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Legal & Scientific Critique of FDA's "No Labeling, No SafetyTesting" Policy on GE Foods

Legal & Scientific Critique of FDA's "No Labeling,
No SafetyTesting" Policy on GE Foods

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
B. There Was Sufficient Doubt About the Safety of GE Foods Within the FDA's Own Scientific Staff to Nullify GRAS Status
C. The FDA Knows There Has Never Been Expert Consensus About the Safety of GE Foods
D. The FDA Has Made Fraudulent Claims About (a) the Existence of Scientific Consensus and (b) the Safety of GE Foods

II. The Technical Evidence Required for GRAS Status Does Not Exist
III. FDA's Proposed Regulations Are Based on Assumptions That Are Scientifically Unsound
IV. Recognizing the Extent to Which FDA's Behavior is Wrong and Reprehensible

This public comment letter on the FDA's proposed regulation of GMOs is a
must read. Please pass it on to anyone interested in the GMO issue.
Druker is an attorney who filed a public interest lawsuit against the FDA
over lack of safety regulations, phony substantial equivalance and other
unfounded regulations. People need to know just how biotech foods got
regulatory approval. It's shocking!

Comments prepared by Steven M. Druker, Executive Director [Alliance for

2 May 2001

[Docket No. 00N-1396]
Dockets Management Branch [HFA-305]
Food and Drug Administration
5630 Fishers Lane
Room 1061
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).

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.

*Modified on other grounds, 424 F.2d 136 (7th Cir. 1970)

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

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 "S�must have technical evidence of safety, usually in
published scientific studies S�." (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 S� 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

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.

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
(641) 472-5554 <>

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