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January 13, 2000
Docket No. 99N-4282
RE: Comments on FDA's Food Biotechnology Policy; Docket No. 99N-4282
Dear Sir or Madam,
The Food Marketing Institute (FMI) is pleased to respond to the Food and Drug Administration's (FDA's) request for comments on the Agency's policy for regulating foods derived from plants developed through modern biotechnology. 64 Fed. Reg. 57470 (Oct. 25, 1999). FDA specifically requested guidance on the Agency's labeling and oversight positions. As explained more fully below, we urge FDA to take a strong leadership role on this issue to ensure the continued confidence of consumers in our food supply. The Agency should implement a system to ensure that all foods or food ingredients produced from modern biotechnology are reviewed by FDA before they are offered for sale to consumers.
FMI is a non-profit association that conducts programs in research, education, industry relations and public affairs on behalf of its 1,500 members and their subsidiaries. Our membership includes food retailers and wholesalers, as well as their customers, in the United States and around the world. FMI's domestic member companies operate approximately 21,000 retail food stores with a combined annual sales volume of $220 billion, which accounts for more than half of all grocery sales in the United States. FMI's retail membership is composed of large multi-store chains, small regional firms, and independent supermarkets. Our international membership includes 200 members from 60 countries.
FMI and its members have a longstanding commitment to ensuring that consumers are offered high quality food and that consumers have confidence in the safety of the food that they purchase. We value the opportunity to work closely with FDA on important food safety issues such as the Partnership for Food Safety Education and the recently completed consumer brochure on irradiation.
With respect to biotechnology, FMI's Board of Directors adopted a policy statement on food produced via biotechnology on October 16, 1999. A copy of the statement, which was also adopted by the Grocery Manufacturers of America, was sent to Commissioner Henney on November 17 in advance of FDA's hearings. FMI also developed a brochure for grocery stores to distribute to consumers to provide objective information on bioengineered foods.1 In light of FDA's leadership role on this issue, our brochure cites the Agency's website as a good source of information for consumers.
As these documents affirm, FMI believes that consumers have a basic right to know the relevant information about the products that they buy, including information about genetically modified foods or foods containing genetically modified ingredients. We support the role and responsibility of FDA to determine appropriate food labeling. With respect to FDA oversight, consultation with FDA should be carried out for all genetically modified foods or food ingredients before the foods are offered to consumers. Such consultation must include a thorough safety review and a determination as to appropriate labeling.
Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) sets forth the statutory standards and requirements for food labels and labeling. 21 U.S.C. § 343. In relevant part, food will be deemed misbranded if it fails to bear specified information or if it is false or misleading in any particular. Section 201(n) of the Act further explains that labeling will be considered misleading if it fails to reveal a material fact. 21 U.S.C.
§ 321(n).
In 1992, FDA issued a notice entitled, "Statement of Policy: Foods Derived from New Plant Varieties" (hereinafter "FDA Policy Statement"), in which the Agency interpreted the statutory requirements with respect to labeling for foods produced through biotechnology. 57 Fed. Reg. 22984 (May 29, 1992). The Agency interprets the Act to require bioengineered food to bear a label containing specific information if the composition of the food differs significantly from its conventional counterpart. 57 Fed. Reg. at 22991; 64 Fed. Reg. at 57471. The examples chosen to illustrate the policy are the presence of an unexpected allergen or a decrease in nutrients from the food's traditional counterparts. In these situations, the labeling would be required to advise consumers of the allergen or the decrease in nutrients, but would not be required to specify that the food was produced via biotechnology.
FMI's policy statement supports the consumers' basic right to know the relevant information about the products that they buy. Clearly, the presence of an unexpected allergen or a significant difference in composition is relevant information about which consumers must be advised. Accordingly, FMI strongly supports FDA's position that foods must be labeled for the presence of an unexpected allergen or any other material characteristic that FDA deems appropriate to disclose.
Furthermore, FDA should prepare a guidance document explaining the criteria for labeling that might be used by a company to voluntarily advise consumers that a particular food was not produced through biotechnology; claims of this type are often referred to collectively as "GM-free" claims. Standardized criteria will prevent marketplace confusion and will provide consumers with a greater degree of certainty about the characteristics of the foods that they purchase. To ensure that the criteria are widely adopted, they should be developed or endorsed by the Food and Drug Administration.2
The criteria must, however, be fair and reasonable. Once standardized criteria are adopted, marketplace confusion will be reduced, thus, highly restrictive standards will be unnecessary. The criteria should be used to ensure the truthfulness of the claims, without inhibiting manufacturers from making lawful claims. FDA's guidance should not impose unreasonable burdens on manufacturers. For example, criteria for claims about foods manufactured without the intentional addition of genetically modified components should permit a reasonable tolerance given the current pervasiveness of bioengineered crops, since their omnipresence is likely to have led to unavoidable commingling of bioengineered crops with crops that were never intended to be produced via biotechnology. FMI supports the right of all manufacturers to provide truthful information to consumers through voluntary labeling; the free flow of information about food in the marketplace should not be restricted unnecessarily.
In this regard, FMI developed the enclosed brochure entitled, "Bioengineered Food and You," which was recently distributed to our members as a source of neutral information for food retailers to offer to the consuming public. Consistent with our policy statement, we asked FDA to collaborate in the drafting and production of the brochure, however, the Agency declined. Although FDA chose not to avail itself of this opportunity to provide information directly to the public, we urge you to communicate directly and effectively with the general public on this issue as soon as possible.
Food is a basic and necessary component of life. Consumers do not want to worry about the safety of the food that they eat or that they feed to their families. However, the general public is increasingly caught between the competing claims of the anti-biotech activists and the biotechnology industry; ultimately, the result will be diminished consumer confidence in the food supply. Consumers are looking for a clear message from a body that is considered trustworthy and neutral; to wit: FDA.
Overall food safety is a primary mission of the Food and Drug Administration, which carefully regulates a substantial portion of the daily American diet. In keeping with its overall mission, FDA has invested significant resources in ensuring that foods produced with biotechnology are likewise safe. Despite its efforts to date, we believe that the Agency has not yet taken sufficient steps to ensure that the general public understands the extent of FDA's role with regard to bioengineered foods; adequate attention to this aspect is necessary to ensure continued consumer confidence in the food supply. FDA must convey its message directly to the public loudly and clearly.
To facilitate direct communication with the general public, FDA might use any or all of the following methods: posting a short, clear statement of policy on the Agency's website; direct interviews with the media; and issuance of an FDA brochure on bioengineered foods that might be offered directly to consumers through a variety of channels, including neighborhood grocery stores.
The Federal Food, Drug, and Cosmetic Act grants FDA the authority to remove any adulterated food from the marketplace, regardless of its method of production. 21 U.S.C. § 342. In addition, the Act gives FDA pre-market review authority over all substances that meet the statutory food additive definition; substances that have been determined by qualified experts to be generally recognized as safe (or GRAS) are specifically exempted from the food additive definition and, therefore, from FDA's pre-market review authority. 21 U.S.C. §§ 321(s), 342(a)(2), 348(a).
The FDA Policy Statement sets forth the Agency's interpretation of its statutory authority in the context of bioengineered foods. 57 Fed. Reg. 22984 (May 29, 1992). It also includes procedures for manufacturers to use in evaluating new food products. 52 Fed. Reg. at 22991. Manufacturers are encouraged to follow these procedures and to consult with FDA on the legal and scientific significance of the data obtained as a result. 52 Fed. Reg. at 22991. For those substances that are GRAS, the consultation process is voluntary; for substances that meet the statutory food additive definition, pre-market review under the separate petition process is required. 21 U.S.C. §§ 342(a)(2), 348(a); 57 Fed. Reg. at 22990.
FMI believes that consultation with FDA must be carried out for all genetically modified foods or food ingredients before these substances are offered to consumers. Consultation should include a safety review and a determination as to appropriate labeling. To the extent that the consultation process is now voluntary, we believe that the process should be made mandatory to ensure that FDA reviews all foods produced via biotechnology for the further goal of ensuring continued consumer confidence in the safety of the food supply.
Enhancing the transparency of the oversight process will likewise facilitate consumer confidence. For example, health and safety data, including the studies submitted to FDA on foods produced via biotechnology, are available to the public under the Freedom of Information Act (FOIA) and FDA's implementing regulations. 5 U.S.C. § 552; 21 C.F.R., Part 20; see, also, 21 C.F.R. § 171.1(h). However, submitting a FOIA request can be a cumbersome process that generally entails a delay of weeks, if not months, between the time the information is requested and its receipt. FDA should post the publicly releasable information on the safety of foods produced via biotechnology on the Agency's website so that interested consumers will have immediate access.
Re-consideration of the data requirements in light of knowledge gained since the policy was implemented may also help to re-assure consumers that FDA is fully informed as to the issues and that the best science is being used to ensure the safety of the food supply. We recommend that the Agency seek guidance on this issue from qualified scientists in industry and academia.
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, Maryland 20852
A. Labeling and Public Information Issues
1. FMI Supports the Consumer's Right To Know Relevant Information and the Role and Responsibility of FDA To Determine Appropriate Food Labeling
2. FDA Should Establish Fair and Reasonable Criteria To Ensure that "GM-Free" Claims Are Truthful and Not Misleading to the Consuming Public
3. FFDA Must Take Responsibility for Its Policy and Provide Clear Information to the General Public on the Regulation of Bioengineered Foods
With respect to public information, our policy statement observes the following:
There is an urgent need to educate the public about food biotechnology and genetically modified foods. This education will be most effective if undertaken as a cooperative effort among the business community, the government, and the scientific and consumer communities.
B. To Boost Consumer Confidence, FDA Should Implement a Process To Enhance Agency Review and Oversight of Bioengineered Foods
We appreciate the opportunity to provide FDA with our comments on this issue and stand ready to work with the Agency on any consumer education efforts that FDA decides to undertake. In the interim, if we may provide further information on our position or assist the Agency in any other way, please do not hesitate to call on us.
Sincerely,
Tim Hammonds
President and CEO
cc: Commissioner Jane E. Henney
William K. Hubbard, Senior Associate Commissioner
Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition
L. Robert Lake, Director, Regulations and Policy
² Consistent criteria for "GM-free" claims used in advertising should be developed by the Federal Trade Commission.
¹ A copy of each document is enclosed.