The often adversarial and litigious nature of the regulatory process in the United States also has shaped research institutions, practices, and possibilities in the environmental health sciences. Indeed, environmental health research was institutionalized at the federal level, in part, as a response to dynamics of contention and litigation surrounding risk assessment by the federal regulatory agencies (Jasanoff 1990, 1995). In the late 1960s and early 1970s, the federal government invested in a massive expansion of research capacity designed to bolster risk assessment by generating new and better scientific practices and identifying omissions, mistakes, and biases in extant data, especially those obtained from nongovernmental sources, such as industry (Jasanoff 1990: 41).
The National Institute of Environmental Health Sciences
The mission of the NIEHS is to support research to define the role of environmental agents in the initiation and progression of human disease.
The goal is to use knowledge from this research to reduce adverse exposures and, thus, reduce preventable diseases and conditions.
Testimony of Samuel Wilson (U.S. GPO 2007: 21)
In 1969, Congress established the NIEHS and mandated it to direct basic research on the effects of environmental factors on human health (RTI 1965; see also Frickel 2004). At the turn of the current century, the NIEHS mission was to “to reduce the burden of human illness and dysfunction from environmental causes.”7 The NIEHS is the only one of the National Institutes of Health (NIH) defined by an independent or etiologic variable—the environment—rather than a disease (e.g., National Cancer Institute, [NCI] National Institute of Neurological Disorders and Stroke [NINDS]), organ or organ system (e.g., National Eye Institute [NEI], National Heart, Lung, and Blood Institute [NHLBI]), or a population group and/or developmental process (e.g., National Institute for Child Health and Human Development [NICHD], National Institute on Aging [NIA]). In the words of a former scientific director of the NIEHS:
the key thing about environmental agents is that they show no disease boundaries, so the same chemical that causes cancer could also cause pulmonary disease, Alzheimer’s, etc. So one of the challenges to environmental health sciences is really to be able to look at all of these different diseases. We don’t have the luxury of just studying cancer. Obviously we have a big institute that just studies cancer [NCI], but they [NIEHS] have to deal with cancer and neurodegenerative diseases, and pulmonary diseases and kidney diseases (Barrett, Oral History Interview February 2004).
NIEHS is also the only National Institute of Health not located in Bethesda, Maryland; rather, its campus is located in Research Triangle Park, North Carolina. The NIEHS contains both an intramural and an extramural division. In 2005, Congress authorized a budget for NIEHS of approximately $650 million.8 The initiatives of the NIEHS include funding not only of intramural and extramural research programs, but also of programs focused on environmental justice and community-based participatory research, as well as a premier peer-reviewed environmental health science journal, Environmental Health Perspectives.9
The research agenda of the NIEHS is shaped not only by its orientation to public policy, but also by an awareness of the missions of the other National Institutes of Health. As I describe in the following chapters, in developing its genomics initiatives, NIEHS scientists were very aware of staying within their own “turf” or “territory” and not “overlapping” with those of other institutes (Interviews 27, 37). I was told repeatedly that the environment is what defines the jurisdiction of the NIEHS, especially in regard to other National Institutes of Health.
That being said, in the context of the contemporary life sciences, the term environment may refer to the cell (which is the environment of the gene), endogenous hormonal profiles (the internal environment of the cells, organs, etc.), indoor or outdoor ambient environments (the environment of the human body), diet and exercise, or stressful life situations. In recent years, environmental health scientists have appealed to broad conceptualizations of the environment and its relationships to public health as a means of integrating behavioral and lifestyle factors into their research.10 In an oral history interview, in which he reflected on his years as the director of the NIEHS (1991–2005), Olden stated:
The environment was defined too narrowly when I got there . . . It was chemical and physical, mostly chemical. They almost never thought of physical, but [when] they would, they thought of radiation. But I said, “you know, the environment’s much more than that. The environment is your lifestyle choice . . . it is diet, nutrition, certain pharmaceutical exposures, and things like poverty . . . ” And so we then expanded the definition and I see it being used more and more. More and more, our definition [is used] by everybody (July 2004, emphasis added).
The broader definition is used “by everybody” in part because of the success of NIEHS advocacy for it:
There was an IOM [Institute of Medicine] Roundtable, around 1999, on environmental health that was the first workshop to endorse a broader definition. As a result, we felt empowered to embrace a wider definition and we began to promote that wider definition. For example, we worked with the surgeon general on the Healthy People 2010 document, which uses the wider definition of environmental health. And then it becomes a self fulfilling proposition, because we can, in turn, invoke the Healthy People 2010 definition . . . (Interview 27, emphasis added).
This expanded definition has been used to advance new foci at the NIEHS, including recent initiatives focused on obesity. As Olden explained:
I wanted to be sure that when I went before Congress or you know and they found out that I was putting 10 to 20 million dollars into behavioral research, [they wouldn’t say,] “Why are you doing that? That’s not your mission.” . . . As a matter of fact I just got the question from the Department [of Health and Human Services] about the Built Environment Conference. So I had to give them the definition of the environment and then their objection went away . . . (July 2004, emphasis added).
In other words, a broad definition of the environment provides a rationale for expanding the jurisdiction of the environmental health sciences: “This is great for the Institute. [It] allows us to expand our programs, our outreach” (Field Notes, NIEHS 2002).11 In one such expansion, the Exposure Biology Program, which the NIEHS leads as part of the Genes, Environment, and Health Initiative (GEI), scientists are working on “the development of innovative technologies to measure environmental exposures, diet, physical activity, psychosocial stress, and addictive substances that contribute to the development of disease.”12 In fact, one of the first requests for applications issued by the program was for “Improved Measures of Diet and Physical Activity for the Genes and Environment Initiative.”13
At the same time, the expansion of the definitions of the environment to include individual behavior—such as diet or physical activity or the use of addictive substances—represents a shift in the focus of environmental health research from largely involuntary exposures (e.g., chemicals in the air, water, and soil) to life-style choices which are, at least nominally, voluntary. Likewise, this may shift the focus of preventive strategies from public policy (e.g., environmental regulation) to individual behavior change.14 As we will see, definitions of the environment in gene-environment interaction generally allow for both of these strategies; this, I argue, has been a factor in their success.
The National Toxicology Program
The NTP . . . is considered a world class toxicology research and testing program and reports from the NTP are widely used around the world for strengthening the science base for regulatory decisions and for informing the public on health issues. Its role in disease prevention should not be minimized . . .
Testimony of George Lucier (US GPO 2007: 59)
The NTP was founded in the