Extracted from Law360
On May 18, the U.S. Environmental Protection Agency added five per- and polyfluoroalkyl substances, or PFAS, to a list of risk-based values for regional screening and removal management levels.
This action comes as several states are gearing up their own efforts to regulate PFAS, and are conducting PFAS site investigations without clear federal guidance or action on PFAS-related issues.
These additions at the federal level will provide guidance to states addressing PFAS contamination, and should send a clear signal to businesses and regulated industries that the EPA will continue to aggressively address PFAS across the nation, including through the anticipated designation of two heavily studied PFAS compounds as hazardous substances.
These federal regulatory initiatives will compound each other, and significantly increase the potential risks of litigation and government enforcement related to PFAS contamination.
PFAS are widely used, long-lasting chemicals that break down very slowly over time. Because of their widespread use and their persistence in the environment, many PFAS are found in the blood of people and animals, and are present at low levels in a variety of consumer, commercial and industrial products and in the environment.
This makes it challenging to study and assess the potential human health and environmental risks.
Regional Screening and Removal Management Levels
Regional screening levels, or RSLs, are used to identify contaminated media — i.e., air, tap water and soil — at a site that may need further investigation. In general, if a contaminant concentration is below the RSL, no further action or investigation is needed. If the concentration is above the RSL, further investigation is generally needed to determine if some action is required.
The EPA considers RSLs to be protective for humans over a lifetime. However, RSLs are not always applicable to a particular site, and do not address nonhuman health endpoints, such as ecological impacts.
Regional removal management levels, or RMLs, are used to support the EPA's decisions to undertake a removal action under the Comprehensive Environmental Response, Compensation, and Liability Act, or CERCLA — also known as the Superfund law — which could include providing alternative drinking water or remediation of contaminated media, if necessary.
These levels may be used to support the decision to undertake a removal action. But final cleanup levels should be selected to address the site-specific threat.
Screening and removal management levels are not cleanup standards. They are risk-based values that help the EPA determine if further investigation or actions are needed to protect public health, such as sampling, assessing risks and taking further action, which could include providing alternative drinking water.
The EPA's Action
On May 18, the EPA added the following five PFAS to the list of RSLs and RMLs:
Hexafluoropropylene Oxide Dimer Acid and Its Ammonium Salt
Hexafluoropropylene oxide dimer acid and its ammonium salt are also known as GenX chemicals.
GenX is a trade name for a processing aid technology used to make high-performance fluoropolymers — e.g., some nonstick coatings — without the use of perfluorooctanoic acid.
Perfluorooctanesulfonic acid, or PFOS, was historically used in many consumer and industrial products, including carpets, rugs, upholstered furniture, nonstick cookware and leather products.
PFOS has also been present in some firefighting foams used at airports, firefighter training facilities and military airfields. PFOS was phased out of production domestically in 2002, but still remains in the environment and in imported goods.
As with PFOS, perfluorooctanoic acid, or PFOA, has been used in a wide range of consumer and industrial products.
The manufacture and import of PFOA has also been phased out in the U.S. as part of the EPA's PFOA Stewardship Program, but the chemical still remains in the environment and in imported goods.
Perfluorononanoic acid was historically used as a processing aid in the emulsion process used to make fluoropolymers, mainly polyvinylidene fluoride.
Perfluorohexanesulfonic acid, or PFHxS, was historically used in stain-resistant fabrics, firefighting foam and food packaging and as a surfactant in industrial processes. PFHxS was phased out of production domestically in 2002, but still remains in the environment and in imported goods.
In addition, a sixth PFAS substance, perfluorobutanesulfonic acid, or PFBS, was added to the RSL and RML lists in 2014. PFBS is a replacement chemical for PFOS. Like PFOS, PFBS has been used in carpeting and carpet cleaners, floor wax and food packaging.
The EPA calculated levels for PFOA, PFOS, PFHxS and perfluorononanoic acid using information based on the Agency for Toxic Substances and Disease Registry's 2021 toxicological profile. Notably, the registry levels for PFOA and PFOS created controversy when they were initially proposed in 2018.
The EPA and other regulatory agencies were concerned that the registry levels for PFOA and PFOS were more stringent than levels the EPA adopted for health advisory levels in 2016. For hexafluoropropylene oxide dimer acid, the EPA used a final, peer-reviewed EPA toxicity value.
The EPA reviews and updates these levels twice a year. Since the science concerning PFAS is constantly evolving, not only are the initial risk-based levels in the RSLs and RMLs likely to change, additional PFAS chemicals may be added to the list as research on the risks of PFAS continues to develop.
Implications of the EPA's Actions
The addition of these five PFAS to the RSL and RML lists is part of the EPA's larger efforts to aggressively regulate PFAS. Earlier this year, the EPA submitted to the White House Office of Management and Budget its plan to designate PFOA and PFOS as hazardous substances under CERCLA.
In the coming weeks, the EPA will issue its proposed rule. The EPA may also request input on the hazardous substance designation for precursors to PFAS, additional PFAS, and groups or subgroups of PFAS. The final regulation, in conjunction with the RSLs and RMLs, will have significant impacts on business and industry.
For example, these regulatory efforts will leverage the full range of Superfund authorities, including reporting requirements that exceed the reportable quantity assigned to the substances and collection of information about the location and extent of PFAS releases.
The EPA or other agencies and private parties could also seek recovery for costs associated with the cleanup of releases of PFAS — which is expected to be expansive, and expensive, given the widespread and pervasive nature of PFAS. CERCLA's joint and several theory of liability will increase the number of potential responsible parties.
Moreover, the EPA's regulatory efforts are expected to result in the reopening of previous investigations and the generation of more PFAS-containing waste.
Accordingly, businesses and industry should prepare in the coming weeks and months for a roller coaster of PFAS regulatory initiatives at the federal level, which are certain to create a host of potential risks and implications that affect operations.