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    • Agency covered up warnings of its own scientists about unique health risks
    • Has continually misrepresented the facts in order to promote the biotech industry

    Uncovering government misbehavior through litigation

    Internal files of the U.S. Food and Drug Administration reveal it has been deceiving the world about the hazards of genetically engineered (GE) foods for almost a decade. This shocking news came to light when a lawsuit forced the FDA to divulge copies of these files (over 44,000 pages). The suit, initiated in May 1998, was coordinated by the Alliance for Bio-Integrity, a non-profit public interest organization which assembled an unprecedented coalition of eminent scientists and religious leaders to stand as plaintiffs. These plaintiffs demand that the FDA uphold its duty under the Food, Drug and Cosmetic Act to ensure that all GE foods are adequately safety tested and labeled.

    FDA scientists protested the attempt to equate GE foods with naturally produced food

    The FDA admits it has been operating under a White House directive "to foster" the biotech industry. Under this directive, FDA was instructed to base its policy on the premise that GE foods are essentially the same as others. However, the agency's own scientists rejected this premise and repeatedly warned that genetic engineering entails a unique set of risks. They emphasized that in contrast to conventional methods, this new technology can produce unintended and essentially unpredictable new toxins, carcinogens and allergens. They cautioned that a GE food could not be considered safe unless it had undergone rigorous feeding tests. Photocopies of 24 FDA documents are at along with more detailed discussions of FDA misbehavior.

    Misrepresenting the facts in order to market the foods

    Nevertheless, FDA bureaucrats disregarded their experts' input and in May, 1992 instituted a policy that presumes GE foods are as safe as conventional ones and do not require any testing. Further, they covered up the memos from their scientists and then declared themselves unaware of any differences between GE foods and others. They have continued to issue deceptive statements for over eight years.

    "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." Dr. Linda Kahl, FDA compliance officer, memo to FDA Biotechnology Coordinator, January 8, 1992.

    "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..." FDA Policy Statement, May 29, 1992

    "there are scientifically justified concerns about the safety of genetically engineered foods and some of them could be quite dangerous. It is because I view the FDA's policy and practices regarding genetically engineered food to be irresponsible -- and because I regard the consequent risk posed for public health to be substantial -- that I have taken the step of joining the lawsuit as a plaintiff." Dr. Philip J. Regal, Professor of Ecology, Behavior and Evolution at the University of Minnesota, an internationally renowned expert in plant genetics. One of nine scientist-plaintiffs in the lawsuit.

    "The FDA has knowingly endangered public health in order to promote the financial interests of giant corporations. In doing so, it has systematically lied and flagrantly violated federal law. It is high time this national disgrace be rectified. All genetically engineered foods must be promptly removed from the market and subjected to the rigorous safety testing called for by the FDA's scientists and required by the Food, Drug and Cosmetic Act." Steven M. Druker, J.D. Executive Director, Alliance for Bio-Integrity; organizer of the lawsuit.

    March 2001

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