Environmental and Public Health Agencies
The federal government's role in protecting environmental quality and public health has expanded dramatically since the 1960s, producing a regulatory framework administered by multiple agencies operating under dozens of statutes. The Environmental Protection Agency, the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, and the Occupational Safety and Health Administration collectively shape the air Americans breathe, the water they drink, the food they eat, the drugs they take, and the workplaces where they earn their livings. This page examines these five agencies, their statutory authorities, and the key laws that define the federal environmental and public health regulatory framework.
Environmental Protection Agency (EPA)
The Environmental Protection Agency was established in 1970 by executive reorganization, consolidating environmental responsibilities that had been scattered across the Departments of the Interior, Agriculture, and Health, Education, and Welfare, as well as several independent bodies. The EPA is an independent agency within the executive branch — it is not a cabinet department, though the EPA Administrator is often granted cabinet-level rank. The EPA employs approximately 15,000 people and operates from its headquarters in Washington, D.C., and ten regional offices across the country.
The EPA administers more than a dozen major environmental statutes, each addressing a distinct aspect of environmental protection. The agency's core functions include setting and enforcing environmental standards, conducting environmental research, providing grants to state environmental programs, and overseeing the cleanup of contaminated sites.
The Clean Air Act
The Clean Air Act (CAA), 42 U.S.C. 7401 et seq., is the comprehensive federal law regulating air emissions from stationary and mobile sources. Originally enacted in 1963 and substantially amended in 1970 and 1990, the CAA authorizes the EPA to establish National Ambient Air Quality Standards (NAAQS) for six criteria pollutants: particulate matter, ozone, carbon monoxide, sulfur dioxide, nitrogen dioxide, and lead. States are required to develop State Implementation Plans (SIPs) demonstrating how they will achieve and maintain compliance with NAAQS.
The 1990 amendments to the CAA established the acid rain program, which introduced a cap-and-trade system for sulfur dioxide emissions — one of the first market-based approaches to environmental regulation — and strengthened provisions addressing hazardous air pollutants, ozone depletion (implementing U.S. obligations under the Montreal Protocol), and permitting requirements for major sources of air pollution. The Supreme Court's decision in Massachusetts v. EPA, 549 U.S. 497 (2007), held that greenhouse gases are "air pollutants" within the meaning of the CAA, opening the door to regulation of carbon dioxide and other greenhouse gas emissions. The scope of the EPA's authority to regulate greenhouse gas emissions under existing statutory authority was subsequently narrowed by the Court in West Virginia v. EPA, 597 U.S. 697 (2022), which applied the "major questions doctrine" to hold that the EPA could not use Section 111(d) of the CAA to restructure the nation's electricity generation mix.
The Clean Water Act
The Clean Water Act (CWA), 33 U.S.C. 1251 et seq., establishes the structure for regulating the discharge of pollutants into the waters of the United States and for setting quality standards for surface waters. The CWA's primary regulatory mechanism is the National Pollutant Discharge Elimination System (NPDES) permit program, which requires any person or entity discharging pollutants from a point source into navigable waters to obtain a permit specifying the types and quantities of pollutants that may be discharged. The EPA sets technology-based effluent limitations for categories of industrial dischargers and water-quality-based limitations where technology-based controls are insufficient to achieve water quality standards.
Section 404 of the CWA regulates the discharge of dredged or fill material into waters of the United States, including wetlands, and is administered jointly by the EPA and the Army Corps of Engineers. The scope of "waters of the United States" — which determines the geographic reach of the CWA's protections — has been one of the most litigated questions in environmental law, with the Supreme Court addressing it in Solid Waste Agency of Northern Cook County v. Army Corps of Engineers, 531 U.S. 159 (2001), Rapanos v. United States, 547 U.S. 715 (2006), and Sackett v. EPA, 598 U.S. 651 (2023), which significantly narrowed the Act's jurisdictional scope.
FIFRA and Pesticide Regulation
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., governs the sale, distribution, and use of pesticides in the United States. FIFRA requires that all pesticides sold or distributed in the United States be registered with the EPA, which evaluates the risks and benefits of each pesticide product before granting registration. The EPA sets tolerances (maximum residue limits) for pesticide residues on food under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, which requires the EPA to ensure with "reasonable certainty" that pesticide residues on food will cause "no harm" — a stricter standard than the risk-benefit balancing applied under FIFRA's general registration provisions.
Superfund and Hazardous Waste
The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), 42 U.S.C. 9601 et seq., commonly known as Superfund, provides authority and funding for the cleanup of hazardous waste sites. CERCLA imposes strict, joint and several, and retroactive liability on parties responsible for contamination — a liability scheme that means a responsible party can be held liable for the full cost of cleanup regardless of the degree of fault, whether the contamination was legal at the time, or whether other parties also contributed to the contamination. The Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6901 et seq., regulates the generation, transportation, treatment, storage, and disposal of hazardous waste from "cradle to grave," providing a comprehensive framework for managing waste that is currently being generated, in contrast to CERCLA's focus on abandoned or historical contamination.
Centers for Disease Control and Prevention (CDC)
The Centers for Disease Control and Prevention is the nation's leading public health agency, charged with protecting the public from health threats through disease surveillance, epidemiological investigation, prevention programs, and emergency response. The CDC is an operating division of the Department of Health and Human Services, headquartered in Atlanta, Georgia, with approximately 12,000 employees and an annual budget of approximately $17 billion.
The CDC's core functions include monitoring and investigating disease outbreaks; maintaining the national disease surveillance system; developing and recommending vaccination schedules; conducting epidemiological and laboratory research; providing technical assistance to state and local health departments; and leading the federal response to public health emergencies, including infectious disease outbreaks, bioterrorism events, and natural disasters with public health consequences. The Advisory Committee on Immunization Practices (ACIP), which operates under CDC auspices, develops the immunization schedules that guide vaccination policy for children and adults.
The CDC's regulatory authority is more limited than the EPA's or FDA's. The CDC operates primarily through surveillance, research, technical assistance, and funding — it issues guidelines and recommendations rather than legally binding regulations in most areas. However, the CDC does exercise regulatory authority in certain domains, including the federal quarantine authority under 42 U.S.C. 264, which authorizes the agency to take measures necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States or between states. The scope and limits of this quarantine authority received unprecedented attention during the COVID-19 pandemic.
National Institutes of Health (NIH)
The National Institutes of Health is the nation's medical research agency and the largest public funder of biomedical research in the world. An agency of the Department of Health and Human Services, the NIH has an annual budget of approximately $48 billion, which supports research conducted at its own laboratories in Bethesda, Maryland, and at universities, medical schools, and research institutions throughout the United States and in more than 90 countries. More than 80 percent of the NIH budget is awarded through approximately 50,000 extramural research grants.
The NIH is composed of 27 Institutes and Centers, each focused on a particular area of biomedical research or public health. The largest by budget is the National Cancer Institute (NCI), followed by the National Institute of Allergy and Infectious Diseases (NIAID), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of General Medical Sciences (NIGMS). The NIH's research portfolio spans basic biological research, clinical trials, translational research, and public health studies.
The NIH does not exercise regulatory authority in the traditional sense — it does not set enforceable standards or issue permits. Its influence on public health is exercised through the research it funds, the scientific consensus its work helps to establish, and the evidence base it provides for decisions made by regulatory agencies like the FDA and EPA. NIH-funded research has contributed to the development of vaccines, cancer treatments, HIV/AIDS therapies, and the fundamental understanding of human genetics, immunology, and disease mechanisms that underlies modern medicine.
Food and Drug Administration (FDA)
The Food and Drug Administration is responsible for protecting and promoting public health through the regulation of food, drugs, medical devices, tobacco products, dietary supplements, cosmetics, veterinary products, and biological products (including vaccines, blood products, and gene therapies). The FDA is an agency within the Department of Health and Human Services, with approximately 18,000 employees and an annual budget of approximately $7 billion (supplemented by user fees paid by regulated industries).
The FDA's primary statutory authority is the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., originally enacted in 1938 following the sulfanilamide disaster in which an untested drug preparation killed over 100 people. The FDCA has been amended extensively, including by the Kefauver-Harris Amendment of 1962 (which required drug manufacturers to demonstrate efficacy as well as safety before receiving FDA approval), the Medical Device Amendments of 1976, the Hatch-Waxman Act of 1984 (which established the framework for generic drug approval), the FDA Modernization Act of 1997, and the FDA Safety and Innovation Act of 2012.
Drug Approval
The FDA's drug approval process is among the most rigorous in the world. Before a new drug can be marketed in the United States, its manufacturer must submit a New Drug Application (NDA) demonstrating, through adequate and well-controlled clinical trials, that the drug is safe and effective for its proposed use. The approval process typically involves three phases of clinical trials: Phase I (small-scale safety studies in healthy volunteers), Phase II (larger studies to evaluate efficacy and side effects), and Phase III (large-scale confirmatory trials). The entire process from initial research to FDA approval takes an average of 10 to 15 years. The FDA also operates accelerated approval pathways for drugs addressing serious or life-threatening conditions, including breakthrough therapy designation, accelerated approval based on surrogate endpoints, fast track designation, and priority review.
Food Safety
The FDA regulates the safety of most food products (with the exception of meat, poultry, and egg products, which are regulated by the USDA's Food Safety and Inspection Service). The FDA Food Safety Modernization Act (FSMA) of 2011, the most significant reform of food safety law in more than 70 years, shifted the FDA's approach from responding to contamination to preventing it. FSMA requires food facilities to develop and implement preventive controls plans, establishes science-based standards for the safe production and harvesting of fruits and vegetables, gives the FDA authority to mandate recalls of contaminated food (previously, recalls were voluntary), and strengthens the FDA's ability to oversee food imports.
Occupational Safety and Health Administration (OSHA)
The Occupational Safety and Health Administration was created by the Occupational Safety and Health Act of 1970 (OSH Act), 29 U.S.C. 651 et seq., to ensure safe and healthful working conditions by setting and enforcing standards and providing training, outreach, education, and assistance. OSHA is an agency within the Department of Labor, with approximately 1,850 inspectors responsible for overseeing more than 8 million workplaces employing over 130 million workers.
OSHA sets mandatory workplace safety and health standards through notice-and-comment rulemaking under the Administrative Procedure Act. Standards address specific hazards including fall protection, exposure to hazardous chemicals, machine guarding, respiratory protection, electrical safety, and bloodborne pathogens. OSHA also issues the General Duty Clause standard under Section 5(a)(1) of the OSH Act, which requires employers to maintain workplaces "free from recognized hazards that are causing or are likely to cause death or serious physical harm" to employees — a catch-all provision that applies even where no specific standard addresses the hazard in question.
OSHA conducts workplace inspections, which may be triggered by worker complaints, reports of serious injuries or fatalities, referrals from other agencies, or targeted inspection programs focused on high-hazard industries. When violations are found, OSHA issues citations and proposes penalties, which can range from $16,131 per violation for serious violations to $161,323 per violation for willful or repeat violations (as adjusted for inflation). Employers may contest citations before the Occupational Safety and Health Review Commission, an independent quasi-judicial agency, with further appeal to the federal courts of appeals.
OSHA's jurisdiction extends to most private-sector employers and their workers in all 50 states. Federal agencies are covered by OSHA standards but are not subject to monetary penalties. State and local government workers are not covered by federal OSHA but may be covered by state plans — 22 states and several territories operate their own OSHA-approved occupational safety and health programs that cover both private and public sector workers. These state plans must be at least as effective as the federal OSHA program.
Cooperative Federalism and the Federal-State Relationship
Most environmental and public health statutes operate through a model of cooperative federalism, in which the federal government sets minimum standards and the states implement and enforce those standards, often with the flexibility to impose more stringent requirements. The Clean Air Act, Clean Water Act, RCRA, and the OSH Act all follow this model. The EPA or OSHA establishes national standards; states develop implementation programs that meet federal requirements; the federal agency approves the state program and delegates primary enforcement authority to the state; and the federal agency retains oversight authority and the power to step in if the state program is inadequate.
This model reflects the practical reality that environmental and public health regulation requires both national uniformity (to prevent a "race to the bottom" in which states compete for industry by lowering standards) and local flexibility (because environmental conditions, industrial composition, and public health needs vary across the country). The federal government provides technical assistance, funding, and a regulatory floor; the states provide the administrative infrastructure and local knowledge necessary for effective implementation.
The cooperative federalism model also creates tensions. States may resent federal mandates as impositions on their sovereignty, particularly when those mandates are underfunded. The federal government may view state implementation as inadequate or politically compromised. Disputes over the allocation of regulatory authority — particularly regarding the scope of federal jurisdiction under statutes like the Clean Water Act — are a recurring feature of environmental law and politics. The balance between federal and state authority in environmental and public health regulation continues to evolve through legislation, judicial decisions, and the practical realities of program implementation.
Public Health Emergency Preparedness
The federal government's public health emergency preparedness framework involves coordination among multiple agencies. The Secretary of Health and Human Services has the authority to declare a public health emergency under Section 319 of the Public Health Service Act, 42 U.S.C. 247d, which activates emergency funding, regulatory flexibilities, and coordination mechanisms. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) coordinates the development, procurement, and distribution of medical countermeasures — including vaccines, therapeutics, and diagnostic tests — for public health emergencies including pandemics, bioterrorism events, and chemical or radiological incidents.
The Strategic National Stockpile (SNS), managed by the Administration for Strategic Preparedness and Response (ASPR) within HHS, maintains large quantities of pharmaceuticals, vaccines, medical supplies, and equipment for deployment during public health emergencies. The CDC's Emergency Operations Center coordinates the public health response to emergencies, deploying epidemiologists, laboratory scientists, and other public health professionals through the Epidemic Intelligence Service (EIS) and other rapid-response teams. The Biomedical Advanced Research and Development Authority (BARDA), also within ASPR, provides funding for the advanced development of medical countermeasures that are not commercially viable but are essential for national preparedness.
The COVID-19 pandemic exposed both the strengths and weaknesses of this emergency preparedness infrastructure. The rapid development and authorization of multiple vaccines demonstrated the capacity of the NIH, FDA, and BARDA to accelerate medical countermeasure development under emergency conditions. At the same time, the pandemic revealed gaps in public health surveillance systems, supply chain vulnerabilities, coordination challenges between federal, state, and local authorities, and the difficulty of maintaining consistent public health communication during a rapidly evolving crisis. These lessons continue to inform ongoing efforts to strengthen the nation's public health preparedness and response capabilities.