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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM’s Bioengineered Feed Regulatory Program

by W. D. Price, Ph.D.
FDA Veterinarian Newsletter September/October 2003 Volume XVIII, No 5

FDA has the responsibility under the Federal Food, Drug, and Cosmetic Act (the Act), to ensure the safety of all domestic and imported foods intended for human or animal consumption.

CVM partners with the Center for Food Safety and Applied Nutrition (CFSAN) in the FDA regulatory program for foods derived from new plant varieties that includes those developed using the tools of modern biotechnology. These products are also known as genetically engineered or bioengineered foods. Within FDA, CFSAN oversees bioengineered plant products or ingredients intended for human consumption, while CVM plays a similar role when these plant products are used as or in animal feed. Bioengineered foods and food ingredients must adhere to the same standards of safety under the Act that apply to their conventionally bred counterparts. This means that these products must be as safe as traditional foods in the market. FDA has broad authority to initiate regulatory action if a product fails to meet the requirements of the Act.

The United States Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) also regulate new plant varieties. When a bioengineered plant contains a pesticide, it is regulated by EPA, which reviews the safety of the pesticide substance. When necessary, EPA establishes tolerances for pesticidal residues in food or exempts a pesticide from the requirement for a tolerance. FDA enforces these pesticide tolerances in food products. USDA’s Animal and Plant Health Inspection Service (APHIS) oversees the agricultural and environmental safety of bioengineered plants during planting and field testing.

CVM and CFSAN have established a consultative process to help developers of new plant varieties comply with the Act’s requirements for new foods, including those obtained using biotechnology. Companies have used the consultative process more than 50 times as they sought to introduce genetically altered plants representing 10 different crops into the U.S. market. FDA is not aware of any bioengineered food product on the market under FDA’s jurisdiction that has not been evaluated by FDA through the consultation process.

Typically, a consultation begins early in the product development cycle, before a new variety is ready for marketing. Company scientists and other officials meet with FDA scientists to describe the product under development and often present an anticipated research program. CVM and CFSAN may offer advice on what analyses are appropriate to assess the safety of the bioengineered food.

After the studies are completed, the data and information on the safety and nutritional assessment of the new variety are provided to FDA for review. FDA evaluates the information for all of the known hazards and also for potential unintended effects on plant composition and nutritional properties, since the varieties may contain changes other than those intended by the firm. Specifically, FDA scientists evaluate whether the newly expressed compounds are safe for food consumption, there are no allergens new to the food, no increases in natural toxicants levels, and no reduction of important nutrient levels. They also determine if the food has been changed in any substantive way such that it would need to be special labeling to reveal the nature of the change to consumers.

Some examples of the information reviewed by FDA include: The name of the food and the crop from which it is derived; the uses of the food, in both human food and animal feed; the sources, identities, and functions of introduced genetic material and its stability in the plant; the purpose or intended technical effect of the modification and its expected effect on the composition or characteristic properties of the food or feed; the identity and function of any new products encoded by the introduced genetic material, including estimates of concentration; comparison of the composition or characteristics of the bioengineered food to that of food derived from the parental variety or other commonly consumed varieties with special emphasis on important nutrients, anti-nutrients, and toxicants that occur naturally in the food; information on whether the genetic modification altered the potential for the bioengineered food to induce allergic responses; and, other information relevant to the safety and nutritional assessment of the bioengineered food.

If questions arise about the data provided for a variety, the company may provide a more detailed explanation of a particular issue or may conduct additional studies. FDA’s experience has been that no bioengineered product has gone on the market until issues have been resolved.

FDA proposed on January 18, 2001, to replace the voluntary premarket notification program with a mandatory process. More than 100,000 comments were received, and FDA is evaluating the comments. FDA also published on January 17, 2001, a draft guidance document for food manufacturers who wish voluntarily to label their products as to whether they contain bioengineered ingredients or not. The guidance applies to both human food and animal feed. In making these changes, FDA hopes to enhance public confidence in the way in which bioengineered foods are regulated.

FDA also is augmenting its food and veterinary medicine advisory committees by adding scientists with agricultural biotechnology expertise. FDA will use these committees to address over-arching scientific questions pertaining to bioengineered foods and animal feed.

FDA is actively participating in the international harmonization work such as the Codex Committees on food labeling, and the “Ad Hoc Committee on Foods Derived from Biotechnology.” The latter committee is especially important because its initial focus is to develop principles and guidelines for the evaluation of the safety of bioengineered foods. CFSAN and CVM are also providing leadership in the Organization for Economic and Cooperative Development (OECD) Task Force on Food and Feed Safety. This Task Force is developing Consensus Papers for use by international bodies regulating bioengineered food and feed.

For more information on CVM consultation process for bioengineered feeds derived from plants, contact W. D. Price, Ph.D. at HFV-220, 7500 Standish Place, Rockville, MD 20855, Telephone 301-827-6652. Email Bill.Price@fda.gov, or visit the CVM's website and www.fda.gov/cfsan.

Dr. Price is a Special Assistant in CVM’s Division of Animal Feeds.