8/31/22 Editor's Note: The original article, published 8/30/22, contained a sentence that read, "Waste management under RCRA will also be impacted as PFOA/PFOS testing, transportation manifesting, and disposal will need to follow hazardous material protocols." This sentence has been edited below to provide clarity.

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On August 26, 2022, the United States Environmental Protection Agency (EPA) announced the proposed designation of perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund. Last week’s announcement came in the form of a pre-publication notice, with publishing to the Federal Register forthcoming. PFOA and PFOS are two of the thousands of per- and polyfluoroalkyl substances (PFAS) flagged as contaminants of emerging regulatory concern.  

The highly anticipated proposed "PFAS designation rule" (PDR) comes as EPA continues to work through its PFAS Action Plan and PFAS Strategic Roadmap. Though it comes as no surprise, the proposal may be this year’s biggest PFAS headline as it introduces an array of new operational and compliance challenges across industries.

To help the regulated community digest EPA’s action to designate PFOA and PFOS as CERCLA hazardous substances, we are launching a series of articles that discuss the PDR, follow the rulemaking developments, and provide a running narrative on what it means for industry. This is Part 1.

What are PFOA and PFOS?

PFOA and PFOS are only two of the thousands of PFAS chemicals, but they have attracted a significant share of the attention associated with PFAS. PFOA/PFOS were phased out of commercial production in the United States (US) in the early 2000s, but remain nearly ubiquitous in the environment due to widespread historical production and use.

PFOA and PFOS follow textbook acid/base chemistry, and therefore may be present in many forms (e.g., as anions, acids, or as salts). Furthermore, either chemical may be present as branched/linear isomers. The regulations and analytical methods are designed to apply to PFOA and PFOS regardless of the chemical form.

What is CERLCA/Superfund?

CERCLA, or Superfund, was enacted in 1980 and provides EPA a funding mechanism and enforcement authority to clean up hazardous waste sites. Through Superfund, EPA can clean up orphan sites or can seek out potentially responsible parties and hold them financially liable for cleanup.

Superfund is a complex suite of regulations with multi-prong processes that closely interact with many other environmental regulations. Whether or not a site falls within Superfund’s purview depends on whether it contains CERCLA hazardous substances. Designating PFOA and PFOS as hazardous substances paves the way for Superfund program involvement.   

What are CERCLA hazardous substances?

Substances are deemed hazardous if they possess certain toxic, physical, and chemical properties that make them substantially and imminently dangerous to human health and/or the environment upon their uncontrolled release. CERCLA hazardous substances generally rely on designations pursuant to other statutes, including the Clean Water Act (CWA), the Clean Air Act (CAA), the Resource Conservation and Recovery Act (RCRA), and the Toxic Substance Control Act (TSCA). However, EPA has the authority to designate substances as hazardous directly under CERCLA Section 102(a), as it proposes to do with PFOA and PFOS. No matter which rule makes the declaration, the effects of a hazardous substance designation stretch across the environmental regulatory fabric.

In general, what compliance requirements does a hazardous substance designation trigger?

From a practical perspective, once designated as hazardous, substances are added to the Superfund (40CFR) Table 302.4 and require mandatory reporting to the National Response Center of any unplanned environmental releases of each substance above the designated reportable quantity (RQ) of one pound (lb) or more over a 24-hour period. In addition to spill rules, hazardous substances are also subject to release tracking; permitting; US Department of Transportation (DOT) manifesting; and reporting under CWA, CAA, RCRA, Toxics Release Inventory (TRI), and/or Hazardous Materials Transportation Action (HMTA). Although PFOA/PFOS are already subject to TSCA Chemical Data Reporting (CDR), phaseouts, and limits, the hazardous designation could trigger additional scrutiny by EPA. According to EPA, the industries potentially affected by this rule include:

What is the intent of EPA’s action?

EPA’s PDR intends to:

• Increase transparency around releases of PFOA/PFOS
• Facilitate a reporting mechanism of PFOA/PFOS presence/releases in the environment
• Hold manufacturers and “significant polluters” accountable for cleaning up contamination
• Enhance community knowledge of the extent and location of PFOA/PFOS and assist in an understanding of how to avoid these chemicals
• Encourage improved waste treatment and management
• Expedite contaminated site cleanup

What about the environmental basis for the action?

In its press release, EPA states there is “…significant evidence that PFOA and PFOS may present a substantial danger to human health or welfare or the environment” and that the PDR aims to “…protect people and communities from the health risks posed by certain PFAS.” EPA elaborates on the potential health risks by stating, “…exposure to PFOA and/or PFOS may lead to cancer, reproductive, developmental, cardiovascular, liver, and immunological effects.”

Yet, EPA scientists acknowledge the lack of answers to their own outstanding questions (e.g., “How much people are exposed to PFAS,” “How harmful PFAS are to people and the environment,” etc.). Moreover, EPA states, “Most known exposures are relatively low.” EPA further states, “Current scientific research suggests that exposure to high levels of certain PFAS may lead to adverse health outcomes. However, research is still ongoing to determine how different levels of exposure to different PFAS can lead to a variety of health effects.”

Thus, the PDR appears to be precautionary in nature rather than based on a body of existing evidence concerning known US population exposure and adverse effects.  

Overall, how might this proposed rule impact the regulated community?

We are in the early stages of the rulemaking activities, so some of the anticipated impacts may change as the proposed rule moves forward. However, certain short- and long-term consequences are likely.

Along with additional reporting and recordkeeping requirements, the most notable change will be to land/groundwater assessments as part of real estate transactions and valuation. Currently, PFAS are not a compulsory analyte. Once the PDR is in place, future land transaction activities will likely need to include assessments. With this development, EPA is anticipated to resume the suspended rulemaking of the Standards and Practices for All Appropriate Inquiries regulation. Federal property transactions will require covenant warranties on cleanup status, as well as permanent liabilities for any additional remediation actions associated with former storage, release, or disposal of PFOA/PFOS at each site for one year or more.

Another notable impact will be on contaminated site work under CERCLA, RCRA, and state cleanup programs, including the potential for reopening formerly closed sites. The prospect for the latter is amplified by EPA’s recent push for extremely low drinking water limits (measured in subparts per trillion).

Although without a direct link to the RCRA rule as of yet, PFOA/PFOS-impacted material/“waste” management will also be impacted as testing, manifesting/placarding/packaging, and disposal will need to follow hazardous material protocols.

Additional PDR effects to watch for include:

• Toxic torts/claims of injury/diminution in value
• Private party lawsuits for cleanup cost recovery
• Pressure to replace PFOA/PFOS industrial chemistries/processes domestically and in imported goods with non-hazardous alternatives
• Public water supply challenges where PFOA/PFOS are detected
• The listing of new sites on EPA's National Priorities List (NPL)
• The potential for EPA to exercise its authority to order private parties to repay cleanup costs or perform cleanup themselves
• Increased frequency of site investigation and environmental risk assessments for PFOA/PFOS
• The potential for EPA to name additional PFAS compounds currently under risk assessment, such as Hexafluoropropylene Oxide (HFPO) Dimer Acid and Perfluorobutane sulfonic acid (PFBS), as hazardous substances      
• The expedited listing of PFOA, PFOS, HFPO, and PFBS as RCRA hazardous materials, thus becoming subject to separate corrective action under that program 

Anything else I should know?

Yes. There are early indications of EPA’s enforcement discretion. Presumably due to the ubiquitous nature of PFAS (it has even been found in rainwater), EPA states that they “...will use enforcement discretion and other approaches to ensure fairness for minor parties who may have been inadvertently impacted by the contamination.”

EPA also states it is “committed to doing further outreach and engagement to hear from impacted communities, wastewater utilities, businesses, farmers, and other parties during the consideration of the proposed rule.”

Notably, the public potable water treatment sector is not mentioned, yet thousands of small and large water providers may be affected. EPA’s position appears to be for case-specific enforcement action, while the regulated community may prefer more a defined/regimented definition of “manufacturer” and “polluter” subject to any enforcement actions.

What’s next?

EPA plans to publish the Notice of Proposed Rulemaking in the Federal Register in the next several weeks. Following publication in the Federal Register, EPA will accept public comment on the proposed rule for a 60-day window (Docket: EPA-HQ-OLEM-2019-0341).

EPA has also indicated it expects to issue an Advance Notice of Proposed Rulemaking in the future to solicit public comment on designating other PFAS chemicals as CERCLA hazardous substances.

What can I be doing now to prepare?

Designating PFOA/PFOS as CERCLA hazardous substances will create an influx of CERCLA sites across industries and could impact sites that have received Records of Decision (RODs) or No Further Action (NFA) letters.

While the impacts of the proposed rule may be considerable, there are ways site owners and operators can begin preparing for regulatory changes, including:

• Watch developments closely
• Examine current chemical inventories
• Scrutinize safety data sheets (SDS) for PFAS-containing chemicals/products
• Look for substitutions/alternate processes
• Implement/extend hazardous substances management programs (if elimination/substitution is not possible)
• Understand reporting requirements
• Create facility-specific conceptual site models (CSMs) to understand on-site/off-site contributions

Connect with us

If you have questions on how EPA’s proposed PDR will impact you, please connect with us using the form linked below. Also, keep an eye out for Part 2 of this article series for updates.