WHY THE FDA’S POLICY ON GENETICALLY ENGINEERED FOODS
IS IRRESPONSIBLE AND ILLEGAL
Steven M. Druker, J.D.
Alliance for Bio-Integrity
Copyright © 2011
Although most Americans (including those who serve in government) are unaware of it, genetically engineered foods are on the market only because the U.S. Food and Drug Administration (FDA) has covered up the warnings of its own scientists, misrepresented the facts, and violated explicit mandates of U.S. law. The following points provide the details and describe the solution.
The Food Additive Amendment of the U.S. Food, Drug and Cosmetic Act institutes a precautionary approach and requires that new additives to food must be demonstrated safe before they are marketed. (21 U.S.C. Sec. 321)
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))
Although the FDA admits that the various genetic materials implanted in bioengineered organisms are within the amendment’s purview, it claims they are exempt from testing because they are generally recognized as safe (GRAS).
However, the FDA’s regulations state that substances added to food that were not in use prior to 1958 cannot qualify as GRAS unless they meet two requirements. Not only must they be acknowledged as safe by an overwhelming consensus of experts, but this consensus must be based on “scientific procedures” – which ordinarily entails studies published in peer-reviewed journals. (21 CFR Sec. 170.30 (a-b) )
FDA regulations further stipulate that these scientific procedures must provide a demonstration of safety and that GRAS substances “…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)) Thus, it’s clear that the GRAS exemption is not supposed to reduce the degree of testing but rather to relieve a producer from performing new tests for substances already known to be safe on the basis of previous ones.
Genetically engineered (GE) foods fail both requirements. There is substantial dispute among experts about their safety; and none has been confirmed safe through adequate testing.
As the FDA was developing its policy on GE foods during 1991- 92, there was not even consensus of safety among its own experts. The predominant opinion was (a) that these new foods entail unique risks, especially the potential for unintended harmful side effects that are difficult to detect and (b) that none can be considered safe unless it has passed rigorous tests capable of screening for such effects. These scientists expressed their concerns in numerous memos to superiors – memos that only came to light in 1998 when the Alliance for Bio-Integrity initiated a lawsuit that forced the FDA to divulge its files.
For example, microbiologist Dr. Louis Pribyl stated: “There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering ….” He added that several aspects of gene- splicing “. . . may be more hazardous . . .” (#4 in the set of photocopies of FDA memos at http://www.biointegrity.org/list.html Numbers after subsequent quotes from FDA scientists refer to the number in this set.) Similarly, Dr. E.J. Matthews of the FDA’s Toxicology Group warned that “. . . genetically modified plants could … contain unexpected high concentrations of plant toxicants…,” and he cautioned that some of these toxicants could be unexpected and could “…be uniquely different chemicals that are usually expressed in unrelated plants.” (2) Citing the potential for such unintended dangers, the Director of FDA’s Center for Veterinary Medicine (CVM) called for bioengineered products to be demonstrated safe prior to marketing. He stated: “… CVM believes that animal feeds derived from genetically modified plants present unique animal and food safety concerns.” (10) (emphasis added) He explained that residues of unexpected substances could make meat and milk products harmful to humans.
In light of these unique risks, agency scientists advised that GE foods should undergo special testing, including toxicological tests. (e.g. 6, 10)
The pervasiveness of the concerns within the scientific staff is attested by a memo from an FDA official who protested the agency was “… trying to fit a square peg into a round hole . . . [by] trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices.” She declared: “The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks.” (1)
Moreover, FDA officials knew there was not a consensus about the safety of GE foods among scientists outside the agency either. For instance, FDA’s Biotechnology Coordinator acknowledged in a letter to a Canadian health official that there was no such consensus in the scientific community at large. He also admitted, “I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict.” (8)
This lack of consensus in itself disqualifies GE foods from GRAS status. But even if consensus did exist, no GE food would qualify as GRAS because none has satisfactorily passed the level of testing that the law requires – and that the FDA experts stated is necessary. The agency’s files demonstrate that as of 1992, there was virtually no evidence to support safety, with one official’s memo to the Biotechnology Coordinator querying: ” … are we asking the scientific experts to generate the basis for this policy statement in the absence of any data?”(1). And the evidentiary base is still deficient because the FDA does not require any testing; and the tests relied on by the EU, Canada, and others do not adequately screen for the unexpected side effects about which the FDA scientists warned. The inadequacy of current testing has been pointed out by numerous experts, including the Royal Society of Canada and the Public Health Association of Australia.
Despite the ample evidence indicating a lack of consensus about safety, as well as the lack of requisite evidence to confirm it, the FDA’s decision-makers (who acknowledge they’ve been operating under a policy “to foster” the U.S. biotechnology industry) declared it is legitimate to presume that all GE foods are GRAS – and can therefore be marketed without any testing. In doing so, they professed themselves “not aware of any information” showing that GE foods differ from others “in any meaningful way,” despite the extensive input from their scientists pointing out the significant differences and their serious implications. (Statement of Policy: Foods Derived From New Plant Varieties, May 29, 1992, Federal Register vol. 57, No. 104 at 22991.)
Although many people have been led to believe that the U.S. district court in Alliance for Bio-Integrity v. Shalala determined that GE foods are on the market legally, its decision actually highlights the extent to which their presence is contrary to the law.
In her written opinion, the judge stated: “Plaintiffs have produced several documents showing significant disagreements among scientific experts.” 116 F.Supp.2d 166 (D.D.C. 2000) at 177. However, she ruled that the crucial issue was not whether GE foods were in fact GRAS at the time of the lawsuit (or were actually GRAS when the FDA issued its policy statement on GE foods in May 1992) but whether FDA administrators had acted arbitrarily in 1992 in presuming that they were GRAS. Therefore, because she held that the case hinged on this narrow procedural issue of whether there had been adequate rational basis for the FDA’s presumption, she said that any evidence showing lack of expert consensus at the time of the lawsuit was irrelevant since it was not within the administrators’ purview when they formed their policy in 1992.
As for the evidence that had been within the FDA’s own files in 1992, she ruled that the administrators were free to disregard the opinions of subordinates when setting policy. (p.178) This conclusion seems odd, since the written opinions of the agency’s scientists represented far more than mere policy preferences. They constituted solid evidence that a significant number of experts did not recognize GE foods as safe. Further, the judge did not mention the fact that the FDA’s biotechnology coordinator had admitted there was not a consensus within the scientific community, even though plaintiffs’ briefs had repeatedly cited the relevant document.
Moreover, the judge also disregarded the fact (repeatedly pointed out to her) that the FDA’s files demonstrated there was insufficient technical evidence about safety to support a presumption that GE foods are GRAS. Although her opinion initially acknowledged that such technical evidence is legally required, she never returned to the issue – a highly irregular outcome.
Thus, the judge did not determine that GE foods are (or ever were) truly GRAS. Nor did she determine that any has been demonstrated safe. She merely held that given the evidence before them in 1992, FDA officials had not acted arbitrarily in presuming that the foods were GRAS. Further, she emphasized that their presumption is, as a matter of law, “rebuttable.” (p.172)
Regardless of whether one agrees that FDA administrators had reasonable basis in 1992 to presume that GE foods are GRAS, it’s obvious this presumption has been decisively rebutted, both by the ever-growing dispute among experts and the ongoing lack of adequate testing.
Consequently, the marketing of GE foods in the U.S. is illegal because none of them is GRAS and none has undergone formal food additive approval. To rectify this situation, the FDA needs to acknowledge the truth, admit that GE foods are not GRAS, and remove them from market. And it must not allow any such product to be re-introduced until it has been confirmed safe through the testing required by law. To do so, the agency does not have to reverse any official determinations, because it has never formally determined that any GE food is GRAS or that any has been demonstrated safe. It merely has to acknowledge that its rebuttable presumption has been solidly rebutted. Otherwise, it will remain in violation of the law – and will continue to deprive Americans of the safeguards that Congress has explicitly mandated.
The following paragraphs more fully document the extent of the FDA’s malfeasance.
A. Addressing the extensive death and disability caused by a GE food
In 1989, the Japanese manufacturer Showa Denko K.K. began marketing a food supplement of the amino acid L-tryptophan that was produced with genetically engineered bacteria. As part of the process, several genes to substantially increase the output of tryptophan were spliced into the bacterial DNA. Within a few months of entering the U.S. market, the bioengineered supplement caused an epidemic of an unusual malady (called EMS) that resulted in the deaths of dozens of people and the permanent disability of at least 1,500 others.
For many preceding years, other manufacturers had marketed food grade L-tryptophan supplements produced from bacteria without use of gene-splicing. Epidemiological evidence from the Center for Disease Control does not link any tryptophan from these other manufacturers with outbreaks of EMS. (Kilbourne, E. Journal of Rheumatology Supplement, vol. 46, Oct. 1996) Further, Showa Denko’s bioengineered tryptophan was found to contain numerous contaminants, at least two of which were novel and had not been seen in any of those conventionally produced batches. It is still not known which contaminant (or combination of them) caused the epidemic.
Although there is no conclusive proof that EMS resulted from genetic engineering, the link has not been ruled out; and many experts think it’s likely that whatever toxin caused the disease was an unexpected side effect of the gene-splicing procedure.
In private, FDA officials confirm that the bioengineering process might have caused the EMS. On September 27, 1991, Dr. James Maryanski, Coordinator of FDA’s Biotechnology Working Group, was questioned by staff of the GAO. According to his record of the meeting: “I said that we have no new information, that we do not yet know the cause of EMS nor can we rule out the engineering of the organism.” Emphasis added. (FDA Administrative Record at 22,923) When I questioned him in private eight years later, Dr. Maryanski again admitted that bioengineering cannot be ruled out. (Personal conversation, Washington, D.C. November 30, 1999)
FDA’s Public Response: On July 18, 1991, Dr. Douglas L. Archer, Deputy Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), testified before the House of Representatives Subcommittee on Human Resources and Intergovernmental Relations about the L-Tryptophan tragedy. He said the incident confirmed the FDA’s warnings about the hazards of many health food supplements and that the deaths and injuries “demonstrate the dangers inherent in the various health fraud schemes that are being perpetrated on segments of the American Public.” Dr. Archer’s prepared remarks never indicated that the toxic batches of L-Tryptophan had been produced through genetic engineering, nor did he once raise the possibility it was this process rather than any presumed problems with L-Tryptophan supplements in general that was the cause of the illnesses.
The FDA and other agencies of the federal executive branch continue to cloud the fact that the fatal L-Tryptophan was derived through bioengineering and persist in the false claim that no GE food has even been associated with a human health problem.
B. Addressing the tests on the “Flavr Savr” tomato
The first GE whole food that the FDA reviewed was Calgene’s “Flavr Savr” tomato. Although the FDA did not require testing, Calgene voluntarily subjected the tomato to animal feeding studies and asked the agency to review the data. FDA scientists noted a pattern of stomach lesions that raised a safety issue. Further, seven of the rats fed one variety of the GE tomato died within two weeks. Commenting on the data, Dr. Robert J. Scheuplein, director of the FDA’s Office of Special Research Skills, wrote: “… the data fall short of ‘a demonstration of safety’ or of a ‘demonstration of reasonable certainty of no harm’ which is the standard we typically apply to food additives. To do that we would need, in my opinion, a study that resolves the safety question raised by the current data.”(15) Dr. Carl B. Johnson of the Additives Evaluation Branch concurred that “… unresolved questions still remain.” (16)
It is noteworthy that FDA officials had instructed their experts to apply a lower safety standard in evaluating the tomato than the standard used for new food additives. (Scheuplein memo, p.4) In doing so, they violated the FDA’s own regulations, which (as earlier noted) mandate that even foods claimed to be GRAS “…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))
FDA Response: The agency claimed that all relevant safety issues had been satisfactorily resolved and said that because the Flavr Savr had performed so well, it would be unnecessary for any subsequent bioengineered food to be subjected to the same standard of testing. To date, there is no reliable evidence showing that any has satisfied the standard the Flavr Savr failed to meet.
C. Addressing the use of antibiotic resistant marker genes
Because most cells subjected to gene implantation techniques fail to incorporate the foreign gene, a large number must be used, and a marker must be attached to the foreign gene in order to identify the cells that have taken it up. The manufacturers decided that genes coding for resistance to anti-biotic chemicals would be the most economical markers. They especially desired to use a gene that confers resistance to kanamycin, a broad-spectrum antibiotic with a significant medical use. On September 30, 1992, FDA’s Biotechnology Coordinator requested the Division of Anti-Infective Drug Products to evaluate the proposed use of the kanamycin resistance marker gene. (11) On December 3, 1992, the Division’s experts submitted their written opinion. To emphasize their concern, they capitalized all the letters in the key sentence of their conclusion: “IT WOULD BE A SERIOUS HEALTH HAZARD TO INTRODUCE A GENE THAT CODES FOR ANTIBIOTIC RESISTANCE INTO THE NORMAL FLORA OF THE GENERAL POPULATION.” Emphasis in original (12) In sending the document to another FDA official, the Division’s director included a cover letter titled, “The tomatoes that will eat Akron.” (The first commercial use of the marker was planned for the Flavr Savr tomato.) He said: “You really need to read this consult. The Division comes down fairly squarely against the kan gene marker in the genetically engineered tomatoes. I know this could have serious ramifications.” (12)
On March 30, 1993 the Division’s Supervisory Microbiologist sent a follow-up memo to the Biotechnology Coordinator in which he strongly criticized the proposed use of the marker. He noted that although other markers are available, industry prefers the anti-biotic resistant ones because they are more economical. He stated that to make the choice on this basis was wrong, considering the risks involved: “In my opinion, the benefit to be gained by the use of the kanamycin resistance marker in transgenic plants is out weighed by the risk imposed in using this marker and aiding its dissemination nation wide. If we allow this proposal, we will be adding a tremendous quantitative load of genetic material to the environment which will probably assure dissemination of kanamycin resistance.” (13)
FDA Response: The agency approved the use of the kanamycin resistance gene not only in tomatoes but in other vegetables as well. Consequently, for many years, most GE foods contained anti-biotic resistance genes. Because most experts have come to agree that it’s more prudent to employ different markers, changes have slowly been made to correct a situation the FDA scientists tried to prevent from happening in the first place.
D. What the FDA says in public
In addition to the false statements noted in the previous sections, the agency has continued to misrepresent the facts. For example, on February 28, 2000, Dr. James Maryanski, the agency’s primary spokesperson on GE foods at that time, responded to revelations in the British press about the memos in the FDA files while addressing the OECD Conference on GE Food Safety in Edinburgh, Scotland. He stated that the staff scientists had merely been “asking questions” about the various issues involved in bioengineered food. But as their own memos clearly indicate, they were making declarative statements, many of them quite emphatic, about the unique potential of bioengineering to induce unintended and unpredictable negative side effects. Further, 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 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, May 29, 1999) Moreover, as previously pointed out, the most extensive test it did review (on the Flavr Savr tomato) raised a safety issue that, according to its own experts, was never resolved.
E. The FDA has an agenda to promote the U.S. biotech industry
The FDA’s acknowledged policy “to foster” the U.S. biotechnology industry is part of a broader executive policy that was initiated by the Reagan/Bush administration – and has continued through each successive administration, including Clinton/Gore and Obama/Biden. Further, when in 1991 the FDA created a new position of Deputy Commissioner for Policy to supervise the formulation of its policy on GE foods, it appointed Michael Taylor, a Washington, D.C. lawyer who had been representing Monsanto and other members of the biotech industry on food regulatory issues. During Mr. Taylor’s tenure as Deputy Commissioner, references to the potential unintended negative effects of bioengineering were progressively deleted from drafts of the policy statement (over the protests of agency scientists), and the final statement was issued claiming (a) that GE foods are no riskier than others and (b) that the agency has no information to the contrary. (Subsequently, Mr. Taylor was hired by Monsanto as Vice-President for Public Policy.) Moreover, when Vice-President Dan Quayle introduced the FDA’s policy statement in 1992, he referred to it as “regulatory relief” for the industry.