From: Afschermaier@ra.rockwell.com Sent: Monday, March 26, 2001 4:29 PM To: fdadockets@oc.fda.gov Subject: dockets 00N-1396 and 00D-1598 Dear FDA Commissioner, The proposed Food and Drug Administration (FDA) regulations fail to require labels or safety tests on genetically engineered (GE) food. The new rules continue to deny Americans the right to know what is in our food, while protecting the economic interests of biotech corporations. The following is an article that I have submitted to a number of newspapers. I think it summarizes my feelings regarding GMO's and the government policies which are being developed to regulate them. The FDA exists to protect and serve the interests of the American people, not American business. I urge you to pursue policies which demonstrate this! Sincerely, Anton F. Schermaier Chesterland, Ohio If you were to learn that there was a conspiracy afoot, in which shady organizations with lots of financial clout, in collaboration with our government, were performing biological experiments on human subjects- on the American people-on your children-on YOU. Would you not be outraged and horrified? Though it sounds like The X-Files, it truly is happening. Granted, those organizations are not that shady, you may even own stock in them, yet they perform experiments on the world's food supply and tamper with our ecosystems in the name progress... But who's progress? Foods containing the products of genetically modified organisms (GMO's) are becoming increasingly common in our supermarkets. A GMO is any organism, such as a vegetable or bacteria that has had its original genetic makeup altered so that it exhibits some new desirable traits such as insect resistant corn or an insulin producing bacteria. I just read an article that praised the introduction of the first GM whole food product that entered the market in 1994-the Flavr Savr Tomato, which was "red, ripe, and able to stay that way during shipping." Strangely, they did not mention a recently discovered U.S. government memo dated 1993, that revealed an experiment in which 4 out of 20 female rodents who were fed this tomato, developed gross stomach lesions. Sure... but rats are not people-they have no business eating tomatoes anyway. And yet in the late 1980's, a company began producing the dietary supplement, tryptophan, using genetically engineered bacteria. Within several months, thousands of people who had been taking the supplement became ill. The final outcome: 37 dead, 1500 permanently disabled with neurological problems. At this stage in its development, genetic engineering is more of a black art than a science. Consider this computer programming analogy to gene splicing. A programmer wants to enhance the functionality of an application program. He doesn't have sufficient experience or understanding to write his own, so he copies the existing one. He locates several hundred lines of code from a different program that seem to do what he wants, and copies them into his program. If the program works after minimal testing, it's ready to sell and since it looks just like the old program, he's going to use the same version number. Consumers don't need to know that there's been a change. The program may in fact work fine-or it may erase your hard drive. Genetic engineering is a form of hi-tech hacking, only genes are being hacked instead of program code. My aim is not to tell horror stories about the evils of GMO's. Biotechnology has the potential to improve our quality of life like nothing else I know. Yet I find the cultivation of technology for its own sake and for the sake of profit alone, to be fundamentally wrong. Playing God with any technology that is not adequately understood or respected, is not only irresponsible and arrogant, it is stupid and dangerous. Proponents of GMO's clamor for consumer tolerance and a chance to work the bugs out of this new technology. To this I say: not without my consent. According to a Harris Poll conducted in Summer 2000, 86% of Americans agree with me, believing that the government "should require labelling of all packaged and other food products stating they include corn, soy, or other products which have come from genetically modified crops." Despite this overwhelming opinion, the FDA recently released its policy regarding genetically engineered foods. Neither labelling nor pre-market safety testing of GM foods will be required. The rigorous safety and toxicological testing required for all food additives will not be applied to GMO's. This means to me, that we have become the test subjects! Clearly, this policy is geared toward protecting biotech companies and food producers-not we, the consumers. GMO advocates, and our FDA wish us to believe that we have nothing to fear. Lest we forget, this is the same FDA which bestowed its blessing upon silicone implants and thalidomide. Where there is money to be had, there will always be panels of experts to provide the requisite safety assurances. The crux of my argument is this: I don't really I care if GMO's are safe. I demand the right to choose what I will or will not put into my body. It is as personal to me, as my choice of clothing, my spiritual beliefs, and my family traditions. No government organization or billion dollar biotech company should have the right to make that decision for me... or for you.