evidence as is required to obtain approval of the substance as a food additive." 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." Yet, neither the FDA's records nor the scientific literature indicate that such a test exists for even one genetically engineered food.

In fact, the main test referenced in FDA files that attempted to demonstrate the safety of a bioengineered food through standard toxicology tests failed to do so. In his comments on this study, Dr. Robert J. Scheuplein, director of the FDA's Office of Special Research Skills, wrote: "... the data fall short of 'a demonstration of safety' or of a 'demonstration of reasonable certainty of no harm' which is the standard we typically apply to food additives. To do that we would need, in my opinion, a study that resolves the safety question raised by the current data." 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. That food was Calgene's "Flavr Savr" tomato, the first genetically engineered organism the FDA reviewed. Interestingly, FDA officials claim that the Flavr Savr passed muster so well that the rigor of its testing will not have to be repeated for other bioengineered foods.

So, although the "generally recognized as safe" exemption was intended to permit marketing of substances whose safety has already been demonstrated through sound testing, the FDA is using it to circumvent testing and to approve substances based on inferences drawn from less rigorous forms of analysis -- inferences that are dubious in the eyes of several of its own as well as many other experts.

D. Genetically Engineered Food Has Caused Death and Disability
In 1988, a Japanese manufacturer, Showa Denko K.K., began marketing a genetically engineered food supplement of the amino acid L-tryptophan in the U.S. In this process, a gene coding for L-Tryptophan was spliced into the DNA of bacteria, and the substance was then extracted. Prior to that time, Showa Denko and other manufacturers had been marketing conventionally produced tryptophan supplements for many years with no ill effects. However, within a few months of entering the market, the genetically engineered supplement caused the deaths of 37 people and the permanent disability of at least 1500 others. (Source: House of Representatives 1991. FDA's Regulation of the Dietary Supplement L-Tryptophan. Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, United States House of Representatives, Washington, D.C.)

It was later shown that the genetically engineered tryptophan contained unusual and highly toxic contaminants. None of the conventionally produced tryptophan previously sold by Showa Denko or concurrently sold by other companies were toxic. Although it was never definitively established that the toxicity resulted from the genetic engineering process, neither has the link been ruled out; and many experts think it is likely that the toxin was an unexpected side effect of the bioengineering procedure. (Id.) It is well-recognized that this procedure can alter cellular activity and generate novel toxins, and the FDA's files contain numerous statements from its own scientists acknowledging this hazard. In the case of the L-Tryptophan, it is probable that the bacterial metabolism was disrupted in such a way that toxins were synthesized. The main reason a definitive answer has not been reached is that all the relevant evidence in Showa Denko's laboratory was destroyed before it could be examined.

Further, it is important to note that the toxins in the supplements were at such a low concentration that standard chemical analysis did not detect them and gave the false impression that the bioengineered batches were pure and safe to consume. Toxicological testing via animal feeding studies could have detected the problem.

On July 18, 1991, Douglas L. Archer, the Deputy Director of FDA's Center for Food Safety and Applied Nutrition (CFSAN), was invited to testify before the House of Representatives Subcommittee on Human Resources and Intergovernmental Relations regarding the agency's actions in response to the L-Tryptophan tragedy. Dr. Archer stated that the deaths and cripplings "demonstrate the dangers inherent in the various health fraud schemes that are being perpetrated on segments of the American Public." He indicated that the problem is that the medical and health claims being made for supplements such as L-Tryptophan are unsubstantiated and that the risks from their use as drugs can be significant. Dr. Archer's prepared remarks did not once indicate that the toxic batches of L-Tryptophan had been produced through genetic engineering, nor did he once raise the possibility that it was this process rather than the inherent unsafety of L-Tryptophan supplements that was the cause of the illnesses. In fact, in his prepared remarks, he made no mention of genetic engineering. (Id.)

On September 27, 1991, Dr. James Maryanski, Coordinator of FDA's CFSAN Biotechnology Working Group, met with representatives of the Government Accounting Office and was questioned about L-Tryptophan and the potential that genetic engineering was the cause of the recent illness (termed EMS). According to Dr. Maryanski's memo of the meeting: "I said that we have no new information, that we do not yet know the cause of EMS nor can we rule out the engineering of the organism."  (emphasis added). (FDA Administrative Record at 22,923.)

On May, 29 1992, the FDA published its policy statement on genetically engineered foods, which presumes there is a reasonable certainty that these foods will not be harmful and therefore does not require they be safety tested. However, as of the date of this summary (October 28, 1999) no one has produced any evidence that rules out the genetic engineering process as the cause of the EMS, and many experts continue to think it is the most probable cause.

To date, the executive branch of the U.S. government continues to ignore the fact that the fatal L-Tryptophan was bioengineered and persists in pretending that no genetically engineered food has been linked with a human health problem. For instance, in September, 1999, David Aaron, U.S. deputy secretary of commerce, declared, "Not a rash, not a sneeze, not a cough, not a watery eye has been developed from this (GM foods), and that's because we have been extremely careful in our process of approving them." (Reported by Reuters, 9-16-99)

The only concrete action the FDA took in response to the spate of bioengineered L-Tryptophan poisonings was to remove all L-Tryptophan supplements from the market. This action is consistent with the agency's claim that genetic engineering is an innocuous process similar to traditional breeding and that the problem stemmed from the risks of health supplements in general.


Thus, even though no conventionally produced L-Tryptophan has been known to cause the illness in question, all such supplements have been banned, while all genetically engineered foods have been cleared for marketing without safety testing, even though there are scientifically justified grounds to suspect the bioengineering process itself was the cause of the L-Tryptophan poisonings.

E. It Is Time for the FDA to Act Responsibly
The FDA says it is now in a listening mode. If it's ears have truly been open, then it's conscience should have been touched. The safety of the world's food supply is at stake. There is more than enough evidence to convince a reasonable man or woman that current FDA policy is unscientific, unwise, irresponsible, and illegal.

Commissioner Henney, I implore you to reconsider the agency's policy and to act as the responsible public servant I am sure that you are.

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