From: Barbaray [barbaray@open.org] Sent: Friday, March 23, 2001 9:59 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 I am very concerned that the FDA proposes to allow the marketing of genetically engineered (GE) foods without environmental or health testing and without labelling to allow consumers to make up their own minds about whether to eat products with GE foods in them. I believe that: * 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. Please reconsider your proposed rules and strengthen them with the above provisions. Thank you. Sincerely, Barbara F. Ciaramitaro 1317 Chemeketa NE Salem, OR 97301-4152