Preserving the Safety of Our Food, the Health of Our
and the Harmony of Our Relationship with Nature
Lawsuit Uncovers Disagreement Within FDA Over Safety of Biotech
--Agency Contradicted Own Experts in Approving Genetically
--Misrepresented Facts in Order to Promote U.S. Biotech Industry
Statement by Steven M. Druker, JD, executive director of the Alliance for
Bio-Integrity, coordinator of the lawsuit against the FDA to obtain mandatory
safety testing and labeling of genetically engineered foods, and an attorney
on the case (in collaboration with the legal department of the Center for
Food Safety in Washington, D.C.)
Prying Out the Facts Through Litigation
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 broad 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
FDA Scientists Protest Attempt to Equate Genetic Engineering with Conventional
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
For instance, Dr. Louis Priybl of the FDA Microbiology Group wrote,
"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 stated: "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
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.
For more information contact: Steven Druker (515) 472-5554.
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