Safe Food: The Politics of Food Safety (36 page)

In 1990, Monsanto said that its studies had satisfied any doubts about whether rBGH milk is safe for human consumption. That year, FDA scientists reviewed more than 130 studies of the effects of rBGH on cows, rats, and humans and also concluded that the hormone does not affect human health. Critics called this conclusion an unprecedented display
of conflict of interest: FDA scientists had produced a favorable evaluation of evidence in support of a drug not yet approved by their agency. Others accused the FDA of colluding with Monsanto because agency scientists could not have conducted the review unless the company had disclosed confidential studies that were not available for evaluation by the general scientific community. A panel of experts recruited by the National Institutes of Health (NIH), however, concluded that milk from rBGH-treated cows was essentially the same—and therefore as safe—as milk from untreated cows. According to one rBGH supporter, the hormone had been tested on 21,000 cows and described in more than 900 research papers by 1992 with no indication of harm to human health.
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Nevertheless, critics continued to raise doubts about the safety of rBGH-milk on two grounds: antibiotics and a substance called
insulin-like growth factor-1
(IGF-1). The concern about antibiotics derives from observations that cows given rBGH develop more frequent infections of their udders (mastitis). The more milk cows produce, the more likely they are to develop mastitis, and rBGH increases milk production. Because farmers treat the infections with antibiotics that can linger in milk and meat, eating foods from treated animals might contribute to selection for antibiotic-resistant bacteria. On this basis, the General Accounting Office (GAO) urged the FDA not to approve rBGH until issues related to mastitis could be resolved. Federal regulations require the FDA to test for antibiotic residues in milk, but the agency is able to test for just a small fraction of animal drugs in common use—just 4 out of 82 in one study—suggesting a lack of ability to monitor such substances. Because of this regulatory gap, another federal committee recommended that the FDA ban rBGH until the antibiotic risks could be evaluated. The Republican administration in power in 1992, however, was committed to a policy of industry deregulation, and it ignored the recommendations.
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IGF-1 concerns critics for three reasons: (1) rBGH increases levels of this factor in cow’s milk, (2) IGF-1 in cows is chemically identical to human IGF-1, and (3) higher levels of IGF-1 in cow’s milk might stimulate premature growth in human infants or cancer in adults. It is difficult to evaluate this last contention given the current state of research. Population studies associate high levels of IGF-1 in blood with a higher risk of prostate cancer in men and breast cancer in premenopausal (but not post-menopausal) women and, perhaps, with a greater risk of high blood pressure, but these findings do not necessarily have anything to do with drinking milk; high IGF-1 levels could be due to genetic or other dietary causes.
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The factor ought to be inactivated during processing and digestion, but
some seems to be absorbed intact. The research gaps have encouraged lingering doubts, demands for reassessment of the safety of rBGH, and lawsuits against the FDA. They also encouraged one anti-rBGH activist, Robert Cohen, to go on a hunger strike in 1999—one of the more extreme forms of protest against foods made with transgenic ingredients.
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The Social Issues
. Protests 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.
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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.”
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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.”
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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.
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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.”
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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 to promote this otherwise problematic product. Public relations firms working for Monsanto engaged in the usual sorts of lobbying activities in support of rBGH approval but also sent “secret agents and spies” to infiltrate citizen’s groups opposed to use of the hormone.
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As a member of the FDA Food Advisory Committee, I attended hearings on rBGH prior to its approval. The FDA had invited interested companies to provide one witness each. Monsanto sent
nine
, some of them supposedly “independent” witnesses (one was a pregnant dairy farmer from upstate New York) whose connections to the company emerged only when FDA officials required them to declare who paid for their travel to the meeting. The company took full advantage of its connections in government, enlisting an influential former Congressman—to whom the secretary of agriculture owed his appointment—to discourage federal studies of the economic effects of rBGH.
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Monsanto wielded other kinds of influence. It withheld consent to publish a peer-reviewed article by independent researchers who used the company’s data to measure amounts of white blood cells—an indicator of mastitis—in rBGH milk. Monsanto reserved the right to publish its own data first but delayed doing so for several years; this delay effectively prevented the FDA from considering the independent analysis during the rBGH approval process. Monsanto researchers argued that mastitis white cell counts depend on how much milk is produced, whether or not the cow is treated with rBGH. In contrast, the independent investigators found milk from rBGH-treated cows to contain more white cells, although they could not say whether the higher counts were due to the drug itself or to the higher milk yield. Eventually, they published the results and revealed the dispute.
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In another incident, Monsanto lawyers pressured Fox Television to refuse a four-part series on rBGH commissioned by one of its Florida stations from two staff investigative reporters. The station suspended the reporters and did not air the series. The reporters documented sales of rBGH-milk by Florida grocers who had pledged not to sell it, and inadequacies in state screening methods for antibiotics in the treated milk. They also said that Monsanto had offered as much as $2 million to Canadian regulators who were considering approval of rBGH, and had made large gifts to universities whose researchers provided data in support of FDA approval. They established a Web site to describe their side of the story and filed a whistle-blower lawsuit against the television station. The case went to trial in mid-2000; it resulted in a clear win for the reporters. The jury agreed that Fox “acted intentionally and deliberately to falsify or distort the plaintiffs’ news reporting on BGH,” and awarded a judgment of $425,000 in damages.
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These incidents were only the most public—and documented—of Monsanto’s actions, most of which took place behind closed doors in Congress, at the FDA, and (as rumored) at newspapers planning to run stories on the possible hazards of rBGH.

Monsanto’s Campaign against Labeling
. Monsanto steadfastly resisted demands for labeling of rBGH milk and recruited dairy industry executives to persuade the FDA to establish favorable labeling guidelines. The company hired two Washington law firms to monitor dairies for advertising and labeling violations and to instigate legal action against milk processors who had “inappropriately” misled customers through labeling practices.
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The FDA asked the Food Advisory Committee to hear testimony on the labeling issue. A Monsanto official explained the company’s
position. Because its surveys indicated that 60% of consumers thought that rBGH labeling implied a safety or contamination risk, mandatory labeling would violate the spirit and intent of the labeling laws and would also “diminish the credibility of the food label and would represent a clear step backward from the wonderful progress that has been achieved.”
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Because the FDA seemed already to have decided the issue and the Advisory Committee’s role was just that—to advise—critics viewed the hearings as a “public relations smokescreen” and “a regulatory charade.”
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Some dairy companies, concerned that consumers might not want to buy milk from hormone-treated cows, began labeling their products “BGH-free.” Monsanto and its industry supporters objected and asked the FDA to establish guidance “rules” on the labeling of dairy products derived from cows
not
treated with rBGH. In February 1994, the FDA stated that it could not require such labeling, but companies could voluntarily say they were not using rBGH, provided “that any statements made are truthful and not misleading.” Although this ruling might sound permissive, the FDA considers “misleading” to apply to any suggestion that untreated milk is superior. Thus, the agency views
BGH-free
as misleading because all milk contains some natural BGH. The term
rBGH-free
also is misleading because the recombinant and natural cow hormones cannot be distinguished. Dairy companies may use such terms only if they provide an explanation of the context: “No significant difference has been shown between milk derived from rBGH-treated and non-rBGH-treated cows.”
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Vermont, which boasts of its quality dairy products, defied the FDA ruling and passed legislation requiring rBGH milk to be labeled: “Vermonters have the right to know what is in the food they eat. . . . In particular, there is a strong public interest in knowing whether or not rBST has been used in the production of milk and milk products.”
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Industry groups acting on behalf of Monsanto quickly and successfully challenged this law in the courts. When several major milk marketers launched new brands certified as coming from cows that had not been treated with the hormone, Monsanto warned them that their labels “might create the impression that something is wrong with milk from treated cows.”
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By May 1994, Monsanto had sued at least two dairy companies on this basis, a situation that made it appear as if “everyone is terrified of Monsanto. . . . It is quite ominous.”
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In Vermont, only a small fraction of farmers continued to use rBGH. Companies like Ben & Jerry’s used their rBGH-free status as a marketing tool, as shown in
figure 19
: “We oppose recombinant bovine growth hormone. The family farmers who supply our milk and cream pledge not to treat their cows with rBGH.”