From: John Tracy [jtracy@carolina.rr.com] Sent: Sunday, March 25, 2001 9:09 AM To: fdadockets@oc.fda.gov Subject: GE products To whom it may concern, I am a physician practicing Family Medicine in North Carolina. Please heed the increasing public concern over the safety of genetically engineered foods. While there are powerful economic interests at work, the addition of an entire class of food to the public domain is an issue requiring careful scrutiny. It is imperative that the FDA follow the dictum, "First, do no harm." There are numerous historical cases in which man's well-intentioned, but poorly conceived manipulation of the environment has led to extensive physical and economic suffering. In particular, it would be advisable to do the following before GE foods are allowed into the general market: 1. Require safety testing, in humans, after appropriate initial testing, for each individual genetically engineered product. 2. Require a careful environmental impact assessment for each individual genetically engineered product. 3. Use large enough samples to detect uncommon, but significant problems. If any food is approved, this food should carry mandatory labeling indicating the type and degree of genetic modification as well as a warning label addressing any threat to sensitive individuals. This labeling should be of the type used in labeling drugs and should list allergy information, any known food-drug or food-food interactions, and anything else unique to the product. While the media can cloud technical issues such as this one, objective information should be made public prior to the official sanction of GE foods. Thanks for your diligence, John W. Tracy, MD