PFAS Management in the United States: Federal Government Urges Focused Approach to Responsibly Manage PFAS

At a period where policymakers across the U.S. have dealt to swiftly implement per- and polyfluoroalkyl substances (PFAS) management solutions, there is a growing consensus at the federal-level that a risk-based management approach emphasizing a more current and targeted PFAS definition, the prioritization of action on high-risk compounds, and expanding recognition of essential or “currently unavoidable uses” is the responsible path forward for effective management.

Despite calls from some advocates to create management regimes for the entire class of PFAS covering over 10,000 compounds, the reality is that only around 770 PFAS compounds are commercially active in the United States. Those advocating for a class-based approach often claim that all well-studied PFAS show human health harms. In fact, when a new PFAS is produced for commercial use in the U.S. it is must be thoroughly reviewed and authorized prior to use by the appropriate federal agencies, like the U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA). Many commercially active PFAS compounds do not possess the combination of properties that would make them PFAS of concern, because they are either insoluble in water, non-bioavailable (cannot penetrate a living cell) or have been well studied and found not to be of concern to human health (non-toxic).

To achieve an effective and responsible PFAS management program, policymakers must prioritize PFAS compounds in commerce that pose the greatest risk to public health and the environment rather than restricting the entire class.

Key Federal agencies say regulations should focus on commercially active PFAS compounds.

The EPA, the Department of Defense (DOD), and the U.S. Department of State have articulated support for regulations that focus on commercially active PFAS compounds.

In 2023, the EPA published final rules for reporting of PFAS usage pursuant to Toxic Substances Control Act (TSCA) Section 8(a)(7) and noted that the definition in the final rules are less broad than the “class-based approach” taken by using other definitions. After assessing whether to use such a class-based approach that would encompass tens of thousands of compounds, EPA chose to adopt a more targeted structural definition that would effectively focus the reporting rules on commercially active compounds.

Similarly, in a 2023 report to Congress, DOD recommended that “Congress and the Federal regulatory agencies should avoid taking a broad, purely ‘structural’ approach to restricting or banning PFAS. It is critical that future laws and regulations consider and balance the range of environmental and health risks associated with different individual PFAS, their essentiality to the U.S. economy and society, and the availability of viable alternatives.” As an example, the report noted the battery industry’s ability to make products for a broad range of commercial and military applications would be greatly impacted if PFAS were no longer available for use in these components.

The same year, the State Department responded to a proposed PFAS regulatory framework received by the European Chemicals Agency (ECHA) that proposes restrictions on PFAS pursuant to REACH, writing that the policies should account for “the safe use of those substances already in commerce, particularly for uses critical to the functioning of society” and called for “effective risk management across the spectrum of PFAS.”

The U.S. continues to expand its risk-based management approach that emphasizes a more current and targeted definition.

The U.S. is moving towards a risk-based management approach for PFAS that aims to prioritize resources and regulatory efforts on the most concerning PFAS compounds, while also promoting the search for reasonable alternatives.

EPA stated that 1,462 compounds are covered by the agency’s TSCA reporting program, 770 of which are understood to be active in U.S. commerce – otherwise known as commercially active. The data that EPA gathers from the rule should be used to inform future risk-based regulations as well as better understand how many PFAS chemicals are truly commercially active in the U.S.

In its 2023 report to Congress, the DOD also cautioned Congress and federal regulatory agencies that “if future PFAS legal and regulatory frameworks ignore the OECD caution on the use of its PFAS definition and seek to broadly restrict the use of PFAS based on chemical structure, there could be extensive economic, industrial competitiveness, and quality-of-life impacts to U.S. society."

EPA released a framework to prevent unsafe new PFAS from entering the market.

The EPA is working to assess the risks associated with PFAS compounds. EPA’s PFAS Strategic Roadmap will be used to qualitatively assess PFAS that are likely persistent, bioaccumulative and toxic (PBT) substances.

In June 2023, the EPA released a framework to advance the evaluation of chemicals before they are permitted to enter commerce. This framework ensures that the EPA will conduct thorough evaluations of chemicals, including PFAS compounds, to determine if they pose unreasonable risks to human health or the environment. Under TSCA, the EPA has the authority to require risk evaluations for both new and existing chemicals.

There is a manageable solution.

SPAN supports responsible PFAS management solutions for addressing PFAS that are scientifically identified as PBT substances, while requiring appropriate restrictions which enable the acceptable use of substances known to be acceptable for their intended use. SPAN stands ready to engage with state and federal policymakers to help promote a uniform and sensible policy approach on PFAS compounds that are consistent with up-to-date scientific and risk-based decision making and supportive of responsible and essential use considerations.