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Synthesis/Regeneration 21   (Winter 2000)

FDA Documents Show It Ignored
GMO Safety Warnings from Its Own Scientists

by Steven Druker, Alliance for Bio-Integrity

In May 1998, a coalition of public interest groups, scientists, and religious leaders filed a landmark lawsuit against the US 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—totaling 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.

The FDA admits it is operating under a directive "to foster" the US biotech industry...

Besides contradicting the FDA's claim that its policy is science-based, this evidence shows the agency violated the US 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 US 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 US 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.

...every genetically engineered food in the US is on the market illegally...

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 US 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 US law.

This June 24, 1999 press release of the Alliance for Bio-Integrity (P.O. Box 110, Iowa City, IA 52244-0110 Tel: 515-472-5554; Fax:515-472-6431 www.bio-integrity.org) is a statement of its executive director, Steven M. Druker, J.D., 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, DC).

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