* The author is an attorney at Sidley Austin Brown & Wood in New York. This Article was prepared in connection with a project on International GMO Regulatory Conflicts undertaken by the Center on Environmental and Land Use Law, New York University, with support from the Rockefeller Foundation. The support of the Center and the Rockefeller Foundation in the preparation of this Article is gratefully acknowledged. The author also wishes to recognize Dorothy Nelkin, Richard Stewart, Ed Levy, Oysim Chin, Roger A. Frie, and Marcy Katz for their contributions in the preparation of this Article.
1 Neil King, Jr., U.S. Official Courts African Allies for Brewing Biotech-Food Fight, Wall St. J., Feb. 22, 2002, at A24. Note that in this Article, I use the terminology “GM” foods or agriculture to refer collectively to plants/crops that have been modified using genetic engineering techniques. This terminology is used as an alternative to “genetically engineered foods,” “Genetically Engineered Organisms” (“GEOs”), “Genetically Modified Organisms” (“GMOs”), or “agricultural biotechnology.”
2 Id. It is not clear that Zoellick was entirely successful in his mission. In late July 2002, Zimbabwe rejected thousands of tons of U.S. emergency food aid consisting of corn because the donations contained genetically modified varieties. According to the reports, Zimbabwe was concerned that if some of the corn was used as seed it could contaminate the native crop, and make it unexportable to Europe. Rick Weiss, Starved for Food, Zimbabwe Rejects U.S. Biotech Corn, Wash. Post, July 31, 2002, at A12.
3 “‘I personally am of the view that we now need to bring a case,’ Zoellick said at a Jan. 9 press conference when asked about the ongoing conflict with the Europeans.” Zoellick Calls For WTO Case Against EU Biotechnology Moratorium, Inside U.S. Trade, Jan. 10, 2003.
4 As this Article went to press, the United States announced that it was filing a case in the World Trade Organization challenging the four-year-old moratorium by the European Union on authorizing GM crops. The United States is joined in its position by Argentina, Canada, and Egypt. Press Release, Office of the United States Trade Representative, U.S. and Cooperating Countries File WTO Case Against EU Moratorium on Biotech Foods and Crops (May 13, 2003), available at http://www.ustr.gov/releases/2003/05/03-31.htm.
5 See FDA, A Description of the U.S. Food Safety System (2000), available at http://www.fsis.usda.gov/OA/codex/system.htm.
6 See generally Marsh Echols, Food Safety Regulation in the European Union and the United States: Different Cultures, Different Laws, 4 Colum. J. Eur. L. 525 (1998). In her article, Marsh Echols explains the U.S. predilection for a risk-based approach as reflective of the national embrace of new technologies. She credits the European approach to the fact that food-safety laws are more reflective of local tradition.
7 See generally Katherine Barrett & Carolyn Raffensperger, From Principle to Action: Applying the Precautionary Principle to Agricultural Biotechnology, 4 Int’l J. Biotechnology 4 (2002); Richard B. Stewart, Environmental Regulatory Decisionmaking Under Uncertainty, 20 Res. L. & Econ. 71 (2002).
8 For a good general outline of the E.U. articulation of the Precautionary Principle, see Eur. Envtl. Agency, Late Lessons from Early Warnings: The Precautionary Principle 1896–2000 (2001), available at http://reports.eea.eu.int/environmental_issua_ report_2001_22/en.
9 References to the Bush Administration are to that of President George H.W. Bush (1989–1993).
10 For an excellent analysis of these events, see Dorothy Nelkin, Threats and Promises: Negotiating the Control of Research, Daedelus, Spring 1978. See also Sheldon Krimsky, Biotechnics and Society: The Rise of Industrial Genetics (1991).
11 On controversies over rDNA, see generally Michael Rogers, Biohazard (1977); Nicholas Wade, The Ultimate Experiment: Man-Made Evolution (1977).
12 See, e.g., Planned Releases of Genetically-Altered Organisms: The Status of Government Research and Regulation: Hearing Before the Subcomm. on Investigations and Oversight of the House Comm. on Science and Technology, 99th Cong. 72 (1985); Biotechnology Regulation: Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Energy and Commerce, 98th Cong. 98–193 (1984); Environmental Implications of Genetic Engineering: Hearing Before the Subomm. on Investigations and Oversight and the Subcomm. on Science, Research and Technology of the House Comm. on Science and Technology, 98th Cong. 2–3 (1983).
13 For a detailed discussion of these developments, see Krimsky, supra note 10.
14 See Jim Drinkard, Biotechnology Predicted to Bring Big Farm Changes, Associated Press, Apr. 21, 1985 (quoting Dr. Bernadine Healy, Deputy Director of the Office of Science and Technology Policy worrying that Congressional hearings raised “concerns that biotechnology may . . . be an example of regulation stifling leadership”).
15 Sheldon Krimsky & Roger P. Wrubel, Agricultural Biotechnology and the Environment: Science, Policy, and Social Issue 249–51 (1996).
16 Another impetus for the creation of this group may have been the legal challenge brought by biotechnology gadfly Jeremy Rifkin in 1984 against the National Institutes of Health that forced the Reagan Administration to consider and propose policies to guide activities of federal agencies responsible for reviewing biotechnology research and its products. See Found. on Econ. Trends v. Heckler, 587 F. Supp. 753, 754, 768–69 (D.D.C. 1984), aff’d in part & vacated in part by 756 F.2d 143 (D.C. Cir. 1985).
17 Proposal for a Coordinated Framework for Regulation of Biotechnology, 49 Fed. Reg. 50,856 (proposed Dec. 31, 1984).
18 Coordinated Framework for the Regulation of Biotechnology, 51 Fed. Reg. 23,302 (proposed June 26, 1986).
19 Id.
20 For a good review of this early period of regulation, see generally Thomas O. McGarity, Federal Regulation of Agricultural Biotechnologies, 20 U. Mich. J.L. Reform 1089 (1987).
21 See USDA, Regulatory Oversight in Biotechnology, Responsible Agencies, at http:// www.aphis.usda.gov/biotech/OECD/usregs.htm (last visited Mar. 19, 2003).
22 A biologic is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of diseases or injuries to humans. Animal Virus, Serum and Toxin Act of 1913, 21 U.S.C. �� 151–159 (2000) (amended 1985).
23 Krimsky, supra note 10, at 197, 204.
24 Principles for Federal Oversight of Biotechnology: Planned Introduction Into the Environment of Organisms With Modified Hereditary Traits, 55 Fed. Reg. 31,118 (proposed July 31, 1990) [hereinafter Principles for Federal Oversight].
25 Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products into the Environment, 57 Fed. Reg. 6753 (proposed Feb. 27, 1992) [hereinafter Exercise of Federal Oversight].
26 Principles for Federal Oversight, supra note 24. The final statement of principles was issued in Exercise of Federal Oversight, supra note 25, after a consideration of the comments. The final document retains and strengthens the fundamental risk-based approach articulated in the Proposed Scope document.
27 Exercise of Federal Oversight, supra note 25, at 6760.
28 Id.
29 Id.
30 President’s Council on Competitiveness, Report on National Biotechnology Policy 11 (1991).
31 Id.
32 Warren E. Leary, Cornucopia of New Foods Is Seen as Policy on Engineering Is Eased, N.Y. Times, May 27, 1992, at A16.
33 Exercise of Federal Oversight, supra note 25, at 6756.
34 Id. at 6755.
35 Id. This approach is sharply criticized by University of Minnesota ecologist Philip J. Regal in articles available on his Web site, biosci.umn.edu/~pregal/foodsafety.htm (last visited May 14, 2003). In his articles, Professor Regal traces the history of his doubts about the safety of GM foods and plants from a scientific perspective. Professor Regal’s concerns stem from the pleiotropic effects that can result from gene insertions and he maintains that these concern were not and have not been adequately addressed by regulatory agencies.
36 Exercise of Federal Oversight, supra note 25, at 6757.
37 See generally Paul S. Naik, Biotechnology Through the Eyes of an Opponent: The Resistance of Activist Jeremy Rifkin, 5 Va. J.L. & Tech. 5 (2000); Interview by PBS with Jeremy Rifkin, President, The Foundation on Economic Trends (Aug. 2000), at http://www.pbs.org/ wgbh/harvest/interviews/rifkin.html.
38 See generally Philip Regal, Are Genetically Engineered Foods Safe? A Quest for Biosafety (1999) (unpublished manuscript), available at http://www.cbs.umn.edu/~pregal/ foodsafety.htm.
39 Mothers for Natural Law, at http://www.safe-food.org (last visited May 14, 2003); The National Family Farm Coalition, Farmer to Farmer Campaign on Genetic Engineering, at http://www.nffc.net/bio4.htm (last visited May 14, 2003).
40 See Judy Schultz, Genetically Altered Food Worries Consumers, Calgary Herald, Sept. 2, 1999, available at http://www.gefoodalert.org/News/news.cfm?News_ID=604; Advocacy Groups Launch Campaign Against Biotech Foods, CBC News, Sept. 8, 1999, available at http://www.gefoodalert.org/News/news.cfm?News_ID=592.
41 Alan Yonan, Jr. Environmentalists Escalate Fight Against Altered Crops, Dow Jones, Aug. 26, 1999, available at http://www.gefoodalert.org/News/news.cfm?News_ID=526; Group Encourages Consumer Support for U.S. Ban on Genetically Altered Food, Daily Rep. Executives (BNA) (Sept. 1, 1999), available at http://www.gefoodalert.org/News/news.cfm?News_ID =559.
42 On September 5, 2002, Monsanto announced a new line of GM corn. See Fierce Biotech: the Biotech Industry’s Daily Monitor, at http://www.fiercebiotech.com (last visited May 14, 2003).
43 See, Lisette Alvarez, Consumers in Europe Reisist Gene Altered Foods, N.Y. Times, Feb. 11, 2003, at A3.
44 George Gaskell et al., Worlds Apart? The Reception of Genetically Modified Foods in Europe and the U.S., 285 Science 384 (1999).
45 See generally Echols, supra note 6.
46 See generally Chaia Heller, From Scientific Risk to Paysan Savoir-Faire: Peasant Expertise in the French and Global Debate Over GM Crops, 11 Sci. as Culture 7 (2002).
47 This perspective has been articulated by Edwin Levy, Fellow, W. Maurice Young Centre for Applied Ethics at the University of British Columbia.
48 Id. � 342(a)(1) (2000).
49 See id. �� 331(b), 332, 333, 334.
50 21 C.F.R. � 170.3(i) (2003).
51 21 U.S.C. � 321(s).
52 Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22,984 (proposed May 29, 1992).
53 Id.
54 Id.
55 Memorandum from David Kessler, Commissioner of Food and Drugs, to the Secretary for Health and Human Services (Mar. 20, 1992).
56 FDA Regulation of Food Products Derived from Genetically-Altered Plants: Points to Consider, available at http://www.bio-integrity.org/FDAdocs/21 (last visited May 14, 2003).
57 Id.
58 57 Fed. Reg. 22,984 (proposed May 29, 1992).
59 Id. at 22,984–85.
60 Id. at 22,988.
61 Id. at 22,984. “The regulatory status of a food, irrespective of the method by which it is developed, is dependent upon the objective characteristics of the food and the intended use of the food.” Id.
62 Id. at 22,990.
63 57 Fed. Reg. 22,984, 22,990 (proposed May 29, 1992).
64 It is also true, as FDA asserted, that all plants contain the nucleotides that comprise genetic material, and therefore that it has historically been part of the diet. Id.
65 See, e.g., Warning Letter from John B. Foret, Director, Division of Programs and Enforcement Policy, FDA, to Robert Ehrlich, President, Robert’s American Gourmet (Jan. 27, 2000); Warning Letter from John B. Foret, Director, Division of Programs and Enforcement Policy, FDA, to John Bello, CEO, South Beach Beverage Company (Feb. 1, 2000) (noting that ingredients such as chromium picolinate, lycopene, Echinacea, gingko biloba, guarana, St. John’s Wort, and gotu kola are not GRAS for use in foods).
66 Comments of certain members of the FDA staff on the 1992 Policy were revealed during the discovery process in Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000). The Alliance for Bio-Integrity has since posted these documents on its Web site. Alliance for Bio-Integrity, Key FDA Documents Revelaing (1) Hazards of Genetically Engineered Foods and (2) Flaws with How Agency Made Its Policy, at http://www.bio-integrity.org/lists.html (last visited May 14, 2003).
67 Memorandum from Linda Kahl, FDA Compliance Officer, to James Maryanski, FDA Biotechnology Coordinator (Jan. 8, 1992) (on file with author).
68 FDA Memorandum On The Use Of Microorganisms And Plants As Whole Foods (Nov. 4, 1991).
69 Id.
70 According to FDA, the agency based its specific informational requests on the material examined in the Calgene Flavr-Savr tomato review. Calgene genetically modified a strain of tomato to reduce activity of a particular enzyme (polygalacturonase) that affects softening of outer tissue during ripening. Because the genetically modified tomato had less of this enzyme, it could remain longer on the vine prior to harvest, thereby enhancing its tomato flavor. 57 Fed. Reg. 22,984 (proposed May 29, 1992).
71 See FDA, Guidance on Consultation Procedures for Foods Derived from New Plant Varieties (1997).
72 See generally Doug Gurian-Sherman, Holes in the Biotech Safety Net: FDA Policy Does Not Assure the Safety of Genetically Engineered Foods (2003), available at http://www.cspinet.org/new/pdf/fda_report__final.pdf.
73 See id. at ii, 4.
74 See id. at 4.
75 See id. at 4, 5.
76 See id.
77 Leila Aboud, Modified-crop Makers Faulted on Safety Data Sent to FDA, Wall St. J., Jan. 7, 2003, at A3.
78 Gurian-Sherman, supra note 72.
79 Id.
80 Aboud, supra note 77, at A3.
81 See generally Echols, supra note 6 (discussing the different responses to novel food technologies).
82 Peter A. Riley et al., U.S. Farmers are Rapidly Adopting Biotech Crops, Agric. Outlook (USDA, Washington, D.C.), Aug. 1998, at 21, available at http://jan.mannlib.cornell.edu/ reports/erssor/economics/ao-bb/1998/ao253.pdf.
83 Mothers for Natural Law, About Mothers for Natural Law, at http://www.safe-food.org/~campaign/about.html (last visited Apr. 7, 2003).
84 Id.
85 Mothers for Natural Law, supra note 39.
86 Mothers for Natural Law, supra note 83.
87 Id.
88 Id.
89 Union for Concerned Scientists, About UCS, at http://www.ucsusa.org/ucs/about (last visited Apr. 7, 2003).
90 Center for Food Safety, Citizen Petition Before the United States Food and Drug Administration, Petition Seeking the Establishment of Mandatory Pre-Market Safety Testing, Pre-Market Environmental Review, & Labeling for all Genetically Engineered Foods, available at http://www.centerforfoodsafety.org/li/BigFDAPetition9.html (last visited May 14, 2003).
91 See The Campaign to Label Genetically Engineered Foods, About Us, at http:// www.thecampaign.org/aboutus.php (last visited May 14, 2003).
92 The Genetically Engineered Foods Right to Know Act, H.R. 3377, 106th Cong. (1999). A companion bill was introduced in the Senate by Senator Boxer in 2000. See S. 2080, 106th Cong. (2000).
93 Genetically Engineered Food Safety Act, H.R. 4813, 107th Cong. (2002).
94 See generally id.
95 116 F. Supp. 2d 166 (D.D.C. 2000).
96 The Religious Freedom Restoration Act of 1993, Pub. L. 103-141, 107 Stat. 1488. This act requires that federal laws or regulations not impede the free exercise of religion.
97 116 F. Supp. 2d at 178. The debate over labeling is discussed further below.
98 Id. at 181.
99 Id. at 170, 172.
100 Id. at 177, 178.
101 Id.
102 21 U.S.C. � 321(n) (2000).
103 Alliance for Bio-Integrity, 116 F. Supp. 2d at 178.
104 In dismissing the case, the court noted that the internal FDA dissent revealed by a few of the estimated 44,000 pages of documents released was insufficient to lead the court to challenge agency discretion. Id. at 177.
105 Press Release, U.S. Department of Health and Human Services, FDA Announces Public Meetings on Bioengineered Foods (Oct. 18, 1999).
106 Center for Food Safety and Applied Nutrition, FDA, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or have Not Been Developed Using Bioengineering (Jan. 2001) (draft) [hereinafter Guidance for Industry], available at http://vm. cfsan.fda.gov/~dms/biolabgu.html.
107 See FDA Transcripts of Public Meetings on Bioengineered Foods (on file with FDA). For more information on the meetings, see generally http://www.fda.gov/oc/biotech/ default.htm (last visited May 14, 2003).
108 Premarket Notice Concerning Bioengineered Foods, 66 Fed. Reg. 4706, 4708 (proposed Jan. 18, 2001) (to be codified at 21 C.F.R. pts. 192, 592).
109 Id.
110 Id.
111 Id.
112 Id. at 4707.
113 66 Fed. Reg. at 4707.
114 Premarket Notice Concerning Bioengineered Foods, 66 Fed. Reg. 4706, 4709 (proposed Jan. 18, 2001) (to be codified at 21 C.F.R. pts. 192, 592).
115 Id.
116 Id. (emphasis added).
117 Id. at 4725.
118 Id. Specifically, FDA states that it will publish the fact of the notification and the agency’s response in an accessible place. To obtain copies of the actual submissions, however, minus confidential information, a Freedom of Information request would need to be filed.
119 See Consumers Union, Consumers Union Comments on Docket No. 00N-1396, Premarket Notice Concerning Bioengineered Foods (May 1, 2001), available at http://con-sumersunion.org/food/biocpi501.htm.
120 Id.
121 Industry Presses FDA for Premarket Biotech Notification, Food Chem. News, Dec. 5, 2002, at 5.
122 See, e.g., Hearing Before the Subcomm. on Health, Education, Labor, and Pensions, 107th Cong. (Sept. 26, 2000) (statement of Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition), available at http://vm.cfsan.fda.gov/~lrd/stbioeng.html.
123 FDA requires special labeling for foods if they pose special safety or usage issues. In the example FDA often gives, if a food had a new protein introduced into it to which people were allergic, FDA would require the label to reveal that information. In its 1992 policy statement, the agency noted that labeling would be required if genes were introduced from foods that were commonly allergenic, unless the developer could scientifically demonstrate that the protein was not responsible for the allergenicity of the original foods.
124 Food Labeling: Foods Derived From New Plant Varieties, 58 Fed. Reg. 25,837 (proposed Apr. 28, 1993). Note that FDA issued a new policy on the use of these terms in 2001, as discussed below.
125 The court in Alliance for Bio-Integrity supported this position.
126 Ctr. for Food Safety & Applied Nutrition, FDA, FDA’s Policy for Foods Developed by Biotechnology (1995), available at http://vm.cfsan.fda.gov/~lrd/biopolcy. html.
127 The Center for Food Safety, Citizen Petition Before the United States Food and Drug Administration (2000) (received Mar. 21, 2000).
128 Center for Science in the Public Interest, National Opinion Poll on Labeling of Genetically Modified Foods (Mar. 30–Apr. 1, 2001), at http://www.cspinet.org/new/ poll_gefoods.html. The CSPI survey also revealed a certain amount of confusion or ambivalence about the GM process. For example, equal numbers stated that they would buy GM fruits or vegetables (or processed foods) as those who stated they would buy products made from cross-bred corn. Fifty-five percent of those surveyed stated that they were not very familiar or not at all familiar with GM foods.
129 Guidance for Industry, supra note 106.
130 Id.
131 See id.
132 Id.
133 Id.
134 Guidance for Industry, supra note 106.
135 Id. It is worth noting that FDA identified the term “genetically modified” itself as confusing and potentially misleading. According to the agency, genetic modification occurs in all plants regardless of human agency and the goal of traditional plant breeding is genetic modification. FDA concludes that
while it is accurate to say that a bioengineered food was “genetically modified,” it likely would be inaccurate to state that a food that had not been produced using biotechnology was “not genetically modified” without clearly providing a context so that the consumer can understand that the statement applies to bioengineering.
Id.
136 Id.
137 Id.
138 FDA’s position may be overturned. The Farm Security and Rural Investment Act of 2002, H.R. 2646, 107th Cong., directed FDA to review its labeling regulation for irradiated food, and until the review is done, to allow companies to seek permission to change the labeling for specific irradiated products. Companies are seeking to use language less alarming to consumers, such as “Cold Pasteurized.” These proposals remain controversial.
139 Irradiation in the Production, Processing, and Handling of Food, 51 Fed. Reg. 13,376 (Apr. 18, 1986) (to be codified at 21 C.F.R. pt. 179). For further discussion, see Frederick Degnan, Food Labeling and the Right-to-Know, 52 Food & Drug L.J. 49 (1997).
140 Alliance for Bio-Integrity, 116 F. Supp. 2d at 178. Courts have also taken this position in cases dealing with the related issue of mandatory labeling for milk produced from cows treated with recombinant Bovine Growth Hormone (“rBGH”), a bioengineered version of growth hormone injected into cows to increase the rate of lactation. The first such case, Stauber v. Shalala, 895 F. Supp. 1178 (W.D. Wis. 1995), involved a challenge to FDA’s determination that it would not require labeling disclosing that dairy products came from rBGH-treated cows. The court granted summary judgement against the plaintiffs on this point, deferring instead to FDA’s finding that there was no difference between dairy products from rBGH-treated or non-treated cows. Id. at 1193.
The second case, International Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2d Cir. 1996), involved an industry challenge to a Vermont law mandating disclosure of rBGH use in the production of milk. The U.S. Court of Appeals for the Second Circuit struck down the Vermont law on grounds that “consumer curiosity” was not “substantial” enough to justify the intrusion on commercial free speech under the First Amendment. Id. at 74.
For further discussion of rBGH and these cases, see Emily Marden, Recombinant Bovine Growth Hormone and the Courts: In Search of Justice, 46 Drake L. Rev. 617 (1998).
141 Scott Kilman & Jill Carroll, Leading the News: Monsanto Admits Unapproved Seed May Be in Crops, Wall St. J., Apr. 15, 2002, at A3.
142 Monsanto’s RT73 Canola Oil was submitted for review under the agency’s 1992 notification policy on April 5, 1995. On September 26, 1995, FDA responded that it had no objection to Monsanto’s conclusion that this product was “not materially different in composition, safety or any other relevant parameter from canola varieties currently on the market and it would not raise issues that would require premarket review or approval by FDA.” Letter from Alan M. Rulis, Ph.D., Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, to Monsanto Company (Sept. 26, 1995).
143 Kilman & Carroll, supra note 141 (quoting Michael P. Phillips of the Biotechnology Industry Organization, an industry trade group).
144 Jill Carroll, FDA Says Monsanto Canola Doesn’t Appear to Pose Risks, Wall St. J., Apr. 16, 2002.
145 Premarket Notice Concerning Bioengineered Foods, 66 Fed. Reg. 4706, 4714 (proposed Jan. 18, 2001) (to be codified at 21 C.F.R. pts. 192, 592). FDA states that it
encourages developers of [GM products] that are not intended for use in food or feed, but that theoretically could enter the food or feed supply, to participate in the consultation program described . . . . This participation would ensure that developers have given careful consideration to the procedures needed to ensure that their products do not inappropriately get into the food supply, and are aware of the legal implications if their products do.
Id.
146 67 Fed. Reg. 50,578 (Aug. 2, 2002).
147 Id.
148 Id.
149 Id. at 50,579
150 Id.
151 Containment is also becoming more prominent as plants producing pharmaceuticals become a reality. The risk is that ordinary food crops could be contaminated with pharmaceuticals. FDA and USDA recently issued a draft guidance on this issue. USDA & FDA, Guidance for Industry: Drug, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Sept. 2002) (draft), available at http://www.fda.gov/cber/gdlns/bioplant.htm. An example of the risk was revealed when regulators discovered that a biotech corn variety engineered to produce an experimental type of insulin had contaminated a neighboring soybean field in Nebraska. The responsible company, ProdiGene, a Texas-based biotechnology company, has since been fined by the authorities. Press Release, USDA, USDA Investigates Biotech Company for Possible Permit Violations (Nov. 13, 2002), available at http://www.aphis.usda.gov/lpa/news/ 2002/11/prodigene.html.
152 Andrew Pollack, Earlier Safety Reviews Proposed for Gene-Altered Crops, N.Y. Times, Aug. 2, 2002, at C3.
153 See, e.g., The Campaign to Label Genetically Engineered Foods, GMO Contamination, at http://www.thecampaign.org/analysis/analysis100501.htm (last visited May 14, 2003).
154 7 U.S.C. � 150aa–jj (repealed 2000).
155 Id. � 150dd.
156 Id. � 150aa(c).
157 Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There is Reason to Believe Are Plant Pests, 52 Fed. Reg. 22,908 (June 16, 1987) (to be codified at C.F.R. pts. 330, 560).
158 See Chairman Nick Smith, Subcomm. on Basic Research of the Comm. on Science, 106th Cong., Seeds of Opportunity: An Assessment of the Benefits, Safety, and Oversight of Plant Genomics and Agricultural Biotechnology 26 (Comm. Print 2000) (citing Sally McCammon, USDA), available at http://www.house.gov/science/ smithreport041300.pdf.
159 7 C.F.R. � 340.1 (2003).
160 Id.
161 Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which there is Reason to Believe are Plant Pests, 52 Fed. Reg. 22,892 (July 16, 1987) (to be codified at 2 C.F.R pts. 330, 340).
162 Genetically Engineered Organisms and Products; Notification Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated Status, 57 Fed. Reg. 53,036 (proposed Nov. 6, 1992) (to be codified at 7 C.F.R. pt. 340).
163 See 7 C.F.R. � 340.3(b); see also USDA, User’s Guide for Introducing Genetically Engineered Plants and Microorganisms, Tech. Bull. No. 1783 � IV (rev. ed. 1997), available at http://www.aphis.usda.gov/bbep/bp/usergd.html.
164 7 C.F.R. � 340.3(d)(2)(v) (2003).
165 Id. � 340.3(d)(2).
166 See 57 Fed. Reg. 53,036 (Nov. 6, 1992) (to be codified at 7 C.F.R. pt. 340).
167 See id.
168 See 58 Fed. Reg. 17,044 (Mar. 31, 1993) (to be codified at 7 C.F.R. pt. 340).
169 Id.
170 Id.
171 Genetically Engineered Organisms and Products; Simplification of Requirements and Procedures for Genetically Engineered Organism, 62 Fed. Reg. 23,945 (May 2, 1997) (codified at 7 C.F.R. �� 340.0, 340.3).
172 Judith E. Beach, Ph.D., No “Killer Tomatoes”: Easing Federal Regulation of Genetically Engineered Plants, 53 Food Drug L.J. 181, 183 (1998). USDA describes the notification program in an industry guideline as being “the simplest way to obtain APHIS permission to import, move, field test a genetically engineered plant . . . applicable in the vast majority of cases.” USDA, Permitting, Notification, and Deregulation, at http://www.aphis.usda. gov/ppq/biotech/ (last visited May 14, 2003).
173 Beach, supra note 172, at 183. At the same time, it should be noted that the USDA has been working on new rules for the review of GM crops to account for the availability of GM crops, since the United States Congress updated a major plant law. USDA: Federal GM Reviewers are ‘superficial’ and protective of big business, says report, Just-Food, Feb. 22, 2002, available at http://www.just-food.com/news_details.asp?art=47999.
174 7 C.F.R. � 340.6 (2003).
175 Id.
176 62 Fed. Reg. 23,945, 23,952 (May 2, 1997) (to be codified at 7 C.F.R. pt. 340).
177 Id.
178 Id.
179 Id.
180 Id.
181 62 Fed. Reg. at 23,952.
182 EU/US Perspectives on Labeling Genetically Engineered Foods, Food Chemical News, June 1998, at 19 [hereinafter EU/US Perspectives].
183 Id. (quoting Arnold Foudin, deputy director for biotechnology, APHIS).
184 62 Fed. Reg. 23,945, 23,952 (May 2, 1997) (to be codified at 7 C.F.R. pt. 340).
185 Id.
186 Id.
187 Id. at 23,953.
188 See EU/US Perspective, supra note 182, at 20.
189 “Terminator” technology is the popular name used to describe genetic seed sterilization, which USDA developed and patented in 1998 together with Delta & Pine Land, the world’s largest cotton company. The technology is used to make the seeds of a plant sterile, so that they cannot be used for a new generation of plants. Seed sterilization was developed to allow seed companies to protect their patents on novel varieties: with the technology in place, a seed company ensures that purchasers cannot make second generation uses of the patented seeds it sells.
190 Secretary of Agriculture Ann M. Veneman, Remarks at the U.N. Food and Agriculture Organization 31st Conference Plenary Session: State of Food and Agriculture, Rome, Italy (Nov. 5, 2001), available at http://www.usda.gov/news/releases/2001/11/0222.htm.
191 Id.
192 Bette Hileman, News of the Week, Chemical & Engineering News, July 19, 1999; Secretary of Agriculture Dan Glickman, Remarks to the National Press Club (July 13, 1999), available at http://www.usda.gov/news/releases/1999/07/0285.
193 Glickman, supra note 192.
194 Press Release, National Academy of Sciences, Regulations of Transgenic Plants Should be Reinforced; Field Monitoring for Environmental Effects is Needed (Feb. 21, 2002).
195 Id.
196 Id.
197 Id.
198 Id.
199 Press Release, supra note 194.
200 Id.
201 Jill Carroll, Reviews of Crops Altered by Genetics Are “Superficial”, Wall. St. J., Feb. 21, 2002.
202 Id.
203 Press Release, Natural Resources Defense Council, NRDC-Led Coalition Calls for USDA to Stop Environmentally Harmful Release of Genetically Engineered Crops (Apr. 26, 2000).
204 Id.
205 Id.
206 Id.
207 7 U.S.C. � 136 (2000).
208 Id. � 136(u).
209 Id. � 136c(d).
210 40 C.F.R. �� 158.165, 158.170, 162.163 (2003).
211 21 U.S.C. � 346(a) (2000).
212 Id. � 346(c)(2).
213 In May 1997, EPA published a Supplemental Notice of Proposed Rulemaking to elicit public comments on its evaluation of the requirements imposed by the Food Quality Protection Act. Plant-Pesticide: Supplemental Notice and Proposed Rulemaking, 62 Fed. Reg. 27,132 (proposed May 16, 1997) (to be codified at 40 C.F.R. pt. 180).
214 Proposed Policy; Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug and Cosmetic Act, 59 Fed. Reg. 60,496 (Nov. 23, 1994).
215 Id.
216 Id. at 60,500.
217 Id. at 60,498.
218 Id. at 60,501.
219 59 Fed. Reg. at 60,502–03.
220 Proposed Policy; Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug and Cosmetic Act, 59 Fed. Reg. 60,496, 60,502 (Nov. 23, 1994).
221 Id.
222 Id. at 60,503.
223 Pesticide Registration Procedures; Pesticide Data Requirements, 53 Fed. Reg. 15,982 (May 4, 1988) (to be codified at 40 C.F.R. pt. 158).
224 The 1994 policy promised to issue data requirements for plant-pesticides at some future date and to solicit comments from the public. Hearing on Plant Genome Science, Subcomm. on Basic Research of the House Comm. on Science, 106th Cong. (Oct. 19, 1999) (testimony of Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, EPA) [hereinafter Testimony of Janet L. Andersen], available at http://commdocs.house.gov/committees/science/hsy215140.000/hsy215140_1.htm. So far, however, this has not taken place.
225 Id. (reflecting that EPA works with each company to determine the appropriate data requirements).
226 59 Fed. Reg. 60,496, 60,511 (Nov. 23, 1994). The agency also assesses the need for environmental and ecological risk data on a case by case basis. Each environmental risk assessment is based on an analysis of the properties of the engineered organism and its target environment. The degree of EPA scrutiny depends on the type of gene product and the intended mode of action. Sharlene Matten, EPA Regulation of Plant-Pesticides and Bt Plant-Pesticide Resistance Management, in Agricultural Biotechnology and Environmental Quality: Gene Escape and Pest Resistance 105 (Nat’l Agric. Biotechnology Council Report No. 10, 1998), available at http://www.cals.cornell.edu/extension/nabc/ pubs/nabc_10.pdf.
227 Regulations Under the Federal Insecticide, Fungicide, and Rodenticide Act for Plant-Incorporated Protectants, 66 Fed. Reg. 37,772 (July 19, 2001) (to be codified at 40 C.F.R. pts. 152, 174).
228 40 C.F.R. � 152.3 (2003).
229 Testimony of Janet L. Andersen, supra note 224.
230 John E. Losey et al., Transgenic Pollen Harms Monarch Larvae, Nature, May 20, 1999.
231 See generally Thomas McGarity & Patricia Hansen, Breeding Distrust: An Assessment And Recommendations For Improving The Regulation Of Plant Derived Genetically Modified Foods (Jan. 11, 2001), http://www.biotech-info.net/Breeding_Distrust.html.
232 Buffers Urged Around Bt Corn Fields, Envtl. News Network, July 14, 1999.
233 U.S. Places Restrictions on Biotech Corn, Envtl. News Network, Jan. 17, 2000.
234 Id.
235 See generally Comm. on Genetically Modified Pest-Protected Plants, Nat’l Acad. of Sci., Genetically Modified Pest-Protected Plants: Science and Regulation (2000).
236 See id. at 37–38.
237 Id.
238 Id.
239 Id. at 63.
240 For a detailed discussion of the development and impact of the StarLink crisis, see Dorothy Nelkin & Emily Marden, The Starlink Controversy: The Competing Frames of Risk Disputes, Int’l J. Biotechnology (forthcoming 2003).
241 There are several chronologies of this dispute. Information is available at the Aventis Web site, http://www.aventis.com, and on the Greenpeace Web site, http://www.green-peace.org.
242 See Allergenicity Assessment of Cry9C BT Corn Plant Pesticide, 64 Fed. Reg. 71,452 (Dec. 21, 1999) (discussing the history of the allergenicity assessment).
243 Issuing a split registration is a fairly common practice by EPA with conventional pesticides, as each registration specifies the crops on which the pesticide can be used. The typical split registration, before StarLink, might allow pesticide use on corn, but not on soy, for example. Split registrations had not, however, been previously used for a GM product and the agency failed to recognize the possible risk of contamination. It is worth noting that AgrEvo and then Aventis (the patent changed hands several times) asked EPA in 1999 and again in late 2000 to re-evaluate the evidence and consider registering StarLink for human uses as well. In each case, EPA’s Scientific Advisory Panel noted that the data was insufficient to rule out potential allergenicity issues. See generally Ctr. for Food Safety & Applied Nutrition, FDA, FDA Evaluations of Consumer Complaints Linked to Foods Allegedly Containing Starlink Corn (2001), available at http:// www.epa.gov/scipoly/sap/2001/july/fda.pdf.
244 Neil Harl et al., The StarLink Situation (July 30, 2001) (unpublished manuscript).
245 See, e.g., Andrew Pollack, 1999 Survey on Genetically Altered Corn Disclosed Some Improper Uses, N.Y. Times, Sept. 4, 2001 (revealing that EPA was aware of containment problems with StarLink as early as 1999, just a year after the product was first commercialized).
246 McGarity, supra note 20, at 108.
247 Alejandro E. Segarra & Jean M. Rawson, StarLink Corn Controversy: Background (Cong. Research Serv. Report No. RS20732, Jan. 10, 2001), available at http:// www.ncseonline.org/NLE/CRSreports/Agriculture/ag-101.pdf.
248 This re-review did not include StarLink. As noted, the registration for this product had been voluntarily withdrawn by the company.
249 The reassessment was announced by EPA in Time Extension for B.t. Corn and B.t. Cotton Plant-Pesticides Expiring Registrations, 65 Fed. Reg. 48,701 (Aug. 9, 2000), and was a response to an initiative by the Clinton Administration to review policies on food biotechnology. See also Announcement of Public meeting; Opportunity to Comment on Implications of Revised Bt Crops Reassessment for Regulatory Decisions Affecting These Products, and on Potential Elements of Regulatory Options, 66 Fed. Reg. 37,227 (July 17, 2001).
250 See, e.g., 65 Fed. Reg. at 48,701.
251 For discussion of the roles of these various groups, see George E.C. York, Global Foods, Local Tastes and Biotechnology: The New Legal Architecture of International Agriculture Trade, 7 Colum. J. Eur. L. 423, 428, 454–65 (2001).
252 E.g. FDA Public Meeting on the Codex Ad Hoc Intergovernmental Task Force on Food Derived from Biotechnology (Dec. 15, 1999) (memorandum on file with author).
253 See York, supra note 251.
254 Eur. Parl. Doc.(COM (2001) 182-C5-0380/01–2001/0180 (COD)) (2002); see also Press Release, Seed Quest, European Parliament Votes on Traceability and Labelling of GMOs (July 3, 2002), available at http://www.seedquest.com/News/releases/2002/july/ 4622.htm. The current E.U. labeling threshold is one percent. Brandon Mitchener, EU Nears Stricter GMO Food Labels, Wall St. J., July 5, 2002, at A8. The vote was only the second step in a legislative process that could take until next year to complete.
255 Mitchener, supra note 254, at A8.