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EPA’s PFOA and PFOS “Hazardous Substance” Designation Process

By Robert J. Schena on December 23, 2020
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For the past several years, much attention has been focused on the United States Environmental Protection Agency’s (EPA) legal authority to respond to PFAS contamination. When EPA published its PFAS Action Plan in February 2019, it discussed, among other things, designating PFOS and PFOA as “hazardous substances” through one of the available statutory mechanisms under CERCLA. A year later in its February 2020 update, EPA again noted that it “continued moving forward with the regulatory process for proposing to designate PFOA and PFOS as hazardous substances under CERCLA.”

While EPA has not recently provided additional detail on the state of its progress, as we discussed in a previous post, President-Elect Biden has indicated his administration’s priority to designate PFOS and PFOA as hazardous substances. We expect that EPA is likely to focus on this process in early 2021 to lay the administrative groundwork for rulemaking.

Next Steps: CERCLA’s Regulatory Process

As highlighted above, in its PFAS action plan EPA noted its consideration of the various available statutory mechanisms through which it can make a “hazardous substance” designation. In context, EPA is referencing the defined term “hazardous substance” under CERCLA, which automatically incorporates a substance designated as such under CERCLA regulations at 40 CFR Part 302, under the Clean Water Act at 40 CFR Part 116, listed as a “hazardous waste” under the Resource Conservation and Recovery Act (RCRA) at 40 CFR Part 261, any “hazardous air pollutant” listed under the Clean Air Act at 42 USC § 7412, and any “imminent hazardous chemical substance” under the Toxic Substance Control Act at 15 USC § 2606.

Regardless of the statutory source of authority, those regulatory options are similar with respect to their administrative processes, which generally require that EPA publish its proposal to designate a “hazardous substance” for public comment in a Notice of Proposed Rulemaking, with at least a 30-day public comment period following its publication. On occasion, EPA may first solicit information from the public through publication of an “Advanced Notice of Proposed Rulemaking” before it develops a proposed regulation. In either instance, members of the public have the opportunity to comment and provide issues for EPA to consider. Following its publication of a Proposed Rulemaking, EPA considers those public comments, makes any necessary changes to its proposed regulation, and then issues and publishes its final regulation, accompanied by EPA’s response-to-comments document.

Following a final promulgation of the designation, CERCLA identifies the substance on its “List of Hazardous Substances and Reportable Quantities” at 40 CFR 302.4. The list also includes the statutory source pursuant to which the substance was designated, the associated Chemical Abstracts Service registry number (CAS number), any relevant RCRA waste number, and any relevant reportable quantity.

We will continue to monitor EPA’s progress towards these designations and other PFAS related regulatory developments as the Biden Administration’s EPA implements its agenda.

  • Posted in:
    Environmental and Climate
  • Organization:
    Fox Rothschild LLP

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