Industrial Chemicals, Pesticides, Public Health, and Ethics
Abstract and Keywords
This chapter provides an overview of ethical issues related to the development of industrial chemicals. While they do contribute to advancements in agriculture, medicine, transportation, hygiene, and human leisure, these chemicals can concomitantly pose serious threats to human and environmental health. The chapter examines the public health cost-benefit of environmental chemicals and the regulatory frameworks for human health protection in various countries, focusing on evidence-based decision-making, risk analysis, a precautionary approach, and international consensus. Specific ethical concerns discussed relate to the impacts and lasting effects of pesticides, the influence of economic stability and profit derived from industrial chemicals, conflicts between public health priorities and environmental protections, and inequities and injustices in the distribution of risks and burdens associated with industrial chemicals.
(p. 704) Introduction
Chemical development and material science have revolutionized agriculture, medicine, commerce, transportation, hygiene, and nearly every other aspect of human life. They have advanced research and innovation, contributed to economic growth, and allowed longer high-quality lives for many individuals. However, there is increasing evidence that many industrial chemicals, including those found in consumer products, may adversely impact public health and environmental health. For example, coal burning, waste incineration, pesticide applications, and chlorine bleaching of paper and pulp create byproducts, known as dioxins, that continuously enter ecosystems, bioaccumulate in food chains, and negatively impact health by increasing risks related to cancer, thyroid disorders, immune deficiencies, cardiovascular events, diabetes, reproductive issues, and developmental disorders (Steenland et al., 1999; Schecter et al., 2006).
When chemicals are used in industrial processes or consumer products, they do not always remain in the intended location or substrate, leading to unintended exposures and the potential for adverse effects on public health. Limiting our exposure to industrial chemicals can be challenging, because they are ubiquitous within our environment. These substances are found not just in the air we breathe and the water we drink, but also in our food, drugs, cosmetics, detergents, personal care products, building materials, and solvents—to name but a few examples. No matter how cautious we may be in our personal decision-making, there is often “nowhere to hide” from toxicants (Cranor, 2011a, 16).
This chapter will consider ethical concerns related to public health and the development and use of industrial chemicals; it examines various regulatory approaches, (p. 705) including evidence-based decision-making, risk analysis, a precautionary approach, and international consensus. Also, the chapter will assess specific ethics issues, including food production and pesticides, the influence of economic stability and profit derived from industrial chemicals, conflicts between public health priorities and environmental protections, and health inequities related to the use of industrial chemicals.
Accurately determining the extent to which a chemical poses a health risk to human populations is complicated. Typically, the health risk associated with a chemical derives from a combination of its potential to do harm (the hazard) and the likelihood of and amount of it reaching a biological target (the exposure). Hazards derive from the ability of a chemical to have a specific adverse effect, depicted with dose-response curves. In most cases, the response is proportional to the dose: higher doses produce greater toxicity than lower doses. Adverse effects are then dependent on the amount of chemical exposure, but they are also influenced by exposure route, duration, timing, and individual susceptibilities (e.g., genetics, sex, co-exposures, age). By understanding the dose-response relationship, scientists can identify a No-Observed-Adverse-Effect-Level (NOAEL) for a given chemical. Based on a combined understanding of hazard and exposure, scientists have also developed the concept of a threshold for toxicological concern using linear extrapolation, below which there would be no appreciable risk to human health (Kroes, Kleiner, and Renwick, 2005). Using this threshold, risk assessors and risk managers can incorporate safety factors to set reference doses (RfDs) (i.e., estimates of daily exposure that are assumed to be without adverse health impacts on humans).
While traditional risk assessment methods have proven appropriate for most chemicals with adequate toxicological information, the assumptions of dose-response proportionality and thresholds for response have both come under increased debate in the scientific community for some specific applications (Vandenberg et al., 2012). Endocrine-disrupting chemicals—commonly found in plasticizers and pesticides (e.g., Bisphenol A, DDT)—have been reported to have adverse effects at low levels that are not observed at higher levels (i.e., non-monotonicity). This is of great concern because RfDs based on high-level testing would not necessarily be protective for low-dose exposures. Further, evidence from cancer studies indicates that carcinogens may not have a threshold level within the environmentally relevant range (Asante-Duah, 2017), because even a minute amount of these substances in the body can increase the risk of cancer or mutations that lead to cancer. Known carcinogens include alcoholic beverage consumption, wood dust, benzene, formaldehyde, nickel compounds, solar radiation, and trichloroethylene found in industrial solvents.
Similar to carcinogens, it has also been postulated that there is no safe threshold for certain neurotoxicants. Exposure to neurotoxicants causes neurodevelopmental and neurodegenerative disorders and subclinical brain dysfunction; this may include (p. 706) autism, attention deficit disorder, or cerebral palsy. As an example, it is now widely recognized that lead can cause adverse neurologic effects at exposure levels that only a decade ago were thought to be safe (Caito and Aschner, 2017). Indeed, current research suggests that there may not be a threshold for lead under which adverse effects are not seen. Similarly, as we develop better tools to measure low-level exposures and subtle effects of arsenic, scientists are similarly beginning to question whether there is any safe level of arsenic exposure (Wasserman et al., 2014). As an alternative to the ongoing low-dose extrapolation debate, it may be more useful to focus on avoidable and unavoidable exposure through biomonitoring and promoting levels of toxicants that are “as low as reasonably achievable” (Neumann, 2009, 459).
The use of industrial chemicals has also substantially modified the environmental ecosystem. One of the most problematic issues is the bioaccumulation of chemicals in the environment, especially persistent organic pollutants (POPs). POPs can be found in many synthetic compounds created for pest control (e.g., DDT), industrial applications such as electrical transformers and additives to paints and lubricants (e.g., PCBs), and stain-resistant consumer goods (e.g., PFAS). Because of their durable chemical structures, POPs do not readily degrade within organisms or in the environment and may bioaccumulate in the fatty tissue of humans and wildlife. As a result, they may have harmful impacts on human health and population health. Exposure to POPs has been associated with significant health issues, including certain cancers, reductions in immune response, impaired reproduction, and severe developmental malformations (UNEP, 2009). Further, because POPs are distributed globally, no single government acting alone can protect its citizens or its environment from the risks related to POPs (Adeola, 2004; Carpenter, 2011).
Regulation of Industrial Chemicals
To protect public and environmental health, the US government has enacted numerous laws to govern the production, use, sale, exposure, and disposal of potentially hazardous chemicals. Specific federal laws exist for (1) food and drugs, (2) pesticides, and (3) toxic chemicals. The Federal Food, Drug, and Cosmetic Act (FFDCA) and other laws provide the Food and Drug Administration (FDA) with broad authority to regulate many food products, dietary supplements, food additives, infant formula, prescription and nonprescription drugs, vaccines, medical devices, cosmetics, veterinary feed and drugs, and tobacco products. Complimentary to the FDA efforts, the Environmental Protection Agency (EPA) sets tolerance levels for pesticides in food or as residue on food for human consumption as well as in animal feed (21 U.S.C. § 301).
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. §§ 136–136y) is the primary statute regulating pesticides in the United States, with the goal of protecting applicators, consumers, and the environment. In 1972 FIFRA was significantly revised and strengthened to place the primary burden of proof for safety on pesticide (p. 707) manufacturers; applicants must show that pesticides “will not cause any unreasonable adverse effects on the environment,” including any risks to human health and environmental health (7 U.S.C. §§ 136–136y). Animal studies seek to determine the dose at which the chemical has NOAEL; post-market reviews may change or revoke registration if adverse effects are discovered. As part of the premarket registration, the EPA determines allowable uses and dosages based on mechanistic and animal studies submitted by companies, and the application of safety factors to ensure public health protection for vulnerable populations. The Food Quality Protection Act (1996) added more significant protections for infants and children by lowering acceptable levels of toxic chemicals in food residue (codified at 21 U.S.C. § 346(a)). States may also enact additional laws should they opt for stricter controls than those provided federally.
Apart from food, drugs, cosmetics, and pesticides, nearly all other chemicals are regulated under the Toxic Substances Control Act (TSCA), first passed in 1976 and amended in 2016 (15 U.S.C. § 2601 et seq. ).1 Current TSCA regulations require manufacturers to send premanufacture notification. New toxic chemicals must be registered and may require testing if exposure poses danger or raises concerns. The regulations explicitly require the protection of vulnerable populations (e.g., children, pregnant women), enhance authority to require manufacturer testing for new and existing chemicals, and increase transparency of toxicity data. The present TSCA inventory includes more than 83,000 chemicals, but an early evaluation by EPA estimates only 35,000 in current active usage. To regulate the use of a chemical under TSCA, the EPA must show that scientific evidence supports a finding of “unreasonable risk.” While the current iteration of the TSCA provides EPA with authority to conduct chemical evaluations during the registration period (ninety-day review process during premarketing) and supports review and regulation efforts through the collection of listing fees, some scientists believe that there are simply too many chemicals to review, given the resources available to the EPA (Krimsky, 2017).
Other countries have adopted more precautionary approaches to the regulation of chemicals. Specifically, the European Union has developed the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) system, wherein the manufacturer and importers must provide sufficient data to demonstrate safety prior to marketing: “no data no market” (European Commission, 2016). The theoretical grounding for this policy is the precautionary principle (PP), which requires “taking preventive action in the face of uncertainty; shifting the burden of proof to the proponents of an activity; exploring a wide range of alternatives to possibly harmful actions; and increasing public participation in decision making” (Kriebel et al., 2001, 871). Regardless of whether one adheres to some form of the precautionary approach, determining an acceptable level of risk remains the key issue in chemical regulation regardless of jurisdiction.
It is logical that countries will adopt different regulatory models tailored to their different needs, priorities, and values within a given jurisdiction. However, chemicals do not adhere or conform to these geographical parameters, and they often have far-reaching consequences, extending internationally and ultimately affecting the balance of the ecosystem worldwide. International consensus, such as the treaty process, has (p. 708) also proven to be an effective approach to address risks associated with a wide range of persistent chemicals. For example, the Stockholm Convention is a global treaty to protect human health and the environment from the harmful effects of POPs (UNEP, 2009). Ratified by more than 150 nations, the Stockholm Convention “requires its parties to take measures to eliminate or reduce the release of POPs into the environment,” effectively banning them on a global scale (UNEP, 2009, Overview; UNEP, 2018).
Public health promotion often encompasses values related to the health and well-being of populations. Typical examples of public health initiatives include disease control, promotion of healthy lifestyles, providing safe food and water, and the creation of accessible health care systems. Although the use of industrial chemicals has helped in many of these endeavors, they also do sometimes hinder these public health initiatives because of conflicting goals or values. In this next section, we will exemplify how public health goals may be helped or hindered in agricultural development, industrial viability, and profit, as well as in terms of environmental justice.
Public Health versus Agriculture
Although developed countries often have a substantial amount of food production, many resource-limited nations have little to no food security, which exacerbates rates of mortality and morbidity. Although there is a strong moral imperative to use pesticides that promote food security on a global scale to ensure basic nourishment, the use of pesticides has concomitantly created many unintended effects on the environment. This section explores the agricultural methods that have historically had various effects on public health.
Industrialization contributed to a revolution in agriculture models, as the mechanized power and technological innovations of tractors, seed drills, cultivators, and reapers enabled large-scale planting and harvesting. To achieve large-scale efficiency and profits, industrial farming turned to monoculture, producing large crops of one fruit or vegetable or grain. However, reducing the biodiversity of crops also limited their natural resistance, providing the opportunity for weeds, insects, and bacteria to blight entire crops. To counter this problem and ensure high yields, the agriculture industry turned to the development and increased use of pesticides (Davis, 2014). In the early twentieth century, various types of arsenate (e.g., copper, lead, calcium) were commonly used on crops. These chemicals resulted in soil contamination, reduced foliage, and a harmful residue on plants, fruits, and vegetables, which contaminated soil and water on an international scale (Nordstrom, 2002; Bencko and Yan Li Foong, 2017). Progress in finding a replacement for arsenic lagged until the development of DDT.
(p. 709) Used during the Second World War to prevent diseases such as typhus and malaria, DDT also effectively killed mosquitoes, houseflies, body lice, Colorado beetles, and gypsy moths (Davis, 2014). Unfortunately, some insects have developed resistance to DDT over time. In her influential book Silent Spring, Rachel Carson (1962) documented the significant negative long-term effects of pesticides (focusing mainly on DDT) on wildlife and humans. Although there was little scientific consensus about the detrimental effects of pesticides at that time, Carson argued that environmental health was imperiled by the use of toxic chemicals driven by corporate greed and corruption. She argued that pesticide use was a moral and urgent matter deserving attention; in so doing, she transferred the “scientific” debate regarding acceptable use of industrial chemicals into the broader public forum that also questioned the right for individuals not to be exposed to chemicals regardless of identified health risks (Murphy, 2018). Subsequently, many countries banned DDT in the 1970s, and in 2001, as mentioned earlier, the United Nations ratified an international treaty at the Stockholm Convention limiting the use of POPs. Nonetheless, the use of various chemicals in industrial agriculture has had a devastating effect on the environment. The ongoing growth of industrial farming continues to erode natural ecosystems, disturbing homeostasis and creating a detrimental amount of nitrogen and phosphorus (namely through algal bloom), which at high levels creates pollutants in water and air, resulting in a detrimental effect on public health to present and future generations (Tilman et al., 2002).
The World Health Organization (WHO) has reported high levels of acute malnutrition in Ethiopia, Kenya, Nigeria, Somalia, Uganda, and Yemen due to food shortages (WHO, 2018). Those shortages not only cause starvation but also weaken the human immune system, thereby rendering populations more susceptible to disease. Agricultural and biotechnological innovation have significantly contributed to increased availability of calories per capita (FAO, 2018). In an effort to increase food production, advances in biotechnology have produced genetically modified organisms (GMOs), some of which include the transfer of insect-resistant genes into plants. Some of these GMO crops actually produce their own pesticides, such as BT toxins. Although the BT toxins were at first deemed to be effective at pest resistance, various insect species have since become resistant to them and other pesticides. Indeed, pesticide resistance is becoming widespread in insects, fungi, mites, weeds, and rodents (Resnik, 2012). The development of pesticide resistance may undermine the gains in food supply that were partly achieved through pesticide use and may further increase food insecurity in an ever-growing world population. Pesticide resistance in certain pests (e.g., mosquitoes) may also increase the incidence of vector-borne diseases, which may result in significant large-scale public health issues.
Intergenerational ethics suggests that future people have the same intrinsic moral value as those currently living, since the only difference is one of temporality (Nolt, 2017). From this perspective, present-day populations have a responsibility to sustain resources for future generations. One could argue, however, that humans are capable of developing technology that will address human and environmental health issues arising in the future, so that science and technological innovation will ultimately prevail. This logic (p. 710) requires a leap of faith and discounts risks to public health and environmental health in the near future. It also begs the question: How much foresight and value should we assign to the well-being of future generations in our current policymaking and decisions regarding industrial chemicals and public health?
Public Health versus Industry and Economic Productivity
While regulation is often necessary to protect human and environmental health against toxic or hazardous chemicals (as in the case of DDT and POPs), overregulation may stifle scientific and industrial development (Resnik, 2012). Industrial wealth and economic growth are often seen as a trade-off to environmental considerations (Wubben, 2000). One may find it ethically sound to prioritize environmentally friendly practices, as they often have a positive effect on environmental protection and sustainability, which are often linked to public health promotion. However, others may prioritize industrial profits that promote economic growth and may result in higher-paying jobs as well as a higher standard of living. Various studies have concluded that economic wealth is an important determinant of public health (Lange and Vollmer, 2017). Interestingly, novel business models have emerged where companies—often referred to as “green” businesses—use corporate social responsibility and environmental stewardship as selling points to enhance profit (Orsato, 2006). Others argue that attention to environmental values may not always support increased profits and so must be seen as having independent and intrinsic value (Figge and Hahn, 2012). Balancing environmental regulation and economic development requires careful consideration of sometimes competing values.
As discussed earlier, to prohibit or regulate the use of a chemical in the United States, it is necessary to demonstrate that it poses an “unreasonable risk.” However, evidence of unreasonable risk can only be established through expensive and often time-consuming toxicology studies on animals or epidemiological studies on humans. Tort law provides potential legal avenues for addressing environmental harm. However, injury compensation requires substantial evidence to prove that a specific chemical caused disease or harm (Cranor, 2011b). When an individual or group seeks legal recourse for harm caused by a chemical, all relevant prior studies completed by the industry must be revealed during the early stages of the legal process. Since many toxic chemicals are put on the market with little study of the effects of long-term or repeated exposure, the evidence required to seek a remedy or compensation is virtually nonexistent. Without studies demonstrating that a chemical presents an unreasonable risk, the legal threat to the chemical corporation essentially disappears. This can ultimately benefit a chemical producer in litigation (Cranor, 2011b). In court, the burden of proof lies with the plaintiff, who typically cannot afford the costly and lengthy studies required to produce evidence.
In order to ensure that more research is conducted prior to the marketing of an industrial chemical, some scholars have promoted the notion of a strong precautionary (p. 711) principle. The precautionary principle advocates for greater precaution (often through regulation) commensurate with the level of scientific uncertainty and suggests that stakeholders engaged in the risk-creating activity should assume the legal burden of proof to more effectively mitigate scientific uncertainty (Sachs, 2011). A strong precautionary principle would promote regulation even in cases where there are considerable economic costs. Some have considered that the precautionary principle should include the development of methods to ultimately reduce individual and public health risks and increase public participation regarding decision-making (Hansen, Carlsen, and Tickner, 2007). Public participation may include public hearings and inquiries, public opinion surveys, referendums, consensus conferences, citizen advisory panels, and focus groups (Rowe and Frewer, 2000). Conversely, opponents of the precautionary principle argue that it is impractical and would paralyze or unduly impede every step in the development and implementation of chemicals and their regulations (Sunstein, 2003). Finally, Gary Marchant and Kenneth Mossman (2004) have suggested that the precautionary principle is “arbitrary and capricious,” because it has been applied in an inconsistent and ad hoc manner in policy and in courts of law.
Environmental Justice and Susceptible Populations
According to the US EPA (2019), environmental justice generally refers to the “fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” Although industry and government may be principally responsible for chemicals that pose risks, the individuals or groups—such as children, the elderly, and factory workers—ultimately bear a disproportionate level of environmental risk to health. Public health decisions are typically rooted in consequentialist and utility-based considerations where the preferred ethical choice is the one that brings the lowest mortality and morbidly rates to the population. Recently, however other theoretical justifications have been suggested. This may include liberal or communitarian ethics (Roberts and Reich, 2002). Liberalist approaches to public health generally include greater emphasis on rights to health or health care, based on the argument that they often pave the way to a range of life-supporting opportunities for individuals or groups. Although a liberal ethics theory may seem to counter public health initiatives—such as an individual’s right to develop chemicals—a liberalist could also argue that an individual has a right not to be exposed to harmful toxicants that deters their future opportunities. Communitarian ethics is often seen as a more logical match to public health, as it emphasizes the community rather than the individual. By embracing virtues in social order and communal responsibility, a communitarian could argue that given the widespread real or potential public health effect of industrial chemicals, regulatory matters should always be developed in collaboration with citizens that will be affected.
Environmental justice issues have been raised by scholars and activist grassroots movements concerned with the devastating and unfair effect of chemical uses on (p. 712) susceptible groups. There are many examples: a disproportionate amount of off-site commercial water landfill isolates are found in proximity to predominantly African American communities in the United States; laborers in mining and stonework are commonly exposed to crystalline silica asbestos; First Nation communities have significant issues with their proximity to radioactive waste; and victims of Hurricanes Katrina and Rita were temporarily housed in trailers with very high concentrations of formaldehyde (Adams et al., 2011; Bullard and Johnson, 2002; Shrader-Frechette, 2002; Maddalena et al., 2009; Burgard and Lin, 2013).
Research has shown that susceptible populations often have few resources or power to protect themselves; they are often minorities disadvantaged in various ways (e.g., education, income, occupation) (Shrader-Frechette, 2002). Conversely, when there is strength in numbers and public support, patient advocacy organizations representing susceptible populations have at times been successful in influencing decisions for increased research, treatment, and awareness of common illnesses, including cancer, diabetes, mental illness, and cardiovascular disease (Rose, 2013).
There is significant debate in the environmental justice literature surrounding the notion of an individual’s ability to “freely consent” to environmental risks. It has been argued that individuals who choose to work in risky environments—e.g., coal miners, farmers, cleaners—should be allowed to do so. The argument rests on the assumption that workers choose their employment and are compensated for their work. Thus, they “freely” accept the occupational and chemical hazards of their jobs, including exposure to hazardous chemicals or byproducts from manufacturing processes. In reality, this scenario of free choice and implicit consent is not entirely accurate. At times, chemical hazards may not be clearly and accurately explained to workers resulting in an inability to assess health risks. Even when health risk information is adequately disclosed, a worker’s choices are often extremely limited in a tight labor market. In such an environment, one accepts the available job regardless of the hazards, or one faces unemployment (Shrader-Frechette, 2002). As such, consent is not actually “free.” Generally, individuals who have considerable wealth and access to many opportunities do not choose to live or work in environmentally risky conditions.
Public Health versus the Environment
Human health and protection of the environment are often seen as symbiotic—what is good for the environment is also good for human health, and vice versa. However, in some cases, policymakers have prioritized public health to the detriment of environmental protections. For example, certain insects and animals present real threats to crops and may reduce human food sources. The resulting malnutrition can reduce cognitive function and immunity, and also increase the rate of tuberculosis and infectious disease (Chandra, 1992; Levitsky and Strupp, 1995; Cegielski and McMurray, 2004). The use of insecticides and pesticides to control or eliminate insects or animals that harm crops and reduce food stocks could be rationalized as a necessary “evil” to safeguard public health.
(p. 713) Mosquito-borne diseases such as Zika, malaria, dengue fever, and West Nile virus take a heavy toll on human health (Tolle, 2009). In the name of public health, widespread spraying of DDT in the 1950s and 1960s nearly eradicated many pathogens. This example illustrates the serious harm that a well-intended decision in the interest of public health can have on the environment as well as human health (Hemingway et al., 2006). While many countries have adopted better alternatives to extensive chemical spraying (such as the clearing of standing water in close proximity to dense populations which lowers morbidity and mortality, especially for malaria [Alonso et al., 1991]), there remains a significant public health threat worldwide from both pathogens and pesticide use. Although other alternatives for mosquito abatement are being pursued, such as genetically modified disease-resistant mosquitoes (Waltz, 2016), these may also create a negative effect on the ecosystem. Central to the debate about how best to control mosquito-borne diseases is the ethics question about the limits of the right of humans to modify species for their own interests. Should human well-being always be superior to that of the environment?
The applied ethics literature has focused on human rights, human health, human well-being, and human values. These human values have been applied to various decision-making problems regarding environmental protection and environmental health. A very limited few in sociology and ethics advocate for a post-anthropocentric model wherein humans forego traditional anthropocentric privileges to value coexistence with all organisms and promote sustainable and ecological values (Ferrando, 2016). Although some might criticize ecological or post-anthropocentric models as being very ideological and lacking decision-making application and feasibility (Resnik, 2009), they do propose a different approach worthy of further consideration; namely, a world in which humans would not make all decisions based on their own interests and would reprioritize based on what is good for the entire ecosystem. Although this notion may seem radical, it may be worthwhile and instructive to reflect on the values, beauty, and balance that a post-anthropocentric view might offer.
Ethical and regulatory issues linked to agriculture, economic growth, environmental justice, and environmental protections are commonplace. Regulation of the chemical industry ranges from less rigorous risk analysis to the more comprehensive application of precautionary principles. This chapter has outlined some of the conflicting goals and values between public health and the agriculture industry, public health and industrial development, public health and environmental justice, and public health and environmental protections. Greater emphasis on social responsibility and community engagement in scientific development and industrial practices will help support decision-making that better serves not only public health but also environmental and intergenerational health. Finally, we might reflect on the benefits of moving from the current anthropocentric model to a post-anthropocentric standpoint that allows for a (p. 714) balanced and open consideration of more ecological and sustainable options and greater coexistence with other organisms.
We thank David B. Resnik and Bruce Androphy for their insightful comments and suggestions regarding this manuscript. Elise M. R. Smith is supported by a collaborative fellowship from the National Institutes of Health (NIH) and the Fonds de Recherche du Québec en Santé (FRQS). The chapter does not represent the view of the NIH, the FRQS, or any governmental institution.
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(1.) Regulation of industrial chemicals is also considered in the Safe Water Drinking Act (42 U.S.C. § 300f) and the Clean Air Act (42 U.S.C. § 7401).