A federal judge is reviewing witness statements and previously undisclosed FDA documents before issuing a summary judgement of a lawsuit Druker is leading on behalf of the Alliance for Bio-Integrity, nine university scientists and 12 religious leaders. The Washington-based International Center for Technology Assessment, a nonprofit organization that has brought previous lawsuits against government agencies on food and environmental safety issues, collaborated with Druker and has provided the lead counsel.
The suit charges the FDA with violating the very federal statute that created the agency, the U.S. Food, Drug and Cosmetic Act, because the FDA does not mandate the testing and labeling of GM foods. For its own part, the FDA asserts in its policy on GM foods that genetically engineered crops are no different than those created through traditional breeding methods. The agency bases its position on the fact that foods derived from traditionally bred crops have a history of safety. Thus the FDA takes the position that genetic engineering is just another traditional breeding method, and reasons that GM foods should be considered safe.
Whatever the judge’s decision, Druker’s actions have made public information that is very damning to both the FDA and the companies selling GM seeds simply because it highlights the central point in the controversy over GM foods: No one has proved beyond a doubt that GM foods and other products are not safe, nor has anyone proved beyond a doubt that these products are safe.
By now, most everyone in the U.S. has probably eaten GM foods in some form. According to the Biotechnology Industry Organization, genetically engineered crops accounted for 25 percent of the corn acreage planted in the U.S. in 1998, 38 percent of the soybean acreage and 45 percent of the cotton acreage. Because the FDA makes no distinction between GM crops and traditionally bred varieties, food producers are not required to separate or label their GM crops in the U.S. So without knowing it, you’ve probably eaten GM soybeans in the breakfast cereal you had this morning, in the chocolate bar you knoshed on this afternoon, and perhaps your baby has had it in his soy-based formula.
The very notion that people are eating foods derived from GM crops without their knowledge — or consent — offended Druker both as a lawyer and as a religious person when he realized this was happening back in 1996. He came upon this information while researching a book examining the relationship between science, religion and ethics. The more he researched, the more he became concerned about genetic engineering and the basic assumptions government regulators were making about the products of this science. Eventually, the 50-year old lawyer set aside his book and took up the cause of suing the FDA.
While he awaits the summary judgement of his lawsuit, Druker has kept a pretty packed schedule that has included an appearance before a panel selected by the FDA to discuss the safety and labeling issues of GM foods. Ironically, the agency has taken Druker’s arguments more seriously than much of the news media. What has made Druker’s lawsuit noteworthy to many editors is that it contends the FDA’s policy on GM foods infringes upon religious freedom rights and is in violation of the Religious Freedom Restoration Act.
This focus on the religious angle has had the effect of putting Druker in a camp with the anti-establishment fringe, a characterization that has stuck. In an Aug. 18, 1999, profile of the lawsuit, the Wall Street Journal covered only the religious aspects of the action, describing Druker as something of a small-town, Torah-thumping fanatic who was “gathering his Noah’s Ark of plaintiffs, many of whom share his mystical spirituality and distrust of authority.”
To be sure, 12 clergy leaders from a variety of established denominations are co-plaintiffs in Druker’s lawsuit — along with nine university scientists. Druker says the university scientists and the clergy leaders were each aware of both the religious and scientific aspects of the lawsuit before signing on. The religious aspects are important, Druker says, but have been overblown. The overriding concern of both clergy and scientists is that the FDA’s handling of GM foods has been unethical.
The lawsuit seeks to force the FDA, at the very least, to label GM foods, to inform consumers of the genes that have been inserted in their foods so they can make a informed dietary decision. At most, Druker and the others would like to see a recall of these products and mandatory testing. To achieve even part of their goals, Druker and the CTA counsel must prove that the FDA has not followed the law to ensure the safety of consumers regarding GM foods.
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.
“Before Druker, we had no hard evidence that our regulatory system was favoring industry,” explains Gabriela Flora, program associate on Agricultural Biotechnologies, at the Minnesota-based Institute for Agriculture and Trade Policy.
By connecting the dots between U.S. regulators and industry, the hard evidence from the Druker case along with public outcry could put the breaks on the once fast-moving industry that the U.S. government has tried so hard to foster. Already, GM crop producers are reeling from partial and complete bans of GM crops throughout the European Union and Asia.
And in the U.S., where GM food fights have paled in comparison to sentiments expressed by Europeans, the tide is turning. Major food producers like U.S.-based Archer Daniels Midland have cut back on the use of GM foods or agreed to segregate and label these foods in their exports to Europe. The recent failure of the WTO negotiations, which were intended to reduce trade barriers, has forced the Clinton Administration to step back from its goal of broadening markets for GM products.
“People from the U.S. Trade Representative’s office stand up and say we have the safest food supply and the strictest regulation in the world, but Druker is showing this isn’t the case,” says Flora. So countries that once questioned the integrity of the U.S. food supply and the integrity of U.S. regulators now have ample ammunition, thanks to Druker, to prevent GM foods — produced mainly by U.S. corporations — from entering their borders.
It is somewhat remarkable that an individual such as Druker would eventually have such an impact on the high-stakes development on the GM foods industry. As he describes it, his involvement began with a simple realization of serious ethical concerns. “What I could see was that there were plans to very quickly restructure a large percentage of the world’s living organisms and that the U.S. government had given it a green light,” Druker says.
In fact, a large community of government officials and scientists — including Gordon Conway and Gary Toenniessen of the Rockefeller Foundation — seemed to hold the same, favorable view. Druker said he was surprised to find that “these presumptions appeared to be dubious to eminent scientists who were not indentured to the biotech industry.” Druker sought out these scientists, many of whom hold faculty positions at some of the most prestigious universities in the U.S. and Europe — including the University of Minnesota, Northwestern University and the University of Leeds.
Before long, nine of these same scientists became plaintiffs in Druker’s lawsuit. What makes their action unusual is that the atmosphere inhabited by molecular biologists and other scientists engaged in biotechnology research is a clubby one. Dissenting views about genetic engineering are discouraged, says Phillip Regal, professor of ecology, behavior and evolution at the University of Minnesota.
Regal is one of the plaintiffs in Druker’s lawsuit. Having a negative view of biotechnology, Regal warns, can cost a researcher his chances at tenure, future employment in industry, and certainly can dry up his resources for research funding. The scientists joining Druker in suing the FDA have done so at great personal and professional risk.
Why are these scientists and Druker doing this? Because they take issue with the way in which the government, corporations, and a significant portion of the scientific community, appear to speak with one voice. That one voice consistently tells the public that the industry must move forward quickly to preserve the U.S. dominance in biotechnology. At the same time, it tells us not to worry — government and industry have already taken care that public health and the environment will not be endangered as we move forward with this technology.
By suing the government, Druker feels he is getting at the major source of the biotechnology juggernaut. The publication of these documents, which Druker has gradually added to the Alliance for Biointegrity Web site since last summer, will have the effect for biotechnology that the tobacco papers had for the cigarette industry: Others will gain ammunition that can be used in later litigation and export restrictions on GM foods.
So in many ways, Druker has already won even before the final judgement is in on his case. “[The FDA memos] are out, and they can never be covered up again,” he says. “If we cannot turn the tide against genetic restructuring within the bounds of science and law, perhaps economic realities will come into play.”
Economic realities have struck. Last month, Novartis and AstraZeneca announced plans to spin off and then merge their agricultural businesses into a new company called Syngenta and Monsanto followed suit nearly two weeks later with Pharmacia Upjohn. The message in these moves is clear: The companies have taken enough of a financial bath with their investments in GM products and are, in a way, washing their hands of these ventures.