CHAPTER 7 - HOW TO SUBMIT AN APPLICATION TO REQUEST A PETITION FOR A TOLERANCE (PERMANENT OR TEMPORARY), OR AN EXEMPTION FROM THE REQUIREMENT OF A TOLERANCE A. GENERAL INFORMATION Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the Environmental Protection Agency (EPA) is responsible for regulating the amount of pesticide residues that can remain in or on food or feed commodities as the result of pesticide application. A tolerance is the legal maximum residue concentration of a pesticide chemical allowed in food or feed. If residues of a pesticide exceed the established tolerance, or no tolerance has been established, the crop may be considered adulterated and may be seized by the Food and Drug Administration, the United States Department of Agriculture, or a state enforcement agency. Tolerances are set under the authority of the FFDCA. FFDCA Section 408 applies to residues on/in raw agricultural commodities (RACs) and Section 409 applies to pesticide residues in processed food or feed commodities which exceed the raw food tolerance. 40 CFR Part 180 - Tolerances and Exemptions from Tolerances for Pesticide Chemicals in or on Raw Agricultural Commodities, provides information on definitions and interpretative regulations, procedures for filing petitions, temporary tolerances, exemptions from the requirement of a tolerance, residue data, fee requirements, specific tolerances and exemptions which have been established for raw agricultural commodities. 40 CFR Part 177 - Issuance of Food Additive Regulations provides information on definitions, procedures for filing petitions for establishment, modification, or revocation of a food additive regulation, withdrawal of petitions, submission of scientific and technical information required to support petitions, and waiver of requirements. In addition, procedures for filing objections and requests for hearings on food additive regulations or petition denials under section 409(f) of the FFDCA are found in 40 CFR Part 178; rules governing formal evidentiary hearings under FFDCA section 409(f) are found in 40 CFR Part 179. 40 CFR Part 185 - Tolerances for Pesticides in Processed Food, provides a listing of tolerances established for residues of pesticides in processed foods (food additive tolerances) resulting from pesticide application during the growing process, direct application to the end food product, or indirect application to the end food product by treating the processing or storage area. (Prior to June 29, 1988, 40 CFR Part 185 was designated 21 CFR Part 193.) 40 CFR Part 186 - Tolerances for Pesticides in Processed Animal Feeds, provides a listing of tolerances established for residues of pesticides in processed animal feeds, which may be present as a result of application of the pesticide to growing crops. (Prior to June 29, 1988, 40 CFR Part 186 was designated 21 CFR Part 561.) B. WHEN ARE PETITIONS FOR TOLERANCES REQUIRED? Tolerances and food/feed additive regulations are required to be established to cover residues resulting from treatment of raw agricultural commodities or processed food; inadvertent residues in rotational or replacement crops; primary or secondary residues in meat, milk, poultry, and eggs; residues in processed food resulting from treatment of the raw commodity and exceeding the raw food tolerance; and expected residues in imported food commodities. Registration of a pesticide is not, however, a prerequisite for establishing a tolerance. For example, EPA may establish a temporary tolerance under section 408(j) to permit the experimental use of a non-registered pesticide, or EPA may establish a tolerance for a pesticide residue resulting from the use of the pesticide in food or feed production in a foreign country. 1. Applications for registration or amended registration - Before a pesticide can be registered for use on a food or feed crop or for use in a food processing or storage area under FIFRA section 3, a tolerance or the exemption from the requirement of a tolerance must be established. In addition, if you propose to amend a currently registered use, for example, by increasing the dosage rates or frequency of application, which might result in residues higher than the established tolerance, a petition to amend the established tolerance may be required. 2. Experimental Use Permits - An application for an experimental use permit proposing use on a food or feed crop or for the proposed experimental use in food processing or storage areas, requires a temporary tolerance for the proposed use if no tolerances are currently established, or if the proposed experimental use might result in residues higher than the established tolerance or if the commodity is to be marketed. The petition for the temporary tolerance must be submitted with the application for the experimental use permit. IMPORTANT NOTE: A temporary tolerance is not required if the commodity is to be destroyed or consumed only by experimental animals. 3. Importation of Pesticide Treated Food - The requirements of sections 408 and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) apply equally to domestically produced and imported food and feed found to contain pesticide residues. Therefore, even though the use of a pesticide in a foreign country is not subject to EPA registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a pesticide residue in imported food or feed must be in conformity with a tolerance, tolerance exemption, or food additive regulation established by EPA or, where appropriate an action level established by the Food and Drug Administration. Shipments of imported food/feed items found to have pesticide residues for which a tolerance, exemption from the requirement of a tolerance, or a food additive regulation has not been issued will be held up and the importer required to either file for a tolerance or exemption from a tolerance, or a food additive regulation; return the shipment to the country of origin; or destroy the shipment. 4. Inerts - 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). Inert ingredients in products labeled for food use must be cleared by EPA before the product can be registered. 40 CFR 152.55 requires that inert ingredients, metabolites, and degradation products, as well as active ingredients, be cleared by the Agency if your product is to be used on food or feed crops. 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, 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 regulations in accordance with 40 CFR 177 (food additive petitions) or 40 CFR 180 (tolerance or exemption petitions). Traditionally, the Agency has recommended against the establishment of a tolerance for a pesticide product unless all of the inert ingredients in the product have been cleared for use on food/feed items. Refer to 40 CFR 180.1001 for a listing of the inert ingredients that have been cleared for use on food/feed items. 5. Adjuvants - Although adjuvants are not subject to registration, 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 with the EPA, under the Federal Food, Drug and Cosmetic Act (FFDCA) prior to being used. Such adjuvants are evaluated by EPA as inert ingredients and undergo the appropriate product chemistry review. Adjuvants cleared for use on food/feed items are listed in 40 CFR 180.1001. C. PROCEDURES FOR FILING A PETITION 1. General - Procedures for filing a petition requesting the establishment of a tolerance, a temporary tolerance, or an exemption from the requirement of a tolerance or a temporary exemption from a tolerance, are described in detail in 40 CFR section 180.7. Additional information concerning requests for temporary tolerances, or a temporary exemption from a tolerance, in conjunction with an experimental use permit can be found in 40 CFR 180.31. There is no application form for petitions. You must submit your request in the format provided in 40 CFR section 180.7. Procedures for filing a petition for establishment, modification, or revocation of a food additive regulation for pesticide residues in or on a particular processed food or group of such foods are described in detail in 40 CFR section 177.81. Additional information concerning requests for amendments or supplements to petitions can be found in 40 CFR 177.92. There is no application form for petitions for food additive regulations. You must submit your request in the format provided in 40 CFR 177.81(e). 2. Completeness of Application - The petition must include the following information in clearly designated sections as follows: a. Section A - The name, chemical identity and composition of the pesticide chemical. To assess the composition of the pesticide, information is required on the manufacturing process, chemical analysis of the active ingredient, certified limits for ingredients of a product, and analytical methods to determine the composition of the pesticide. You should also refer to 40 CFR Parts 158.150 - 190, Product Chemistry Data Requirements and the Pesticide Assessment Guidelines, Subdivision D - Product Chemistry for more detailed information. IMPORTANT NOTE: The Agency evaluates the composition data to determine whether impurities could constitute a significant component of the residues in food and feed commodities. Impurities that arise in the manufacture of pesticides can become a residue problem, if they are not identified before tolerances are established. Dioxins and nitrosamines are the best known examples of significant impurities of toxicological concern. If impurities are at levels that may lead to toxicologically significant residues in crops, then tolerances would be established for them, as well as for the active ingredient. Once problem impurities are identified, adjustments to the manufacturing process or additional purification steps may be necessary to reduce the impurities to a safe level. b. Section B - The amount, frequency, and time of application of the pesticide chemical. This refers to the directions for use, dosage rates, number of applications, restrictions, pre-harvest intervals, and times of application that you intend to provide on the label of the product you intend to market. c. Section C - Full reports on investigations made with respect to the safety of the pesticide chemical. 40 CFR Part 158.340, Toxicology Data Requirements, identifies the types of toxicity data that are needed to support a petition request. The required data are identified under the "Food Crop" headings. d. Section D - The results of tests on the amount of residue remaining, including a description of the analytical method used. Information on testing for the amount of residue remaining in the raw agricultural commodity or processed food or feed, when the pesticide is applied according to the proposed label directions, is provided in 40 CFR Part 180.34 - Tests on the amount of residue remaining, Part 158.240 - Residue Chemistry Data Requirements, and the Pesticide Assessment Guidelines, Subdivision O - Residue Chemistry. (Refer to Chapter 16 of this manual for a source.) Submission of analytical methods to EPA for use in tolerance enforcement - You will need to develop and submit accurate and precise analytical methods for identifying and measuring the amount of pesticide residues in the agricultural commodity and processed foods. Those methods need to be practical in order to be used in tolerance enforcement and should meet all of the requirements for pesticide residue methods identified in the Pesticide Assessment Guidelines, Subdivision O - Residue Chemistry. The analytical method for enforcement cannot be marked as Confidential or Trade Secret. In addition, registrants need to submit to EPA pesticide validation data showing the results from their own laboratory as well as the results from an independent laboratory tryout that confirms those results. The exact procedure for conducting an independent laboratory tryout can be found in PR Notice 88-5. IMPORTANT NOTE: If EPA does not receive all of the items identified above, the petition will be considered incomplete and returned without further notice. e. Section E - Practical methods for removing residue that exceeds any proposed tolerance. Tolerances are usually set at levels which are adequate to cover residues that are likely to result from a proposed use without any special processing of the commodities to reduce residues to the tolerance level. Information in this section would provide for a necessary and useful pesticide treatment which results in residues larger than a safe tolerance level, but which can be reduced to the tolerance level by washing or some other means proposed in the petition. f. Section F - Proposed tolerances for the pesticide chemical if tolerances are proposed. Tolerances should be proposed in terms which best represent the total toxic residues on the raw agricultural commodity, whether it be the parent pesticide or altered forms of it, or both. An exemption from the requirement of a tolerance may be proposed when appropriate. According to 40 CFR 180.1001(a) " An exemption from a tolerance shall be granted when it appears that the total quantity of the pesticide chemical in or on all raw agricultural commodities for which it is useful under conditions of use currently prevailing or proposed will involve no hazard to human health". When an exemption is proposed, data may need to be presented to show the level of residues to be expected. When residues on a processed food derived from the raw agricultural commodity exceed the proposed tolerance on the raw agricultural commodity, appropriate tolerances should also be proposed in this section for the processed food under FFDCA Section 409. g. Section G - Reasonable grounds in support of the petition. This section should include a rationale of how the residue data support the proposed tolerance, brief discussions on the adequacy of the analytical method with respect to sensitivity and determination of total toxic residues, an explanation of any aberrant residue values reported, an explanation for the omission or substitution of required data or information, discussion of fate of the pesticide in the environment (i.e., soil persistence, contamination of ground water or run-off water) and any residue considerations applicable to the proposed use. In addition a summary of the grounds for safety of the proposed tolerance based on the toxicology data submitted under Section C, may also be included. The petition for food additive regulations must include the following information as set forth at 40 CFR 177.102. a. The name and composition of the food additive that is a subject of the petition, and the chemical composition of each component of the food additive. The name, chemical identity, and composition of each pesticide residue that is a subject of the petition. The identity of the processed food(s) in question. b. A statement of any conditions of use proposed for the food additive, including all directions, recommendations, and suggestions proposed regarding the use of the food additive, i.e., the amount, frequency, method, and time of application or other use, and copy of its proposed labeling. c. Full reports of investigations made with respect to the toxicity of the food additive and of its safety for the proposed use, including full information as to the methods and controls used in conducting such investigations. d. The results of tests to determine the identity and amount of pesticide residues in or on the processed food resulting from the proposed use of the food additive, including a description of the analytical methods used, and a description of practicable methods for measuring such pesticide residues. e. Full reports of investigations made with respect to the toxicity of such pesticide residues, including full information as to the methods and controls used in conducting such investigations. f. All relevant data bearing on the physical or other technical effects such food additive is intended to produce, and the quantity of such food additive required to produce such effect. g. The terms of each food additive regulation proposed. h. Any other information relevant to the approval of the petition known to the petitioner that is unfavorable to the petition. i. A statement of why, in the petitioner's opinion, it would be reasonable for the Administrator to approve the petition, taking into account the terms of the FFDCA and FIFRA, 40 CFR Part 177, the petition, the data and information submitted or cited in support of the petition, and other information available to the Agency. j. An informative summary of the petition and of the data information, and arguments submitted or cited in support of the petition, and a statement that the petitioner agrees that such summary or any information it contains may be published as a part of the notice to the public under 40 CFR 177.88 or as part of a proposal under 40 CFR 177.130. The summary need not refer to any method or process that is entitled to protection as a trade secret under FFDCA section 301(j). 3. Data - Three copies of any data required to be submitted in support of the petition must be submitted in accordance with the data formatting requirements set forth in PR Notice 86-5. 4. Application for registration or amendment under FIFRA section 3 - Except in certain instances, a petition request must be accompanied with an application for registration, an application to amend the registration of a currently registered product, or an experimental use permit for the uses proposed in the petition. A request for an import tolerance generally would not require an accompanying application for registration. 5. Fee Requirements - Each petition request must be accompanied by the appropriate fee as specified in 40 CFR 180.33. It would be helpful if a photo-copy of the fee check were submitted with the petition request in case any questions arise concerning whether the fee was submitted as required. The fees will be adjusted annually in accordance with section 180.33(o). You should refer to the February 7, 1991 Federal Register Notice (56 FR 4946) for a more detailed discussion of tolerance processing fees. The fees vary considerably according to type of petition requested and its complexity. A very brief, general discussion of some of the fees required for the more frequently requested petitions follows: a. For the establishment of a new tolerance or a tolerance higher than that already established (with certain exceptions) the fee is $52,000, plus $1,300 for each raw agricultural commodity more than nine on which the establishment of a tolerance is requested. b. For the establishment of a tolerance at a lower numerical level(s) than already established for the pesticide, or for additional raw agricultural commodities at the same numerical level as already established the fee is $11,900 plus $825 for each raw agricultural commodity on which a tolerance is requested. c. For requests for an exemption from the requirement of a tolerance or repeal of an exemption the fee is $9,575. d. For temporary tolerances or a temporary tolerance exemption from the requirement of a tolerance the fee is generally $20,775, except as provided below. A request for an extension or renewal of a temporary tolerance or temporary exemption requires a fee of $2,950. e. For requests for a temporary tolerance for a pesticide which has a tolerance for other uses at the same numerical level or a higher numerical level the fee is $10,375 plus $825 for each raw agricultural commodity on which the temporary tolerance is sought. f. Waiver or refund request must be accompanied by a fee of $1,300, which will be refunded if the waiver is granted. The Agency may waive or refund part or all of any tolerance petition fee, if it is in the public interest to do so, or if the fee would result in unreasonable hardship on the applicant. A request for a waiver or a fee refund must be submitted in writing to the Agency in accordance with 40 CFR section 180.33(m). IMPORTANT NOTE: Fee waiver requests affect the processing times for the petition since the fee waiver request must be processed before the petition is put into review. The fee waiver review can typically take 2-3 months. To avoid this delay, petitioners can submit the full fee with the petition and request that the fee be returned if the Agency agrees with the applicant that the petition is in the public interest. The petition can then be put under review while the refund request is being evaluated. IMPORTANT NOTE: These fees may change without notice being published in this manual. All fees must be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency. All payment of fees must be forwarded to the following address: Environmental Protection Agency Headquarters Accounting Operations Branch Office of Pesticide Programs (Tolerance Fees) P.O. Box 360277M Pittsburgh, PA 15251 The payments should be specifically labeled "Tolerance Petition Fees" and should be accompanied only by a copy of the letter or petition requesting the tolerance. The actual letter or petition, along with supporting data should be forwarded within 30 days of payment of the fee to the following address: Document Processing Desk (PETN) Office of Pesticide Programs - H7504C U.S. EPA 401 M Street, S.W. Washington, D.C. 20460 A petition will not be accepted for processing until the required fees have been submitted. A petition for which a waiver of fees has been requested will not be accepted for processing until the fee has been waived, or if the waiver is denied, the proper fee is submitted. A request for waiver or refund will not be accepted after scientific review of a petition has begun. Refer to Chapter 8 of this manual for additional information on tolerance petition fees and other fees. 6. Incomplete Petitions - Petitions will not be accepted for processing if the proper fee has not been submitted, if any of the required data are lacking or the petition is otherwise determined to be incomplete. If a petition is not accepted for processing because it is incomplete, it will be returned. The original fee amount submitted, less a charge of $1,300 for handling and initial review, will also be returned. If a petition is withdrawn by the petitioner after initial processing but before significant scientific review has begun, the original fee, less $1,300 for handling and initial review, will be returned. If an unacceptable petition is resubmitted, it will require the appropriate fee that would be required if it were submitted for the first time. D. WHO TO CONTACT FOR ADDITIONAL INFORMATION If you have any questions concerning 1) whether a petition for a tolerance is required, 2) the appropriate fee, 3) how to submit your request for a petition for tolerance and/or application for product registration, or 4) what data are required to support your petition for tolerance and/or application for product registration, please contact the appropriate Product Manager for the pesticide. If the petition request involves a new chemical not yet assigned to a Product Manager, you should contact the appropriate Deputy Branch Chief, or Branch Chief for a Product Manager assignment. Refer to Chapter 18 of this manual for a listing of the various Product Managers, Deputy Branch Chiefs and Branch Chiefs. E. REFERENCES CITED IN CHAPTER 7 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 158 - Data requirements for registration. Part 177 - Issuance of Food Additive Regulations. Part 178 - Objections and Requests for Hearings. Part 179 - Formal Evidentiary Public Hearing. Part 180 - Tolerances and exemptions from tolerances for pesticide chemicals in or on raw agricultural commodities. Part 185 - Tolerances for pesticides in food administered by the Environmental Protection Agency (Prior to June 29, 1988, 40 CFR Part 185 was designated 21 CFR Part 193) Part 186 - Tolerances for pesticides in animal feeds administered by the Environmental Protection Agency (Prior to June 29, 1988, 40 CFR Part 186 was designated 21 CFR Part 561) 2. Federal Food Drug and Cosmetic Act Section 408 - Tolerance for pesticide chemicals in or on raw agricultural commodities Section 409 - Food additives 3. Pesticide Assessment Guidelines, Subdivision D, Product Chemistry, EPA-540/09-82-018. 4. Pesticide Assessment Guidelines, Subdivision O, Residue Chemistry, EPA-540/09-82-023. 5. PR Notice 86-5 - Standard Format for data submitted under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and certain provisions of the Federal Food, Drug and Cosmetic Act FFDCA). Issued July 29, 1986. 6. PR Notice 88-5 - Tolerance Enforcement Methods - Independent Laboratory Confirmation by Petitioner, Issued July 15, 1988. 7. Federal Register Notice, Regulation of Pesticides in Food: Addressing the Delaney Paradox - Policy Statement, October 19, 1988 (53 FR 41104). 8. Federal Register Notice, Tolerance Processing Fees, February 7, 1991 (56 FR 4946).