Modification and consumer information: Modern biotechnology and the regulation of information

Food and Drug Law Journal

Volumn 55, Issue 1, 2000, Pages 105-117

  Beales III, J Howard ^a  

^a GEORGE WASHINGTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; CONSUMER; COST; DNA MODIFICATION; FOOD AND DRUG ADMINISTRATION; FOOD PACKAGING; FOOD SAFETY; GOVERNMENT; INFORMATION SCIENCE; REGULATORY MECHANISM; REVIEW;

BIOTECHNOLOGY; CONSUMER PRODUCT SAFETY; COSTS AND COST ANALYSIS; EUROPEAN UNION; FOOD INDUSTRY; GENETIC ENGINEERING; HUMANS; INFORMATION SERVICES; ORGANISMS, GENETICALLY MODIFIED; PRODUCT LABELING; RISK; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033998707     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (67)

1. See, e.g., Kirsten S. Beaudoin, On Tonight's Menu: Toasted Cornbread with Firefly Genes? Adapting Food Labeling Law to Consumer Protection Needs in the Biotech Century, 83 MARQ, L. REV. 237 (1999).
2. Henry Miller, Food Produced with New Biotechnology: Can Labeling Anti-Consumer? 14 J. PUB. POL'Y & MKTG. 330 (1995).
3. See HENRY I. MILLER, POLICY CONTROVERSY IN BIOTECHNOLOGY: AN INSIDER'S VIEW 15 (1997).
4. Bruce N. Ames, Science and the Environment, 43 FREEMAN 343 (1993).
5. Far example, conventional breeding techniques have produced celery with high levels of the natural carcinogen psoralen, and potatoes with high levels of solanine, a natural pesticide. Frank B. Cross, Paradoxical Perils of the Precautionary Principle, 52 WASH. & LEE L. REV. 851, 873 (1996).
6. NATIONAL ACADEMY OF SCIENCES, INTRODUCTION OF RECOMBINANT DNA-ENGINEERED ORGANISMS INTO THE ENVIRONMENT: KEY ISSUES (1987).
7. NATIONAL RESEARCH COUNCIL, FIELD TESTING GENETICALLY MODIFIED ORGANIMS: FRAMEWORK FOR DECISIONS (1989).
8. JOINT FOOD AND AGRICULTURE ORGANIZATION/WORLD HEALTH ORGANIZATION CONSULTATION, BIOTECHNOLOGY AND FOOD SAFETY (1996) (last visited Feb. 15, 2000) 〈www.fao.org/es/esn/biotech/conclude.htm〉.
9. CLIVE JAMES, INTERNATIONAL SERVICE FOR THE ACQUISITION OF AGRI-BIOTECH APPLICATIONS, GLOBAL REVIEW OF COMMERCIALIZED TRANSGENIC CROPS: 1998, ISAAA BRIEFS NO. 8.
10. EC COUNCIL REGULATION NO. 1139/98, May 26, 1998. For a discussion of how this labeling regulation emerged from the political response to the approval of genetically modified corn (maize), despite the lack of any credible health and safety risk, see Terence P. Stewart & David S. Johanson, Policy in Flux: The European Union's Laws on Agricultural Biotechnology and Their Effects on International Trade, 4 DRAKE J. AGRIC. L. 243 (1999).
11. EC COUNCIL REGULATION NO. 1139/98, May 26, 1998. For a discussion of how this labeling regulation emerged from the political response to the approval of genetically modified corn (maize), despite the lack of any credible health and safety risk, see Terence P. Stewart & David S. Johanson, Policy in Flux: The European Union's Laws on Agricultural Biotechnology and Their Effects on International Trade, 4 DRAKE J. AGRIC. L. 243 (1999).
12. If the products are not "equivalent," the regulation would appear to require distinguishing "genetically modified pesticide resistant soy" from "genetically modified insect and pesticide resistant soy." A product no longer is equivalent if scientific assessment "can demonstrate that the characteristics assessed are different in comparison with a conventional food or food ingredient, having regard to the accepted limits of natural variations for such characteristics." EC COUNCIL REGULATION NO. 258/97 of the European Parliament and of the Council, Jan. 27, 1997, Article 8.
13. This categorization is based on Peter A. Riley & Linwood Hoffman, Value Enhanced Crops: Biotechnology's Next Stage, AGRIC. OUTLOOK 18 (1999) (available at 〈www.econ.ag.gov/epubs/pdf/agout/ mar99〉) (last visited Feb. 16, 2000); see also, MONSANTO CO. 1997 ANNUAL REPORT 8 (1998).
14. This categorization is based on Peter A. Riley & Linwood Hoffman, Value Enhanced Crops: Biotechnology's Next Stage, AGRIC. OUTLOOK 18 (1999) (available at 〈www.econ.ag.gov/epubs/pdf/agout/ mar99〉) (last visited Feb. 16, 2000); see also, MONSANTO CO. 1997 ANNUAL REPORT 8 (1998).
15. MONSANTO CO. 1997 ANNUAL REPORT, supra note 12.
16. Id.
17. T.A.B. Sanders, Food Production and Food Safety, 218 BRIT. MED. J. 1689 (1999).
18. Miller, supra note 3, at 5.
19. Svante Paabo, Neolithic Genetic Engineering, 398 NATURE 194 (1999).
20. Henry I. Miller, Foods of the Future: The New Biotechnology and FDA Regulation, 269 JAMA 910 (1993).
21. Under EC regulations, a genetically modified organism is one produced usingrDNA techniques using vector systems, direct introduction of genetic material into an organism, or cell fusion techniques where new organisms are formed "by means of methods that do not occur naturally." See Council Directive 90/220/EEC, Apr. 23, 1990, Article 2 (2), and Annex I (A).
22. Gilian K. Hadfield & David Thomson, An Information Based Approach to Labeling Biotechnology Consumer Products; 21 J. CONSUMER POL'Y 551 (1991).
23. Regulation of pesticide residues, for example, relies on setting tolerances for acceptable exposure levels, rather than on identifying either the possible presence of residues or the specific pesticides employed. In the absence of any specific hazard, potential toxicity is a limitless rationale for special labeling. Virtually any hybridized plant might have as undiscovered hazards. Indeed, humans consumed animal flesh literally for millennia before the hazards of diets high in cholesterol and saturated fat were recognized. See Harry Sadeghi, Redefining the "Pest" in Pesticides: Environmental Protection or Exacerbation of Half-truths about What We Eat? 29 U. WEST. L.A. L. REV. 327 (1998).
24. As a practical matter, food manufacturers do not want to add unnecessary allergens to any product, and seed companies, therefore, have no incentive to market crops that would do so. GMOs that incorporate significant allergens are unlikely to survive in the marketplace, unless they offer some substantial economic advantage. The need to identify the allergen and segregate the crop would preclude modifications that offer only small advantages. Julie A. Nordlee, Steve L. Taylor, Jeffrey A. Townsend, Laurie A. Thomas & Robert K. Bush, Identification of a Brazil-Nut Allergen in Transgenic Soybeans, 334 NEW ENG. J. MED. 688 (1996).
25. "Considerable similarity" was discovered in the extent to which transgenic soybeans and raw brazil nut extracts bind to the immune system proteins that mediate allergic responses. Id. at 690. Moreover, rDNA techniques are widely used to reproduce and study allergens. See R. Valenta, S. Vrtala, S. Laffer, S. Spitzauer & D. Kraft, Recombinant Allergens, 53 ALLERGY 552 (1998).
26. For example, different foods might include oil from soybeans or corn, modified to increase pesticide resistance, insect resistance, or both, or modified canola, or enzymes from genetically altered bacteria. Because generic labels that the product included GMOs or ingredients produced from GMOs would be the same for all such products, they would include different potential sources of any problem that might appear.
27. Int'l Dairy Foods Ass'n v. Amestoy, 92 F.3d 67 (2d Cir. 1996). "Absent, however, some indication that this information bears on a reasonable concern for human health or safety or some other sufficiently substantial governmental concern, the manufacturers cannot be compelled to disclose it. Instead, those consumers interested in such information should exercise the power of their purses by buying products from manufacturers who voluntarily reveal it. Accordingly, we hold that consumer curiosity alone is not a strong enough state interest to sustain the compulsion of even an accurate, factual statement." Id. at 74.
28. Logically, such special labeling should be limited to GMOs incorporating copies of animal genes. Genes copied from other plants or bacteria would not raise the same ethical issues.
29. Of course, some may see an ethical issue regardless of the lack of a scientific foundation for the distinction. As discussed below, voluntary labeling would allow these individuals to pursue their own beliefs, but it would not require the majority who do not share those beliefs to subsidize them.
30. Food & Drug Administration, Food Labeling: Foods Derived From New Plant Varieties, 58 Fed. Reg. 25,837, 25,839 (Apr. 28, 1993).
31. MILLER, supra note 3, at 17.
32. This and other surveys are discussed in Lona Aldrich & Noel Blisard, Consumer Acceptance of Biotechnology: Lessons From the rBST Experience, Current Issues in Economics of Food Markets, AGRIC. INFO. BULL. NO. 747-01, (Dec. 1998).
33. If the concern is the inherent uncertainty about a product that has not been consumed for an extended period, a disclosure more closely attuned to the problem may be that "this product has been on the market for less than x years." The minimal benefit of such a requirement is apparent.
34. Thomas P. Redick, William A. Reavey & Dirk Michels, Private Legal Mechanisms for Regulating the Risks of Genetically Modified Organisms: An Alternative Path Within the Biosafety Protocol, 4 ENVTL. L. 1, 11-12 (1997).
35. NATIONAL ACADEMY OF SCIENCES, supra note 6, at 11.
36. NATIONAL INSTITUTES OF HEALTH, NATIONAL BIOTECHNOLOGY BOARD REP. 2 (1992).
37. ". . . each of these ideal qualities has a kind of existence, and the particular things that partake of them get their name from them . . ." GREAT DIALOGUES OF PLATO 506 (translated by W.H.D. Rouse, 1956).
38. Sharon Walsh, In the Food Industry, the New Competition is Kosher, WASH. POST, May 30, 1998, at A1.
39. See Dan L. Burk, The Milk Free Zone: Federal and Local Interests in Regulating Recombinant BST, 22 COLUM. J. ENVTL. L. 227 (1997). Burk includes a comprehensive discussion of the science and politics of the rBST debate.
40. Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows That Have Not Been Treated with Recombinant Bovine Somatotropin, 59 Fed. Reg. 6279 (Feb. 10, 1994).
41. Id. at 6280. The labeling requirements, and the response of some states, are discussed in more detail in Terence J. Centner & Kyle W. Lathrop, Labeling rBST-Derived Milk Products: State Responses to Federal Law, 45 KAN. L. REV. 511 (1997).
42. For example, regulations require disclosure that a fruit juice is unpasteurized, because unpasteurized products pose particular, identifiable risks. Thus, unpasteurized fruit juices must bear a label stating: "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems." See 21 C.F.R. §101.17(g)(2) (1996). Regulations, however, do not require disclosure of the living conditions of animals or that the cattle were treated with rBST, although some consumers might care about such differences. Animal living conditions and use of veterinary drugs have been controversial issues in the Agricultural Departments proposed rules to establish national organic standards. 62 Fed. Reg. 65,850 (Dec. 16, 1997); comments on rule available at 〈www.am3.usda/gov/nop/index.htm〉 (last visited Feb. 16, 2000).
43. Organic claims are governed by the Federal Organic Foods Production Act of 1990, Pub. L. No. 101-624, 104 Stat. 3935 (codified at 7 U.S.C. § 6501 (1999)). The Agricultural Marketing Service estimates that 11 state and 33 private organic certifying agencies provide organic certification to producers and handlers. See Program to assess Organic Certifying Agencies, 64 Fed. Reg. 30,861, 30,862 (1999). USDA has not yet adopted national standards. See note 40.
44. There is nothing "paternalistic" about relying on scientific assessments of risk to determine whether mandatory labeling is appropriate. When scientific evidence indicates that important differences exist, labels alerting consumers to the difference, and reduce the costs for consumers of identifying the choice that best satisfies their preferences. Conversely, when the scientific consensus is that no meaningful difference exists, labels that highlight the difference at best can encourage consumers to search for information they likely will find irrelevant, and may lead consumers to make inferior choices in the mistaken belief that the difference is meaningful.
45. See sources listed, supra note 41.
46. The allocation of costs may also be constitutionally significant in challenges to state labeling requirements under the Commerce Clause. See Burk, supra note 37, at 315.
47. For a discussion of the limits of surveys in the context of valuing environmental benefits, see Peter A. Diamond & Jerry A. Hausman, Contigent Valuation: Is Some Number Better Than No Number? 8 J. ECON. PERSP. 45 (1994).
48. Aldrich & Blisard, supra note 30, at 2.
49. Id. at 3.
50. Id.
51. There is little basis for concern that markets will not reveal information because consumers do not know that a difference exists that might be relevant to them. When entrepreneurs identify a potential difference of value to consumers, it normally is the products with an advantage that first reveal the difference. Such producers have incentives to convey the information in the most effective way possible, Disclosure by the "best" products then generates pressure on other products to disclose as well, a phenomenon known as the unfolding principle. See Paul Rubin, The Economics of Regulating Deception, 10 CATO J. 667 (1991). Empirical evidence in support of the unfolding principle is discussed in Pauline M. Ippolito & Alan D. Mathios, The Regulation of Science Based Claims in Advertising, 13 J. CONSUMER POL'Y 413 (1990).
52. There is little basis for concern that markets will not reveal information because consumers do not know that a difference exists that might be relevant to them. When entrepreneurs identify a potential difference of value to consumers, it normally is the products with an advantage that first reveal the difference. Such producers have incentives to convey the information in the most effective way possible, Disclosure by the "best" products then generates pressure on other products to disclose as well, a phenomenon known as the unfolding principle. See Paul Rubin, The Economics of Regulating Deception, 10 CATO J. 667 (1991). Empirical evidence in support of the unfolding principle is discussed in Pauline M. Ippolito & Alan D. Mathios, The Regulation of Science Based Claims in Advertising, 13 J. CONSUMER POL'Y 413 (1990).
53. See Burk, supra note 37, at 232-33 (discussing the inability to detect differences between milk from cows treated with rBST and untreated cows). In other cases, processing may destroy evidence of differences in genetic origin. See Stewart & Johanson, supra note 10, at 283-85; see also Hadfield & Thomson, supra note 20, at 571 (noting the need for separation).
54. Other countries differ in this regard. For example, Canada has a formal regulatory mechanism to determine which varieties can be grown, and distinguishes varieties based on visual characteristics of kernels throughout the distribution system. Similarly, in France marketing by variety also is common. Vera Krischik, Comparison of Grain Marketing in Major Grain-Producing Countries, in STORED PROD. MGMT, at 21-27, available at, 〈www.okstate.edu/OSU_Ag/agedcm4h/pearl/e912/index.html〉 (last visited Feb. 17, 2000).
55. See generally Official United States Standards for Grain, 7 C.F.R. § 810.
56. Even for a given grain variety, key characteristics such as protein content may vary considerably from farm to farm, depending on local growing conditions. See Bruce L. Dahl & William W. Wilson, Consistency of Quality Characteristics in Hard Red Spring Wheats, in AGRICULTURAL ECON. REP. NO. 393, at 63067 (May, 1998).
57. Vera Krischik, David Shipman, & Richard Stuckey, How Grain Moves Through the Marketing System, in STORED PROD. MGMT, at 19, available at 〈www.okstate.edu/OSU_Ag/agedcm4h/pearl/3912/index.html〉 (last visited Feb. 18, 2000).
58. Id.
59. CHARLES R. HURBURGH, JR., CENTER FOR AGRICULTURAL AND RURAL DEVELOPMENT, IOWA STATE UNIVERSITY, INITIATION OF END-USER SPECIFIC GRAIN MARKETING AT IOWA ELEVATORS (1997).
60. The Wall Street Journal reports cash prices for commodities daily. On February 17, 2000, corn was $2.055 per bushel (a year ago the price was $2.05 per bushel) and soybeans were $4.90 per bushel (a year ago the price was $4.72 per bushel). WALL ST. J., Feb. 18, 2000, at C18.
61. HURBURGH, supra note 56, at 1.
62. Id.
63. The genetic endowment of virtually all modern crops has been altered through thousands of years of human selection, cross breeding, and, more recently, hybridization. As used in the text, "genetically modified" refers to modifications introduced through the use of modern biotechnology. See Rick Weiss, Food War Claims its Casualties, WASH. POST, Sept. 12, 1999, at A23.
64. Rick Weiss, Seeds of Discord: Monsanto's Gene Police Raise Alarm on Farmers' Rights, Rural Tradition, WASH. POST, Feb. 3, 1999, at A1.
65. Id.
66. If some buyers dislike GMOs for their own reasons, the market price of such crops would be less than the price of their "unmodified" relatives. For input traits, farmers would have no reason to plant such crops unless the productivity advantage more than offset the price disadvantage.
67. Guides for the Use of Environmental Marketing Claims, 16 C.F.R. § 260. The principles behind the guides are discussed in J. HOWARD BEALES & TIMOTHY J. MURIS, STATE AND FEDERAL REGULATION OF NATIONAL ADVERTISING (1993).