03 May 2000

Biotechnology Initiative Expands Regulatory Process

By Merle D. Kellerhals, Jr.
Washington File Staff Writer

Washington -- A new initiative launched by the Clinton administration to enhance the regulation of genetically modified foods reaffirms the U.S. government's support for a science-based regulatory approach to agricultural biotechnology, a White House statement says.

The initiative announced by the administration May 3 strengthens the oversight roles of the U.S. Department of Agriculture (USDA), Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), which are the key agencies directly charged with regulating biotechnology, the White House said in its announcement. The initiative enhances "public education and outreach" of all the agencies involved in the regulatory approach, the statement said.

One aspect of the seven-part initiative calls for the Council on Environmental Quality (CEQ) and the Office of Science and Technology (OSTP) to conduct a six-month assessment of U.S. environmental regulations related to agricultural biotechnology, the statement said. If the researchers consider the environmental regulations inadequate, then they will make recommendations to improve them, administration officials said.

Also under the plan announced by the administration:

• FDA will require the U.S. food industry to give it notification four months in advance of the introduction of any new genetically modified (GM) food products. The information submitted by the food producers along with the FDA's conclusions will be made available to the public. Previously, the food industry was simply requested to give voluntary notification to FDA.

• USDA, FDA and EPA will launch an expanded program of peer-reviewed research that focuses on current and future safety issues surrounding genetically engineered foods.

• FDA will develop guidelines for the voluntary labeling of foods that will indicate whether the food product contains genetically engineered ingredients. The guidelines will spell out exactly how ingredients will be identified in a truthful and unconfusing way.

• USDA will work to develop new testing methods and procedures for detecting the presence of genetically engineered ingredients in foods. These new testing methods will be certified by USDA and possibly an outside source to verify accuracy.

• USDA, FDA, EPA and the U.S. Department of State will expand existing public education and outreach programs for domestic and foreign audiences to improve understanding of how the U.S. food safety regulatory process works and the roles of the key agencies.

• Finally, the initiative requires USDA to provide farmers with reliable market access information for making decisions about what to plant -- with guidance on specific types of new crops and varieties.

Additionally, the Clinton administration said the United States -- in announcing this new initiative -- was not embracing the "precautionary principle" that has been proposed by the European Union and others in the global regulation of genetically engineered foods. Some governments employ the precautionary principle to block food imports even when no scientific evidence has shown that the food harms humans or animals.

The United States opposes the "precautionary principle," the statement said, because of its vague definition and departure from science-based criteria in international standards. The concept could become an arbitrary and political means of excluding imported products for any reason, it said.

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