Table Of Content

Historic, Archive Document Do not assume content reflects current scientific knowledge, policies, or practices. Reserve 3SB933 Draft Copy — July 1991 B32 *.U6U87 1991 -User’s Guide Requirements for Exemption of Regulated Articles United States Department of Agriculture Animal and Plant Health Inspection Service Biotechnology, Biologics, and Environmental Protection United States Department of Agriculture Fy National Agricultural Library > United States Anima! and Biotecnnology 4 1 Department of Plant Healtn Biologics. and wy Agriculture Inspection Environmental Service Protection Dear Reader: The purpose of this User’s Guide is to help you prepare a petition for exemption for a genetically modified organism subject to the Animal and Plant Health Inspection Service regulations in 7 CFR Part 340. These regulations are entitled, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There is Reason to Believe Are Plant Pests.” While the petition process in § 340.4 of the regulations may be used as a mechanism for either adding organisms to the list of regulated organisms in § 340.2(a) or adding to the list of exempted organisms in § 340.2(b), we anticipate that most petitions submitted will be to expand the list of exempted organisms. We have included a hypothetical petition for cotton which has been genetically modified to be tolerant to the herbicide glyphosate or resistant to certain lepidop- teran insects. It should be noted that the scope and breadth of a potenual exemption is determined by the petitioner and the data that is available to support a specific petition for exemption. Inclusion of this petition in the guide is for illustrative purposes only and does not mean that the U.S. Department of Agriculture has already reached a decision on the merits of a petition for this organism or any other organism. If you have any questions, please call our Biotechnology Permits staff at Area Code (301) 436-7612. Sincerely, ar Terry L. Medley, J.D. Director Biotechnology, Biologics, and Environmental Protection ey APHIS - Protecting American Agriculture (md rom Sa ’ t LG i. x ce 28 hibis rin TK > a Tee vilesa ve wet son aaa r. Wo 41 Boe oe fs > iO Soe ‘ ms) 7 jéue 2 a Ae : oerm ei aala er e i + te 5 ene) oe : : hs SOG tite Yo eed = T' F‘ VU ROAS ee nett 7 Athan “eae ; | myeZ i : e | pie: aie « bainul sil ip a | a fisiuso de pbeatd ie tide eta resin ool PPR oC ay oh MR ler eee note Big a9 ANON notefelve ged neiskel 21 sl) wie aeon tool lick 7 EEEEE E E Table of Contents Introduction Section 1. Questions and Answers Section 2. |S ample Transmittal Letter and Petition Form Section3. 7 CFR 340.4 Section 4. Sample Petition for Genetically Modified Cotton Plants Wank bas 2eciteeyO ieottes jettimerueyT aiqinsd »’ onea c ARO i’. a? 7 Section 1. ASI and ANOUS.