40 CFR Part 152 -- Pesticide Registration and Classification Procedures

Table of Contents

152.1    Scope
152.3    Definitions
152.5    Pests
152.8    Products That are not Pesticides Because They are not for use Against Pests
152.10    Products That are not Pesticides Because They are not Deemed to be used for a
            Pesticidal Effect
152.15    Pesticide Products Required to be Registered
152.20    Exemptions for Pesticides Regulated by Another Federal Agency
152.25    Exemptions for Pesticides of a Character not Requiring FIFRA Regulation
152.30    Pesticides That may be Transferred, Sold, or Distributed without Registration
152.40    Who May Apply
152.42    Application for New Registration
152.43    Alternate Formulations
152.44    Application for Amended Registration
152.46    Notification and Non-Notification Changes to Registrations
152.50    Contents of Application
152.55    Where to Send Applications and Correspondence

Subpart D    Reregistration Procedures     (Reserved)
152.80    General
152.81    Applicability
152.83    Definitions
152.84    When Materials must be Submitted to the Agency
152.85    Formulators' Exemption
152.86    The Cite-All Method
152.90    The Selective Method
152.91    Waiver of a Data Requirement
152.92    Submission of a New Valid Study
152.93    Citation of a Previously Submitted Valid Study
152.94    Citation of a Public Literature Study or Study Generated at Government Expense
152.95    Citation of All Studies in the Agency's Files Pertinent to a Specific Data
            Requirement
152.96    Documentation of a Data Gap
152.97    Rights and Obligations of Data Submitters
152.98    Procedures for Transfer of Exclusive Use or Compensation Rights to Another
            Person
152.99    Petitions to Cancel Registration
152.100    Scope
152.102    Publication
152.104    Completeness of Applications
152.105    Incomplete Applications
152.107    Review of Data
152.108    Review of Labeling
152.110    Time for Agency Review
152.111    Choice of Standards for Review of Applications
152.112    Approval of Registration Under FIFRA Sec. 3(c)(5)
152.113    Approval of Registration Under FIFRA Sec. 3(c)(7) -- Products That do not Contain
            a New Active Ingredient
152.114    Approval of Registration Under FIFRA Sec. 3(c)(7) -- Products That Contain a New
            Active Ingredient
152.115    Conditions of Registration
152.116    Notice of Intent to Register to Original Submitters of Exclusive Use Data
152.117    Notification to Applicant
152.118    Denial of Application
152.119    Availability of Material in Support of Registration
152.122    Currency of Address of Record and Authorized Agent
152.125    Submission of Information Pertaining to Adverse Effects
152.130    Distribution Under Approved Labeling
152.132    Supplemental Distribution
152.135    Transfer of Registration
152.138    Voluntary Cancellation    (Removed)


        Subpart A -- General Provisions

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

§152.1 Scope.

    Part 152 sets forth procedures, requirements and criteria concerning the registration and reregistration of pesticide products under FIFRA sec. 3, and for associated regulatory activities affecting registration. These latter regulatory activities include data compensation and exclusive use (subpart E), and the classification of pesticide uses (subpart I).

§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.
    (a) "Act" or "FIFRA" means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136 - 136y).
    (b) "Active ingredient" means any substance (or group of structurally similar substances if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA sec. 2(a).
    (c) "Acute dermal LD(50)" means a statistically derived estimate of the single dermal dose of a substance that would cause 50 percent mortality to the test population under specified conditions.
    (d) "Acute inhalation LC(50)" means a statistically derived estimate of the concentration of a substance that would cause 50 percent mortality to the test population under specified conditions.
    (e) "Acute oral LD(50)" means a statistically derived estimate of the single oral dose of a substance that would cause 50 percent mortality to the test population under specified conditions.
    (f) "Administrator" means the Administrator of the United States Environmental Protection Agency or his delegate.
    (g) "Agency" means the United States Environmental Protection Agency (EPA), unless otherwise specified.
    (h) "Applicant" means a person who applies for a registration, amended registration, or reregistration, under FIFRA sec. 3.
    (i) "Biological control agent" means any living organism applied to or introduced into the environment that is intended to function as a pesticide against another organism declared to be a pest by the Administrator.
    (j) "Distribute or sell" and other grammatical variations of the term such as "distributed or sold" and "distribution or sale," means the acts of distributing, selling, offering for sale, holding for sale, shipping, holding for shipment, delivering for shipment, or receiving and (having so received) delivering or offering to deliver, or releasing for shipment to any person in any State.
    (k) "End use product" means a pesticide product whose labeling
    (1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating, or regulating the growth of plants, and
    (2) Does not state that the product may be used to manufacture or formulate other pesticide products.
    (l) "Final printed labeling" means the label or labeling of the product when distributed or sold. Final printed labeling does not include the package of the product, unless the labeling is an integral part of the package.
    (m) "Inert ingredient" means any substance (or group of structurally similar substances if designated by the Agency), other than an active ingredient, which is intentionally included in a pesticide product.
    (n) "Institutional use" means any application of a pesticide in or around any property or facility that functions to provide a service to the general public or to public or private organizations, including but not limited to:
    (1) Hospitals and nursing homes.
    (2) Schools other than preschools and day care facilities.
    (3) Museums and libraries.
    (4) Sports facilities.
    (5) Office buildings.
    (o) Manufacturing use product means any pesticide product that is not an end-use product.
    (p) "New use," when used with respect to a product containing a particular active ingredient, means:
    (1) Any proposed use pattern that would require the establishment of, the increase in, or the exemption from the requirement of, a tolerance or food additive regulation under section 408 or 409 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.
    (q) "Operated by the same producer," when used with respect to two establishments, means that each such establishment is either owned by, or leased for operation by and under the control of, the same person. The term does not include establishments owned or operated by different persons, regardless of contractual agreement between such persons.
    (r) "Package or packaging" means the immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution, sale, consumption, use, or storage. The term does not include any shipping or bulk container used for transporting or delivering the pesticide unless it is the only such package.
    (s) "Pesticide" means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, other than any article that:
    (1) Is a new animal drug under FFDCA sec. 201(w), or
    (2) Is an animal drug that has been determined by regulation of the Secretary of Health and Human Services not to be a new animal drug, or
    (3) Is an animal feed under FFDCA sec. 201(x) that bears or contains any substances described by paragraph (s)(1) or (2) of this section.
    (t) "Pesticide product" means a pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold. The term includes any physical apparatus used to deliver or apply the pesticide if distributed or sold with the pesticide.
    (u) "Residential use" means use of a pesticide directly:
    (1) On humans or pets,
    (2) In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or
    (3) In any preschool or day care facility.

§152.5 Pests.

    An organism is declared to be a pest under circumstances that make it deleterious to man or the environment, if it is:
    (a) Any vertebrate animal other than man;
    (b) Any invertebrate animal, including but not limited to, any insect, other arthropod, nematode, or mollusk such as a slug and snail, but excluding any internal parasite of living man or other living animals;
    (c) Any plant growing where not wanted, including any moss, alga, liverwort, or other plant of any higher order, and any plant part such as a root; or
    (d) Any fungus, bacterium, virus, or other microorganisms, 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 sec. 201(g)(1)) and cosmetics (as defined in FFDCA sec. 201(i)).

§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 product intended for use only for the control of fungi, bacteria, viruses, or other microorganisms in or on living man or animals, and labeled accordingly.
    (b) A product intended for use only for control of internal invertebrate parasites or nematodes in living man or animals, and labeled accordingly.
    (c) A product of any of the following types, intended only to aid the growth of desirable plants:
    (1) A fertilizer product not containing a pesticide.
    (2) 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.
    (3) A plant inoculant product consisting of microorganisms applied to the plant or soil for the purpose of enhancing the availability or uptake of plant nutrients through the root system.
    (4) A soil amendment product containing a substance or substances added to the soil for the purpose of improving soil characteristics favorable for plant growth.
    (d) A product intended to force bees from hives for the collection of honey crops.


§152.10 Products that are not pesticides because they are not deemed to be used for a pesticidal effect.

    A product that is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or regulate the growth of plants, is not considered to be a pesticide. The following types of products or articles are not considered to be pesticides unless a pesticidal claim is made on their labeling or in connection with their sale and distribution:
    (a) Deodorizers, bleaches, and cleaning agents;
    (b) Products not containing toxicants, intended only to attract pests for survey or detection purposes, and labeled accordingly;
    (c) Products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants, such as certain pruning paints to trees.


§152.15 Pesticide products required to be registered.

    No person may distribute or sell any pesticide product that is not registered under the Act, except as provided in §§ 152.20, 152.25, and 152.30. A pesticide is any substance (or mixture of substances) intended for a pesticidal purpose, i.e., use for the purpose of preventing, destroying, repelling, or mitigating any pest or use as a plant regulator, defoliant, or desiccant. A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
    (a) The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise):
    (1) That the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or
    (2) That the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or
    (b) The substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide; or
    (c) The person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose.


        Subpart B -- Exemptions

§152.20 Exemptions for pesticides regulated by another Federal agency.

    The pesticides or classes of pesticide listed in this section are exempt from all requirements of FIFRA. The Agency has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated by another Federal agency.
    (a) Certain biological control agents.
    (1) Except as provided by paragraph (a)(3) of this section, all biological control agents are exempt from FIFRA requirements.
    (2) If the Agency determines that an individual biological control agent or class of biological control agents is no longer adequately regulated by another Federal agency, and that it should not otherwise be exempted from the requirements of FIFRA, the Agency will revoke this exemption by amending paragraph (a)(3) of this section.
    (3) The following biological control agents are not exempt from FIFRA requirements:
    (i) Eucaryotic microorganisms, including protozoa, algae and fungi;
    (ii) Procaryotic microorganisms, including bacteria; and
    (iii) Viruses.
    (b) Certain human drugs. A pesticide product that is offered solely for human use and also is a new drug within the meaning of FFDCA sec. 201(p) or is an article that has been determined by the Secretary of Health and Human Services not to be a new drug by a regulation establishing conditions of use for the article, is exempt from the requirements of FIFRA. Such products are subject to regulation in accordance with the Federal Food, Drug, and Cosmetic Act and implementing regulations.


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

    The pesticides or classes of pesticides listed in this section have been determined to be of a character not requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended for use, and used, only in the manner specified.
    (a) Treated articles or substances. An article or substance treated with, or containing, a pesticide to protect the article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insect or fungus infestation), if the pesticide is registered for such use.
    (b) Pheromones and pheromone traps. Pheromones and identical or substantially similar compounds labeled for use only in pheromone traps (or labeled for use in a manner which the Administrator determines poses no greater risk of adverse effects on the environment than use in pheromone traps), and pheromone traps in which those compounds are the sole active ingredient(s).
    (1) For the purposes of this paragraph, a pheromone is a compound produced by an arthropod which, alone or in combination with other such compounds, modifies the behavior of other individuals of the same species.
    (2) For the purposes of this paragraph, a synthetically produced compound is identical to a pheromone only when their molecular structures are identical, or when the only differences between the molecular structures are between the stereochemical isomer ratios of the two compounds, except that a synthetic compound found to have toxicological properties significantly different from a pheromone is not identical.
    (3) When a compound possesses many characteristics of a pheromone but does not meet the criteria in paragraph (a)(2) of this section, it may, after review by the Agency, be deemed a substantially similar compound.
    (4) For the purposes of this paragraph, a pheromone trap is a device containing a pheromone or an identical or substantially similar compound used for the sole purpose of attracting, and trapping or killing, target arthropods. Pheromone traps are intended to achieve pest control by removal of target organisms from their natural environment and do not result in increased levels of pheromones or identical or substantially similar compounds over a significant fraction of the treated area.
    (c) Preservatives for biological specimens.
    (1) Embalming fluids.
    (2) Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of learning.
    (3) Products used to preserve the integrity of milk, urine, blood, or other body fluids for laboratory analysis.
    (d) Vitamin hormone products. Vitamin hormone horticultural products consisting of mixtures of plant hormones, plant nutrients, inoculants, or soil amendments, which meet the following criteria:
    (1) The product, in the undiluted package concentration at which it is distributed or sold, meets the criteria of § 156.10(h)(1) 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.
    (e) Foods. Products consisting of foods and containing no active ingredients, which are used to attract pests.
    (f) Natural cedar.
    (1) Natural cedar blocks, chips, shavings, balls, chests, drawer liners, paneling, and needles that meet all of the following criteria:
    (i) The product consists totally of cedarwood or natural cedar.
    (ii) The product is not treated, combined, or impregnated with any additional substance(s).
    (iii) The product bears claims or directions for use solely to repel arthropods other than ticks or to retard mildew, and no additional claims are made in sale or distribution. The labeling must be limited to specific arthropods, or must exclude ticks if any general term such as "arthropods," "insects," "bugs," or any other broad inclusive term, is used. The exemption does not apply to natural cedar products claimed to repel ticks.
    (2) The exemption does not apply to cedar oil, or formulated products which contain cedar oil, other cedar extracts, or ground cedar wood as part of a mixture.
    (g) Minimum risk pesticides --
    (1) Exempted products. Products containing the following active ingredients are exempt from the requirements of FIFRA, alone or in combination with other substances listed in this paragraph, provided that all of the criteria of this section are met.
    Castor oil (U.S.P. or equivalent)
    Cedar oil
    Cinnamon and cinnamon oil
    Citric acid
    Citronella and Citronella oil
    Cloves and clove oil
    Corn gluten meal
    Corn oil
    Cottonseed oil
    Dried Blood
    Eugenol
    Garlic and garlic oil
    Geraniol
    Geranium oil
    Lauryl sulfate
    Lemongrass oil
    Linseed oil
    Malic acid Mint and mint oil
    Peppermint and peppermint oil
    2-Phenethyl propionate (2-phenylethyl propionate)
    Potassium sorbate
    Putrescent whole egg solids
    Rosemary and rosemary oil
    Sesame (includes ground sesame plant) and sesame oil
    Sodium chloride (common salt)
    Sodium lauryl sulfate
    Soybean oil
    Thyme and thyme oil
    White pepper
    Zinc metal strips (consisting solely of zinc metal and impurities)
    (2) Permitted inerts. A pesticide product exempt under paragraph (g)(1) of this section may only include inert ingredients listed in the most current List 4A. This list is updated periodically and is published in the Federal Register. The most current list may be obtained by writing to Registration Support Branch (4A Inerts List) Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington DC 20460.
    (3) Other conditions of exemption. All of the following conditions must be met for products to be exempted under this section:
    (i) Each product containing the substance must bear a label identifying the name and percentage (by weight) of each active ingredient and the name of each inert ingredient.
    (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) The product must not include any false and misleading labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) through (viii).

§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 distributed or sold, or otherwise transferred, to the extent described by this section.
    (a) A pesticide transferred between registered establishments operated by the same producer. An unregistered pesticide may be transferred between registered establishments operated by the same producer. The pesticide as transferred must be labeled in accordance with Part 156 of this chapter.
    (b) A pesticide transferred between registered establishments not operated by the same producer. An unregistered pesticide may be transferred between registered establishments not operated by the same producer if:
    (1) The transfer is solely for the purpose of further formulation, packaging, or labeling into a product that is registered;
    (2) Each active ingredient in the pesticide, at the time of transfer, is present as a result of incorporation into the pesticide of either:
    (i) A registered product; or
    (ii) A pesticide that is produced by the registrant of the final product; and
    (3) The product as transferred is labeled in accordance with Part 156 of this chapter.
    (c) A pesticide distributed or sold under an experimental use permit.
    (1) An unregistered pesticide may be distributed or sold in accordance with the terms of an experimental use permit issued under FIFRA sec. 5, if the product is labeled in accordance with §172.6 of this chapter.
    (2) An unregistered pesticide may be distributed or sold in accordance with the provisions of §172.3 of this chapter, pertaining to use of a pesticide for which an experimental use permit is not required, provided the product is labeled in accordance with Part 156 of this chapter.
    (d) A pesticide transferred solely for export. An unregistered pesticide may be transferred within the United States solely for export if it meets the following conditions:
    (1) The product is prepared and packaged according to the specifications of the foreign purchaser; and
    (2) The product is labeled in accordance with Part 156 of this chapter.
    (e) A pesticide distributed or sold under an emergency exemption. An unregistered pesticide may be distributed or sold in accordance with the terms of an emergency exemption under FIFRA sec. 18, if the product is labeled in accordance with Part 156 of this chapter.
    (f) A pesticide transferred for purposes of disposal. An unregistered, suspended, or cancelled pesticide may be transferred solely for disposal in accordance with FIFRA sec. 19 or an applicable Administrator's order. The product must be labeled in accordance with Part 156 of this chapter.
    (g) Existing stocks of a formerly registered product. A cancelled or suspended pesticide may be distributed or sold to the extent and in the manner specified in an order issued by the Administrator concerning existing stocks of the pesticide.


        Subpart C -- Registration Procedures

§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 determined 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 § 158.180 must be suitable for use on both the basic formulation and the alternate formulation.
    (c) Notwithstanding the criteria in this section, the Agency may determine that an alternate formulation must be separately registered. If EPA makes this determination, the Agency will notify the applicant of its determination and its reasons. Thereafter the application for an alternate formulation will be treated as an application for new registration, and the alternate formulation will be assigned a new registration number.


§152.44 Application for amended registration.

    (a) Except as provided by § 152.46, any modification in the composition, labeling, or packaging of a registered product must be submitted with an application for amended registration. The applicant must submit the information required by § 152.50, as applicable to the change requested. If an application for amended registration is required, the application must be approved by the Agency before the product, as modified, may legally be distributed or sold.
    (b) In its discretion, the Agency may:
    (1) Waive the requirement for submission of an application for amended registration;
    (2) Require that the applicant certify to the Agency that he has complied with an Agency directive rather than submit an application for amended registration; or
    (3) Permit an applicant to consolidate an amendment affecting a number of products into a single application.
    (4) Permit an applicant to modify a registration by notification or non-notification in accordance with § 152.46.

[As amended at 61 FR 33039, June 26, 1996]


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