Although the NTP contracts with facilities around the country, it resides on the NIEHS campus in Research Triangle Park, North Carolina. NIEHS scientists describe the mission of the NTP as “permeating” throughout the Institute as “in one way or another, a lot of people are directly or indirectly involved in and influenced by what goes on with NTP” (Interview 80). Approximately 95% of the scientists working in the National Toxicology Program also have faculty positions at the NIEHS, and the director of the NIEHS is also the director of the NTP. The NTP mandate is to strengthen the science base in toxicology; to develop and validate improved testing methods; and to provide information about potentially toxic chemicals to public health regulatory and research agencies, the scientific and medical communities, and the public (NTP 2002). A significant accomplishment of the NTP has been the development of standardized bioassays for use in toxicology testing and risk assessment:
We developed protocols for doing dosing, [for] how to interpret results, and we’ve succeeded in having those interpretations adopted by both government and industry. This was a huge challenge. Think of all the factors: gender of animal, strain of animal, feeding cycle, light cycle, care cycle, the number of animals in a cage, the dosing mechanism—whether or not it causes the animal pain or is a feeding method. There are all these things to dispute. But, over time, the American scientific community has bought in to this model of testing science. And during that time, the Institute held the line and maintained funding to develop and validate the models (Interview S27, emphasis added).
Since 1978, the NTP has been responsible also for meeting the Congressional mandate for a list of agents to which a significant number of people in the United States are exposed that are “known” or “reasonably anticipated” to be human carcinogens.15
Environmental health scientists at the NIEHS and NTP articulate their work as a form of “public service”: “At the NIEHS and NTP, we engage in a special form of public service—producing scientific knowledge that promotes individual and public health.”16 As we have seen, the NIEHS distinguishes itself by emphasizing its public health mission. For example, when asked about the mission of the NTP, a toxicologist elaborated:
Our studies are used in the regulatory process, but they also relate to the issue of disease prevention, which I think NIH does not do enough on. I think a lot of resources go into treating . . . disease conditions, but if you ask the average person on the street, would they be more interested in a drug to treat a cancer or research to prevent that cancer from having developed? I don’t think there’s any doubt what the answer will be (Interview S96).
Additionally, many environmental health scientists distinguish their work from “science for the sake of science,” arguing that it rather is “largely driven by issues that relate to safety of consumer products, occupational exposures, human exposure from substances in the environment, as well as the effects of chemicals on environmental species” (Schwetz 2001: 3–8). For NTP researchers in particular, this means contributing to “regulatory science” (Jasanoff 1990), that is, research oriented specifically to the needs of the regulatory agencies. However, the line between basic research and regulatory research seems especially porous in the environmental health sciences.17 Environmental health scientists working in academic research centers, where one might expect to find an orientation to basic research, report that their research agendas also are influenced by the needs of the regulatory agencies:
The regulatory agendas lead to a need for information. So a large part of environmental health science is driven by what is regulated, what is proposed for regulation, and especially what is set on a regular calendar for re-regulation, like all the Clean Air Act criteria pollutants (Interview S09).
In publications also, NIEHS scientists note that “NIEHS-supported research has also served as the source of information for many of the regulatory standards put forward by the US environmental health regulatory agencies to protect human health” (Olden, Guthrie, & Newton 2001: 1966).
Consequently, in contrast to scientists who draw firm boundaries between their research and its potential political implications, environmental health scientists—and especially those working in toxicology—state rather that “toxicology is a political science” (Interview S42). In making this point, a pathologist described the surprise of researchers who come to the environmental health sciences from other fields and discover that their findings have political consequences:
Scientists who venture into toxicology sometimes find themselves causing uproars. They’re surprised, because they’re used to debating cancer pathways in the literature. But, they start one of those debates here and a product is pulled off the shelves (Interview S42).
At the same time, NIEHS administrators engage in extensive boundary work (Gieryn 1999; see also Jasanoff 1990) by emphasizing that the content of their science itself must be “apolitical”: “integrity and being apolitical . . . is our stock-in-trade . . . anything we deal with is based on the science . . . ” (Interview S37). Such comments highlight the charged relationship between environmental health science and environmental regulation.
Regulating Environmental Exposures
A positive epidemiology or clinical finding really is a failure of public health policy.
Testimony of George Lucier (US GPO 2007: 54)
Beginning in the 1970s, Congress charged a combination of old and new federal agencies with responsibility for assessing the risks of environmental contaminants and formulating regulations to protect the public’s health and the health of the environment (Jasanoff 1990). Included in this mandate was the new Environmental Protection Agency (EPA),18 which was founded in 1970 to “consolidate in one agency a variety of federal research, monitoring, standard-setting and enforcement activities to ensure environmental protection” (Lewis 1985). EPA’s mission is to protect human health and to safeguard the natural environment, that is, the air, water, and land, upon which life depends.
The Agency’s regulatory authority is constituted in a panoply of laws. Considering the regulation of a single substance—mercury—makes clear the complexity of environmental regulation. The EPA regulates mercury in the environment under the Clear Air Act, the Clean Water Act, the Resource Conservation and Recovery Act, and the Safe Drinking Water Act. Each of these acts provides EPA with the jurisdiction to issues rules and standards governing a different route through which humans may be exposed to mercury. For example, the Clean Air Act includes special provisions for dealing with air toxics emitted from utilities, giving EPA the authority to regulate power plant mercury emissions.19 Many states also have developed regulations aimed at reducing mercury emissions to air, land, and water; these often are more stringent than those promulgated at the federal level.20 Additionally, when found in consumer products, mercury is subject to regulatory oversight by other federal agencies. For example, although EPA is charged with assessing and regulating the risks of mercury in fish caught by sport fishers, the FDA is responsible for regulating mercury exposure in commercially caught fish and shellfish.21 The Consumer Product Safety Commission (CPSC) has regulatory oversight for consumer products, and has issued warnings regarding mercury vapors in herbal remedies sold at botanicas.22
At the center of the EPA’s efforts to implement its mission is the process of risk assessment, which refers to “the systematic scientific characterization of potential adverse health effects resulting from human exposures to hazardous agents or situations” (NRC 1983: 1). The goal of risk assessment is to determine whether an environmental hazard might cause harm to exposed persons and ecosystems and to inform regulatory decision