U. S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Office of Premarket Approval
November 2000
FDA's 1992 policy addresses foods derived from new varieties including those developed via recombinant DNA technology (commonly referred to as genetic engineering). At Calgene's request, FDA evaluated the safety and nutritional data collected by the firm and issued its decision that the Flavr SavrTM tomato is as safe as other commercial varieties of tomato in May, 1994. Following that decision, FDA has not found it necessary to conduct comprehensive scientific reviews of foods derived from bioengineered plants based on the attributes of these products, but consistent with its 1992 policy, FDA expects developers to consult with the agency on safety and regulatory questions. FDA is requesting that firms provide a summary of their food (including animal feed) safety and nutritional assessment to the agency and discuss their results with agency scientists prior to commercial distribution (see accompanying article on consultation procedures). Developers have completed this process for the products listed below. Each entry represents a separate consultation and each consultation may represent more than one line of the traits indicated. The products are grouped by the year in which their consultations were completed. The trait introduced into the variety as well as the origin and identity of the introduced gene responsible for the trait are given. Note that the listed products may have pending regulatory issues with EPA or USDA/APHIS.
| Firm | New Variety | Trait Gene & Source |
| 2000 | ||
| Aventis CropScience | Male sterile corn | The barnase gene from Bacillus amyloliquefaciens. |
| Glufosinate tolerant rice | The bar gene encoding phosphinothricin acetyltransferase (PAT) from Streptomyces hygroscopicus | |
| Monsanto Co. | Glyphosate tolerant corn | The enolpyruvylshikimate-3-phosphate synthase (EPSPS) gene from Agrobacterium sp. strain CP4 |
| 1999 | ||
| Agritope Inc. | Modified fruit ripening cantaloupe | S-adenosylmethionine hydrolase gene from E. coli bacteriophage T3. |
| BASF AG | Phytaseed canola | The phytase gene from Aspergillus niger var van Tieghem. |
| Rhone-Poulenc Ag Company | Bromoxynil tolerant canola | The nitrilase gene from Klebsiella pneumoniae subsp. ozaenae. |
| 1998 | ||
| AgrEvo, Inc. | Glufosinate tolerant soybean | Phosphinothricin acetyltransferase gene from Streptomyces viridochromogenes. |
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| Glufosinate tolerant sugar beet | Phosphinothricin acetyltransferase gene from Streptomyces viridochromogenes. | |
| Insect protected and glufosinate tolerant corn | The gene encoding the protein cry9C (from Bacillus thuringiensis subsp. tolworthi) and the bar gene encoding phosphinothricin acetyltransferase (PAT; from Streptomyces hygroscopicus). The safe use of cry9C as a pesticide is regulated by the Environmental Protection Agency (EPA). In a regulation issued on May 22, 1998, EPA permitted the use of corn containing cry9C in animal feed (40 CFR 180.1192). The use of cry9C in human food is pending at EPA. For additional information about EPA's evaluation of cry9C in human food, see www.epa.gov. | |
| Male sterile or fertility restorer and glufosinate tolerant canola | The male sterile canola contains the barnase gene and the fertility restorer canola contains the barstar gene from Bacillus amyloliquefaciens. Both lines have the phosphinothricin acetyltransferase gene from Streptomyces hygroscopis. | |
| Calgene Co. | Bromoxynil tolerant/insect protected cotton | Nitrilase gene from Klebsiella pneumoniae and the cryIA(c) gene from Bacillus thuringiensis subsp. kurstaki. |
| Insect protected tomato | The cryIA(c) gene from Bacillus thuringiensis subsp. kurstaki. | |
| Monsanto Co. | Glyphosate tolerant corn | A modified enolpyruvylshikimate-3-phosphate synthase gene from corn. |
| Insect and virus protected potato | The cryIIIA gene from Bacillus thuringiensis (Bt) sp. tenebrionis and the Potato Leafroll Virus replicase gene. | |
| Insect and virus protected potato | The cryIIIA gene from Bacillus thuringiensis (Bt) sp. tenebrionis and the Potato Virus Y coat protein gene. | |
| Monsanto Co./Novartis | Glyphosate tolerant sugar beet | The enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium sp. strain CP4, and a truncated glyphosate oxidoreductase gene from Ochrobactrum anthropi. |
| Pioneer Hi-Bred | Male sterile corn | The DNA Adenine methylase gene from Escherichia coli. |
| University of Saskatchewan | Sulfonylurea tolerant flax | Acetolactate synthase gene from Arabidopsis. |
| 1997 | ||
| AgrEvo, Inc. | Glufosinate tolerant canola | Phosphinothricin acetyltransferase gene from Streptomyces viridochromogenes. |
| Bejo Zaden BV | Male sterile radicchio rosso | The barnase gene from Bacillus amyloliquefaciens. |
| Dekalb Genetics Corp. | Insect protected corn | The cryIA(c) gene from Bacillus thuringiensis (Bt). |
| DuPont | High oleic acid soybean | Sense suppression of the GmFad2-1 gene which encodes a delta-12 desaturase enzyme. |
| Seminis Vegetable Seeds | Virus resistant squash | Coat protein genes of cucumber mosaic virus, zucchini yellow mosaic virus, and watermelon mosaic virus 2. |
| University of Hawaii/Cornell University | Virus resistant papaya | Coat protein gene of the papaya ringspot virus. |
| 1996 | ||
| Agritope Inc. | Modified fruit ripening tomato | S-adenosylmethionine hydrolase gene from E. coli bacteriophage T3. |
| Dekalb Genetics Corp. | Glufosinate tolerant corn | Phosphinothricin acetyl transferase gene from Streptomyces hygroscopicus. |
| DuPont | Sufonylurea tolerant cotton | Acetolactate synthase gene from tobacco, Nicotiana tabacum cv. Xanthi. |
| Monsanto Co. | Insect protected potato | The cryIIIA gene from Bacillus thuringiensis |
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| Insect protected corn | The cryIA(b) gene from Bacillus thuringiensis subsp. kurstaki. | |
| Insect protected corn | The cryIA(b) gene from Bacillus thuringiensis subsp. kurstaki. | |
| Glyphosate tolerant/insect protected corn | The enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium sp. strain CP4 and the glyphosate oxidoreductase gene from Ochrobactrum anthropi in the glyphosate tolerant lines. The CryIA(b) gene from Bacillus thuringiensis subsp. kurstaki in lines that are also insect protected. | |
| Northrup King Co. | Insect protected corn | The cryIA(b) gene from Bacillus thuringiensis (Bt) subsp. kurstaki. |
| Plant Genetic Systems NV | Male sterile and fertility restorer oilseed rape | The male sterile oilseed rape contains the barnase gene from Bacillus amyloliquefaciens; the fertility restorer lines express the barstar gene from Bacillus amyloliquefaciens. |
| Male sterile corn | The barnase gene from Bacillus amyloliquefaciens | |
| 1995 | ||
| AgrEvo Inc. | Glufosinate tolerant canola | Phosphinothricin acetyltransferase gene from Streptomyces viridochromogenes. |
| Glufosinate tolerant corn | Phosphinothricin acetyltransferase gene from Streptomyces viridochromogenes. | |
| Calgene Inc. | Laurate canola | The 12:0 acyl carrier protein thioesterase gene from California bay, Umbellularia californica. |
| Ciba-Geigy Corp. | Insect protected corn | The cry1A(b) gene from Bacillus thuringiensis kurstaki. |
| Monsanto Co. | Glyphosate tolerant cotton | Enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium sp. strain CP4. |
| Glyphosate tolerant canola | Enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium sp. strain CP4. | |
| Insect protected cotton | The cryIA(c) from Bacillus thuringiensis (Bt) subsp. kurstaki. | |
| 1994 | ||
| Asgrow Seed Co. | Virus resistant squash | Coat protein genes of watermelon mosaic virus 2 and zucchini yellow mosaic virus. |
| Calgene Inc. | Flavr Savr™ tomato | Antisense polygalacturonase gene from tomato. |
| Bromoxynil tolerant cotton | A nitrilase gene isolated from Klebsiella ozaenae. | |
| DNA Plant Technology Corp. | Improved ripening tomato | A fragment of the aminocyclopropane carboxylic acid synthase gene from tomato. |
| Monsanto Co. | Glyphosate tolerant soybean | Enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium sp. strain CP4. |
| Improved ripening tomato | Aminocyclopropane carboxylic acid deaminase gene from Pseudomonas chloraphis strain 6G5. | |
| Insect protected potato | The cryIIIA gene from Bacillus thuringiensis (Bt) sp. tenebrionis. | |
| Zeneca Plant Science | Delayed softening tomato | A fragment of the polygalacturonase gene from tomato. |
FDA Biotechnology Website
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2000-NOV-07
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