From: Ken Walton [kwalton@mum.edu] Sent: Saturday, March 31, 2001 2:00 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 FDA: As a Ph.D. trained in molecular biology, I am outraged by the failure of our government to protect its citizens from the dangerous products being produced by large corporations. The FDA has ceased to be a defender of public safety and is now merely a handmaiden to these corporations. Corporations are not interested in our safety or in the future of our country. The profit motive is their only law, and this is a great shame for humanity. We are the laughing stock of the world. Any half-educated individual can understand that there are major risks inherent in unnatural chemical substances and most of all in the artificial scrambling of genetic information. The potential dangers of these products to human health and the environment are well accepted by biologists around the world. It is largely only those who have direct or indirect corporate funding that are willing to ignore the high risks involved. Your new rules for regulating GE organisms and foods are a farce. If they are not overhauled to include real safety testing by independent laboratories and labeling of all products sold, whether seeds for planting or food constituents for human or animal consumption, I wager a year's pay that the day will come when people will compare our government with Hitler's, and the FDA with Auschwitz. Perish the thought! I am dead serious about this. If such a disaster is to be avoided, the FDA must: … Require mandatory pre-market comprehensive environmental review. 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. … Require mandatory pre-market long-term health testing. GE products could be toxic, cause allergic responses, have lower nutritional value, and compromise immune responses in consumers. … Require mandatory labeling of GE 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 producers liable should any of these novel products be hazardous. … 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 for waking up. Kenneth G. Walton 1000 N 4th Street Fairfield, IA 52557