Druker and the CTA may have already won the war, even if the battle is still undecided. As part of the lawsuit, the FDA was required to turn over to Druker some 44,000 internal documents. These include memos from agency scientists criticizing the FDA's developing policy on GM foods.

The policy, which was published in the Federal Register in May 1992, is regarded even by the FDA's own scientists as an industry cheat sheet: "The initial intent of the document was to present scientific considerations and to avoid telling industry what tests to run and how to go about doing it," said Louis J. Pribyl, an FDA microbiologist in a February 1992 memo.

Yet a major part of this policy is a flowchart that effectively tells a company not only what to test in a crop but what results will be needed for the product to be considered safe. By including the flowcharts and telling the companies what to test and what results to get to meet safety standards and by listing all the tests and the answers, Pribyl felt that the FDA made it possible for companies to tailor their tests to get the results they would need.

Prior to Druker's lawsuit, evidence that FDA policy was written largely to favor industry was a set of loosely connected dots. Besides the published policy in the Federal Register, there were Bush administration statements about the FDA regulations between 1991 and 1992. Vice President Dan Quayle in particular said the policy was part of a "regulatory relief program" that was intended to ensure the dominant position of the U.S. biotechnology industry.

And finally, there was a special investigation by the General Accounting Office, the investigative arm of Congress, of the FDA in 1994 that focused on potential conflicts of interest regarding several agency officials who had once been employed by the agro-pharmaceutical corporation Monsanto. Chief among the targets was Michael Taylor, whose job it was at the FDA to oversee and approve the very policies that would regulate GM products. Prior to joining the FDA, Taylor was a partner at King & Spalding, Monsanto's external counsel on regulatory issues. The GAO report found no improprieties on Taylor's part. But the document did make the connection between Monsanto and one of the main authors of FDA policy.

Now, with the newly disclosed FDA documents in Druker's hands, the holes in this picture are filling in. The published policy is based on the idea that genetically engineered crops are no different than those created through traditional methods. Yet in previously undisclosed FDA memos, at least 10 of the 17 scientists who took part in shaping the Federal Register document along with other FDA researchers invited to comment -- including head scientists from the agency's Division of Food Chemistry and Toxicology, Center for Veterinary Medicine, Biological and Organic Chemistry Section -- cast serious doubts on the scientific evidence for this assumption.

As Linda Kahl, an FDA compliance officer, noted in a memo dated Jan. 8, 1992, the FDA's approach to writing the policy was the equivalent of "putting a square peg in a round hole -- are we asking the scientific experts to generate the basis for this policy statement in the absence of any data? It is an exercise in hypotheses forced on individuals whose jobs and training ordinarily deal with facts."

Even the FDA official with approval authority over the policy, Biotechnology Coordinator James Maryanski, raised questions about the agency's assumptions. In a letter to a Canadian government official dated Oct. 23, 1991, Maryanski acknowledged that there was no scientific consensus about the safety of GM foods. He also admitted that the potential for genetic engineering to introduce new compounds into foods that could trigger allergic reactions "is particularly difficult to predict."

In these documents, Druker and the CTA counsel believe they have proved that the FDA disregarded warnings of many of its own scientists about the unique risks posed by genetically engineered foods; that it covered up these opinions; and took a public stance that was entirely the opposite in tone and message than the private, internal memos.

In October 1999, the FDA announced a series of meetings around the country to discuss the safety of GM foods. Maryanski, who participated in these panels, asserted, "We are meeting our goal of ensuring that these new products meet the same safety standards as traditional foods."

One model GM product that agency officials like Maryanski hold up as proof of the safety of GM foods is the Flavr Savr tomato, but the new memos have bruised the product's reputation. The Flavr Savr tomato was engineered to ripen slowly, to give tomatoes a longer shelf life. It had to undergo more stringent food testing because its developer, California-based Calgene, had applied for market approval prior to the enactment of the FDA's new policy on GM foods.

In 1994, Flavr Savr failed as a consumer product because all the genetically engineered advantages were lost in the shipping and packing stage, which bruised the tomatoes and gave them an aged appearance. According to an FDA internal memo, Flavr Savr also failed to meet the agency standards of safety.

In an assessment that went to Maryanski and others, Robert J. Scheuplein, director of the agency's office of special research skills, found a problem with some of the testing data on the Flavr Savr. Scheuplein was unsatisfied with the explanations of Calgene scientists about one difference between regularly bred tomatoes and the Flavr Savr.

Although he regarded the effect as small, Scheuplein did say: "The data do not show the Calgene product to be unsafe but 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."

With regard to how the agency was instructing its scientists to regard GM foods in testing, Scheuplein said, "It has been made clear to us that this present submission [the Flavr Savr] is not a food additive petition and the safety standard is not the food additive standard. It is less than that, but I am not sure exactly how much less."

The chilling implication revealed in this memo is that all other GM crops have undergone less stringent testing. In fact, testing is handled not by the agency but through voluntary consultations between the companies and the FDA with company scientists running the tests.

Previously undisclosed papers such as these tell the story of how the FDA flouted its own laws and ignored the advice and warnings of its own scientists in the process of pushing through a food technology that seemed to have immediate benefit only for the producers -- namely agrochemical companies including Monsanto, DuPont and Novartis.

The ramifications stretch far beyond the U.S. borders. Together, these documents with the resulting FDA policy confirm the very fears expressed last November by WTO protesters in Seattle: that globalization will lead governments to speed up industry growth at the expense of thorough public health precautions. This is precisely what has happened with GM foods.

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