In May 1998 the Alliance for Bio-Integrity led a group of public interest organizations, life scientists, and religious leaders in filing a lawsuit against the U.S. Food and Drug Administration (FDA) to gain mandatory safety testing and labeling of genetically engineered (GE) foods. During the discovery process, the agency was required to provide plaintiffs copies of over 44,000 pages of internal records. Photocopies of 24 documents from these files are in a numbered list for viewing and printing on our website (www.biointegrity.org). The quotes from FDA scientists below were excerpted from this group, each followed by the document number from which it comes.<www.biointegrity.org>
B. Addressing the extensive death and disability caused by a GE food
In 1989, the Japanese manufacturer Showa Denko K.K. began marketing a genetically engineered supplement of the amino acid L-tryptophan in the U.S. In producing it, a gene to increase tryptophan yield was spliced into the DNA of bacteria, from which the substance was then extracted. Within a few months of entering the market, the bioengineered supplement caused an epidemic of an unusual malady (called EMS) that resulted in the death of 37 people and the permanent disability of at least 1,500 others. (FDA’s Regulation of the Dietary Supplement L-Tryptophan. Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, U.S. House of Representatives, Washington, D.C., 1991)
For many preceding years, other manufacturers had marketed L-tryptophan supplements produced from bacteria without use of gene-splicing. Epidemiological evidence from the Center for Disease Control does not link any tryptophan from these other manufacturers with outbreaks of EMS. (Kilbourne, E. Journal of Rheumatology Supplement, vol. 46, Oct. 1996) Further, Showa Denko’s genetically engineered tryptophan was found to contain at least one unusual toxic contaminant never before seen in any of those conventionally produced batches.
Although there is no conclusive proof that EMS resulted from genetic engineering, the link has not been ruled out; and many experts think it likely that whatever toxins caused the disease were unexpected side effects of the gene-splicing procedure. It is well-recognized this procedure can alter cellular activity and generate novel toxins, as the statements in the next section show. (See also T.J. Simat, et. al. “Synthesis, Formation and Occurrence of Contaminants in Biotechnologically Manufactured L-Tryptophan,” Proceedings of the 9th International Meeting on Tryptophan Research, Hamburg, Germany, 10-14th Oct., 1998). The main reason a definitive answer has not been reached is that the relevant evidence in Showa Denko’s laboratory was destroyed before it could be examined.
FDA scientists confirm that the bioengineering process might have caused the EMS. On September 27, 1991, Dr. James Maryanski, Coordinator of FDA’s Biotechnology Working Group, discussed the matter with other government officials. According to his record 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) When directly questioned, Dr. Maryanski continues to acknowledge that bioengineering cannot be ruled out. (FDA Public Meeting on Bioengineered Foods, Washington, D.C. November 30, 1999)
FDA Response: On July 18, 1991, Dr. Douglas L. Archer, Deputy Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), testified before the House of Representatives Subcommittee on Human Resources and Intergovernmental Relations about the L-Tryptophan tragedy. He said the incident confirmed the FDA’s warnings about the hazards of many health food supplements and that the deaths and injuries “demonstrate the dangers inherent in the various health fraud schemes that are being perpetrated on segments of the American Public.” Dr. Archer’s prepared remarks never indicated that the toxic batches of L-Tryptophan had been produced through genetic engineering, nor did he once raise the possibility it was this process rather than any presumed problems with L-Tryptophan supplements in general that was the cause of the illnesses.
On May, 29 1992 the FDA formally recognized genetically engineered foods to be safe and declared they do not require safety testing. (U.S. law clearly states that a new method of producing food such as bioengineering can only be presumed safe if there is a “reasonable certainty” it will not be harmful. 21 CFR Sec.170.3(i)) Further, rather than adopt a precautionary approach to bioengineering, the FDA instead removed all L-Tryptophan supplements from the market. Thus, even though no conventionally produced L-Tryptophan has been linked with an EMS outbreak, all such supplements have been banned, while all genetically engineered foods have been cleared for sale without testing, even though there are scientifically justified grounds to suspect the bioengineering process itself was the cause of the EMS epidemic. To date, the executive branch of the U.S. government continues to blur the fact that the fatal L-Tryptophan was genetically engineered and persists in claiming that no GE 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 [GE foods], and that’s because we have been extremely careful in our process of approving them.” (Reuters, September 16, 1999)…”