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

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. As part of the discovery process, the agency was required to provide the plaintiffs with copies of over 44,000 pages of its internal records. Reproductions of 24 documents from these files are available for viewing and printing on our website: <www.biointegrity.org>. Most of the quotes from FDA scientists that follow were excerpted from this group. The documents are in a numbered list, and each quotation is followed by the number of the document from which it comes.

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 genetically engineered supplement caused 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 has never linked any tryptophan from these other manufacturers with EMS. (Kilbourne, E. Journal of Rheumatology Supplement,

Although there is no conclusive proof that EMS resulted from the 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 bioengineering procedure. (It is well-recognized this procedure can alter cellular activity and generate novel toxins, as the statements in the next section show.) 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 genetic engineering process cannot be ruled out as the cause of the EMS. On September 27, 1991, Dr. James Maryanski, Coordinator of FDA's Biotechnology Working Group, discussed the L-Tryptophan problem with representatives of the Government Accounting Office. According to Dr. Maryanski's 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)

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 cripplings "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 shown to cause harm, 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 L-Tryptophan poisonings To date, the executive branch of the U.S. government continues to blur the fact that the fatal L-Tryptophan was bioengineered 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." (Reported by Reuters, September 16, 1999)

FDA files indicate that the majority of its scientists who commented on bioengineered foods identified reasonable grounds on which their safety can be doubted. Several issued strong warnings. The predominant view was that genetic engineering entails distinct risks and that its products cannot be regarded as safe unless they have been confirmed to be so through appropriate feeding studies.

For example, 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 . . ." (4) Similarly, Dr. E.J. Matthews of the FDA's Toxicology Group warned that ". . . genetically modified plants could ... contain unexpected high concentrations of plant toxicants...," and he cautioned that some of these toxicants could be unexpected and could "...be uniquely different chemicals that are usually expressed in unrelated plants." (2) Citing the potential for such unintended dangers, the Director of FDA's Center for Veterinary Medicine (CVM) called for bioengineered products to be demonstrated safe prior to marketing. He stated: "... CVM believes that animal feeds derived from genetically modified plants present unique animal and food safety concerns." (10) He explained that residues of unexpected substances could make meat and milk products harmful to humans. And the head of the Biological and Organic Chemistry Section chided agency bureaucrats for turning prior policy "on its head" in attempting to equate bioengineered foods with their conventional counterparts. He also pointed out that lack of definitive evidence that a GE food is dangerous does not assure safety, noting that "in this instance ignorance is not bliss." (7)

The numerous in-house critiques of the proposed policy are summed up by Dr. Linda Kahl, a compliance officer, who protested 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." (1)

In light of these unique risks, FDA scientists advised that genetically engineered foods should undergo special testing. The Division of Food Chemistry and Technology cautioned, "... some undesirable effects such as ... 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, i.e., every transformant should be evaluated before it enters the marketplace." (6) These experts advised the evaluation should include toxicological tests.

Not only was the agency 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. For instance, FDA Biotechnology Coordinator, Dr. James Maryanski, acknowledged in a letter to a Canadian official on October 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." (8)

FDA Response: On May, 29 1992 the decision-makers issued a policy statement asserting there is overwhelming consensus among scientists that GE foods do not entail different risks than conventional ones. Accordingly, the policy presumes every GE food is as safe as its conventional counterpart unless demonstrated otherwise. (The only exception is for foods from one of the few species involved in the most common food allergies.) The FDA does not require any testing, and testing is done on a purely voluntary basis by the manufacturer, with all critical decisions left to its discretion. (As noted in Section B, U.S. law says new foods such as these cannot be deemed safe unless there is a "reasonable certainty" they will not be harmful. Further, determination of safety must be based on solid evidence from standard testing. 21 CFR 170.3(b)&(h))

Because most cells subjected to gene implantation techniques do not successfully incorporate the foreign gene, a large number must be used, and a marker must be attached to the foreign gene in order to identify the cells that have taken it up. For various reasons, industry desired to employ genes coding for resistance to anti-biotic chemicals, especially kanamycin, which has an important medical use. On September 30, 1992, FDA’s Biotechnology Coordinator requested the Division of Anti-Infective Drug Products to evaluate the proposed use of the kanamycin resistance marker gene. (11) On December 3, 1992, the Division’s experts submitted their written opinion. In their conclusion, they stated: "IT WOULD BE A SERIOUS HEALTH HAZARD TO INTRODUCE A GENE THAT CODES FOR ANTI-BIOTIC RESISTANCE INTO THE NORMAL FLORA OF THE GENERAL POPULATION." (emphasis in original) (12) In sending the document to another FDA official, the Division’s director included a cover letter titled, "The tomatoes that will eat Akron." (The first commercial use of the marker was planned for the Flavr Savr tomato.) He said: "You really need to read this consult. The Division comes down fairly squarely against the kan gene marker in the genetically engineered tomatoes. I know this could have serious ramifications." (12) On March 30, 1993 the Division’s Supervisory Microbiologist sent a follow-up memo to the Biotechnology Coordinator in which he strongly criticized the proposed use of the marker. He noted that though other markers are available, industry prefers the anti-biotic resistant ones because they are more economical. He stated that to make the choice on this basis was wrong, considering the risks involved: "In my opinion, the benefit to be gained by the use of the kanamycin resistance marker in transgenic plants is out weighed by the risk imposed in using this marker and aiding its dissemination nation wide. If we allow this proposal, we will be adding a tremendous quantitative load of genetic material to the environment which will probably assure dissemination of kanamycin resistance." (13)

FDA Response: The agency approved the use of the kanamycin resistance gene not only in tomatoes but in other vegetables as well. Currently, most bioengineered foods contain anti-biotic resistant genes.

The first GE whole food that the FDA reviewed was Calgene's "Flavr Savr" tomato. Although the FDA did not require testing, Calgene voluntarily subjected the tomato to feeding studies and asked the agency to review the data. FDA scientists noted a pattern of stomach lesions that raised a safety issue and repeatedly requested Calgene to provide additional data in order to resolve it. The record indicates that such data was never produced. Commenting on the data at hand, 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."(15) Dr. Carl B. Johnson of the Additives Evaluation Branch concurred that "... unresolved questions still remain." (16)

FDA Response: The agency approved the tomato. Further, it claimed that all relevant safety issues had been satisfactorily resolved and said that because the Flavr Savr had performed so well, it would be unnecessary for any subsequent bioengineered food to be subjected to the same rigorous standard of testing. To date, there is no reliable evidence showing that any has successfully met the standard the Flavr Savr failed to meet.

Despite the extensive input it received from its scientists about the risks of genetically engineered foods and the extent to which they differ from conventional ones, the FDA’s official policy statement 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 ...." (Statement of Policy: Foods Derived From New Plant Varieties, May 29, 1992, Federal Register vol. 57, No. 104 at 22991.) Moreover, the agency has continued to misrepresent the facts. On February 28, 2000, Dr. James Maryanski, the primary FDA spokesperson on GE foods, stated to the OECD Conference on GM Food Safety in Edinburgh, Scotland that the agency’s scientists had merely been asking questions about the various issues involved in bioengineered food.

The reader is invited to review the quotations reported above and to read the other FDA documents posted on our website and assess how many scientists were asking questions in the manner described by Dr. Maryanski and how many were making declarative statements, many of them quite emphatic, about potential problems.