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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) (available in PDF - 2 MB). 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.
Most bioengineered plants are considered "regulated articles" under regulations of the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA). At some stage of research and development of a regulated article that is intended for use as a food crop, a developer requests from APHIS a determination of the article's regulatory status. For additional information about APHIS' regulation of bioengineered plants, see APHIS' Role in Biotechnology on the USDA/APHIS Internet site.
The safe use of pesticidal substances is regulated by the Environmental Protection Agency (EPA). Thus, a bioengineered food that is the subject of a consultation with FDA may contain an introduced pesticidal substance also known as a plant-incorporated protectant (PIP) that is subject to review by EPA. In the table below, FDA has used an asterisk (*) to identify each bioengineered food that contains a PIP. For additional information about EPA's regulation of bioengineered foods that contain a pesticidal substance, see EPA's Internet site.
The table below lists all completed consultations about bioengineered foods. This table:
Completed Submissions Organized by Year and File Number (BNF No.) | ||||||
---|---|---|---|---|---|---|
Submissions Completed in 2008 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 111, Submitted June 28, 2007 by Pioneer Hi-Bred, For use in Human food and animal feed | ||||||
Corn | Glyphosate N-acetyltransferase (GAT), modified acetolactate synthase (ZM-HRA) | Bacillus licheniformis; corn | Tolerance to both acetolactate synthase-inhibiting herbicides and the herbicide glyphosate | Event 98140 | Sept. 9, 2008 | Sept. 9, 2008 |
Submissions Completed in 2007 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 108, Submitted November 16, 2006 by Pioneer Hi-Bred, For use in Human food and animal feed | ||||||
Soybean | Glyphosate N-acetyltransferase (GAT), modified acetolactate synthase (GM-HRA) | Bacillus licheniformis; soybean | Tolerance to both acetolactate synthase-inhibiting herbicides and the herbicide glyphosate | Event 356043 | Sep 21, 2007 | Sep 21, 2007 |
BNF No. 107, Submitted October 13, 2006 by Monsanto Company, For use in Human food and animal feed | ||||||
Corn* | Cry1A.105, Cry2Ab2 | Bacillus thuringiensis subspp. aizawai and kurstaki | Resistance to Lepidopteran insects | MON 89034 | Aug 8, 2007 | July 25, 2007 |
BNF No. 95, Submitted August 31, 2005 by Syngenta Seeds, Inc., For use in Human food and animal feed | ||||||
Corn | AMY797E alpha-amylase | Three microbes from order Thermococcales | Alpha-amylase expression | Event 3272 | Aug 7, 2007 | Aug 7, 2007 |
BNF No. 104, Submitted March 26, 2006 by Monsanto Company, For use in Human food and animal feed | ||||||
Soybean | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | Tolerance to the herbicide glyphosate | MON 89788 (MON-89788-1) | Jan 19, 2007 | Jan 19, 2007 |
BNF No. 99, Submitted February 23, 2005 by Syngenta Seeds, Inc., For use in Human food and animal feed | ||||||
Corn* | Cry3A | Bacillus thuringiensis subsp. Tenebrionis | Resistance to corn rootworm | MIR604 | Jan 30, 2007 | Jan 30, 2007 |
Submissions Completed in 2005 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 98, Submitted May 27, 2004 by Monsanto Company, For use in Human food and animal feed | ||||||
Cotton | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | Tolerance to the herbicide glyphosate | MON-88913-8 | Mar 7, 2005 | Mar 7, 2005 |
BNF No. 97, Submitted March 30, 2004 by Monsanto Company, For use in Human food and animal feed | ||||||
Corn* | Cry3Bb1; 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) |
Bacillus thuringiensis subsp. kumamotoensis; Agrobacterium sp. strain CP4 |
Resistance to corn rootworm; Tolerance to the herbicide glyphosate |
MON 88017 | Jan 12, 2005 | Jan 5, 2005 |
BNF No. 94, Submitted October 27, 2003 by Syngenta Seeds, Inc., For use in Human food and animal feed | ||||||
Cotton* | VIP3A protein | B. thuringiensis, strain AB88 | Resistance to lepidopteran insects | Transformation Event COT102 | Jul 8, 2005 | Jul 7, 2005 |
BNF No. 87, Submitted August 10, 2004 by Monsanto Company, For use in Human food and animal feed | ||||||
Corn | dihydrodipicolinate synthase (cDHDPS) | Corynebacterium glutamicum | Increase lysine level for use in animal feed | REN-ØØØ38-3 or Maize Event LY038 | Oct 5, 2005 | Sep 30, 2005 |
Submissions Completed in 2004 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 93, Submitted June 30, 2003 by Mycogen Seeds c/o Dow AgroSciences LLC, For use in Human food and animal feed | ||||||
Corn* | Cry1F; phosphinothricin acetyltransferase (PAT) |
Bacillus thuringiensis subsp. aizawai; Streptomyces hygroscopicus |
Resistance to certain lepidopteran insects; Tolerance to the herbicide glufosinate-ammonium |
Event TC6275 | June 30, 2004 | June 28, 2004 |
BNF No. 92, Submitted March 18, 2003 by Mycogen Seeds c/o Dow AgroSciences LLC, For use in Human food and animal feed | ||||||
Cotton* | Cry1Ac; phosphinothricin acetyltransferase (PAT) |
Bacillus thuringiensis subsp. kurstaki; Streptomyces viridochromogenes |
Resistance to certain Lepidopteran insects; Tolerance to the herbicide glufosinate-ammonium |
Event 3006-210-23 | August 3, 2004 | July 28, 2004 |
BNF No. 90, Submitted April 16, 2003 by Monsanto Company and KWS SAAT AG, For use in Human food and animal feed | ||||||
Sugar Beet | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | tolerance to the herbicide glyphosate (N-phosphonomethyl glycine) |
Event H7-1 | August 17, 2004 | August 7, 2004 |
BNF No. 85, Submitted March 17, 2003 by Mycogen Seeds c/o Dow AgroSciences LLC, For use in Human food and animal feed | ||||||
Cotton* | Cry1F; phosphinothricin acetyltransferase (PAT) |
Bacillus thuringiensis subsp. aizawai; Streptomyces viridochromogenes |
Resistance to lepidopteran insects; Tolerance to the herbicide glufosinate-ammonium |
Event 281-24-236 | May 10, 2004 | May 5, 2004 |
BNF No. 84, Submitted October 6, 2003 by Monsanto Company and Forage Genetics, For use in Human food and animal feed | ||||||
Alfalfa | 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | Tolerance to the herbicide glyphosate | Event J101 and Event J163 | Dec. 10, 2004 | Dec. 8, 2004 |
BNF No. 81, Submitted December 11, 2003 by Mycogen Seeds c/o Dow AgroSciences LLC, For use in Human food and animal feed | ||||||
Corn* | Cry34Ab1, Cry35Ab1, phosphinothricin acetyltransferase (PAT) |
Bacillus thuringiensis strain PS149B1; Streptomyces viridochromogenes |
Resistance to Coleopteran insects; Tolerance to the herbicide glufosinate-ammonium |
DAS-59122-7 | October 4, 2004 | September 28, 2004 |
BNF No. 80, Submitted June 28, 2002 by Monsanto Company, For use in Human food and animal feed | ||||||
Wheat | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | tolerance to the herbicide glyphosate (N-phosphonomethyl-glycine) | MON 71800 | July 22, 2004 | July 22, 2004 |
Submissions Completed in 2003 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 86, Submitted August 30, 2002 by Bayer CropScience USA LP, For use in Human food and animal feed | ||||||
Cotton | phosphinothricin-N-acetyltransferase (PAT) | Streptomyces hygroscopicus | Tolerance to the herbicide glufosinate-ammonium | LLCotton25 | Apr. 2, 2003 | June 5, 2003 |
BNF No. 79, Submitted September 13, 2002 by Monsanto and The Scotts Company, For use in animal feed | ||||||
Creeping bentgrass | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. Strain CP4 | Tolerance to the herbicide glyphosate | Event ASR368 | Sep. 23, 2003 | Sep. 11, 2003 |
Submissions Completed in 2002 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 77, Submitted April 30, 2001 by Monsanto, For use in Human food and animal feed | ||||||
Oilseed rape (Canola) | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS); Glyphosate oxidoreductase (GOX) | Agrobacterium sp. strain CP4, Ochrobactrum anthropi strain LBAA | Tolerance to the herbicide glyphosate | GT200 | Sep. 5, 2002 | Sep. 4, 2002 |
BNF No. 74, Submitted June 29, 2000 by Monsanto, For use in Human food and animal feed | ||||||
Cotton* | Cry2ab; Cry1ac | Bacillus thuringiensis subsp. kumamotoensis | Resistance to lepidopteran insects | 15985 | July 18, 2002 | July 16, 2002 |
Submissions Completed in 2001 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 75, Submitted September 25, 2000 by Monsanto, For use in Human food and animal feed | ||||||
Corn* | Modified Cry3Bb1 | Bacillus thuringiensis subsp. kumamotoensis | Resistance to coleopteran insects, including corn rootworm | MON 863 | Dec. 31, 2001 | Dec. 31, 2001 |
BNF No. 73, Submitted June 28, 2000 by Dow AgroSciences LLC, For use in Human food and animal feed | ||||||
Corn* | Cry1F protein; Phosphinothricin acetyltransferase (PAT) | Bacillus thuringiensis; Streptomyces viridochromogenes | Resistance to certain lepidopteran insects; tolerance to the herbicide glufosinate-ammonium | 1507 | May 18, 2001 | June 8, 2001 |
Submissions Completed in 2000 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 71, Submitted February 28, 2000 by Monsanto, For use in Human food and animal feed | ||||||
Corn | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | Tolerance to the herbicide glyphosate | NK603 | Oct. 18, 2000 | Oct. 9, 2000 |
BNF No. 66, Submitted June 7, 1999 by Aventis Crop Science, For use in Human food and animal feed | ||||||
Corn | Barnase; Phosphinothricin acetyltransferase (PAT) | Bacillus amyloliquefaciens; Streptomyces hygroscopicus | Male Sterility; tolerance to glufosinate-ammonium | MS6 | Apr. 4, 2000 | Apr. 4, 2000 |
BNF No. 63, Submitted November 30, 1999 by Aventis Crop Science, For use in Human food and animal feed | ||||||
Rice | Phosphinothricin acetyltransferase (PAT) | Streptomyces hygroscopicus | Tolerance to the herbicide glufosinate-ammonium | LLRICE E06; LLRICE E62 | Aug. 31, 2000 | Aug. 30, 2000 |
Submissions Completed in 1999 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 64, Submitted May 10, 1999 by Rhone-Poulenc, For use in Human food and animal feed | ||||||
Canola | Nitrilase | Klebsiella ozaenae subsp. ozaenae | Tolerance to the herbicide bromoxynil | OXY-235 | Oct. 20, 1999 | Oct. 13, 1999 |
BNF No. 60, Submitted May 5, 1999 by Agritope, For use in Human food | ||||||
Cantaloupe | S-adenosylmethionine hydrolase | E. coli bacteriophage T3 | Delayed fruit ripening due to reduced ethylene synthesis | A and B | Dec. 9, 1999 | Oct. 20, 1999 |
BNF No. 52, Submitted Nov. 13, 1997 by BASF, For use in animal feed | ||||||
Canola | Phytase | Aspergillus niger van Tieghem | Degradation of phytate in animal feed | MPS961, 962, 963, 964, 965 | July 2, 1999 | Mar. 4, 1999 |
Submissions Completed in 1998 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 57 Submitted May 29, 1998 by AgrEvo, For use in Human food and animal feed | ||||||
Canola | Barnase; Phosphinothricin acetyltransferase (PAT) | Bacillus amyloliquefaciens, Streptomyces hygroscopicus | Male sterility; Tolerance to glufosinate-ammonium | MS8 | Sep. 16, 1998 | Aug. 5, 1998 |
BNF No. 57, Submitted May 29, 1998 by AgrEvo, For use in Human food and animal feed | ||||||
Canola | Barstar; Phosphinothricin acetyltransferase (PAT) | Bacillus amyloliquefaciens, Streptomyces hygroscopicus | Fertility restorer; Tolerance to glufosinate-ammonium | RF3 | Sep. 16, 1998 | Aug. 5, 1998 |
BNF No. 56, Submitted June 5, 1998 by Monsanto and Novartis Seeds, For use in Human food and animal feed | ||||||
Sugar beet | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | Tolerance to the herbicide glyphosate | GTS B77 | Nov. 3, 1998 | Sep. 28, 1998 |
BNF No. 55, Submitted March 31, 1998 by AgrEvo, For use in Human food and animal feed | ||||||
Soybean | Phosphinothricin acetyltransferase (PAT) | Streptomyces viridochromogenes | Tolerance to the herbicide glufosinate-ammonium | A2704-12, A5547-127 | May 15, 1998 | Apr. 21, 1998 |
BNF No. 54, Submitted Dec. 22, 1997 by Calgene, For use in Human food | ||||||
Tomato* | CryIAc protein | Bacillus thuringiensis subsp. kurstaki (Btk) | Resistance to certain lepidopteran insects | 5345 | Feb. 24, 1998 | Feb. 3, 1998 |
BNF No. 51, Submitted Aug. 20, 1997 by Monsanto, For use in Human food and animal feed | ||||||
Corn | Modified 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Corn | Tolerance to the herbicide glyphosate | GA21 | Feb. 13, 1998 | Feb. 10, 1998 |
BNF No. 50, Submitted Oct. 27, 1997 by U of Saskatchewan, For use in Human food and animal feed | ||||||
Flax | Acetolactate synthase (csr-1) | Arabidopsis | Tolerance to the herbicide sulfonylurea | CDC Triffid | May 15, 1998 | Mar. 24, 1998 |
BNF No. 49, Submitted Aug. 4, 1997 by Monsanto, For use in Human food and animal feed | ||||||
Potato* | CryIIIA; PVY coat protein | Bacillus thuringiensis subsp. tenebrionis (Btt); Potato virus Y (PVY) | Resistance to Colorado potato beetle and PVY | SEMT15-02, SEMT15-15, SEMT15-07, HLMT15-3, HLMT15-15, HLMT15-46, RBMT15-10 | Jan. 8, 1998 | Jan. 2, 1998 |
BNF No. 48, Submitted July 21, 1997 by Monsanto, For use in Human food and animal feed | ||||||
Potato* | CryIIIA; PLRV Replicase | Bacillus thuringiensis subsp. tenebrionis (Btt); Potato leafroll virus (PLRV) | Resistance to Colorado potato beetle and PLRV | RBMT21-129 -152 -350 RBMT22-82 -186 -238 -262 |
Jan. 8, 1998 | Jan. 2, 1998 |
BNF No. 47, Submitted Sep. 18, 1997 by Calgene, For use in Human food and animal feed | ||||||
Cotton* | Nitrilase; Cry1Ac protein | Klebsiella pneumoniae subsp. ozaene; Bacillus thuringiensis var. kurstaki (Btk) | Tolerance to the herbicide bromoxynil; Resistance to certain lepidopteran insects | 31707, 31803, 31807, 31808, 42317 | Jan. 28, 1998 | Dec. 12, 1997 |
BNF No. 41, Submitted Mar. 3, 1998 by AgrEvo, For use in animal feed | ||||||
Corn* | Cry9C protein; Phosphinothricin acetyl transferase (PAT) | Bacillus thuringiensis subsp. tolworthi (Bt); Streptomyces hygroscopicus | Resistance to several lepidopteran insects; Tolerance to the herbicide glufosinate-ammonium | CBH35-1 | May 29, 1998 | May 29, 1998 |
BNF No. 38, Submitted June 19, 1998 by AgrEvo, For use in Human food and animal feed | ||||||
Sugar beet | Phosphinothricin acetyltransferase (PAT) | Streptomyces viridochromogenes | Tolerance to the herbicide glufosinate-ammonium | T120-7 | Oct. 8, 1998 | Sep. 9, 1998 |
BNF No. 36, Submitted Apr. 15, 1998 by Pioneer Hi-Bred, For use in Human food and animal feed | ||||||
Corn | DNA adenine methylase (DAM); Phosphinothricin acetyl transferase (PAT) | Escherichia coli; Streptomyces viridochromogenes | Male sterility; tolerance to glufosinate-ammonium | 676, 678, 680 | Dec. 24, 1998 | Dec. 11, 1998 |
Submissions Completed in 1997 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 46, Submitted May 29, 1997 by AgrEvo, For use in Human food and animal feed | ||||||
Canola | Phosphinothricin acetyltransferase (PAT) | Streptomyces viridochromogenes | Tolerance to the herbicide glufosinate-ammonium | T45 | Aug. 25, 1997 | Aug. 18, 1997 |
BNF No. 45, Submitted May 20, 1997 by Bejo Zaden BV, For use in Human food | ||||||
Radicchio | Barnase; phosphinothricin acetyltransferase (PAT) | Bacillus amyloliquefaciens; Streptomyces hygroscopicus | Male Sterility; tolerance to glufosinate-ammonium | RM3-3, RM3-4, RM3-6 | Oct. 22, 1997 | Oct. 16, 1997 |
BNF No. 43, Submitted Feb. 26, 1997 by Seminis Vegetable Seeds, For use in Human food | ||||||
Squash* | Coat proteins from CMV, ZYMV, and WMV2 | Cucumber mosaic virus (CMV), zucchini yellow mosaic virus (ZYMV), and watermelon mosaic virus 2 (WMV2) | Resistance to the viruses CMV, ZYMV and WMV2 | CZW3 | July 10, 1997 | July 1, 1997 |
BNF No. 42, Submitted Jan. 3, 1997 by U of Hawaii, For use in Human food | ||||||
Papaya* | PRV coat protein | Papaya ringspot virus (PRSV) | Resistance to PRSV | 55-1 | Sep. 19, 1997 | Sep. 12, 1997 |
BNF No. 40, Submitted Sep. 30, 1996 by Dekalb Genetics, For use in Human food and animal feed | ||||||
Corn* | CryIAc | Bacillus thuringiensis subsp. kurstaki (Btk) | Resistance to European corn borer | DBT418 | Mar. 11, 1997 | Mar. 11, 1997 |
BNF No. 39, Submitted Aug. 28, 1996 by DuPont, For use in Human food and animal feed | ||||||
Soybean | GmFad2-1 gene to suppress endogenous GmFad2-1 gene, which encodes delta-12 desaturase | Soybean | High oleic acid soybean oil | G94-1, G94-19, G94-168 | Mar. 14, 1997 | Dec. 5, 1996 |
Submissions Completed in 1996 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 35, Submitted July 2, 1996 by Monsanto, For use in Human food and animal feed | ||||||
Corn* | CryIAb protein 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS); Glyphosate oxidoreductase |
Bacillus thuringiensis subsp. kurstaki (Btk); Agrobacterium sp. strain CP4; Ochrobactrum anthropi | Resistance to European corn borer; Tolerance to the herbicide glyphosate | MON 802, MON 805, MON 830, MON 831, MON 832 | Nov. 5, 1996 | Sep. 6, 1996 |
BNF No. 34, Submitted June 6, 1996 by Monsanto, For use in Human food and animal feed | ||||||
Corn* | CryIAb protein | Bacillus thuringiensis subsp. kurstaki (Btk) | Resistance to European corn borer | MON 809, MON 810 | Sep. 25, 1996 | Sep. 18, 1996 |
BNF No. 33, Submitted Jan. 24, 1996 by Monsanto, For use in Human food and animal feed | ||||||
Potato* | CryIIIA protein | Bacillus thuringiensis var. tenebrionis (Btt) | Resistance to Colorado potato beetle | ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36, SPBT02-5, SPBT02-7 | Apr. 4, 1996 | Mar. 25, 1996 |
BNF No. 32, Submitted July 6, 1995 by Plant Genetic Systems, N.V., For use in Human food and animal feed | ||||||
Oilseed rape | Barnase; phosphinothricin acetyl transferase (PAT) | Bacillus amyloliquefaciens; Streptomyces hygroscopicus | Male sterility; tolerance to glufosinate-ammonium | MS1[B91-4] | Apr. 4, 1996 | Mar. 25, 1996 |
BNF No. 32, Submitted July 6, 1995 and Oct. 23, 1995 by Plant Genetic Systems, N.V., For use in Human food and animal feed | ||||||
Oilseed rape (Canola) | Barstar; phosphinothricin acetyl transferase (PAT) | Bacillus amyloliquefaciens; Streptomyces hygroscopicus | Fertility restorer; tolerance to glufosinate-ammonium | RF1[B93-101], RF2[B94-2] | Apr. 4, 1996 | Mar. 25, 1996 |
BNF No. 31, Submitted Jan. 12, 1996 by Plant Genetic Systems (America), Inc., For use in Human food and animal feed | ||||||
Corn | Barnase; phosphinothricin acetyl transferase (PAT) | Bacillus amyloliquefaciens; Streptomyces hygroscopicus | Male sterility; tolerance to glufosinate-ammonium | MS3 | June 7, 1996 | Mar. 15, 1996 |
BNF No. 30, Submitted Feb. 21, 1996 by DuPont, For use in Human food and animal feed | ||||||
Cotton | Acetolactate synthase (ALS) | Nicotiana tabacum cv. Xanthi (Tobacco) | Tolerance to the herbicide sulfonylurea | 19-51a | June 28, 1996 | June 28, 1996 |
BNF No. 28, Submitted Nov. 17, 1995 by Dekalb Genetics, For use in Human food and animal feed | ||||||
Corn | Phosphinothricin acetyltransferase (PAT) | Streptomyces hygroscopicus | Tolerance to the herbicide glufosinate-ammonium | DLL25 | Mar. 8, 1996 | Jan. 25, 1996 |
BNF No. 18, Submitted Sep. 15, 1995 by Monsanto, For use in Human food and animal feed | ||||||
Corn* | CryIAb protein | Bacillus thuringiensis subsp. kurstaki (Btk) | Resistance to European corn borer | MON 801 | July 24, 1996 | July 22, 1996 |
BNF No. 17, Submitted Oct. 25, 1995 by Northrup King, For use in Human food and animal feed | ||||||
Corn* | CryIAb protein | Bacillus thuringiensis subsp. kurstaki (Btk) | Resistance to European corn borer | Bt11 | May 22, 1996 | May 22, 1996 |
BNF No. 14, Submitted Jan. 16, 1996 by Agritope, For use in Human food | ||||||
Tomato | S-adenosylmethionine hydrolase | Escherichia coli bacteriophage T3 | Delayed fruit ripening due to reduced ethylene synthesis | 35-1-N | Mar. 20, 1996 | Feb. 22, 1996 |
Submissions Completed in 1995 | ||||||
Food |
Gene, Gene Product, or Gene Fragment |
Source |
Intended Effect |
Designation |
FDA Letter |
FDA Memo |
BNF No. 29, Submitted Aug. 29, 1995 by AgrEvo, For use in Human food and animal feed | ||||||
Corn | Phosphinothricin acetyltransferase (PAT) | Streptomyces viridochromogenes | Tolerance to the herbicide glufosinate-ammonium | T14, T25 | Dec. 14, 1995 | Dec. 12, 1995 |
BNF No. 26, Submitted Apr. 13, 1995 by Monsanto, For use in Human food and animal feed | ||||||
Cotton | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | Tolerance to the herbicide glyphosate | 1445, 1698 | Sep. 8, 1995 | Sep. 8, 1995 |
BNF No. 25, Submitted Aug. 17, 1992 by Calgene, For use in Human food and animal feed | ||||||
Oilseed rape (Canola) | 12:0 acyl carrier protein thioesterase | Umbellularia californica (California Bay) | High laurate canola oil | 23 | July 13, 1995 | Apr. 4, 1995 |
BNF No. 24, Submitted Mar. 2, 1995 by Ciba Geigy, For use in Human food and animal feed | ||||||
Corn* | CryIAb protein | Bacillus thuringiensis subsp. kurstaki (Btk) | Resistance to European corn borer | 176 | July 14, 1995 | July 14, 1995 |
BNF No. 23, Submitted Mar. 17, 1995 by AgrEvo, For use in Human food and animal feed | ||||||
Oilseed rape (Canola) | Phosphinothricin acetyltransferase(PAT) | Streptomyces viridochromogenes | Tolerance to the herbicide glufosinate-ammonium | HCN92 | Apr. 20, 1995 | Mar. 17, 1995 |
BNF No. 20, Submitted Apr. 3, 1995 by Monsanto, For use in Human food and animal feed | ||||||
Oilseed rape (Canola) | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS); Glyphosate oxidoreductase (GOX) | Agrobacterium sp. strain CP4, Achromobacter sp. strain LBAA | Tolerance to the herbicide glyphosate | GT73 | Sep. 26, 1995 | Sep. 26, 1995 |
BNF No. 13, Submitted Nov. 21, 1994 by Monsanto, For use in Human food and animal feed | ||||||
Cotton* | CryIAc protein | Bacillus thuringiensis subsp. kurstaki (Btk) | Resistance to cotton ballworm, pink bollworm, and tobacco budworm | 531 | June 1, 1995 | Feb. 27, 1995 |
757, 1076 | May 30, 1995 | |||||
BNF No. 07, Submitted Sep. 16, 1994 by DNA Plant Technology, For use in Human food | ||||||
Tomato | A fragment of the gene encoding amino cyclopropane carboxylic acid synthase (ACCS) to suppress the endogenous ACCS enzyme | Tomato | Delayed ripening due to reduced ethylene synthesis | 1345-4 | Apr. 5, 1995 | Oct. 4, 1994 |
BNF No. 06, Submitted Sep. 6, 1994 by Asgrow, For use in Human food | ||||||
Squash* | ZYMV and WMV2 coat proteins | Zuchini yellow mosaic virus (ZYMV) and watermelon mosaic virus 2 (WMV2) | Resistance to ZYMV and WMV2 | ZW20 | Apr. 5, 1995 | Oct. 3, 1994 |
BNF No. 05, Submitted Aug. 25, 1994 by Monsanto, For use in Human food and animal feed | ||||||
Potato* | CryIIIA protein | Bacillus thuringiensis subsp. tenebrionis (Btt) | Resistance to Colorado potato beetle | BT6, BT10, BT12, BT16, BT17, BT18, and BT23 | Apr. 5, 1995 | Sep. 23, 1994 |
BNF No. 04, Submitted June 14, 1994 by Calgene, For use in Human food and animal feed | ||||||
Cotton | Nitrilase | Klebsiella ozaenae | Tolerance to the herbicide Bromoxynil | BXN cotton | Apr. 5, 1995 | Sep. 20, 1994 |
BNF No. 03, Submitted Sep. 6, 1994 by Zeneca, For use in Human food | ||||||
Tomato | A fragment of the polygalacturonase (PG) gene to suppress the endogenous PG enzyme | Tomato | Delayed softening due to reduced pectin degradation | B, Da, F | Apr. 5, 1995 | Sep. 20, 1994 |
BNF No. 02, Submitted Aug. 26, 1994 by Monsanto, For use in Human food | ||||||
Tomato | 1-aminocyclopropane- 1-carboxylic acid deaminase (ACCD) | Pseudomonas chlororaphis | Delayed softening due to reduced ethylene synthesis | 8338 | Apr. 5, 1995 | Sep. 19, 1994 |
BNF No. 01, Submitted Sep. 2, 1994 by Monsanto, For use in Human food and animal feed | ||||||
Soybean | 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) | Agrobacterium sp. strain CP4 | Tolerance to the herbicide glyphosate | 40-3-2 | Jan. 27, 1995 | Sep. 19, 1994 |