Safe Food: The Politics of Food Safety (37 page)

FIGURE 19
. Soon after the FDA’s approval of recombinant bovine growth hormone (rBGH), Ben & Jerry’s used product labels to display the company’s policy on this drug. These statements conform to the FDA’s 1994 guidelines on voluntary labeling of milk products derived from cows that had not been treated with rBGH.

Monsanto’s Revolving Door to the FDA
. A nagging concern throughout the deliberations over rBGH was the revolving door through which employees of Monsanto and FDA exchanged positions. In Washington, DC, the law firm King & Spalding filed a brief with the FDA on behalf of Monsanto arguing that the agency could not legally justify a labeling requirement for rBGH milk. The primary author of the document was a former FDA chief counsel.
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Furthermore, three FDA staff members involved in rBGH regulatory decisions had previously worked for Monsanto, either directly or indirectly. This connection led several members of Congress to question whether the FDA had colluded with Monsanto in approving the drug, and they demanded a GAO investigation.
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The GAO reviewed more than 40,000 pages of documents, interviewed 54 people, and evaluated the financial disclosures and conflict-of-interest statements of all FDA employees involved in the rBGH approval. Although
the GAO concluded “there were no conflicting financial interests,” its report raised discomfiting questions. One FDA employee, Dr. Margaret Miller, worked for Monsanto from 1985 to 1989 as a laboratory supervisor responsible for evaluating tests that measured rBGH and IGF-1 levels in cow blood, tissues, and milk. Within a year or so of leaving Monsanto, she was helping draft FDA responses to citizens’ petitions seeking to halt sales of rBGH milk and to congressional queries about rBGH. She also contributed advice on matters directly related to rBGH approval. GAO investigators said she had followed the letter of federal ethics regulations, but expressed some concerns about her adherence to their spirit. They said the FDA commissioner was so “visibly surprised” in 1993 to learn of Dr. Miller’s employment with Monsanto that he ordered an internal review of her activities. Although the internal review also concluded that she had not violated ethical standards, it said her participation in rBGH matters “does raise questions.”

GAO investigators were even more troubled by issues related to the role of Michael Taylor. Mr. Taylor, whom we encountered in
chapter 2
as the courageous USDA official responsible for instituting Pathogen Reduction: HACCP, began his career as a lawyer with the FDA. He left the agency to work for King & Spalding, the firm representing Monsanto, but returned to the FDA in 1991 as deputy commissioner for policy, and he held that position during the time the agency conducted its rBGH safety review. At the time, Mr. Taylor had been with the FDA for more than two years, but newly passed ethical guidelines applied only to the first year of employment, so his activities were “not covered by the appearance of loss of impartiality provisions.”
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Mr. Taylor is a coauthor of the FDA’s 1992 policy statement on genetically engineered plant foods (discussed below), and he signed the
Federal Register
notice on labeling of rBGH milk. Although other FDA officials responsible for those policies shared his views, court documents later released as a result of a 1999 lawsuit revealed considerable disagreement about the policies within the agency. FDA officials told the GAO that Mr. Taylor had recused himself from matters related to rBGH and “never sought to influence the thrust or content” of the agency’s policies. Nevertheless, Congressman Bernard Sanders (Ind-VT) viewed Mr. Taylor’s involvement as casting doubt about the impartiality of the rBGH review process. Mr. Sanders said the ethics rules in this situation “were often stretched to the breaking point and were broken on a number of occasions. The FDA allowed corporate influence to run rampant in its approval of BGH. . . . This is exactly the kind of thing that sends consumers
the message that federal bureaucrats care more about corporate profits than they do about consumer health and safety. . . . The bottom line is that Monsanto’s product received favorable treatment when it probably should not have.”
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Monsanto’s Political Success
. Monsanto succeeded in obtaining FDA approval of rBGH without a labeling requirement. In March 1995, the company claimed that it had sold 14.5 million doses of rBGH during the previous year and that 13,000 dairy farmers, representing 11% of the potential market, were using the hormone. Sales were especially strong in New York (where 10% of dairy farmers used the drug) and Wisconsin (15%), but were especially weak in Vermont. Although early sales fell short of expectations, Monsanto says that rBGH broke even in 1996, increased sales by 30% in 1997, and has been profitable ever since. As one sympathetic observer explained, “a profit-oriented company like Monsanto wouldn’t make that kind of investment for a product that’s not successful . . . rBST is saving dairy farming.”
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USDA economists maintain that the controversy over use of rBGH has had little effect on consumer demand for milk, principally because of lack of evidence of harm.
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Consumer attitudes toward rBGH milk in the United States are difficult to evaluate, however, not least because of the lack of labeling. Surveys that deliberately probe outrage factors tend to identify substantial concern about the safety of rBGH, especially among people who do not trust the FDA or perceive little benefit from the product. In contrast, industry-sponsored surveys reveal lukewarm opinions on the matter. For example, respondents to a 1994 survey reacted positively, but only slightly so (scoring 6.18 on a scale where 10 is strongly positive), to this reassuring statement: “The National Institutes of Health, the American Medical Association, and several other independent medical groups have found milk from cows that receive BST is unchanged, safe, and nutritionally the same as milk currently on grocery store shelves. Given this information, how acceptable do you find the use of BST?”
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Despite such attempts to guide public opinion, surveys demonstrate consistent support for labeling rBGH and all transgenic products. Although the industry demands that the marketplace decide the commercial fate of the hormone, consumers cannot easily make their opinions known if the products are not labeled. One index of underlying public opinion is the spectacular growth in sales of organic (“rBGH-free”) milk from $16 million in 1996 to almost $31 million in 1997, a rate of increase
substantially higher than that of nearly any other food product.
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I have heard Monsanto officials say that company scientists developed rBGH because it was technically possible to do so and that they had given no thought to its societal implications. In 1996 I visited the company offices in St. Louis and met Monsanto scientists who had worked on the project. They told me that they believed rBGH would help produce more milk, and more milk would help to alleviate world food shortages. Whatever the motives, once the company committed research funding to rBGH, it needed to recoup the investment, and it appears to have done so. Furthermore, Monsanto’s determined effort to achieve approval of rBGH succeeded in a more important respect. Because rBGH raised more safety issues than the transgenic foods that followed, its approval smoothed the way for subsequent FDA actions on herbicide- and
Bt-
resistant crops. During the time the FDA was responding to pressures to approve rBGH, its staff was also working on policies for approval of transgenic foods.

Until now, this chapter has examined the politics of a genetically engineered drug, albeit one involved in food production. We now turn to genetically engineered foods themselves. In mid-1992, the FDA issued a policy statement on the regulation of plant foods produced through biotechnology.
Figure 20
outlines this policy. As explained by FDA commissioner Dr. David Kessler, the agency developed the policy to be “scientifically and legally sound and . . . adequate to fully protect public health while not inhibiting innovation.”
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He said the policy reflected the prevailing view among senior FDA officials that foods produced through recombinant DNA techniques raised no new safety concerns and therefore could be overseen by applying the agency’s existing rules for food additives. In FDA-speak: “In most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or
substantially similar
to substances commonly found in food” (emphasis added). The FDA would only require premarket review for foods that contained known allergens or toxins or were substantially altered in nutrient content.
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The doctrine of
substantial similarity
, or
substantial equivalence
as it later came to be called, meant that the FDA would be taking after-the-fact action to recall products if they caused problems. The agency’s safety evaluation would focus on changes in the “objective” characteristics of foods—new substances, toxins, allergens, or nutrients—not on the techniques used to produce them. To determine whether transgenic foods raised safety concerns, the FDA would hold private “consultations” with industry. These would be
voluntary
. The agency would require them only when the objective characteristics raised safety questions; otherwise, companies would not need to obtain approval in advance, conduct premarket safety evaluations, or label the foods in any special way. These policies remained in place until 2001, when the FDA required premarket notification.
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FIGURE 20
. The FDA’s 1992 policy on the safety assessment of genetically modified plants. Companies did not need to consult FDA unless the transgenic plants contained allergens, toxins, or unusual components, or exhibited significant alterations in nutrient content. (Source: FDA.
Federal Register
57:22984–23005, May 29, 1992.)

The food biotechnology industry welcomed these 1992 “efforts by the White House to provide . . . as much regulatory relief as possible,” and viewed the policy as “a very strong incentive for investment in the agricultural/food biotechnology area.”
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One investment analyst summarized the FDA’s announcement as an “assurance that after all a company’s planning for a picnic, the government won’t rain on it.”
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Consumer groups, however, criticized the policy as inadequate to protect public safety and threatened mail campaigns and legal challenges. A 1999 lawsuit, for example, obtained 44,000 pages of documents related to the FDA policy. The documents revealed that some FDA scientists had been concerned about the lack of data on safety risks and thought the policy too favorable to the industry. Overall, the (ultimately unsuccessful) lawsuit concluded, “There is more than enough evidence to convince a reasonable man or woman that current FDA policy is unscientific, unwise, irresponsible, and illegal.”
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Other critics attacked the idea of substantial equivalence as a basis for policy. “Substantial equivalence,” they said, “is a pseudoscientific concept because it is a commercial and political judgment masquerading as if it were scientific. It is, moreover, inherently antiscientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit potentially informative scientific research.”
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In the meantime, critics seized on the lack of labeling as a cause for action. Celebrity chefs in New York City called for a boycott of genetically engineered foods. The chef leading the boycott, Rick Moonen (then at Oceana, New York City), explained to the press: “As a chef, I am responsible for every plate of food in my restaurant. . . . The consumers put their dietetic, religious and allergic confidences in my hands, and with no requirements for safety testing, I am not permitted to fulfill my obligations. But what is most disturbing to me is the idea of selling the food without a label.”
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Some commentators understood that the no-labeling policy of “least regulatory resistance” would increase public suspicion of genetically engineered foods, especially since press accounts had begun referring to them as
Frankenfoods
, and cartoonists were taking full advantage of this satirical opportunity.
Figure 21
gives one such example. To allay public fears, a federal study recommended a formal review of the entire federal regulatory framework for food biotechnology in order to establish a more equitable balance between promotion of the industry and protection of the public, but no such review took place. The FDA went forward with the policy and by the end of 1995 had approved the marketing of tomatoes genetically engineered to reach optimal ripening after they were picked; squash resistant to viruses; potatoes and corn resistant to insects; and cotton, corn, and soybeans resistant to herbicides. By mid-2001, the FDA had accomplished 52 consultations on these and other genetically modified food plants, meaning that they could now be marketed.
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The first of these consultations began in 1991 and concluded in 1994. Because it established the precedent for approval of subsequent foods, we now examine the politics of Calgene’s delayed ripening tomato, the “Flavr Savr,” and the fate of transgenic tomatoes in the United States and Great Britain.