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FDA Releases New Biotech Rules.

The FDA announced proposed rules governing the approval of foods derived from biotechnology, making mandatory the current voluntary consultative procedure and issuing guidelines for producers who want to label products that contain no genetically modified ingredients. There is a 60-day comment period before the changes take effect.

Companies selling genetically modified foods or ingredients would need to notify the FDA of any new bioengineered or genetically modified (GM) crop at least four months before the resulting products are available to consumers, and to submit data showing the product to be safe. The FDA would then review the company-supplied information and, if it had no concerns, issue a letter of approval. While EPA will make all company supplied information available to the public, the proposed rule warned that proprietary information would continue to be protected. Companies working on a new bioengineered food will be encouraged to participate in a pre-submission consultation program, under which they would write to FDA and ask to consult about a bioengineered food.

Because FDA considers most GM foods to be substantially equivalent to their conventional counterparts, the agency again declined to require bioengineered products to undergo the same extensive premarket approval process required for food additives, or to require bioengineered products to be labeled. In fact, the guidance states that it might be misleading for companies to use the terms "not genetically modified" and "GMO free," because "most, if not all, cultivated food crops have been genetically modified." A claim of being "free" of genetically modified ingredients would require the establishment of a threshold above which the claim may not be used, and no such threshold currently exists. "The agency suggests that the term 'free' either not be used in a bioengineering label statement or that it be in a context that makes clear that a zero level of bioengineered material is not implied," the guidance states.
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Publication:Food & Drink Weekly
Geographic Code:1USA
Date:Jan 22, 2001
Words:311
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