From: Leland Walmsley [lelandnwa@yahoo.com] Sent: Friday, December 17, 2004 4:49 PM To: Dockets, FDA Subject: RE: Docket No. 2004D-0369 Dear Commissioner Crawford, I am writing to express my disappointment at the FDA's draft "Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use." I am deeply concerned that these new guidelines are a step backward in strengthening public confidence in the regulation of genetically engineered foods. These new guidelines for genetically engineered crops still in testing would allow them to contaminate the nation's food supply with genetic material. Companies are encouraged to voluntarily seek safety review of genetically engineered traits that could escape field test plots and enter the food supply. Such review could have the effect of exempting such contaminants from being declared food adulterants under existing Federal food safety laws. The developers of biotech crops still in the testing phase now have no incentive to contain genetic pollution from whatever compounds they are engineering into crop plants. These guidelines also allow companies to voluntarily perform an abridged safety assessment of genetic material from biotech crops. This confidential, limited review would grant biotech crop manufacturers the legal cover to allow these engineered test crops to enter the American food supply prior to full government pre-market oversight and safety review. The proposed review involves no safety tests in animals, a standard method to test for toxicity. It also excludes testing for unintended effects caused by genetic engineering, and sets no limits for the amount of contamination of food allowed. I urge you to reject this misconceived policy. The FDA should be devising rules and procedures to STOP contamination of the food supply with experimental transgenic proteins, not give rubber stamp approval to such contamination when it occurs. Finally, I urge the FDA to replace its current non-rigorous "voluntary consultation" process with a mandatory, science-based review process designed to ensure food safety. Sincerely, NWA, Inc. Leland Walmsley - CFO Santa Barbara: 805-684-1718 Cell: 805-895-9520 -------------------------------------------------------------------------------- Do you Yahoo!? Yahoo! Mail - Easier than ever with enhanced search. Learn more.