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AN OPEN CHALLENGE TO THE DIRECTORS OF THE OECD CONFERENCE ON GENETICALLY ENGINEERED FOODS, EDINBURGH, 2000: Demonstrate Your Commitment to a Science Based, Transparent and Truthful Process [ mirrored from http://www.biointegrity.org/challenge.html ] Background In a news release of 16 September, 1999, OECD Secretary-General Donald Johnson emphasized the importance of gaining "the public's confidence" in how the organization handles biotechnology issues. He explained: "I think it's important that the world realise there's a process being introduced that will be characterized by transparency and truthfulness in which all stakeholders will have the opportunity to make their views and concerns known...." He committed the OECD to a "science based approach," and he pledged that its framework for addressing the issue of biotechnology "will meet the tests of transparency, inclusiveness, analytical soundness, objectivity and credibility." I applaud those goals, and I hope they are fully adhered to. However, the organizers of the Edinburgh meeting have apparently determined that the "inclusiveness" and "objectivity" principles can be honored at the same time that, as described in a Scotland on Sunday article of 27 February, they run "a stage-managed conference" that is heavily weighted toward presentations "designed to calm public fears" and to which a mere "handful" of delegates with opposing views have been invited. In such a situation, it is necessary to issue a clear and compelling challenge that obliges the organizers to live up to the ideals they claim to hold. Statement of Relevant Facts 1. The OECD states it has done "pioneering work" on the concept of substantial equivalence, and it asserts that this concept "is now accepted world-wide by food safety assessment experts." (News Release of 16 September, 1999) 2. This concept holds that if a bioengineered organism and its conventional counterpart are found to be substantially similar across a limited range of variables (e.g. composition of proteins, minerals, vitamins, etc.), they can be presumed substantially equivalent in all other respects as well. This implies that chemical analysis can adequately screen for unintended negative side effects and that confirmation of equivalence through rigorous feeding studies is not required. 3. The concept of substantial equivalence is thus based on the assumption that recombinant DNA technology (genetic engineering) is itself substantially equivalent to conventional breeding and entails no greater risks of inducing essentially unpredictable negative side effects. 4. In reality, while the concept of substantial equivalence is accepted by proponents of biotechnology and by many nations and organizations that seek to promote it, the concept is strongly criticized by a significant segment of the scientific community. 5. These experts state it is unsound to presume that genetic engineering is essentially similar to conventional breeding. They point to the well-recognized potential for genetic engineering to disrupt cellular function and induce the generation of toxins, carcinogens, allergens and anti-nutritive substances in a different manner and to a different degree than do conventional practices. 6. They emphasize that because these unintended substances can be unpredictable and of a type never before seen in any of the species involved in the gene transfer, it is not possible to adequately screen for them through chemical analysis alone, since such a method generally can only detect substances that are expected. (A strong critique of the concept of substantial equivalence appeared in Nature, vol. 401, 7 Oct. 1999 pp. 525-6.) 7. Among the scientists who hold the above views are nine experts who have taken the unprecedented step of becoming plaintiffs in the lawsuit led by the Alliance for Bio-Integrity against the U.S. Food and Drug Administration (FDA) challenging that agency's reliance on the concept of substantial equivalence and demanding the institution of mandatory, rigorous safety testing of all genetically engineered foods. These scientist-plaintiffs include a professor of molecular and cell biology at the University of California at Berkeley, a respected molecular biologist at the State University of New York, and the associate director of targeted mutagenics at Northwestern University Medical School. This latter scientist routinely employs bioengineering in the medical field, but is troubled it is being used in food production without adequate safeguards. (A list of the plaintiffs is available at the website of the Alliance for Bio-Integrity at: www.biointegrity.org/Lawsuit.html) 8. Also included as plaintiffs are Professor Philip Regal, an internationally renowned plant biologist at the University of Minnesota, and Dr. John Fagan, Professor of Molecular Biology at Maharishi University of Management and recipient of a Research Career Development Award from the National Cancer Institute, who have submitted sworn declarations to the court detailing major differences between genetic engineering and conventional breeding and explaining the weaknesses of a safety assessment strategy based on the precautionary principle. Dr. Richard Lacey, M.D., Ph.D., Emeritus Professor of Medical Microbiology at the University of Leeds has also submitted such a declaration. (Because he is not a U.S. citizen, Dr. Lacey could not be a plaintiff.) All the declarations assert that genetic engineering entails a unique set of risks, and Professor Regal's states "... there are scientifically justified concerns about the safety of genetically engineered foods, and some of them could be quite dangerous." (These declarations are available at www.biointegrity.org) 9. Further, over 250 scientists from 34 countries have signed an Open Letter to All Governments expressing extreme concern about hazards posed by GM foods to food safety and human and animal health. They call for an immediate suspension of all environmental releases of GM crops and products. The signatories include a geneticist with the U.S. Department of Agriculture (now retired), a professor of molecular biology at M.I.T., and the director of the Woods Hole Research Center in the U.S. 10. Moreover, although the decision-makers at the FDA base its official policy on the assumption that genetic engineering is substantially the same as conventional breeding, the FDA's scientific staff largely repudiated it. The majority of the agency's technical experts who reviewed the issue identified reasonable grounds on which to doubt the safety of genetically engineered foods, and several issued strong warnings. The predominant view was that genetic engineering entails distinct risks and that its products cannot be regarded as safe unless they have satisfactorily been so confirmed through appropriate feeding studies. As FDA compliance officer Dr. Linda Kahl summarized the input from the agency's scientists: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (For a detailed discussion, see Appendix I, Alliance for Bio-Integrity's Executive Summary of the FDA scientists' comments.) 11. The FDA acknowledges that during the time it developed its policy on genetically engineered foods it was functioning under a White House directive to "foster" the U.S. biotechnology industry and that such a promotional agenda continues to exist. Further, when then Vice-President Dan Quayle announced the FDA's policy presuming all genetically engineered foods to be safe in the absence of testing, he referred to it as regulatory relief for the industry. 12. Numerous NGO's and other public interest organizations point out that application of the concept of substantial equivalence to bioengineered foods is inconsistent with the "precautionary principle," which holds that in cases where there are grounds for reasonable doubt, a new food should not be marketed until its safety has been established through suitable tests. 13. United States law clearly mandates application of the precautionary principle to genetically engineered foods, and it distinguishes such foods from those produced by traditional selective breeding through sexual reproduction. While the latter may be presumed safe based on prior history of safe use, food yielding organisms produced through genetic engineering can only be recognized as safe based on clear demonstration of safety through standard testing procedures, and the results of such tests must ordinarily be published in the peer-reviewed scientific literature. In effect, U.S. law presumes every genetically engineered food unsafe until proven safe. (See Appendix II, Alliance for Bio-Integrity's Advisory on the Precautionary Principle.) 14. The three experts who have submitted declarations to the court in the Alliance for Bio-Integrity lawsuit have all asserted under penalty of perjury that to the best of their knowledge, there are no published studies that demonstrate the safety of even a single genetically engineered food and that no such food has yet to be established safe through appropriate tests. 15.. According to these experts, because each insertion of genetic material through recombinant DNA technology is a distinct event entailing a unique set of potential negative side effects, even if one type of bioengineered food eventually is confirmed safe, it would not imply that any others are similarly safe. Moreover, they emphasize that due to the facts that (a) an inserted genetic construct can exert different effects at different points on the DNA strand and (b) there is no way to precisely control where insertion occurs, if one particular bioengineered vegetable (such as soya bean) were established safe, any other similar soya bean derived from a different insertional event would still have to be established safe through independent testing, even if the inserted constructs were identical. Internal memos by FDA scientists accord with this reasoning. 17. In fact, not only did the FDA draw improper implications about the safety of all bioengineered foods from the data on the Flavr Savr, it failed to acknowledge that the Flavr Savr did not pass its own tests. FDA experts stated that a pattern of stomach lesions in the lab animals raised a safety issue that was not resolved and that the tomato could not be deemed safe based on the data at hand. (See Executive Summary, Section E.) Nonetheless, the FDA claimed that all safety issues were satisfactorily resolved. 18. Genetically engineered food has already killed or crippled numerous people. In 1989, a genetically engineered supplement of the amino acid L-tryptophan manufactured by the Japanese company Showa Denko caused the deaths of 37 people and the permanent disability of at least 1,500 others. It was later found that the genetically engineered tryptophan contained unusual and highly toxic contaminants. No conventionally produced tryptophan sold by other companies has been shown to have caused the type of malady caused by Showa Denko's product. (Kilbourne, E. Journal of Rheumatology Supplement, vol. 46, Oct. 1996.) Although it was never definitively established that the toxicity resulted from the genetic engineering process, neither has the link been ruled out; and many experts think it is likely that the toxin was an unexpected side effect of the bioengineering procedure. The main reason a definitive answer has not been reached is that all the relevant evidence in Showa Denko's laboratory was destroyed before it could be examined. The FDA confirms that the genetic engineering process cannot be ruled out as the cause of the toxins. (For a fuller discussion, see Executive Summary, Section B.) The Challenge In light of the above facts and the OECD's expressed goals of adhering to an approach that is science-based, objective, analytically sound, truthful, and credible, it is quite reasonable and appropriate that the conference be required to forthrightly and fully respond to the following requests. This is especially so considering that we are not engaged in abstract academic debate but are dealing with the safety of the world's food supply -- and considering that hundreds of millions of people the world over are daily consuming significant quantities of food derived from genetically engineered organisms, in most instances without their knowledge or their consent. 1. If you have information demonstrating that any food produced through genetic engineering is safe for animals and humans to consume, identify which particular products have been so confirmed and provide references to the journals, etc. in which the relevant studies have been published. If the study is unpublished, provide a copy of the original. Note that the definition of safety employed by U.S. law for such cases is that the evidence should establish there is a reasonable certainty that the food will not be harmful under its intended conditions of use. (See Advisory on the Precautionary Principle.) This means that safety cannot be imputed by balancing supposed benefits against risks. Rather, it can only be established by confirming that the food poses no risks greater than in the ordinary case of a food produced through conventional breeding. 2. As a point of information, according to the standards of U.S. law, every genetically engineered food must be demonstrated safe prior to marketing, regardless of how many scientists assume it is safe. If the standard of the United States were to be deemed appropriate for the rest of the world, then all unproven bioengineered foods should be withdrawn from the market. 3. If the U.S. standard were regarded as overly strict, the standards of the precautionary principle, which has been adopted by the nations participating in the Montreal Bio-Safety Protocol, would be the norm. According to this principle, if there is a scientific basis for reasonable doubt about the safety of any unproven genetically engineered food, it should be withdrawn unless and until it is proven safe. 4. Therefore, in order to justify the marketing of any unproven bioengineered foods under this framework, the objections to the concept of substantial equivalence and the doubts about safety of GM foods expressed by the FDA's scientists, the plaintiffs in the lawsuit, and hundreds of other experts around the world would have to be demonstrated devoid of a reasonable basis. 5. It is thus important that you be challenged to make such a demonstration-- or to acknowledge the reasonableness of the doubts. If you attempt the former, please answer the points discussed in the foregoing statement of facts and in the plaintiffs' declarations specifically (i.e. discuss the issues of position effects, the use of viral promoters, etc. individually). Any attempted refutations should be detailed. Please also bear in mind that the essential comparison is between genetically engineered foods and those produced through the traditional breeding safely practiced for centuries. The former must be shown to be as safe as the latter. If there are specific cases of techniques other than genetic engineering that themselves entail higher risk than does the traditional breeding practiced for centuries, you can discuss those risks and compare them to those entailed by genetic engineering. But do not lump the two categories of non-genetic engineering together. Remember too that considerations of potential benefits should not be relied on in an attempt to reach conclusions. The focus is solely upon the extent to which there are or are not reasonable grounds for imputing risk. Also, please note that you are not being asked to offer any opinion about the merits of the lawsuit against the FDA or about interpretations of U.S. or international law. You are only being asked to address the scientific issues. By doing so, you will not be presumed to endorse any legal interpretations stated in this challenge, so it is not necessary for you to present objections to such legal interpretions that you may have -- although you are obviously free to do so. 6. In the interest of transparency, it is appropriate that all participants should be required to disclose whatever financial relationships they may have with the biotechnology industry. I therefore request that every delegate be required to specify whether he or she (a) is directly employed by an entity or organization (either for profit or nonprofit) that performs biotechnology or actively promotes it or (b) receives financial support from such an entity or organization in the form of (1) consultation fees (or other types of payments) or (2) research grants (or other similar funding). I request that a comprehensive list containing these disclosures be provided. Please provide your written answer to this challenge at the same time that you present the consensus document of the conference. Preferably, the answer will be integrated into that document, with a clear acknowledgement that it is specifically addressing this challenge. Thank you for cooperating to advance the cause of sound science, transparency and objectivity, and for helping provide a reliable basis on which government decisions can be made. Steven M. Druker Executive Director Alliance for Bio-Integrity [Source: From List: GE@naturallaw.org.nz date: Sat, 25 Mar 2000 21:08:31 +1200 Article mirrored from http://www.biointegrity.org/challenge.html ] Feedback to: <welcome@ecoglobe.org.nz>

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26 March ecoglobe news 2000

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