From: Richard Burmeister [rishib@lisco.com] Sent: Friday, March 23, 2001 11:30 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 Dear Sir or Madam, The FDA absolutely must: 1) Require mandatory pre-market comprehensive environmental review of GE products. 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. 2) Require mandatory pre-market long-term health testing of GE products. GE products could be toxic, cause allergic responses, have lower nutritional value, and compromise immune responses in consumers. 3) 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. 4) 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. To do anything less would be a complete abrogation of your responsibilities. In fact, it would be criminally negligent. The FDA's current reckless and dangerous disregard for the safety of the people of the United States of America must stop. Wake up now before any serious damage is done. Sincerely, Richard Burmeister 1120 E. Madison Avenue Fairfield, Iowa 52556