From: Tim/Barbara Murray [barbtim@mindspring.com] Sent: Monday, March 26, 2001 12:31 PM To: fdadockets@oc.fda.gov Dear FDA, I have strong opposition to the lack of safety inspections, testing, and consumer protections that are being allowed to occur in the area of Genetic Engineering (GE). I thought you were supposed to be the watchdog of health and safety for the consumer. With these new rules it certainly appears to me otherwise. In what other area would you ever permit such risks of unknown dangers to be approved without adequate testing and labeling. It is unthinkable that you would not set much stronger safe guards. Here are some of my specific suggestions (below). Please take my comments to your governing board. I speak for a number of my friends and colleagues. Thank you for your attention to this matter. Sincerely yours, Rev.Barbara Murray 1.. You must require mandatory pre-market comprehensive environmental review of proposed GE products and hybrids.. Unlike any other kind of previously known, conventional pollutants, where a given amount of pollutant causes a limited amount of damage, a small number of mutant genes could start a population explosion and reproduce forever, causing irreversible, unlimited and irreparable damage. Witness the runaway spread of AIDS, because the threat was initally underestimated.. Can anyone in authority, responsibly and honestly, attest that they are safe with certainty? Of course not. I would not want that onus on me. Do you? 2, You must 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. You have a long and illustrious history of thoroughly testing unknown commodites before allowing them to be released on unknowing and unwitting consumers. Why should GE products be different? 3. You must 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 or not. Consumers would be deprived of the critical knowledge needed to hold food producers accountable and liable should any of these new products be later found to be hazardous to our health. 4. Introduction of GE foods, etc., as a standard practice is an extremely massive change affecting probably everyone and likely to be irreversible, with permanent consequences (whatever they are) to everyone, now & forever. It's not an issue to be just blithely rubber stamped with "approval". 5. It's time for you to re-examine your conflicts of interest with some of the GE industries, etc., which you should be regulating much more carefully.. Some of your past employees have been allowed to work for 'GE' biotech companies, then work for you writing the very regulatory rules on that company's product, then return to work for the same company again. At a minimum, this is a dubious business practice, for you of all agencies who should operate above reproach. I'm told that 92% of FDA advisory committee meetings had at least one person attending who was allowed to make rulings in spite of some type of conflict of interest. While I admit that such dual loyalties are not in themselves necessarily harmful to the public interest, I must say that I have been disappointed to hear of your proposed positions in the GE controversy and of your standards of decision making. This could be a positive, turning point for you as an agency if you choose to seize this opportunity to self-police and revise these questionable practices. Please set the record straight, and please do the right thing in these upcoming hearings and rulings on GE that will determine our health and safety and that of our children for generations to come. We're counting on you to realize the very real seriousness of this threat and take appropriate action..