Regulatory Developments

Biden Administration Announces Multi-Agency Plan to Confront PFAS Pollution; EPA Releases Strategic Roadmap

October 19, 2021

On October 18, 2021, the Biden Administration announced a multi-agency plan to address per- and polyfluoroalkyl substances (PFAS) contamination nationwide. According to the White House, agencies, including the U.S. Environmental Protection Agency (EPA), the Department of Defense (DOD), the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), and the Department of Health and Human Services (DHHS), will take actions to prevent PFAS from being released into the air, drinking systems, and food supply and to expand cleanup efforts to remediate the impacts of PFAS pollution. To facilitate the coordination of PFAS response activities across the government, Biden Administration officials yesterday convened a first meeting of the newly-formed Interagency Policy Committee on PFAS, under the leadership of White House Council on Environmental Quality (CEQ) Chair Brenda Mallory. During the meeting, agency leaders discussed their progress and plans for addressing PFAS contamination and reducing the risks to American families. The Interagency Policy Committee on PFAS will work to coordinate and help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country.

EPA announced the release of its PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024 (Strategic Roadmap), which sets timelines by which EPA plans to take specific actions during the first term of the Biden Administration. EPA states that the Strategic Roadmap is the result of a “thorough analysis” conducted by the EPA Council on PFAS established by EPA Administrator Michael Regan in April 2021. The Strategic Roadmap is centered on three guiding strategies: increase investments in research; leverage authorities to take action now to restrict PFAS chemicals from being released into the environment; and accelerate the cleanup of PFAS contamination. According to EPA, over the coming weeks, it will be working to partner for progress on PFAS. EPA will engage with a wide range of stakeholders to continue to identify collaborative solutions to the PFAS challenge, including two national webinars that will be held on October 26 and November 2, 2021.

As outlined by EPA, a number of offices will be taking the following key actions.
 

The Office of Chemical Safety and Pollution Prevention (OCSPP)

Publish a national PFAS testing strategy intended to deepen understanding of the impacts of categories of PFAS, including potential hazards to human health and the environment. The testing strategy requires PFAS manufacturers to provide EPA toxicity data and information on categories of PFAS chemicals. EPA will select the PFAS to be tested “based on an approach that breaks the large number of PFAS into smaller categories based on similar features and considers what existing data are available for each category.” According to EPA’s Strategic Roadmap announcement, the initial set of test orders for PFAS, “which are expected in a matter of months,” will be strategically selected from more than 20 different categories of PFAS. According to EPA, this set of orders will provide it with critical information on more than 2,000 other similar PFAS that fall within these categories. (October 18, 2021.)
 
Ensure a robust review process for new PFAS under the Toxic Substances Control Act (TSCA) to ensure these substances are safe before they enter commerce. (Ongoing.)
 
Review existing PFAS under TSCA to ensure existing PFAS are being used in ways that do not present concerns and to prevent resumed production of legacy PFAS or their use in new ways. (Expected summer 2022 and ongoing.)
 
Enhance PFAS reporting under the Toxics Release Inventory (TRI) by proposing a rulemaking to remove exemptions and exclusions for toxic chemical reporting. (Expected spring 2022.)
 
Issue final new PFAS reporting requirements under TSCA Section 8 to characterize better the sources and quantities of manufactured PFAS in the United States. EPA proposed reporting and recordkeeping requirements for PFAS on June 28, 2021. 86 Fed. Reg. 33926. EPA proposes to require all persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazard. More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.” Bergeson & Campbell, P.C. (B&C®) Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D., discussed EPA’s proposed rules and what the regulated community must know and do to comply in a September 9, 2021, webinar. A recording is available online. (Expected winter 2022.)
 

Office of Water (OW)

Undertake nationwide monitoring for PFAS in drinking water under the fifth Unregulated Contaminant Monitoring Rule (UCMR), significantly expanding the number of drinking water systems participating in the program, pending sufficient appropriations by Congress. (Expected fall 2021.)
 
Establish a national primary drinking water regulation for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) that would set enforceable limits and require monitoring of public water supplies, while evaluating additional PFAS and groups of PFAS. (Proposed rule fall 2022, final rule fall 2023.)
 
Publish the final toxicity assessment for GenX and five additional PFAS -- perfluorobutanoic acid (PFBA), perfluorohexanoic acid (PFHxA), perfluorohexanesulfonic acid (PFHxS), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA) -- to understand better their human health and environmental effects. (Expected fall 2021 and ongoing.)
 
Publish health advisories for GenX and perfluorobutane sulfonic acid (PFBS) based on final toxicity assessments to enable tribes, states, and local governments to inform the public and take appropriate action. (Expected spring 2022.)
 
Restrict PFAS discharges from industrial sources through a multi-faceted Effluent Limitations Guidelines program to establish proactively national technology-based regulatory limits, including progress on the nine industrial categories in the proposed PFAS Action Act of 2021 (H.R. 2467). The priority industry categories in H.R. 2467 are organic chemicals, plastics, and synthetic fibers; pulp, paper, and paperboard; textile mills; electroplating; metal finishing; leather tanning and finishing; paint formulating; electrical and electronic components; and plastics molding and forming. (Expected 2022 and ongoing.)
 
Leverage National Pollutant Discharge Elimination System permitting to reduce PFAS discharges to waterways at the source and obtain more comprehensive information through monitoring of the sources of PFAS and quantity of PFAS discharged by these sources. (Expected winter 2022.)
 
Publish improved analytical methods to enable 40 PFAS to be monitored in eight different environmental matrices and to update methods for drinking-water monitoring. (Expected fall 2022 and fall 2024.)
 
Publish final recommended ambient water quality criteria for PFAS for aquatic life and human health to help Tribes and states develop standards, write permits, and assess cumulative impacts. (Expected winter 2022 and fall 2024.)
 
Enhance data availability on PFAS in fish tissue to better assess the impacts of PFAS on the aquatic environment and to inform federal, state, and Tribal efforts to set PFAS fish advisories. (Expected summer 2022 and spring 2023.)
 
Issue a final risk assessment for PFOA and PFOS in biosolids that will serve as the basis for determining whether regulation of PFOA and PFOS in biosolids is appropriate. (Expected winter 2024.)
 

Office of Land and Emergency Management (OLEM)

Propose to designate certain PFAS as Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) hazardous substances to require reporting of PFOA and PFAS releases, enhance the availability of data, and ensure agencies can recover cleanup costs. (Proposed rule expected spring 2022, final rule expected summer 2023.)
 
Issue an advance notice of proposed rulemaking on various PFAS under CERCLA to seek public input on whether to seek CERCLA designation of other PFAS. (Expected spring 2022.)
 
Issue updated guidance on destroying and disposing PFAS to reflect public comments on interim guidance and to reflect newly published research results. (Expected fall 2023.)
 

Office of Air and Radiation (OAR)

Build the technical foundation to address PFAS air emissions to identify sources, develop and issue final monitoring approaches for stack emissions and ambient air, develop information on cost-effective mitigation technologies, and increase understanding of the fate and transport of PFAS air emissions to inform potential regulatory and non-regulatory mitigation options. (Expected fall 2022 and ongoing.)
 

Office of Research and Development (ORD)

Develop and validate methods to detect and measure PFAS in the environment, including additional targeted methods for detecting and measuring specific PFAS, non-targeted methods for identifying unknown PFAS in the environment, and exploring “total PFAS” methods. (Ongoing.)
 
Advance the science to assess human health and environmental risks from PFAS by developing human health toxicity assessments under EPA’s Integrated Risk Information System (IRIS) program; compiling and summarizing available and relevant scientific information; identifying PFAS sources, transport, and exposure pathways; and characterizing how exposure to PFAS may contribute to cumulative impacts on communities. (Ongoing.)
 
Evaluate and develop technologies for reducing PFAS in the environment to inform decisions on drinking water and wastewater treatment, contaminated site cleanup and remediation, air emission controls, and end-of-life materials management. (Ongoing.)
 

Cross-Program

Engage directly with affected communities in all EPA regions to understand how PFAS contamination impacts their lives and livelihoods, building on a recommendation from EPA’s National Environmental Justice Advisory Council. (Expected fall 2021 and ongoing.)
 
Use enforcement tools to identify and address better PFAS releases at facilities, as appropriate, to require actions by responsible parties, to limit future releases, and to address existing contamination. (Ongoing.)
 
Accelerate public health protections by identifying PFAS categories based on toxicological data for hazard assessment and decision-making and based on removal technologies. (Expected winter 2021 and ongoing.)
 
Establish a PFAS Voluntary Stewardship Program to challenge industry to go above and beyond regulatory or compliance requirements to reduce releases of PFAS into the environment. (Expected spring 2022.)
 
Educate the public about the risks of PFAS to help the public understand what PFAS are, how they are used, and how they can impact their health. (Expected fall 2021 and ongoing.)
 
Issue an annual public report on progress towards PFAS commitments included in the Strategic Roadmap, as well as future actions EPA may take. (Winter 2022 and ongoing.)
 

Commentary

EPA is making good on its commitment to pursue aggressive action under its statutory authorities to address PFAS contamination. EPA will continue to be challenged, however, by the breadth of the category created by its PFAS definition. EPA’s “National PFAS Testing Strategy” divides PFAS into categories based on the sort of molecule that contains the perfluoro group, but does not differentiate based on the length of the perfluoro group. This illustrates how broad the category is. EPA’s list of PFAS candidates includes a Freon molecule, a PFOS precursor, two epoxides, a betaine surfactant, a morpholine, a perfluoroalkane, and an alcohol. The perfluoro chain lengths range from two to eight fully fluorinated carbons. The physicochemical properties, fate characteristics, and health and ecological effects will vary widely across those categories and candidates. The data sets for PFOS and PFOA are much more robust than the other PFAS, and those data are expected to support much of EPA’s actions on the eight perfluorinated carbon PFAS. We note, however, the characteristics of PFOS and PFOA are not representative of many of the testing candidates EPA has identified. Assuming all PFAS are equally toxic is as unsupportable as assuming that all organic compounds that have an aromatic ring are equally toxic. Aromatic substances vary widely in their properties and hazards: benzene and benzo[a]pyrene (a polycyclic aromatic hydrocarbon, or PAH) are both quite toxic and are carcinogenic; and lignin (the biopolymer that is a major component of wood) and tryptophan (an essential amino acid) are much less toxic.

EPA is primarily focused on using its authority under TSCA, the Clean Water Act (CWA), and the Safe Drinking Water Act (SDWA) to address PFAS, and there are supporting roles for EPA’s air and waste offices. ORD also has a significant role in developing information to support the EPA program offices’ broader efforts. Other federal agencies and departments have important roles to play. In particular, FDA will have a key role in addressing use of PFAS in food packaging and in cosmetics, both potential direct sources of PFAS exposure.

Regulators need information about the hazards of the PFAS classes given their various chain lengths so that all decision-makers, whether public or private, can make informed decisions about whether a particular PFAS is appropriate in any particular use. EPA needs information about the prevalence of PFAS in the environment to understand where problematic PFAS are found, and EPA needs to find new detection and remediation methods, so that when found, PFAS can be mitigated safely, effectively, and efficiently.

EPA’s plan is an aggressive step toward understanding and managing risks from PFAS. Proceeding in a manner that is supported by science and in compliance with the law offers the best chance of success.


 
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