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28 June 20225 minute read

EPA’s new ultralow PFAS health advisory levels portend regulatory and litigation risks – but do not overextend them

On June 15, 2022, the United States Environmental Protection Agency released updated and new drinking water health advisory levels (HALs) for four per- and polyfluoroalkyl substances (PFAS).

While these HALs are not enforcement standards, they set the stage for robust and enforceable regulatory limits and cleanup requirements in the near future. EPA updated its interim HALs for two well-known PFAS compounds, PFOA (perfluorooctanoic acid) and PFOS (perfluorooctane sulfonic acid), to four parts per quadrillion and 20 parts per quadrillion, respectively.

These are unprecedented lows – well below present detection capabilities – and they dramatically reduce both analytes’ prior HALs of 70 parts per trillion in 2016 (which were themselves remarkably low at the time). EPA further established final HALS for PFBS (perfluorobutane sulfonic acid and its potassium salt) at 2 parts per billion, and GenX (hexafluoropropylene oxide dimer acid and its ammonium salt) at 10 parts per trillion.

Under the federal Safe Drinking Water Act, EPA issues HALs for substances not subject to an enforceable National Primary Drinking Water Regulation (NPDWR). These advisories give technical information to states, local governments, and tribes about contaminants in drinking water that purportedly cause negative human health effects. In developing lifetime HALs, EPA takes into account contaminant exposures beyond drinking water, including from air, food, and consumer products.

Although not enforceable per se, HALs influence future enforceable requirements at state and federal levels; states have used PFAS HALs to develop their own enforceable drinking water standards and likely will do so again with the new HALs. Moreover, the HALs and their supporting analysis may aid in forming enforceable PFOA and PFOS Maximum Contaminant Levels (MCLs) – expected this year.

HALs in context: what they are, and what they are not

The PFAS HALs are the latest development in EPA’s broader PFAS Strategic Roadmap, which sets research, restriction, and remediation regulatory goals for the next few years, aiming to comprehensively address PFAS contamination and limit future PFAS manufacturing and usage. Following this Roadmap, EPA plans to propose PFOA and PFOS MCLs this Fall, establishing enforceable federal drinking water standards (these may be less stringent than the HALs because EPA must consider economic feasibility and technological realities in crafting such standards).

There is much more to come in PFAS regulation, and stakeholders across many industries are keenly focused on liability risks arising from PFAS issues. In that context, it is critical to analyze HALs for what they are – and what they are not.

First, these new ultralow HALs encompass only four specific PFAS compounds. They do not purport to predict risk for the hundreds of other PFAS compounds sometimes found in consumer products, cosmetics, food packaging, and other material goods. The huge differences even among just these four HALs (the HAL for PFBS is 500,000 times higher than that for PFOA) illustrate the importance of not conflating one PFAS compound’s potential risk with another’s. Individualized treatment of each PFAS compound is critical in assessing risks and actions.

Second, HALs are drinking water standards. They are not proxies for acceptable levels in any other media – soil, sediment, non-drinking water – and they absolutely do not establish or even suggest safe concentrations in textiles, carpets, cookware, cosmetics, food packaging, or other consumer products, all of which involve multi-varied exposure pathways and different scientific considerations than those at issue in drinking water health risk analyses.

The focus on PFAS is increasing

Politicians, regulators, the public, plaintiffs’ lawyers, and industry participants continue to increase their focus on PFAS compounds. PFAS regulation in products and packaging is evolving rapidly as legislators and regulators grapple to balance consumer safety with technological feasibility, economic impacts, and other relevant lawmaking considerations.

These laws typically address PFAS intentionally added to a product for a technical or functional effect. Where states have set specific thresholds for PFAS content in products, legislators have done so at the parts per million total organic fluorine (TOF, an umbrella category of PFAS compounds) ceiling, only dipping as low as 300 parts per billion in recent proposals. This recognizes the practical realities, unique challenges, and more limited exposure pathways presented outside the drinking water context. On top of that, cross-contamination risks are omnipresent in the manufacturing and products world (PFAS in a shopping bag, a retail store’s carpet, or even a shopper’s hands could cause a product to show detectable levels greater than EPA HALs).

Given all of these factors, it is critical that EPA’s HALs for PFOA, PFOS, PFBS, and GenX, which remain interim and subject to the EPA’s Science Advisory Board’s ultimate recommendation in relation to establishing MCLs, not be overstated, misapplied, or misunderstood to suggest risk levels for other PFAS compounds, or in non-drinking water contexts, lest they create meaningless and unattainable standards of little use to anyone.

Just one link in the chain

In summary, the PFAS HALs represent a significant next step in PFAS regulations nationwide. But they are one link in a massive regulatory chain and the hype and awe surrounding EPA’s issuance of parts per quadrillion levels must not confuse the issue: these HALs are not to be extended beyond their ambit of drinking water advisory concentrations for the four specific PFAS compounds involved.

PFAS regulations continue to develop rapidly, and the DLA Piper Product Liability and Environmental teams actively monitor the space to best assist their diverse clientele. To learn more, please contact any of the authors.