Regulation of Per- and Polyfluoroalkyl Substances

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During the first half of 2022, the U.S. Environmental Protection Agency (EPA) continued to make progress on the actions outlined in its per- and polyfluoroalkyl substances (PFAS) Strategic Roadmap, which contains a schedule of the agency’s anticipated activities regarding PFAS for the next three years.  

On June 15, 2022, EPA issued four drinking water health advisories for PFAS at near zero levels. EPA set interim updated lifetime Health Advisory Levels (HALs) of 0.004 parts per trillion (ppt) (or 4 parts per quadrillion) for perfluorooctanoic acid (PFOA) and 0.02 ppt for perfluorooctane sulfonic acid (PFOS). The previous HALs for PFOA and PFOS were 70 ppt. EPA also established final HALs of 10 ppt for hexafluoropropylene oxide dimer acid and its ammonium salt (GenX chemicals) and 2,000 ppt for perfluorobutane sulfonic acid and its potassium salt (PFBS).  

EPA acknowledges that the new HALs for PFOA and PFOS are below the level of both detection (determining whether a substance is present) and quantitation (the ability to reliably determine how much of a substance is present) under currently approved analytical methods. Therefore, environmental testing laboratories will have both a challenge and an opportunity to develop improved testing methodologies to accurately quantify concentrations of PFAS at the HAL levels. 

Although the HALs are not legally enforceable, these drastically reduced levels will inform the EPA’s development of National Primary Drinking Water Regulations (NPDWRs) for PFOA and PFOS, which are still anticipated to be proposed by the end of 2022, as well as potential NPDWRs for other PFAS or groups of PFAS. EPA must consider economic factors and technical feasibility when proposing NPDWRs, but the new HALs will guide the establishment of the NPDWRs. 

For addressing groundwater contaminated with PFAS, the new HALs may prompt states that have issued, or are in the process of issuing, groundwater cleanup criteria for these PFAS to consider more stringent remediation levels. For example, some states adopted EPA’s previous 70 ppt HAL as a remediation standard, while other states established standards below the 70 ppt level, but those standards are now considerably higher than the new HALs. It will be interesting to see if states move quickly to adopt or revise their cleanup standards, or instead wait for EPA to issue its proposed NPDWRs (EPA drinking water standards typically are default groundwater remediation standards). 

EPA still plans to issue a proposed rule to designate PFOA and PFOS as Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) hazardous substances. The hazardous substance designations would enhance the ability of government authorities to obtain information regarding the location and extent of releases of these chemicals, as well as for EPA, other agencies, and private parties to seek cost recovery or contribution for costs incurred for their cleanup. In the interim, on May 18, 2022, EPA added five PFAS [GenX chemicals, PFOS, PFOA, perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS)] to the list of Regional Screening Levels (RSLs) and Regional Removal Management Levels (RMLs), which help EPA determine if further investigation or actions are needed to protect public health in locations where PFAS are detected. The subsequently issued HALs might trigger EPA to revisit these RSLs and RMLs. 

Finally, EPA is working on setting effluent guidelines and developing analytical methods (EPA’s draft Method 1633) and water quality criteria for PFAS in wastewater discharges. As that work is continuing, EPA issued a memorandum on April 28, 2022, describing steps that permit writers can implement under the existing National Pollutant Discharge Elimination System (NPDES) and pretreatment programs to enhance monitoring provisions, use draft Method 1633, and implement pollution prevention and best management practices to address PFAS discharges at the source. The memorandum provides guidance for EPA-issued NPDES permits and for industrial users where EPA is the pretreatment control authority. However, states that have been authorized by EPA to issue their own NPDES permits, while not bound by EPA’s memorandum, may decide to adopt some or all its guidance.  

Manufacturers should continue to monitor closely the regulatory developments surrounding PFAS, which are occurring at the federal and state levels on a weekly, if not daily, basis. As a threshold matter, manufacturers should assess whether their operations use PFAS chemicals either intentionally or unintentionally. As PFAS are subject to more regulatory scrutiny, manufacturers should consider alternatives to these chemicals, if available, because continued use of PFAS will only become more complicated and will expose manufacturers to increasing potential liabilities. The unique challenges that PFAS poses to manufacturers in the context of real estate and corporate deals and site remediation were discussed during our complimentary two-part webinar miniseries on June 21 and 22. 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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