From: Grosshoppa@aol.com Sent: Sunday, March 25, 2001 7:43 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 To whom it may concern: While I am excited about the frontiers of genetic research and the answers (and relief) it will bring to many diseases, I have concerns regarding genetically engineered foods. I am not against these foods, but I feel that rigorous environmental testing is mandatory prior to marketing. Unlike conventional pollutants, where a given amount of pollutant causes a limited amount of damage, a small number of mutant genes could have a population explosion and reproduce forever, causing unlimited and irreparable damage. We may know what these mutant genes can do in the foods they are researched in, but species crossover, which is well-known to occur, may have a surprising and deliterious unexpected effect. The FDA must require mandatory pre-market long-term health testing. Genetically engineered products could be toxic, cause allergic responses, have lower nutritional value, and compromise immune responses in consumers. The FDA must require mandatory labeling of genetically engineered products. Without mandatory labeling, neither consumers nor health professionals will know if an allergic or toxic reaction was the result of a genetically engineered food. Consumers would be deprived of the critical knowledge needed to hold food producers liable should any of these novel products be hazardous. The FDA must end its cozy relationship with the industries it purports to be regulating. People have been allowed to work for a biotech company, then work for the FDA writing the regulatory rules on that company's product, then go back to working for the company. Ninety-two percent of FDA advisory committee meetings had at least one conflict of interest. Thank you very much for your time. Sincerely, Shirley Shelton Shirley B. Shelton, DVM, DACVIM (Neurology) Home: 528 Treymoor Lake Circle Alabaster AL 35007 Work: University of Alabama at Birmingham 1720 7th Ave South - SC 1061 -or- 1670 University Blvd - VH 406C Birmingham, Alabama 35294 Phone: (205) 934-3336 email: grosshoppa@aol.com