On February 14, 2019, the Environmental Protection Agency (EPA) released an Action Plan for addressing per- and polyfluoroalkyl substances (collectively, PFAS), a group of chemical compounds that has been linked to negative human health impacts for sensitive populations. Although the Action Plan contains proposals aimed at minimizing the risks surrounding PFAS, binding, enforceable, promulgated standards are likely several years away. In the meantime, parties with affected interests have several opportunities to engage in advocacy and have been actively doing so.
What Are PFAS?
PFAS are a group of related, synthetic chemicals that include multiple fluorine atoms. PFAS have been commonly used in the United States since the 1940s to create products including water-repellent and stain-resistant fabrics, nonstick cookware, cosmetics, and firefighting foam. PFAS have been nicknamed "forever chemicals" because they break down very slowly; due to their use in common household items and their persistence, PFAS are present in the blood of most US residents.1
EPA, the Agency for Toxic Substances and Disease Registry and others have asserted that PFAS may be linked to a litany of human health impacts. The two oldest and most common PFAS chemicals, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), have been removed from the marketplace due to concerns about their health impacts. Manufacturers have replaced them with shorter-chain "next generation" PFAS that are believed to be safer.
Regulatory History of PFAS
Due to concerns about human health effects, EPA has long been called upon to regulate PFAS chemicals. The most stringent form of regulation would require setting a Maximum Contaminant Level (MCL) under the Safe Drinking Water Act (SDWA). An MCL is a binding limit on the level of a contaminant allowed in a public water system. EPA has not yet set an MCL for any PFAS chemical.
In 2009, EPA first issued a health advisory regarding PFOA and PFOS. A health advisory is a nonbinding guidance document that EPA issues to assist state and local entities in regulating contaminants for which it has not yet set an MCL. EPA's health advisory set recommended levels of PFOA and PFOS in drinking water at 0.4 and 0.2 parts per billion, respectively. In 2016, EPA issued a new health advisory setting a much lower threshold for both contaminants: 70 parts per trillion. The new health advisory, which superseded the 2009 levels, brought PFAS back into the spotlight and created public alarm as people reacted to EPA's declaration that the water that they had been consuming and assuming safe was now considered hazardous.
In May 2018, then-Administrator Scott Pruitt held an EPA PFAS Summit, in which he announced that EPA was considering whether to adopt an MCL, with specific consideration of the 70 parts per trillion threshold, and using EPA's authority under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, commonly known as Superfund) to initiate groundwater remediation efforts in the meantime.
On February 1, 2019, a group of 20 senators and congressional representatives asked Acting Administrator Andrew Wheeler to set an MCL for PFOA and PFOS. The group noted that EPA "health advisories are non-enforceable and deprive the states of much-needed federal guidance on how to determine and implement effective drinking water standards for PFOA and PFOS chemicals."2 In the absence of federal standards, many states have acted to set their own drinking water standards for PFAS or otherwise regulate the substances. These state standards are inconsistent, which presents challenges and confusion for regulators and the regulated community alike.
EPA's PFAS Action Plan
Against this backdrop, and based on a series of EPA meetings with stakeholders across the country and in response to the approximately 120,000 comments submitted to the public docket, EPA last week released its Action Plan.3 The Action Plan lays out steps to (1) regulate PFOA and PFOS, for which significant data exist, and (2) stimulate research and regulatory activities to address more recently developed PFAS, such as "GenX" chemicals. The Action Plan includes a combination of short-term (to be accomplished within two years) and long-term (expected to take more than two years to complete) goals and actions.
The steps proposed in the Action Plan fit under four umbrellas: (1) drinking water; (2) mitigating releases and exposures; (3) toxics regulation; and (4) research, communications and enforcement. While the Action Plan contains dozens of proposals, the most significant are:
- The Action Plan does not propose a specific MCL for any PFAS chemical. However, it expresses EPA's intention to begin the MCL process in 2019 by proposing a regulatory determination for PFOA and PFOS (that is, a determination of whether EPA should regulate the substances based on a consideration of adverse health effects, the chemicals' presence in public water systems and the potential to reduce health risks through regulation). The MCL process requires formal rulemaking and extensive public engagement, so even if EPA determines it is appropriate to regulate PFOA and PFOS, an MCL could still be years away.
- The Action Plan states that EPA is committed to using new detection methods to monitor additional PFAS in drinking water starting in 2020. These efforts will focus on the presence of PFAS in public water systems to inform future regulations, and will be capable of identifying PFAS at lower minimum reporting levels than were previously possible.
Mitigating releases and exposures
- EPA has initiated the administrative process to designate PFOA and PFOS as CERCLA "hazardous substances." This would open the door to using CERCLA response authorities to address PFAS in groundwater. Adding PFAS to CERCLA's hazardous substances list also would expand liability for potentially responsible parties.
- The Action Plan states that EPA is in the process of developing interim recommendations for addressing groundwater contaminated with PFOA and PFOS to address cleanup goals before these chemicals are added to the hazardous substance list. These recommendations are intended for use by federal agencies, states, tribes and communities engaging in site-specific cleanup efforts. The recommendations will be subject to public review and comment before they are finalized.
- EPA intends to evaluate the viability of developing ambient water quality criteria for PFAS under Section 304 of the Clean Water Act. Section 304 criteria would allow states to control releases of PFAS into waterways through their National Pollutant Discharge Elimination System (NPDES) permitting programs.
- The Action Plan announces that EPA, starting in 2019, will examine existing information and seek new data from specific industries (airports and producers of organic chemicals, plastics, synthetic fibers, pulp and paper, and textiles) to identify industrial sources of PFAS groundwater pollution that may warrant regulation through national Effluent Limitation Guidelines and Standards (ELGs). ELGs would require identified sources to take action to address their releases.
- EPA is currently working through the rulemaking process to issue a new Significant New Use Rule (SNUR) for PFAS under the Toxic Substances Control Act (TSCA) to mitigate the risks from new PFAS. When implementing a SNUR, EPA is required to review the use or importation of a new chemical substance to identify whether it presents unreasonable risks and, if so, apply controls to mitigate those risks before the chemical enters commerce.
- EPA is considering whether to add PFAS chemicals to the Toxics Release Inventory (TRI) Program. The TRI is used to track releases of chemicals that may pose a threat to human health and the environment. Facilities must report the release of chemicals on the TRI, and TRI data are used to inform private and governmental decision-making. Currently, no PFAS chemicals are included on the TRI, so there is no obligation to report their release under the Emergency Planning and Community Right-to-Know Act.
- EPA is in the process of developing toxicity assessments of GenX chemicals and perfluorobutanesulfonic acid (PFBS), two of the newer PFAS chemicals that were designed to replace PFOS and PFOA. EPA intends to release final toxicity values for these chemicals in 2019 and develop toxicity values for five other PFAS starting in 2020. These toxicity values will help inform regulatory and risk management decisions by EPA, states, tribes and local communities, under the appropriate regulations and statutes.
Research, communications and enforcement
- The Action Plan proposes a slate of research and development activities geared toward assessing the risks that PFAS present and the appropriate ways to manage those risks. The proposed research focuses on four areas: (1) the human health and ecological effects of exposure to PFAS; (2) significant sources, pathways and exposures to humans and ecosystems; (3) the costs and effectiveness of various remediation methods; and (4) science required to support stakeholder efforts to address PFAS.
- EPA acknowledges the challenge of effectively communicating to the public the complicated issues surrounding PFAS, and aims to improve communication with stakeholders. Among other proposals, the Action Plan describes a plan to create a communications "toolbox" for federal, state, tribal and local regulators to use when interfacing with the public.
- The Action Plan indicates that EPA may undertake enforcement efforts where PFAS contamination poses an imminent and substantial endangerment to public health or welfare. As a general matter, however, the Action Plan states that EPA will employ an enforcement strategy that relies first on state and local authorities.
If fully implemented, EPA's Action Plan would represent a major shift in the regulation of PFAS. The Action Plan lays out an array of commitments and proposals, many of which present opportunities for public participation. The regulated community should closely monitor the regulatory processes that develop for promulgation of standards as well as the related actions, and should participate in those processes as their interests warrant.
1 Agency for Toxic Substances and Disease Registry, PFAS Blood Testing (June 2017).
2 Letter to Acting Administrator Wheeler (Feb. 1, 2019).
3 EPA's Per- and Polyfluoroalkyl Substances (PFAS) Action Plan (Feb. 2019).
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