Science, law, and politics in the food and drug administration's genetically engineered foods policy: FDA's 1992 policy statement

Nutrition Reviews

Volumn 63, Issue 5, 2005, Pages 171-181

  Pelletier, David L ^a  

^a Cornell University ^*  (United States)

Author keywords

Food safety; Scientific uncertainty; Unintended effects

Indexed keywords

ALLERGEN;

AGRICULTURAL PROCEDURES; ALLERGY; ARTICLE; FOOD AND DRUG ADMINISTRATION; GENETICALLY MODIFIED FOOD; LAW; MANAGEMENT; MUTAGENESIS; NONHUMAN; PLEIOTROPY; SCREENING TEST; TOXICITY; TRANSGENE;

ALLERGENS; FOOD, GENETICALLY MODIFIED; HUMANS; LEGISLATION, FOOD; SAFETY; TOXINS, BIOLOGICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 18644379659     PISSN: 00296643     EISSN: None     Source Type: Journal    
DOI: 10.1301/nr.2005.may.000-000     Document Type: Article

References (47)

1. Committee on Biosciences Research in Agriculture. National Research Council. New Directions for Biosciences Research in Agriculture: High-Reward Opportunities. Washington, DC: National Academies Press; 1985. Available at: http://www.nap.edu/openbook/0309035422/html/R1.html. Accessed April 11, 2005.
2. Glickman D. New crops, new century, new challenges: How will scientists, farmers and consumers learn to love biotechnology and what happens if they don't? [transcript]. Press Release No. 0285.99. National Press Club. July 13, 1999.
3. Biotechnology Industry Organization. When Given the Facts, Consumers Support Biotechnology. Available at: http://www.bio.org/foodag/background/ consumer.asp. Accessed April 11, 2005.
4. Persley GJ. Agricultural Biotechnology and the Poor: Promethean Science. Washington, DC: Consultative Group on International Agricultural Research; 2000. Available at: http://www.cgiar.org/biotech/rep0100/persley.pdf. Accessed April 11, 2005.
5. Food and Agriculture Organization. FAO Statement on Biotechnology. Rome: FAO; 2000. Available at: http://www.fao.org/biotech/stat.asp. Accessed April 11, 2005.
6. Commission of the European Communities. White Paper on Food Safety. Brussels: Commission of the European Communities; 2000. Available at: http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub06_en.pdf. Accessed April 11, 2005.
7. Consumers Union. Consumers Union's Comments on Docket No. 99N-4282, Biotechnology in the Year 2000 and Beyond. New York: Consumers Union; 2000. Available at: http://www.consumersunion. org/food/fdacpi100. Accessed April 11, 2005.
8. McGarity TO, Hansen PI; Food Policy Institute of the Consumer Federation of America. Breeding Distrust: An Assessment and Recommendations for Improving the Regulation of Plant Derived Genetically Modified Foods. Washington, DC: Consumer's Federation of America; 2001. Available at: http://www.biotech-info. net/Breeding_Distrust.html. Accessed April 11, 2005.
9. Natural Resources Defense Fund. NRDC Led Coalition Calls for USDA to Stop Environmentally Harmful Releases of Genetically Engineered Crops. Washington, DC: Natural Resources Defense Fund; 2000. Available at: http://www.nrdc.org/ media/pressReleases/0004262.asp. Accessed April 11, 2005.
10. Who's Afraid? The Economist; June 19, 1999.
11. Better dead than GM-fed? The Economist; September 19, 2002. Available online at: http://www. economist.com/science/displayStory.cfm?story_ id=1337197. Accessed April 11, 2005.
12. To Plant or Not to Plant. The Economist; January 15, 2000.
13. Monsanto faces growing skepticism on two fronts. New York Times; August 4, 1999.
14. Prakash C, Bruhn C. Sound science and foods from biotechnology. San Diego Union Tribune, June 14, 2000.
15. Leisinger K. Ethical challenges of agricultural biotechnology for developing countries. In: Persley G, Lantin M, eds. Agricultural Biotechnology and the Poor. Washington, DC: Consultative Group on International Agriculture Research; 2000.
16. Pinstrup-Andersen P, Schioler E. Seeds of Contention. Baltimore: John Hopkins University Press; 2000.
17. Wolfenbarger L, Phifer P. The ecological risks and benefits of genetically engineered plants. Science. 2000;290:2088-2093.
18. Clark E, Lehman H. Assessment of GM crops in commercial agriculture. Journal of Agricultural and Environmental Ethics. 2001;14:3-28.
19. Physicians and Scientists for Responsible Application of Science and Technology. Declaration. Available at: http://www.psrast.org/decl.htm. Accessed April 12, 2005.
20. Ferrara J. Paving the way for biotechnology: Federal regulators and industry PR. In: Tokar B, ed. Redesigning Life. New York: Zed Books, Ltd.; 2001.
21. Eichenwald K, Kolata G, Petersen M. Biotechnology food: From lab to a debacle. New York Times; January 25, 2001.
22. Pelletier D. Science, law, and politics in FDA's genetically engineered foods policy: scientific concerns and uncertainties. Nutr Rev. In press.
23. Food and Drug Administration. Statement of policy: Foods derived from new plant varieties. Federal Register. 1992;57:22984-23001.
24. Charles D. Lords of the Harvest. Cambridge, MA: Perseus Publishing; 2001.
25. Hart K. Eating in the Dark. New York: Pantheon Books; 2002.
26. Winston M. Travels in the Genetically Modified Zone. Cambridge, MA: Harvard University Press; 2002.
27. Office of Science and Technology Policy. Coordinated framework for regulation of biotechnology. Federal Register. 1986;51:23303-23393.
28. Clydesdale F, ed. Allergenicity of Foods Produced by Genetic Modification: Critical Reviews in Food Science and Nutrition Special Supplement. Vol. 36. Boca Raton, FL: CRC Press; 1996.
29. Office of Science and Technology Policy. Exercise of federal oversight within scope of statutory authority: planned introduction of biotechnology products into the environment: announcement of policy. Federal Register. 1992;57:6753-6762.
30. Food and Drug Administration. Premarket notice concerning bioengineered foods: proposed rules. Federal Register. 2001;66:4706-4738.
31. Food and Agriculture Organization and World Health Organization. Strategies for Assessing the Safety of Foods Produced by Biotechnology. Report of a Joint FAO/WHO Consultation. Geneva: FAO/ WHO; 1991.
32. Institute of Food Technologists. Human safety evaluation of rDNA biotechnology-derived foods: IFT expert report on biotechnology and foods. Food Technology. 2000;54:15-23.
33. Millstone E, Brunner E, Mayer S. Beyond 'substantial equivalence'. Nature. 1999;401:525-526.
34. Food and Agriculture Organization and World Health Organization. Safety Aspects of Genetically Modified Foods of Plant Origin. Geneva: FAO/WHO; 2000.
35. Institute of Medicine. Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. Washington, DC: Institute of Medicine; 2004.
36. US General Accounting Office. Genetically Modified Foods: Experts View Regimen of Safety Tests as Adequate, But FDA's Evaluation Process Could Be Enhanced. Washington, DC: GAO; 2002.
37. Food and Drug Administration. Substances generally regarded as safe: proposed rule. Federal Register. 1997;62:18937-18964.
38. National Research Council. Genetically Modified Pest Protected Plants: Science and Regulation. Washington, DC: National Academies Press; 2000.
39. Gurian-Sherman D. Holes in the Biotech Safety Net: FDA Policy Does Not Assure the Safety of Genetically Engineered Foods. Washington, DC: Center for Science in the Public Interest; 2003.
40. Metcalfe D, Astwood J, Townsend R, Sampson H, Taylor S, Fuchs R. Assessment of the allergenic potential of foods derived from genetically engineered crop plants. Crit Rev Food Sci Nutr. 1996;36(suppl):S165-S186.
41. Scientific Advisory Panel. Assessment of scientific information concerning StarLink corn. Report of the FIFRA Scientific Advisory Panel Meeting. Paper presented at: FIFRA Scientific Advisory Panel Meeting; December 1, 2000; Rosslyn, VA.
42. National Research Council. Ensuring Safe Food: From Production to Consumption. Washington, DC: National Academies Press; 1998.
43. Food and Agriculture Organization. State of Food Insecurity in the World. Rome: FAO; 1999.
44. US Department of State. Fact sheet: questions and answers on U.S. food aid donations containing bioengineered crops; January 17, 2003. Available online at: http://www.state.gov/e/eb/rls/fs/16736.htm. Accessed April 12, 2005.
45. Bush steps up attack on EU over its ban on biotech crops. Wall Street Journal; May 22, 2003.
46. Freese W, Schubert D. Safety testing and regulation of genetically engineered foods. Biotechnology and Genetic Engineering Reviews. 2004;21:299-324.
47. Wilson A, Latham J, Steinbrecher R. Genome Scrambling: Myth or Reality? Transformation-Induced Mutations In Transgenic Crop Plants; 2004. Available online at: http://www.econexus.info/pdf/ENx-Genome-Scrambling-Summary.pdf. Accessed April 12, 2005.