U.S. Government Regulation of Food Biotechnology

The food industry stands behind food and food products that have been improved through biotechnology and ensures that they meet all federal requirements for quality and safety. The U.S. government plays an essential role in maintaining the public's confidence in the safety of the food supply. The public's continued confidence concerning plant biotechnology ultimately flows from a system of comprehensive regulatory reviews and oversight of developments in biotech crops based on sound science, transparent decision making and public involvement. This system has been in place for more than a decade.

Three federal agencies are involved in reviewing advances in plant biotechnology and together provide a coordinated framework to ensure human and environmental safety. Their responsibilities are:

FDA		Safety & labeling of whole foods, food ingredients and additives
USDA		Biotech plants; Field test inspection
EPA		Registration for use of pesticides and herbicides

Prior to commercialization, biotech-derived foods must also conform with federal marketing requirements, including seed certification laws, the Federal Food, Drug, and Cosmetic Act; the Federal Insecticide, Fungicide and Rodenticide Act; and the Federal Plant Pest Act.

U.S. Food and Drug Administration
Since 1992 the FDA has determined that foods from plants produced through biotechnology are, as a class, as safe as those from plants developed through conventional breeding, and should therefore be regulated the same as any other foods entering the market. Accordingly, the FDA evaluates the application of biotechnology to food products on a case-by-case basis, as it does with any other food.

Under the Food, Drug and Cosmetic Act, the FDA usually focuses on the product, the food, or food ingredients, rather than on the plant development processes used in their production, as the basis for regulation. The same holds true for food and ingredients derived through biotechnology. The FDA offers a series of testing procedures that enable food manufacturers to anticipate safety concerns and to consult with the FDA as necessary for regulatory review of new plant varieties and products testing under development.

The FDA assessment process focuses on the following areas:

FDA Assessment

Safety and nutritional value of newly introduced proteins Identity, composition and nutritional value of modified carbohydrates, fats or oils Concentration and bioavailability of nutrients for which food crop is consumed Potential for allergens to be transferred from one food source to another

To ensure safety, a variety of toxicological and other product safety data are supplied to the FDA for food products or ingredients produced through the use of new plant varieties. The FDA requires developers to notify the agency at least four months in advance of commercializing any biotech food or animal feed and does a thorough evaluation of the data. In practice, biotech companies have filed notices of commercialization long before the four-month minimum.

Labeling
The FDA's food labeling policy applies to all foods, including those developed through biotechnology, and is designed to ensure consumer safety and protection. Since 1992, the FDA has maintained that a biotech food or ingredient would require a specific label only if the food is substantially different from its traditional counterpart. As an example, biotech foods that contain higher levels of essential vitamins and nutrients or that have lower levels of saturated fat would require explanatory labeling.

Currently, biotech varieties of corn, cotton, soybeans, papaya and canola are commonly grown by American farmers and are prevalent throughout the food and feed supply. None of these crops are substantially different from their traditional counterparts, and therefore none require additional labels. The FDA also has developed draft guidelines for companies that wish to voluntarily label food products that do or do not contain biotech ingredients, so long as the label is not false or misleading.

U.S. Department of Agriculture
USDA and EPA currently have primary responsibility for assessing the ecological effects of new plants developed through biotechnology. The Animal and Plant Health Inspection Service within the USDA is the primary agency regulating the safety testing of biotechnology-enhanced plants that are not insect or disease-resistant. APHIS approval must be obtained before proceeding to field-test or commercialize a biotechnology-derived plant.

In order to test a biotechnology-derived plant in the field, applicants seek from APHIS an environmental release permit. Once testing is allowed, APHIS and state agriculture officials can inspect the test field throughout the process to ensure that tests are conducted safely.

Before biotechnology-enhanced crops can be grown commercially, a petition must be submitted to APHIS containing scientific details about the plant, results of field tests and any indirect effects on other plants. This petition is published in the Federal Register, allowing the public time to comment. When the USDA has determined that the product is safe for field use, it is approved for commercialization.

Environmental Protection Agency
In addition to APHIS, the EPA also regulates herbicides and has jurisdiction over crops that are insect and disease resistant under the Federal Insecticide, Fungicide and Rodenticide Act. Environmental exposures to pesticide substances produced in crops are regulated by the EPA to ensure that there are no unreasonable adverse effects on the environment, including non-targeted insects, birds, fish, deer and other species.

The EPA’s regulations focus on the pesticide produced by the plant, rather than on the plant as a whole. Such pesticides are subject to registration requirements similar to other pesticides. The agency requires developers of new plant-pesticides to obtain experimental use permits. Prior to any field testing, EPA officials must review and approve permit applications for genetically enhanced pesticides in crop plants containing pesticidal properties.

Conclusion
The safety of biotechnology has been supported by numerous national and international health organizations, including the American Medical Association, American Dietetic Association, United Nations Food and Agriculture Organization, and the World Health Organization. In April 2000, a review sponsored by the National Academy of Sciences and conducted by the U.S. National Research Council's Committee on Genetically Modified and Pest-Protected Plants found no evidence either that biotechnology foods were unsafe to eat or that their health and environmental risks differed substantially from their conventional counterparts.

While these endorsements are important indicators of the broad level of support for food biotechnology, the Alliance for Better Foods recognize that the basis of public trust in the safety of our food supply lies in transparency and openness in the government review process. It therefore supports an honest and open assessment of current food safety regulations and requirements governing the development of food biotechnology.

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