Special labeling requirements for genetically engineered food: How sound are the analytical frameworks used by FDA and food producers?

Food and Drug Law Journal

Volumn 54, Issue 4, 1999, Pages 667-688

  Winn, Lara Beth ^a  

^a Law Firm McDermott Will and Emery   (United States)

Author keywords

[No Author keywords available]

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NON PRESCRIPTION DRUG;

CONSUMER; DIET SUPPLEMENTATION; DRUG INDUSTRY; DRUG INFORMATION; DRUG LABELING; DRUG LEGISLATION; FOOD ANALYSIS; FOOD AND DRUG ADMINISTRATION; REVIEW; UNITED STATES;

FOOD INDUSTRY; FOOD LABELING; FOOD TECHNOLOGY; GENETIC ENGINEERING; HUMANS; INTERNATIONAL COOPERATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033376193     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (122)

1. See Andrew Pollack, Biotechnology Treaty Stalls as U.S. and Developing Nations Quarrel, N.Y. TIMES, Feb. 23, 1999, at A9 [hereinafter Pollack, Biotechnology Treaty].
2. "Biotech food" refers to genetically engineered food. It is important to note that "genetically engineered," "genetically modified," and other similar terms used throughout this article refer to the human manipulation of genes. These terms do not include the natural manipulation of genes through traditional methods of plant breeding (to which genetic engineering is compared).
3. FDA's safety assessment is not at issue here, as the conclusion reached in this paper is not affected by safety issues. The agency's labeling analysis is flawed, even under the assumption that biotech food is absolutely safe for human consumption.
4. WILLIAM BAINS, BIOTECHNOLOGY FROM A TO Z 153 (2d ed. 1993).
5. See id. at 276.
6. See FDA, Center for Food Safety and Applied Nutrition, FDA's Policy for Foods Developed by Biotechnology: FDA Education/Compliance Program, 1995 (last modified July 3, 1997) 〈wm.cfsan.fda.gov/~lrd/ bioeme.html〉 [hereinafter Education/Compliance Program].
7. The differences between genetic engineering and traditional plant breeding are explained in more detail below. See discussion infra Part II.A.1.
8. The biotech food examples in this paragraph are discussed in the following sources: Alan Goldhammer, The Regulation of Agricultural Biotechnology: An Industrial Perspective, 48 FOOD & DRUG L.J. 501 (1993); Education/Compliance Program, supra note 6; Biotech Foods Ready for Primetime, Experts Say, PURDUE NEWS, Dec. 1998 (visited Jan. 29, 1999) 〈news.uns.purdue.edu〉 [hereinafter Biotech Foods Ready for Primetime]; Union of Concerned Scientists, The Gene Exchange: A Public Voice on Biotechnology and Agriculture (visited Jan. 29, 1999) 〈www.ucsusa.org/Gene〉; and Mothers for Natural Law, Genetically Engineered Crops (visited Jan. 29, 1999) 〈www.safe-food.org〉.
9. The biotech food examples in this paragraph are discussed in the following sources: Alan Goldhammer, The Regulation of Agricultural Biotechnology: An Industrial Perspective, 48 FOOD & DRUG L.J. 501 (1993); Education/Compliance Program, supra note 6; Biotech Foods Ready for Primetime, Experts Say, PURDUE NEWS, Dec. 1998 (visited Jan. 29, 1999) 〈news.uns.purdue.edu〉 [hereinafter Biotech Foods Ready for Primetime]; Union of Concerned Scientists, The Gene Exchange: A Public Voice on Biotechnology and Agriculture (visited Jan. 29, 1999) 〈www.ucsusa.org/Gene〉; and Mothers for Natural Law, Genetically Engineered Crops (visited Jan. 29, 1999) 〈www.safe-food.org〉.
10. The biotech food examples in this paragraph are discussed in the following sources: Alan Goldhammer, The Regulation of Agricultural Biotechnology: An Industrial Perspective, 48 FOOD & DRUG L.J. 501 (1993); Education/Compliance Program, supra note 6; Biotech Foods Ready for Primetime, Experts Say, PURDUE NEWS, Dec. 1998 (visited Jan. 29, 1999) 〈news.uns.purdue.edu〉 [hereinafter Biotech Foods Ready for Primetime]; Union of Concerned Scientists, The Gene Exchange: A Public Voice on Biotechnology and Agriculture (visited Jan. 29, 1999) 〈www.ucsusa.org/Gene〉; and Mothers for Natural Law, Genetically Engineered Crops (visited Jan. 29, 1999) 〈www.safe-food.org〉.
11. The biotech food examples in this paragraph are discussed in the following sources: Alan Goldhammer, The Regulation of Agricultural Biotechnology: An Industrial Perspective, 48 FOOD & DRUG L.J. 501 (1993); Education/Compliance Program, supra note 6; Biotech Foods Ready for Primetime, Experts Say, PURDUE NEWS, Dec. 1998 (visited Jan. 29, 1999) 〈news.uns.purdue.edu〉 [hereinafter Biotech Foods Ready for Primetime]; Union of Concerned Scientists, The Gene Exchange: A Public Voice on Biotechnology and Agriculture (visited Jan. 29, 1999) 〈www.ucsusa.org/Gene〉; and Mothers for Natural Law, Genetically Engineered Crops (visited Jan. 29, 1999) 〈www.safe-food.org〉.
12. The biotech food examples in this paragraph are discussed in the following sources: Alan Goldhammer, The Regulation of Agricultural Biotechnology: An Industrial Perspective, 48 FOOD & DRUG L.J. 501 (1993); Education/Compliance Program, supra note 6; Biotech Foods Ready for Primetime, Experts Say, PURDUE NEWS, Dec. 1998 (visited Jan. 29, 1999) 〈news.uns.purdue.edu〉 [hereinafter Biotech Foods Ready for Primetime]; Union of Concerned Scientists, The Gene Exchange: A Public Voice on Biotechnology and Agriculture (visited Jan. 29, 1999) 〈www.ucsusa.org/Gene〉; and Mothers for Natural Law, Genetically Engineered Crops (visited Jan. 29, 1999) 〈www.safe-food.org〉.
13. See generally Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22,984 (May 29, 1992).
14. See id.
15. Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. §§ 301-393 (1994).
16. See id. For an example of a regulation that treats rDNA technology the same as selective breeding, see 21 C.F.R. §§ 170.30(f)(1), (2) (1996).
17. The exceptions to this rule exist when 1) the common or usual name is no longer applicable to the new genetically engineered food, or 2) a safety or usage issue exists to which consumers must be alerted. See Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. at 22,991.
18. See id.
19. See id.
20. See Education/Compliance Program, supra note 6.
21. See 21 U.S.C. § 331(b)(FDCA § 301(b)).
22. See id. §§ 343(a), (i).
23. See id. § 343(a).
24. FDCA § 321(n). The statutory provision also requires one to consider the "representations made or suggested by statement, word, design, device, or any combination thereof," when determining whether a label is misleading.
25. Although the two contexts are not identical, they are sufficiently similar for purposes of determining what it means to omit "material" information from a food label.
26. See Irradiation in the Production, Processing, and Handling of Food, 51 Fed. Reg. 13,376, 13,388 (Apr. 18, 1986).
27. See Petition to Government (visited Jan. 29, 1999) 〈csf.colorado.edu/sustainability/plants/esa/0870/ html〉. The petition urges the mandatory labeling of all foods derived from, processed with, containing, or consisting of genetically engineered organisms before they are released into commercial markets.
28. Telephone conversation with a representative from Mothers for Natural Law (Feb. 1999).
29. See 6 V.S.A. § 2754, cited in International Dairy Foods Ass'n v. Amestoy, 898 F. Supp. 246 (D. Vt. 1995.
30. See International Dairy Foods Ass'n v. Amestoy, 92 F.3d 67 (2d Cir. 1996).
31. Henry I. Miller, No Need to Fear Mutant Peaches, WALL ST. J. EUR., June 22, 1998, at 10.
32. See Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. at 22,886.
33. See id. at 22,991.
34. FDA discussed the possibility that irradiation could change the organoleptic properties of irradiated food, and explained that such changes may not be visually apparent. In the absence of both irradiation information and a visual signal, there is an implied representation that the food has not been processed, and thus the agency concluded that irradiation information is material with respect to a consumer's perception of processed versus unprocessed food. See 51 Fed. Reg. at 13,388. Irradiation labeling provides one example of an issue FDA acted on in the absence of safety concerns. Even if FDA wrongly decided this issue, many other regulations (e.g., the use of geographic terms, the common or usual name, and product weight information) illustrate that safety is not always important in finding certain information to be material.
35. See id. For the actual requirements, see 21 C.F.R. § 179.26(c). FDA recently announced that the agency is considering revising the irradiation labeling requirements. See Irradiation in the Production, Processing, and Handling of Food, 64 Fed. Reg. 7,834 (Feb. 17, 1999).
36. The analogy presented here would be disingenuous without noting that it is not perfect. There is a difference between the impact of genetic engineering on conventional food and the impact of irradiation on conventional food. As of 1992, FDA was not aware of any information that suggested that biotech food would exhibit attributes different from those demonstrated by traditionally developed food. See Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. at 25,839. Irradiation, on the other hand, seems to affect the organoleptic properties of food, although the degree to which this actually occurs is questionable. Some sources report that irradiation does not change the flavor of food, or at least does so only to the extent that the changes are equal to or smaller than changes from cooking, canning, or freezing food. See IFIC, Questions and Answers About Food Irradiation (last modified Dec., 1997) 〈ificinfo.health.org.qanda/qairradi.htm〉. According to IFIC, several groups have conducted taste tests of irradiated and non-irradiated foods, and consumers cannot detect a difference in appearance, odor, or flavor. See IFIC, Charting a Course to Understanding Food Irradiation (March/April 1998) (visited Jan. 29, 1999) 〈ificinfo.health.org/insight/marapr98/chartcourse.htm〉 [hereinafter Charting a Course].
37. The analogy presented here would be disingenuous without noting that it is not perfect. There is a difference between the impact of genetic engineering on conventional food and the impact of irradiation on conventional food. As of 1992, FDA was not aware of any information that suggested that biotech food would exhibit attributes different from those demonstrated by traditionally developed food. See Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. at 25,839. Irradiation, on the other hand, seems to affect the organoleptic properties of food, although the degree to which this actually occurs is questionable. Some sources report that irradiation does not change the flavor of food, or at least does so only to the extent that the changes are equal to or smaller than changes from cooking, canning, or freezing food. See IFIC, Questions and Answers About Food Irradiation (last modified Dec., 1997) 〈ificinfo.health.org.qanda/qairradi.htm〉. According to IFIC, several groups have conducted taste tests of irradiated and non-irradiated foods, and consumers cannot detect a difference in appearance, odor, or flavor. See IFIC, Charting a Course to Understanding Food Irradiation (March/April 1998) (visited Jan. 29, 1999) 〈ificinfo.health.org/insight/marapr98/chartcourse.htm〉 [hereinafter Charting a Course].
38. The analogy presented here would be disingenuous without noting that it is not perfect. There is a difference between the impact of genetic engineering on conventional food and the impact of irradiation on conventional food. As of 1992, FDA was not aware of any information that suggested that biotech food would exhibit attributes different from those demonstrated by traditionally developed food. See Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. at 25,839. Irradiation, on the other hand, seems to affect the organoleptic properties of food, although the degree to which this actually occurs is questionable. Some sources report that irradiation does not change the flavor of food, or at least does so only to the extent that the changes are equal to or smaller than changes from cooking, canning, or freezing food. See IFIC, Questions and Answers About Food Irradiation (last modified Dec., 1997) 〈ificinfo.health.org.qanda/qairradi.htm〉. According to IFIC, several groups have conducted taste tests of irradiated and non-irradiated foods, and consumers cannot detect a difference in appearance, odor, or flavor. See IFIC, Charting a Course to Understanding Food Irradiation (March/April 1998) (visited Jan. 29, 1999) 〈ificinfo.health.org/insight/marapr98/chartcourse.htm〉 [hereinafter Charting a Course].
39. See FDCA § 343(i).
40. 57 Fed. Reg. at 22,991.
41. 21 C.F.R. § 102.5(c).
42. References to "ingredient" are eliminated from the provision quoted.
43. See THE RAMDOM HOUSE COLLEGE DICTIONARY REVISED EDITION 226, 275.
44. Proposed Common or Usual Names, 37 Fed. Reg. 12,327 (June 22, 1972).
45. Common or Usual Names for Nonstandardized Foods, 38 Fed. Reg. 6964, 6965 (Mar. 14, 1973).
46. Food Standards of Identity, Quality and Fill of Container; Common or Usual Name Regulations; Request for Comments on Existing Regulations, 60 Fed. Reg. 67,492, 67,498 (Dec. 29, 1995).
47. For a more detailed discussion of this issue, see infra II.B, III.A,B.
48. 21 C.F.R. § 102.5(a).
49. See Frozen Desserts: Removal of Standards of Identity for Ice Milk and Goat's Milk Ice Milk; Amendment of Standards of Identity for Ice Cream and Frozen Custard and Goat's Milk Ice Cream, 59 Fed. Reg. 47,072, 47,073 (Sept 14, 1994).
50. See Crabmeat; Amendment of Common or Usual Name Regulation, 59 Fed. Reg. 36,103, 36,106 (1994).
51. "Better food decisions" refers to decisions consumers make about which foods to purchase and eat. The decisions are better in the sense that consumers are provided with meaningful information that allows them to make fully informed selections. Health and safety are not the only factors consumers consider. Therefore, providing consumers with information that is not related to health or safety still may help them make better food decisions.
52. It is important to recognize, however that there are limitations on this idea, especially if the information is confusing or consumers do not know how to use the information.
53. The applicable portion of § 321(n) differs in each context. When FDA wishes to require food manufacturers to provide additional information on the label, the agency relies on the "omission" portion of § 321(n). When FDA wants to require the clarification of information on a food label, the agency invokes the "misleading representations" portion of § 321(n). For purposes of the following discussion, the distinction between the two parts of the statutory provision is one without a difference, because each part expresses the same concern for providing information to consumers that will help them make better food decisions.
54. See Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, 38 Fed. Reg. 2124 (Jan. 19, 1973).
55. See Federick H. Degnan, The Food Label and the Right-to-Know, 52 FOOD & DRUG L.J. 49, 51 (1997). FDA's failure to provide a clear explanation of why such information is deemed material suggest that materiality was not the key issue here. Perhaps FDA mentioned materiality to justify fittting the labeling requirements under the misbranded provision.
56. Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Labeling Act, 38 Fed. Reg. 6951, 6952 (1973).
57. Nutrition Labeling: Proposed Criteria for Food Label Information Panel, 37 Fed. Reg. 6493, 6496 (Mar. 30, 1972).
58. This conclusion is bolstered by Federick Degnan's observation that the goal of the Nutrition Labeling and education Act of 1990 reforms is the "communication of essential information to enable consumers to choose foods more wisely." Degnan, supra note 49, at 54.
59. See Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms, 56 Fed. Reg. 60,421, 60,464 (1991).
60. See 21 C.F.R. § 101.95.
61. 56 Fed. Reg. at 60,462.
62. Although FDA cited only §343(a) in its discussion of statutory authority (see Labeling of Food; Misleading Representation Regarding Origin of Food or Ingredient, 35 Fed. Reg. 9214 (1971)), § 321(n) is automatically implied, as it discusses how to determine when a label is misleading.
63. See 21 C.F.R. § 101.18(c).
64. The complaints focused on names such as "Idaho potatoes" which allegedly was used for potatoes grown elsewhere; "Louisiana hot sauce," for hot sauce made in another state; and the use of "Florida" on citrus products that had citrus ingredients from states other than Florida. See Labeling of Food; Misleading Representation Regarding Origin of Food or Ingredient, 35 Fed. Reg. at 9214.
65. FDA also may have reacted to complaints by embassies and trade associations of various countries that filed complaints concerning the use of information on domestic product labels that implied some relationship between that food and a foreign country. See id.
66. See id.
67. The misbranding provision may be merely the vehicle through which FDA can accomplish its objectives, and may not carry all that much importance in and of itself.
68. A 1997 survey of 1000 U.S. consumers showed that 93% wanted biotech food to be labeled. See Scott Kilman & Jonathan Friedland, Growth Industry: As Geneticists Develop an Appetite for Greens, Mr. Romo Flourishes, WALL ST. J. EUR., Jan. 28, 1999.
69. See, e.g., Amestoy, 92 F.3d 67 at 77 (dissent).
70. See, e.g., Mothers for Natural Law, What are the Dangers? (visited Jan. 29, 1999) 〈www.safe-food.org/ -issue/dangers/html〉.
71. See, e.g., Amestoy, 92 F.3d at 75-76 (dissent). See also Michael Pollan, Playing God in the Garden, N.Y. TIMES MAG., Oct. 25, 1998, at 44. To defend the position that biotech foods are different, activists rely on the notion that the food is intentionally modified so it will be different from its natural kind. Furthermore, this difference is important, as evidenced by the fact that biotech food companies seek patients for their creations. Mothers for Natural Law, Claims and Facts (visited Jan. 29, 1999) 〈www.safe-food.org/-issue/claims.html〉.
72. See, e.g., Amestoy, 92 F.3d at 75-76 (dissent). See also Michael Pollan, Playing God in the Garden, N.Y. TIMES MAG., Oct. 25, 1998, at 44. To defend the position that biotech foods are different, activists rely on the notion that the food is intentionally modified so it will be different from its natural kind. Furthermore, this difference is important, as evidenced by the fact that biotech food companies seek patients for their creations. Mothers for Natural Law, Claims and Facts (visited Jan. 29, 1999) 〈www.safe-food.org/-issue/claims.html〉.
73. Charles Hess, former USDA Assistant Secretary for Science and Education, expressed this view at a conference in 1991. See HENRY I. MILLER, POLICY CONTROVERSY IN BIOTECHNOLOGY: AN INSIDER'S VIEW 11 (1997).
74. FDA, FDA's Mission (last modified Oct. 19, 1998)〈www.fda.gov.opacom/morechoices/mission.html〉.
75. "In Britain, and to an extent in the rest of Europe, public opinion has turned so strongly against the genetic engineering of food crops that any negative result will produce headlines." Seeds of Discontent, ECONOMIST, Feb. 20-26, 1999, at 75. An independent opinion poll showed that 88% of Irish consumers want clear labeling of genetically modified foods. See Kevin O'Sullivan, IRT Home News: Monsanto Accused of Misleading Consumers, IR. TIMES, Feb. 6, 1999, at 4.
76. "In Britain, and to an extent in the rest of Europe, public opinion has turned so strongly against the genetic engineering of food crops that any negative result will produce headlines." Seeds of Discontent, ECONOMIST, Feb. 20-26, 1999, at 75. An independent opinion poll showed that 88% of Irish consumers want clear labeling of genetically modified foods. See Kevin O'Sullivan, IRT Home News: Monsanto Accused of Misleading Consumers, IR. TIMES, Feb. 6, 1999, at 4.
77. See, e.g., Written Question No. 2767/97 by Mihail Papayannakis to the Commission: Protection of consumers from genetically manipulated products, 1998 O.J. (C 117).
78. See Opinion of the Economic and Social Committee on Genetically Modified Organisms in Agriculture - Impact on the Common Agricultural Policy, 1998 O.J. (C 284).
79. In Defense of the Demon Seed, ECONOMIST, June 13, 1998.
80. See id.
81. See European Parliament and Council Directive 258/97, Concerning Novel Foods and Novel Food Ingredients, 1997, O.J. (L 43).
82. See Antoinette Long & Pascal Cardonnel, Practical Implications of the Novel Foods Regulation, 8 EUR. FOOD L. REV. 11 (1998).
83. See European Parliament and Council Directive 258/97, 1997, O.J. (L 43) at art. 8, par. 1.
84. Individual Member States are responsible for interpreting and implementing the directive. See Commission of the European Communities, Written Question No. 2144/97 by Hiltrud Breyer, 1998 O.J. (C 082). Some European countries are limiting the import of genetically engineered seeds or food. See Andrew Pollack, U.S. and Allies Block Treaty on Genetically Altered Goods, N.Y. TIMES, Feb. 25, 1999, at A1 [hereinafter Pollack, U.S. and Allies]. Austria, Luxembourg, and Norway refuse to accept imports of genetically altered crops. See Pollan, supra note 65, Britain recently issued an order to restaurants and other food providers to tell customers if their meals contain genetically modified products. See Britain: 'Genetic Food' Warning, N.Y. TIMES, Mar. 19, 1999, at A6. Failure to comply could result in fines up to $8750.
85. Individual Member States are responsible for interpreting and implementing the directive. See Commission of the European Communities, Written Question No. 2144/97 by Hiltrud Breyer, 1998 O.J. (C 082). Some European countries are limiting the import of genetically engineered seeds or food. See Andrew Pollack, U.S. and Allies Block Treaty on Genetically Altered Goods, N.Y. TIMES, Feb. 25, 1999, at A1 [hereinafter Pollack, U.S. and Allies]. Austria, Luxembourg, and Norway refuse to accept imports of genetically altered crops. See Pollan, supra note 65, Britain recently issued an order to restaurants and other food providers to tell customers if their meals contain genetically modified products. See Britain: 'Genetic Food' Warning, N.Y. TIMES, Mar. 19, 1999, at A6. Failure to comply could result in fines up to $8750.
86. Commission of the European Communities, Opinion of the Economic and Social Committee on Genetically Modified Organisms in Agriculture - Impact on the Common Agricultural Policy, 1998 O.J. (C 284) 39. Although not part of the EU, New Zealand complained that it was warned by the United States that its more restrictive approach to biotech food labeling could negatively impact their bilateral trade relationship and potentially end any chance of a New Zealand-United States Free Trade Agreement. See Echoes of Nuke Ban in Food Labeling Debate, EVENING POST, Dec. 23, 1998, at 6.
87. The Biosafety Protocol information throughout this discussion can be found in the following sources: Genetically Modified Free Trade, ECONOMIST, Feb. 20-26, 1999, at 76; Andrew Pollack, Setting Rules for Biotechnology Trade, N.Y. TIMES, Feb. 15, 1999, at A8; Pollack, Biotechnology Treaty, supra note 1; and Pollack, U.S. and Allies, supra note 76.
88. The Biosafety Protocol information throughout this discussion can be found in the following sources: Genetically Modified Free Trade, ECONOMIST, Feb. 20-26, 1999, at 76; Andrew Pollack, Setting Rules for Biotechnology Trade, N.Y. TIMES, Feb. 15, 1999, at A8; Pollack, Biotechnology Treaty, supra note 1; and Pollack, U.S. and Allies, supra note 76.
89. The Biosafety Protocol information throughout this discussion can be found in the following sources: Genetically Modified Free Trade, ECONOMIST, Feb. 20-26, 1999, at 76; Andrew Pollack, Setting Rules for Biotechnology Trade, N.Y. TIMES, Feb. 15, 1999, at A8; Pollack, Biotechnology Treaty, supra note 1; and Pollack, U.S. and Allies, supra note 76.
90. The Biosafety Protocol information throughout this discussion can be found in the following sources: Genetically Modified Free Trade, ECONOMIST, Feb. 20-26, 1999, at 76; Andrew Pollack, Setting Rules for Biotechnology Trade, N.Y. TIMES, Feb. 15, 1999, at A8; Pollack, Biotechnology Treaty, supra note 1; and Pollack, U.S. and Allies, supra note 76.
91. See Pollack, U.S. and Allies, supra note 76.
92. See id.
93. See id.
94. See id.
95. See GATT Secretariat, Report of the Panel on United States - Restrictions on Imports of Tuna, June 16, 1994; WTO Report of the Appellate Body, EC Measures Concerning Meat and Meat Products (Hormones), Jan. 16, 1998.
96. See GATT Secretariat, Report of the Panel on United States - Restrictions on Imports of Tuna, June 16, 1994; WTO Report of the Appellate Body, EC Measures Concerning Meat and Meat Products (Hormones), Jan. 16, 1998.
97. See GATT Secretariat, Report of the Panel on United States - Restrictions on Imports of Tuna, June 16, 1994.
98. See GATT, art. XX, par. (b), Oct. 30, 1947 (as amended through 1966) ("Subjet to the requirement that such measures are not applied in a manner which would constitute . . . discrimination between countries where the same conditions prevail, or a disguised restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption . . . of measures . . . necessary to protect . . . animal . . . life or health.").
99. See id.
100. For more information about this issue, see David E. Sanger, Imports Face Higher Tariffs on Beef Issue, N.Y. TIMES, Mar. 23, 1999, at C1 [hereinafter Sanger, Imports]; WTO Report of the Appellate Body, EC Measures Concerning Meat and Meat Products (Hormones), Jan. 16, 1998.
101. For more information about this issue, see David E. Sanger, Imports Face Higher Tariffs on Beef Issue, N.Y. TIMES, Mar. 23, 1999, at C1 [hereinafter Sanger, Imports]; WTO Report of the Appellate Body, EC Measures Concerning Meat and Meat Products (Hormones), Jan. 16, 1998.
102. See Sanger, Imports, supra note 87.
103. See id.
104. See Dale Blumenthal, FDA, Food Irradiation: Toxic to Bacteria, Safe for Humans (November 1990) (visited Feb. 2, 1999) 〈www.verity.fda.gov〉.
105. See Irradiation in the Production, Processing, and Handling of Food, 53 Fed. Reg. 53, 176, 53,204 (1988). Market tests show that once consumers learn about irradiation, they will buy irradiated foods. See Blumenthal, supra note 90.
106. See 51 Fed. Reg. at 13,388.
107. See id.
108. This premise is bolstered by Dr. Christine Bruhn, a professor of food science at the University of California-Davis, who believes that consumer education is effective in increasing understanding and acceptance of food irradiation. See Charting a Course, supra note 32.
109. Regardless of the actual success of optional irradiation labeling statements in terms of educating consumers and assuaging their fears, the approach taken in that context provides a model for at least a starting point if FDA were to require special biotech food labeling. Manufacturers, along with FDA, would have to engage in market research and development to create a label that educates consumers properly, without scaring them. This is an achievable task.
110. See 51 Fed. Reg. at 13,395.
111. See, e.g., MILLER, POLICY CONTROVERSY, supra note 66, at 100.
112. See 53 Fed. Reg. at 53,205; 51 Fed. Reg. at 13,389.
113. See 51 Fed. Reg. at 13,389.
114. The problem with this approach, however, is that on a legal level, it probably would not survive under the misbranded provisions of the FDCA. If a label, in the absence of genetic engineering information, is considered to be misleading, it would be misleading whether the food is first or second generation. Legally, then, distinguishing between food generations may not be reasonable.
115. See Bewusster Verzicht auf Gentechnik (Conscious Rejection of Genetic Technology), FRANKFURTER RUNDSCHAU, Oct. 23, 1998, at 29.
116. See MILLER, POLICY CONTROVERSY, supra note 66, at 98, 100-01. At the Biosafety Protocol conference, Argentina and Canada opposed efforts to require segregation of modified and unmodified crops, because they claimed that the handling, storage, and trasport costs would be increased by as much as 20%. See Seeds of Discontent, supra note 68, at 76.
117. See MILLER, POLICY CONTROVERSY, supra note 66, at 98, 100-01. At the Biosafety Protocol conference, Argentina and Canada opposed efforts to require segregation of modified and unmodified crops, because they claimed that the handling, storage, and trasport costs would be increased by as much as 20%. See Seeds of Discontent, supra note 68, at 76.
118. If any of the other processes mentioned above were marked by this combination of characteristics, maybe FDA should have required special food labeling for them.
119. Personal telephone communication with Lisa Watson, Calgene (Jan. 1999).
120. See Biotech Foods Ready for Primetime, supra note 8.
121. According to Susan Harlander, Vice President, Pillsbury, identity preservation is very important. First, the cost of pesticides is significant. Furthermore, growers of certain biotech foods must pay a technology or royalty fee for the seeds. Consequently, to realize the benefits of biotech crops, farmers need to separate them from ordinary crops. It would be inefficient and wasteful to both purchase biotech seeds and spray them unnecessarily with expensive pesticides. Harlander also pointed out that the importance of identity preservation throughout the food production process will grow over time as crops will be engineered genetically to express nutritional and processing advantages that require different types of processing than their traditional counterparts. In general, crop segregation will play a vital role in the ability to capture the value of biotech food. Personal telephone conversation (Mar. 1999).
122. See supra notes 51, 53, 56.