Comments to the FDA on "Biotechnology for the Year 2000 and Beyond"

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The Biotechnology Industry Organization (BIO) commends the Food and Drug Administration (FDA) for conducting three public meetings in November and December of 1999 which addressed "Biotechnology in the Year 2000 and Beyond". BIO also appreciated the opportunity to participate on both the Food Safety and Public Information panels at FDA's first public meeting in Chicago, Illinois. From our perspective, it was reassuring to note that in none of the recent FDA public meetings were any new issues identified. In preparation for the first meeting, BIO submitted written remarks that addressed the questions FDA posed to the public concerning plant varieties improved through the use of biotechnology . The following comments are central to ensuring public confidence in the safety of products that have completed the FDA review process.

Transparency
BIO strongly encourages FDA to make more information available to the public regarding the consultation process and the testing of food and feed products improved through biotechnology. The information should be made available through a number of venues such as FDA's Web site, brochures, pamphlets, and articles in the media.

BIO also urges FDA to provide more information to the public about the implementation of its policy. For example, once a company has completed the consultation process, information should be posted on FDA's web site describing the new product. The listing should include the numerous tests routinely conducted and a summary of the data submitted, results of the review of the product by FDA advisory committees, and information provided to the company indicating the consultative process has been completed. We strongly urge FDA to make information easily accessible by the public and in a manner consistent with the generally accepted standards for safeguarding confidential business information.

Labeling
We agree with FDA's implementation of the 1992 policy that requires labeling for significant changes including nutrients or the introduction of allergens. The Food, Drug and Cosmetic Act allows food producers to provide choices through voluntary label statements as long as labels are truthful and not misleading. If food companies were to pursue voluntary labeling, FDA should help by establishing uniform guidelines or criteria to ensure that consumers can continue to rely on labels for accurate information. Furthermore, FDA and the Federal Trade Commission must assure that the public is not mislead by packaging or advertising that would in any way suggest or imply products developed using biotechnology are less safe.

Changing policy to require special labeling for foods derived from biotechnology, where there have been no significant compositional changes related to nutrition or safety, could significantly impact consumer perception of the safety of these foods. It would also undermine the confidence consumers presently have in the information for which they look to food labels. Such a policy could impair the long-term viability of this important technology which has the potential to provide safer and more nutritious food, reduce costs and increase productivity, thereby enabling our ever-increasing population to be better fed.

A sound labeling policy can and should recognize the rights of consumers to a safe and nutritious food supply, while facilitating consumer choice based on clear, meaningful, truthful and non-misleading information about the product. We urge the FDA to work closely with BIO and other stakeholders to develop standards the industry could use in providing such information to consumers.

Consultations
The FDA consultation process has been successful because it has provided a mechanism to ensure that all relevant scientific, safety and regulatory issues are resolved prior to commercial distribution of foods produced from biotechnology-derived plant varieties. The FDA flow charts provide a decision tree approach that focuses on key safety considerations. The decision trees are consistent with over ten different authoritative bodies, international guidelines and recommendations from such renowned institutions as the World Health Organization, Food and Agriculture Organization, Organization for Economic Cooperation and Development, International Life Sciences Institute, and the International Food Biotechnology Council. The decision trees provide a workable process for conducting the safety assessment required for all new food products under federal law. Under the Federal Food, Drug and Cosmetic Act, agricultural biotechnology developers have an obligation to ensure that the commodities utilized and the foods available to consumers are safe and in compliance with applicable legal requirements.

The current policy, developed 15 years ago, originated with full public input and participation which included implementing the Coordinated Framework, effectively using the advice of the FDA Food Advisory Panel, and holding many public meetings. During the past 15 years, FDA has provided numerous opportunities for public comment and input to assure the concerns of all stakeholders have been heard and addressed.

FDA has shown that it is committed to an interactive consultation process. The process is flexible to enable a case-by-case assessment that anticipates new products and methods. It also has leveraged the experience gained in completing consultations on over 40 products to date.

The agricultural biotechnology industry is totally committed to developing safe and nutritious crops that are trusted and valued by consumers, farmers and food companies. The FDA consultation process, together with the regulatory reviews conducted by EPA and USDA, are critical to establishing and maintaining this trust.

Farmers, our immediate customers, need the assurance that these products are safe and nutritious when they make decisions on planting and marketing. Our industry also understands that food companies and our ultimate customer, the consumer need the assurance that these crops and derived food ingredients are safe. The FDA safety assessment requirements and consultation process provides this assurance. We believe the current science-based and flexible process should continue and at this time should not be subject to any "sunset" provision.

Thank you for the opportunity to provide comments on FDA's current policy.

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