COMMENTS OF THE
COMMENTS OF THE
COMPETITIVE ENTERPRISE INSTITUTE
TO THE FOOD AND DRUG ADMINISTRATION
REGARDING THE AGENCY’S PROPOSED RULE FOR
PREMARKET NOTICE CONCERNING BIOENGINEERED FOODS
May 3, 2001
Docket No. 00N-1396, Proposed rule
66 FR 4706 (January 18, 2001)
The Competitive Enterprise Institute (CEI) appreciates the opportunity to submit these comments regarding the Food and Drug Administration’s proposed rule regarding Premarket Notice for Bioengineered Foods. CEI is a non-profit research and advocacy organization and has been extensively involved in issues dealing with food safety and other matters of public health. Examples of this work include: CEI’s comments regarding the Food and Drug Administration’s Public Meetings on Biotechnology in the Year 2000 and Beyond (64 FR 57470, October 25, 1999); the organization’s statement against mandatory labeling of recombinant Bovine Somatotropin-derived dairy products at the May 6, 1993 Joint Meeting of the Food and Veterinary Medicine Advisory Committees (See 58 FR 21314, April 20, 1993); and its comments regarding FDA’s proposal on voluntary labeling of recombinant Bovine Somatotropin-derived dairy products (59 FR 6279, February 10, 1994). Other examples include CEI’s comments regarding the U.S. Department of Agriculture’s National Organic Program (62 FR 65850, December 16, 1997 and 65 FR 13512, March 13, 2000), and CEI’s law suit challenging the federal ban on voluntary mentions on product labels of the health benefits of moderate alcohol consumption (CEI, et al., v. Rubin, Civil Action No. 96-2476 TPJ).
On May 29, 1992, the Food and Drug Administration published in the Federal Register (57 FR 22984 et seq.) its “Statement of Policy: Foods Derived from New Plant Varieties,” expanding the agency’s interpretation of the Federal Food, Drug and Cosmetics Act with respect to foods derived from new plant varieties, including those developed with recombinant DNA techniques. Under that interpretation, evaluations of the safety of such foods are to be based on the “objective characteristics of the food product or its components rather than the fact that new development methods were used.” In its Statement of Policy, FDA issued guidance to plant breeders regarding many of the scientific considerations for evaluating the safety and nutritional aspects of foods from new plant varieties, including those from traditional methods, tissue culture, and rDNA techniques. This guidance document included several flow charts with a stepwise progression of questions for determining situations in which producers should consult with FDA on scientific issues.
Since 1994, the FDA has evaluated more than 45 rDNA-manipulated plant varieties, and it has been able to resolve issues regarding food safety adequately. Under the Federal Food, Drug and Cosmetics Act, developers and marketers of new foods have a responsibility to ensure that the foods they offer to consumers are safe and in compliance with all requirements of the Act (57 FR 22985). Producers have heretofore demonstrated a willingness to act in good faith in developing new plant varieties that are comprehensively tested to ensure human and animal safety. Furthermore, seed and crop plant producers and food manufacturers have numerous market incentives to produce and sell only products that are safe for human and animal consumption – including such reasons as maintenance of brand reputation and legal liability.
CEI commends the FDA for its 1992 decision to evaluate foods produced from new plant varieties based solely on the objective, risk-related characteristics of new plant varieties and the foods derived from them. CEI views FDA’s proposed rule regarding premarket notice of all bioengineered foods as forsaking the agency’s near-decade long commitment to treating new plant varieties equally and fairly under the law.
II. FDA’s Proposed Premarket Notice Requirement
As FDA notes in both its 1992 Statement of Policy (57 FR 22991) and its January 2001 Federal Register notice (66 FR 4709, 4710), all breeding techniques have the ability to generate unintended or unexpected effects on the phenotype of the plant in ways relevant to food safety. Yet, by its own acknowledgement, FDA has not identified “any new scientific information that raises questions about the safety of bioengineered foods currently being marketed” (66 FR 4708). In its January 2001 Federal Register notice, FDA provides several reasons for its proposed change in policy to require premarket notice of new plant varieties derived from rDNA techniques. As regards most of these points, however, FDA admits that there are similar concerns with foods derived from plants modified in more traditional ways.
The primary motivation for the proposed change seems to be that, “because breeders utilizing rDNA technology can introduce genetic material from a much wider ranger of sources than previously possible, there is a greater likelihood that the modified food will contain substances that are significantly different from, or are present in food at a significantly higher level than counterpart substances historically consumed in food. In such circumstances, the new substances may not be GRAS and may require regulation as food additives” (66 FR 4709). FDA adds further that, “rDNA techniques have a greater potential, relative to conventional methods of breeding, to result in the development of foods that present legal status questions” (66 FR 4711).
While it is true that rDNA technology permits the introduction of genetic material (and its consequent gene products) from a broader range of sources than traditional breeding, it is not at all clear that this possibility alone merits heightened scrutiny for all new plant varieties developed with rDNA techniques. Such an alteration in policy would therefore represent a sea change in FDA’s long standing commitment to regulating the risk-related products of rDNA technology and not the process itself.
Thousands of new plant varieties, created without recombinant DNA techniques, are developed, tested, and marketed every year without any need for premarket review or consultation by the FDA or any other regulatory body. Nor is any safety testing required by law, even though new varieties produced with more traditional methods often contain hundreds of unique proteins and other constituents. Both interspecific and intergeneric hybridization have been used for at least a century to transfer genes not previously known to be present in the food supply from wild varieties into cultivated ones. Furthermore, the intentional use of mutagenic agents to modify plant genetic material also can result in the creation of substances not previously known to be present in the food supply.
FDA acknowledges that the agency “has not found it necessary to assess routinely the safety of foods derived from such breeding methods, because over the last 50 to 60 years that some of these techniques have been used in plant breeding, breeders have used well-established practices successfully to identify and eliminate, prior to commercial use, plants that exhibit unexpected adverse traits” (66 FR 4711). Yet FDA has not made clear why such established practices are incapable of identifying and eliminating adverse traits from rDNA-manipulated plants.
Consequently, in the opinion of the Competitive Enterprise Institute, the reasons given in FDA’s January 2001 Federal Register notice fail to justify the wholly disproportionate regulatory burden proposed only for new plant varieties developed with rDNA techniques. This proposed change in policy seems to suggest that FDA expects that all plants developed with rDNA techniques will have undergone transformations that merit heightened scrutiny under the Act. This is clearly not the case.
Furthermore, if the FDA suspects that many, or even most, rDNA-manipulated plant varieties will in the future contain substances that are not known to have been previously present in the food supply, it need not create a one-size-fits-all regulatory scheme to deal with potential risks to consumers. The agency could incorporate such concerns into its documents providing guidance on consultation procedures for foods derived from new plant varieties. There is no reason why FDA could not address rDNA-manipulated plants generally within its existing voluntary consultation process and require premarket notice only for those specific new plant varieties that raise risk-related concerns.
Given the safety record of new plant varieties generally, and that of new plant varieties developed with recombinant DNA techniques specifically, the proposed strengthening of the FDA’s regulatory apparatus is clearly unwarranted. Requiring premarket notification, could prove detrimental to consumer choice and public health by further slowing the development process of new plant varieties and new foods derived from them, by making the development process more costly, and by having a possibly “chilling” effect on the development of new foods.
Such an approach to regulation is theoretically designed to ensure that new products do not pose a threat of negative health effects. Such a policy, however, ignores the risk of forgoing new products and the potential of new products to reduce existing risks to public health. The benefit of introducing new products in a timely manner goes beyond the obvious advantage of providing consumers with new and different foods from which to choose. It also includes such benefits as providing greater agricultural productivity – which tends to make foods less expensive – as well as the potential to make foods more wholesome, nutritious, and durable. Consequently, the Competitive Enterprise Institute strongly opposes the FDA’s proposed rule requiring premarket notification of plants derived from rDNA techniques.
May 3, 2001
Director of Food Safety Policy
Competitive Enterprise Institute
1001 Connecticut Avenue, NW
Washington, DC 20036
 In 1996 and again in 1997, FDA provided additional guidance to breeders using rDNA techniques, advising them “that it is in the best interests of the regulated industry and the agency for developers to inform FDA … prior to commercial distribution, about foods or feed derived from new plant varieties, including those derived using rDNA techniques” (U.S. Food and Drug Administration, “Guidance on Consultation Procedures: Foods Derived From New Plant Varieties, October, 1997).
 Steve L. Taylor and Susan L. Hefle, “Seeking clarity in the debate over the safety of GM foods,” Nature, Vol. 402 (December 9, 1999) p. 575; and National Research Council, Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues (Washington, DC: National Academy Press, 1987).
 Robert M. Goodman, Holly Hauptli, Anne Crossway, and Vic C. Knauf, “Gene Transfer in Crop Improvement,” Science, Vol. 236 (April 3, 1987) pp. 48-54.
 International Atomic Energy Agency, Plant Mutation Breeding for Crop Improvement, Proceedings of a Symposium, Vienna, Austria, 18-22 June 1990 (Vienna: FAO/IAEA, 1990).