Making Sense of TSCA’s New PFAS Requirements

Since its inception nearly 50 years ago, the U.S.’s Toxic Substances Control Act (TSCA) has had a direct, uncomplicated mandate: to prevent unreasonable risk of injury to human health or the environment through the regulation of new and existing chemicals. Passed in 1976 under the Ford Administration, the TSCA carries out this central responsibility through a broad raft of regulatory measures. Administered by the Environmental Protection Agency (EPA), the Toxic Substances Control Act oversees reporting and testing requirements, reviews pre-manufacture notices (PMN) for the proposed introduction of new chemicals into the U.S. marketplace, and imposes a variety of restrictions on chemicals deemed to pose some level of risk to human beings or the environment. In addition, the law manages the TSCA Inventory, the EPA’s exhaustive list of chemical substances under its purview. 

The TSCA Inventory now encompasses more than 86,000 chemicals. Some of the more high-profile substances the law has regulated and imposed restrictions on in the past include lead, radon, asbestos, and polychlorinated biphenyls (PCBs). In recent years, however, the EPA has shifted an increasing amount of resources and attention toward a relatively new family of chemicals: per- and polyfluorinated alkyl substances (PFAS). These substances have come under growing scrutiny since the turn of the century, as the scientific community and the public at large learn more about PFAS’ toxicity and their litany of negative health effects. In response, the EPA has used the Toxic Substances Control Act to set forth several new regulations intended to take on the sprawling, multifaceted challenge of reining in these notorious “forever chemicals.”

Sounding the Alarm on PFAS

PFAS have been around since the 1940s, when 3M and DuPont began manufacturing the chemicals for use in a wide variety of everyday household products. The highly resilient, dazzlingly versatile compounds quickly became instrumental to the production of everything from cars and cookware to apparel and fast food packaging. But the mass adoption of PFAS came with consequences the vast majority of Americans weren’t aware of, and it would take several more decades for the nation to develop a fuller understanding of the dangerous effects posed by these hyper-functional and increasingly widespread chemicals. 

By the 2000s, a slew of studies and a groundbreaking lawsuit were revealing that PFAS were not only bioaccumulative—meaning they build up over time in living organisms—but also alarmingly detrimental to human health. High levels of PFAS in human beings were linked to a number of serious diseases, including hypertension, thyroid disease, and multiple forms of cancer. Further, evidence was building that the PFAS family, which encompasses around 15,000 synthetic chemicals, was leaching into soil, groundwater, and rivers all over the world, contaminating drinking water and marine ecosystems. In short, at the same time that these forever chemicals were transforming a dizzying array of consumer products and reverberating across nearly every corner of the manufacturing landscape, they were also infiltrating human beings and our natural environments, seeping into water, blood, and tissue and releasing an array of injurious effects. (Our 2023 piece on the history of PFAS covers this in greater detail.)

Following the studies and investigations, the dangers of PFAS became irrefutable, and the EPA knew it had to do something. In 2006, the agency established the PFOA Stewardship Program. The initiative negotiated an agreement among eight of the world’s largest PFAS manufacturers to phase out long-chain PFAS by 2015. Next, they used significant new use rules, or SNURs, to restrict the ways certain PFAS can be used. While the regulatory measures were certainly a start, they didn’t come close to a comprehensive plan for addressing the rapid rise of such harmful, distressingly pervasive toxic substances.

Fortunately, the past few years have seen the Toxic Substances Control Act take a more aggressive stance toward PFAS. Through a myriad of targeted measures, the TSCA is trying to develop a more thorough understanding of the scope of these toxic substances and initiating longer-term strategies for ameliorating their multitude of negative impacts. 

TSCA Compliance and PFAS Reporting Obligations 

On October 11, 2023, the EPA published a final rule under the Toxic Substances Control Act Section 8(a)(7), titled Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. The new rule requires all covered businesses—including manufacturers and importers of one of around 1,400 PFAS compounds—to submit a report to the EPA detailing their use of PFAS. The TSCA regulations are not, however, part of a new set of ongoing compliance responsibilities. Rather, they represent a onetime TSCA compliance obligation intended to help the agency better grasp the prevalence of PFAS usage in the U.S.

To achieve this end, the EPA is requiring companies to retroactively report on their PFAS usage from January 1, 2011 to December 31, 2022. In enforcing the new TSCA regulations, the agency is using what it calls a “structural definition” of PFAS, which includes one of “three structures: 

• R-(CF2)-CF(R′)R′′, where both the CF2 and CF moieties are saturated carbons;

• R–CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; and 

• CF3C(CF3)R′R′′, where R′ and R′′ can either be F or saturated carbons.”

What Needs to Be Reported

Entities covered under the new rule must submit a wide breadth of information to achieve TSCA compliance. This includes—but is by no means limited to—the chemical’s common name and CAS; composition of the PFAS; total volume of the substance being manufactured or processed; maximum concentrations of the compound within the specific product; and any manufacturing byproducts and their corresponding disposal processes. In addition, businesses must present all available information on the known environmental and health effects of the PFAS in use. Not all covered entities have the same TSCA compliance obligations, however, and companies should verify their specific classification under the rule to understand the full scope of their options and responsibilities.

Reporting Timelines 

The final rule officially went into effect on November 13, 2023, and manufacturers and importers are being given a year to carry out the massive data collection undertaking the new TSCA regulations call for. The EPA submission period begins on November 12, 2024, and closes on May 8, 2025, providing covered entities with a six-month window to report. Smaller manufacturers who also function as article importers are being given an additional six months. The reporting window for these entities closes on November 10, 2025. 

It’s also critical to note that covered manufacturers and importers are obligated to retain all information and documentation reported to the EPA under the new TSCA compliance measures for at least five years after the submission period closes. 

Due Diligence and “Reasonably Ascertainable” Information

The EPA understands that some manufacturers and importers may not have access to the full scope of data and information being requested through the new TSCA regulations. To acknowledge these potential limitations, the agency has included a “Not Known or Reasonably Ascertainable” (NKRA) option on many of the reporting forms. 

This, of course, begs the question of how the EPA and Toxic Substances Control Act define “reasonably ascertainable.” The final rule does provide some measure of clarification on this subjective phrasing. According to the EPA, “‘Known to or reasonably ascertainable by’ is defined to include ‘all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.’” Put differently, the framework of expectations the rule is imposing on covered entities extends beyond the data and information immediately accessible to them. In some cases, manufacturers and importers may need to carry out specific due diligence measures to fulfill their TSCA compliance obligations. 

What do these due diligence measures look like? Businesses should be prepared to reach out to manufacturers and other stakeholders along the supply chain to produce a more complete picture of the toxic substances in their products and materials. This may entail contacting “upstream suppliers or downstream users” to gather data on chemical composition, concentrations, safety, and sales figures. Manufacturers and importers focused on meeting TSCA compliance requirements and lowering their risk profile may also consider more extensive processes. These include carrying out a material review to assess the likelihood that a product, component, or other material contains PFAS, or even undergoing third party testing to make a more definitive determination. While such measures are not required by the new TSCA regulations, they can be advantageous to a company’s overall compliance strategy and risk mitigation efforts. 

Estimated Costs to Private Sector 

Finally, it’s worth quickly taking stock of the financial burden this TSCA compliance requirement is imposing on the private sector. According to the EPA’s own estimates, the onetime reporting requirements will cost in-scope entities approximately $876 million, necessitating an additional 11.6 million work hours for these businesses. 

Significant New Use Rule for PFAS

In addition to the new TSCA regulations, the EPA finalized a significant new use rule (SNUR) for PFAS on January 8. The SNUR prohibits any companies operating in the U.S. from resuming the manufacturing of any of 329 currently inactive PFAS without a complete review and risk determination conducted by the agency. The measure is part of the Biden Administration’s aggressive regulatory strategy on forever chemicals. It also represents a major advancement in the EPA’s so-called PFAS Strategic Roadmap. 

The SNUR applies to all PFAS designated as “inactive” on the TSCA Inventory and not subject to a preexisting SNUR. 

TSCA Regulations and PFAS 

With its revered history of investigating suspect chemicals and establishing comprehensive restrictions on those found to pose undue health and environmental hazards, the Toxic Substances Control Act is the regulatory instrument best positioned to combat PFAS. Considering just how pervasive the forever chemicals have become over the past 75 years, though, this task demands a dynamic, adaptable approach that utilizes the full powers of the EPA. 

The measures enacted over the past year or so are an incremental—if not altogether decisive—steps forward on this front. The sweeping reporting initiative is critical from an information-gathering standpoint, and will certainly help the EPA craft more robust TSCA regulations in the medium term. SNURs, meanwhile, will gradually chip away at the number of PFAS in active use. Because of their singular combination of beneficial properties and the innumerable industrial and consumer applications for those properties, forever chemicals will not recede from the market on their own. That will require a succession of forceful regulatory actions implemented over the course of a decade or longer—something the EPA and the Toxic Substances Control Act are only at the very earliest stages of accomplishing.