AN OPEN LETTER TO GOVERNOR THOMAS J. VILSACK Please Be Aware You Are Making Claims About the Safety of Genetically Engineered Foods That Are Blatantly False Steven M. Druker Executive Director Alliance for Bio-Integrity www.biointegrity.org September 4, 2002 Dear Governor Vilsack: I am concerned, and surprised, that you continue to vigorously promote genetically engineered foods despite substantial evidence I directly presented to you showing (a) that they pose unique risks to human health, (b) that the FDA¹s own scientific experts have cautioned about these risks and (c) that sound science has been circumvented and the facts consistently distorted in order to get these foods on the market. Further, I am concerned that you continue to mislead the public by making false claims about the safety of genetically engineered foods and that the Governors Biotechnology Partnership, which you founded and chair, is likewise misrepresenting the facts. This is especially puzzling because the evidence I gave you provides ample basis to recognize the inaccuracy of the various misrepresentations being made by you and the Partnership. Since I know you are essentially a good and decent man, I expect you will want to make the necessary changes as soon as possible. The following paragraphs are designed to assist by reviewing the pertinent facts. On May 31, 2001 you held a town meeting in Fairfield at which I informed you, in the presence of the hundreds of citizens in attendance, that the U.S. Food and Drug Administration had permitted the marketing of genetically engineered (GE) foods even though its own scientists had repeatedly warned about their unique health risks.[i] In particular, I explained: · By bringing a lawsuit against the FDA, my organization obtained copies of its internal files on GE foods. · These files clearly reveal that the FDA¹s scientific experts conducted a comprehensive review of GE foods and overwhelmingly concluded that the process of genetic engineering is inherently hazardous and that every new food it produces entails a unique set of health risks. They warned that no GE food could be considered safe unless it has been conclusively demonstrated to be so through extensive testing that includes toxicological feeding studies using the whole food. · However, the FDA¹s politically appointed administrators operating under a White House directive ³to foster² the biotechnology industry covered up these warnings, professed themselves ³not aware of any information² showing that GE foods differ from others, and allowed GE foods to be marketed without any testing by claiming there is an overwhelming consensus among experts they are safe. I offered to give you documents I had prepared that summarized the concerns of the FDA experts and quoted extensively from their internal memos, with references to photocopies of the originals that are on our website www.biointegrity.org You asked me to hand them to your assistant, Dusky Terry. In the packet, I included a paper with a fuller explanation of the health risks of GE foods and statements from numerous other experts who have cautioned about them. Shortly thereafter I phoned Dusky to follow up, and he informed me you had asked him to give you all those documents and that they were in your possession. He assured me that you really do read the documents you ask for. In addition to what I told you in person, the documents you read alerted you to the following facts: a. Although biotech proponents claim genetic engineering is essentially the same as producing new crop varieties through conventional breeding, the FDA scientists strongly disputed this claim and stated it entails different risks, especially the risks of producing unintended and essentially unpredictable new toxins, carcinogens and allergens that are difficult to detect. b. The pervasiveness of this view within the scientific staff is attested by a memo from an FDA official stating: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." c. This view is shared by numerous other experts who are not funded by the biotech industry, and hundreds have issued warnings about the risks of GE foods, including professors of molecular biology from Harvard, M.I.T., and the University of California, Berkeley. Professor Philip Regal, a renowned expert in plant genetics at the University of Minnesota, has written: " there are scientifically justified concerns about the safety of genetically engineered foods, and some of them could be quite dangerous.² d. A report issued February 5, 2001 by an expert panel of the Royal Society of Canada states it is ³scientifically unjustifiable² to presume that GE foods are safe. It says the ³default prediction² for every GE food should be that unexpected and potentially harmful changes have occurred; and it concludes that the current approach to testing cannot adequately screen for such unexpected alterations. In the words of the Toronto Star: ³The experts say this approach is fatally flawed .² e. In the U.S., the FDA does not even require this flawed system of testing. Rather, it presumes all GE foods are safe based solely on its claim that there is an overwhelming consensus among scientists that they are safe a claim that clearly is not only false but fraudulent. It persists in this practice despite the fact the U.S. Food, Drug and Cosmetic Act requires such new foods to be demonstrated safe through scientific procedures, even if there is unanimous consensus about their safety. f. There is no reliable, peer-reviewed evidence that even one GE food has satisfactorily completed the type of safety testing process that the FDA experts as well as those of the Royal Society of Canada have determined to be necessary. g. Even though the tests to date have been inadequate, they have frequently yielded problematic results. For instance, there is mounting evidence of GE plants with substantial and unexpected alterations in chemical composition. In 2000, the Public Health Association of Australia (PHAA) analyzed Monsanto¹s data on three GE plants (herbicide resistant corn and canola, and pesticide-producing corn) and in all three cases discovered several statistically significant differences in chemical composition from the non-GE counterpart. The PHAA report states that the differences cannot be attributed solely to the known products of the inserted genes and cautions that these plants may contain unexpected and to date unidentified new substances that could be harmful to humans. Further, recent investigation by Japanese scientists reveals that Monsanto¹s data on its ³Roundup Ready² soybean, the most widely planted GE crop, shows important differences between the GE bean and its conventional counterpart. For example, after standard heat processing of both the GE and non-GE beans, the concentrations of three harmful substances were significantly higher in the GE samples. Many tests on other GE foods have likewise revealed chemical alterations that are statistically significant and potentially hazardous. Somehow, in your enthusiasm to promote genetically engineered foods, you have disregarded this evidence, even to the extent of making statements that are fully at odds with it. For instance, the standard form letter you send to Iowans who write you with concerns about GE foods declares: ³Let me assure you that federal agencies are rigorously involved in determining that these products are indeed safe. The Food and Drug Administration tests for toxins and allergic reactions to genetically altered food .²[ii] And the website of the Governors Biotechnology Partnership proclaims that it ³stands firmly behind the proven safety and ongoing benefits of biotechnology.²[iii] (emphasis added) However, as the evidence you possess clearly shows: (a) the FDA does not perform any safety testing on GE foods; (b) it does not require the manufacturers to do any safety testing on them either contrary to the advice of its own scientific staff; and (c) no GE food has been proven safe through the testing that the FDA¹s experts said is necessary. Governor Vilsack, you have stated that your goal is to increase public understanding of biotechnology. If you truly desire to do so, it is essential for you · to correct the false statements you have made regarding biotechnology (including those that are on the Governors Biotechnology Partnership website) and to issue a public retraction · to disseminate to the public a fair report on what the FDA¹s scientific experts actually said about the hazards of GE foods and to acknowledge that the FDA does not regulate these foods at all a fact that the FDA has admitted in a document it filed in federal court · to sponsor a public debate on the risks and benefits of GE foods, with special emphasis on the food safety issue, at which I will appear along with any proponent of biotechnology that you select. I hope you will soon set the record straight, and I will be happy to serve as an advisor to assure the accuracy of statements you make about biotechnology in the future. [i] The report on the meeting in the Ottumwa Courier, June 1, 2001 describes the nature of my communication to you. [ii] From a letter you sent to a concerned Iowan dated June 13, 2002 [iii] This statement is still on the Partnership¹s website as of September 4, 2002. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - For SC email list T-and-C, send: GET TERMS-AND-CONDITIONS.CURRENT to [log in to unmask]