Contact: Steven Druker, ph. 515-472-5554,
or Bob Roth, ph. 515-469-5081
For Immediate Release:
June 24, 1999
Lawsuit in U.S.A. Uncovers Disagreement
Within FDA Over Safety of Biotech Foods
Agency Contradicted Own Experts in Approving Genetically Engineered
-- 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'
False Claims and a Policy at Odds with the Law
The FDA's records reveal it declared genetically engineered foods to
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
FDA Scientists Protest Attempt to Equate Genetic Engineering with
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
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
"...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
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
marketing of substances whose safety has already been demonstrated
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.