From: Center for Food Safety [action@foodsafetynow.org] Sent: Wednesday, February 14, 2001 3:57 PM To: FDA Commissioner Cc: president@whitehouse.gov; vice.president@whitehouse.gov; fdadockets@oc.fda.gov; fdadockets@oc.fda.gov Subject: Oppose the New FDA Regulations on GE Foods! FDA Commissioner Dockets Management Branch (HFA 305) Food and Drug Administration 5630 Fisher's Lane, rm. 1061 Rockville, MD 20852 RE: Docket No. 00N-1396, and 00D-1598 Dear FDA, I am outraged by your new policies on genetically engineered (GE)foods. Despite overwhelming consumer demand, your agency still fails to require safety testing and mandatory labeling for GE foods. Your “notification” policy is an insult to consumers, and irresponsibly ignores strong scientific evidence of numerous potential health and environmental risks to GE foods. You should be aware that these foods could be toxic, could cause allergic responses, could have lower nutrition value, could compromise immune responses in consumers, and could cause irreparable damage to the environment. I am also greatly opposed to your new “voluntary labeling” policy, which denies consumers a basic right to know. 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 will also be deprived of the critical knowledge they need to hold food producers liable should any of these novel foods prove hazardous. Your agency admits to receiving more than 50,000 comments last year regarding genetically engineered foods. You concede: “Most of the comments that addressed labeling requested mandatory disclosure of the fact that the food or its ingredients was bioengineered or was produced from bioengineered food.” Yet you ignore the will of the public saying the comments “did not provide data or other information regarding consequences to consumers from eating the food.” The truth is there has been ample evidence submitted to the FDA revealing that these foods are NOT “substantially equivalent “ to non-genetically engineered foods. Yet your agency continues to ignore this evidence. Studies have shown that biotech soybeans contain altered levels of nutrients such as isoflavones. They have been shown to have higher levels of Kunitz trypsin inhibitor, a known antinutrient and allergen. Genetically engineered foods contain antibiotic marker genes and many contain built-in pesticides. These are not found in non-genetically engineered foods. I do not want to eat these biotech foods, but without mandatory labeling I have no choice. Last year, Monsanto admitted to finding “unexpected gene fragments” in their genetically engineered soybeans. What other “unexpected gene fragments” are contained in other genetically engineered foods? The truth is that the FDA does not know, because these experimental foods have not been adequately tested. New proteins never before consumed by humans are being created and brought to market without any extensive tests being done to show that they are not causing allergies, cancer or other diseases. In the case of genetically engineered foods, the FDA has done a poor job of protecting the safety of consumers. Please remember that the potential allergies created by the ingestion of StarLink corn completely escaped the FDA regulatory guidelines. It was the EPA that discovered the digestive problems associated with StarLink corn. The FDA has been accused of being a pawn of biotech industry. It is documents such as your Draft Guidance for Industry that leads many to feel this belief holds some truth. In your Draft Guidance you question whether manufacturers who choose not to use genetically engineered ingredients should be able to label their products as GMO Free. It is bad enough that the FDA does not require the mandatory labeling of genetically engineered foods. Now your agency even seems to be exploring the idea of restricting the ability of a manufacturer to let consumers know the products are not genetically engineered. Such regulatory restrictions would be an outrageous act of censorship by the FDA. Genetically engineered foods are required to be labeled in the European Union nations, in Japan, Australia, New Zealand and other countries. Recently, both the E.U.-U.S. Biotechnology Consultative Forum and the Consumer Federation of America recommended mandatory labeling of genetically engineered foods. The FDA should stop working on behalf of the manufacturers of genetically engineered foods and begin to work for the safety and rights of the American public. I insist that genetically engineered foods be labeled! Your proposed rules ignore serious concerns, and appear to be a decision made to convenience industry at the expense of public health and the environment. I will not accept your attempt to make me a guinea pig of these untested foods, and I trust you will take my concern along with the thousands of others into serious consideration. Sincerely, Annalee Letchinger Annalee Letchinger 6711 N. Ashland Chicago, IL, 60626 CC: The President Vice President Dick Cheney FDA Dockets Management [Docket No. 00N-1396] Senator Richard J. Durbin Senator Peter Fitzgerald Representative Janice SchakowskyFDA Dockets Management [Docket No. 00D-1598] To the recipient -- this fax/email message has come to you via the Center for Food Safety web site -- a public tool for providing input on food safety issues. The user/site visitor had complete control over editing the content of this message. Thus, the opinions expressed in this message are not necessarily those of CFS or its parent organization, ICTA. Please contact CFS at (202)547-9359 or email office@centerforfoodsafety.org with any questions. Thank you. ___________________________________________________________________________ This letter was composed at www.foodsafetynow.org, a web site maintained by: The Center for Food Safety, 666 Pennsylvania Ave, SE, Suite 302 Washington, DC 20003 PH: (202)547-9359 Fax: (202)547-9429 Email: office@centerforfoodsafety.org web: www.centerforfoodsafety.org