From: Lissa E. Harris [leh24@cornell.edu] Sent: Tuesday, April 03, 2001 9:55 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 Dear Sir or Madam, I am writing to comment on the proposed rules for genetically-engineered (GE) foods. I am very concerned by the FDA's apparent disregard for the potential (and actual) hazards of GE food. As a consumer, I have no power to decide whether or not to consume GE food, which is not tested to ensure that it will not have negative effects on my health or the environment. I believe that most Americans would agree that it is reasonable for companies to be required to tell consumers whether or not their products are genetically engineered, so that we would be able to make an informed choice about buying them. I urge you to incorporate the following considerations into your proposed regulations. * 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 irreparable damage. * 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. * 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 they need to hold producers liable should any of these novel products be hazardous. * FDA must end its cozy relationship with industries it purports to be regulating. People have been allowed to work for a biotech company, then work for FDA writing the regulatory rules on that company's product, then go back to working for the company. 92% of FDA advisory committee meetings had at least one conflict of interest. This is a matter of grave importance to me and to millions of Americans. Please do not continue to ignore legitimate public concerns about safety in the interest of the biotech industry's bottom line. Sincerely, Lissa E. Harris 433 1/2 N. Aurora St. #2 Ithaca, NY 14850