Safe Food_ Bacteria, Biotechnology, and Bioterrorism - Marion Nestle [125]
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.36 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.
The Politics of Transgenic Food Plants
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.”37 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.38
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.39
FIGURE 20. The FDA’s 1992 policy on the safety assessment of genetically modified plants. Companies did not need to consult