[Code of Federal Regulations] [Title 40, Volume 23] [Revised as of July 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 40CFR180.31] [Page 334-335] 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. 180.31 Temporary tolerances. (a) A temporary tolerance (or exemption from a tolerance) established under authority of section 408(j) of the act shall be deemed to be a tolerance (or exemption from the requirement of a tolerance) for the purposes of section 408(a) (1) or (2) of the act. (b)(1) A request for a temporary tolerance or a temporary exemption from a tolerance by a person who has obtained an experimental permit for a pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act shall be accompanied by a copy of such experimental permit, such data as are available on subjects outlined in clauses (A), (B), (C), (D), (E), (F), and (G) of section 408(d)(1) of FFDCA, and an advance deposit to cover fees as provided in Sec. 180.33(d), except that no fee under this section shall be levied during the period beginning on October 1, 2003, and ending on September 30, 2008. (2) Before an experimental permit has been obtained, the Pesticides Tolerance Division upon request of the Environmental Protection Agency or a person who proposes to apply for an experimental permit will consider available data and discuss its adequacy for the purpose of justifying a tolerance or exemption from a tolerance. (c) A notice of the issuance of a temporary tolerance outlining any restrictions as to use of the chemical imposed under the experimental permit under the Federal Insecticide, Fungicide, and Rodenticide Act may be published in the Federal Register if the Administrator deems such publication desirable. (d) A temporary tolerance or exemption from a tolerance may be issued for [[Page 335]] a period designed to allow the orderly marketing of the raw agricultural commodities produced while testing a pesticide chemical under an experimental permit issued under authority of the Federal Insecticide, Fungicide, and Rodenticide Act when the Administrator concludes that the public health can be adequately protected during such marketing. A temporary tolerance or exemption from a tolerance may be revoked if the experimental permit is revoked, or may be revoked at any time if it develops that the application for a temporary tolerance contains a misstatement of a material fact or that new scientific data or experience with the pesticide chemical indicates that it may be hazardous to the public health. (e) Conditions under which a temporary tolerance is established shall include: (1) A limitation on the amount of the chemical to be used on the designated crops permitted under the experimental permit. (2) A limitation for the use of the chemical on the designated crops to bona fide experimental use by qualified persons as indicated in the experimental permit. (3) A requirement that the person or firm which obtains the experimental permit for which the temporary tolerance is established will immediately inform the Environmental Protection Agency of any reports on findings from the experimental use that have a bearing on safety. (4) A requirement that the person or firm which obtained the experimental permit for which the temporary tolerance is established will keep records of production, distribution, and performance for a period of 2 years and, on request, at any reasonable time, make these records available to any authorized officer or employee of the Environmental Protection Agency. [36 FR 22540, Nov. 25, 1971, as amended at 69 FR 12544, Mar. 17, 2004] Effective Date Note: At 70 FR 33362, June 8, 2005, Sec. 180.31 was revised, effective Aug. 8, 2005. For the convenience of the user, the revised text is set forth as follows: Sec. 180.31 Temporary tolerances. (a) A temporary tolerance (or exemption from a tolerance)established under the authority of FFDCA section 408(r) shall be deemed to be a tolerance (or exemption from the requirement of a tolerance) for the purposes of FFDCA section 408(a)(1) or (a)(2) and for the purposes of Sec. 180.30. (b) A request for a temporary tolerance or a temporary exemptionfrom a tolerance by a person who has obtained or is seeking an experimental permit for a pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act shall be accompanied by such data as are available on subjects outlined in Sec. 180.7(b) and an advance deposit to cover fees as provided in Sec. 180.33. (c) To obtain a temporary tolerance, a requestor must comply withthe petition procedures specified in FFDCA section 408(d) and Sec. 180.7 except as provided in this section. (d) A temporary tolerance or exemption from a tolerance may beissued for a period designed to allow the orderly marketing of the rawagricultural commodities produced while testing a pesticide chemical under an experimental permit issued under authority of the Federal Insecticide, Fungicide, and Rodenticide Act if the Administrator concludes that the safety standard in FFDCA section 408(b)(2) or (c), as applicable, is met. Subject to the requirements of FFDCA section 408(e), a temporary tolerance or exemption from a tolerance may be revoked if the experimental permit is revoked, or may be revoked at any time if it develops that the application for a temporary tolerance contains a misstatement of a material fact or that new scientific data or experience with the pesticide chemical indicates that it does not meet the safety standard in FFDCA section 408(b)(2) or (c), as applicable. (e) Conditions under which a temporary tolerance is establishedshall include: (1) A limitation on the amount of the chemical to be used on thedesignated crops permitted under the experimental permit. (2) A limitation for the use of the chemical on the designatedcrops to bona fide experimental use by qualified persons as indicated in the experimental permit. (3) A requirement that the person or firm which obtains theexperimental permit for which the temporary tolerance is established will immediately inform the Environmental Protection Agency of any reports on findings from the experimental use that have a bearing on safety. (4) A requirement that the person or firm which obtained theexperimental permit for which the temporary tolerance is established will keep records of production, distribution, and performance for a period of 2 years and, on request, at any reasonable time, make these records available to any authorized officer or employee of the Environmental Protection Agency. 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