08 May 2000

Text: FDA Announces Rules on Bioengineered Foods, Feeds

The U.S. Food and Drug Administration (FDA) will publish a rule requiring developers of bioengineered food and animal feed to notify the agency within four months of plans to market those products, the agency says.

"FDA will also require that specific information be submitted to help determine whether the foods or animal feeds pose any potential safety, labeling or adulteration issues," the agency said in an announcement May 3. The FDA announcement followed a Clinton administration announcement that it was enhancing the regulatory process for food and feed produced through agricultural biotechnology.

The agency, one of three federal agencies charged with the regulation of agricultural biotechnology, said it was also developing guidance to assist food manufacturers that want to voluntarily label their foods as made "with or without the use of bioengineered ingredients."

The rules and guidance were included in the administration initiative that aims to reassure U.S. consumers and those abroad that bioengineered food and animal feed from the United States are as safe as their non-bioengineered counterparts, said FDA Commissioner Jane Henney.

Following is the text of the FDA announcement:

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U.S. Department of Health and Human Services
FOOD AND DRUG ADMINISTRATION

Washington, D.C.

May 3, 2000

FDA to Strengthen Pre-market Review of Bioengineered Foods

The Food and Drug Administration (FDA) announced today plans to refine its regulatory approach regarding foods derived through the use of modern biotechnology. The initiatives unveiled stem in part from input received during FDA's public outreach meetings held late last year and build upon programs already underway at FDA to help ensure the safety of all foods.

"FDA's scientific review continues to show that all bioengineered foods sold here in the United States today are as safe as their non-bioengineered counterparts, "said Jane E. Henney, MD, Commissioner of Food and Drugs. "We believe our initiatives will provide the public with continued confidence in the safety of these foods."

FDA will publish a proposed rule mandating that developers of bioengineered foods and animal feeds notify the agency when they intend to market such products. FDA also will require that specific information be submitted to help determine whether the foods or animal feeds pose any potential safety, labeling or adulteration issues.

Although the current consultative process has worked well, and the agency believes it has been consulted on all bioengineered foods and feeds currently on the market, FDA will propose to strengthen this process by specifically requiring developers to notify the agency of their intent to market a food or animal feed from a bioengineered plant at least 120 days before marketing. After reviewing the company's submission, FDA will issue a letter to the firm describing its conclusion about the regulatory status of the food or animal feed. To make sure that consumers also have access to product information, FDA will propose that submitted information and the agency's conclusions be made available to the public, consistent with applicable disclosure laws, by posting them on the FDA Web site for easy viewing.

In a related step, the agency will augment 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 also announced today plans to draft labeling guidance to assist manufacturers who wish to voluntarily label their foods being made with or without the use of bioengineered ingredients. The guidelines will help ensure that labeling is truthful and informative. To receive maximum consumer input, FDA will develop the guidelines with the use of focus groups and will seek public comment on the draft guidance.

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