What is the Environmental Protection Agency and what role does it play in US regulations?
The Environmental Protection Agency is an agency within the U.S. federal government with a clear, straightforward mission: to protect the health of individuals and the environment. It carries out this vital mission in a variety of different ways. These include the implementation and enforcement of environmental regulations; the disbursement of grants to state governments, environmental nonprofit organizations, and other entities that share the EPA’s objectives; and laboratory research intended to help us better understand the challenges we face with respect to public health, the climate, and the world’s ecosystems.
One of the EPA’s most significant—and sprawling—responsibilities is the regulation of the manufacturing and use of chemicals deemed to be hazardous to human health or the environment. As the agency explains, “Under a broad range of federal statutes, EPA gathers health, safety, and exposure data; requires necessary testing; and controls human and environmental exposures for numerous chemical substances and mixtures.” Some of the most prominent chemicals regulated by the EPA include lead, mercury, pesticides, per- and polyfluoroalkyl substances (PFAS), and polychlorinated biphenyls (PCBs).
Because our understanding of the long-term effects of chemicals is constantly evolving, the Environmental Protection Agency’s role in chemical regulations is fluid and dynamic, subject to regular revision and expansion in step with our growing grasp of these substances.
To understand the birth of the Environmental Protection Agency, it’s important to have some sense of the sociopolitical atmosphere of the 1960s. For perhaps the first time in the nation’s history, large swaths of Americans were becoming increasingly aware of and concerned about the toxic effects of chemicals on the environment, natural resources, and human health. In part as a response to this swell of public interest in environmental and ecological issues, President Richard Nixon signed an executive order in 1970 officially establishing the EPA.
In its early days, the EPA absorbed a raft of divisions and bureaus from other agencies, including programs established for regulating pesticides, air pollution, and public drinking water. But the newly created agency was more than just a consolidation of initiatives distributed across various other federal departments. It operated with a level of funding and authority that its predecessors didn’t have. This authority enabled it to, among other things, establish and enforce water and air quality standards, research potentially hazardous chemical substances, and lead state governments in efforts to ensure a cleaner, safer environment for American citizens. In short, the agency—which started with a budget of $1.4 billion and nearly 6,000 employees—represented a groundbreaking effort on the part of the US government to make mitigating pollution and protecting the environment a top-tier priority.
The first version of the Federal Water Pollution Control Act, or FWPCA, was initially established in 1948—over two decades prior to the foundation of the Environmental Protection Agency. But with the Federal Water Pollution Control Act Amendments of 1972, passed under the direction of the EPA, the law was expanded in an array of critical ways. The 1972 amendments enhanced the original FWPCA—which would come to be colloquially known as the Clean Water Act—and significantly increased its reach in protecting one of our most precious resources. The EPA, tasked with the administration of the Clean Water Act, was given the following new responsibilities:
Today, the Clean Water Act is considered a landmark piece of environmental legislation. Over fifty years since the crucial amendments were first enacted, it remains a powerful demonstration of the ways federal agencies, state governments, municipalities, and private businesses can collaborate to reduce pollution and improve health outcomes for citizens.
Four years after the advancement of the Clean Water Act, the US would pass an equally influential bill that would revolutionize the way the government regulated chemicals in the US. The Toxic Substances Control Act (TSCA), signed into law in 1976, charges the EPA with overseeing the manufacturing, distribution, and use of commercial chemicals in the US.
The implementation and enforcement of the TSCA is a massive task by almost any measure. The EPA must review notifications for new chemical substances, ensure that companies are carrying out sufficient testing of potentially hazardous chemicals, and maintain the TSCA Inventory, which currently encompasses more than 86,000 chemicals.
Perhaps the EPA’s most consequential responsibility with respect to the TSCA is the role it plays in regulating new chemicals. Companies planning on manufacturing or importing a new chemical in the US must notify the EPA through something called a pre-manufacture notice (PMN). Following the submission of the PMN, the EPA has 90 days to undertake its “chemicals review process” to evaluate the relative risk of the new chemical substance. Within this timeframe, EPA risk assessors employ sophisticated predictive modeling to evaluate the potential effects of a given chemical on individuals and the surrounding environment.
An amendment to the TSCA was passed into law in 2016. Termed the Lautenberg Chemical Safety Act, it requires the EPA to “make an affirmative determination” on whether each new chemical substance it reviews poses an unreasonable risk to human health or the environment. The amendment imposes an even greater degree of responsibility on EPA officials to make careful, meticulous determinations about the safety of chemicals entering the US market.
In recent years, the EPA has ramped up its efforts to understand hazards posed by per- and polyfluoroalkyl substances (PFAS). In 2021 the EPA established a “strategic roadmap” intended to move the agency forward regarding its regulation of PFAS. The roadmap proposed a “whole-of-agency” approach to tackling the myriad problems presented by PFAS. These include increasing the EPA’s investment in researching PFAS’ toxic effects and the most promising interventions, enhancing strategies for preventing future PFAS pollution, and expanding remediation efforts.
More recently, the EPA has enacted new reporting requirements for PFAS. These new regulations—which Z2Data recently discussed with compliance expert Mike Kirschner—require any parties manufacturing or importing PFAS or articles containing substances within the PFAS family to electronically report to the EPA specific details regarding the chemicals they are using. These include uses, production volumes, byproducts, and all available information on health and environmental effects. The EPA’s final rule on the new reporting and record-keeping requirements can be read here.
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