APHIS oversees American agriculture, protecting against pests and diseases. It is the lead agency regulating the safe field-testing of biotechnology-derived new plant varieties and certain microorganisms. As such, APHIS grants approval for and licenses veterinary biological substances including animal vaccines that may be the products of biotechnology.
The EPA approves new herbicidal and pesticidal substances. It issues permits for testing herbicides and biotechnology-derived plants containing new pesticides. When the EPA makes a determination about whether to register a new pesticide, it considers human safety, environmental impact, its effectiveness on the target pest, and any consequences for other, nontarget species. The EPA establishes and enforces the guidelines that ensure safe use of genetically engineered products classified as pesticides.
The FDA ensures that foods derived from new bioengineered plant varieties are safe and nutritious—they must meet or exceed the same high standards of safety applied to any food product. The FDA is also responsible for issuing and enforcing regulations to ensure that all food and feed labels, including those related to biotechnology, are truthful and do not mislead consumers. Table 9.1 lists genes, gene fragments, and GM products (with their intended effects) that were submitted to the FDA from 1994 to early 2005.
The National Academy of Sciences Reports
On April 5, 2000, the National Academy of Sciences (NAS), an organization created by the U.S. Congress in 1863 to advise the government about scientific and technical matters, released a report about proposed EPA regulation of recombinant DNA-manipulated plants. Interpretations of the report varied—some observers deemed it an NAS seal of approval and testimony to the safety of genetically altered foods, while others denounced its scientific methodology and recommendations for complicated, cumbersome regulation of GM crops and foods. One of the key questions the report attempted to answer was whether the use of recombinant DNA techniques should automatically prompt EPA regulation. Earlier studies and many biotechnology firms and scientific professional societies advised against regulation, cautioning that it would likely:
- Discourage development of new pest-resistant crops, thereby prolonging the use of potentially harmful synthetic chemical pesticides.
- Increase the regulatory requirements for organizations developing pest-resistant crops, as well as increasing federal and state bureaucracies.
- Limit the use of biotechnology for the development of pest-resistant plants to those developers able to pay the increased costs associated with additional regulation.
- Compromise the United States' ability to compete in international markets.
- Limit the use of valuable genetic resources and new technologies to improve crop protection from pests and diseases.
As a result, the biotechnology industry and scientific community were surprised when the NAS report recommended strengthening the EPA regulatory approach, which is voluntary, not mandatory; but they were also relieved that the report did not advise product labeling. Consumers and public interest groups complained that the 261-page NAS report discounted the potential health hazards of GM foods. Still, the report did not entirely overlook potential health and ecological perils, observing that GM crops may produce unexpected allergens and toxic substances in food and may create far-reaching environmental effects, including harm to beneficial insects, proliferation of superweeds, and adverse effects on soil organisms. Although the NAS found no evidence that genetically engineered foods harm humans, it admitted that there had been insufficient testing to support or refute the premise of safety.
Although the biotechnology industry heralded the report as generally favorable, media representatives charged that the NAS panel members were biased and had conflicts of interest such as accepting money from biotechnology firms and laboratories. Ultimately, the report satisfied no one, creating as many controversies as it was originally intended to resolve.
In July 2004 the Institute of Medicine (IOM) of the National Academy of Sciences published The Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. The USDA, FDA, and Environmental Protection Agency commissioned the National Academies to assess the potential for adverse health effects from genetically engineered foods compared with foods altered in other ways, and to provide guidance on how to identify and evaluate the likelihood of those effects. While adverse health effects from genetic engineering have not been detected in the human population, the technique is new and concerns about its safety remain.
The IOM report urged federal agencies to assess the safety of genetically altered foods on a case-by-case basis to determine whether unintended changes in their composition have the potential to adversely affect human health, and calls for greater scrutiny of foods containing new compounds or unusual amounts of naturally occurring substances.
The report presented a framework to guide federal agencies in selecting the course and intensity of safety assessment. A new genetically modified food whose composition is very similar to a commonly used conventional version may warrant little or no additional safety evaluation. If, however, an unknown substance has been detected in a food, more detailed analyses should be
TABLE 9.1
FDA list of completed consultations on bioengineered foods, 1994–2005
| Completed submissions organized by year and file number (BNF No.) | ||||||
| Food | Gene, gene product, or gene fragment | Source | Intended effect | Designation | FDA letter | FDA memo |
| Submissions completed in 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 |
| Submissions completed in 2004 | ||||||
| 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 30, 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 | Aug. 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 | Aug. 17, 2004 | Aug. 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 | Oct. 4, 2004 | Sep. 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 | ||||||
| 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 | ||||||
| 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 |
TABLE 9.1
FDA list of completed consultations on bioengineered foods, 1994–2005 [CONTINUED]
| Completed submissions organized by year and file number (BNF No.) | ||||||
| Food | Gene, gene product, or gene fragment | Source | Intended effect | Designation | FDA letter | FDA memo |
| Submissions completed in 2001 | ||||||
| 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 | ||||||
| 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 | ||||||
| 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 | ||||||
| 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 |
TABLE 9.1
FDA list of completed consultations on bioengineered foods, 1994–2005 [CONTINUED]
| Completed submissions organized by year and file number (BNF No.) | ||||||
| Food | Gene, gene product, or gene fragment | Source | Intended effect | Designation | FDA letter | FDA memo |
| 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 | ||||||
| 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 |
TABLE 9.1
FDA list of completed consultations on bioengineered foods, 1994–2005 [CONTINUED]
| Completed submissions organized by year and file number (BNF No.) | ||||||
| Food | Gene, gene product, or gene fragment | Source | Intended effect | Designation | FDA letter | FDA memo |
| Submissions completed in 1996 | ||||||
| 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 | ||||||
| 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 |
TABLE 9.1
FDA list of completed consultations on bioengineered foods, 1994–2005 [CONTINUED]
| Completed submissions organized by year and file number (BNF No.) | ||||||
| Food | Gene, gene product, or gene fragment | Source | Intended effect | Designation | FDA letter | FDA memo |
| 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 | 531 757, 1076 |
June 1, 1995 | Feb. 27, 1995 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 |
| Submissions completed in 1994 | ||||||
| BNF FLAVR SAVR, submitted Aug. 12, 1991 by Calgene, for use in human food | ||||||
| Tomato | Antisense polygalacturonase (PG) gene to suppress the endogenous PG enzyme | Tomato | Delayed softening due to reduced pectin degradation | CR3-613; CR3-623 | May 17, 1994 (PDF) | May 17, 1994 (PDF) |
| Note: 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. The FDA has used an asterisk (*) to identify each bioengineered food that contains a PIP. | ||||||
conducted to determine whether an allergen or toxin may be present. Similarly, foods with nutrient levels that fall outside the normal range should be assessed for their potential impact on consumers' diets and health.
The IOM was also charged with examining the safety of foods from cloned animals. The report recommended that the safety evaluation of these foods should focus on the product itself rather than the process used to create it, and advised that the evaluations compare foods from cloned animals with comparable food products from non-cloned animals. Although there is no evidence that foods from cloned animals pose an increased risk to consumers, the report cautioned that cloned animals engineered to produce pharmaceuticals should not be permitted to enter the food chain.
Criticisms of the U.S. Regulatory Approach
Opponents of GM foods do not believe there are sufficient government regulations in place to control U.S. production and distribution of these foods. They argue that there has not been enough research or long-term experience with these foods, and as a result the health consequences of growing and eating such foods as well as the environmental impact are not yet known. Proponents claim the benefits of transgenic foods—improved flavor, increased nutritional value, longer shelf life, and greater yields—surpass any potential risks. They also discount the health risks, observing that nearly half the soybean crop and a quarter of all corn grown in the United States consists of transgenic varieties, meaning that Americans have been consuming transgenic food products for years and, as of 2005, there have been no reports of adverse health effects as a result.
Since the late 1990s there have been protests staged to oppose the widespread use and consumption of GM foods as well as attacks on facilities conducting research on transgenic crops and companies marketing GM products. Protesters have dubbed the transgenic crops "Frankenfoods," likening them to Frankenstein's monster, a creature who looked normal on the outside but was actually a man-made freak. Greenpeace, an organization that opposes the creation of GM foods, and other activists staged protests at the World Trade Organization (WTO) meeting in Seattle on November 30, 1999. Greenpeace also hung an anti-GM banner on Kellogg's "Cereal City" museum in 2000. It hopes that such actions will move U.S. lawmakers to require labeling of transgenic foods. They are inspired by the example of European consumers, who demanded and have been granted product labeling that enables them to choose whether to purchase and consume GM foods.
On May 9, 2001, the Center for Food Safety and a coalition of more than sixty petitioners, consisting of consumer and environmental protection organizations along with fishing companies and fishermen, filed legal petitions with the FDA, the U.S. Department of Interior, the U.S. Department of Commerce, the U.S. Department of Defense, and the USDA to request a moratorium on the domestic marketing and importation of transgenic fish until the FDA adequately addressed environmental impact and human food safety issues. The petition observed that
unintended releases of transgenic fish into the world's waters may cause significant impacts to the environment and endangered species. New studies have shown that transgenic fish are more aggressive, eat more food, and will attract more mates than wild fish. In addition, these studies show that although transgenic fish will attract more mates, their offspring will be less fit and less likely to survive. As a result, scientists predict that transgenic fish will cause some species to become extinct within only a few generations. Once one species becomes extinct, other species will likely be affected. There are already 114 species of fish, including Atlantic salmon that are listed under the Endangered Species Act. Allowing transgenic fish in ocean pens may significantly increase this number of listed species.
On May 23, 2003, Greenpeace mounted a campaign against Senate Majority Leader Bill Frist, condemning him for supporting legislation that induces African nations to accept GM food by implying that it might be tied to receiving AIDS-prevention funding. Just two days earlier President George Bush maintained that American efforts to reduce hunger in Africa have been thwarted by European policies, specifically objection to the use of genetically engineered crops. The president had already signed a bill that would allow the United States to withhold AIDS medications from African nations if they refused genetically engineered food aid.
In 2004 a consortium of citizen groups including the CFS, Friends of the Earth, Pesticide Action Network North America, and KAHEA: The Hawaiian-Environmental Alliance filed a lawsuit in federal district court seeking to force the USDA to review the environmental and public health impacts of open-air field tests of biopharmaceutical crops genetically engineered to produce industrial chemicals and drugs and to disclose the locations of the field tests. On February 4, 2005, the USDA was forced by court order to reveal the locations of these sites in Hawaii. In a press release issued by CFS on February 8, 2005, Peter Jenkins of CFS said, "Allowing food crops to be engineered to produce chemicals or drugs is bad enough but hiding the location of the test fields from an at-risk public is indefensible. Yet we find our own government fighting on the side of the biotech industry to keep the public in the dark about drug-laced food crops" (Center for Food Safety, "Government Forced to Disclose Locations of Test Sites of Biopharmaceutical Crops," February 8, 2005, http://www.centerforfoodsafety.org/ press_release 2.8.05.cfm).
American Consumers' Opinions Vary
Public opinion surveys about GM foods conducted during the late 1990s revealed a range of consumer viewpoints. A February 1999 telephone survey conducted by the International Food Information Council about the safety and labeling of genetically engineered foods found that more than half of the survey respondents (58%) felt that labeling GM foods "would be costly and confusing to consumers," and only 38% of those surveyed were aware that GM foods were sold in American supermarkets.
In "Transgenic Pollen Harms Monarch Larvae" (Nature, vol. 319, May 20, 1999), John E. Losey, Linda S. Rayor, and Maureen E. Carter suggested that pollen from genetically engineered corn threatens the survival of the monarch butterfly. A May 1999 CNN Online Poll, which was conducted the same month the article was published, found that three-quarters of respondents believed GM crops should be put on hold pending further study. (Critics contested that the article and follow-up studies maintained that pollen from the genetically modified corn rarely reached toxic levels on the milkweed even when monarch butterfly larvae were feeding on plants adjacent to the field of corn.)
A 1999 Time magazine poll found that 81% of American consumers wanted genetically engineered foods to be labeled. In the September 2000 market research survey by BSMG Worldwide for the Grocery Manufacturers of America, two-thirds of respondents said they were concerned about biotechnology issues, and nearly half (48%) opposed any use of genetic modification in food production. Women, who generally do the grocery shopping, were more likely than men to express negative feelings about gene-altered foods, as were African-Americans and older adults. Just 15% of respondents were aware that GM foods were available in the majority of supermarkets, and the overwhelming majority of those surveyed supported mandatory labeling of such foods.
The July 2001 Gallup Poll found that many Americans were generally positive, but not excited or especially interested or concerned about GM food. Most survey respondents were neither aware nor informed about the genetic modification of food—in 2001 a full 40% said they had not heard much or had heard nothing at all about the issue. More than half of all respondents (52%) said they supported biotechnological applications to food production, and the proportion of people who either supported or were opposed to biotech foods was relatively unchanged from a 1999 survey. About the same proportion (53%) did not feel that biotech foods posed a serious health hazard to consumers; and less than one-third of those surveyed felt GM foods posed a hazard to consumers. Respondents with higher education levels tended to show increased support for the use of biotechnology in food production—59% of those with college degrees and 65% of respondents with postgraduate degrees favored this application of biotechnology.
One year later, the Gallup Organization found Americans' views about bioengineered foods were relatively unchanged, although 30% of those polled in July 2002 said they actively avoided foods produced using biotechnology. Respondents were actually more likely to reject produce grown with pesticides (39%) and artificially sweetened foods (50%) than GM foods. More than half of the respondents (52%) did not even consider whether they should consume or avoid foods produced using biotechnology.
The most recent Gallup Organization data about Americans' interest in and concern about genetically modified food found that in 2003 even fewer respondents (9%) followed news about biotechnology "very closely" than had in 2001 (11%). In 2003 a full 25% of respondents admitted that they were not following news about genetic engineering and genetic modification of food "at all," and an additional 34% said they did not follow such news "too closely." (See Table 9.2.) Interestingly, when queried about their support of or opposition to the use of biotechnology in agriculture and food production in 2003, 7% more respondents said they strongly or moderately opposed its use, and 5% fewer expressed moderate support for it. In 2003 just 47% of respondents expressed support for the use of biotechnology, down from 52% in 2001. (See Table 9.3.)
Further, the 2003 Gallup Poll recorded the highest percentage of people who believed that foods produced using biotechnology pose a serious health hazard to consumers in recent years. Thirty-four percent of respondents said they knew or had heard that genetically modified foods were hazardous, a 4% increase from 2001. (See Table 9.4.) Women, people living in the East, Americans with a high school education or less, and people in households earning $30,000 or less were more likely to believe that foods produced using biotechnology present a health hazard than men, people living in the West, and households with income in excess of $30,000. Republicans are less likely to feel that genetically modified foods are dangerous than are Democrats or independents. Whites are much less likely than nonwhites to say that genetically modified food poses a hazard. Twenty-nine percent of whites think
TABLE 9.2
Public awareness of the genetic modification of food, 2001–03
"HOW CLOSELY HAVE YOU FOLLOWED NEWS ABOUT THE GENETIC MODIFICATION OF FOOD?"
| Very closely | Somewhat closely | Not too closely | Not at all | No opinion | |
| 2003 July 7–9 | 9% | 32 | 34 | 25 | — |
| 2001 July 19–22* | 11% | 34 | 33 | 21 | 1 |
| *Asked of a half sample | |||||
TABLE 9.3
Public opinion on the use of biotechnology in agriculture and food production, 1999–2003
"WOULD YOU SAY YOU STRONGLY SUPPORT, MODERATELY SUPPORT, MODERATELY OPPOSE, OR STRONGLY OPPOSE THE USE OF BIOTECHNOLOGY IN AGRICULTURE AND FOOD PRODUCTION?"
| Strongly support | Moderately support | Moderately oppose | Strongly oppose | No opinion | |
| 2003 July 7–9 | 9% | 38 | 27 | 18 | 8 |
| 2001 July 19–22 | 9% | 43 | 24 | 14 | 10 |
| 2000 March 30–Apr 2 | 12% | 36 | 23 | 18 | 11 |
| 1999 September 23–26 | 9% | 42 | 25 | 16 | 8 |
modified foods could be dangerous, while more than half (52%) of nonwhites feel such foods could pose health hazards.
In "Genetically Altered Foods: Hazard or Harmless?" ("Poll Analyses," Gallup Organization, August 12, 2003), Gallup healthcare editor Rick Blizzard characterized the public's main concerns about genetically modified food:
- The potential for food allergies to arise in response to unknown gene combinations
- Apprehension about increasing resistance to antibiotics as a result of ingesting food with antibiotic-resistant genes
- Fear of possible toxicity from foods modified to produce pesticides
TABLE 9.4
Public opinion whether biotechnology poses a health hazard to consumers, 1999–2003
"DO YOU BELIEVE THAT FOODS PRODUCED USING BIOTECHNOLOGY POSE A SERIOUS HEALTH HAZARD TO CONSUMERS?"
| Yes | No | No opinion | |
| 2003 July 7–9 | 34% | 54 | 12 |
| 2001 July 19–22 | 30% | 53 | 17 |
| 2000 March 30–Apr 2 | 30% | 51 | 19 |
| 1999 September 23–26 | 27% | 53 | 20 |
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