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ONE “Toxicology Is a Political Science”

In September 2007, an array of prominent environmental health scientists and activists was called to testify before Congress. Seated before the Domestic Policy Subcommittee of the House of Representative’s Committee on Oversight and Government Reform were Samuel Wilson, then acting Director of the National Institute of Environmental Health Sciences (NIEHS), George Lucier, former Director of the National Toxicology Program (NTP), Lynn Goldman, a professor of environmental health science at the Johns Hopkins University School of Public Health, Peggy Shepard, the Executive Director of the EJ group West Harlem Environmental Action (WEACT), and Stefani Hines, a member of the National Advisory Environmental Health Sciences Council (NAEHSC).¹ The question before them was no less than whether the NIEHS was fulfilling its public health mission. Specifically under scrutiny was “a new set of research priorities” at the NIEHS, which had been implemented by its recently departed Director, David Schwartz.² The chairman of the subcommittee opened the hearing with two questions: “At what cost has come Dr. Schwartz’s new direction for the NIEHS?” and “Should the new NIEHS research directions and priorities . . . continue?” (US GPO 2007: 2).

Particularly at stake in the hearing was the boundary between biomedicine, with its focus on curing disease in individuals, and public health, with its focus on population-based disease prevention. In fact, the focal concern of the subcommittee was whether the NIEHS was becoming too biomedical in its orientation and thereby failing to meet its public health mandate. In his opening comments, the subcommittee chair expressed concern about the shifting of “significant resources toward research that was clinical in nature and which focused on discoveries that would contribute to treating or curing disease once a patient was already afflicted” (US GPO 2007: 1). In advance of this hearing, the staff of the subcommittee had “performed its own analysis of the NIEHS’ new research direction and priorities” and reached the conclusion that the public health focus of the NIEHS was being replaced with “programs of a clinical nature” (US GPO 2007: 2).

During the hearing, the speakers used a series of contrasts to distinguish the NIEHS and the NTP in particular, as well as the environmental health sciences more broadly, from the clinical focus of most biomedical research. To begin, in contrast to research that focuses on clinical treatments, the environmental health sciences focus on disease prevention: “NIEHS is the only institute with a primary mission of public health, rather than clinical medicine . . . ” (US GPO 2007: 69). In contrast to research that is oriented to the development of new drugs or medical treatments, the environmental health sciences inform public policy, “mak[ing] major impacts on human health through research translation to public policy, not to the bedside” (US GPO 2007: 69). In contrast to research that is individually oriented, the environmental health sciences contribute to protecting the health of the population, serving as “the source of key information regarding the health impacts of pollution . . . used daily in setting protective federal, state, and local policies, in arguing for the protection of children, the elderly, and our communities” (US GPO 2007: 77). In contrast to research that is defined by a specific disease or organ, the environmental health sciences investigate environmental exposures which affect multiple bodily systems and are associated with myriad diseases: “Every disease has an environmental component, thus NIEHS’s responsibilities encompass all human diseases, rather than following the more common model of focus on a specific disease or organ system”³ (US GPO 2007: 26). In contrast to research that can be accomplished in laboratory and clinical settings alone, the environmental health sciences engage with affected communities and must consider their concerns: “We must be productively linked to our constituents . . . to fulfill the promise of our mission” (US GPO 2007: 29). Again, the boundary between biomedicine and public health was a focal concern, as speakers emphasized that “prevention and environmental intervention represent the most effective and efficient ways to improve human health, and this core principle should not be lost in favor of technical, individually oriented medical solutions” (US GPO 2007: 72).

Given the preventive and public health focus of the scientists testifying before the panel, their comments regarding molecular genetics and genomics were quite striking. Genetics has most often been associated with exactly the technical, clinical, individually oriented biomedical approaches that scientists described as what the environmental health sciences are not. However, in their testimonies before Congress, these speakers highlighted molecular genetic approaches as a promising solution to the ongoing and seemingly intractable problems confronted by scientists who seek to explicate relationships between environments, human bodies, and health and illness. Repeatedly, in their description of the agenda of the NIEHS, they asserted powerfully the importance of “new opportunities in science” (US GPO 2007: 23), particularly in molecular genetics and genomics, for environmental health research. Goldman described the NIEHS as “positioned to harness the next generation of scientific advances, such as in molecular biology and genetics, in the service of advancing environmental health sciences” (US GPO 2007: 70). Wilson explicitly connected molecular genetics research to the public health mission of the NIEHS, stating, “Our understanding of how the environment operates at the molecular level can also provide insights on interventions and early markers for disease . . . ” and emphasizing the importance of evaluating how “emerging technologies can be used to enhance public health prevention strategies” (US GPO 2007: 21, 28, emphasis added). Lucier highlighted the importance of “technological innovations and molecular biology” for the NTP. Likewise, Hines emphasized the importance of approaches that would “bring environmental health research out of the sidelines where it consists only of testing chemicals for toxicity into a more mainstream role where research would investigate how environmental agents contribute to specific diseases that impact public health on a large scale” (US GPO 2007: 79–80).

What can we learn from this hearing? First, the major institutions of environmental health research must answer to Congress for their actions. They are accountable, particularly, for their contributions to public health policy.⁴ Their funding depends on meeting their missions and mandates, as understood by politicians in Congress. Second, and related, the environmental health sciences have defined themselves as being part of public health and in contrast to biomedicine. Indeed, the NIEHS consciously seeks to establish an identity as “the prevention Institute.”⁵ At the center of this distinction is the difference between protecting health and preventing illness using population-level interventions, such as environmental regulation, versus treating disease using individual clinical interventions, such as pharmaceuticals. Third, given their focus on population-level interventions, there has been a push within the environmental health sciences to engage with affected communities and to work collaboratively to address environmental concerns. Fourth, by 2007, leading environmental health scientists, standing in front of the legislative body that authorizes their funding, were making strong claims about the importance of molecular genetic techniques to their public health mission.

Explaining why and how molecular genetics became positioned as a critical component of environmental health research, regulation, and policy making is the central concern of this book. Toward that end, my goal in this chapter is to provide a map of the institutional actors in the U.S. environmental health arena and to introduce their relationships and key struggles. In so doing, I draw both on the comments made before Congress in 2007 and a broader sociological analysis.⁶

THE ENVIRONMENTAL HEALTH ARENA

Understanding Environmental Exposures

At the center of the environmental health arena are questions and controversies about whether specific environmental exposure poses a risk to human health and, if so, under what conditions (e.g., at what dose, via which routes of exposure, for whom, etc.) and how such risks are best controlled. Environmental health scientists and scientific institutions play a central role in this arena. In most instances, knowledge of environmental hazards is contingent upon “the ‘sensory organs of science’—theories, experiments, measuring instruments—in order to become visible or interpretable as hazards at all” (Beck 1992: 27, emphasis in original). Chemicals in the settings where we live, work, and play, in what we eat, and in the products we use to care for our bodies, clean our homes, tend to our yards, and so on are often neither visible nor perceptible to the persons being exposed to them (Altman et al. 2008). Additionally, many toxic substances have a lengthy latency period before the effects of exposure emerge, and others may affect not the person exposed but her or his children (Schettler et al. 2000; Steingraber 2003). Consequently, people are exposed without their knowledge to combinations of chemicals as they move through their homes, workplaces, and communities. Moreover, although members of the public may fear, perceive, and even document evidence of suspected environmental hazards (Brown & Mikkelson 1994), the legitimate recognition of a risk requires the tools and practices of science: “So long as risks are not recognized scientifically, they do not exist—at least not legally, medically, technologically, or socially—and they are thus not prevented, treated or compensated for. No amount of collective moaning can change this, only science” (Beck 1992: 71).

This “scientization” has been challenged by environmental health activists, who argue that individuals and communities have important “lay knowledge” about environmental hazards (Corburn 2005) and should not be excluded from policy debates (Brown 2007: 19). There is some evidence that activists’ challenges to the technical practices of environmental health science have created opportunities for new forms of knowledge production (Ottinger & Cohen 2011). Nonetheless, environmental health science remains the authoritative idiom for making claims about the effects of environmental exposures on human health. As we will see, science is therefore also the idiom in and through which controversies about the effects of environmental exposures and regulatory strategies take place.

Explaining the relationships among bodies, environmental exposures, and human health and illness is the primary focus of the sciences of environmental epidemiology and toxicology. Epidemiology is the study of “disease occurrence in human populations and the factors that influence these patterns” (Lillienfield & Stolley 1994: 3). Epidemiologists use a variety of study designs, all of which rely heavily on statistical techniques, for establishing and quantifying the relationships between exposure to risk factors and disease outcomes in human populations. Environmental epidemiologists focus particularly on the effects of exposures in the ambient environment (e.g., air, water, soil). Toxicology is “the study of the adverse effects of xenobiotics” (Gallo 1996: 3) and includes both the study of absorption, distribution, excretion, and biotransformation of such agents and the analysis of basic toxicological processes within specific organ systems. Although much toxicology is ultimately concerned with human health and illness, toxicologists rely heavily on animal models, in vitro bioassays, and laboratory research (Sellers 1997; NTP 2002). Epidemiology and toxicology are the “core sciences” of public health in the United States (Omenn 2000). Institutionally, academic departments of epidemiology and toxicology are located in schools of public health, where their faculties often staff multidisciplinary environmental health research centers.

The location of environmental health science within the context of public health has had profound implications for the work of environmental health scientists, shaping patterns of funding, defining markets for their research, and determining opportunity structures for employment. In contrast to much research in the contemporary life sciences, which is oriented to biomedical interventions such as new pharmaceuticals or devices, the primary consumers of environmental health research include risk assessors, regulators, and policy makers; there is no promise of a lucrative “magic bullet,” or cure, to environmental exposures or their consequences. This dynamic was highlighted at the Congressional hearing, when the subcommittee chair noted “ . . . a significant failure of the market system: there is little profit in prevention when compared to treatment” (US GPO 2007: 7). As such, there are few incentives for private sector investment in environmental health research, aside from that sponsored by companies seeking EPA or FDA approval for their products. As one environmental health scientist commented, “ . . . in contrast to a lot of other biomedical research where there are opportunities to make money, to patent a new drug, to patent a new protein, [in the environmental health sciences] you’re constantly fighting an uphill battle with economic forces that would rather preserve the status quo” (Interview S50).

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 wake of Congressional dissatisfaction with the performance of the NCI Bioassay Program, which had faltered in its efforts to expand testing programs as directed (and funded) by the National Cancer Act (Smith 1979). The NIEHS was given the “the lead role” in the NTP in 1978, by order of Health, Education, and Welfare secretary Joseph Califano. In 1981, the NCI Carcinogenesis Bioassay Program and, with it, many research scientists were transferred to the NIEHS. At that time, the NTP became a permanent activity of the Department of Health and Human Services (DHHS), charged with coordinating toxicological testing programs within the Department (Weisburger 1983).

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 making.²³ Broadly speaking, risk assessment has four stages: (1) hazard identification—the determination of whether a substance is linked to a particular human health or environmental effect; (2) dose response—the estimation of the relationship between exposure and its potential effects on health; (3) exposure assessment—assessment of the source of pollution, the nature of migration from the source, and the location of people relative to it; and (4) risk characterization—a synthesis of the previous three steps and the uncertainties therein (Corburn 2005: 85–87; see also NRC 1983). Environmental health research has a central role in each stage; however, risk management strategies are shaped also by economic, legal, political, and technological considerations (Faustman & Omenn 1996; NRC 1983). As a toxicologist noted with some frustration, “even when the science is clear,” the EPA is required to consult with diverse stakeholders and consider “nonscientific” concerns as part of a complete regulatory review process (Interview P05). Nonetheless, many environmental health scientists are strongly oriented to the goal of informing risk assessment; descriptions of toxicology, in particular, often emphasize its important role in the risk assessment process (Smith 2001). Even more dramatically, a former NTP scientist told me that “the only reason to do toxicology is to address issues in risk assessment” (Interview S81).

Risk assessment and regulation at the EPA generally have focused on the ambient environment, that is, on assessing and controlling, via public policy, chemicals in the environment that may pose a threat to human health. There are a few examples of laws in which biological variations among humans are incorporated in regulatory processes. For example, the Clean Air Act of 1990 and the Food Quality Protection Act of 1996 had specific provisions for the protection of sensitive groups within the general population, such as children and people with asthma. Likewise, there are a few instances of regulators recommending that the risks posed by exposure to environmental chemicals be remediated by an individual behavior.²⁴ However, the predominant approach to protecting the health of the public vis-à-vis environmental risks has been to control the emission and concentration of harmful chemicals in the air, water, and soil.

This population-level approach contrasts with the individual-level approaches, focused rather on clinical interventions and on behavioral and lifestyle factors, that are central to both biomedicine and the “dominant epidemiological paradigm” (Brown 2007). Insofar as health care utilization, behavioral, factors, and lifestyle factors are seen as individual choices, individual-level approaches tend to hold individuals responsible for their health status (Brown 2007: 20; Petersen & Lupton 1996). In contrast, in public policy approaches, the state retains the responsibility that it acquired in the eighteenth or nineteenth century—the precise timing varying across national contexts—to secure the general conditions of public health by maintaining clean air, water, and food (Rose 2001: 6).

These public policy applications of environmental health science, in turn, have reinforced the alignment of environmental health research with public health. The NIEHS and NTP track the uptake of their research by regulatory agencies as a measure of the contribution of their scholarship.²⁵ Likewise, environmental health scientists emphasize the potential of their research to intervene at the “front end of disease, or disease etiology, and prevention” (US GPO 2007: 21). Among the consequences of the historical alignment of the environmental health sciences with public health and public policy approaches is that, in order to defend their jurisdiction—and maintain their funding—environmental health scientists must articulate their contribution to public health and maintain clear boundaries with biomedicine.

The public policy applications of environmental health science increase the scrutiny given to such science, which is regularly challenged in regulatory reviews and in litigation. In the United States, the centrality of scientific knowledge in environmental regulation and the readiness of the courts to adjudicate complex scientific questions have given litigating parties incentives to reframe fundamentally political and economic cleavages as disputes over scientific evidence (Jasanoff 1995: 67; Michaels 2008).²⁶ As a toxicologist noted grimly, “The court cases occur when trying to apply [research] findings to regulations” (Interview S38). Such challenges may center on claims about specific, local exposures and their effects on a community’s health (Allen 2003; Brown & Mikkelson 1994; Corburn 2005) or on whether and how it is necessary to regulate substances commonly used in industrial manufacturing of widely distributed consumer products (Jasanoff 1995; Markowitz & Rosner 2002).

Both industry and environmental health advocacy groups have established their own research institutes, as well as collaborations with university-based environmental health scientists, as a means of participating more fully in this arena (Brown et al. 2006).²⁷ Fundamentally, this means that environmental health research is frequently and publicly contested. That said, these contestations take very different forms. As I discuss later in this chapter, environmental health and justice advocates argue broadly for more protective and democratic approaches to environmental risk assessment and regulation. In contrast, in the past half century, regulated industries have invested significant financial and institutional resources in the politicization of scientific uncertainty, seeking to convince the judiciary and the public that the evidentiary base for environmental regulation is “junk science” (Michaels 2008; Oreskes & Conway 2010; Ong & Glantz 2001).

“Better Living Through Chemistry”²⁸

An improved understanding of environmental health risks is important because economic development plays a vital role in the U.S. and world economy and to human welfare . . .

Testimony of Lynn Goldman (US GPO 2007:66)

Today’s chemical industry includes companies producing a staggering array of products that are central to contemporary life. According to the American Chemistry Council (ACC), the trade group that represents the $720 billion industry, chemical production in the United States encompasses five product segments: pharmaceuticals, basic chemicals (i.e., commodity chemicals produced in large volume and with broad applications), specialty chemicals (i.e., low-volume, high-value compounds with very specific applications), agricultural chemicals (e.g., pesticides and fertilizers), and consumer products. Our homes are full of chemical products, such as vitamins, prescription and over-the-counter drugs, vinyl flooring, cosmetics, soaps, lotions, shampoo, pantyhose, DVDs, diapers, and household cleaners; most of us use multiple chemical substances each day (Altman et al. 2008).

Chemical production has contributed to the expansion of the American economy and remains a major component of it; the ACC proudly describes the U.S. economy as “chemistry dependent.” Nearly 800,000 people were directly employed by the chemical industry in 2010, and the ACC estimates that for every job created in the business of chemistry, 5.5 jobs are created in other sectors of the economy. In 2010, chemical products accounted for 12% of U.S. exports.

Despite the role of chemistry in creating what the ACC calls the “American standard of living,” both the specific products of the chemical industry and the industrial manufacturing processes through which they come into being have been the subject of contentious politics for over a century. Concerns about conditions within factories—and their effects on workers’ health—gave rise to broader questions about the health consequences of chemical exposures outside these concentrated industrial settings (Seller 1997). For over a hundred years, the chemical industry has contended that its voluntary compliance with health safeguards will be sufficient to protect the health of workers and the public. However, as noted by public health historians, “there have always been those inside and outside of government who believed that voluntary compliance . . . is not sufficient to safeguard the public’s health for the reason that industry’s financial interests often prevent it from doing what would be socially responsible” (Markowitz & Rosner 2002: 3).

Advocating for Environmental Health and Justice

To answer the question of why some communities are more affected by some disease, NIEHS must continue to assess the degree to which environmental exposures disproportionately impact specific communities, to understand the effects of multiple and cumulative exposures, and ultimately what types of intervention will effectively reduce those disparities in health burdens.

Testimony of Peggy Shepard (US GPO 2007: 72)

Another defining characteristic of the environmental health arena is social movement activism focused on issues of environmental health and justice. Since the 1980s, disease-oriented advocacy groups have demanded a voice in decisions about research funding, the inclusion of specific groups in clinical research, and a broader concern for the needs of people who are ill in the process of registering and making available new pharmaceuticals (Epstein 1996, 2007). Environmental health and justice activists share these concerns; however, insofar as they focus on the social structures and processes in and through which people are exposed to environmental hazards (Brown et al. 2003), their scope and critique are broader than those of many health social movement groups. Environmental justice is the principle that “all people and communities are entitled to equal protection of environmental and public health laws and regulations” (Bullard, in Brulle & Pellow 2006). In the United States, the environmental justice movement (EJM) emphasizes particularly the role of racism and poverty in determining exposure to environmental hazards and the irreplaceable role of public policy in redressing injustice (Brulle & Pellow 2006).

Environmental justice emerged as a focus for the NIEHS under the leadership of Dr. Kenneth Olden. In 1994, the NIEHS established extramural funding for the Environmental Justice: Partnerships for Communication Program. The goal of the program is “to enable community residents to more actively participate in the full spectrum of research.” Toward this end, the grant application process required three-way partnerships among “a community organization, an environmental health researcher and a health care professional” who committed to work together “to develop models and approaches to building communication, trust and capacity, with the final goal of increasing community participation in the research process.”²⁹ In 1995, the Institute launched the Community-Based Participatory Research (CBPR) Program to promote “active community involvement in the processes that shape research and intervention strategies, as well as in the conduct of research studies.” At the center of this program are community-university partnerships focused on environmental health research and interventions.³⁰ Such collaborations have been complicated by the “inherent disparities in the relationships between a university and the communities that they study”; nonetheless, research conducted under the auspices of this program has contributed to activists’ efforts to document health problems in contaminated communities (Cable, Mix, & Hasting 2005: 68–69). In the context of the NIH, “where participatory research is weak to nonexistent,” the NIEHS’s approach provides a model for successful collaboration between activists and scientists (Brown 2007: 246-248).

In recent years, environmental health activists have become involved in scientific knowledge production, as a part of their advocacy efforts. For example, they may engage in techniques of popular epidemiology, a process in which concerned citizens systematically gather data about environmental health risks and illness in their community (Brown & Mikkelson 1994), or street science, the combination of local knowledge with professional scientific expertise (Corburn 2005). Often, these efforts are undertaken as a means of challenging the “dominant epidemiological paradigm” for a disease and demanding new resources for disease prevention or treatment; successful challenges to the dominant epidemiological paradigm are often the result of collaboration between environmental health activists and environmental health scientists (Brown 2007: 37). There are many obstacles to citizen-scientist collaborations, not the least of which is that many environmental activists are committed to the idea that science is not the only legitimate form of expertise in the domain of environmental health and illness (Corburn 2005: 37–40). However, there are an increasing number of examples of collaborations between environmental health activists and sympathetic scientists in formulating hypotheses about the environmental causation of illness in a community (Brown 2007: 37; see also Allen 2003; Sze 2007). Some have suggested that, over time, these collaborations may produce “ruptures” in scientific practices—and institutions—thereby creating opportunities for the transformation of environmental health research (Ottinger & Cohen 2011).³¹

Environmental health and justice activists have also challenged the risk assessment paradigm, suggesting that the precautionary principle would provide better protection (Brown, Mayer, & Linder 2002; Tickner 2003). There are two general versions of the precautionary principle; the strong version states that no action should be taken unless there is full certainty that it will do no harm, and the weak version states that “lack of full certainty is not a justification for preventing an action that might be harmful” (Morris 2000: 1). In regard to environmental regulation, the precautionary principle approach would require that “suspect substances must be held off the market until their potential dangers are more clearly understood and their safety is better established” and would support regulatory action “even before the existing data absolutely prove danger” (Markowitz & Rosner 2002: 6). Proponents of the precautionary principle point out that uncertainties inherent in the scientific risk assessment processes have been used to contest or forestall regulation, such that industrial interests may invest in research specifically intended to “insinuate ambiguity” (Proctor 1995: 102; see also Jasanoff 1990); calls for regulatory delays on the grounds of insufficient and/or incomplete evidence “are a regular part of the PR package of the tobacco, petrochemical, and other industries . . . the net effect is to shift the focus from the need to eliminate a probable hazard to the need to resolve a certain ambiguity” (Proctor 1995: 130). At stake in these debates is the best means of protecting public health.

MECHANISMS OF CHANGE

Collectively, the dynamics among environmental health scientists, regulators, activists, and industry mean that the environmental health sciences fundamentally differ from sciences in which controversy may be concealed within a “core set” of deeply involved researchers (Collins 1985). In contrast, domains of contention, knowledge gaps, and sources of uncertainty within the environmental health sciences are both defined and publicized by the contentious politics of the environmental health arena and its myriad stakeholders.³² These dynamics have profoundly shaped the foci and pace of research at the NTP and NIEHS: “This [dynamic] is very different than . . . [at] most of the other NIH institutes and extramural constituencies, because they can do their research via the classical scientific approach and don’t have this sort of overriding pressure for validation/precision on a short time-frame” (Interview S27). As such, environmental health scientists report that they are strongly motivated to strengthen the certainty and, related, the legitimacy of their research. In contrast to other scientists, environmental health researchers must not only produce knowledge that will meet the standards of their scientific peers, but also ensure that it is robust to both technical and legal challenges by outside parties. Beginning in the 1980s, environmental health scientists began to consider how studying environmental exposures at the molecular genetic level might serve as a means to these interrelated ends.

In some ways, it is unsurprising that environmental health scientists would turn to research on molecular mechanisms of environmental illness as a means of strengthening the certainty and legitimacy of their research. As early as the 1980s, the NTP came under pressure to develop its research on the molecular mechanisms behind responses to environmental chemicals.³³ In 1984, the NTP Board of Scientific Counselor’s Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation Report recommended that the National Toxicology Program “establish a goal of better understanding mechanisms by developing a battery of short term tests that measures the widest possible number of endpoints (including promotion, transformation, and chemical interaction with oncogenes)” (NTP 1984: 92). Then, again, in 1992, a scientific review panel convened to evaluate the NTP reported that the program “places too much emphasis on testing per se” and not enough on understanding underlying mechanisms through which exposures to specific substances cause adverse outcomes (Stone 1993). “Developing and applying tools of modern toxicology and molecular biology” became part of the official mission of the NTP (NTP 2002, 2, emphasis added). As one scientist recalled, there was concern that, unless it found ways to incorporate molecular genetic techniques, “the NTP would be a toxicology program of only historical interest” (Interview S32).

At this time, there was a burgeoning interest in genetics across the life sciences. By the 1990s, molecular genetics and genomics were at the apex of biomedical research in the United States. The power of genetic explanations for human health and illness was manifest in massive public investiture in the Human Genome Project (HGP), as well as in policy debates, popular culture, and a wide variety of research enterprises (Nelkin & Lindee 1994; Lindee 2005). Proponents of the HGP predicted that it would provide a new understanding of “what it means to be a human being” (Bodmer & McKie 1997: vii) and a new sense of our biological possibilities. Simply put, there was a massive genetics bandwagon in the life sciences, replete with new questions, technologies, and training programs, all focused on the molecular vision of life (Fujimura 1996). NIH leaders heralded especially the “revolutionary” implications of molecular genetic and genomic research for clinical practice (Collins 1999).

Environmental health scientists report that the ascendance of molecular genetic research in the life sciences raised concerns about the status of their research, which, on the whole, was not focused at the molecular level. Scientists recalled becoming alarmed by the perception that environmental health research was relatively “not innovative . . . not basic science driven” (Interview S20), especially compared to molecular biology. Such concerns about environmental health science being “behind the leading edge” (Field Notes, NIEHS 2002) had implications for the status and prestige of institutions that fund and implement environmental health research. In articulating his support of initiatives that focus environmental health research at the molecular level, a former director of the NIEHS explained:

I think we were perceived as not being terribly mainstream and relevant, so we had to change. We had to incorporate modern science, take advantage of new innovations in cell and molecular biology and develop new test systems (Olden, Oral History Interview February 2004).

Or, as molecular epidemiologist put it, by the 1990s, NIEHS was under considerable pressure to establish itself as more than just “a rat toxicology institute” (Field Notes, NIEHS June 2002). Indeed, although even critics aver that “rat toxicology” has made significant contributions to protecting public health and safety, many scientists assign it a lower status than “basic” laboratory research.³⁴ According to a university-based environmental health scientist, starting in the 1980s, the NIEHS was not “getting as much money as it deserved”; one explanation for this is that it was perceived as “falling behind completely, compared to the rest of NIH” (Interview S20). Some respondents noted also that although the NIEHS has “great stature” by virtue of being part of the NIH, within the NIH, the NIEHS has to struggle to overcome being positioned as the “country cousins” (Interview P03) of the Institutes or “NCI [National Cancer Institute] South . . . a copy cat version” (Stone 1993); these are both derogatory references that refer to the NIEHS’s North Carolina location to impugn its scientific standing. At the NIEHS, I was told, “The genomics revolution is washing over us. Either we incorporate it or we’ll be left behind” (Field Notes, NIEHS July 2002).³⁵

At the same time that they rose to the myriad challenges of the genomic revolution, environmental health scientists had to find ways to incorporate genomics into their research in ways that would support their public health mission; as made vivid in their testimonies before Congress in 2007, this constitutes a primary rationale for their jurisdiction and funding. To be sure, environmental health scientists were not alone in seeking to articulate how the genomic revolution could contribute to public health. For example, in 1997, the Centers for Disease Control and Prevention (CDC) opened an Office of Genetics and Disease Prevention (now known as the Office of Public Health Genomics), which was tasked with developing strategies for “assist[ing] public health professionals in promoting health and preventing disease and disability among people for whom the consequences of an inherited risk can be ameliorated.”³⁶ Throughout the late 1990s, the CDC sponsored a series of conference on genetics, public health, and disease prevention.³⁷ In 2000, an edited volume, entitled Genetics and Public Health in the 21st Century: Using Genetic Information to Improve Health and Prevent Disease, presented “a framework for the integration of advances in human genetics into public health practice” (Khoury, Burke, & Thomson 2000). However, the assumption underlying these programs and frameworks was that “genetic information in public health is appropriate in diagnosing, treating and preventing disease, disability, and death among people who inherit specific genotypes.”³⁸ Newborn genetic screening and predisposition testing of individuals from families affected by heritable conditions were oft cited models for how genetics could improve public health (see Khoury, Burke, & Thomson 2000). This individual-level focus on screening and behavior change fit well with the assumption that genomics would allow clinicians to customize interventions to individuals’ genotypes.³⁹ However, it was not well aligned with the public policy and regulatory orientation of the environmental health sciences.

In fact, the challenge of articulating the public health and public policy relevance of developing genomics in the environmental health sciences was accentuated by widespread predictions that the primary contribution of genomics to human health would be a profound personalization of clinical practice. “Personalized medicine”—that is, medical practice in which preventive screening, lifestyle, and dietary modifications, diagnostics, targeted drug therapies and family planning are all tailored to an individual’s genetic profile—is the holy grail of contemporary genomics research (e.g., Collins 1999; Feero, Guttmacher, & Collins 2008). Given that individual, clinical biomedical interventions are precisely what environmental health science traditionally is not, environmental health researchers were faced with the challenge of how to develop ways of engaging with genomics that strengthened their field, rather than increasing its marginalization.

As we will see, there has been tremendous variation in scientists’ strategies for incorporating genomics into environmental health research, risk assessment, and regulation. Starting in the 1980s, and accelerating thereafter, environmental health scientists developed diverse molecular techniques and practices—such as environmental genomics, molecular epidemiology, and toxicogenomics—tailored to the specific questions and struggles at the center of their subfields, as well as the broader challenges posed by the contentious politics of the environmental health arena and the rise of molecular genetics.⁴⁰ Although some of these practices built on extant lines of research, others aimed to establish wholly new research foci and techniques. Further, while many of these practices sought to articulate applications of genomics specific to the process of environmental health risk assessment and regulation, others sought to extend the reach of environmental health science into clinical settings, establishing new and potentially lucrative markets for environmental health research. Before turning to those specific practices, however, it is important to examine scientists’ broad rationale for the turn to research on gene-environment interaction spanning these fields. The next chapter describes how a “consensus critique” was used to mobilize the struggles and challenges of the environmental health arena in support of the idea that research on gene-environment interaction is essential to the public health mission of the environmental health sciences.