[co-author: Edward Mahaffey, Law Clerk]
On October 18, 2021, the US Environmental Protection Agency (EPA) announced its PFAS Strategic Roadmap (Roadmap or Plan), the agency's new approach to comprehensively addressing the threat to public health and the environment from per- and polyfluoroalkyl substances (PFAS). In issuing the Roadmap, EPA has segued from the prior administration's PFAS Action Plan to implementing the agency's new PFAS playbook developed since the Biden administration came into office. While the Roadmap describes a potentially sweeping array of new studies, test protocols, regulations, and other proactive measures, many of the most critical ones are not expected to be completed or come to fruition before mid-2022, continuing the pattern of the federal government's slower pace than a number of states in addressing PFAS risks.
Also, later in October 2021, EPA took some additional actions discussed in the Roadmap, including publishing the National PFAS Testing Strategy, and a final human health toxicity assessment of a subset of PFAS chemicals known as "GenX." Further, in response to a petition from the Governor of New Mexico, the agency announced that it would conduct two new rulemaking proceedings, which are expected to more comprehensively regulate PFAS chemicals under the Resource Conservation and Recovery Act (RCRA), and provide another avenue under federal law for requiring PFAS remediation pursuant to the corrective measure provisions of RCRA.
The PFAS Strategic Roadmap
EPA's planned actions under the Roadmap can be grouped into three general categories based on the agency's description of its approach to addressing PFAS: 1) increasing "investments in research;" 2) leveraging state and local "authorities to take action" to restrict releases of PFAS chemicals; and 3) accelerating the remediation of PFAS contamination.
Investments in Research
Much of the Roadmap concerns data collection and other forms of research, some of which will occur or be completed fairly distant in time; for example, the final form of the data-gathering rule for "any PFAS manufactured since 2011" is expected "before January 1, 2023." While the final rule for nationwide monitoring for PFAS in drinking water is expected in 2021, the actual sample collection would not occur until "a 12-month period from January 2023 through December 2025."
Other research discussed in the Roadmap features the ongoing work of the EPA's Office of Research and Development (ORD), such as an initiative to develop better methods of detection and measurement "to assess human health and environmental risks from PFAS" and "develop technologies for reducing PFAS in the environment." In addition to the human health toxicity assessment for GenX released shortly after the Roadmap, ORD is developing toxicity assessments for another five PFAS compounds: PFBA, PFHxA, PFHxS, PFNA, and PFDA. The National PFAS Testing Strategy, discussed infra, is another major element of the EPA's PFAS research program.
Actions to Restrict Releases of PFAS Chemicals
Key restrictions on PFAS under the Roadmap are expected in 2022, but in some cases, such as designation of PFOA and PFOS as hazardous substances and biosolids regulation, final rules will take longer. Also, some planned actions, such as the issuance of public health advisories for other PFAS compounds, would not themselves impose restrictions on PFAS; rather, they are intended to provide a predicate for state, local, and tribal governments to regulate these compounds.
EPA does plan to establish federally enforceable National Primary Drinking Water Regulations for PFOS and PFOA with a proposed rule in fall 2022; however, a final rule is not expected until fall 2023. The lengthy time period before the imposition of regulatory restrictions on these chemicals is striking, as they are the two most studied PFAS compounds. These compounds have been subject to EPA drinking water health advisories of 70 parts per trillion (ppt), combined, since 2016; many states have regulated PFOA and PFOS at much lower levels, setting maximum contaminant levels (MCLs) as low as 8 ppt for PFOA in Michigan and 10 ppt each for PFOA and PFAS in New York. (Some states set MCLs for other PFAS as well; Michigan and New Hampshire have MCLs of 6ppt and 11 ppt, respectively, for PFNA, although no state has established an MCL for GenX.). In November 2021, the agency sent four draft documents, which it said indicated that "negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood," to the Science Advisory Board for review.
The Roadmap also discusses how EPA will seek to limit PFAS in wastewater by regulating discharges into rivers and streams for nine industrial categories under the agency's Effluent Limitations Guidelines (ELGs). This action, too, will take considerable time, however; the agency "plans to make significant progress in its ELG regulatory work by the end of 2024." On the other hand, reduction of PFAS discharges to waterways via the National Pollutant Discharge Elimination System (NPDES) is expected to come sooner, in winter 2022. Biosolids regulation, though, will occur later, if at all. EPA plans to complete the risk assessment for PFOA and PFOS in biosolids by Winter 2024, which will serve as the basis for determining whether such regulation is needed.
Key tools for placing restrictions on PFAS also are provided by the Toxic Substances Control Act (TSCA). For example, the TSCA New Chemicals program oversees the safety of new chemicals, determining and mitigating unreasonable risks before allowing a chemical to be manufactured. EPA claims that it is scrutinizing new PFAS compounds under the New Chemicals program more rigorously than was done during the prior administration, and that it also is reviewing prior decisions on PFAS under the program. Moreover, in summer 2022, the agency plans to impose new safety requirements for significant new uses of existing PFAS, and to use its authority to "designate uses of a chemical that are not currently ongoing – and potentially all uses associated with an inactive chemical – as 'significant new uses.'"
Remediation of PFAS Contamination
Of the Roadmap’s three categories, the least attention is focused on remediation, which is an extremely costly undertaking. As reported by a group of 18 Attorneys General in a November 15, 2021 letter to the Senate Committee on Environmental and Public Works: “Our states are spending tens of millions of taxpayer dollars to protect our residents from PFAS by remediating PFAS contamination in drinking water, providing alternative drinking water supplies, testing the blood of residents of impacted communities, and determining the scope of contamination.” Although the letter expresses appreciation for EPA’s publication of the Roadmap, the Attorneys General, nonetheless, request expedited action by the Committee on bi-partisan PFAS legislation passed by the House of Representatives (H.R. 2467) in July 2021 because “[t]he serious public health threats posed by PFAS contamination and the significant budgetary impacts incurred by our states in response call for swift Congressional action.”
Much of the Roadmap’s discussion of remediation involves conducting research concerning the cleanup of contaminated sites and safe disposal of PFAS. By fall 2023, EPA plans to publish updated guidance on disposal and destruction of PFAS and materials containing PFAS, reflecting public comments on and the further research to be conducted following the agency’s December 2020 issuance of incomplete interim guidance on the topic.
The PFAS disposal and destruction considerations that this research and agency guidance will seek to address implicate both technical and environmental justice issues. For example, of particular concern is the military’s use of incineration to dispose of its huge stockpile of firefighting foam (AFFF). This practice has sparked controversy and lawsuits stemming from worries about the health effects of residual PFAS air emissions containing chemical compounds that contaminate soil and water sources. In fact, such a problem occurred when the company with whom the Department of Defense contracted in East Liverpool, Ohio to incinerated 800,000 gallons of AFFF failed to meet the requisite temperatures to destroy the PFAS, and emissions from the incinerator stacks became airborne in a surrounding majority-African-American residential neighborhood and schoolyard. Under the leadership of EPA Administrator, Michael Regan, the agency has been attentive to the environmental justice aspects of addressing PFAS health risks. Mr. Regan has emphasized on several occasions that an underlying purpose of the Plan and related activities is to protect from further exposure the underserved and vulnerable communities that have suffered from PFAS pollution in a variety of environmental media.
To enhance the remediation process, EPA has included a proposal to designate PFOA and PFOS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), which is planned to occur in spring 2022, with a final rule in summer 2023. Such a designation would trigger the investigation of facilities from which a release of PFOA or PFOS is believed to have occurred, according to the detailed regulatory procedures contained in the National Contingency Plan. Moreover, the designation of PFOA and PFOS, and possibly other PFAS compounds, as CERCLA hazardous substances would enable EPA and states to pursue remediation and cost recovery from potentially responsible parties (PRPs) at such facilities, which may include other federal agencies and departments. Claims for relief also would be available for individuals, and public and private entities (such as water authorities) to seek cost recovery or contribution for clean-up costs from PRPs, as applicable under CERCLA.
The GenX Human Health Toxicity Assessment
On October 25, 2021 the EPA published its final human health toxicity assessment for GenX. The assessment concluded that GenX was considerably more harmful than EPA had previously believed; the chronic reference dose (“an estimate of the amount of a chemical a person can ingest daily over a lifetime…that is unlikely to lead to adverse health effects in humans”) for GenX chemicals in the final assessment was 0.000003 (3 x 10-6) mg/kg-day, well below the 2018 draft assessment’s chronic reference dose of 0.00008 (8 x 10-5) mg/kg-day. Specific health risks include effects "on the liver, kidneys, the immune system, development of offspring, and an association with cancer." According to EPA's Roadmap, the assessment does not automatically impose or lead to the issuance of regulations; rather, it enables "policy makers to determine if, and when, it is appropriate to take action to reduce exposure to a chemical."
GenX has commonly been used as a short-chain replacement for PFOA, a different PFAS chemical with longer-established health risks. Short-chain PFAS, so called because of the shorter chains of carbon atoms in their molecular structure, have increasingly replaced long-chain PFAS such as PFOA and PFOS due to health concerns, but some recent research has found that short-chain PFAS poses similar risks. As head of the North Carolina Department of Environmental Quality, before becoming EPA Administrator, Michael Regan successfully pursued an enforcement action against Chemours Company alleging that it had caused pervasive GenX contamination of the Cape Fear River, a drinking water source for several hundred thousand residents.
The National PFAS Testing Strategy
In October 2021, EPA released the National PFAS Testing Strategy (Strategy). The purpose of the Strategy is "to deepen understanding of the impacts of PFAS, including potential hazards to human health and the environment" by helping the "EPA identify and select PFAS for which the Agency will require testing using Toxic Substances Control Act (TSCA) authorities." There are thousands of different PFAS chemicals and little, if any, toxicity data exists for most of them. Thus, each of the compounds cannot be fully tested individually in a reasonable time frame. The Strategy divides the PFAS chemicals into categories "based on information about similarities in structure, physical-chemical properties, and existing test data on the toxicity of PFAS." "EPA will seek to identify important gaps in existing data and select one or more candidate chemicals within identified categories for additional study." The first round of testing will begin by the end of 2021.
The Strategy already has stirred controversy among various interest groups regarding the approach by which EPA will group the multifarious PFAS compounds for study and, possibly, regulation. Many of these organizations have advocated for restriction of PFAS as a class rather than individual compounds, fearing that regulating individual compounds separately would lead to further delay while allowing numerous potentially dangerous substances to slip through the cracks. The chemical companies would prefer that chemicals be regulated on as narrow a basis as possible. The EPA's categorization strategy falls somewhere in between. EPA has not explicitly ruled out regulating PFAS as a class, though, and both the Strategy and the other scientific research contemplated by the Roadmap may lead to new scientifically supportable approaches to categorizing PFAS.
Addressing PFAS Contamination Under RCRA
On October 26, 2021, in response to a petition by New Mexico Governor Michelle Lujan Grisham, EPA announced that it would initiate two rulemaking proceedings to address PFAS under RCRA. The purpose of one rulemaking would be to list PFOA, (PFOS, PFBS), and GenX as Hazardous Constituents under RCRA, a prerequisite to regulating these PFAS chemicals subject to RCRA. However, EPA does not provide a date by which the agency will commence this first step toward regulating PFAS as RCRA hazardous waste.
According to Mr. Regan, the second rulemaking would clarify that 1) "the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste under RCRA section 1004(5);" and 2) emerging "contaminants such as PFAS can be addressed through RCRA corrective action." Once chemicals are designated as hazardous waste under RCRA, they also are hazardous substances under CERCLA.
The Roadmap is an ambitious endeavor that will take substantial federal government resources to complete by the close of the first Biden Administration, as proposed. Reaction to the Roadmap from environment groups has been mixed, with some praising the Roadmap while others criticize it as too slow a process and lacking in concrete announced actions.
In the meantime, states will continue to conduct their own investigations of PFAS in different media and for varying uses, promulgate regulations addressing a growing number of PFAS compounds and the sources in which they are found, and seek to enforce those regulations. Moreover, the substantial amount of ongoing PFAS litigation, as exemplified by the many hundreds of consolidated AFFF cases, will continue to expand. In short, it appears that we still are seeing only the tip of the PFAS iceberg, Therefore, it is essential that interested, and potentially impacted entities, maintain a close eye on EPA's anticipated heightened level of PFAS-related activity under the Roadmap and otherwise.
 https://www.epa.gov/pfas/pfas-strategic-roadmap-epas-commitments-action-2021-2024; https://www.epa.gov/newsreleases/epa-administrator-regan-announces-comprehensive-national-strategy-confront-pfas.
 https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf, 12.
 Id. at 18-19.
 Id. at 13.
 Id. at 12-13.
 https://casetext.com/regulation/michigan-administrative-code/department-environmental-quality/drinking-water-municipal-assistance-division/supplying-water-to-the-public/part-6-state-drinking-water-standards-and-analytical/section-r-32510604g-mcls-for-per-and-polyfluoroalkyl-substances; https://regs.health.ny.gov/sites/default/files/proposed-regulations/Maximum%20Contaminant%20Levels%20%28MCLs%29.pdf.
 https://casetext.com/regulation/michigan-administrative-code/department-environmental-quality/drinking-water-municipal-assistance-division/supplying-water-to-the-public/part-6-state-drinking-water-standards-and-analytical/section-r-32510604g-mcls-for-per-and-polyfluoroalkyl-substances; https://legiscan.com/NH/text/HB1264/2020.
 https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf, 13.
 Id. at 14.
 Id. at 16.
 Id. at 11.
 https://ag.ny.gov/sites/default/files/pfas_letter_to_epw_11.15.2021.pdf, 1.
 https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf, 19.
 Id. at 17.
 A cornerstone of the Biden Administration’s policies is environmental justice, which EPA defines as "the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation and enforcement of environmental laws, regulations and policies."
 https://www.wsj.com/articles/air-contamination-from-forever-chemicals-sparks-concern-11584792001; https://wtov9.com/news/local/lawsuit-against-east-liverpool-incinerator-company-to-be-heard-next-week.
 https://www.epa.gov/newsreleases/epa-administrator-regan-announces-comprehensive-national-strategy-confront-pfas; https://www.epa.gov/newsreleases/epa-advances-science-protect-public-pfoa-and-pfos-drinking-water.
 Id. at 17.
 The National Oil and Hazardous Substances Pollution Contingency Plan is the federal government's plan for responding to oil spills and released of hazardous substances. See 40 CFR Part 300.
 42 USC § 9602, 9604, and 9606.
 42 USC § 9607(a) and 9613(f).
 https://www.epa.gov/system/files/documents/2021-10/pfas-natl-test-strategy.pdf, 3.
 See 40 CFR 261, Appendix VIII.
 https://ncpolicywatch.com/2021/10/20/federal-epa-finally-launches-effort-to-curb-pfas-pollution-but-task-is-massive-and-daunting/; https://theintercept.com/2021/10/19/pfas-epa-water-dupont-chemours/.