January 18, 2001

The Food and Drug Administration Wednesday issued a proposed rule that would require food developers to notify FDA at least 120 days in advance of their intent to market a food or animal feed developed through biotechnology and to provide information to demonstrate that the product is as safe as its conventional counterpart. In a separate but related action, FDA is issuing a draft guidance document that would provide direction to manufacturers who wish to label their food products as being made with or without ingredients developed through biotechnology.

"These initiatives will further assure that all food products developed using the tools of modern biotechnology are known to the Food and Drug Administration, so that FDA can continue to examine these products before they reach the market" said Jane E. Henney, FDA commissioner. "These measures will permit the review process to be more transparent to the public, one of the primary issues voiced during FDA's public hearings on this issue."

Currently, developers of food and feed developed through biotechnology participate in a voluntary consultation program with FDA. To date, all such food and feed marketed in the U.S. have gone through the consultation program before they have entered the market.

Although FDA says this voluntary consultation process has worked well since its inception in 1994, a series of FDA-sponsored public meetings and subsequent written public comments indicated considerable public support for a mandatory and more transparent process. The proposed rule announced today, would, if finalized make mandatory pre-market consultation for bioengineered foods and feeds.

In addition, consistent with applicable disclosure rules, FDA intends to post information submitted by manufacturers, as well as FDA's responses, in the agency's electronic reading room. This information can be reached through FDA's Website at www.fda.gov/foi/electrr.htm. This proposed rule can be accessed at www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm.

Written comments on the proposed rule to require premarket notification may be submitted by March 28, 2001 to Dockets Management Branch (HFA-305), Food and Drug Administration 5630 Fishers Lane, Rm. 1061, Rockville MD 20852.

Written comments on the information collection provisions of the proposed rule may be submitted by February 12, 2001 to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 724 17th St. NW, rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA.

A copy of the draft guidance on labeling bioengineered foods is available on the Internet at www.cfsan.fda.gov/~dms/guidance.htm. It also may be requested by calling 202-205-4561, faxing a request to 202-205-4594, or writing to the Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St., SW, Washington, D.C. 20204 (enclose a self addressed label or include a fax number with the request).

To ensure adequate consideration, written comments on the labeling guidance should be submitted by March 13. However, comments on the guidance may be submitted at any time. Written comments concerning the collection of information provisions of the draft labeling guidance may be submitted by March 13. All comments on the draft guidance may be submitted to the Dockets Management Branch at the address above.

Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO), said the FDA announcement "is another milestone towards maintaining consumer confidence in and support for biotechnology as an essential tool in modern food production."

The "increased openness and accountability that will flow from the changes ‘ FDA announced provide "renewed grounds for the confidence American consumers have in our food supply and the regulatory system to ensure its safety. The U.S. regulatory system is a model around the world because it is grounded in science, not superstition, or uninformed emotion."

Michael F. Jacobson, executive director of the Center for Science in the Public Interest, called the actions "modest steps in the right direction for increasing public confidence in genetically engineered foods."

A mandatory review would help ensure that such foods are safe, and voluntary labeling should help consumers who want to buy non-engineered foods, he added. "To foster greater public participation in the debate over genetic engineering, the FDA should take the additional step of announcing in the Federal Register all notifications of new products, detailed explanations of final decisions, and opportunities for public comments."

Rep. Dennis J. Kucinich (D-OH), however, blasted the proposal. It "does nothing to protect the health and safety of consumers," he said. "It seems the aim of this proposal is purely public relations. It tries to convince consumers that their government is protecting them. In fact, the government is protecting industry."

Kucinich believes FDA's actions avoid "real consumer choice" with voluntary labeling and substitutes mandatory safety testing "with meaningless notification and consultation. This results in a proliferation of genetically engineered food in the grocery store without assurance that the food is safe."