Safe Food: The Politics of Food Safety (35 page)

When dealing with questions about the risks of genetically modified foods, industry leaders are fond of saying that nobody has died yet from eating them. This may be a correct assessment, but it misses the point. In a situation in which the risks of genetically modified foods are questionable but so are the benefits, point of view becomes the critical factor in interpretation. Regardless of the remoteness of safety concerns, the intensity of criticism—and the vulnerability of the industry—have prompted government agencies to take safety issues seriously. In 2002 alone, the General Accounting Office (GAO) chided the FDA for not doing a better job of validating information provided by food biotechnology companies, disclosing its evaluation methods, and developing new testing methods to ensure the safety of genetically modified foods. The White House Office of Science and Technology Policy asked the FDA, EPA, and USDA to strengthen restrictions on field testing to prevent escape of transgenes, and scientific panels of the National Academies urged more careful safety evaluation of genetically modified plants and animals.
⁶²

Regardless of the outcome of such actions, the safety questions discussed here—whether genetically modified foods cause allergies, antibiotic resistance, higher production of lectins, or the death of monarch butterflies, and whether they decrease or increase the use of pesticides—are not necessarily the primary issues. Genetically modified foods
already
pervade the food supply. The experiment is in progress; its results will emerge in due course. Whether such an experiment is in the public interest—or for that matter is in the interest of the industry—will also be
revealed in time. If food biotechnology is political, it is because the public has no choice but to participate in this experiment. Thus, the important question is
who gets to decide
. In the next chapter, we will consider how agricultural biotechnology companies—particularly Monsanto—convinced regulatory agencies that questions about societal risks and benefits do not need to be addressed before planting transgenic foods, that the foods require no special labels, and that the public has no choice about whether to consume them.

AMONG THE LESSONS OF THE STARLINK CORN EPISODE IS THIS:
genetically modified ingredients pervade the U.S. food supply, but consumers cannot identify them because the foods are not labeled. This situation was not inevitable. Federal agencies made “science-based” decisions that transgenic foods are equivalent to conventional foods (DNA is DNA no matter where it comes from) and require no special regulatory oversight. In this chapter, we will see how the biotechnology industry lobbied successfully for this approach, using the now familiar mantra: the techniques are inherently safe, the products are no different than those produced through traditional genetics, and labeling is not only unnecessary but misleading.

In choosing this approach, federal regulators permitted companies to develop genetically modified foods without having to alert regulatory agencies (premarket notification), evaluate the safety of the products in advance (premarket testing), or label them once they were ready to market. In approving transgenic foods, they restricted the debate to science-based issues of safety. If the foods appeared safe for human health they could be marketed: plant first, then deal with problems. As discussed earlier, this approach differs from the method required by the precautionary principle: demonstrate safety
before
planting. The science-based approach also excluded debate about the societal issues summarized in
table 2
(
page 17
). The regulatory agencies interpreted their mandates to mean that they could not consider dread-and-outrage factors when making decisions about genetically modified foods.

This chapter examines how food biotechnology companies achieved
a “plant first” regulatory environment. To understand the politics of the current system, we must recall that Congress wrote the principal laws affecting food safety in 1906, long before anyone knew anything about DNA, let alone transgenic foods. As noted earlier, the discovery of recombinant DNA techniques in the 1970s stimulated discussion about how to assure their safety. At hearings in 1983, Congress reviewed arguments for federal regulation of biotechnology. The following year, under pressure from the pharmaceutical industry, the White House Office of Science and Technology Policy (OSTP) proposed a “Coordinated Framework” for the regulation of biotechnology and issued a final version in 1986. The pharmaceutical industry argued that because DNA is DNA, drugs produced through recombinant techniques require no special considerations, laws, or agencies. The OSTP agreed and established four principles: (1) existing laws are sufficient for regulation, (2) regulation applies to the products, not the processes by which they were developed, (3) safety should be assessed on a case-by-case basis, and (4) agencies should coordinate their regulatory efforts.
¹

This last principle would prove especially challenging because the Coordinated Framework distributed regulatory responsibilities among a large number of federal entities: three offices reporting directly to the president; three cabinet-level federal agencies; two major subagencies within one cabinet-level agency; eight centers, services, offices, or programs within major agencies; and five federal committees—all operating under the authority of 10 distinct acts of Congress. Any regulatory plan of that complexity suggests that coordination will be difficult—impossible is more like it—and that oversight will be plagued from the start by gaps, duplication of effort, and overlapping responsibilities. Like the oversight scheme for food safety, the Coordinated Framework reveals the need for a single food agency.

The Coordinated Framework applies to foods as well as drugs and assigns three agencies to their regulation, two at the cabinet level—the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA)—and a subagency of a third (the Department of Health and Human Services), the Food and Drug Administration (FDA). Genetically modified foods, however, do not easily fit into the existing regulatory categories of these agencies, leaving much room for interpretation. Moreover, the three agencies operate under different laws. The Plant Pest Act allows the USDA to regulate transgenic crops as
plant pests
when they contain genes or regulatory DNA segments from potentially harmful organisms: insects, nematodes, slugs, and snails, but also bacteria, fungi,
and viruses. Because just about all gene donors are on this list, most transgenic plants require USDA permits to allow them to be field-tested, transported through interstate commerce, or imported. Over time, the USDA has modified its regulations to make it easier for companies to plant genetically engineered crops without having to obtain permits.
²

In contrast, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires the EPA to “register” transgenic foods as
plant-pesticides
(or, as they are now called,
plant-incorporated protectants
). If a crop is bioengineered to contain the toxin from
Bacillus thuringiensis
(
Bt
), for example, the EPA considers it to contain a pesticide and regulates the plant as it would any pesticidal chemical. Ordinarily, makers of
Bt
crops must submit voluminous information about the toxin’s effects on health and the environment, but the EPA can and does grant exceptions.

To further complicate matters, the FDA regulates transgenic foods as
food additives
under the provisions of the Food, Drug, and Cosmetic Act. Unless food additives are generally recognized as safe (GRAS), meaning that they have a history of safe use, they require premarket approval; manufacturers must submit evidence demonstrating “reasonable certainty” that an additive will not be harmful if used appropriately. In practice, the FDA has jurisdiction over all genetically modified foods, although it shares regulatory authority over plants that have to be field-tested or transported across state lines with USDA, and those containing the
Bt
toxin with EPA. Dealing separately with two—let alone three—agencies is guaranteed to be a lengthy, complicated, and expensive process, and food biotechnology companies complain that the regulations are cumbersome and restrictive. They also complain that the regulations are contrary to the intention of the Coordinated Framework because they hold genetically modified foods to
higher
safety standards than conventional foods.
³
To evaluate such contentions, let’s begin by examining the FDA’s role in regulating transgenic foods and the ways in which the biotechnology industry has influenced that role.

The FDA’s main function is to regulate drugs, and its food activities are decidedly secondary. By the early 1990s, the FDA had approved at least 15 recombinant drugs for medical use, with recombinant insulin among the earliest in 1982. The benefits of many of these drugs seem evident. Recombinant insulin, unlike that obtained from pigs, has an amino acid structure identical to that of human insulin and can be produced in unlimited
quantities. So can recombinant enzymes used in food manufacture such as chymosin, an enzyme used to coagulate milk in the early steps of cheese making. In the past, cheese makers obtained chymosin as part of a mixture called rennet, which had to be extracted from the stomachs of calves and was expensive and of inconsistent composition. Scientists bioengineered the gene for chymosin into bacteria, and the FDA approved the recombinant enzyme in 1990. Such drugs and enzymes elicited few objections from critics of biotechnology, mainly because of the obvious advantages. Transgenic chymosin, for example, does not require the slaughter of baby calves. Also, manufacturers did not publicize its origin, as they saw “little to gain from waving the biotech flag.”
⁴
Transgenic drugs did not become controversial until they affected food more directly, as was the case with the cow growth hormone, recombinant bovine somatotropin (rbST)—a drug that affects
milk
. Because the approval process for this drug was so evidently political—interweaving considerations of science, safety, commercial objectives, and societal issues—and because it paved the way for subsequent FDA approval of transgenic foods, the case of bovine growth hormone is worth close examination.

The politics of this animal drug begin with its very name. Proponents of the drug use the scientific term
bovine somatotropin
(bST), whereas critics tend to use the more recognizable
bovine growth hormone
(BGH). Both put an
r
in front to distinguish the genetically engineered drug from the natural hormone in cows. For simplicity, this chapter uses rBGH. Whatever it is called, the recombinant hormone increases milk production in cows by 10–20%. It proved controversial from the start, and questions about its safety continue to be debated, especially in Canada and Europe. Monsanto developed the bioengineering capacity to create rBGH in the early 1980s, and the company quickly promoted it as a means to increase the efficiency of dairy farming. Although this use might appear to be of great benefit to consumers as well as to farmers, critics soon raised questions about the possibility of adverse effects of the drug on human health, animal welfare, and the economic viability of small dairy farms. Furthermore, consumers would have no choice about whether to buy products resulting from use of the hormone, as milk from cows treated with rBGH (shorthand: rBGH milk) would not be labeled as genetically engineered.
⁵

When the FDA approved rBGH as a new animal drug in 1993, available
analytical methods could not easily distinguish milk from treated and untreated cows.
⁶
Because the naturally occurring BGH in cow’s milk was indistinguishable from rBGH, the agency ruled that labeling would be misleading because the milks are the same. Monsanto and other biotechnology companies viewed disclosure as a threat to the future of agricultural biotechnology. If rBGH failed in the marketplace, the entire industry might be in jeopardy. The industry extolled rBGH and the equivalent hormone in pigs as “biotechnological miracles that would give consumers more for their money at less cost to the environment,” but worried that “ignorance, nostalgia and a Luddite view of technology” would prevent the drugs—but also transgenic foods in general—from reaching the marketplace.
⁷

Industry leaders had grounds for concern. By 1989, when Monsanto was testing rBGH on commercial farms in nearly every important dairy state, the drug was already under attack by groups concerned about family farms as well as by those suspicious of any kind of genetic engineering. Several supermarket chains refused to carry milk from rBGH-treated cows, and the owners of Ben & Jerry’s announced that they would label ice cream packages with a statement opposing use of the hormone. Before the drug had even been approved for commercial use, the state legislatures of Wisconsin and Minnesota temporarily banned sales of rBGH. By 1992, four major supermarket chains, two large manufacturers of dairy products, and the nation’s largest dairy cooperative joined the boycott, as did many small farmers, dairy cooperatives, and grocery chains.
⁸

The Safety Issues
. Bovine somatotropin stimulates milk production. The hormone, a protein, is always present in cow’s milk at low concentrations. Milk from rBGH-treated cows contains both the natural and recombinant hormones. Neither the natural nor the recombinant hormone is likely to affect human health; the cow hormones differ in structure from the human hormone, are not biologically active in humans, and do not promote human growth. Furthermore, like all proteins, cow hormones are largely digested to their constituent amino acids and, therefore, inactivated in the human digestive tract.