Tag: per and polyfluoroalkyl substances

White House OSTP Releases PFAS Federal R&D Strategic Plan

The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl Substances (PFAS) Federal Research and Development Strategic Plan (Strategic Plan). Prepared by the Joint Subcommittee on Environment, Innovation, and Public Health PFAS Strategy Team (PFAS ST) of the National Science and Technology Council, the Strategic Plan provides a federal strategy and implementation plan for addressing the strategic areas identified in the 2023 Per- and Polyfluoroalkyl Substances (PFAS) Report (PFAS Report). The Strategic Plan is intended to be a companion document to the PFAS Report. The activities described in the Strategic Plan are reviewed through the Office of Management and Budget (OMB) annual budget process and subject to available resources.

Background

As reported in our March 16, 2023, blog item, the PFAS Report provides an analysis of the state of the science of PFAS and information that will be used to direct the development of a federal strategic plan. The PFAS Report focuses on the current science of PFAS as a chemical class, identifies scientific consensus, and portrays uncertainties in the scientific information where consensus is still sought. The PFAS Report identifies four key strategic areas that, when addressed, will generate actionable information to address PFAS: removal, destruction, or degradation of PFAS; safer and environmentally friendlier alternatives; sources and pathways of exposure to PFAS; and toxicity of PFAS. The gaps and opportunities identified in the PFAS Report were used to develop the Strategic Plan.

Strategic Plan

Based on the four strategic areas presented in the 2023 PFAS Report, the PFAS ST identified four strategic goals that will drive federal research and development (R&D) efforts regarding PFAS:

  • Provide relevant, high-quality scientific data that increase the understanding of PFAS exposure pathways to inform federal decisions that reduce risks to human health and the environment;
  • Effectively and equitably communicate federal work and results regarding PFAS R&D through engagement with impacted communities and federal, Tribal, state, and local agencies;
  • Identify research and technologies to address PFAS contamination and mitigate the adverse impacts on communities; and
  • Generate information that facilitates informed procurement decisions by federal agencies, manufacturers, and consumers regarding products that contain or use PFAS and PFAS alternatives to reduce adverse human health and environmental effects.

According to the Strategic Plan, the PFAS ST identified five R&D strategies within the strategic research areas that address the identified knowledge gaps. The R&D strategies and select tasks to achieve the objectives within each strategy include:

  • Understand PFAS exposure pathways to individuals and communities:
    • Further characterize potential PFAS exposures in the built environment, including schools, workplaces, and other indoor/household environments. According to the Strategic Plan, this would include the co-occurrence and use of consumer products and understanding the lifecycle of products with regard to PFAS exposure;
    • Initiate studies regarding PFAS co-exposure and potential interactions with other contaminants (including other PFAS) in environmental samples, such as nano- and microplastics, petroleum constituents, metals, pesticides, and pharmaceuticals;
    • Initiate and continue studies of the physical-chemical properties of PFAS and mixtures of PFAS;
    • Investigate additional pathways and routes of exposure, such as direct contact, dermal absorption, oral ingestion, and inhalation from indoor and outdoor environments (residential, consumer, and occupational exposures); and
    • Develop and support studies of PFAS exposures in indoor environments through collection of dust, air, consumer products, and other media where biomonitoring may also be conducted;
  • Address current PFAS measurement challenges through the development of standards, advanced sampling, and analytical methodologies:
    • Develop and refine analytical methods and data collection methods to evaluate PFAS content, migration, and emissions from consumer, commercial, and industrial products, and their impact on workplace and indoor environments;
    • Develop testing programs and methods related to quantifying PFAS content, migration, and emissions in animal/livestock feed, food and food packaging, indoor exposure (dust, home/office materials), workplace settings, and consumer products; and
    • Develop and validate real-time, rapid, and remote PFAS screening methods using analytical sensors, PFAS proxies, passive sampling devices, and other novel technologies for the detection of PFAS in media;
  • Understand the toxicological mechanisms, human and environmental health effects, and risks of PFAS exposure:
    • Develop scientifically supported classification schemes for PFAS with respect to adverse impacts on human health and the environment;
    • Develop and support research regarding the human toxicity and ecotoxicity testing of PFAS as mixtures with PFAS and other co-occurring chemicals;
    • Support research to understand further the mechanism of action of PFAS toxicity, advance development of adverse outcome pathways, and understand the impact of PFAS mixture toxicities when evaluating cumulative health effects;
    • Develop and support epidemiological studies designed to identify communities near significant sources of PFAS contamination that may have environmental justice concerns, including occupationally exposed populations and populations, communities, and/or lifestages that are more susceptible to PFAS exposure or adverse health outcomes;
    • Explore the development of a federal data-sharing strategy to use interagency toxicological and epidemiological data to determine human health endpoints of concern from PFAS exposure; and
    • Develop classification strategies that enable grouping of PFAS by hazard identification, exposure assessment, and dose-response studies in support of risk assessments;
  • Develop, evaluate, and demonstrate technologies for the removal, destruction, and disposal of PFAS:
    • Continue to support the foundational research that advances technologies for the destruction of PFAS by both thermal and non-thermal approaches;
    • Support the implementation of removal and destruction technologies that apply to discharge and releases at the point of manufacturing; and
    • Develop and implement models to evaluate technology performance, short-term and long-term costs, energy demands, scalability, and the composition of treated materials that are released to the environment;
  • Identify PFAS alternatives and evaluate their human health and environmental effects:
    • Engage with academic and private sector industrial researchers to support the development of novel, less toxic alternative chemistries and processes for sustainable PFAS alternatives;
    • Identify and evaluate critical and essential uses of PFAS within individual agencies and sectors;
    • Develop an interagency-aligned evaluation framework for prioritizing research on specific PFAS alternatives that includes considerations regarding sustainability; performance; viability and timeframe to transition; dependency on foreign sources of materials; criticality of the current product to national security, critical infrastructure, climate change mitigation, and public health; and criticality of the need for a replacement product or process;
    • Support research to advance sustainable manufacturing and circularity of PFAS-based processes and products to preserve current critical and essential uses, which will enable an orderly transition to PFAS alternatives in critical manufacturing sectors that are dependent on PFAS;
    • Develop a database of the current commercial inventory of alternative materials and products with relevant chemical and toxicological information, manufacturer production capacity, and performance comparison of the alternatives to PFAS-containing materials and products; and
    • Continue to assess human health and environmental effects posed by alternative materials and products for use in comparison to other product formulations, including PFAS-containing product formulations.

Commentary

Bergeson & Campbell, P.C. (B&C®) acknowledges that OSTP’s PFAS Strategy may benefit from the U.S. Environmental Protection Agency’s (EPA) regulatory activities under the Toxic Substances Control Act (TSCA) and other initiatives. We provide below representative examples of these activities.

Between 2022 and 2024, EPA issued TSCA Section 4 test orders requiring manufacturers and/or processors to perform various studies on four PFAS (i.e., 6:2 fluorotelomer sulfonamide betaine [6:2 FTSB], trifluoro(trifluoromethyl)oxirane [HFPO], 2,3,3,3-tetrafluoro-2-heptafluoropropoxy) propanoyl fluoride [HFPO-DAF], and 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-Heptadecafluoro-N-(2-hydroxyethyl)-N-methyloctane-1-sulfonamide [NMeFOSE]).

EPA also intends on initiating ten additional TSCA Section 4 test orders per year on PFAS between fiscal year (FY) 2024 and FY 2026 (i.e., October 1, 2024-September 30, 2027). EPA’s activities under TSCA Section 4 may lead to the development of data that provide a better understanding of the human health and environmental effects of specific types of PFAS.

The TSCA Section 8(a)(7) rule on the reporting and recordkeeping of manufacture and import of PFAS will provide additional information on PFAS uses, production volumes, disposal, exposures, and hazards. In addition, EPA’s publication of its updated PFAS category analysis may help frame how to use data on PFAS for which testing has been (or is in the process of being) completed to fill data gaps on related PFAS.

Further, EPA’s Office of Research and Development (ORD) and Office of Land Use and Emergency Management (OLEM) have made significant contributions on analytical methods for detecting PFAS in various media and guidance for destroying and disposing of PFAS and PFAS-containing materials, respectively. The TSCA Section 8(a)(7) information along with EPA’s advancements with identifying PFAS in environmental media may aid with identifying those PFAS and the associated uses that lead to the greatest environmental releases.

Collectively, EPA’s activities on PFAS will advance the objectives of OSTP’s PFAS Strategy. This information may also aid with differentiating the types of PFAS that present the greatest concerns to human health and the environment versus those chemistries that do not. After all, many chemical substances, including pharmaceuticals and pesticides, meet one or more of the existing definitions for PFAS and have clear public health benefits, yet do not present the same concerns as those PFAS that have significant concerns (e.g., perfluorooctanoic acid).

©2024 Bergeson & Campbell, P.C.
For more news on PFAS Federal R&D Strategic Plans, visit the NLR Environmental Energy Resources section.

U.S. EPA Finalizes Designation of Two PFAS Chemicals as Hazardous Substances Under CERCLA

On April 19, the U.S. Environmental Protection Agency (EPA) released its long-awaited final rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as “hazardous substances” under Section 102(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or “Superfund”) (the “Final Rule”). The designation, which takes effect 60 days after the final rule is published in the Federal Register, will provide expanded investigation and remediation authority to EPA, will provide a powerful tool for private actions under CERCLA, and will trigger additional release reporting requirements. It will also expand enforcement authority in states that regulate CERCLA-designated hazardous substances.

Hazardous Substance Designation of PFOA and PFOS Has Broad Implications for Cleanups and CERCLA Liability

PFOA and PFOS are two specific chemical compounds within a broad group of thousands of manmade chemicals known as per- and polyfluoroalkyl substances (PFAS). EPA focused its regulatory efforts on these two PFAS; however, the vast majority of PFAS remain unregulated under CERCLA even after issuance of the Final Rule.

Designating PFOA and PFOS as hazardous substances triggers numerous requirements. The primary impact of the Final Rule is that it incorporates PFOS and PFOA into CERCLA’s strict, joint and several liability framework. This change grants EPA the power to investigate releases of PFOA and PFOS and compel potentially responsible parties (PRPs), including owners and operators of a property or facility, to remediate releases of PFOA and PFOS through the specific CERCLA enforcement provisions. PRPs also now have a clear private right of action under CERCLA to pursue cost recovery and contribution actions. Additionally, when the Final Rule becomes effective, facilities will be required to immediately report releases of PFOA and PFOS above their designated “reportable quantities,” (currently one pound within a 24-hour period), to the National Response Center and relevant state or tribal authorities.

Furthermore, many states include CERCLA hazardous substances under their cleanup statutes, meaning these states will now be able to require remediation of PFOA and PFOS under state law.

Listing PFOA and PFOS as “hazardous substances” under CERCLA does not make PFOA or PFOS contaminated waste a “hazardous waste” or a “hazardous constituent” under the Resource Conservation and Recovery Act. However, this designation does require the U.S. Department of Transportation to designate PFOA and PFOS as “hazardous materials” for purposes of transport under the Hazardous Materials Regulations.

While the PFOA and PFOS CERCLA Listing is Final, Questions Remain

As noted in our prior article on the proposed rule, EPA’s designation of PFOA and PFOS as “hazardous substances” leaves several questions unanswered.

  • How will EPA’s CERCLA enforcement discretion policy really play out in practice? 

    Concurrently with the publication of the Final Rule, EPA also released a PFAS Enforcement Discretion and Settlement Policy under CERCLA. This enforcement policy captures EPA’s current position that it does not intend to pursue PRPs under circumstances where “equitable factors” do not support doing so. Enumerated circumstances in the policy include so-called “passive receivers” of PFAS, including community water systems and publicly-owned treatment works, publicly-owned municipal solid waste landfills, publicly-owned airports and local fire departments, and farms where PFAS-containing biosolids are applied to the land. However, EPA’s enforcement policy—which is not binding upon the agency and is subject to change at any time—should be viewed with a healthy dose of skepticism among regulated industries, considering the sheer breadth of potential CERCLA liability for these substances, as well as continued Congressional proposals to codify exemptions for passive receivers within the CERCLA statute itself. Notably, the agency’s enforcement position does not in any way prevent private parties from initiating cost recovery or contribution actions under CERCLA.

  • How will regulated industries manage the costs of PFOA and PFOS cleanup?PFAS contamination can be wide-ranging due to several factors unique to the chemicals themselves. Further, unlike remediation technologies for other well-studied contaminants, existing remediation technologies for PFOA and PFOS are nascent at best and are expensive at a large scale. It is therefore often difficult to even estimate accurate cost ranges for PFOA and PFOS cleanups, but costs can easily run into the millions of dollars at complex sites. Although EPA has published interim guidance on PFOA and PFOS disposal methods, and the recently passed Infrastructure Investment and Jobs Act provides $3.5 billion over five years for Superfund cleanups, the methods and money may not go as far as planned if cleanup costs for PFOA and PFOS sites end up exponentially higher.
  • How will EPA handle potential PFOA and PFOS contamination at closed Superfund sites?In response to comments seeking clarification on whether designating PFOA and PFOS will lead to the reopening of closed Superfund sites, EPA stated that the final rule “has no impact” on EPA’s authority to list PFOA and PFOS sites as Superfund sites. EPA’s question-and-answers page—which we note is not a binding statement from the agency—also states that “[d]esignation will not change EPA’s process for listing and/or deleting [National Priorities List (NPL)] sites or evaluating remedies’ protectiveness through five-year reviews, and it will not require PFOA and PFOS sampling at NPL (final or deleted) sites.” While the final rule does not require PFOA and PFOS sampling at closed sites, it does not prevent EPA from ordering sampling at these sites. PRPs who may have long ago stopped budgeting for remedial costs at existing or legacy locations that were remediated years and even decades ago, may find that they are required to revisit these sites where PFOA and PFOS may be present.
  • What cleanup standards will govern PFOA and PFOS remediation?There is a current patchwork of state regulatory standards relating to PFAS, ranging from binding cleanup levels, advisory guidance, or no PFAS standards at all, which may lead to similarly patchwork cleanup standards depending on which standards are applied as an appropriate “applicable or relevant and appropriate requirement” (ARAR) at a specific site. In addition, on April 10, 2024, EPA issued a final rule setting Maximum Contaminant Levels (MCL) for PFOA and PFOS in drinking water at 4.0 parts per trillion (ppt), individually. While these drinking water standards are separate from EPA’s final rule listing PFOA and PFOS as “hazardous substances” under CERCLA, the “hazardous substances” rule notes that the MCL may be an appropriate ARAR for cleanup efforts under CERCLA.
  • What other PFAS will EPA next target under CERCLA?As noted above, PFOA and PFOS are two specific PFAS among thousands of others currently and historically used. Much of the science on the potential health effects of PFAS (both individual chemical compounds and as a class) continues to evolve. In the meantime, EPA has moved to regulate additional types of PFAS under other statutes. For example, as we noted in a previous client alert, EPA recently published a proposed rule listing seven other PFAS compounds as hazardous constituents under RCRA. Some or all of these PFAS may eventually be targets of future CERCLA rulemaking efforts.

Next Steps

The Final Rule will take effect 60 days after it is published in the Federal Register. Affected parties should consider their portfolio of planned, active, and in some cases, closed remediation sites for potential implications, and companies may consider reviewing and updating their hazardous substance reporting and transportation protocols to address PFOA and PFOS as applicable.

© 2024 Foley & Lardner LLP
For more on PFAS, visit the NLR Environmental, Energy & Resources section.