FDA Policy on GMOs is "irresponsible and illegal"
Date Added to website 2nd April 2014
[Note from GM0Free Cymru: It is often stated that the American policy on GMOs is underpinned by this strange thing called "substantial equivalence." As Steven Druker of the Alliance for Bio-Integrity points out, it is not. American policy is based -- very loosely -- on the principle called GRAS. On the other hand, Europe has placed much greater stress on the woolly and unscientific term "Substantial Equivalence" -- and some bodies have even tried to elevate the term to the status of a "Principle." we will look at that problem -- and it is a problem in Europe -- in a future post. In the meantime, Steven Druker's account below is a chilling reminder that politicians and even judges will go where they want to go, in order to foster the interests of industry, regardless of what the law actually says........]
Unfortunately, the confusion about whether "substantial equivalence" is an operative legal concept in US food safety law continues. It is not. And that's very clear. The operative legal concept is "Generally Recognized as Safe" (GRAS). In contrast to SE, GRAS is well-defined. The document below provides clear definitions of the two GRAS criteria, each of which should have been satisfied by every GE food.
GRAS status cannot rest on hypotheses or theoretical reasoning but must be grounded in solid technical evidence of safety; and that evidence must positively demonstrate that there's a reasonable certainty the specific product will not be harmful. Further, the evidence has to be so well-known and compelling that almost all experts have become convinced of the product's safety. Therefore, such compelling evidence should have been generated for each GE food (and for each insertion event), and it should have been widely available to the scientific community. Moreover, there should not be a significant dispute among experts as to whether safety has been established; and the fact that there always has been, and that it has progressively grown larger, demonstrates that no GE food has ever been legally GRAS.
In our lawsuit challenging FDA policy on GE foods, the issue of "substantial equivalence" was never debated, and the term was not even mentioned in the the judge's opinion. The argument centered on whether the two GRAS criteria had both been met. And because neither had, the judge was forced to play strange games in order to uphold the FDA and avoid upsetting the applecart. The 2nd document posted below explains how the judge evaded confronting the unpleasant truth that neither of the criteria had been met.
Steven Druker
WHY THE FDA'S POLICY ON GENETICALLY ENGINEERED FOODS IS IRRESPONSIBLE AND ILLEGAL
Steven M. Druker, J.D. President and Executive Director Alliance for Bio-Integrity http://www.biointegrity.org/WhyFDAPolicyIrresponsible.htm
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.
1. 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)
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))
3. 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).
4. 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) )
5. 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.
6. 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.
7. As the FDA was developing its policy on GE foods during 1991-92, there was not even consensus about 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.
8. 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 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.
9. In light of these unique risks, agency scientists advised that GE foods should undergo special testing, including toxicological tests. (e.g. 6, 10)
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)
11. 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)
12. 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.
13. 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 that as long as a GE food does not introduce a known toxin or allergen, they would presume that it's 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," even though they had received 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.)
14. 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.
15. 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.
16. 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.
17. 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.
18. 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)
19. Regardless of whether one agrees that the FDA administrators had reasonable basis in 1992 to presume that all GE foods are GRAS, it's obvious that this presumption has been clearly and continuously rebutted, both by the ever-growing dispute among experts and the ongoing lack of adequate testing.
20. 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 the 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.
©Steven M. Druker, 2011 ALLIANCE FOR BIO-INTEGRITY Preserving the Safety of Our Food, the Health of Our Environment, and the Harmony of Our Relationship with Nature
HOW A U.S. DISTRICT COURT REVEALED THE FLAWS IN THE FDA'S POLICY ON GENETICALLY ENGINEERED FOODS
A Report on the Results of Alliance for Bio-Integrity, et al. v. Shalala, et al.
Steven M. Druker, J.D., Executive Director
In May of 1998 the Alliance for Bio-Integrity led an unprecedented coalition of public interest groups, religious leaders, and eminent scientists in filing a lawsuit to reform U.S. Food and Drug Administration (FDA) policy on genetically engineered (GE) foods. The suit was filed in U.S. District Court in Washington, D.C., and its outcome has demonstrated the irresponsibility of FDA policy and the falsity of some of the major claims made in support of GE foods. Proponents of these foods claim that: (a) the FDA rigorously regulates them; (b) FDA policy is science-based; and (c) there is overwhelming scientific consensus that GE foods are safe. But on September 29, 2000 Judge Coleen Kollar-Kotelly issued a ruling that starkly refutes each claim. She determined that:
The FDA is not regulating GE foods at all.
The FDA's politically appointed bureaucrats did not follow the advice and warnings of the agency's scientific staff regarding GE foods but disregarded them.
There were "significant disagreements" among scientific experts about the safety of GE foods.
Further, the judge avoided the issue of whether adequate safety testing has been done and failed to make a determination that GE foods have been demonstrated to be safe – even though such a determination is legally required in order for these foods to be on the market. Despite the above findings, the judge upheld the FDA's policy on narrow technical grounds. As plaintiffs, our burden was to demonstrate that in May 1992, the FDA administrators had abused their discretion by acting arbitrarily and capriciously in adopting the presumption that GE foods are generally recognized as safe (GRAS). This was the key issue: whether the administrators had acted arbitrarily in presuming that GE foods are GRAS, not whether these foods actually are. Ultimately, the judge held that the administrators had not acted arbitrarily and that their policy could therefore stand. However, in reaching her decision, she had to disregard a considerable amount of evidence.
The following paragraphs more fully explain what her opinion said and the facts it ignored, while clearing up several misunderstandings that have been generated.
A. The Suit Entailed Extensive Proceedings and Elicited a Substantial Written Opinion
In referring to the outcome of our suit, proponents of GE foods usually state merely that the court dismissed it, thereby implying that our action had no legal merit and was rejected without the need for substantial legal proceedings. In fact, extensive proceedings occurred during which both sides submitted a series of three written arguments, after which the court issued its ruling in an elaborate written opinion. By mutual agreement, there was not a trial, because there was no need for one. That's because trials are only used to resolve disputed issues of fact, and in our case the material facts were limited to the contents of the documents in the FDA's files – and were therefore undisputed. The court's judgment was not issued until more than two years after we filed the lawsuit, and only after issuing this judgment did the court then dismiss our suit, which is the standard result in such situations.
B. Establishing That the FDA Does Not Regulate GE Foods
Plaintiffs alleged that FDA violated the National Environmental Protection Act (NEPA) by not performing an Environmental Assessment or preparing an Environmental Impact Statement. In response, the FDA argued its policy is not subject to these requirements because it does not regulate GE foods in any manner and is therefore not a significant federal action. The judge agreed with the FDA. She declared that its policy on GE foods is essentially one of "inaction" and does "not impose any … obligations" on the biotech industry.
C. Disregarding Evidence of Disagreement Within the Scientific Community
The FDA claims that GE foods are recognized as safe by an overwhelming consensus among scientists, and this is the sole legal basis on which it has allowed them on the market. The lawsuit refuted this claim by demonstrating there is a substantial conflict among experts. Nine wellcredentialed scientific experts took the unprecedented step of joining the suit as plaintiffs to emphasize their concerns about the hazards of GE foods, and several submitted declarations detailing the scientific grounds for regarding these foods as unreasonably risky.
The judge acknowledged we had introduced many statements from experts explaining that genetic engineering is "inherently risky", and she stated: "Plaintiffs have produced several documents showing significant disagreements among scientific experts." However, she said that because she was specifically reviewing an FDA policy decision of May 1992, she was restricted to consider only the information the FDA had before it at that time. She then ruled that based on that information, the FDA administrators had reasonable grounds to presume there was an overwhelming consensus about safety as of May 1992.
This ruling is puzzling in light of the fact we had called the judge's attention to evidence in the FDA files demonstrating that by 1991 the agency clearly knew there was not a scientific consensus about the safety of GE foods. One significant piece of evidence is a letter of October 23, 1991 from FDA's biotechnology coordinator to a Canadian health official. In commenting on a document that contained proposed guidelines for assessing the safety of GE foods, the biotech coordinator 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." He added: "I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict." (As an aspect of the lawsuit, the FDA was required to give us copies of all its internal files relating to GE foods; and copies of several key documents are posted on our website www.biointegrity.org The letter quoted from is #8 in this set.)
Surprisingly, the judge's opinion failed to mention this letter. It also failed to properly address the fact that by May 1992 the FDA knew that most of its own experts regarded GE foods as more risky than conventional ones – which in itself shows they are not generally recognized as safe. This point is more fully discussed in the following paragraph.
D. Permitting FDA Administrators To Ignore the Warnings of Their Own Experts – and To Misrepresent the Facts
Before the FDA issued its policy statement, it had been extensively informed by its own experts that GE foods are inherently risky and cannot be presumed safe. These records clearly show (1) that the predominant opinion of the agency's own scientific experts was that GE foods pose unique health risks and (2) that they repeatedly cautioned their superiors about these risks. The uniformity of opinion within the FDA's scientific staff is attested by the official responsible for monitoring their 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." (Document #1at www.biointegrity.org ) Further, during the lawsuit the FDA never cited even one document from any of its scientists supporting its claim that GE foods do not pose additional risks and do not need to be tested.
The judge acknowledged the FDA's files contained statements from its scientists "warning" about unintended harmful side effects and "criticizing" the lack of scientific basis for the FDA's policy. However, she held that the agency's politically appointed administrators were legally entitled to establish policy despite the contrary opinion of their scientific staff. Doing so, she disregarded the fact that the FDA administrators were not merely setting policy but were perpetrating a major misrepresentation of reality: they were alleging there is an overwhelming consensus that GE foods are safe when the overwhelming consensus of their own experts was that such foods entail unique risks. Moreover, the judge failed to mention another blatant misrepresentation we had brought to her attention. The FDA administrators had not only disregarded the information from their scientists but had even denied they knew of any such thing. In their formal policy statement they claimed: "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." The law clearly does not grant federal administrators discretion to intentionally misstate basic facts, and it's remarkable that the judge allowed FDA bureaucrats to do so.
E. Overlooking the Fact That No Adequate Evidence of Safety Exists
The law explicitly requires that even if there is overwhelming expert consensus about the safety of a new food (such as GE foods), each product must still be demonstrated safe through "technical evidence." The FDA's own experts clearly informed their superiors about the kinds of tests that are necessary to yield such evidence (e.g. long-term toxicological feeding studies using the whole GE food). But such tests are rarely used for GE foods, and no GE food on the market has been confirmed safe through them – as our scientist-plaintiffs thoroughly explained in statements filed with the court. Moreover, we directed the judge's attention to a memo by an FDA official to the Biotechnology Coordinator admitting that the necessary evidence was lacking: " . . . [A]re we asking the scientific experts to generate the basis for this policy statement in the absence of any data?" (Document #1 at www.biointegrity.org )
Although in her initial summary of the law, the judge stated that technical evidence of safety is required, she then sidestepped this crucial issue and completely failed to address it. Consequently, she did not make any finding that GE foods have been demonstrated to be safe. Had she forthrightly addressed the issue, she would have been obliged to acknowledge that the requisite evidence was lacking in 1992 and was still lacking in 2000 – and that GE foods are on the market illegally.
F. Outcome: Continuation of FDA's 1992 Policy Despite Exposure of its Illegality
The judge ruled that the FDA administrators did not act arbitrarily in 1992 when they presumed that GE foods are generally recognized as safe – even though it is clear from the FDA's own files that (a) such general recognition has never existed within the scientific community and (b) the technical evidence of safety upon which such recognition is legally required to rest has never existed either. The judge did not rule that GE foods actually have been shown to be safe. Nor did she determine that there ever was a general recognition of safety among the FDA scientists or within the scientific community. Moreover, she did not even say that the FDA could justifiably continue to presume that GE foods are safe. Her decision was limited to the particular exercise of discretion made by the FDA in May of 1992. She ruled that at that specific point in time, the FDA was entitled to have presumed there was a general recognition of safety among scientific experts; but she indicated we had presented evidence showing that there was not a general recognition of safety at the time we filed our suit. Further, she emphasized that the FDA's presumption is supposed to be rebuttable by evidence it receives to the contrary. Nonetheless, the FDA continues to pretend that there is an overwhelming consensus among experts that GE foods have been demonstrated to be safe.
Because of the major flaws in the judge's opinion, we filed an appeal in November 2000. Then in January 2001, the FDA proposed new regulations on GE foods. Although these regulations still did not require any safety testing or labeling of GE foods, had they been implemented, they would have replaced the informal policy decision of May 1992 against which our lawsuit was brought. This appeared to render it a waste of time for us to further pursue our suit, because if the proposed regulations had been enacted, our suit would have become moot and we would have needed to proceed against the new regulations by filing a new lawsuit. Therefore, the Alliance for Bio-Integrity and the other plaintiffs in our lawsuit dropped our appeal, intending to bring a new lawsuit when the regulations took effect.
However, after we dropped our appeal, and after a two-year delay in enacting the proposed regulations, the FDA announced it was withdrawing them. So the FDA continues to rely on its policy statement of 1992, and we cannot revive our appeal of the court's decision. Further, because the 1992 policy has already been upheld in a federal court, it might be difficult for anyone else to sustain a new lawsuit against it. This means that GE foods will continue to be unknowingly consumed by most Americans on a daily basis even though they are on the market in stark violation of the food safety laws.
On balance, our lawsuit accomplished a lot by exposing the FDA's fraud and revealing the unsoundness of its policy and the irresponsibility of its behavior. Even though we failed to overturn the FDA's policy, the court's ruling refutes the standard claims of the biotech industry about the rigor of FDA oversight and the proven safety of its gene-altered products. It gives the FDA nothing to be proud of nor does it give the biotech industry anything to brag about. But it does give all consumers something to be very concerned about.