PFAS: Looking Back on a Year of Activity and Preparing for 2022

Vinson & Elkins LLP

In 2021, there was sustained and fast-paced executive action from the Biden administration focused on emphasizing and addressing the environmental and human health effects of per- and poly-fluoroalkyl substances, more commonly known as “PFAS.” From then President-elect Biden’s commitment to tackling water contamination (including an express mention of PFAS) in The Biden Plan to Secure Environmental Justice and Equitable Economic Opportunity in January, to the confirmation hearings of Michael Regan as Administrator of the Environmental Protection Agency (“EPA”) in February and March, to the release of the PFAS Strategic Roadmap in October, PFAS was front and center of the administration’s regulatory agenda.

Before looking forward to 2022, a year in which PFAS will continue to prove a focus of the agency per the PFAS Strategic Roadmap, it is worth recapping the numerous actions addressing PFAS over the past year, especially given the significant foundation many of these actions will have in the acceleration and implementation of law and policy addressing such “forever chemicals.”

A Brief Primer on PFAS

PFAS chemicals are prolific in number and presence. This class of chemicals, including perfluorooctanoic acid (“PFOA”), perfluorooctane sulfonate (“PFOS”), and hexafluoropropylene oxide dimer acid and its ammonium salt (“GenX chemicals”), have been manufactured and used globally for many decades and can be found in a number of sources, such as food, drinking water, and commercial household products, as well as industrial products, such as firefighting foam, paint, and construction materials. The man-made chemicals have a tendency to accumulate and avoid breaking down in the environment, and some have been linked to a range of adverse human health effects, including cancer, thyroid hormone disruption, negative impacts on the immune system, increased cholesterol levels, and low infant birth weights, at sufficient levels of exposure.

Notable EPA Actions in 2021

PFAS Strategic Roadmap

EPA has expressed a firm commitment to addressing PFAS as evidenced by the announcement and publication of the PFAS Strategic Roadmap (“Roadmap”) on October 18, 2021. The Roadmap offers a multifaceted, integrated approach outlining the agency’s actions to address PFAS over the next three years (2022 through 2024) focused by three “central directives”: (1) research; (2) restrict; and (3) remediate. The Roadmap provides important insights into what we can expect from EPA indicating new regulations integrated into existing programs led by several of the agency’s offices, such as the Office of Chemical Safety and Pollution Prevention, the Office of Water, and the Office of Land and Emergency Management. EPA’s Roadmap, developed by the EPA Council on PFAS, places particular emphasis on ensuring engagement and equitable access to solutions regarding low-income and communities of color.

Safe Drinking Water Act – Revisions to the UCMR 5

On December 27, 2021, in accordance with the Roadmap, EPA published a final rule under the Safe Drinking Water Act (“SDWA”) requiring public water systems to collect national occurrence data for 29 PFAS chemicals and lithium under the Unregulated Contaminant Monitoring Rule (“UCMR”) 5. Presently, PFAS and lithium are not subject to national primary drinking water regulations, thus collection of data under UCMR 5 may inform EPA’s understanding of the frequency and levels of these 29 PFAS in the nation’s drinking water. Per the Roadmap, the agency claims that the data will aid the agency in making science-based decisions and prioritize the protection of disadvantaged communities. The final rule applies to public water systems, community water systems, and non-transient non-community water systems as defined by the rule.

Resource Conservation and Recovery Act – “Hazardous Constituents”

In a partial response to a petition from New Mexico’s Governor, Michelle Lujan Grisham, on October 26, 2021, EPA proposed to add four PFAS — PFOA, PFOS, perfluorobutane sulfonic acid (“PFBS”), and GenX chemicals — as “hazardous constituents” under the Resource Conservation and Recovery Act (“RCRA”). Based on EPA’s evaluation of existing data, alongside the agency’s record to support the proposed rule, these chemicals, as “hazardous constituents,” will be subject to corrective action requirements under RCRA at waste treatment, storage, and disposal facilities. Relatedly, EPA also noted that it intended to initiate a second rulemaking to “clarify” its regulations regarding the RCRA Corrective Action Program. Per EPA, the rulemaking would “clarify that emerging contaminants such as PFAS can be addressed” through the Program.

EPA’s proposed rulemakings here indicate a potential first step towards listing wastes containing PFOA, PFOS, PFBS, and GenX chemicals under Subpart C of RCRA. This would subject the wastes to RCRA’s hazardous waste regulatory requirements and have important implications for cleanup liability under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”).

GenX Chemicals – Human Health Toxicity Assessment

Included in the Roadmap as a key action, on October 25, 2021, EPA released a final human health toxicity assessment for two PFAS substances—hexafluoropropylene oxide dimer acid and its ammonium salt—also known as GenX chemicals. The assessment provides information on the toxicity of the chemicals, concluding that oral ingestion of the chemicals through drinking water has potential adverse health effects on the hepatic, hematological, renal, reproductive, and immune systems and has also been linked to liver and pancreatic cancer. The assessment established chronic and subchronic reference doses1 for the GenX chemicals which can be combined with other specific exposure information to inform health-based national standards. The reference doses can also be used to inform clean-up levels at local sites and non-regulatory advisory levels and to develop health protective levels based on oral exposure for the chemicals in drinking water, ambient water, and soil.

Although the toxicity assessment is not a binding regulation, or enforceable, it shows one more step by the agency to set regulatory standards that include GenX chemicals.

FY 2022-2026 EPA Strategic Plan Draft

On October 1, 2021, EPA released its Draft FY 2022-2026 EPA Strategic Plan (“Draft Plan”), communicating the agency’s priorities over the next four years and providing a roadmap of the same. The Draft Plan was required by the Government Performance and Results Act Modernization Act of 2010 and sets forth seven strategic goals focused on the protection of both the environment and human health. More specifically, the Draft Plan includes addressing PFAS under four of EPA’s goals: (a) Goal 3: Enforce Environmental Laws and Ensure Compliance; (b) Goal 4: Ensure Clean and Healthy Air for All Communities; (c) Goal 5: Ensure Clean and Safe Water for All Communities; and (d) Goal 6: Safeguard and Revitalize Communities.

To “hold environmental violators and responsible parties accountable,” EPA plans to use the CERCLA Superfund enforcement program to “compel parties that manufacture or release PFAS . . . in violation of the law to return to compliance.” Additionally, EPA will utilize the program to compel parties to address potential endangerment caused by the chemicals. As part of Goal 4, the agency intends to work with air agencies to develop improved measurement methods for, among others, PFAS, to continue supporting air quality planning and environmental justice analyses. PFAS is most extensively addressed by EPA as part of its priority to provide clean and safe water for all communities and includes a commitment to work alongside states to identity infrastructure projects to address PFAS contamination. The agency also commits to “fully leveraging” its authority and working closely with its federal, state, local, and Tribal partners. Finally, pursuant to Goal 6 and, more specifically, cleaning up and restoring contaminated sites, especially in overburdened areas, EPA provides that it is undertaking an agency-wide effort “to determine the best way to mitigate and reduce PFAS pollution” and refers to many of the key actions incorporated into the Roadmap.

Through inclusion of PFAS in EPA’s Draft Plan, alongside the release of the Roadmap later in the same month, the agency’s continued commitment to address PFAS pollution and mitigate contamination is clear, especially in under-served communities.

Preliminary Plan 15 – Wastewater

In September 2021, EPA released its Preliminary Effluent Guidelines Program Plan 15 (“Preliminary Plan 15”), which included two new rulemakings intended to reduce PFAS discharges by revising effluent limitation guidelines (“ELGs”) and pretreatment standards for two groups: (1) an Organic Chemicals, Plastics and Synthetic Fibers (“OCPSF”) category and (2) a Metal Finishing category. The former will address PFAS discharges from facilities manufacturing PFAS with the latter addressing PFAS discharges from chromium electroplating facilities. In addition to the rulemakings, EPA also intends to conduct “detailed studies” on PFAS in wastewater discharges from landfills and textile and carpet mills. Finally, alongside the Preliminary Plan 15, EPA published its Multi-Industry Per- and Polyfluoroalkyl Substances (PFAS) Study—2021 Preliminary Report, which summarizes the results of EPA’s study of industrial discharges of PFAS from five point source categories: (i) OCPSF manufacturing; (ii) metal finishing; (iii) pulp, paper, and paperboard manufacturing; (iv) textile miles; and (v) commercial airports.

The proposed rulemakings in Preliminary Plan 15 are likely to take several years to come to fruition. However, the action demonstrates EPA’s clear commitment to addressing and limiting PFAS in industrial wastewater discharges.

Toxic Substances Control Act – Recordkeeping and Reporting

On June 10, 2021, EPA announced a proposed rulemaking under the Toxic Substances Control Act (“TSCA”). The proposed rule requires those who currently or previously manufactured or imported PFAS since 2011 as a “chemical substance” to provide the agency with information concerning the types, amounts, and environmental and health effects of the PFAS they produce (including imports). Importantly, EPA stated there were no exemptions to such reporting obligations under the rule, thereby allowing it to create a comprehensive data set. The proposed rule also covers the manufacture of PFAS as a byproduct and, in total, covers at least 1,364 types of PFAS (as well as any PFAS chemicals that fall under EPA’s “structural definition”).

In the proposed rule, EPA noted its intention to use the data collected to support the assessment of new and existing chemicals under the TSCA. EPA also indicated that the information could be used to inform other regulatory activities to include regulations under the SDWA, RCRA, and CERCLA. A finalized rule is expected by December 2022.

Other Federal Actions Related to PFAS

A number of other actions addressing PFAS transpired in 2021. This included other federal agencies taking proactive steps to address PFAS, as well as legislation providing funding for PFAS. President Biden has also released Executive Orders concerning PFAS.

National Defense Authorization Act for Fiscal Year 2022

On December 27, 2021, President Biden signed into law S. 1605, the National Defense Authorization Act for Fiscal Year 2022 (the “Act”), authorizing fiscal year appropriations for the Department of Defense, the Department of State, and the Department of Energy national security programs. Although the House-passed version of the bill removed several stringent PFAS-related measures, the bill as passed still required the establishment of a “PFAS Task Force” within the Department of Defense, with duties to include monitoring the health aspects of exposure to PFAS, identifying and funding the procurement of an alternative to firefighting foam containing PFAS, and for the PFAS Task Force to coordinate with the Department of Defense to mitigate the effects of releases of PFAS, and assessing perceptions of Congress and the public of the Department of Defense’s efforts regarding the mitigation of the effects of releases of PFAS from its activities.

The Act authorizes additional appropriations for PFAS under environmental restoration funds for the respective branches of the military ($98,800,000 for the Army; $167,300,000 for the Navy; and $175,000,000 for the Air Force) and an additional $74,000,000 for environmental restoration at formerly used sites. Furthermore, the Act implements a temporary moratorium on the disposal of PFAS by incineration until the Secretary of Defense implements interim guidance by EPA addressing destruction and disposal.

The Food and Drug Administration – Testing of Food Supply

Over the next three years, the Food and Drug Administration (“FDA”) will continue to expand its PFAS analysis method development to test the food supply, advancing its estimates of dietary exposure to PFAS from food. Posted on December 19, 2021, FDA released its method for measuring 16 PFAS in food using liquid-chromatography tandem mass spectrometry. Earlier in the year, FDA had released the results of its first survey of PFAS in nationally distributed processed foods collected from the agency’s Total Diet Study (“TDS”). FDA’s TDS monitors levels of nutrients and contaminants in foods commonly eaten by people in the United States. The results of the survey — FDA’s first round of expanded representative testing — showed that 164 of the 167 foods tested had no detectable levels of PFAS. FDA also provides support to states when areas of suspected PFAS contamination may impact food.

Several other agencies, to include the Department of Homeland Security, the Department of Health and Human Services, and the Department of Agriculture, are taking steps to address PFAS in air, water, and food. On October 18, 2021, President Biden’s White House released a statement announcing not just the launch of EPA’s Roadmap, but also steps taken by such agencies, and others, as part of a government-wide approach.

Executive Order 14057, Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability

On December 8, 2021, President Biden signed Executive Order 14057 directing the Federal Government to “lead by example” and use its scale and procurement power to “lead[] the Nation on a firm path to net-zero emissions by 2050.” In an accompanying document, The Federal Sustainability Plan: Catalyzing America’s Clean Energy Industries and Jobs (“Federal Sustainability Plan”), the Federal Government is directed to “orient” its procurement and operations efforts to, among other principles, prioritize the purchase of sustainable products, such as products without PFAS.

Infrastructure Investment and Jobs Act

In November 2021, President Biden signed the Infrastructure Investment and Jobs Act providing over $10 billion for states to address emerging contaminants, such as PFAS, in drinking water and wastewater. As part of this funding, and via the Drinking Water State Revolving Fund, $4 billion will be distributed to assist water utilities in addressing emerging contaminants in drinking water “with a focus on” PFAS.

Upcoming Actions in 20222

Per EPA’s Roadmap, actions addressing PFAS will remain center stage. The following key actions are just a few to keep a watchful eye on:

  • Emergency Planning and Community Right to Know Act (“EPCRA”): EPA intends to propose a rulemaking in Spring 2022 categorizing PFAS on the Toxic Release Inventory (“TRI”) as “Chemicals of Special Concern.” EPA will also continue updating the list of PFAS subject to the TRI.
  • CERCLA: By Spring 2022, EPA hopes to release a proposed rulemaking designating PFOA and PFOS as “hazardous substances” under CERCLA. The implications of this designation will be significant for many industries, enhancing the ability of EPA and other agencies to seek cost recovery or contributions incurred for cleanup. At the same time as this proposed rulemaking, EPA will also release an advance notice of proposed rulemaking seeking public input as to whether other PFAS should be similarly designated.
  • SDWA: Pursuant to the SDWA, EPA has authority to set enforceable National Primary Drinking Water Regulations for drinking water contaminants and can require monitoring of public water supplies. EPA has not yet established drinking water regulations for any PFAS but, in March 2021, published the Fourth Regulatory Determinations, which included a final determination to regulate PFOA and PFOS in drinking water. By Fall 2022, the agency will publish a proposed rule establishing National Primary Drinking Water Regulations for these two PFAS chemicals.
  • Additionally, by Spring 2022, EPA intends to publish health advisories for PFBS and GenX chemicals based on final toxicity assessments (see above). EPA plans to produce accompanying fact sheets to the health advisories to ensure access to the information. Finally, EPA will develop additional health advisories as it completes toxicity assessments for other PFAS chemicals.
  • Clean Water Act: Under its ELG program, EPA will launch detailed studies where the agency has preliminary data on PFAS discharges but such data is insufficient to support a potential rulemaking currently. These studies are expected to be complete by Fall 2022 and will inform the agency’s decision regarding future rulemaking by the end of the year. Additionally, for industrial categories where the phaseout of PFAS is projected by 2024 (g., pulp, paperboard, and airports), EPA will address both the results of monitoring and whether future regulatory action is required in its Final ELG Plan 15, set for release in Fall 2022 too.
  • Alongside this, EPA hopes to “leverage” the National Pollutant Discharge Elimination System (“NPDES”) program to reduce discharges of PFAS at sources of releases. The information attained by the agency through monitoring of the sources of PFAS and the quantity of the chemicals discharged will help to inform which industrial categories it will study for future ELG actions. More specifically, EPA will propose monitoring at those facilities where PFAS are expected, or suspected, to be present in wastewater and stormwater discharges. EPA will use its published analytical method 1633, which includes coverage of 40 unique PFAS, to determine such facilities.
  • TSCA: By Winter 2022, EPA plans to finalize its proposed rule to collect information on PFAS manufactured since 2011. As noted above, EPA published its proposed rule in June 2021 and will take the next year to consider public comments before finalization.

Takeaways

The most evident takeaway from 2021 is the Biden administration’s strong public commitment to addressing PFAS under a number of statutes and programs. EPA’s actions to date indicate that 2022 will also be a big year for regulatory activity related to PFAS. EPA’s Roadmap sets forth a number of key actions for the upcoming year which take steps towards regulating PFAS chemicals under numerous environmental laws. Depending on the ultimate outcome of the proposals, these actions will likely increase the burdens imposed on regulated entities and the authority of federal agencies to take action on PFAS. Some of EPA’s proposed actions could result in increased costs of compliance or, where applicable, costly cleanup actions for a wide variety of industries, such as aviation, construction, and energy. Businesses within these industries will have to implement time and resource efforts in response to EPA’s actions to identify, manage, and mitigate their potential risks associated with PFAS in their operations, to include manufacturing and waste disposal.

If your business has not already assessed how future PFAS regulation may impact its operations and legal liabilities, 2022 is the year to begin internal assessments and external tracking of PFAS-related activities at both the federal and state level.

1 “An estimate of the concentration of dose of a substance . . . to which a human population (including sensitive subgroups) can be exposed that it likely to be without an appreciable risk of deleterious effects during a lifetime.” EPA, Human Health Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid and Its Ammonium Salt (CASRN 13252-13-6 and CASRN 62037-80-3) at 30 (Oct. 2021).

2 EPA’s Roadmap provides a timeline for PFAS-related actions covering not just 2022, but 2023 through 2024. This list is limited to what we can expect this year.

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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