ADVISORY ON GENETICALLY ENGINEERED FOODS

HOW THE U.S. FOOD AND DRUG ADMINISTRATION IS MISREPRESENTING THE FACTS AND VIOLATING THE LAW

Prepared by Steven M. Druker, J.D., Executive Director

I. U.S. Law Requires That Bioengineered Foods Be Proven Safe

Although the U.S. Food, Drug and Cosmetic Act does not specifically refer to the "precautionary principle," it effectively mandates application of this principle to foods containing new additives. It clearly requires that such additives be demonstrated safe through standard scientific testing before they are marketed. (21 U.S.C. § 321).

While the FDA agrees that pieces of foreign DNA spliced into an edible plant (and all substances they then produce) are in principle food additives, it claims they are relieved from the testing requirements by the exemption granted to substances that are "generally recognized as safe" (GRAS). It argues they are sufficiently similar to substances that are GRAS to support an inference that they are likewise safe.

However, the GRAS exemption itself embodies the precautionary principle and contains strict criteria. First, as both the FDA’s regulations and the federal courts have decreed, general recognition of safety can only be imputed if there is an overwhelming consensus in the community of qualified experts. While unanimity is not required, a significant disagreement prevents a determination that consensus exists. Second, even if there is unanimous consensus, the law prescribes it cannot rest on hypotheses but must be based on scientific evidence that clearly establishes safety. Both the FDA’s regulations and the federal courts have heretofore consistently held that such evidence should include studies published in the peer-reviewed scientific literature. (21 CFR Sec. 170.3(h)). Moreover, FDA regulations emphasize that the tests supporting a general recognition of safety "...require the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive." (21 CFR Sec. 170.30(b)) This means, in the FDA's words, that the tests must demonstrate "a reasonable certainty ... that the substance is not harmful under its intended conditions of use." (21 CFR Sec. 170.3(i)). Therefore, even if there were scientific consensus about the safety of bioengineered foods, the law clearly requires that their safety still must be established through standard scientific tests.

II. Bioengineered Foods Are On the U.S. Market Illegally

No genetically engineered food has yet satisfied the criteria mandated by U.S. law.

1. These New Foods Are Not Generally Recognized as Safe -- Even Within the FDA

Many well-qualified life scientists regard genetically engineered foods as riskier than

conventional foods, and nine such experts are so concerned they have taken the unprecedented step of becoming plaintiffs in the lawsuit my organization has brought against the FDA to ensure rigorous safety testing of all genetically engineered foods. These scientist-plaintiffs include Dr. Richard Strohman, a professor of molecular and cell biology at the University of California at Berkeley; Dr. Rama Dwivedi, associate director of targeted mutagenics at Northwestern University Medical School; and Professor Philip Regal, a renowned plant biologist at the University of Minnesota, who has stated in a sworn declaration to the court, "... there are scientifically justified concerns about the safety of genetically engineered foods, and some of them could be quite dangerous."

Further, numerous scientists within the FDA also recognize the unique risks of bioengineered foods. The agency’s files contain memorandum after memorandum warning about the potential of gene-splicing to produce unexpected toxins and allergens in a different manner and to a different degree than do conventional methods. As FDA microbiologist Dr. Louis Pribyl stated: "There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering ...." He added that several aspects of gene splicing ". . . may be more hazardous . . ." The numerous in-house warnings are best summed up by Dr. Linda Kahl, a compliance officer, who protested 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 declared: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks."

(Note: These FDA documents came to light through our lawsuit, and photocopies of several are on our website: <www.biointegrity.org> Also available is my statement as a member of the food safety panel at the FDA Public Meeting in Washington on Nov. 30, 1999, which more thoroughly discusses the scientific and legal issues and the FDA’s irresponsible behavior.)

Neither the FDA's records nor the scientific literature indicate that even one bioengineered food has been established safe as required by law. In fact, the main study attempting to do so failed. That test involved the "Flavr Savr" tomato, the first engineered organism the FDA reviewed. In his comments on the study, the director of FDA's Office of Special Research Skills stated it raised a safety issue that was not resolved. Yet, the agency approved that product anyway on the grounds it was generally recognized as safe -- even though the law requires such recognition be based on precisely the kind of test that had failed to demonstrate safety. Interestingly, FDA officials claim that the Flavr Savr performed so well that the rigor of its testing will not have to be repeated for other bioengineered foods.

Not only did the FDA know about the concerns of its own experts, it also knew there was major disagreement about bioengineered foods in the scientific community at large. For instance, the FDA Biotechnology Coordinator acknowledged in a letter to a Canadian official on Oct. 23, 1991 that there was not a scientific consensus about safety. He also admitted, "I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict." Nonetheless, the FDA’s official policy statement of May, 1992 declares: "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 ...." (Federal Register vol. 57, No. 104 at 22991.) Agency spokespersons continue to make this claim. Perhaps the FDA’s propensity to misrepresent the facts stems from its admitted agenda to "foster" the U.S. biotech industry.