CHAPTER 1 - WHO MUST APPLY FOR REGISTRATION OF A PESTICIDE A. PRODUCTS THAT REQUIRE REGISTRATION Those who develop products to control pests are subject to regulation under several Federal laws. However, only certain pest control products are subject to registration. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires that before any person in any state or foreign country can sell or distribute any pesticide in the United States, they must obtain a registration (or license) from the U.S. Environmental Protection Agency (EPA). The term "pesticide", as defined in FIFRA section 2(u), means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant. It is important to understand that FIFRA and the implementing regulations at 40 CFR parts 150-189, are the governing federal law regarding the sale, distribution and use of pesticides. Those who are subject to the law are responsible for understanding and complying with the terms of the law. Anyone who plans to sell or distribute a product that is intended to control a pest or manipulate a plant must become familiar with the definition of pesticide in the law and regulations. Particular attention should be paid to the terms "substance" or "mixtures of substances" in the definition of pesticide. These terms provide the key to separating pesticides from devices. If the product contains a substance that is intended to affect a pest or plant by causing a physiological reaction when the target organism is exposed to the substance then the product is considered to be a pesticide and will require registration unless exempted, as discussed below. On the other hand, if the pest is controlled by a mechanical action the product will be considered a device and registration is not required. However, devices are subject to other provisions of the law, which are more thoroughly explained in Chapter 10. IMPORTANT NOTE: The Agency has determined that, since humans are not pests as defined by FIFRA, it will not register products whose label bears claims for control of humans. It is also important to fully understand the term "intent". Intent under the law can simply be demonstrated by more than overt pesticidal claims. As set forth at 40 CFR section 152.15, a substance is considered to be intended for a pesticidal purpose requiring registration, if: a) The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise) that 1) the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or 2) 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. EXAMPLE: Products that have no claims to control insects on the product label, but whose name includes the name of a substance commonly recognized as having pesticidal properties will be recognized as a pesticide because the targeted consumer will know that such a substance is a well established pesticide. Additionally, it is important to note that the definition for a pesticide does not make any reference to the level or kind of toxicity that a product may exhibit in order to be considered a pesticide. Therefore, toxicity does not have any place in determining if a product is a pesticide. Toxicity is taken into consideration by EPA when it requires supporting information (i.e. data) and when it determines if a product can be registered, and if so what limitations will be placed on it before it can be registered. Products that have very minimal toxicity such as garlic, red pepper, eucalyptus, mustard, citric acid, soap, menthol and cedar wood have been required to be registered. It is important to become familiar with the other definitions in the law and regulations. The definitions for devices, active and inert ingredients and pests are terms that will be vital in more fully understanding the definition for a pesticide. IMPORTANT NOTE: If you need assistance in determining if your product is a pesticide or device under FIFRA, you may contact the appropriate Branch Chief in the Antimicrobial, Herbicide/ Fungicide and Insecticide/Rodenticide Branches in the Registration Division. The contact should be made in writing and should include detailed information about what is intended and what the product is made of. Submission of a proposed label for the product would also be helpful. The addresses and/or FAX numbers for the Branch Chiefs are found in Chapter 18. Please send nothing via FAX that is considered confidential. B. PRODUCTS OR SUBSTANCES THAT DO NOT REQUIRE REGISTRATION 1. Adjuvants: An adjuvant is a subsidiary ingredient or additive in a mixture which contributes to the effectiveness of the primary ingredient. Adjuvants are most commonly added to pesticides use dilutions in tank mixes by growers or applicators prior to application to the crop or site to be treated. Agricultural chemical adjuvants are grouped according to their intended purpose in the tank mix and include but are not limited to the following groups: acidifying agents, buffering agents, anti-foam agents, defoaming agents, anti-transpirants, color adjuvants (such as dyes and brighteners), compatibility agents, crop oil concentrates, oil surfactants, deposition agents, drift reduction agents, foam markers, feeding stimulants, herbicide safeners, spreaders, extenders, adhesive agents, suspension agents, gelling agents, synergists, wetting agents, emulsifiers, dispersing agents, penetrants, tank and equipment cleaners, neutralizers, water absorbants, and water softeners. It is important to note that although adjuvants are not subject to registration when added in tank mixes by growers, those adjuvants intended for use in conjunction with a pesticide in tank mixes for application to a food or feed crop/site are required to be cleared under the Federal Food, Drug and Cosmetic Act (FFDCA), prior to being used. Adjuvants that are to be used with pesticides are evaluated in a process similar to the one for inert ingredients. Adjuvants intended for non-pesticidal uses on a food or feed crop/site are to be cleared with the FDA prior to being used. Refer to 21 CFR 182.99 and 40 CFR 180.1001(c) and (d). 2. Devices: A device is 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. As stated above in the previous section, registration is not applicable for devices, although devices are subject to other provisions of the law. Refer to Chapter 10 for further information. 3. Pesticide Intermediates: Pesticide intermediates are substances which are not themselves pesticides, but which undergo chemical reactions resulting in the formation of a pesticide. Pesticide intermediates are not subject to registration under FIFRA but are subject to regulation under the Toxic Substances Control Act (TSCA). Questions regarding intermediates should be referred to the Office of Pollution Prevention and Toxics (OPPT). Pesticide intermediates include any beginning or intermediate material which is a chemical precursor to a pesticide active ingredient, whether produced in situ or obtained from other sources. 4. Pesticides and pest control organisms that have been exempted from the registration requirements of FIFRA by the Agency under 40 CFR Part 152, Subpart B - Exemptions. a. Pest control organisms such as insect predators, nematodes, and macroscopic parasites. (40 CFR section 152.20(a)). b. Those pesticides, such as (1) certain biological control agents and (2) certain human drugs, that are exempted because they are regulated by another Agency. (40 CFR section 152.20(a)and (b)). c. Those pesticides, such as (1) pesticide- treated articles or substances, (2) pheromones in pheromone traps, (3) preservatives for biological specimens, (4) vitamin-hormone horticultural products, and (5) foods, that are of a character not requiring regulation under FIFRA. (40 CFR section 152.25) d. Pesticides transferred between registered establishments operated by the same producer. (40 CFR section 152.30 (a)). e. Pesticides transferred between registered establishments not operated by the same producer if the transfer is solely for the purpose of further formulation, packaging, or labeling into a product that is registered and only if each active ingredient in the pesticide, at the time of transfer, is present as a result of incorporation into the pesticide of either a registered product or a pesticide that is produced by the registrant of the final product. (40 CFR section 152.30(b)). f. Pesticides distributed or sold under an experimental use permit issued under FIFRA section 5 if the product is labeled in accordance with 40 CFR 172.6. (40 CFR section 152.30(c)(1)). g. Pesticides distributed or sold in accordance with 40 CFR 172.3, pertaining to use of a pesticide for which an experimental use permit is not required. (40 CFR section 152.30 (c)(2)). h. Pesticides transferred within the United States solely for export if the product is prepared and packaged according to the specifications of the foreign purchaser. (40 CFR section 152.30(d)). (Refer to Section D of this chapter for a discussion on the importation and exportation of pesticides.) i. Pesticides distributed or sold in accordance with the terms of an emergency exemption under FIFRA section 18. (40 CFR section 152.30(e)). j. Unregistered, suspended, or canceled pesticides transferred solely for purposes of disposal in accordance with FIFRA section 19 or an applicable Administrator's order. (40 CFR section 152.30(f)). k. Distribution and sale of existing stocks of formerly registered pesticides to the extent and in the manner specified in an order issued by the Administrator concerning existing stocks of the pesticide. (40 CFR section 152.30(g)). C. PESTICIDES INTENDED FOR USE ON FOOD OR FEED No person may distribute or sell any pesticide product, whether produced domestically or imported, that is not registered under FIFRA, except as noted in CFR 40 sections 152.20, 152.25, and 152.30. (Refer to Section C. of this chapter for a discussion of pest management products that are regulated but which do not require registration and to Section D of this chapter for a discussion on the importation and exportation of pesticides.) In addition, pesticide products intended for use on food and/or feed crops are required to have pesticide residue tolerances established under the Federal Food, Drug, and Cosmetic Act (FFDCA). The biologically active component which is called the active ingredient. In addition to the active ingredient, pesticide products may contain intentionally added biologically inactive components called inert ingredients. As with active ingredients, inert ingredients in pesticide product formulations are regulated under both the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended and the Federal Food, Drug, and Cosmetic Act (FFDCA). If your proposed labeling bears instructions for use of the product on food or feed crops, or if the intended use of the product results or may be expected to result, directly or indirectly, in pesticide residues in or on food or feed (including residues of any active ingredient, inert ingredient, metabolite, or degradation product), you must submit a statement indicating whether a tolerance, exemption from the requirement of a tolerance, or a food additive regulation has been issued by the Agency under section 408 or 409 of the Federal Food Drug and Cosmetic Act (FFDCA). If a tolerance, exemption from the requirement of a tolerance, or a food additive regulation has not been issued for such residues, your application must be accompanied by a petition for establishment of appropriate tolerances, exemptions from the requirement of a tolerance, or food additive regulation in accordance with 40 CFR 180. D. IMPORTATION AND EXPORTATION OF PESTICIDES Refer to FIFRA section 17 for information concerning the importation and exportation requirements for pesticides. Except for the exemptions from the requirements of FIFRA listed under 40 CFR Part 152, Subpart B (see B 1., 2., and 3 above), FIFRA requires that before any person in any state or foreign country can sell or distribute any pesticide in the United States, they must obtain a registration from EPA. Pesticides produced by foreign manufacturers and imported into the U.S. must comply with all requirements applicable to domestic producers. In addition, the regulations require an importer to submit to EPA a Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) for review and determination as to whether the shipment should be sampled and/or permitted entry into the U.S. Applicants for importation of pesticides should follow the guidance on "How to Apply For Registration of a Conventional Pesticide" in Chapter 2 of this manual. FIFRA section 17 states that no pesticide produced solely for export to any foreign country, shall be deemed in violation of FIFRA, when prepared or packaged to the specifications or directions of the foreign producer, except that producers of such devices are subject to sections 2(p), 2(q)(1)(A), (C), (C), (D), (E), (G) and (H), 2(q)(2)(A), (B), (C)(i) and (iii), and (D). FIFRA section 17(a)(2) further states that prior to the export of any pesticide not registered under section 3 or sold under section 6(a)(1) of FIFRA the foreign purchaser must have signed a Prior Informed Consent statement acknowledging that the purchaser understands that such pesticide is not registered for use in the United States and cannot be sold in the United States under FIFRA. A copy of that statement shall be transmitted to an appropriate official of the government of the importing country. E. TYPES OF PESTICIDE REGISTRATION YOU MAY OBTAIN There are two general types of pesticide registrations available. You may (1) obtain a registration for your own product, or (2) become a supplemental registrant (often termed a "distributor" or "subregistrant") for a product that someone else has already registered. These types of registrations, together with amendments to a registration, are described in more detail below. 1. TO OBTAIN A REGISTRATION FOR YOUR OWN PRODUCT If you wish to obtain the registration for your own pesticide product, you are responsible for submitting all of the information and data that are required to support the registration. The information includes forms, proposed product labeling, technical and scientific data that are required on the specific product that you intend to make (or formulate) and how you will comply with the data compensation requirements. See Chapter 2 for detailed instructions on how to submit your own application for pesticide registration. 2. TO OBTAIN A SUPPLEMENTAL REGISTRATION TO DISTRIBUTE A PRODUCT REGISTERED BY SOMEONE ELSE If you do not wish to register your own product, but would rather market a product that is currently registered to another company and you are willing to enter into an agreement with that company, the basic registrant may include you as a supplemental registrant to his registration so that you may market his product under your name. See Chapter 5 for detailed instructions on how to submit an application for supplemental registration of a pesticide product. 3. TO AMEND THE REGISTRATION OF A PRODUCT YOU ALREADY HAVE REGISTERED WITH THE EPA If you have a product that is already registered with the EPA, and wish to change the formulation or labeling text (i.e., add, delete or change formulation components or label precautionary statements, add or change uses) you must file an application to amend the registration of your product. There are certain changes that you may make that do not require an amendment application but simply require that you notify the Agency of the change, and other changes that require no notification at all. See Chapter 4 for detailed instructions on how to submit an application for amended registration of a pesticide product. 4. UNCONDITIONAL/CONDITIONAL REGISTRATION The Agency has discretion to review applications for registration under either the unconditional registration criteria of FIFRA section 3(c)(5) or the conditional registration criteria of FIFRA section 3(c)(7). a. UNCONDITIONAL REGISTRATION: An application will be approved under the unconditional registration criteria only if the Agency has (1) determined that the application is complete and is accompanied by all materials required by FIFRA, including, but not limited to evidence that the applicant has complied with the data compensation requirements; (2) reviewed all relevant data in its possession; (3) determined that no additional data are necessary to make the determinations required under FIFRA section 3(c)(5) with respect to the subject product; (4) 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; (5) 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;and (6) that the product is not misbranded according to 40 CFR 152.2(q) and 40 CFR 156; (7) determined that, 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 of any active or inert ingredient of the product 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 section 408, section 409 or both; and (8) if the product, in addition to being a pesticide, is a drug within the meaning of FFDCA section 201(q), the Agency has been notified by the FDA that the product complies with any requirements imposed by FDA. b. CONDITIONAL REGISTRATION: 1. Products that do not contain a new active ingredient: 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 pesticide products, only if the Agency has determined that (1) it possesses all data necessary to make the determinations required under FIFRA sections 3(c)(7)(A) or (B), which includes 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; (3) the application is complete and is accompanied by all materials required by the Act, including, but not limited to, evidence of compliance with the data compensation requirements; (4) the composition of the products is such as to warrant the proposed efficacy claims for it, if efficacy data are required to be submitted; (5) the product is not misbranded according to 40 CFR 152.2(q) and 40 CFR 156; (6)determined that, 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 of any active or inert ingredient of the product 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 section 408, section 409 or both; and (7) if the product, in addition to being a pesticide, is a drug within the meaning of FFDCA section 201(q), the Agency has been notified by the FDA that the product complies with any requirements imposed by FDA. However, the Agency will not approve the conditional registration of (1) any pesticide unless it 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; (2) any pesticide product for a new use if (a) the pesticide is the subject of a special review, based on a use of the product that results in human dietary exposure and (b) the proposed 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 (determined with the concurrence of the Secretary of Agriculture). Each registration issued for substantially similar products and new uses shall be conditioned upon the submission or citation by the registrant of all data which are required for unconditional registration of his product under FIFRA section 3(c)(5), but which have not yet been submitted, no later than the time such data are required to be submitted for similar pesticide products already registered. If a notice requiring submission of such data has been issued under FIFRA section 3(c)(2)(B) prior to the date of approval of the application, the applicant must submit or cite the data described by that notice at the time specified by that notice. The applicant must agree to these conditions before the application may be approved. If any condition of the registration of the product is not satisfied, or if the Agency determines that the registrant has failed to initiate or pursue appropriate action toward fulfillment of any condition, the Agency will issue a notice of intent to cancel under FIFRA section 6(e) and 40 CFR 152.148. 2. 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 section 3(c)(5) if the Agency determines that (1) insufficient time has elapsed since the imposition of the data requirement for those data to have been developed; (2) all other required test data and materials have been submitted to the Agency; (3) the application is complete and is accompanied by all materials required by FIFRA, including, but not limited to evidence that the applicant has complied with the data compensation requirements; (4) has reviewed all relevant data in its possession; (5) 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; (6) that the product is not misbranded according to 40 CFR 152.2(q) and 40 CFR 156; (7) determined that, 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 of any active or inert ingredient of the product 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 section 408, section 409 or both; and (8) if the product, in addition to being a pesticide, is a drug within the meaning of FFDCA section 201(q), the Agency has been notified by the FDA that the product complies with any requirements imposed by FDA; (9) the use of the pesticide product during the period of the conditional registration will not cause any unreasonable adverse effect on the environment; and (10) the registration of the pesticide product and its subsequent use during the period of the conditional registration are in the public interest. Each registration issued for a new active ingredient shall be conditioned upon the applicant's agreement to each of the following conditions: (1) the applicant will submit remaining required data (and interim reports if required) in accordance with a schedule approved by the Agency; (2) the registration will expire upon a date established by the Agency, if the registrant fails to submit data as required by the Agency. The expiration date will be established based upon the length of time necessary to generate and submit the required data. If the studies are submitted in a timely manner, the registration will be canceled if the Agency determines, based on the data (alone, or in conjunction 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 section 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. If any condition of the registration of the product is not satisfied, or if the Agency determines that the registrant has failed to initiate or pursue appropriate action toward fulfillment of any condition, the Agency will issue a notice of intent to cancel under FIFRA section 6(e) and 40 CFR 152.148. IMPORTANT NOTE: A Data Matrix Chart, identifying the FIFRA Section 158 data requirements for the product for which registration is requested, must be submitted with your application for registra- tion of a product containing a new active ingredient or for registration of a new use of a currently registered product. Failure to submit a Data Matrix Chart with your application could result in your application being rejected. F. WHO TO CONTACT FOR ADDITIONAL INFORMATION If you have any questions, or require additional information concerning your application for registration, contact the Product Manager assigned to the pesticide in your product. A listing of Product Managers and a sampling of the pesticides they are responsible for may be found in Chapter 18. If you have questions of a general nature that do not pertain to any specific pesticide, or pertain to a new pesticide active ingredient for which you have not made an application, contact the Deputy Branch Chief or the Branch Chief's office for the type of pesticide (i.e., insecticide, fungicide, antimicrobial etc.) for which you have a question. A listing of the various Deputy Branch Chiefs, and Branch Chiefs can be found in Chapter 18. If you have any questions concerning devices, whether they are subject to the Act, or establishment registration, please contact the Office of Compliance Monitoring, Compliance Division, (EN-342), Environmental Protection Agency, 401 M St., S.W., Washington, D.C., 20460. Telephone (202) 260-7835. G. REFERENCES CITED IN CHAPTER 1 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 152 - Pesticide registration and classification procedures Part 158 - Data requirements for registration Part 172 - Experimental Use Permits Part 180 - Tolerances and exemptions from tolerances for pesticide chemicals in or on raw agricultural commodities 2. Code of Federal Regulations, Title 21 Part 182 - Substances generally recognized as safe 3. Federal Insecticide, Fungicide and Rodenticide Act, as amended October, 1988 Section 2 - Definitions Section 3 - Registration of pesticides Section 7 - Registration of establishments