Comments prepared by Steven M. Druker,
Executive Director [Alliance for Bio-Integrity]
2 May 2001
[Docket No. 00N-1396]
Dockets Management Branch [HFA-305]
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
To Whom It May Concern:
The Alliance for Bio-Integrity (ABI) provides the following comments in response to the Department of Health and Human Services, Food and Drug Administration's ("FDA") "Premarket Notice Concerning Bioengineered Foods" 66 Fed. Reg. 4706 (January 18, 2001).
If it looks like corn and tastes like corn . . . what's the problem???
In submitting these comments, the Alliance for Bio-Integrity incorporates by reference all documents submitted to the District Court and the FDA (including the complaint, legal briefs, and declarations) and all the assertions made therein, as well as the administrative record provided by the FDA, in the case of Alliance for Bio-Integrity, et al, v. Shalala, et al, Docket No. 98-1300 (CKK) (filed May 27, 1998).
More specifically, ABI finds the new FDA proposal to be not only inadequate and contrary to the best scientific knowledge, but (a) contrary to the clear intent of U.S. law and (b) based on misrepresentation. Further, ABI maintains that a full consideration of the evidence makes it difficult to believe that these misrepresentations are innocent mistakes but instead strongly indicates they are fraudulent and are part of a calculated, systematic endeavor to deceive Congress and the American people about the potential health hazards of bioengineered foods (commonly referred to as "genetically engineered" or "GE" foods). This statement is not made lightly but is based on thorough knowledge of the facts, and it is prompted by a belief that such behavior on the part of the agency entrusted with assuring the safety of the nation's food must be clearly categorized as wrong, directly confronted, and promptly corrected.
The following paragraphs explain in detail why the FDA's behavior in permitting the marketing of bioengineered foods is so unscientific, unethical, and unacceptable - and why the proposed regulations must be withdrawn and every bioengineered food withheld from the market until proper testing has confirmed it is safe according to the standard required by law.
I. FDA's Claim That GE Foods Are Generally Recognized As Safe is False and Fraudulent
A. The Required Level of Consensus is Very High
As the FDA's regulations prescribe 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, a significant disagreement prevents a determination that consensus exists. (62 Fed. Reg. At 18939.) Further, it takes only a few experts to provide the requisite level of disagreement. For instance, in United States v. Seven Cartons . . . Ferro-Lac, 293 F. Supp. 660, 664 (N.D. Il. 1968) the court agreed with the FDA that there was not general recognition of safety, based solely on the affidavits of two scientists who said that they were not aware of any studies in the pharmacological-toxicological literature on the intended use of the substance.
B. There Was Sufficient Doubt About the Safety of GE Foods Within the FDA's Own Scientific Staff to Nullify GRAS Status
Prior to the FDA's issuance of its May 1992 policy statement presuming that GE foods are generally recognized as safe (GRAS), its own experts had expressed concerns about the unique potential health hazards of these new foods in numerous memos to agency decision-makers. The pervasiveness of the concerns 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." (FDA Administrative Record (hereinafter "A.R.") at 18,953.) Quotations from many of the FDA scientists are in the briefs we submitted to the court in the previously mentioned lawsuit. The FDA has the original memos in its possession, and photocopies of over twenty key ones are on our website http//www.biointegrity.org Further, although the District Court upheld the FDA on narrow technical grounds in the lawsuit, it acknowledged that concerns had been raised by the FDA experts, and it did not state that the required level of disagreement was lacking. Rather, the court ruled that the upper level administrators had discretion to disregard their experts in making a GRAS determination. Even if this ruling is correct (which is highly dubious), it is still the case that the overwhelming opinion of the FDA experts was that no GE food can be presumed safe unless it has been confirmed so through rigorous toxicological feeding studies.
C. The FDA Knows There Has Never Been Expert Consensus About the Safety of GE Foods
In 1992, when the FDA issued its formal presumption that GE foods are GRAS, it was well aware that not only were they not recognized as safe by its own experts but that there was in fact no consensus in the scientific community at large. This lack of consensus was clearly acknowledged by Dr. James Maryanski, FDA's Biotechnology Coordinator, in a letter to a Canadian official on October 23, 1991. (A.R. at 22925)
Moreover, the FDA is also well aware that substantial disagreement in the scientific community about the safety of GE foods not only continues but is broadening and intensifying - and that it is more than enough to prevent these products from qualifying as GRAS. The mere fact that nine well-credentialed experts joined our lawsuit as plaintiffs and asserted they viewed GE foods as inherently more hazardous than their conventional counterparts was in itself sufficient evidence that the legally required level of consensus does not exist. The District Court clearly acknowledged the lack of consensus by stating: "Plaintiffs have produced several documents showing significant disagreements among scientific experts." However, it said that because it was specifically reviewing FDA's policy decision of 1992, it was restricted to consider only the information the FDA had before it at that time.
However, even if the court was correct in concluding that all evidence since May 1992 was irrelevant for purposes of that particular legal action (a conclusion that appears seriously flawed), it in no way told the FDA it had license to ignore such evidence in making its decisions after that date. But that is precisely what the FDA persists in doing. It systematically disregards the extensive evidence demonstrating the existence of significant expert disagreement about the safety of GE foods that has been presented to it by our lawsuit, at the series of public meetings it held in 1999, and through other formal channels; it pretends that this evidence is somehow nonexistent; and it gives the false impression in its public pronouncements that there is overwhelming consensus about safety.
D. The FDA Has Made Fraudulent Claims About (a) the Existence of Scientific Consensus and (b) the Safety of GE Foods
Accordingly, it is obvious that the FDA's claims (issued in May, 1992 and repeated up to the present) that there is general recognition of safety are not only false but fraudulent. Moreover, the agency has flatly denied having any information showing that GE foods differ in any meaningful way from other foods, even though its own files are replete with such information, much of it from its own experts. One of the most blatant examples of such fraudulent misrepresentation is the following assertion in the agency's formal policy statement of May 29, 1992: "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..." It is difficult for a reasonable man or woman to regard this statement as anything other than a calculated attempt to deceive the public and evade the law.
II. The Technical Evidence Required for GRAS Status Does Not Exist
As the FDA's own regulations make clear, in addition to overwhelming consensus about safety, GRAS status requires that this consensus be based on technical evidence that clearly demonstrates safety. The court acknowledged this requirement, stating that to qualify as GRAS, a substance "must have technical evidence of safety, usually in published scientific studies ." (Citing 21 C.F.R. Sec. 170.30 (a-b); 62 Fed. Reg. 18940.) This means, in the words of FDA's own regulations, 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 there were scientific consensus about the safety of bioengineered foods, the law clearly requires that their safety still must be established through standard scientific tests.
The evidence presented in our lawsuit made it clear that such technical evidence of safety does not currently exist for any GE food. Interestingly, although we plaintiffs emphasized this point in our legal briefs, and although the court acknowledged a requirement for technical evidence in its opinion, the opinion then drops the subject completely and never addresses the issue of whether such evidence actually exists in the case of GE foods. Consequently, there has yet to be an actual judicial ruling on this particular issue, and the FDA is not justified in claiming that such technical evidence exists.
Yet, in practice, the FDA does try to give the impression that there has been scientific demonstration of safety. 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." Yet 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 Š consistent with its 1992 policy." (Reported in The Lancet, May 29, 1999) Moreover, according to the FDA's own experts, the most extensive test it did review (on the Flavr Savr tomato) raised an unresolved safety issue. (A.R. 004258-60; 005092-95; 005117-19)
III. FDA's Proposed Regulations Are Based on Assumptions That Are Scientifically Unsound
As noted above, FDA's proposed regulations do not rest on solid evidence. Rather, besides the agency's fraudulent claims about GRAS status, its regulations rest on an unfounded assumption - the assumption that producing new varieties of food-yielding organisms through recombinant DNA technology ("genetic engineering") is inherently no more hazardous than doing so through traditional breeding. Not only is this assumption empirically unsubstantiated, the weight of the evidence is against it. The FDA has already been extensively informed about the unique potential for GE foods to contain unexpected and harmful substances. (e.g. Center for Food Safety Comments of April 10, 2001) Recent evidence provides added justification for concern about unexpected side effects.
First, the discoveries of the human genome project released in early 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. For instance, Aventis's data revealed statistically significant differences between T25 herbicide-resistant maize and its conventional counterpart in terms of carbohydrate, amino acid and fatty acid composition.
Research at the Rowett Institute on two lines of GE potatoes found several statistically significant compositional differences between each one and the nonGE parental line. Further, there was even statistically significant difference between the two GE lines, although they were derived from the same line using the same foreign gene - indicating that the effects of an inserted gene vary with its position. Moreover, the Public Health Association of Australia (PHAA) analyzed Monsanto's data on three GE plants (herbicide resistant maize and canola, and pesticide-producing maize) and in all three cases discovered several statistically significant differences in chemical composition from the nonGE counterpart. The PHAA report (October 2000) 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. (This report is attached.)
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.
IV. Recognizing the Extent to Which FDA's Behavior is Wrong and Reprehensible
Based on all the evidence, it is difficult for any rational and morally aware individual to condone the FDA's behavior; and it is high time that those responsible for this ongoing behavior be confronted with the fact that what they are doing is deeply wrong and reprehensible. The FDA's behavior is more than irresponsible and even more than unconscionable. It is criminal. It is clearly criminal for officials entrusted with ensuring the safety of the nation's food to be allowing a flood of new products on the market when they have been adequately informed by their own and other experts that these products entail unique human health hazards. And it is yet more criminal for these officials to repeatedly lie about the facts to the public and its elected officials.
Those FDA officials who have knowingly perpetrated or facilitated such fraud must realize that someday soon they may well be prosecuted and imprisoned - especially if some GE foods cause widespread death and disability. Their misdeeds are fully documented and they cannot long escape a formal reckoning.
For now, the only way the agency can even begin to atone for its crimes is to openly acknowledge the facts and promptly ban every GE food unless and until it is established safe in the rigorous manner prescribed by law. Anything less is legally and morally unacceptable.
Modified on other grounds, 424 F.2d 136 (7th Cir. 1970)
Alliance For Bio-Integrity
Preserving the Safety of Our Food, the Health of Our Environment,
and the Harmony of Our Relationship with Nature
406 West Depot Avenue, Fairfield, Iowa 52556