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TITLE:  FDA documents show they ignored GMO safety warnings from
        their own scientists
SOURCE: Alliance for Bio-Integrity, U.S., Press Release
DATE:   June 24, 1999

----------------- archive: http://www.gene.ch/ ------------------


FDA Documents Show They Ignored GMO Safety Warnings From Their
Own Scientists
Alliance for Bio-Integrity
P.O. Box 110, Iowa City
IA 52244-0110
Tel: +1-515-472-5554
Fax:+1-515-472-6431
www.bio-integrity.org
Contact: Steven Druker, ph. 515-472-5554, or
         Bob Roth, ph. 515-469-5081

For Immediate Release: June 24, 1999

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Lawsuit in U.S.A. Uncovers Disagreement Within FDA Over Safety of
Biotech Foods
Agency Contradicted Own Experts in Approving Genetically
Engineered Foods -- Misrepresented Facts in Order to Promote U.S.
Biotech Industry

Statement by Steven M. Druker, J.D., executive director of the
Alliance for Bio-Integrity, coordinator of the lawsuit against
the FDA to obtain mandatory safety testing and labeling of gene
spliced foods, and an attorney on the case (in collaboration with
the Legal Department of the Center for Technology Assessment in
Washington, D.C.).

In May 1998, a coalition of public interest groups, scientists,
and religious leaders filed a landmark lawsuit against the U.S.
Food and Drug Administration to obtain mandatory safety testing
and labeling of all genetically engineered foods (Alliance for
Bio-Integrity, et. al. v. Shalala). Nine eminent life scientists
joined the coalition in order to emphasize the degree to which
they think FDA policy is scientifically unsound and morally
irresponsible. Now, the FDA's own files confirm how well-founded
are their concerns. The FDA was required to deliver copies of
these files--totalling over 44,000 pages--to the plaintiffs'
attorneys.


False Claims and a Policy at Odds with the Law

The FDA's records reveal it declared genetically engineered foods
to be safe in the face of disagreement from its own experts--all
the while claiming a broad scientific consensus supported its
stance. Internal reports and memoranda disclose:
(1) agency scientists repeatedly cautioned that foods produced
    through recombinant DNA technology entail different risks
    than do their conventionally produced counterparts and
(2) that this input was consistently disregarded by the
    bureaucrats who crafted the agency's current policy, which
    treats bioengineered foods the same as natural ones.
Besides contradicting the FDA's claim that its policy is science
based, this evidence shows the agency violated the U.S. Food,
Drug and Cosmetic Act in allowing genetically engineered foods to
be marketed without testing on the premise that they are
generally recognized as safe by qualified experts.


FDA Scientists Protest Attempt to Equate Genetic Engineering with
Conventional Breeding

The FDA admits it is operating under a directive "to foster" the
U.S. biotech industry; and this directive advocates the premise
that bioengineered foods are essentially the same as others.
However, the agency's attempts to bend its policy to conform with
this premise met strong resistance from its own scientists, who
repeatedly warned that genetic engineering differs from
conventional practices and entails a unique set of risks.
Numerous agency experts protested that drafts of the Statement of
Policy were ignoring the recognized potential for bioengineering
to produce unexpected toxins and allergens in a different manner
and to a different degree than do conventional methods.

According to Dr. Louis Priybl of the FDA Microbiology Group,
"There is a profound difference between the types of unexpected
effects from traditional breeding and genetic engineering which
is just glanced over in this document." He added that several
aspects of gene splicing "...may be more hazardous."

Dr. Linda Kahl, an FDA compliance officer, objected that 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 said: "The
processes of genetic engineering and traditional breeding are
different, and according to the technical experts in the agency,
they lead to different risks."

Moreover, Dr. Jim Maryanski, the FDA Biotechnology Coordinator,
acknowledged there is no consensus about the safety of
genetically engineered foods in the scientific community at
large, and FDA scientists advised they should undergo special
testing, including toxicological tests.


Misrepresenting the Facts in Order to Approve the Foods

Nonetheless, so strong was the FDA's motivation to promote the
biotech industry that it not only disregarded the warnings of its
own scientists about the unique risks of gene-spliced foods, it
dismissed them and took a public position that was the opposite.
Its official policy asserts: "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...."
Thus, although agency experts advised that genetically engineered
foods should be subjected to special testing, the bureaucrats in
charge of the policy proclaimed these foods require no testing at
all.


Violating Federal Law

Besides violating basic canons of ethics, the FDA's behavior
flagrantly violates the U.S. Food, Drug and Cosmetic Act, which
mandates that new food additives be established safe through
testing prior to marketing. While the FDA admits that
bioengineered organisms fall under this provision, it claims they
are exempt from testing because they are "generally recognized as
safe" (GRAS), even though it knows they are not recognized as
safe even by its own scientists let alone by a consensus in the
scientific community.

Further, the statute prescribes that additives like those in
bioengineered foods can only be recognized as safe on the basis
of tests that have established their harmlessness. But no such
tests exist for gene-spliced foods. So, although the GRAS
exemption was intended to permit marketing of substances whose
safety has already been demonstrated through testing, the FDA is
using it to circumvent testing and to approve substances based
largely on conjecture--conjecture that is dubious in the eyes of
its own and many other experts.

Consequently, every genetically engineered food in the U.S. is on
the market illegally and should be recalled for rigorous safety
testing. The FDA has deliberately unleashed a host of potentially
harmful foods onto American dinner tables in blatant violation of
U.S. law.



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