From: Shelley Koffler [shelley.koffler@us.brann.com] Sent: Monday, March 26, 2001 4:12 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 To Whom It May Concern, I am writing to express my OPPOSITION to the The Food and Drug Administration's proposed new rules on genetically engineered (GE) foods. I believe GE foods to be an unacceptable health risk. The long-term effects of eating GE food are unknown and potentially very dangerous. Enough reasonable doubt exists about GE foods' safety as to merit more research and testing before allowing them to be sold and consumed. The following points detail my stand on this critical issue: * 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. > >* The FDA 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. > >* The FDA 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. Consumers > would be deprived of the critical knowledge needed to hold > food producers liable should any of these novel products > be hazardous. > >* The FDA must 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 the opportunity to voice my opposition to the FDA's proposed new rules on GE foods and products. I hope that my opinion and others like it will help to disuade the FDA from proceding further with its proposed regulations concerning this matter. Sincerely, Shelley Koffler 7 Greenwich Place Baltimore, MD 21208