Full press statement, 9 July, 2003

How the US govermnent is misrepresenting the facts about the risks of genetically engineered foods

Advisory on US law and gentically engineered food

Steven M. Druker, J.D. Biography

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US public interest attorney Steven M. Druker, director of the Alliance for Bio-Integrity, is coming to Europe to expose how GM foods only got on the EU market through systematic deception by the US government – and how the Bush Administration is deepening the deception in its attempt to overturn the EU regulatory structure. Mr Druker has extensive knowledge of the deception because he organised a lawsuit that forced the US Food and Drug Administration (FDA) to divulge over 44,000 pages of its internal files on GM foods. He is an authority on the legal and scientific issues of GM foods and has appeared on expert panels at conferences held by the US National Research Council and the FDA and has met with government officials around the world.

Mr Druker will also demonstrate how EU officials have themselves misled their citizens by disregarding the well-recognised risks of GM foods and pretending they are substantially the same as other foods – and how they have violated the precautionary principle and EU food law in the process.

Basic points that will be explained:

• Although the Bush Administration attacks the "precautionary principle" as an illegitimate restraint on trade, it is actually the cornerstone of US Food Safety Law
• US law clearly mandates that the precautionary principle be applied to GM food – and to an even stricter degree than does EU law
• GM foods gained approval in the EU only because the US Food and Drug Administration (FDA) covered up extensive warnings of its own experts, blatantly misrepresented the facts, and violated its own laws
• The EU regulatory process disregards sound scientific practices and has approved GM foods based on data that is grossly deficient and that in some cases even indicates potential health hazards

Press contact: Leopold Fransen +32 4965 78520 leopold.fransen@pi.be

Contact: While in Europe during July, contact Steven Druker through

Geert Ritsema of Friends of the Earth 31 6 290 05 908 (mobile)

After July in the US at 1-641-472-8008 sdruker@biointegrity.org

GM foods only got on the EU market through systematic deception by the US government – and the Bush Administration is deepening the deception in its current attempt to overturn EU regulatory policy and force GM foods upon Europeans without proper precautions and without even labels. This is the charge leveled today by American public interest attorney Steven M. Druker, who directs the nonprofit Alliance for Bio-Integrity. He also asserts that EU regulators have themselves dishonored the precautionary principle and disregarded sound science in order to approve GM foods for human consumption.

Mr. Druker helped expose the United States’ deception by initiating a lawsuit that forced the US Food and Drug Administration (FDA) to divulge over 44,000 pages of its internal files on GM foods, which revealed how the agency’s bureaucrats covered up extensive warnings of their own scientists about the unique risks of GM foods. He is an authority on the legal and scientific issues of GM foods and has appeared on expert panels at conferences held by the US National Research Council and the FDA and has met with government officials around the world. The following paragraphs amplify his assertions in more detail.

The FDA's records reveal its own scientific experts overwhelmingly concluded that genetic engineering has unique potential to produce unintended and essentially unpredictable new toxins and other harmful substances. They cautioned that a GM food could not be considered safe unless it had undergone rigorous toxicological tests using the whole food. The uniformity of opinion is attested by the FDA official responsible for summarizing the expert input, who reported: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (Photocopies of 24 key FDA documents are in a numbered set at www.biointegrity.org The preceding quote is from #1.)

Nevertheless, FDA bureaucrats, who admit they have been operating under an on-going White House directive "to foster" the biotech industry, disregarded their experts’ warnings and covered them up. They then declared there is an overwhelming consensus among experts that GM foods are so safe they don’t need to be tested, even though they knew their own experts regarded them as uniquely hazardous – and even though they knew there was not a consensus about safety in the scientific community at large, as evidenced in a letter by the FDA Biotechnology Coordinator. (FDA document #8 at www.biointegrity.org ) And to deepen the deception, they claimed they were not aware of any information showing that GM foods differ from others in any meaningful way.

Druker states: "If the US government had told the truth, no GM foods would have come to market in the US or the EU, since the EU would not have approved them if the US had not."

"Having duped the EU into approving GM foods in the first place, the US is now trying to force open the European market as widely as possible by dismantling the EU’s precautionary safeguards and destroying its new labeling laws," says Druker. "This attack on EU’s precautionary policy relies on another major deception: the false pretense that such use of the precautionary principle is an illegal restraint on trade and that the US is free to resist it. In reality, Mr. Bush is obligated to uphold the precautionary principle at home and respect it abroad because it is the cornerstone of US food safety law." He points out that this has been the case since Congress passed the Food Additive Amendment in 1958, which unequivocally requires that new additives be proven safe. As the official Senate report described the intent of this law: "While Congress did not want to unnecessarily stifle technological advances, it nevertheless intended that additives created through new technologies be proven safe before they go to market." S. Rep. 2422, 1958 U.S.C.C.A.N. 5301-2. (emphasis added)

"This law clearly applies to GM foods,"states Druker. "By allowing them on the market without proof of safety, the FDA is flagrantly breaking it in order to promote the interests of Monsanto, Dupont, and other giant corporations. And yet the US government self-righteously accuses the EU of violating international law by implementing an even a lower degree of precaution than is required by US law."

"Unfortunately, EU regulators themselves went on to mislead the public by claiming they’re applying the precautionary principle to GM foods when in fact they have been disregarding well-recognized risks and failing to institute the level of safety testing required by their own law," says Druker. He notes that they have ignored the unique potential of GM foods for unpredictable results, failed to require the kinds of tests recommended by the FDA experts, and have instead relied on tests that do not adequately screen for the potential negative effects about which they warned. "EU regulation is based on the presumption that the only changes that will occur in a GMO are those that are intended. The Royal Society of Canada has branded this presumption ‘scientifically unjustifiable’ and stated that instead the ‘default presumption’ for every GM food should be that the genetic alteration has induced unintended and potentially hazardous side effects." (Expert Panel Report of 2001)

Further, even within the narrow parameters in which they have operated, EU regulators have failed to uphold adequate standards. For one thing, the research on which they’ve relied does not meet basic scientific standards. Experts with the Public Health Association of Australia (PHAA) thoroughly reviewed many of the data packages the manufacturers submitted to the regulators and have reported they lack key information that is routinely provided in scientific research and is required to enable meaningful review by others. They stated that such research could not have qualified for publication in peer-reviewed journals and should not have been accepted by the regulators. (PHAA Written Comments to ANZFA, October 2000.) And a team of Japanese scientists who reviewed Monsanto’s tests on its "Roundup Ready" soybean (which has been approved in the EU) found so many irregularities in the safety assessment they concluded it was "inadequate and incomplete." (The team was headed by Dr. Masaharu Kawata, an Assistant Professor in the School of Science at Nagoya University. Their report was published in the Japanese journal Technology and Human Beings, vol.11, Nov. 2000, pp. 24-33)

Druker points out that even this deficient data has in many cases revealed potential problems that the regulators have ignored. For instance, the PHAA analyzed Monsanto’s data from controlled studies on three of its GM plants (herbicide resistant maize and canola, and pesticide-producing corn) and in all three cases discovered several statistically significant differences in chemical composition (including amino acid profiles) between the GM organism and its non-GM counterpart. The PHAA report (October 2000) states that the differences in the amino acids 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 proteins that could be harmful to humans. Nonetheless, the EU has approved two of these plants for human consumption.

"One of the most glaring flaws in EU regulation is the acceptance of untested GM animal feed," says Druker. "EU citizens have for years been unknowingly consuming meat, milk and eggs from animals raised on this feed because no labels have been required, and the new laws still fail to do so for the end product. This is troubling in light of the fact the FDA experts stated that GM animal feed presents ‘unique … food safety concerns’ because residues of unexpected substances could make meat and milk products harmful to humans. (See FDA document #10 at www.biointegrity.org ) However, their warnings were covered up and the kinds of tests they called for have yet to be adequately conducted."

"In light of the flawed presumption on which it rests, the deficient data it accepts, and the potential dangers toward which even this data frequently points, it’s clear that EU regulation of GM foods is out of line with both sound science and the precautionary principle," says Druker. "This means the regulators are breaching EU food law, which calls for the precautionary principle ‘in cases where the scientific basis is insufficient or some uncertainty exists.’" Green Paper: General Principles of Food Law in the EU, 30/4/97.

Druker concludes, "It’s astounding that this venture to radically transform the production of our food continues to be portrayed as based in sound science and rigorous regulation when in fact it depends on flagrant disregard of both science and the food safety laws. Such deception ranks as one of the greatest frauds ever perpetrated." He continues: " It should be clear by now that genetic engineering is the wrong way for agriculture to go. The technology is inherently risky, but industry refuses to perform the kinds of tests that are minimally required to screen for the full range of hazards. And if regulators actually required the tests that sound science dictates, it would be an economic disaster for the industry because, in contrast to the pharmaceutical industry, the food industry is not structured to bear the costs of rigorous long-term toxicological tests for each new product. The economic realities of GM food are incompatible with the scientific necessities."

More detailed documentation of the points in this release are provided by the accompanying documents, which will also be available at www.biointegrity.org

STEVEN M. DRUKER, J.D.

Executive Director

Alliance for Bio-Integrity

www.biointegrity.org

1. Genetically engineered (GE) foods have been allowed on the market in the United States, Europe, and other nations because of systematic misrepresentations by the US government, and their continued marketing depends on continuation of the misrepresentations.
2. This fraud was exposed by a lawsuit against the US Food and Drug Administration (FDA) that compelled it to release its internal files on GE foods. I coordinated this lawsuit as Executive Director of the Alliance for Bio-Integrity.
3. The FDA's records reveal that its own scientific experts overwhelmingly concluded that genetic engineering differs from conventional breeding and has unique potential to produce unintended and essentially unpredictable new toxins and other harmful substances. They cautioned that a GE food could not be considered safe unless it had undergone rigorous toxicological tests using the whole food. The uniformity of opinion is attested by the FDA official responsible for summarizing the expert input, who reported: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (Photocopies of 24 key FDA documents are in a numbered set on our website www.biointegrity.org The preceding quote is from #1.)
4. Nevertheless, FDA bureaucrats, who admit they have been operating under an on-going White House directive "to foster" the biotech industry, disregarded their experts’ input and in May, 1992 instituted a policy that presumes GE foods are as safe as conventional ones and do not require any testing. Further, they covered up the warnings from their scientists and then declared themselves unaware of any information showing that GE foods differ from others in any meaningful way. They additionally claimed there is overwhelming recognition among experts that GE foods are as safe as others, even though they knew their own experts regarded them as uniquely hazardous – and even though they knew that there was not a consensus about the safety of GE foods in the scientific community at large. For example, the FDA Biotechnology Coordinator acknowledged this lack of consensus in a letter to a Canadian health official on October 23, 1991 commenting on a document that discussed GE foods. He stated: "As I know you are aware, there are a number of specific issues addressed in the document for which a scientific consensus does not exist currently, especially the need for specific toxicology tests." (FDA document #8 at www.biointegrity.org )
5. The FDA has continued to issue deceptive statements for nine years. For instance, on May 3, 2000, the FDA Commissioner declared: "FDA’s scientific review continues to show that all bioengineered foods sold here in the United States today are as safe as their non-bioengineered counterparts." But the year before, the FDA clearly acknowledged it does not perform substantial reviews of GE foods, stating: "FDA has not found it necessary to conduct comprehensive scientific reviews of foods derived from bioengineered plants … consistent with its 1992 policy." (Reported in The Lancet, Vol. 353, No. 9167, May 29, 1999) As of July 2003 the FDA continues to claim there is an overwhelming consensus among experts that GE foods are safe despite the fact the agency has repeatedly been notified through formal channels that numerous eminent scientists consider these new foods to be inherently more hazardous than their conventional counterparts.
6. If the FDA had not misrepresented the facts about the unique risks and the scientific concerns but instead had honestly acknowledged them, no GE foods would yet have come to market in the US. Nor would they have yet been marketed in Europe, since if the US had not approved them, the EU would not have done so.

EU Regulators Have Failed to Follow Sound Science and the Requirements of Their Law

7. Moreover, the EU regulators have ignored the unique potential of GE foods for unpredictable results, failed to require the kinds of tests recommended by the FDA experts, and have instead relied on tests that do not adequately screen for the potential negative effects about which they warned.
8. The inadequacy of the current tests is highlighted by the fact that eminent experts submitted declarations to a US federal court in May 1999 asserting there is no reliable evidence demonstrating that any GE food is safe. (e.g. www.biointegrity.org/laceydeclaration.html ) Accordingly, the court stated that there are "significant disagreements among scientific experts" regarding safety.
9. The basic approach on which EU (and Canadian) regulation of GE foods is based – the concept of "substantial equivalence" – is so unsound that a report from the Royal Society of Canada issued February 5, 2001 criticizes it as "scientifically unjustifiable." In the words of the Toronto Star: "The experts say this approach is fatally flawed … and exposes Canadians to several potential health risks, including toxicity and allergic reactions." (Feb. 5, 2001)
10. Further, even within the narrow parameters in which they have operated, the EU regulators have failed to uphold adequate standards. For one thing, the research on which they have relied is generally deficient and does not meet basic scientific protocols. Experts with the Public Health Association of Australia (PHAA) thoroughly reviewed many of the data packages the manufacturers submitted to the regulators and have reported they lack key information that is routinely provided in scientific research and is required to enable meaningful review by others. They stated that such research could not have qualified for publication in peer-reviewed journals and should not have been accepted by the regulators. (PHAA Written Comments to ANZFA, October 2000.) And a team of Japanese scientists who reviewed Monsanto’s tests on its "Roundup Ready" soybean (which has been approved in the EU) found so many irregularities in the safety assessment they concluded it was "inadequate and incomplete." Their November 2000 report concludes: "The safety assessment of the Monsanto Roundup Ready soybean needs to be reassessed." (The team was headed by Dr. Masaharu Kawata, an Assistant Professor in the School of Science at Nagoya University. Their report was published in the Japanese journal Technology and Human Beings, vol.11, Nov. 2000, pp. 24-33)
11. Moreover, even this deficient data has in many cases revealed potential problems that the regulators have ignored. For instance, the EU authorities have approved several GE foods that are clearly different from their conventional counterparts, even though the differences raise reasonable doubts about safety. These foods include three of Monsanto’s GE crops: a variety of maize, a variety of canola, and the Roundup Ready soybean. (Details provided in # 14 below.)
12. Although consumer resistance has prevented most GE foods from being marketed in Europe, large quantities of GE crops have been imported for animal feed; and EU citizens have for years been unknowingly consuming meat, milk and eggs from animals raised on this feed because no labels have been required. Nor will they be required on the end product by the new laws of 2003. Moreover, the US FDA experts stated that feeding GE crops to farm animals presents "unique … food safety concerns" because residues of unexpected substances could make meat and milk products harmful to humans. (See FDA document #10 at www.biointegrity.org ) However, their warnings were covered up by the FDA administrators, and the kinds of tests they called for have not been conducted.
13. Consequently, the marketing of GE foods in the EU is contrary to the guiding principle of EU food law, which is based on the precautionary principle. For instance, the European Commission has stated it "...will be guided in its risk analysis by the precautionary principle in cases where the scientific basis is insufficient or some uncertainty exists." Green Paper: General Principles of Food Law in the EU, 30 April 1997.
14. Recent evidence provides added justification for concern about unexpected harmful side effects. First, the discoveries of the human genome project released February 2001 (a) confirm that the foundational assumptions of genetic engineering are overly simplistic and seriously unsound and (b) indicate that recombinant DNA techniques entail greater potential for unpredictable hazards than was previously suspected even by experts advocating a more precautionary approach. Second, there is mounting evidence of GE plants with substantial – and unexpected – alterations in chemical composition. (a) Aventis’s data shows statistically significant differences between T25 herbicide-resistant maize and its conventional counterpart in terms of carbohydrate, amino acid and fatty acid composition. (b) The Public Health Association of Australia (PHAA) analyzed Monsanto’s data from controlled studies on three of its GE plants (herbicide resistant maize and canola, and pesticide-producing corn) and in all three cases discovered several statistically significant differences in chemical composition (including amino acid profiles) between the GE organism and its non-GE counterpart. The PHAA report (October 2000) states that the differences in the amino acids 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 proteins that could be harmful to humans. (c) Recent investigation by Japanese scientists reveals that Monsanto’s data on its Roundup Ready soybean, the most widely planted GE crop, shows important differences between the GE bean and its conventional counterpart. For instance, after heat processing of both the GE and non-GE beans, the concentrations of three harmful substances were significantly higher in the GE samples. Third, research at UK’s John Innes Centre confirms that the viral promoter used in almost all GE plants can facilitate various abnormal genetic recombinations. This could lead to serious disruptions or to generation of new and hazardous chemicals. Additionally, experts warn that parts of existing viruses could recombine into novel and more dangerous viruses.
15. Accordingly, hundreds of scientists have signed an open letter to the world’s governments warning of the hazards and calling for a moratorium on all GE foods. Signatories include professors of biology from Harvard and the Massachusetts Institute of Technology, and the director of the renowned Woods Hole Research Center. Further, nine scientific experts were so concerned they took the unprecedented step of joining as plaintiffs in the Alliance for Bio-Integrity’s lawsuit against the U.S. Food and Drug Administration (FDA). By asserting that they regard GE foods to entail unique risks, they refuted FDA’s claim that experts overwhelmingly recognize them as safe. They include a professor of molecular biology at the University of California, Berkeley; the co-director of Targeted Mutagenics at Northwestern University Medical School; and a renowned expert in plant genetics at the University of Minnesota whose declaration to the court stated: "…there are scientifically justified concerns about the safety of genetically engineered foods, and some of them could be quite dangerous." Further, the respected UK medical journal The Lancet has strongly criticized the presumption that GE foods entail no greater risks of unexpected effects than conventional ones, stating that there are "good reasons to believe that specific risks may exist" and that "governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health." (May 29, 1999).
16. Because of the systematic misrepresentations by the US government and the extensive warnings about the risks of GE foods raised by that government’s own experts, the EU should boldly resist US pressures to import additional GE foods. Moreover, in light of the above facts, it is evident that (a) there is insufficient evidence to demonstrate that any GE food is safe and (b) there is a deep degree of doubt about their safety on the part of numerous experts. Accordingly, it is difficult to see how the presence of any GE food on the EU market is consistent with the precautionary principle that EU regulators are legally bound to uphold "… in cases where the scientific basis is insufficient or some uncertainty exists." Green Paper: General Principles of Food Law in the EU, 30 April 1997. Therefore, it is prudent and proper for the EU authorities to promptly ban all GE foods, including those they have already approved.

• The Bush Administration’s Assault on the EU Moratorium is Based on Major Misrepresentations
• US Law Mandates Rigorous Application of the Precautionary Principle
• US Approval of GE Foods Is Contrary to Law and Occurs Through Government Deception

Steven M. Druker, J.D.

Executive Director

Alliance for Bio-Integrity

(A US Public Interest Organization)

www.biointegrity.org

1. U.S. food safety law has mandated the precautionary approach since 1958. In that year, Congress passed the Food Additive Amendment to the Food, Drug and Cosmetic Act requiring that new additives to food be demonstrated safe through standard scientific testing before they are marketed. (21 U.S.C. Sec. 321).
2. An official Senate report described the intent of the amendment as follows: "While Congress did not want to unnecessarily stifle technological advances, it nevertheless intended that additives created through new technologies be proven safe before they go to market. S. Rep. 2422, 1958 U.S.C.C.A.N. 5301-2. (emphasis added) This clearly shows that the precautionary principle is the cornerstone of food safety law in the United States.
3. However, although the Bush Administration is legally required to uphold the precautionary principle at home and honor it abroad, it is doing neither. Instead, it claims that the principle is an illegitimate restraint on business and trade – and that the US is free to disregard it and to resist its application by the EU. As reported in the New York Times on May 18, "The Bush administration believes the precautionary principle is an unjustified constraint on business and does not even recognize the existence of the doctrine."
4. If the U.S. government was following the law, not only would it respect the EU’s precautionary policy on GE foods, it would have prevented these foods from coming to market in America until they had been proven safe.
5. By allowing GE foods to be marketed without proof of safety, the U.S. Food and Drug Administration (FDA) is violating its own laws; and it attempts to justify this violation by fallacious arguments.
6. While FDA administrators acknowledge that pieces of foreign DNA spliced into an edible plant (and all substances produced by them) are in principle food additives, they claim these genes and gene-products are exempt from the testing ordinarily required for additives because they are "generally recognized as safe" (GRAS).
7. This claim is patently false. The law specifies that in order to be classified GRAS, foods containing new additives must meet two requirements; and GE foods do not fulfill either of them.
8. First, as both the FDA’s regulations and the federal courts have decreed, general recognition of safety can only be imputed if there is an overwhelming consensus in the community of qualified experts. While unanimity is not required, any significant disagreement prevents a determination that consensus exists.
9. The requisite consensus for GE foods has never existed, and the FDA is well aware of it because the predominant consensus among its own experts was that these foods entail unique risks and cannot be presumed safe. This was revealed when my organization brought a lawsuit against the FDA that forced it to divulge its files. As these files show, the FDA’s scientists repeatedly warned their superiors that genetic engineering can disrupt the organism in unpredictable ways and cause the production of unintended harmful substances that are difficult to detect. For instance, an FDA toxicologist cautioned that GE plants could contain unexpected toxins that might "...be uniquely different chemicals that are usually expressed in unrelated plants." (Photocopies of 24 key FDA documents are in a numbered set on our website www.biointegrity.org The preceding quote is from #2.)
10. The pervasiveness of concern within the FDA’s scientific staff is attested by the official responsible for summarizing the expert input, who reported: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (FDA Document #1 at www.biointegrity.org ) Because of the potential for unexpected harmful effects, the FDA experts stated that every GE food should undergo rigorous testing to screen for them.
11. Further, FDA’s Biotechnology Coordinator admitted there is not a consensus about safety among experts outside the FDA either. On October 23, 1991, he wrote a letter to a Canadian health official commenting on a document that discussed GE foods. He stated: "As I know you are aware, there are a number of specific issues addressed in the document for which a scientific consensus does not exist currently, especially the need for specific toxicology tests." (FDA Document #8)
12. Today, experts are far more divided about the safety of GE foods than in 1991. For instance, hundreds have signed an open letter calling for a moratorium, and a 2001 report of the expert panel of the Royal Society of Canada states that (a) it is "scientifically unjustifiable" to presume that GE foods are safe and (b) the "default presumption" for every GE food should be that the genetic alteration has induced unintended and potentially hazardous side effects.
13. But even in the case of unanimity, U.S. law additionally prescribes that consensus cannot rest on hypotheses but must be based on scientific evidence that clearly establishes safety. Both the FDA’s regulations and the federal courts have consistently held that such evidence should include studies published in the peer-reviewed scientific literature. (21 CFR Sec. 170.3(h)). Moreover, FDA regulations emphasize that the tests supporting a general recognition of safety "...require the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive." (21 CFR Sec. 170.30(b)) This means, in the FDA's words, that the tests must demonstrate "a reasonable certainty ... that the substance is not harmful under its intended conditions of use." (21 CFR Sec. 170.3(i)). Therefore, even if expert consensus about the safety of GE foods actually existed, the law requires that their safety still must be established through standard scientific tests.
14. Again, the FDA’s own files reveal this requirement has not been met. One of the agency’s scientists noted "the paucity of data" about GE foods (FDA Administrative Record at 18695), and another wrote a memo to the Biotechnology Coordinator saying: " . . . (A)re we asking the scientific experts to generate the basis for this policy statement in the absence of any data?" (FDA document #1.)
15. Further, because the FDA does not require tests of GE foods and performs no substantial scientific reviews, it still has no evidence demonstrating that any are safe. As the agency has itself acknowledged: "FDA has not found it necessary to conduct comprehensive scientific reviews of foods derived from bioengineered plants … consistent with its 1992 policy." (Reported in The Lancet, Vol. 353, No. 9167, May 29, 1999) Moreover, eminent experts have made formal declarations that no GE food has been proven safe according to the legal standard. (e.g. www.biointegrity.org/laceydeclaration.html )

In Order to Promote GE Foods, the FDA Is Breaking the Law and Misrepresenting the Facts

16. However, as the FDA administrators themselves admit, they have been operating since 1987 under an ongoing White House directive "to foster" the biotech industry. And in their desire to do so, they claimed there is an overwhelming consensus among experts that GE foods are as safe as others, even though they knew that their own experts regarded them as uniquely hazardous and that no such consensus exists in the scientific community.
17. Further, although US law requires that every GE food be demonstrated safe prior to marketing, and although the FDA experts called for extensive safety testing as a matter of scientific as well as legal necessity, the FDA administrators allowed GE foods to be marketed without requiring any safety testing at all. And to deepen the deception, besides disregarding their experts’ warnings, they covered them up and then denied they had received any such input by claiming: "The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way…." (Federal Register vol. 57, No. 104 at 22991.)
18. To date, the sole purported legal basis for the marketing of GE foods in the U.S. is the blatantly false claim that they are recognized as safe by an overwhelming consensus of scientific experts.
19. Therefore, any member of the WTO is authorized by WTO rules to adopt the standard dictated by U.S. law; and the U.S. cannot justifiably object to it. (Agreement on Sanitary and Phytosanitary Measures, Art. 5 paragraph 7).

Summary and Conclusion

20. In light of all the above facts, the U.S. challenge to the EU’s policy on GE foods could be easily defeated. The U.S. government requires no testing of GE foods and has no reliable evidence they are safe; it has disregarded and misrepresented the warnings of its own scientists; its own law mandates the precautionary principle, yet it attacks that principle as a grievous violation of international law; and the sole purported legal basis for its approval of GE foods is the fraudulent claim they are generally recognized as safe.

Executive Director, Alliance for Bio-Integrity

BIOGRAPHICAL SUMMARY

Steven M. Druker is a public interest attorney who founded the Alliance for Bio-Integrity, a non-profit organization dedicated to promoting technologies that foster human and environmental health and addressing the problems of those that do not. The Alliance's first major project is to gain a more rational and responsible policy on the use of genetic engineering. As executive director of the Alliance, Mr. Druker organized a lawsuit against the U.S. Food and Drug Administration (FDA) that forced the agency to divulge its files on genetically engineered (GE) foods, which revealed how the politically appointed administrators had covered up the extensive warnings of their own scientists about the unique hazards of these foods and have systematically misrepresented the facts since 1992. In organizing the suit, he assembled an unprecedented coalition of eminent scientists and religious leaders to stand as plaintiffs.

Since founding the Alliance in 1996, Mr. Druker has become known as one of the leading figures discussing the problems of genetically engineered foods, viewed from both the scientific and the spiritual/ethical perspectives. He has made presentations throughout the U.S. and in Canada, New Zealand, Australia, and sixteen countries in Europe, Asia, and South America. He has participated in scientific conferences, lectured at universities (including the Biological Laboratories at Harvard, Tel Aviv University, and the main agricultural university in Denmark) and appeared on several expert panels, including the food safety panel at a conference of the National Research Council and the panel on scientific, safety and regulatory issues at a public meeting of the U.S. Food and Drug Administration. He was also invited to the White House Executive Offices to discuss the environmental risks of agricultural biotechnology at a meeting of the Interagency Sustainable Development Indicator Group of the President's Council on Environmental Quality. He has been a featured speaker at a meeting for M.P.’s at the House of Commons in London; at a symposium at the National Congress of Brazil; and at press conferences sponsored by (a) the Green Party members of the European Parliament (at the Parliament building), (b) the Swedish Consumers Association (in Stockholm), and (c) the Brazilian Medical Association (in Sao Paulo). He has appeared on several nationally broadcast radio and television programs in the U.S. and the other nations he has visited, including several interviews on various BBC programs and presentations at the Cleveland City Club, the Ford Hall Forum in Boston, and the Cambridge Forum, which were aired over National Public Radio. He was also a featured guest on NPR’s The Connection.

Prior to founding the Alliance for Bio-Integrity, he devoted substantial time to the study of human development and ethics and lectured extensively in these fields for professional groups and at universities, including presentations at the Center for Moral Development at the Harvard Graduate School of Education, the Rensselaer Polytechnic Institute, and the San Francisco Lawyers Club. He co-authored the introductory and final chapters of Higher Stages of Human Development, published by Oxford University Press, and wrote a chapter on ethical development for Transcendence and Mature Thought in Adulthood, published by Rowman and Littlefield.

He received his Juris Doctor from the Boalt Hall School of Law at the University of California, Berkeley, where he was elected to the California Law Review and to the Order of the Coif (the legal honor society). He also received his B.A. from U.C. Berkeley. He majored in philosophy, received a special award for "Outstanding Accomplishment" in that field, was elected to Phi Beta Kappa in his junior year, and graduated with "Great Distinction in General Scholarship."