(This is the very last paragraph of the following report. I wanted to open with it as it deserves saying twice!).
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. And it’s high time that the American people were informed of this fact.
WHY THE FDA’S POLICY ON GENETICALLY ENGINEERED FOODS
IS FRAUDULENT AND ILLEGAL
Steven M. Druker, J.D.
Executive Director
Alliance for Bio-Integrity
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.
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)
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). (Statement of Policy: Foods Derived From New Plant
Varieties, May 29, 1992, Federal Register vol. 57, No. 104 at 22991)
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 entail 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 lawsuit led by the Alliance for Bio-Integrity forced the FDA to
divulge its files. [Copies of these FDA memos are posted on www.biointegrity.org]
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 . . ." (FDA Document 4 at
http://www.biointegrity.org) 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." (FDA Document 2 at
http://www.biointegrity.org) 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 [emphasis added] animal and food safety concerns." (FDA Document 10 at
http://www.biointegrity.org) 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. FDA Documents 2 and 6 at http://www.biointegrity.org)
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." (FDA Document 1 at http://www.biointegrity.org)
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." (FDA Document 8 at http://www.biointegrity.org)
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?” (FDA Document 1 at
http://www.biointegrity.org) 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. (Also see paragraph 27 below.)
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. (The agency’s promotional policy was acknowledgement in “Genetically
Engineered Foods,” FDA Consumer, Jan.-Feb. 1993, p.14. Its fraudulent denial of awareness appears
in: 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 made 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. (Alliance for Bio-Integrity v. Shalala. 116 F. Supp. 2d 166 (D.D.C. 2000) at p. 179)
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. (116
F.Supp.2d 166 (D.D.C. 2000) 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
failed to 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 emphasized it and cited
the relevant document.
17. She additionally disregarded the fact (which had also been clearly 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. Therefore, because she ignored so much important evidence, her ruling is highly questionable.
It’s also quite narrow. She 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. This is a crucial point, because even if one believes that the FDA administrators had reasonable
basis in 1992 to presume that all GE foods are GRAS, it’s obvious that their rebuttable presumption
has been clearly and continuously rebutted – both by the ever-growing dispute among experts and the
ongoing lack of adequate testing.
20. Moreover, the lack of consensus and the lack of evidence are glaringly apparent, as the next seven
paragraphs amply demonstrate.
21. In the Alliance for Bio-Integrity lawsuit, nine of the plaintiffs were well-credentialed life
scientists (including tenured professors at UC Berkeley, Rutgers, the University of Minnesota, and the
NYU School of Medicine) who asserted they did not regard GE foods as safe. As noted in paragraph
15 above, the judge acknowledged we had demonstrated there were “significant disagreements
among scientific experts.” This in itself established that as of May 1998, GE foods could not be
considered GRAS.
22. The following year, the respected medical journal The Lancet strongly criticized the presumption
that GE foods entail no greater risks of unexpected effects than conventional foods, 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.”
(The Lancet, Volume 353, Issue 9167, Page 1811, 29 May 1999)
23. In 2001, an expert panel of the Royal Society of Canada issued a report declaring (a) that it is
“scientifically unjustifiable” to presume that GE foods are safe and (b) that the “default presumption”
for every GE food should be that the genetic alteration has induced unintended and potentially
hazardous side effects. (“Elements of Precaution: Recommendations for the Regulation of Food
Biotechnology in Canada; An Expert Panel Report on the Future of Food Biotechnology prepared by
The Royal Society of Canada at the request of Health Canada Canadian Food Inspection Agency and
Environment Canada” The Royal Society of Canada, January 2001) In describing the report’s
criticism of the current approach to regulating GE foods, the Toronto Star stated: “The experts say
this approach is fatally flawed … and exposes Canadians to several potential health risks, including
toxicity and allergic reactions.” (Calamai, P., “Ottawa Rapped, Expert Study Considered Major
Setback for Biotech Industry,” Toronto Star , February 5, 2001)
24. The British Medical Association has also expressed reservations about the safety of these novel
products. As described in the British Medical Journal, the Association released a 2004 report stating
that “more research is needed to show that genetically modified (GM) food crops and ingredients are
safe for people and the environment and that they offer real benefits over traditionally grown foods.”
(Kmietowicz, Z. “GM Foods Should Be Submitted to Further Studies, says BMA,” British Medical
Journal, 2004 March 13; 328(7440): 602)
25. In October 2013, a large number of well-qualified experts signed a statement asserting that there
is not a consensus about the safety of GE foods and that their safety has not been adequately
demonstrated. As of December 10 of that year, the statement had 297 signatories.
(http://www.ensser.org/increasing-public-information/no-scientific-consensus-on-gmo-safety/)
26. Thus, the absence of requisite consensus is irrefutable, especially in light of the fact that the FDA
has, in court, established that an additive was not GRAS merely by producing testimony from two
experts who did not regard it as safe. (United States v. Seven Cartons . . . Ferro-Lac, 293 F. Supp.
660, 664 (N.D. Il. 1968)
27. Further, not only has there never been a genuine consensus about the safety of GE foods, the
evidentiary base on which such a consensus is legally required to rest has never existed either – and is
still absent. This is well-attested by David Schubert, a professor at the Salk Institute for Biological Studies, who recently asserted: “As a medical research scientist who published a comprehensive,
peer-reviewed critique of genetically modified food safety testing, I can state confidently that it is
false to say such foods and the toxic chemicals they require are extensively tested and proved safe. No
producer-independent safety testing, long-term or multigenerational rodent studies or epidemiological
studies have been done to support the hypothesis that these foods are safe.” (Letter to the LA Times,
October 28, 2012)
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. And it’s high time that the American people were informed of this fact.
