U.S. Law Requires That GE Foods Be Proven
Safe
- U.S. food safety law has mandated the precautionary approach since
1958. In that year, Congress passed the Food Additive Amendment to
the Food, Drug and Cosmetic Act requiring that new additives to food
be demonstrated safe through standard scientific testing 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) This clearly
shows that the precautionary principle is the cornerstone of food
safety law in the United States.
- However, although the Bush Administration is legally required to
uphold the precautionary principle at home and honor it abroad, it
is doing neither. Instead, it claims that the principle is an illegitimate
restraint on business and trade - and that the US is free to disregard
it and to resist its application by the EU. As reported in the New
York Times on May 18, "The Bush administration believes the precautionary
principle is an unjustified constraint on business and does not even
recognize the existence of the doctrine."
- If the U.S. government was following the law, not only would it
respect the EU's precautionary policy on GE foods, it would have prevented
these foods from coming to market in America until they had been proven
safe.
- By allowing GE foods to be marketed without proof of safety, the
U.S. Food and Drug Administration (FDA) is violating its own laws;
and it attempts to justify this violation by fallacious arguments.
- While FDA administrators acknowledge that pieces of foreign DNA
spliced into an edible plant (and all substances produced by them)
are in principle food additives, they claim these genes and gene-products
are exempt from the testing ordinarily required for additives because
they are "generally recognized as safe" (GRAS).
- This claim is patently false. The law specifies that in order to
be classified GRAS, foods containing new additives must meet two requirements;
and GE foods do not fulfill either of them.
- First, as both the FDA's regulations 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, any significant disagreement prevents
a determination that consensus exists.
- The requisite consensus for GE foods has never existed, and the
FDA is well aware of it because the predominant consensus among its
own experts was that these foods entail unique risks and cannot be
presumed safe. This was revealed when my organization brought a lawsuit
against the FDA that forced it to divulge its files. As these files
show, the FDA's scientists repeatedly warned their superiors that
genetic engineering can disrupt the organism in unpredictable ways
and cause the production of unintended harmful substances that are
difficult to detect. For instance, an FDA toxicologist cautioned that
GE plants could contain unexpected toxins that might "...be uniquely
different chemicals that are usually expressed in unrelated plants."
(Photocopies of 24 key FDA documents are in a numbered set on our
website www.biointegrity.org The preceding quote is from #2.)
- The pervasiveness of concern within the FDA's scientific staff is
attested by the official responsible for summarizing the expert 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." (FDA Document #1 at
www.biointegrity.org ) Because of the potential for unexpected harmful
effects, the FDA experts stated that every GE food should undergo
rigorous testing to screen for them.
- Further, FDA's Biotechnology Coordinator admitted there is not a
consensus about safety among experts outside the FDA either. On October
23, 1991, he wrote a letter to a Canadian health official commenting
on a document that discussed GE foods. He 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." (FDA Document
#8)
- Today, experts are far more divided about the safety of GE foods
than in 1991. For instance, hundreds have signed an open letter calling
for a moratorium, and a 2001 report of the expert panel of the Royal
Society of Canada states that (a) it is "scientifically unjustifiable"
to presume that GE foods are safe and (b) the "default presumption"
for every GE food should be that the genetic alteration has induced
unintended and potentially hazardous side effects.
- But even in the case of unanimity, U.S. law additionally prescribes
that consensus cannot rest on hypotheses but must be based on scientific
evidence that clearly establishes safety. Both the FDA's regulations
and the federal courts have consistently held that such evidence should
include studies published in the peer-reviewed scientific literature.
(21 CFR Sec. 170.3(h)). Moreover, FDA regulations emphasize that the
tests supporting a general recognition of safety "...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)) This means, in the FDA's words, 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 expert consensus about the safety
of GE foods actually existed, the law requires that their safety still
must be established through standard scientific tests.
- Again, the FDA's own files reveal this requirement has not been
met. One of the agency's scientists noted "the paucity of data"
about GE foods (FDA Administrative Record at 18695), and another wrote
a memo to the Biotechnology Coordinator saying: " . . . (A)re
we asking the scientific experts to generate the basis for this policy
statement in the absence of any data?" (FDA document #1.)
- Further, because the FDA does not require tests of GE foods and
performs no substantial scientific reviews, it still has no evidence
demonstrating that any are safe. As the agency has itself acknowledged:
"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, Vol. 353, No.
9167, May 29, 1999) Moreover, eminent experts have made formal declarations
that no GE food has been proven safe according to the legal standard.
(e.g. www.biointegrity.org/laceydeclaration.html )
In Order to Promote GE Foods, the FDA Is
Breaking the Law and Misrepresenting the Facts
- However, as the FDA administrators themselves admit, they have been
operating since 1987 under an ongoing White House directive "to
foster" the biotech industry. And in their desire to do so, they
claimed there is an overwhelming consensus among experts that GE foods
are as safe as others, even though they knew that their own experts
regarded them as uniquely hazardous and that no such consensus exists
in the scientific community.
- Further, although US law requires that every GE food be demonstrated
safe prior to marketing, and although the FDA experts called for extensive
safety testing as a matter of scientific as well as legal necessity,
the FDA administrators allowed GE foods to be marketed without requiring
any safety testing at all. And to deepen the deception, besides disregarding
their experts' warnings, they covered them up and then denied they
had received any such input by claiming: "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…."
(Federal Register vol. 57, No. 104 at 22991.)
- To date, the sole purported legal basis for the marketing of GE
foods in the U.S. is the blatantly false claim that they are recognized
as safe by an overwhelming consensus of scientific experts.
Summary and Conclusion
- The U.S. government requires no testing of GE foods and has no reliable
evidence they are safe; it has disregarded and misrepresented the
warnings of its own scientists; its own law mandates the precautionary
principle, yet it attacks that principle as a grievous violation of
international law; and the sole purported legal basis for its approval
of GE foods is the fraudulent claim they are generally recognized
as safe.
- In light of the above facts, the U.S. challenge to the EU's policy
on GE foods is quite vulnerable, especially because it appears that
any member of the WTO is empowered by WTO rules to adopt the standard
dictated by U.S. law; and the U.S. could not justifiably object to
it. (Agreement on Sanitary and Phytosanitary Measures, Art. 5 paragraph
7).
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