JUNE 1999 · VOLUME 20· NUMBER 6

The Food and Drug Administration (FDA) declared genetically engineered foods to be safe in the face of serious disagreement from its own experts.

Internal reports and memos obtained by lawyers suing the FDA over the approval of the biotech foods reveal the FDA's own scientists warned that foods produced through recombinant DNA technology entail different risks than do their conventionally produced counterparts.

But these scientists were consistently disregarded by the bureaucrats who approved the agency's current policy of treating bioengineered foods the same as natural foods.

"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," warned Dr. Louis Priybl of the FDA's Microbiology Group in criticizing a 1992 FDA draft policy paper on the issue.

Dr. Linda Kayl, an FDA compliance officer, complained that the FDA was "trying to fit a square peg into a round hole" by concluding that "there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices."

"The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks," Kayl said.

Kayl and other FDA scientists recommended that genetically engineered foods undergo special testing.

For example, the FDA's Division of Food Chemistry and Technology warned that "undesirable effects such as the appearance of new, not previously identified toxicants ... may escape breeders' attention unless genetically engineered plants are evaluated specifically for these changes. Such evaluations should be performed on a case-by-case basis -- every transformant should be evaluated before it enters the marketplace."

The Alliance for Bio-Integrity, the lead plaintiff in the lawsuit against the FDA, is seeking to force the FDA to mandate safety testing and labeling of all genetically engineered foods.

"Not only was the FDA aware of uncertainties within its own ranks, it also knew there was considerable disagreement about the safety of genetically engineered foods in the scientific community at large," the Alliance's Steven Druker told a conference on biotech foods in Washington, D.C. in June.

"Even though the FDA knew that genetically engineered foods are not even uniformly recognized as safe by its own scientists -- let alone by a consensus within the scientific community -- it declared them to be generally recognized as safe," Druker said. "And although agency experts advised that genetically engineered foods should be subjected to special testing, including feeding studies to screen for unexpected toxins, the bureaucrats in charge of the policy proclaimed that these foods require no testing at all and left decisions about testing to the discretion of the industry."

Druker argues that, in approving biotech foods, the FDA violated the Food, Drug and Cosmetic Act and that genetically engineered foods are illegally on the U.S. market as a result. He wants these foods recalled and subjected to rigorous safety testing.

"The American people deserve better than they have received from the FDA when it comes to bioengineered foods," says Druker.

"They have a right not to be subjected to foods that are potentially harmful, and the FDA has a duty to uphold this right," he says. "It is high time that the agency reinstates reason and responsibility."

-- Russell Mokhiber