There has been lots of chatter about potential regulation of per- and polyfluoroalkyl substances (PFAS). Below, we highlight some regulatory actions that are proceeding or under consideration. Manufacturers, importers, municipalities, water utilities, farmers, and users of PFAS containing products should be paying close attention to what is coming next.
ANY regulatory action must be supported with:
- An administrative record;
- Resolution of specific technical issues; and,
- Collection and consideration of public comment.
This means that the regulated community does not need to be blind-sided. There are many opportunities for the regulated community to provide input on any PFAS regulatory action.
This Alert provides insights into what to expect next, who is affected, and opportunities for input.
PFAS are synthetic compounds with a very strong carbon-fluorine bond. This bond makes PFAS heat, stain, and water-resistant, valuable qualities for many industrial and consumer applications. This bond also makes PFAS very resistant to breakdown in the environment, giving rise to the nickname “forever chemicals.”
Since the 1940s PFAS have been used in hundreds of industrial applications, such as fire-fighting foam, metal plating, and aerospace technology, and hundreds of consumer products, such as carpeting, clothing, upholstery, and grease-proof food contact materials (think pizza boxes).
Studies indicate that perfluorooctane-sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) (the most studied PFAS) can cause adverse health effects in laboratory animals. EPA also has developed a drinking water health advisory for PFOA and PFOS at a level at which EPA determined health effects are not anticipated to occur over lifetime exposure. EPA is developing additional PFAS toxicity assessments.
While PFOS and PFOA are no longer used in the United States, other PFAS (of which there are thousands) and products containing PFAS remain in commerce. Due to widespread uses, PFAS, including PFOS and PFOA, have been detected in drinking water, ground water, surface water, landfill leachate, wastewater effluent, biosolids, and dust.
EPA is considering a variety of regulatory responses, some of which are discussed below.
Safe Drinking Water Act
After review, on February 22, 2021, the Biden administration approved two Safe Drinking Water Act (SDWA) PFAS regulatory actions that were awaiting Federal Register publication at the end of the Trump administration.
The first action, published in the Federal Register on March 3, 2021, is a final determination to regulate under the SDWA both PFOS and PFOA (the two PFAS for which EPA issued a health advisory in 2016). This action does not establish any regulation. It is a necessary step under the SDWA that begins the process to propose and promulgate a national primary drinking water regulation.
What is next:
Under the SDWA, EPA now must propose a national primary drinking water regulation (usually a maximum contaminant level or MCL) for PFOA and PFOS within 24 months, i.e., by March 3, 2023 and promulgate the regulation within 18 months after proposal, i.e., by September 3, 2024 (unless EPA grants itself an extension of up to 9 months which would push a final regulation into 2025). Once promulgated, MCLs go into effect three years after they are finalized, and EPA or a state may grant an extension of up to two years to allow capital investments.
Who is affected and what they can do:
Meeting MCLs is a regulatory requirement for public water systems (i.e., systems conveying drinking water to at least 15 service connections or that regularly serve at least 25 individuals). Public water systems should be proactive and provide EPA with information on cost, technical capabilities for both detection and treatment, and any unique circumstances or limitations.
The second action, published in the Federal Register on March 11, 2021, is a proposal to require public water systems to collect data on 29 PFAS. Comments on the proposal are due on May 10, 2021. Data collected under EPA’s monitoring rules provide needed information on the presence of contaminants in public water systems that may support a determination that the contaminant occurs at a frequency and level of public health concern and that EPA has a meaningful opportunity for health risk reduction, both of which are necessary components of a later determination that the development of a MCL is appropriate.
What is next:
EPA will finalize the monitoring requirements, data collection, and the potential for additional regulatory determinations and MCLs in the years to come, based on the data collected.
Who is affected and what can they do:
As noted above, public water systems must meet MCLs and should be paying attention to and participating in these developments by providing cost, technical, and impacts information.
Clean Water Act
On March 17, 2021, the EPA published in the Federal Register an advance notice of proposed rulemaking (ANPRM) seeking data from PFAS manufacturers and PFAS formulators to support the development of effluent limitations guidelines (ELGs), including new source performance standards (NSPS) for direct dischargers and pretreatment standards for facilities that send wastewater to municipal treatment works (POTWs), to be applicable to PFAS manufacturers and formulators in those categories or subcategories. An ANPRM is not a regulatory action.
ELGs are established by EPA for categories of industrial dischargers and are based on the degree of control that can be achieved using various levels of pollution control technology, as specified in the Clean Water Act (CWA) (e.g., Best Practicable Control Technology Currently Available (BPT), Best Conventional Pollutant Control Technology (BCT), Best Available Technology Economically Achievable (BAT). All ELGs require information on available controls, cost, and existing performance in the industry, or an appropriate subcategory.
NSPS are based on the greatest degree of effluent reduction achievable based on best available demonstrated control technology.
Pretreatment standards must prevent pass through or interference with a POTW. For existing sources, they are developed based on information similar to that used to develop BPT and BAT. For new sources, they are developed based on information similar to that used to develop NSPS.
What is next:
EPA will propose ELGs, including NSPS and pretreatment standards, for at least some PFAS in a few years.
Who is affected and what can they do:
The universe of affected facilities is potentially large and currently unknown. The new ELGs may apply to manufacturers that produce PFAS compounds or precursors through processes like electrochemical fluorination and telomerization. These facilities are currently subject to the EPA’s ELG for the Organic Chemicals, Plastics and Synthetic Fibers (OCPSF) point source category (40 CFR part 414), which may be amended. The OCPSF category consists of 1,000 chemical facilities producing over 25,000 end products, such as benzene, toluene, polypropylene, polyvinyl chloride, chlorinated solvents, rubber precursors, rayon, nylon, and polyester.
The new ELGs also may apply to manufacturers that use PFAS (PFAS formulators) when producing final products such as weather-proof caulking or intermediary products for use in the manufacture of commercial goods, such as a grease-proof coating for a pizza box, or waterproofing for clothing and footwear. Finally, while not currently the subject of this ANPRM, EPA also has developed information on end users of PFAS products such as auto facilities and metal finishers, as well as inadvertent recipients of PFAS contaminated material, such as industrial and commercial laundries.
As CWA standards are highly dependent on information about available technologies and their use, entities in sectors that have been the subject of EPA or state focus should be providing information to EPA, particularly if they believe that certain treatment technologies would be cost-prohibitive or ineffective. Such information is critical to establishing sub-categories or even exemptions.
EPA has completed studies of PFAS manufacturers and users, including a study focused on OCPSF facilities, pulp and paper manufacturers, textile and carpet manufacturers, and commercial airports. EPA also has collected discharge information from certain companies, as well as POTWs. Currently, there have been two permits issued with PFAS limits, and four permits with PFAS monitoring requirements. In contrast, EPA’s Toxic Controlled Substances Act (TSCA) inventory includes over a 1,000 PFAS, of which 500 are believed to be active. EPA is seeking extensive information on wastewater treatment and management practices as well as monitoring data and analytical methods used (currently there is none approved for wastewater regulation under the CWA).
EPA’s Multi-Industry Study has been withheld from the docket as an enforcement confidential document. However, data provided by individual companies is available, as well as state and EPA data from some POTWs. At present, EPA has identified only six PFAS manufacturing facilities and ten PFAS formulators. However, the universe, particularly of formulators, is likely much larger. In addition, Michigan has shared information with EPA on 50 sources of PFAS discharges in the auto facility, metal finishing, and commercial and industrial laundry sectors that Michigan considers significant.
Comments on the ANPRM are due on May 17, 2021, but engagement on this (or any) rulemaking can be ongoing.
It is important to note that PFAS are pollutants, and the unpermitted discharge of a pollutant is a violation of the CWA. While EPA has withheld as enforcement confidential both its Multi-Industry Study and discharge data collected by EPA’s enforcement office, the available information could be mined to use in CWA citizen suits or other litigation.
Earth & Water Law is available to counsel companies on how to limit their legal exposure. If a facility is not certain whether or not they have PFAS in its wastewater, Earth & Water Law also could arrange a self-audit that is protected from disclosure under attorney-client privilege and provide advice on decisions on self-disclosures.
CERCLA Hazardous Substance Listing or RCRA Hazardous Waste Listing
In 2019, the Trump administration announced in its PFAS Action Plan that it intended to initiate the regulatory process to add PFOS and PFOA to the list of hazardous substances under CERCLA, using its authority under section 102 of that Act (an authority that has never before been used), and sent a proposed rule to the Office of Management and Budget. At the end of the Trump administration, EPA replaced that approach with an ANPRM signed on January 14, 2021, that sought information on whether EPA should proceed with a hazardous substance listing under CERCLA or whether using hazardous waste listing authorities under RCRA would be preferable. The ANPRM also sought information needed to support either approach. That ANPRM was posted on EPA’s website, but the Biden Administration did not publish it in the Federal Register.
What is next:
A decision by the Biden Administration on which approach to take and a proposed listing under either authority
Who is affected and what can they do:
As EPA noted in the ANPRM, a CERCLA hazardous substance listing could affect PFOA and PFOS manufacturers; PFOA and PFOS processors; manufacturers of products containing PFOA and PFOS; downstream product manufacturers and users of PFOA and PFOS products; and waste management and wastewater facilities.
All RCRA hazardous wastes are CERCLA hazardous substances. EPA has experience listing hazardous wastes. In addition, EPA has the ability to tailor the identification of a new RCRA hazardous waste, either by providing a toxicity threshold if EPA uses its authority to add a new characteristic waste to its RCRA regulations, or to focus on either specific industrial sources, specific uses, or specific chemicals under its authorities to list hazardous wastes.
EPA also has received two petitions seeking identification of PFAS as hazardous wastes. Eventually, EPA will have to respond to these petitions. Failure to respond would be subject to judicial review.
This rulemaking is at a critical juncture. EPA will have to soon choose which regulatory path to pursue or whether an ANPRM is appropriate and is under pressure to act quickly. Entities interested in a tailored approach to any action that will lead to CERCLA liability for PFAS releases should be taking action now, to develop recommendations and present those recommendations, and record support, to the appropriate officials.
Earth & Water Law
Earth & Water Law’s PFAS Team is available to provide advice on any of the matters addressed in this Alert. Earth & Water Law can facilitate the organization of coalitions with aligned interests who wish to engage in the rulemaking process.
Our full-service team consists of experts that collaborate to provide unparalleled insights and solutions for legal risk management and mitigation in a cost-efficient manner. We regularly collaborate with in-house counsel and other firms to deliver unparalleled results.
For more information or immediate assistance, please contact any of the team members below:
Susan Parker Bodine
Mary Ellen Ternes