[Code of Federal Regulations] [Title 40, Volume 22] [Revised as of July 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 40CFR180.7] [Page 324-325] TITLE 40--PROTECTION OF ENVIRONMENT CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PART 180_TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE CHEMICALS IN FOOD--Table of Contents Subpart B_Procedural Regulations Sec. 180.7 Petitions proposing tolerances or exemptions for pesticide residues in or on raw agricultural commodities. Procedure for Filing Petitions (a) Petitions to be filed with the Agency under the provisions of section 408(d) shall be submitted in duplicate to the Registration Division. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall be accompanied by an advance deposit for fees described in Sec. 180.33. The petition shall state petitioner's mail address to which notice of objection under section 408(d)(5) may be sent. (b) Petitions shall include the following data and be submitted in the following form: (Date) -------------------- Registration Division, Environmental Protection Agency, Washington, DC 20460 Dear Sirs: The undersigned, ----------, submits this petition pursuant to section 408(d)(1) of the Federal Food, Drug, and Cosmetic Act with respect to the pesticide chemical ----------. Attached hereto, in duplicate and constituting a part of this petition, are the following: A. The name, chemical identity, and composition of the pesticide chemical. (If the pesticide chemical is an ingredient of an economic poison, the complete quantitative formula of the resulting economic poison should be submitted. The submission of this information does not restrict the application of any tolerance or exemption granted to the specific formula(s) submitted.) B. The amount, frequency, and time of application of the pesticide chemical. C. Full reports of investigations made with respect to the safety of the pesticide chemical. (These reports should include, where necessary, detailed data derived from appropriate animal or other biological experiments in which the methods used and the results obtained are clearly set forth.) D. The results of tests on the amount of residue remaining, including a description of the analytical method used. (See Sec. 180.34 for further information about residue tests.) E. Practicable methods for removing residue that exceeds any proposed tolerance. F. Proposed tolerances for the pesticida chemical if tolerances are proposed. G. Reasonable grounds in support of the petition. Enclosed is (money order, bank draft, or certified check) for $---- --, payable to the Environmental Protection Agency to cover clerical operations, initial administrative review, and the cost incurred in considering the petition after it has been filed. Very truly yours, ________________________________________________________________________ (Petitioner) Per____________________________________________________________________ ________________________________________________________________________ (Indicate authority) Mail address___________________________________________________________ This petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an authorized official. The data specified under the several lettered headings should be on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by reference to the earlier one. The petition shall be submitted in duplicate. The petitioner shall show that he has registered or has submitted an application for the registration of an economic poison containing the pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act. (c) Except as noted in paragraph (d) of this section, a petition shall not be accepted for filing if any of the data prescribed by section 408(d) are lacking [[Page 325]] or are not set forth so as to be readily understood. The availability to the public of information provided to, or otherwise obtained by, the Agency under this part shall be governed by part 2 of this chapter. (d) The Registration Division shall notify the petitioner within 15 days after its receipt of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. Copy of the notice shall be sent to the Registration Division, Environmental Protection Agency. If accepted, the date of notification becomes the date of filing for the purposes of section 408(d)(1). If petitioner desires, he may supplement a deficient petition after notification as to deficiencies. If the supplementary material or explanation of petition is deemed acceptable, petitioner shall be notified, and date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified. The date of such notification becomes the date of filing. The Administrator shall publish in the Federal Register within 30 days a notice of filing, name of petitioner, and a brief outline of the petition, including description of analytical method or reference to a publication in which it appears, if such publication is generally available. (e) The Registration Division may request a sample of the pesticide chemical at any time while a petition is under consideration. The Registration Division shall specify in its request for a sample of the pesticide chemical, a quantity which it deems adequate to permit tests of analytical methods used to determine residues of the pesticide chemical and of methods proposed by the petitioner for removing any residues of the chemical that exceed the tolerance proposed. The date used for computing the 90-day limit for the purposes of section 408(d)(2) shall be moved forward 1 day for each day in excess of 15 from the mailing date of the request taken by the petitioner to submit the sample. If the sample is not submitted within 180 days after mailing date of the request, the petition will be considered withdrawn without prejudice. (f) The date of receipt from the Administration of certification as to usefulness shall be the date used for computing the 90-day limit for the purposes of section 408(d)(2). (g) If the petition is not referred to an advisory committee, or upon receipt of the report of an advisory committee under Sec. 180.12(c) if such a referral occurred, the Administrator shall determine, in accordance with the Act, whether to issue an order that establishes, modifies, or revokes a tolerance regulation (whether or not in accord with the action proposed by the petitioner), or whether to publish a proposed tolerance regulation and request public comment thereon under Sec. 180.29. The Administrator shall publish in the Federal Register such order or proposed regulation. After receiving comments on any proposed regulation, the Administrator may issue an order that establishes modifies, or revokes a tolerance regulation. An order published under this section shall describe briefly how to submit objections and requests for a hearing under part 178 of this chapter. A regulation issued under this section shall be effective on the date of publication in the Federal Register unless otherwise provided in the regulation. [36 FR 22540, Nov. 25, 1971, as amended at 41 FR 36918, Sept. 1, 1976; 46 FR 34345, July 1, 1981; 55 FR 21200, May 23, 1990; 55 FR 50299, Dec. 5, 1990]