Get Ready for FDA Cover-Up on StarLink Corn

The Real Issue of Genetically Engineered Food

Richard Caplan
Environmental Advocate
U.S. Public Interest Research Group, a member of the Genetically Engineered
Food Alert coalition
218 D Street, S.E.
Washington, DC 20003
Work phone (202)546-9707
Home phone (202)544-3555

March 30, 2001

The Centers for Disease Control and Food and Drug Administration (FDA) will
soon jointly announce the results of tests on whether members of the public
had allergic reactions to a type of genetically engineered corn called
StarLink. Both the biotechnology industry and its critics are eagerly
awaiting the results. But the intense focus on allergenicity has obscured
deeper issues: regulatory breakdown, legal transgression, and attempts to
evade liability.

If it turns out that the small sample of individuals who allowed blood
samples to be taken appear not to have had allergic reactions, biotechnology
proponents will complain that critics of genetically engineered food cost
the industry huge sums of money and needless headache.

On the other hand, if the tests confirm that people had allergic reactions,
many critics of genetically engineered crops will say, "We told you so." But
the media and public need to be clear on what we actually told people in the
first place.

A 1996 study published in the New England Journal of Medicine clearly
established that genetic engineering could introduce allergens into crops,
by describing an experiment in which an allergenic gene from a Brazil nut
was spliced into a soybean. But many genetically engineered crops, both in
commercialization and in the laboratory, involve the transfer of genes that
have never been part of the human diet before, making determinations on the
likelihood that the resulting product will be an allergen far more complex.

Industry frequently cites the 1996 research on the Brazil nut-soybean
combination as a successful example of self-restraint, as that particular
product was halted before commercialization. But in fact industry has
continued to move forward in commercializing other products with the same
allergenic gene, a clear and profound disregard for public health.

StarLink corn was approved for animal feed and industrial uses only, but not
direct human consumption. This is because testing on StarLink raised the
possibility that the corn would cause allergic reactions in people. The
developer of StarLink, Aventis, tried to get approval for human consumption
anyway, submitting data that the U.S. Environmental Protection Agency (EPA)
dismissed in part as "significantly flawed." Subsequently, EPA convened two
scientific advisory panels on StarLink, both of which refused to recommend
approval for the corn because of health concerns.

Despite the findings of independent scientists that StarLink corn should not
be allowed into our food, the Genetically Engineered Food Alert coalition
announced in September 2000 a finding of StarLink in Kraft's Taco Bell taco
shells. Tests by our coalition later confirmed StarLink's presence in
Western Family products and Safeway products. Over 300 products were
eventually recalled under a Class II recall by FDA because of health

Although we acknowledged, as do many independent scientists, that StarLink
might make people sick, the real point of our announcement was that Aventis
violated a written agreement they had with the EPA to keep StarLink out of
the food supply. The company put the livelihood of farmers and public health
at risk as a result. Along with health concerns and farmer impacts, the
focus should remain on the disturbing corporate irresponsibility of arguably
the largest biotechnology company in the world.

Another scientific advisory panel, convened by EPA to look at all
genetically engineered crops designed to produce insecticides, published its
analysis in March 2001 of the available science. It stated that the key
proteins in StarLink and many other genetically engineered crops (known as
Bt proteins) "could allergenic sources." And yet Aventis is fighting
bitterly to have StarLink approved as an after-the-fact reward for its
malfeasance. The reward for breaking the law should not be having the law

Regardless of the results of the allergy tests, it's clear the StarLink
debacle is an example of a largely unregulated industry breaking the law and
then seeking to have the rules changed to suit its needs when it is caught.
The United States has weak--and in some cases nonexistent--regulations in
place for genetically engineered foods. It's time to rein in this industry
before it causes more damage. This can be largely accomplished by three
simple things: mandatory and comprehensive safety testing, mandatory
labeling, and liability for any harm caused by these products placed
squarely on the biotechnology companies themselves. Only then will the
debate be properly focused.

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