From: Center for Food Safety [action@foodsafetynow.org] Sent: Monday, March 19, 2001 3:49 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 March 19, 2001 Dear FDA, I am writing to extend remarks I submitted in a letter to this docket early this morning. In that letter, I advised your agency to modify its at least recent apparent nonchalance toward regulating foods whose safety is not fully ascertained, and for you to order a ban on the sale of all bioengineered food until and unless adequate human and environmental safety assessments of the process can be made. I felt it important for the record to make the case about my perception of your agency's recent past carelessness, to demonstrate the FDA's real need to reflect on and reinvigorate its role in protecting the public. I stated, "Previously, your agency has overseen and supported the growth of the Monosodium glutamate (MSG) and aspartate (a major ingredient in Nutrasweet) industries, also in the face of strong scientific opposition based on extensive research." Both are scientifically classified as excitotoxins for their potential to overstimulate particular neurons, to damage and death at times. While I proceeded to examine in depth FDA's troubling role in approving monosodium glutamate as a GRAS (generally recognized as safe) food, I neglected to explore your role in the approval of aspartate, another substance that occurs naturally in the human body. The circumstances surrounding your approval of this second substance, aspartate, strengthen the argument that the FDA has gone off course and needs to be proactive in the bioengineering realm. I again draw upon the book, "Excitotoxins" the Taste That Kills", by by Russell L. Blaylock, M.D., Health Press, Santa Fe, New Mexico, 1997. Prior to your approving aspartame in 1981, according to Blaylock, Nutrasweet's manufacturer, G.D. Searle, found in a rat study that the higher the rate of aspartame, the higher the incidence of brain tumors. When Dr. John Olney pointed this out the the FDA "Aspartame Board of Inquiry", he was told that those tumors were spontaneous. But Dr. Olney, a trained neuropathologist, had reviewed spontaneously occuring tumors in about 59000 rats, and found them to occur in only about .08%. This compared with a 3.75% occurence in the aspartame fed rats, with an overall tumor rate 47 times greater than expected from spontaneous tumors. Searle estimated the spontaneous rate to be .15 %, making their findings 25 times greater than expected. Further studies found that the rate of tumors developing spontaneously begins increasing after two years, which is when the Searle study ended. In fact brain tumors are rare before 1-1/2 years. After Olney's criticism, Searl conducted two followup experiments. Blaylock points out that it is strange that the FDA would even accept a followup study from the very company having a financial stake in the outcome. In 1975, the FDA director had found "sloppy" lab techniques, clerical errors, mixed up animals, animals not getting the drugs they were supposed to get, pathological specimens lost because of improper handling, and a variety of other errors, even if all innocent, conspire to obscure positive findings and produce falsely negative results." They surprisingly found in one of those studies an incidence of tumors in the control group of 3.13 % and in the aspartame group 3.33%. The other study examined another concern of Olney's, the role of diketopiperazine (DKP), which resembles a powerful brain tumor-causing chemical, N-nitrosourea. The results were not submitted until after FDA approved asparame. That study produced another strange result, with 1.62% tumor occurence in the control group, and 1.52 in the aspartame group. The strange findings were later part of the subject of a drug enforcement division of the Bureau of Foods report (Bressler Report). Specifically referring to the DKP study, the report charged Searle Company with "failure to maintain control and experimental animals on separate racks and failure to mark animals to ensure against mixups between experimentals and controls." Yet, the FDA never took any action to revoke approval. What was especially unconscionable was for the FDA to accept a study from the very company that it had found fault with in a previous investigation. A subsequent study suggests a connection with Nutrasweet and primary lymphoma brain tumor. Clearly, FDA dropped the ball on this matter. I implore that in the matter of bioengineered foods, that the FDA adopt a new course. I believe you must seek repeal of the Presidential directive initiated by Reagan/Bush and continued with Clinton/Gore that the Alliance for Bio-Integrity indicates you acknowledged receiving, "to foster" the U.S. biotechnology industry. ("Genetically Engineered Foods," FDA Consumer, Jan.-Feb. 1993, p.14), and thereafter ban bioengineered foods until its safety can be ascertained. Sincerely, Andrew Bruck P.S. I would like to acknowledge information sources for my previous submission that I had failed to identify. Genetically Engineered Foods: Are They Safe?, by Laura Ticciati and Robin Ticciati, Ph. D. Keats Publishing Chicago, Illinois, 1998 (tryptophan, aphid/potato references) How to Live Longer and Feel Better, by Linus Pauling, W.H. Freeman and Co. (aspirin toxicity reference) Andrew Bruck 3364 Knight St Jacksonville, FL, 32205 CC: The President Vice President Dick Cheney FDA Dockets Management [Docket No. 00N-1396] Senator Bob Graham Senator Bill Nelson Representative Corrine Brown Representative Ander CrenshawFDA 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