EPA Proposed Regulatory Determination Represents a Step in Creating Standards for PFAS

On February 20, 2020, the U.S. Environmental Protection Agency (EPA or the Agency) took another step toward tightening its regulation of a wide range of several thousand synthetic chemicals known as perfluoroalkyl substances (PFAS) by issuing a pre-publication notice of a proposed regulatory determination to develop drinking water standards for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). PFOA and PFOS are among the two most-studied PFAS chemicals, and although they have been largely phased out in the United States, they remain a focus of regulatory attention due to their persistent, bioaccumulative and toxic properties, which also are shared by other PFAS. PFAS, as a whole, have come under increasing regulatory scrutiny due to recent high-profile litigation involving companies such as 3M and Wolverine Worldwide.

Given that it may still take several years to finalize the MCL, EPA has stated that the proposed determination represents “the beginning of the Agency’s regulatory development process, not the end.” Nevertheless, it marks just the second time that EPA has determined that pollutants meet the Safe Drinking Water Act, 42 U.S.C. 300f, et seq. (SDWA) criteria for setting such standards since the SDWA was substantially amended in 1996 to require the consideration of detailed risk and cost assessments, and best available peer-reviewed science, when developing Maximum Contaminant Levels (MCLs). In this connection, the proposal marks another instance of EPA follow-through on a critical aspect of its February 2019 PFAS Action Plan, as well as a response to increasing pressure from lawmakers, states, and others to protect the nation’s drinking water supply from PFAS.

Significance of EPA’s Regulatory Action
The SDWA requires EPA to make regulatory determinations every five years for at least five unregulated contaminants. EPA’s action signifies the Agency’s preliminary determination that PFOA and PFOS:

  • Have an adverse effect on human health;
  • Occur in public water systems with a frequency and at levels of public health concern; and
  • Must be regulated to reduce health risks for persons served by public water systems.

Besides soliciting data and public feedback relevant to these criteria in the case of PFOA and PFOS, EPA’s notice outlines three potential pathways for regulating additional PFAS:

  • Evaluating each additional PFAS on an individual basis;
  • Evaluating additional PFAS based on different grouping approaches (e.g., physiochemical properties); or
  • Evaluating additional PFAS based on drinking water treatment techniques, as they develop.

Although the proposed regulatory determination does not directly address this issue, indications from EPA over the course of the last several months indicate that the Agency is not backing off of its health risk advisory level of 70 ppt for PFOA and PFOS, despite criticism from industry that this standard is overly aggressive.1 EPA established this level in 2016, and upheld it in both its 2019 PFAS Action Plan and December 2019 Interim Recommendations for Addressing Groundwater Contaminated with PFOA and PFOS. In the December 2019 Interim Recommendations, EPA also recommended a screening level of 40 ppt to determine if PFOA and/or PFOS is present at a site at levels that warrant further investigation.

Varying state and federal standards indicate ongoing disagreement over the proper standard for PFOA and PFOS. Some states favor more stringent standards than EPA’s advisory level, while others have opted for less stringent levels. Against this backdrop of differing state standards, EPA Administrator Wheeler has previously said that an MCL will help communities with monitoring, detecting, and addressing PFAS.

Entities Likely to be Impacted by a Proposed Drinking Water Standard
The establishment of an MCL would impose requirements, first and foremost, on water utilities and owners and operators of public water systems responsible for complying with the National Primary Drinking Water Regulations. These requirements could be particularly onerous for public water systems located near businesses and facilities where PFOA and PFOS have been used or disposed. These latter include:

  • Chemical plants;
  • Manufacturing facilities where electroplating and/or coating operations involving PFOA and PFOS were performed;
  • Landfills where PFAS-containing waste have been disposed; and
  • Military installations, airports, petroleum refineries, and other locations where firefighting activities involving aqueous firefighting foam have been performed.

Releases from such facilities have been identified as sources of PFOA and PFOS contamination in public water systems in several states, and the past few years have witnessed several lawsuits by drinking water utilities against such facilities2, as well as efforts by states, such as California, New Jersey and New York, to obtain information from businesses to better understand the potential for PFAS-related impacts to drinking water supplies.

However, the establishment of an MCL for PFOA and PFOS is also of concern to responsible parties at environmental cleanup sites. Inasmuch as MCLs serve as default cleanup standards, whatever drinking water standards EPA establishes for PFOA and PFOS will influence regulatory determinations regarding the adequacy of environmental remedial efforts. This could be a significant cost driver for parties responsible for environmental cleanups, for EPA’s 70 ppt health risk advisory level is lower, by orders of magnitude, than the cleanup standards in place for industrial chemicals typically encountered during site remediations. Furthermore, given that the attention given to PFAS is a relatively new phenomenon and that environmental cleanups often take decades to complete and that many sites that have received closure have done so subject to long-term monitoring requirements and other controls, the establishment of an MCL for PFOA and PFOS may result in responsible parties having to revisit aspects of site investigation and remedial projects presently deemed to have been completed.

Finally, one of the main dilemmas that regulated industry will face once an MCL for PFOA and PFOS is established is how to meet the standard. PFAS remedial technologies are still being developed, and while certain technologies have shown promise, there is no consensus regarding a technologically viable and cost-effective method for treatment or removal.

What Potentially Affected Businesses Can Do to Minimize Enforcement and Business Risks
In light of the above, businesses are advised to take a proactive approach in dealing with PFAS. Practical measures that should be considered in view of EPA’s regulatory determination include the following:

  • Companies who may be affected by EPA’s establishment of an MCL are recommended to take advantage of the public comment period, which will remain open until 60 days after publication of the proposed regulatory determination in the Federal Register. EPA is especially interested to obtain data on the health and safety risks of PFAS, as well as on its prevalence in drinking water systems. The Agency may be persuaded to adopt a more lenient standard that 70 ppt if provided with data indicating that its current health advisory level is unnecessarily stringent.
  • Owners and operators of “consecutive public water systems” that obtain their water from other regulated systems and that believe they may meet the exemption criteria of SDWA § 1411 (42 U.S.C. § 300g) are advised to begin exploring possible means of formalizing exemptions, before PFAS-related requirements become effective.
  • Remedial parties should assess the potential for PFAS contamination at cleanup sites and devise strategies for addressing possible impacts and dealing with regulators about PFAS.

Pillsbury has substantial experience in each of these areas.

1 Industry criticism has to do with EPA’s reliance on reference doses for PFOA and PFOS in developmental toxicity studies performed on mice. See, e.g., Luebker, D.J., M.T. Case, R.G. York, J.A. Moore, K.J. Hansen, and J.L. Butenhoff. 2005. “Two-generation reproduction and cross-foster studies of perfluorooctanesulfonate (PFOS) in rats.” Toxicology 215:126–148; Lau, C., J.R. Thibodeaux, R.G. Hanson, M.G. Narotsky, J.M. Rogers, A.B. Lindstrom, and M.J. Strynar. 2006. “Effects of perfluorooctanoic acid exposure during pregnancy in the mouse.” Toxicological Sciences 90:510–518.
2 See, e.g., Ridgewood Water v. 3M Company et al, Case No. 2:19-cv-02198 in the U.S. District Court for South Carolina (2019); Emerald Coast Utilities Authority v. 3M Co. et al, Case No. 3:09-cv-0036 in the U.S. District Court for the Northern District of Florida (2018); West Morgan-East Limestone Water and Sewer Authority et al v. 3M Company et al, Case No. 5:15-cv-01750 in the U.S. District Court for the Northern District of Alabama (2015).