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FDA to Issue Guidelines On Evaluating Biotech Food

By Michael S. Rosenwald
Washington Post Staff Writer
Wednesday, November 24, 2004; Page E01

The Food and Drug Administration will publish draft guidelines today that would encourage companies to submit voluntary safety evaluations of bioengineered food crops that sometimes drift and cross-pollinate with plants in nearby fields.

The biotech industry welcomed the new approach, but environmental and food-safety advocates called it a poor substitute for the rigorous testing they have sought before the planting of scientifically engineered crops that could enter the nation's food supply.

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"This doesn't get us on the road to full mandatory testing, which is what we've been saying is needed," said Joseph Mendelson III, the legal director at the Center for Food Safety. "It's trying to put a Band-Aid on problems that need a wholesale fix."

The current system encourages companies developing a bioengineered food crop to consult with the FDA early in its development on possible scientific and regulatory issues. Under the new FDA guidelines, which are to be published today in the Federal Register, companies also would be asked to conduct a voluntary safety evaluation and submit it to the agency.

Critics of bioengineered crops have called instead for full-scale, mandatory safety testing and prohibiting the introduction of new biotech foods without detailed FDA certification that they are safe.

FDA officials said the new, voluntary guidelines will give regulators a more detailed and advanced understanding of bioengineered crops should they become cross-pollinated with material entering the food supply.

The agency said in a statement that its policy is to encourage "communication early in the development process for a new plant variety." But the FDA added that it "has not found and does not believe that new plant varieties under development for food and feed use generally pose any safety or regulatory concerns."

Michael J. Phillips, a vice president with the industry's largest trade group, the Biotechnology Industry Organization, welcomed the new guidelines, saying member companies have always communicated extensively with the FDA.

For a number of years, biotechnology companies, their critics and the FDA have wrestled behind the scenes over how the government should regulate plant varieties that are being genetically engineered.

The prospect of bioengineered food crops has caused controversy in the United States, and the idea has met strong consumer resistance in Europe. That has made the American food industry concerned about its export markets.

In 2000, a genetically modified corn seed called Starlink mixed with other varieties of corn and forced several food companies to recall products. A worldwide drop in corn prices followed. Farmers and consumers sued Starlink creator Aventis SA and other companies involved with its development and distribution. The consumers said Starlink caused allergic reactions.

Mendelson said the new guidelines "are preparing us for the inevitable situation where more Starlinks happen. Essentially, the FDA is acknowledging that it will happen again."

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