From: Mitchell M. May [mmay@lasal.net] Sent: Monday, March 26, 2001 11:27 AM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 Dear FDA, As both a consumer (and parent of two) as well as a scientist with my training in experimental research design, I am very concerned by what appears to be the highly skewed position the FDA is taking when it comes to your proposed position and labeling with GE items. From an unbiased science point of view (what other kind of science should there be) the FDA's position on GE foods in particular would never be accepted in any research program I have ever been a part of, and any "scientist" one who took such a premature position as the FDA has, would be severely reprimanded for showing a bias prior to proper studies, controls, and controls being demonstrated. With such severely deficient and insufficient studies on introducing GE foods into the human food chain, it is without proper and adequate knowledge and without precedent in this current age of science that such a widespread introduction into the human food chain should be allowed. I remain very hopeful that the potential promises of GE foods will indeed be realized for the needs of our developing world. However, we must be certain we fully understand and can control all the aspects of the GE process and all the possible ramifications of it. It is extremely concerning that we are far from understanding the entirety of letting GE foods into the food chain, and yet there has been an "extra allowance" in the FDA supporting their release without the science any where near complete. Unfortunately, of course everyone assumes a political and economic bias that would allow such to occur, how else is one to view this, given no other lobby or interest would ever be granted such a premature release. If this is going to be your position, then it is totally irresponsible on the other side to not let consumers have complete and full information for them to make up their own mind as to whether they wish to consume GE foods or not. Consumers have a right and the FDA has a mandate to give full and unbiased facts to consumers as to whether that food or product has or does not have GE factors within it. It is not for the FDA to decide what consumers should and should not know, any withholding of such information can only be for some bias or position, any of which is unethical. Even if consumers make a decision to not purchase GE based on their own bias, misinformation or bad science, that is not for the FDA or any other government body to interfere with, that is the right of the consumer alone. You must as a bare minimum both require all GE containing foods to be labeled as such and likewise to allow all foods not containing GE to be labeled as such. Your reasoning that companies not be allowed to label foods as non-GE is clearly stretching logic and is again a bias that leads one back to economic interests and not science or the will of the public. What is there to fear in giving people the choice, why are you intent on controlling information and not allowing the public to decide for themselves. You are shooting yourselves in the foot as the public sees the FDA as taking sides in this debate, and if the FDA is to retain any credibility it must require solid and sufficient science regarding GE foods and it must allow the public to be fully informed on what GE foods they are purchasing and feeding their families. I am concerned that GE foods will actually have a huge set back if they are jammed down the peoples throat and not dealt with full disclosure and integrity. Sincerely, Mitchell M. May, Ph.D.