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about the safety of rBGH obscure an underlying issue—its economic impact. The production of milk in the United States has long exceeded demand, and the government has long subsidized the dairy industry through purchases of surplus milk. Monsanto contends that costs to farmers will decline because fewer cows will produce more milk, and the savings will be passed on to consumers. This last benefit seems doubtful, mainly because dairy prices are tightly linked to federal support programs. If prices fall, levels of taxpayer-supported federal spending would increase to protect farm incomes. Critics also raise concerns about the effects of rBGH on the cows themselves; higher milk production stresses cows and leads to more frequent mastitis and sores at injection sites (an issue of animal rights). Although Monsanto asserts that appropriate veterinary and herd-management practices minimize such problems, farmers report them regularly. The FDA, however, views these complaints as raising no new concerns about animal health.13

Use of rBGH also raises questions about effects on rural life. If people drink less milk to avoid rBGH, or if it increases veterinary costs, the drug might contribute to the ongoing attrition of small dairy farms. Jerry Cohen, then an owner of Ben & Jerry’s, told the FDA Food Advisory Committee in 1993: “We do know that the use of BGH will increase the supply of milk at a time when we already have a tremendous surplus. It does not make any sense to exacerbate this problem with a product about which there are so many legitimate doubts, a product whose principal beneficiaries will be chemical companies and corporate agribusiness.”14 That the product affects milk itself raises issues. As ethicist Arthur Caplan explained, “Is there any product in the world that has tried harder to sell itself as wholesome and pure than milk? . . . It is a food for innocent, trusting children, culturally laden with symbolism. Any adulteration of milk . . . is seen as taboo.”15 Despite this range of concerns, Monsanto only needed to overcome doubts about the safety of the drug for human health to obtain FDA approval.

Monsanto’s Campaign for Approval. Monsanto’s efforts to obtain FDA approval for rBGH began as soon as it produced the drug. At the company’s request, the FDA permitted distribution of rBGH for limited use on an experimental basis in 1985, and subsequently affirmed the safety of rBGH milk and meat in 1988, 1989, and again in 1990, as did the NIH in 1990 and the Office of Technology Assessment (OTA) in 1991. When the FDA’s approval of rBGH as a new animal drug appeared imminent in August 1993, Congress imposed a 90-day moratorium on sales. The U.S. Senate, concerned about the fate of small dairy farms, asked for a moratorium lasting an entire year, but House opposition forced a compromise resulting in the shorter time limit.16 After lengthy deliberations, advisory committee consultations, and public hearings, the FDA approved rBGH as a new animal drug in November 1993 and ruled that milk produced by cows treated with the hormone would not need to be labeled. In announcing this decision, FDA commissioner Dr. David Kessler stated: “There is virtually no difference in milk from treated and untreated cows. . . . In fact, it’s not possible using current scientific techniques to tell them apart. We have looked carefully at every single question raised, and we are confident this product is safe for consumers, for cows and for the environment.”17 The FDA approval applied only to Monsanto’s rBGH, although approvals for similar products from other companies seemed sure to follow. Industry representatives hailed the decision as a victory for Monsanto, an indication of reduced regulatory barriers, and a precedent for approving forthcoming products of agricultural biotechnology.

This resounding success was no accident. As early as 1987, business analysts expected rBGH to generate millions of dollars in annual sales. The potential for large returns on investment explains Monsanto’s unusually aggressive sales tactics and political actions