From GM-FREE magazine - Aug/Sept 1999

US REGULATORS IGNORED THEIR OWN SCIENTISTS' WARNING OVER GM FOOD

All GM foods are on the market illegally, claims lawyer Steven Druker of the Alliance for Bio-lntegrity. The Alliance is a U.S.-based coalition of public interests groups, individuals, scientists and religious organisations which has launched a lawsuit against the U.S. Food and Drug Administration (FDA), the regulatory agency which allowed GM foods onto the U.S. and world markets. Here is Steven Druker's summary of the Alliance for Bio-Integrity's case against what is often called "the strictest regulatory agency in the world".

* The FDA acknowledes that since the Bush administration it has operated under a directive to "foster" the U.S. biotech industry. One way it has sought to advance this goal is by permitting GM foods to be sold without labels, thus keeping consumers in the dark.

* Further, as part of its promotional efforts, the FDA has adopted a policy that treats GM foods as "substantially equivalent" to natural ones. It claims that GM foods are no riskier than others and that they are recognized as safe by an overwhelming consensus within the scientific community. Accordingly, it has allowed these foods to be marketed without any required safety testing.

* In its zeal to promote the industry, the FDA has made claims about the established safety of GM foods that are fraudulent - and calculated to deceive the public.

* Besides violating ethics, the FDA's actions have violated federal law. In consequence, every GM food being sold in the United States today is being sold illegally; and every one of them should be taken off the market and subjected to rigorous safety testing.

* Evidence for these statements is contained in the FDA's own files. The FDA's internal records reveal a gap between what its bureaucrats proclaim in public and what its own scientists say in-house. As the agency was trying to craft a policy on GM foods that would treat them as much as possible like natural foods, it met strong resistance from its own scientists, who repeatedly warned that GM differs from conventional practices and entails a unique set of risks.

* Numerous agency experts protested that FDA policy drafts ignored the known potential for GM to produce unexpected toxins and allergens. For example, microbiologist Dr Louis Pribyl said: "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." He added that several aspects of gene splicing "may be more hazardous." Dr E.J. Matthews of the FDA's Toxicology Group warned that "genetically modified plants could... contain unexpected high concentrations of plant toxicants..."

* The numerous in-house critiques of the agency's proposed policy 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 said: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks."

* In light of these unique risks, FDA scientists advised that GM foods should undergo special toxicological tests. 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 [GM organism] should be evaluated before it enters the marketplace."

* Not only was the agency aware of uncertainties within its own ranks, it also knew there was disagreement about the safety of GM foods in the scientific community. For instance, the FDA Biotechnology Coordinator, Dr Jim Maryanski, acknowledged in a letter to a Canadian official that there was no scientific consensus on the need for toxicology tests. He also said, "I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict."

* Nonetheless, so strong was the FDA's motivation to promote the biotech industry that it not only disregarded the warnings of its own scientists about the unique risks of GM foods, it covered them up and took a public position that was squarely opposite. In its official Statement of Policy on bioengineered foods the FDA asserts: "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..." Thus, bureaucrats in charge of the policy claimed that these foods require no testing and left decisions about testing to the industry.

* These actions violate the U.S. Food, Drug and Cosmetic Act. In this statute, Congress mandated that all new food additives are to be considered unsafe until proven safe.

* But the FDA decided to push ahead by going around the law. It claimed that GM foods are "generally recognized as safe," and thus exempt from testing. In making this claim, the FDA fraudulently misrepresented the facts, since it was aware GM foods are not even recognized as safe by its own scientists, let alone by a consensus in the scientific community.

* Further, the statute says that additives such as those in GM foods can only be recognized as safe on the basis of tests that have established their harmlessness. But no such tests exist in the case of GM foods. The one test that attempted to demonstrate the safety of such a food through standard toxicology tests was so flawed that FDA scientists dismissed it as not capable of demonstrating anything. Yet the agency approved that food anyway on the basis that it was already recognized as safe. That food was Calgene's "Flavr Savr" tomato, the first GM organism the FDA reviewed.

* Subsequent to that, the record does not reveal any other attempts to demonstrate the safety of any GM food through standard scientific tests. So, although the "generally recognized as safe" exemption was intended to allow marketing of foods whose safety has been demonstrated through testing, the FDA is using it to circumvent testing and to approve substances based primarily on conjecture. Consequently, every GM food in the U.S. is on the market illegally and should be recalled for rigorous safety testing.

* The FDA's policy is even more troubling because it was adopted in spite of the fact over 35 people were killed and over 1,500 others permanently disabled by eating a food supplement, l-tryptophan, produced with GM bacteria during 1988-89.

* The FDA's Dr Jim Maryanski admitted to the Government Accounting Office that the FDA did not yet know the cause of the tryptophan-induced illness and could not rule out the genetic engineering process. Yet the FDA subsequently issued its policy declaring GM foods to be safe.

* Why has the FDA been so driven to flaunt the law and override its own experts? The administrative record reveals that agency bureaucrats were under pressure from the White House and the Office of Management and Budget to approve these new foods quickly with minimal regulation.

* Interestingly, Michael Taylor, a Washington, D.C. lawyer who had long represented Monsanto and the International Food Biotechnology Council, was appointed FDA Deputy Commissioner of Policy during the very period the policy on GM foods was being crafted and adopted. Subsequently, Mr. Taylor became Monsanto's vice-president for public affairs.

* Thus, we are looking at a sorry picture of rampant deceit and disrespect for law. The FDA policy on GM food is illogical, irresponsible and illegal. It proclaims to be based in sound science, but instead relies on illusion. The agency's behavior in this case is unconscionable and reprehensible and it must be reformed. That is why the Alliance for Bio-Integrity is spearheading a lawsuit to force the FDA to obey the law and begin mandatory safety testing and labeling of all GM foods.

* Nine eminent life scientists have joined the Alliance for Bio-Integrity as plaintiffs so they can emphasize the extent to which they think FDA policy is scientifically unsound and morally irresponsible. These include Prof Liebe Cavalieri, a molecular biologist at the State University of New York, who publicly denounced the FDA's claim about the equivalence of GM foods and natural ones as a "disgraceful sham."

* In addition, seventeen individuals and organizations have joined as plaintiffs because they view the genetic engineering of food to be an arrogant disruption of the integrity of God's creation. These plaintiffs include seven Christian clergy, three rabbis, a Buddhist, and a Hindu religious organization.

* The Alliance for Bio-Integrity is demanding that any genetically engineered foods on the market should be labeled in order to uphold consumer choice, and that no GM food should come to market without having been proved safe through solid testing. This is required not only by common sense, but by the law of our land.

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