On September 6, 2022, the EPA proposed a rule to designate the two most studied Per- and Polyfluoroalkyl Substances (PFAS) compounds, 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 of 1980, as amended (CERCLA). PFAS are a broad category of man-made chemicals that have been manufactured since the 1940s and used in a variety of products for their heat- and stain-resistance, including stain- and water-repellant fabrics, nonstick products, paints, lubricants, cleaning products and fire-fighting foams. PFAS are often referred to as “forever chemicals” due to their persistence in the human body and their resistance to degradation in the environment. PFAS are found throughout the environment, including on top of Mount Everest . Comments on the Proposed Rule must be received on or before November 7, 2022.[1] EPA has also indicated that they anticipate issued an Advance Notice Of Proposed Rulemaking after the close of the comment period on the Proposed Rule to seek public comment on designating other are PFAS chemicals as hazardous substances.

As previously reported in July 2021 by Kilpatrick Townsend, CERCLA - One Potential Landing Spot for Regulation of PFAS, the potential pathways to regulate PFAS have been hotly debated for several years, including the possibility of designating PFAS as CERCLA “hazardous substances.” While the potential regulation of PFAS as CERCLA “hazardous substances” predates the Biden Administration, President Biden pledged to tackle PFAS, including by designating as CERCLA hazardous substances, from the earliest days of his campaign. Given that federal legislation introduced to address PFAS has stalled in Congress, it is not surprising that the Administration chose to unilaterally address this issue in a rule making.[2]

The designation of PFOA and PFOS as CERCLA hazardous substances raise a multitude of concerns. Most commentary focuses on the very real impacts such a designation could have on investigation and remediation obligations at CERCLA National Priority List (NPL) sites. These concerns include whether such designation could result in reopening of closed NPL sites, identification of new NPL sites, and flagging of additional potentially responsible parties (PRPs). In addition, regardless of whether or not a site is listed on the NPL, investigation and remediation obligations for any site where PFOA and PFOS are detected are likely to become more complicated and more expensive.

Beyond the impacts on CERCLA investigation and remediation obligations, other statutory and regulatory obligations could be impacted by such a designation. The Proposed Rule notes that the designation of PFOA and PFOS as CERCLA hazardous substances may trigger CERCLA emergency release reporting obligations under 40 CFR §302.6. This regulation requires that any person in charge of a facility must immediately report to the National Response Center upon knowledge that a release of a hazardous substance exceeding its Reportable Quantity (RQ) to the environment has occurred in a 24-hour period.[3] Significantly, rather than use its technical and regulatory expertise to determine what amount of PFOA and PFOS released to the environment poses an actual and immediate threat to human health and the environment, EPA ducks that judgment and proposes the default RQ of one pound or more in a 24-hour period EPA, in the Proposed Rule’s discussion of the Paperwork Reduction Act and the Regulatory Flexibility Act, downplays the actual economic impacts of this potential reporting obligation noting that the number of reportable releases ranging from 0 to 660 with a total annual cost of $370,000 per year and an estimated cost to prepare a report of $561. However, the actual impacts are more nuanced and uncertain and many questions remain to be evaluated.

Who is likely to “release” PFOA and PFOS? The Proposed Rule indicates that the manufacture of PFOA and PFOS in the United States is very limited, noting that the “principal worldwide manufacturers of PFOA and PFOS and related chemicals phased out their production in the early 2000's”; however, PFOA and PFOS continue to be imported and used by a number of United States manufacturers and industries.[4] PFOS and PFOS may continue to be used in firefighting suppressants (typically referred to as Aqueous Film Forming Foams (AFFF)). Significantly, PFOA and PFOS are also found in multitudes of consumer products such as high performance/water performance clothing, fast food wrappers and containers and even something as insignificant as dental floss.

When is there a release of PFOA and PFOS from a “facility?” Beyond the typical “facilities” that one considers under common parlance, it bears remembering that, under CERCLA, a “facility” is, in essence, “any site or area where a hazardous substance has been deposited, stored, disposed of, or placed, or otherwise come to be located.”[5] Although “facility” does not include any consumer product in consumer use, it could apply to “releases” prior to reaching the actual consumer. Although it appears unlikely that EPA would seek to regulate a release of consumer products containing PFOA and PFOS under CERCLA, nothing is beyond the realm of imagination in the environmental world.

Was there a release to the “environment?” “Environment” is broadly construed for purposes of CERCLA reporting, including all environmental media - air, water, and land. Although it does not include releases that are wholly contained inside a building, EPA has determined that there is a active vents or openings or cracks in the floor could result in a release to the environment. While a release of PFOA and PFOS to the environment in the manufacturing/industrial context will be construed consistently with current guidance and practices, it is less clear whether a release of consumer products or articles containing PFOA and PFOS could be a release to the environment. The hypotheticals are endless. What result if a truck carrying a load of coated fast food containers falls off a bridge into a creek? Could someone claim that those hamburger containers in the creek was a release to the environment? Should someone know the quantity of PFOA and PFOS in these hamburger containers? Should someone know whether the hamburger containers can leach PFOA or PFOS into the creek?

Was there a release exceeding the “Reportable Quantity”? The default RQ of one pound PFOA or PFOS is very stringent and it is unclear whether there are appropriate or available analytical tests to determine whether such a release of this quantity occurred. PFOA and PFOS are believed to cause human health adverse effects at extremely low concentrations. In fact, some “action levels” are beyond laboratory detection limits.[6] Further, most hazardous substances, including PFOA and PFOS, do not exist in pure forms, but rather are found in mixtures or solutions. If the quantity of all of the hazardous substances of the mixture is known, reporting of a release is required when the RQ of an individual constituent is exceeded. However, if the quantity of one or more of the hazardous substances of the mixture or solution is unknown, notification is required where the total amount of the mixture or the solution released equals or exceeds the RQ for the constituent with the lowest RQ. In other words, if the quantity of the PFOA or PFOS in a mixture is unknown, reporting is required when one pound of the mixture is released to the environment.

This is where defensible compliance with the rule becomes virtually impossible – is it possible to determine the quantity and concentration of PFOA and PFOS in a mixture? If not, does this compel reporting even if it is believed that the concentration of PFOA and PFOS is very low? In such a case, do you need actual documentation and data to avoid reporting? Further, as EPA requires “immediate” reporting upon “knowledge,” which includes “constructive knowledge,” all of these questions should be assessed sooner than later in the event that there is a spill or release. EPA tends to not have much patience with regard to giving facilities sufficient time to confirm whether or not a reportable release occurred.

Conclusion. These issues are not simply technical issues but illustrates the poor policy judgment of a federal agency when a new substance is simply added to a 42-year-old program with all of its highly developed procedures, regulations, guidance documents and case law decisions simply for apparent political expediency. EPA wants to “do something” on this watch with PFAS chemicals, but the reporting obligation ambiguities alone, which are now triggered, demonstrate the lack of due process notice of obligations that the regulated community and communities potentially affected deserve and need. Further, if the reporting scenarios were as limited as EPA says, the more prudent policy would be for EPA to simply defer this portion of the Proposed Rule until the agency and the regulated community gain experience with the rule, the science, and the practical challenges and develop the necessary technical information to identify the accurate “quantity” at which a release of PFOA and PFOS presents a risk. It is incumbent on companies to have an accurate understanding of the quantities of PFOA and PFOS that may be found or utilized in its manufacturing or other processes. In addition, the potential implications on consumer products should be better understood and evaluated. It is obvious that the Proposed Rule is just a first step at shaking the hornets’ nest of PFAS regulation. Kilpatrick Townsend will continue to follow these issues and report on the hidden or novel issues presented.