From: Mark Sorensen [msorens1@ci.tucson.az.us] Sent: Monday, March 26, 2001 10:08 AM To: fdadockets@oc.fda.gov Subject: Docket OON-1396 & Docket OOD-1598 Following are my opinions as a citizen. Please take these into account in making your decisions regarding the referenced docket items. Thank you. 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. Genetically engineered products could be toxic, cause allergic responses, have lower nutritional value, and compromise immune responses in consumers. The FDA must require mandatory labeling of genetically-engineered 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. In order to eliminate illegal conflict of interset, the FDA must end its cozy relationship with the industries it purports to be regulating. The FDA should disallow the current practice of allowing people 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. It is time for the FDA to accomplish its true mission of serving the people rather than business interests in conflict with the public good. Mark Sorensen 6020 West Potrillo Place Tucson, AZ 85743 marksbfl2000@netscape.net -- MZ