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List of Completed Consultations on Bioengineered Foods
In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human foods and animal feeds derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using recombinant deoxyribonucleic acid (rDNA) technology. This site refers to foods derived from plant varieties that are developed using rDNA technology as "bioengineered foods."
In the 1992 policy, FDA recommended that developers consult with FDA about bioengineered foods under development; since issuance of the 1992 policy, developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food; FDA evaluates the submission and responds to the developer by letter.
In the Federal Register of January 18, 2001 (the premarket notification proposal; 66 FR 4706), FDA issued a proposed rule that would require that developers submit a scientific and regulatory assessment of the bioengineered food 120 days before the bioengineered food is marketed. In the premarket notification proposal, FDA recommends that developers continue the practice of consulting with the agency before submitting the required premarket notice. The comment period for the proposed rule ended on April 3, 2001.
| BNF No. | Name of Developer | Address |
|---|---|---|
| 57, 55, 46, 41, 38, 29, 23 | AgrEvo (now Aventis Crop Science) | P.O. Box 12014; 2 T.W. Alexander Drive; Research Triangle Park, NC 27709 |
| 60, 14 | Agritope | 16160 Upper Boones Ferry Road; Portland, OR 97224 |
| 6 | Asgrow Seed Co./Upjohn | 7000 Portage Road; Kalamazoo, MI 49001 |
| 66, 63 | Aventis (now Bayer) Crop Science | P.O. Box 12014; 2 T.W. Alexander Drive; Research Triangle Park, NC 27709 |
| 52 | BASF | c/o Morgan, Lewis, and Bockius, LLP; 1800 M Street, N.W.; Washington, DC 20036 |
| 109, 86 | Bayer Crop Science | P.O. Box 12014; 2 T.W. Alexander Drive; Research Triangle Park, NC 27709 |
| 45 | Bejo Zaden BV | P.O. Box 50; Trambaan 1; 1749 ZH Warmenhuizen; The Netherlands |
| 54, 47, 25, 4,FMF 526, Docket 91A-0330 | Calgene | 1920 Fifth Street; Davis, CA 95616 |
| 24 | Ciba-Geigy Corporation | Ciba Seeds Agricultural Biotechnology; 3054 Cornwallis Road; Research Triangle Park, NC 27709 |
| 40, 28 | Dekalb Genetics | Discovery Research; 62 Maritime Drive; Mystic, Conn 06355 |
| 7 | DNA Plant Technology | 6701 San Pablo Avenue; Oakland, CA 94608 |
| 73, , 811, 851, 921, 931, | Dow AgroSciences LLC | 9330 Zionsville Rd; Indianapolis, IN 46268 |
| 39, 30 | DuPont Agricultural Products | P.O. Box 80402; Wilmington, DE 18880 |
| 107, 104, 98, 97, 902, 874, 843, 80, 79, 77, 75, 74, 71, 56, 51, 49, 48, 35, 34, 33, 26, 20, 18, 13, 5, 2, 1 | Monsanto | 800 N. Lindbergh Blvd., St. Louis, MO 63167 |
| 17 | Northrup King | P.O. Box 959; Minneapolis, MN 55440 |
| 56 | Novartis Seeds, Inc. (Now Syngenta Seeds) | 3054 Cornwallis Road; Research Triangle Park, NC 27709 |
| 110, 111, 108, 36 | Pioneer Hi-Bred | 7100 NW 62nd Avenue; P.O. Box 1000; Johnston, IA 50131 |
| 31 | Plant Genetic Systems (America), Inc. | 7200 Hickman Road; Des Moines, IA 50322 |
| 32 | Plant Genetic Systems, N.V. | Jozef Plateaustraat 22; B-9000 Gent; Belgium |
| 64 | Rhone-Poulenc Ag Science | P.O. Box 12014; 2 T. W. Alexander Drive; Research Triangle Park, NC 27709 |
| 79 | The Scotts Company | 1411 Scottslawn Road; Maryville, OH 43041 |
| 43 | Seminis Vegetable Seeds, Inc. | 37437 State Highway 16; Woodland, CA 95695 |
| 113, 99, 95, 94, FMF 763 | Syngenta Seeds, Inc. | P.O. Box 12257 3054 Cornwallis Road Research Triangle Park, NC 27709-2257 |
| 101 | Agricultural Research Service, United States Department of Agriculture | Appalachian Fruit Research Station, 2217 Wiltshire Road, Kearneysville, WV 25430-2771 |
| 100 | University of Florida | Citrus Research and Education Center; 700 Experiment Station Road; Lake Alfred, FL 33850-1299 |
| 42 | University of Hawaii | Dept. of Horticulture; 3190 Maile Way; Honolulu, HI 96822 |
| 50 | University of Saskatchewan | 51 Campus Drive; Saskatoon SK S7N 5A8 Canada |
| 3 | Zeneca Plant Science | 1800 Concord Pike; Wilmington, DE 19897 |
| 1Submitted by Mycogen Seeds c/o Dow AgriSciences LLC 2Submitted by Monsanto Company and KWS SAAT AG 3Submitted by Monsanto Company and Forage Genetics Incorporated 4Submitted by Monsanto Company on behalf of Renessen LLC | ||
