicant has not responded, or if the applicant subsequently fails to complete the application within the time scheduled for completion, the Agency will terminate any action on such application, and will treat the application as if it had been withdrawn by the applicant. Any subsequent submission relating to the same product must be submitted as a new application. § 152.107 Review of data. (a) The Agency normally will review data submitted with an application that have not previously been submitted to the Agency. (b) The Agency normally will review other data submitted or cited by an applicant only: (1) As part of the process of reregistering currently registered products; (2) When acting on an application for registration of a product containing a new active ingredient; (3) If such data have been flagged in accordance with § 158.34 or § 161.34 of this chapter; or (4) When the Agency determines that it would otherwise serve the public interest. (c) If the Agency finds that it needs additional data in order to determine whether the product may be registered, it will notify the applicant as early as possible in the review process. [53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007] § 152.108 Review of labeling. The Agency will review all draft labeling submitted with the application. If an applicant for amended registration submits only that portion of the labeling proposed for amendment, the Agency may review the entire label, as revised by the proposed changes, in deciding whether to approve the amendment. The Agency will not approve final printed labeling, but will selectively review it for compliance. § 152.110 Time for agency review. The Agency will complete its review of applications as expeditiously as possible. Applications subject to specific timeframes under the fee schedule established by FIFRA section 33 will be reviewed within the timeframes established for the application or action type. [73 FR 75595, Dec. 12, 2008] § 152.111 Choice of standards for review of applications. The Agency has discretion to review applications under either the unconditional registration criteria of FIFRA sec. 3(c)(5) or the conditional registration criteria of FIFRA sec. 3(c)(7). The type of review chosen depends primarily on the extent to which the relevant data base has been reviewed for completeness and scientific validity. EPA conducts data reviews needed to support unconditional registrations on a chemical-by-chemical basis, according to an established priority list. Except for applications for registration of a new active ingredient or in special cases where it finds immediate review to be warranted, the Agency will not commence a complete review of the existing data base on a given chemical in response to receipt of an application for registration. Instead the Agency will review the application using the criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B). § 152.112 Approval of registration under FIFRA sec. 3(c)(5). EPA will approve an application under the criteria of FIFRA sec. 3(c)(5) only if: (a) The Agency has determined that the application is complete and is accompanied by all materials required by the Act and this part, including, but not limited to, evidence of compliance with subpart E of this part; (b) The Agency has reviewed all relevant data in the possession of the Agency (see §§ 152.107 and 152.111); (c) The Agency has determined that no additional data are necessary to make the determinations required by FIFRA sec. 3(c)(5) with respect to the pesticide product which is the subject of the application; (d) The Agency has determined that the composition of the product is such as to warrant the proposed efficacy claims for it, if efficacy data are required to be submitted for the product by part 158 or part 161 of this chapter, as applicable. (e) The Agency has determined that the product will perform its intended function without unreasonable adverse effects on the environment, and that, when used in accordance with widespread and commonly recognized practice, the product will not generally cause unreasonable adverse effects on the environment; (f) The Agency has determined that the product is not misbranded as that term is defined in FIFRA sec. 2(q) and part 156 of this chapter, and its labeling and packaging comply with the applicable requirements of the Act, this part, and parts 156 and 157 of this chapter; (g) If the proposed labeling bears directions for use on food, animal feed, or food or feed crops, or if the intended use of the pesticide results or may reasonably be expected to result, directly or indirectly, in pesticide residues (including residues of any active or inert ingredient of the product, or of any metabolite or degradation product thereof) in or on food or animal feed, all necessary tolerances, exemptions from the requirement of a tolerance, and food additive regulations have been issued under FFDCA sec. 408, and (h) If the product, in addition to being a pesticide, is a drug within the meaning of FFDCA sec. 201(q), the Agency has been notified by the Food and Drug Administration (FDA) that the product complies with any requirements imposed by FDA. [53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007; 73 FR 75595, Dec. 12, 2008] § 152.113 Approval of registration under FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient. (a) Except as provided in paragraph (b) of this section, the Agency may approve an application for registration or amended registration of a pesticide product, each of whose active ingredients is contained in one or more other registered peticide products, only if the Agency has determined that: (1) It possesses all data necessary to make the determinations required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide product which is the subject of the application (including, at a minimum, data needed to characterize any incremental risk that would result from approval of the application); (2) Approval of the application would not significantly increase the risk of any unreasonable adverse effect on the environment; and (3) The criteria of § 152.112(a), (d), and (f) through (h) have been satisfied. (b) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined that the applicant's product and its proposed use are identical or substantially similar to a currently registered pesticide and use, or that the pesticide and its proposed use differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment. (c) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if: (1) The pesticide is the subject of a special review, based on a use of the product that results in human dietary exposure; and (2) The proposed new use involves use on a major food or feed crop, or involves use on a minor food or feed crop for which there is available an effective alternative registered pesticide which does not meet the risk criteria associated with human dietary exposure. The determination of available and effective alternatives shall be made with the concurrence of the Secretary of Agriculture. § 152.114 Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new active ingredient. An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a period of time sufficient for the generation and submission of certain of the data necessary for a finding of registrability under FIFRA sec. 3(c)(5) if the Agency determines that: (a) Insufficient time has elapsed since the imposition of the data requirement for those data to have been developed; (b) All other required test data and materials have been submitted to the Agency; (c) The criteria in § 152.112(a), (b), (d), and (f) through (h) have been satisfied; (d) The use of the pesticide product during the period of the conditional registration will not cause any unreasonable adverse effect on the environment; and (e) The registration of the pesticide product and its subsequent use during the period of the conditional registration are in the public interest. § 152.115 Conditions of registration. (a) Substantially similar products and new uses. (b) New active ingredients. (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. (d) Cancellation if condition is not satisfied. [53 FR 15980, May 4, 1988, as amended at 60 FR 32096, June 19, 1995] § 152.116 Notice of intent to register to original submitters of exclusive use data. (a) Except as provided in paragraph (c) of this section, at least 30 days before registration of a product containing an active ingredient for which a previously submitted study is eligible for exclusive use under FIFRA sec. 3(c)(1)(F)(i), the Agency will notify the original submitter of the exclusive use study of the intended registration of the product. If requested by the exclusive use data submitter within 30 days, the Agency will also provide the applicant's list of data requirements and method of demonstrating compliance with each data requirement. (b) Within 30 days after receipt of the Agency's notice, or of the applicant's list of data requirements, whichever is later, the exclusive use data submitter may challenge the issuance of the registration in accordance with the procedures in § 152.99 (b) and (c). If the Agency finds that the challenge has merit, it will issue a notice of denial of the application. The applicant may then avail himself of the hearing procedures provided by FIFRA sec. 3(c)(6). If the Agency finds that the challenge is without merit, it will deny the petition and register the applicant's product. Denial of the petition is a final Agency action. (c) If an applicant has submitted to the Agency a certification from an exclusive use data submitter that he is aware of the applicant's application for registration, and does not object to the issuance of the registration, the Agency will not provide the 30-day notification described in paragraph (a) of this section to that exclusive use data submitter. [53 FR 15980, May 4, 1988, as amended at 73 FR 75595, Dec. 12, 2008] § 152.117 Notification to applicant. The Agency will notify the applicant of the approval of his application by a Notice of Registration for new registration, or by a letter in the case of an amended registration. § 152.118 Denial of application. (a) Basis for denial. (b) Notification of applicant. (c) Opportunity for remedy by the applicant. (d) Notice of denial. Federal Register, (e) Hearing rights. § 152.119 Availability of material in support of registration. (a) The information submitted to support a registration application shall be part of the official Agency file for that registration. (b) Within 30 days after registration, the Agency will make available for public inspection, upon request, the materials required by subpart E to be submitted with an application. Materials that will be publicly available include an applicant's list of data requirements, the method used by the applicant to demonstrate compliance for each data requirement, and the applicant's citations of specific studies in the Agency's possession if applicable. (c) Except as provided by FIFRA sec. 10, within 30 days after registration, the data on which the Agency based its decision to register the product will be made available for public inspection, upon request, in accordance with the procedures in 40 CFR part 2. Subpart G—Obligations and Rights of Registrants Source: 53 FR 15983, May 4, 1988, unless otherwise noted. § 152.122 Currency of address of record and authorized agent. (a) The registrant must keep the Agency informed of his current name and address of record. If the Agency's good faith attempts to contact the registrant are not successful, the Agency will issue in the Federal Register (b) The registrant must also notify the Agency if he changes his authorized agent. § 152.125 Submission of information pertaining to adverse effects. If at any time the registrant receives or becomes aware of any factual information regarding unreasonable adverse effects of the pesticide on the environment that has not previously been submitted to the Agency, the registrant shall, in accordance with FIFRA section 6(a)(2) and the requirements of part 159, subpart D of this chapter, provide such information to the Agency, clearly identified as FIFRA 6(a)(2) data. [73 FR 75595, Dec. 12, 2008] § 152.130 Distribution under approved labeling. (a) A registrant may distribute or sell a registered product with the composition, packaging and labeling currently approved by the Agency. (b) A registrant may distribute or sell a product under labeling bearing any subset of the approved directions for use, provided that in limiting the uses listed on the label, no changes would be necessary in precautionary statements, use classification, or packaging of the product. (c) Normally, if the product labeling is amended on the initiative of the registrant, by submission of an application for amended registration, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after approval of the revision, unless an order subsequently issued by the Agency under FIFRA sec. 6 or 13 provides otherwise. However, if paragraph (d) of this section applies to the registrant's product, the time frames established by the Agency in accordance with that paragraph shall take precedence. (d) If a product's labeling is required to be revised as a result of the issuance of a Registration Standard, a Label Improvement Program notice, or a notice concluding a special review process, the Agency will specify in the notice to the registrant the period of time that previously approved labeling may be used. In all cases, supplemental or sticker labeling may be used as an interim compliance measure for a reasonable period of time. The Agency may establish dates as follows governing when label changes must appear on labels: (1) The Agency may establish a date after which all product distributed or sold by the registrant must bear revised labeling. (2) The Agency may also establish a date after which no product may be distributed or sold by any person unless it bears revised labeling. This date will provide sufficient time for product in channels of trade to be distributed or sold to users or otherwise disposed of. § 152.132 Supplemental distribution. The registrant may distribute or sell his registered product under another person's name and address instead of (or in addition to) his own. Such distribution and sale is termed “supplemental distribution” and the product is referred to as a “distributor product.” The distributor is considered an agent of the registrant for all intents and purposes under the Act, and both the registrant and the distributor may be held liable for violations pertaining to the distributor product. Supplemental distribution is permitted upon notification to the Agency if all the following conditions are met: (a) The registrant has submitted to the Agency for each distributor product a statement signed by both the registrant and the distributor listing the names and addresses of the registrant and the distributor, the distributor's company number, the additional brand name(s) to be used, and the registration number of the registered product. (b) The distributor product is produced, packaged and labeled in a registered establishment operated by the same producer (or under contract in accordance with § 152.30) who produces, packages, and labels the registered product. (c) The distributor product is not repackaged (remains in the producer's unopened container). (d) The label of the distributor product is the same as that of the registered product, except that: (1) The product name of the distributor product may be different (but may not be misleading); (2) The name and address of the distributor may appear instead of that of the registrant; (3) The registration number of the registered product must be followed by a dash, followed by the distributor's company number (obtainable from the Agency upon request); (4) The establishment number must be that of the final establishment at which the product was produced; and (5) Specific claims may be deleted, provided that no other changes are necessary. (e) Voluntary cancellation of a product applies to the registered product and all distributor products distributed or sold under that registration number. The registrant is responsible for ensuring that distributors under his cancelled registration are notified and comply with the terms of the cancellation. [53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995] § 152.135 Transfer of registration. (a) A registrant may transfer the registration of a product to another person, and the registered product may be distributed and sold without the requirement of a new application for registration by that other person, if the parties submit to the Agency the documents listed in paragraphs (b) and (c) of this section, and receive Agency approval as described in paragraph (d) of this section. (b) Persons seeking approval of a transfer of registration must provide a document signed by the authorized representative of the registrant (the transferor) and of the person to whom the registration is transferred (the transferee) that contains the following information: (1) The name, address and State of incorporation (if any) of the transferor; (2) The name, address and State of incorporation of the transferee; (3) The name(s) and EPA registration number(s) of the product(s) being transferred; (4) A statement that the transferor transfers irrevocably to the transferee all right, title, and interest in the EPA registration(s) listed in the document; (5) A statement that the transferred registration(s) shall not serve as collateral or otherwise secure any loan or other payment arrangement or executory promise, and that the registration(s) shall not revert to the transferor unless a new transfer agreement is submitted to and approved by the Agency; (6) A description of the general nature of the underlying transaction, e.g., merger, spinoff, bankruptcy transfer (no financial information need be disclosed); (7) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and (8) An acknowledgment by the transferee that his rights and duties concerning the registration under FIFRA and this chapter will be deemed by EPA to be the same as those of the transferor at the time the transfer is approved. (c) In addition, the transferor must submit to the Agency a notarized statement affirming that: (1) The person signing the transfer agreement is authorized by the registrant to bind the transferor; (2) No court order prohibits the transfer, and that any required court approvals have been obtained; and (3) The transfer is authorized under all relevant Federal, State and local laws and all relevant corporate charters, bylaws, partnerships, or other agreements. (d) If the required documents are submitted, and no information available to the Agency indicates that the information is incorrect, the Agency will approve the transfer without requiring that the transferee obtain a new registration. The Agency will notify the transferor and transferee of its approval. (e) The transfer will be effective on the date of Agency approval. Thereafter the transferee will be regarded as the registrant for all purposes under FIFRA. (f) Rights to exclusive use of data or compensation under FIFRA section 3(c)(1)(F) are separate from the registration itself and may be retained by the transferor, or may be transferred independently in accordance with the provisions of § 152.98. If the registrant as the original data submitter wishes to transfer data rights at the same time as he transfers the registration, he may submit a single transfer document containing the information required by this section for both the registration and the data. [53 FR 15983, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 73 FR 75595, Dec. 12, 2008] Subpart H [Reserved] Subpart I—Classification of Pesticides Source: 53 FR 15986, May 4, 1988, unless otherwise noted. § 152.160 Scope. (a) Types of classification. (b) Kinds of restrictions. § 152.161 Definitions. In addition to the definitions in § 152.3, the following terms are defined for the purposes of this subpart: (a) Dietary LC 50 (b) Outdoor use § 152.164 Classification procedures. (a) Grouping of products for classification purposes. (1) Contain the same active ingredients. (2) Contain the same active ingredients in a particular concentration range, formulation type, or combination of concentration range and formulation type. (3) Have uses in common. (4) Have other characteristics, such as toxicity, flammability, or physical properties, in common. (b) Classification reviews. (1) As part of the review of an application for new registration of a product containing an active ingredient not contained in any currently registered product. (2) As part of the review of an application for a new use of a product, if existing uses of that product previously have been classified for restricted use. Review of a restricted use product at this time is for the purpose of determining whether the new use should also be classified for restricted use. Normally the Agency will not conduct initial classification reviews for existing uses of individual products in conjunction with an application for amended registration. (3) As part of the process of developing or amending a registration standard for a pesticide. The Agency normally will conduct classification reviews of all uses of a currently registered pesticide at this time. (4) As part of any special review of a pesticide, in accordance with the procedures of 40 CFR part 154. (c) Classification procedures. (i) A copy of the amended label and any supplemental labeling to be used as an interim compliance measure. (ii) A statement, which the Agency considers a report under the Act, that the registrant will comply with the labeling requirements prescribed by the Agency within the timeframes prescribed by the regulation. (iii) An application for amended registration to delete the uses which have been restricted, or to “split” the registration into two registrations, one including only restricted or all uses, and the other including only uses that have not been classified. (2) Alternatively, EPA may notify the applicant or registrant of the classification decision and require that he submit the information required by paragraph (c)(1) of this section. The Agency may deny registration or initiate cancellation proceedings if the registrant fails to comply within the timeframes established by the Agency in its notification. § 152.166 Labeling of restricted use products. (a) Products intended for end use. (b) Products intended only for formulation. § 152.167 Distribution and sale of restricted use products. Unless modified by the Agency, the compliance dates in this section shall apply to restricted use products. (a) Sale by registrant or producer. (i) Bears an approved amended label which contains the terms of restricted use imposed by the Agency and otherwise complies with part 156 of this chapter; (ii) Bears a sticker containing the product name, EPA registration number, and any terms of restricted use imposed by the Agency; or (iii) Is accompanied by supplemental labeling bearing the information listed in paragraph (a)(1)(ii) of this section. (2) If the registrant chooses to delete the restricted uses from his product label, that product may not be distributed or sold after the 180th day after the effective date of classification unless the product bears amended labeling with the restricted uses deleted. (3) Notwithstanding paragraphs (a) (1) and (2) of this section, after the 270th day after the effective date of classification, no registrant or producer may distribute or sell a product that does not bear the approved amended label. After that date, stickers and supplemental labeling described in paragraph (a)(1) (ii) and (iii) are no longer acceptable. (b) Sale by retailer. § 152.168 Advertising of restricted use products. (a) Any product classified for restricted use shall not be advertised unless the advertisement contains a statement of its restricted use classification. (b) The requirement in paragraph (a) of this section applies to all advertisements of the product, including, but not limited, to: (1) Brochures, pamphlets, circulars and similar material offered to purchasers at the point of sale or by direct mail. (2) Newspapers, magazines, newsletters and other material in circulation or available to the public. (3) Broadcast media such as radio and television. (4) Telephone advertising. (5) Billboards and posters. (c) The requirement may be satisfied for printed material by inclusion of the statement “Restricted Use Pesticide,” or the terms of restriction, prominently in the advertisement. The requirement may be satisfied with respect to broadcast or telephone advertising by inclusion in the broadcast of the spoken words “Restricted use pesticide,” or a statement of the terms of restriction. (d) The requirements of this section shall be effective: (1) After 270 days after the effective date of restriction of a product that is currently registered, unless the Agency specifies a shorter time period; (2) Upon the effective date of registration of a product not currently registered. § 152.170 Criteria for restriction to use by certified applicators. (a) General criteria. (1) Its toxicity exceeds one or more of the specific hazard criteria in paragraph (b) or (c) of this section, or evidence described in paragraph (d) of this section substantiates that the product or use poses a serious hazard that may be mitigated by restricting its use; (2) Its labeling, when considered according to the factors in paragraph (e)(2) of this section, is not adequate to mitigate these hazard(s); (3) Restriction of the product would decrease the risk of adverse effects; and (4) The decrease in risks of the pesticide as a result of restriction would exceed the decrease in benefits. (b) Criteria for human hazard Residential and institutional uses. (i) The pesticide, as diluted for use, has an acute oral LD 50 (ii) The pesticide, as formulated, has an acute dermal LD 50 (iii) The pesticide, as formulated, has an acute inhalation LC 50 (iv) The pesticide, as formulated, is corrosive to the eye (causes irreversible destruction of ocular tissue) or results in corneal involvement or irritation persisting for more than 7 days; (v) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or scarring) or causes severe irritation (severe erythema or edema) at 72 hours; or (vi) When used in accordance with label directions, or widespread and commonly recognized practice, the pesticide may cause significant subchronic, chronic or delayed toxic effects on man as a result of single or multiple exposures to the product ingredients or residues. (2) All other uses. (i) The pesticide, as formulated, has an acute oral LD 50 (ii) The pesticide, as formulated, has an acute dermal LD 50 (iii) The pesticide, as diluted for use, has an acute dermal LD 50 (iv) The pesticide, as formulated, has an acute inhalation LC 50 (v) The pesticide, as formulated, is corrosive to the eye or causes corneal involvement or irritation persisting for more than 21 days; (vi) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or scarring); or (vii) When used in accordance with label directions, or widespread and commonly recognized practice, the pesticide may cause significant subchronic toxicity, chronic toxicity, or delayed toxic effects on man, as a result of single or multiple exposures to the product ingredients or residues. (c) Criteria for hazard to non-target species All products. (i) When used according to label directions, application results in residues of the pesticide, its metabolites, or its degradation products, in the diet of exposed mammalian wildlife, immediately after application, such that: (A) The level of such residues equals or exceeds one-fifth of the acute dietary LC 50 (B) The amount of pesticide consumed in one feeding day (mg/kg/day) equals or exceeds one-fifth of the mammalian acute oral LD 50 (ii) When used according to label directions, application results, immediately after application, in residues of the pesticide, its metabolites or its degradation products, in the diet of exposed birds at levels that equal or exceed one-fifth of the avian subacute dietary LC 50 (iii) When used according to label directions, application results in residues of the pesticide, its metabolites or its degradation products, in water that equal or exceed one-tenth of the acute LC 50 (iv) Under conditions of label use or widespread and commonly recognized practice, the pesticide may cause discernible adverse effects on non-target organisms, such as significant mortality or effects on the physiology, growth, population levels or reproduction rates of such organisms, resulting from direct or indirect exposure to the pesticide, its metabolites or its degradation products. (2) Granular products. (i) The formulated product has an acute avian or mammalian oral LD 50 (ii) It is intended to be applied in such a manner that significant exposure to birds or mammals may occur. (d) Other evidence. (e) Alternative labeling language. (2) The labeling will be judged adequate if it meets all the following criteria: (i) The user, in order to follow label directions, would not be required to perform complex operations or procedures requiring specialized training and/or experience. (ii) The label directions do not call for specialized apparatus, protective equipment, or materials that reasonably would not be available to the general public. (iii) Failure to follow label directions in a minor way would result in few or no significant adverse effects. (iv) Following directions for use would result in few or no significant adverse effects of a delayed or indirect nature through bioaccumulation, persistence, or pesticide movement from the original application site. (v) Widespread and commonly recognized practices of use would not nullify or detract from label directions such that unreasonable adverse effects on the environment might occur. § 152.171 Restrictions other than those relating to use by certified applicators. The Agency may by regulation impose restrictions on a product or class of products if it determines that: (a) Without such restrictions, the product when used in accordance with warnings, cautions and directions for use or in accordance with widespread and commonly recognized practices of use may cause unreasonable adverse effects on the environment; and (b) The decrease in risks as a result of restricted use would exceed the decrease in benefits as a result of restricted use. § 152.175 Pesticides classified for restricted use. The following uses of pesticide products containing the active ingredients specified below have been classified for restricted use and are limited to use by or under the direct supervision of a certified applicator. Active ingredient Formulation Use pattern Classification 1 Criteria influencing restriction Acrolein As sole active ingredient. No mixtures registered All uses Restricted Inhalation hazard to humans. Residue effects on avian species and aquatic organisms. Aldicarb As sole active ingredient Ornamental uses (indoor and outdoor) ......do Other hazards—accident history. No mixtures registered Agricultural crop uses Under further evaluation Aluminum phosphide As sole active ingredient. No mixtures registered ......do ......do Inhalation hazard to humans. Azinphos methyl All liquids with a concentration greater than 13.5 pct ......do ......do Do. All other formulations ......do Under futher evaluation. Carbofuran All concentrate suspensions and wettable powders 40% and greater ......do ......do Acute inhalation toxicity. All granular formulations Rice Under evaluation All granular and fertilizer formulations All uses except rice ......do Chloropicrin All formulations greater than 2% All uses ......do Acute inhalation toxicity. All formulations Rodent control ......do Hazard to non-target organisms. All formulations 2% and less Outdoor uses (other than rodent control) Unclassified Clonitralid All wettable powders 70% and greater All uses Restricted Acute inhalation toxicity. All granulars and wettable powders Molluscide uses Restricted Effects on aquatic organisms. Pressurized sprays 0.55% and less Hospital antiseptics Unclassified Dicrotophos All liquid formulations 8% and greater All uses Restricted Acute dermal toxicity; residue effects on avian species (except for tree injections). Disulfoton All emulsifiable concentrates 65% and greater, all emulsifiable concentrates and concentrate solutions 21% and greater with fensulfothion 43% and greater, all emulsifiable concentrates 32% and greater in combination with 32% fensulfothion and greater ......do Restricted Do. Non-aqueous solution 95% and greater Commercial seed treatment Restricted Acute dermal toxicity. Granular formulations 10% and greater Indoor uses (greenhouse) ......do Acute inhalation toxicity. Ethoprop Emulsifiable concentrates 40% and greater Aquatic uses ......do Acute dermal toxicity. All granular and fertilizer formulations All uses Under evaluation Ethyl parathion All granular and dust formulations greater than 2 pct, fertilizer formulations, wettable powders, emulsifiable concentrates, concentrated suspensions, concentrated solutions ......do Restricted Inhalation hazard to humans. Acute dermal toxicity. Residue effects on mammalian, aquatic, avian species. Smoke fumigants ......do ......do Inhalation hazard to humans. Dust and granular formulations 2 pct and below ......do ......do Other hazards—accident history. Fenamiphos Emulsifiable concentrates 35% and greater ......do ......do Acute dermal toxicity. Fonofos Emulsifiable concentrates 44% and greater ......do ......do Acute dermal toxicity. Emulsifiable concentrates 12.6% and less with pebulate 50.3% and less Tobacco Unclassified Methamidophos Liquid formulations 40% and greater ......do Restricted Acute dermal toxicity; residue effects on avian species. Dust formulations 2.5% and greater ......do ......do Residue effects on avian species. Methidathion All formulations All uses except nursery stock, safflower and sunflower ......do Do. All formulations Nursery stock, safflower and sunflower Unclassified Methomyl As sole active ingredient in 1 pct to 2.5 baits (except 1 pct fly bait) Nondomestic outdoors-agricultural crops, ornamental and turf. All other registered uses Restricted Residue effects on mammalian species. All concentrated solution formulations ......do ......do Other hazards-accident history. 90 pct wettable powder formulations (not in water soluble bags) ......do ......do Do. 90 pct wettable powder formulation in water soluble bags ......do Unclassified All granular formulations ......do ......do 25 pct wettable powder formulations ......do ......do In 1.24 pct to 2.5 pct dusts as sole active ingredient and in mixtures with fungicides and chlorinated hydrocarbon, inorganic phosphate and biological insecticides ......do ......do Methyl bromide All formulations in containers greater than 1.5 lb All uses Restricted Do. Containers with not more than 1.5 lb of methyl bromide with 0.25 pct to 2.0 pct chloropicrin as an indicator Single applications (nondomestic use) for soil treatment in closed systems Unclassified Container with not more than 1.5 lb having no indicator All uses Restricted Do. Methyl parathion All dust and granular formulations less than 5 pct ......do ......do Other hazards-accident history. All foliar applications restricted based on residue effects on mammalian and avian species. Microencapsulated ......do ......do Residue effects on avian species. Hazard to bees. All dust and granular formulations 5 pct and greater and all wettable powders and liquids ......do ......do Acute dermal toxicity. Residue effects on mammalian and avian species. Nicotine (alkaloid) Liquid and dry formulations 14% and above Indoor (greenhouse) ......do Acute inhalation toxicity. All formulations Applications to cranberries ......do Effects on aquatic organisms. Liquid and dry formulations 1.5% and less All uses (domestic and nondomestic) Unclassified Paraquat (dichloride) and paraquat bis(methyl sulfate) All formulations and concentrations except those listed below All uses Restricted Other hazards. Use and accident history, human toxicological data. Pressurized spray formulations containing 0.44 pct Paraquat bis(methyl sulfate) and 15 pct petroleum distillates as active ingredients Spot weed and grass control ......do Liquid fertilizers containing concentrations of 0.025 pct paraquat dichloride and 0.03 percent atrazine; 0.03 pct paraquat dichloride and 0.37 pct atrazine, 0.04 pct paraquat dichloride and 0.49 pct atrazine All uses Unclassified Phorate Liquid formulations 65% and greater ......do Restricted Acute dermal toxicity. All granular formulations Rice ......do Effects on aquatic organisms. Phosphamidon Liquid formulations 75% and greater ......do ......do Acute dermal toxicity. Dust formulations 1.5% and greater ......do ......do Do. Picloram All formulations and concentrations except tordon 101 R ......do ......do Hazard to nontarget organisms (specifically nontarget plants both crop and noncrop). Tordon 101 R forestry herbicide containing 5.4 pct picloram and 20.9 pct 2.4-D Control of unwanted trees by cut surface treatment Unclassified Sodium cyanide 3 All capsules and ball formulations All uses Restricted Inhalation hazard to humans. Sodium fluoroacetate All solutions and dry baits ......do ......do Acute oral toxicity. Hazard to nontarget organisms. Use and accident history. Strychnine All dry baits, pellets and powder formulations greater than 0.5 pct ......do ......do Acute oral toxicity. Hazard to nontarget avain species. Use and accident history. All dry baits, pellets and powder formulations All uses calling for burrow builders ......do Hazard to nontarget organisms. All dry baits, pellets and powder formulations 0.5 pct and below All uses except subsoil ......do Do. ......do All subsoil uses Unclassified Sulfotepp Sprays and smoke generators All uses Restricted Inhalation hazard to humans. Zinc Phosphide All formulations 2% and less All domestic uses and non-domestic uses in and around buildings Unclassified All dry formulations 60% and greater All uses Restricted Acute inhalation toxicity. All bait formulations Non-domestic outdoor uses (other than around buildings) ......do Hazard to non-target organisms. All dry formulations 10% and greater Domestic uses ......do Acute oral toxicity. 1 2 3 Note [43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46 FR 5698, Jan. 19, 1981. Redesignated and amended at 53 FR 15988, May 4, 1988; 60 FR 32096, June 19, 1995] Subparts J-T [Reserved] Subpart U—Registration Fees Source: 53 FR 19114, May 26, 1988, unless otherwise noted. § 152.400 Purpose. Subpart U prescribes fees to be charged for the pesticide regulatory activities set forth in § 152.403 as performed by the Environmental Protection Agency (as authorized by 31 U.S.C. 9701 and Pub. L. 100-202) and provisions regarding their payment. § 152.401 Inapplicability of fee provisions to applications filed prior to October 1, 1997. No fee required by this subpart U shall be levied with respect to any application filed during the period beginning on October 25, 1988, and ending on September 30, 1997. See FIFRA section 4(i)(7) (added to FIFRA by Pub. L. 100-532, October 25, 1988, 102 Stat. 2654). [53 FR 11923, Mar. 22, 1989] § 152.403 Definitions of fee categories. (a) New chemical registration review (b) New biochemical and microbial registration review (c) New use pattern registration review (d) Old chemical registration review (e) Amendment review (f) Experimental use permit review [53 FR 19114, May 26, 1988, as amended at 72 FR 61028, Oct. 26, 2007] § 152.404 Fee amounts. The fee prescribed by the following table must be submitted with each application for registration, amended registration or experimental use permit. Fees will be adjusted annually in accordance with § 152.410. The Agency may waive or refund fees in accordance with § 152.412. Table—Registration Fees Type of review Fee New chemical $184,500 New biochemical or microbial 64,000 New use pattern 33,800 Experimental use permit 4,500 Old chemical 4,000 Amendment 700 [53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993] § 152.406 Submission of supplementary data. Applicants may submit data to supplement pending applications without incurring additional charges if the proper fee was paid with submission of the original application and subsequent submissions of supplementary data do not constitute a change in the type of registration action requested. [53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993] § 152.408 Special considerations. (a) If two or more applicants apply for a new chemical registration for products having the same active ingredient and each applicant provides a set of data in support of the registration developed independently of the other applicants' data, then each applicant submitting an independent set of data shall be charged the full new chemical registration review fee. (b) If two or more applicants apply for a new chemical registration for products having the same active ingredient and the applicants have jointly developed or paid for the joint development of a common set of data to support their applications for registration, then each applicant shall be charged an equal share of the total fee for review of the applications for all of the subject products. The total fee will include the sum of the new chemical registration review fee for one product and one old chemical registration review fee for each additional product. (c) If an application is received for registration of a product that contains two or more new chemical active ingredients and a different set of generic data is required by the Agency for each new chemical for the purpose of registration, the applicant will be required to pay the full new chemical registration review fee for each active ingredient. § 152.410 Adjustment of fees. (a) The fee schedule will be adjusted annually by the same percentage as the percent change in the Federal General Schedule (GS) pay scale. Such adjustments will be published in the Federal Register (b) Processing costs and fees will be reviewed periodically and changes will be made to the schedule as necessary. Such adjustments will be published for notice and comment in the Federal Register. § 152.412 Waivers and refunds. (a) Refunds. (b) Waiver of fees for activities initiated by the Agency. (c) Waiver of fees for activities initiated by applicants. (1) Minor use. (2) IR-4. (3) Severe economic impact. (i) The company applying had less than $40 million in gross revenue (including all revenue sources) in the most recently concluded fiscal year of operation, and a single fee would constitute more than 3 percent of the applicant's gross revenue from pesticide sales in the most recently completed fiscal year of operation, or (ii) The company applying had less than $40 million in gross revenue (including all revenue sources) in the most recently concluded fiscal year of operation, and the cumulative registration fees paid during the 12 months following the applicant's most recently completed fiscal year, including any registration fees paid for the applicant for which a waiver is requested, constitute more than 3 percent of the applicant's gross revenue from pesticide sales in the most recently concluded fiscal year of operation. (iii) The Agency will not grant such a waiver if it determines that the entity submitting the application has been formed or manipulated to qualify for such a waiver. (4) Public interest. [53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993] § 152.414 Procedures. (a) Procedures for requesting a waiver. (2) A payment of $1,200 for processing the waiver or the amount of the actual fee, whichever is less, must be submitted simultaneously to the address set forth in paragraph (b) of this section. This fee will be refunded (or applied to any resulting partial fee) if the waiver is granted. Payment of fees for the registration activities, in contrast to the waiver fee, shall not be required until the Agency makes a determination on the waiver request. Since the actual fee is submitted to an address different than the one to which the waiver request is submitted, a copy of the payment document must be submitted with the waiver request that is submitted to the Office of Pesticide Programs' Document Processing Desk as described in paragraph (a)(1) of this section. No fee is required from a person who has no financial interest in the application. (b) Procedures for payment of fees. (c) Procedures for submitting application and supporting data. [53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993; 69 FR 39864, July 1, 2004; 71 FR 35545, June 21, 2006] Subparts V-Y [Reserved] Subpart Z—Devices § 152.500 Requirements for devices. (a) A device is defined as any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom. (b) A device is not required to be registered under FIFRA sec. 3. The Agency has issued a policy statement concerning its authority and activities with respect to devices, which was published in the Federal Register (1) FIFRA sec. 2(q)(1) and part 156 of this chapter, with respect to labeling; (2) FIFRA sec. 7 and part 167 of this chapter, with respect to establishment registration and reporting; (3) FIFRA sec. 8 and part 169 of this chapter, with respect to books and records; (4) FIFRA sec. 9, with respect to inspection of establishments; (5) FIFRA sec. 12, 13, and 14, with respect to violations, enforcement activities, and penalties; (6) FIFRA sec. 17, with respect to import and export of devices; (7) FIFRA sec. 25(c)(3), with respect to child-resistant packaging; and (8) FIFRA sec. 25(c)(4), with respect to the Agency's authority to declare devices subject to certain provisions of the Act. [53 FR 15990, May 4, 1988. Redesignated at 60 FR 32096, June 19, 1995]

Related documents

• 50 CFR Part 600 — Magnuson-Stevens Act Provisions#512148
• 50 CFR Part 622 — Fisheries of the Caribbean, Gulf of America, and South Atlantic#512149
• 50 CFR Part 635 — Atlantic Highly Migratory Species#512150
• 50 CFR Part 648 — Fisheries of the Northeastern United States#512151
• 50 CFR Part 660 — Fisheries off West Coast States#512152