Genetic engineering has both risks and the potential to provide significant benefits. The Coordinated Framework for Regulation of Biotechnology relies on existing federal laws and agencies to assure that genetically engineered products are safe. The goal is to balance the need for safety with the need to avoid impeding the biotech industry. This article reviews U.S. laws of greatest significance to agricultural and food-related biotechnology, and the regulatory roles of the Food and Drug Administration, the Environmental Protection Agency, and the U.S. Department of Agriculture's Animal and Plant Health Inspection Service. It concludes that consumers, farmers, and the environment are well protected by that system. However, because of the rapid development of biotechnology the regulatory system should be improved, and its underlying strengths better communicated to the public.
Get full access to this article
View all access options for this article.
References
1.
Better study is urged of biotech crop's effects. (2000, February 18). The Washington Post [Online], p. A02. Retrieved June 13, 2000, from the World Wide Web: http://www.washingtonpost.com/wp-srv/national/feed/a3012-2000feb18.htm
2.
Biotechnology Industry Organization. (1999). Food and ag biotech government regulation [Online]. Retrieved June 13, 2000, from the World Wide Web: http://www.bio.org/food&ag/regulation.html
3.
Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23302 (1986).
4.
Decision documents and publications [Online]. (2000, June 4). Available: http://www.aphis.usda.gov/biotech/pubs.html
5.
Environmental Implications of Genetic Engineering, report by Subcommittee on Investigations & Oversight to House Committee on Science and Technology, 98th Cong., 2d Sess. (1984).
6.
Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C.A. § 301 et seq. (West 1999).
7.
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C.A. § 136 et seq. (West 1999).
8.
Federal Plant Pest Act, 7 U.S.C.A. § 150aa et seq. (West 1999).
9.
Federal Seed Act, 7 U.S.C.A. § 1551 et seq. (West 1999).
10.
Final Policy Statement for Research and Regulation of Biotechnology Processes and Products, 51 Fed. Reg. 23336 (1986).
11.
Food Quality Protection Act of 1996, 21 U.S.C.A. §§ 321, 331, 333, 342, 346a (West 1999).
12.
Foundation on Economic Trends v. Heckler, 756 F. 2d 143 (D.C. Cir., 1985).
13.
Information system for biotechnology [Online]. (2000, June 13). Available: http://gophisb.biochem.vt.edu/
14.
International survey of herbicide-resistant weeds [Online]. (2000, June 13). Available: http://www.weedscience.com/
15.
Kessler, D. A. , Taylor, M. R., Maryanski, J. H., Flamm, E. L., & Kahl, L. S. (1992). The safety of foods developed by biotechnology. Science, 256, 1747-1749.
16.
Lackey, J. (2000a, June 13). Corn [Online]. Available: http://www.aphis.usda.gov/biotech/corn.html
17.
Lackey, J. (2000b, June 13). Soybean [Online]. Available: http://www.aphis.usda.gov/biotech/soybean.html
18.
Malinowski, M. J. (1999). Biotechnology: Law, business, and regulation. New York: Aspen Law & Business.
19.
Mikkelsen, T. R. , Andersen, B., & Bagger, J. R. (1996). The risk of crop transgene spread. Nature, 380, 31.
20.
NAS ban on plasmid engineering . (1974). Nature, 250, 175.
21.
National Research Council . (2000). Genetically modified pest-protected plants: Science and regulation [Online]. Washington, DC: National Academy Press. Retrieved May 9, 2000, from the World Wide Web: http://books.nap.edu/catalog/9795.html
22.
Nelson, G. C., Josling, T., Bullock, D., Unnevehr, L., Rosegrant, M., & Hill, L. (1999). The economics and politics of genetically modified organisms in agriculture: Implications for WTO 2000. Bulletin 809, Office of Research, College of ACES, University of Illinois at Urbana-Champaign.
23.
Organization for Economic Cooperation and Development. (1993). Safety evaluation of foods derived by modern biotechnology: Concepts and principles [Online]. Retrieved June 13, 2000, from the World Wide Web: http://www.oecd.org//dsti/sti/s_t/biotech/prod/MODERN.pdf
24.
Organization for Economic Cooperation and Development. (2000, June 13). Oecd's database of field trials [Online]. Available: http://www.olis.oecd.org/biotrack.nsf/
25.
Pesticide fact sheet [Online]. (2000, June 13). Available: http://www.epa.gov/docs/fedrgstr/EPA-PEST/1997/September/Day-10/cry.htm
26.
Petition for Determination of Nonregulated Status, 7 C.F.R. § 340.6 (1997).
27.
Petitions of nonregulated status granted by APHIS [Online]. (2000, June 13). Available: http://www.aphis.usda.gov/biotech/not_reg.html
28.
Plant-Pesticides Subject to the Federal Insecticide, Fungicide and Rodenticide Act, 59 Fed. Reg. 60535 (1994) (to be codified at 40 C.F.R. § 174.5).
29.
Proposal for a Coordinated Framework, 49 Fed. Reg. 50856 (1984).
30.
Recombinant DNA Research Guidelines, 41 Fed. Reg. 27902 (1984).
31.
Recombinant DNA Research Guidelines, 43 Fed. Reg. 60108 (1978).
32.
Restrictions on the Introduction of Regulated Articles, 7 C.F.R. § 340.0 (1997).
33.
Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 2298 (1992). Retrieved June 13, 2000, from the World Wide Web: http://vm.cfsan.fda.gov/~acrobat/fr920529.pdf
34.
Statement of Policy for Regulation of Biotechnology Processes and Products, 49 Fed. Reg. 50897 (1984).
35.
Thompson, L. (2000, January-February). Are bioengineered foods safe? FDA Consumer Magazine [Online]. Retrieved June 14, 2000, from the World Wide Web: http://www.fda.gov/fdac/features/2000/100_bio.html
36.
Toxic Substances Control Act, 15 U.S.C.A. § 2601 et seq. (West 1998).
37.
U.S. Department of Agriculture. (2000a, June 13). Agricultural biotechnology: Permitting notification, and deregulation [Online]. Available: http://www.aphis.usda.gov/biotech/
38.
U.S. Department of Agriculture. (2000b, June 13). Petitions of nonregulated status granted by APHIS [Online]. Available: http://www.aphis.usda.gov/biotech/not_reg.html
39.
U.S. Department of Health and Human Services. (2000, June 13). FDA to strengthen pre-market review of bioengineered foods [Online]. Available: http://vm.cfsan.fda.gov/~Ird/hhbioen2.html
40.
U.S. Food and Drug Administration. (1998). Guidance for industry: Use of antibiotic resistance marker genes in transgenic plants [Online]. Retrieved June 13, 2000, from the World Wide Web: http://vm.cfsan.fda.gov/~dms/OPA-ARMG.HTMLHTML
41.
U.S. Food and Drug Administration. (2000a, June 13). Foods derived from new plant varieties derived through recombinant DNA technology: Final consultations under FDA's 1992 policy [Online]. Available: http://vm.cfsan.fda.gov/~Ird/biocon.html
42.
U.S. Food and Drug Administration. (2000b, June 14). Bioengineered foods [Online]. Available: http://www.fda.gov/oc/biotech/default.htm
43.
U.S. regulatory oversight in biotechnology [Online]. (2000, June 13). Available: http://www.aphis.usda.gov/biotech/OECD/usregs.htm
44.
White House Office of the Press Secretary. (2000). Clinton administration agencies announce food and agricultural biotechnology initiatives: Strengthening science based regulation and consumer access to information. Retrieved May 9, 2000, from the World Wide Web: http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi: //oma.eop.gov.us/2000/5/4/10.text.1
45.
Witt, S. C. (1990). Biotechnology, microbes and the environment. San Francisco: Center for Science Information.
