From: gainsforth@knowledgeworkers.com Sent: Thursday, February 08, 2001 10:49 AM To: fdadockets@oc.fda.gov Subject: Oppose FDA's New Regulations on Genetically Engineered Food Guy Gainsforth 666 Weston Road Larkspur, CO 80118 gainsforth@knowledgeworkers.com RE: Docket No. 00N-1396, and 00D-1598 Dear FDA, I am very concerned regarding the new policies on genetically engineered (GE) foods. A lack of safety testing and mandatory labeling for GE foods, as well as the "notification policy" you have proposed does not go far enough in protecting the consumers. How many products have we seen over the years that come back to haunt us, through improper testing, labeling, and just a naïve sense that our science is infallible? At this point, there is no possible way we can know the effects of the GE science, not just on the consumers, but also the environment. I have spent 20 years in the manufacturing industry, including automotive safety and aerospace, and it would always amaze me at just how often a well documented process would be bypassed because of ship dates, financial considerations, or just middle management making a decision on their own that certain steps just were not required…in his or her opinion. A documented process is only used when it is financially convenient. Time after time, I watch people side step procedure. Fortunately, there were systems in place that seemed to catch any problems before they got out to the public. However, you cannot count on this. A prime example, Starlink corn in the Kraft foods. There is no doubt in my mind that the corn is 100% safe, but that's not the problem. The system failed allowing an unapproved GE product entered our food chain. That was (hopefully) a relatively safe product--what about those development products we don't know about? I, like many others, see great promise for GE products…down the road. We do not know the effects of this science yet 100% of the time. If a tire fails, there could be an accident. A bad chip, a broken computer. However, with this new and potentially wonderful science, we do not know the effects yet. We can't. This is why I feel the FDA, consumers, and the corporations wishing to market this cannot take the short, easy road. People have a right to know what is out there and that manufacturers are using the STRICTEST guidelines development, production, and in process practices. To do less could result in an incredible catastrophe. I'm sure it will cost more for the product, but if it is as good as manufacturers claim, people will by the product. Look at organic; it is a huge industry, and yet those products cost more. I ask you to please reconsider this entire subject create guidelines from the expertise and concerns from you, the companies involved, and consumer groups. Without this equal partnership, our children could end up with one more mess to clean up due to our lack of vision. Sincerely, Guy Gainsforth Guy Gainsforth