2022 was a foundational year for the Environmental Protection Agency’s (EPA) planned actions to regulate per- and poly-fluoroalkyl substances (PFAS) under its PFAS Strategic Roadmap (Roadmap). Since issuing its Roadmap in October 2021, EPA has set out to lay the groundwork for its cradle to grave regulation of PFAS through proposed rules, advisory documents, memoranda, and guidance addressing PFAS cleanup, PFAS in drinking water and aquatic environments, PFAS in manufacturing and consumer products, PFAS research, and PFAS enforcement actions.
Although all of EPA’s actions in 2022 impact federal and state regulators, businesses, investors, and consumers, there are four actions that stand out from the rest. First, EPA initiated the rulemaking process to designate two PFAS, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)—a statute which the agency has historically never used to designate hazardous substances. The proposed rule will impose stringent reporting requirements for releases of PFOA and PFOS and will enable EPA or potentially responsible parties to seek cost recovery for cleanup, which would expose countless entities to CERCLA strict liability. In many instances, the liability would extend to passive receivers of materials containing PFAS—like landfills or water treatment facilities—that bear no responsibility for creating the PFAS for which they are now liable. In addition to pursing new facilities contaminated with PFOA and PFOS, EPA could also reopen previously remediated sites when it suspects these substances could be found at a specific site. The impact of this proposed rule is reflected in the over 600 comments that EPA received relating to this rule.
The final rule designating PFOA and PFOS as hazardous substances under CERCLA is expected to be published by August 2023. However, this rule may not be the end. EPA has indicated that it may use its CERCLA authority to designate other PFAS as hazardous substances. EPA is also planning to propose designating PFOA, PFOS, perfluorobutane sulfonic acid (PFBS), and hexafluoropropylene oxide dimer acid and its ammonium salt (HFPO-DA or GenX) as hazardous constituents under the Resource Conservation and Recovery Act later this year.
Second, EPA’s interim PFOS and PFOA health advisories (HAs), as well as its final GenX and PFBS HAs, have caused significant debate and resistance. HAs are non-enforceable and non-regulatory limits for contaminants not subject to national drinking water standards. Although all four HAs have drawn objections, EPA’s interim PFOS and PFOA HAs—currently set at .02 parts per trillion (ppt) for PFOS and .004 ppt for PFOA—are the most problematic. At .02 and .004 ppt, the interim HAs are set a levels that are currently unverifiable, as those levels are orders of magnitude below the current testing limit. In other words, it is impossible to measure whether any sample of water meets the interim PFOS and PFOA HAs. EPA’s GenX HA—currently set at 10 ppt—can be tested for and verified, but GenX HA is set at a number that is less than half of the closest state level (Ohio’s GenX level is set 21 ppt). Unlike PFOA, PFOS, and GenX, the final PFBS HA of 2,000 ppt is not the lowest in the country. For example, Hawaii (600 ppt) and Washington (345 ppt) have lower levels.
Despite their non-enforceable, non-regulatory nature, HAs do carry repercussions for regulated entities. For example, some states use these levels as the basis for their own drinking water regulations. HAs are also commonly used by federal and state agencies to set remedial standards for contaminated sites. Given these repercussions, it is no surprise that EPA’s interim and final HAs have already seen industry pushback. Once the EPA issues its Safe Drinking Water Standard for these PFAS, the regulatory framework will change, and the levels will be enforceable.
Third, EPA added risk-based screening levels for PFOA, PFOS, perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS), and GenX to its Regional Screening Level (RSL) and Removal Management Level (RML) lists. These PFAS joined PFBS, which was originally listed in 2014. Although the RSL and RML are not cleanup standards, EPA uses these levels to determine whether further action at a site is necessary. The RSL and RML are certain to increase environmental and legal jeopardy for companies that used or manufactured these five PFAS at past, current, and future superfund sites.
Fourth, EPA issued its proposed rule to eliminate the Trump-era rule exempting de minimis releases of certain PFAS from the Toxic Release Inventory (TRI) reporting requirement. The Trump-era rule—which is the rule currently on the books—allows facilities using any of the 180 PFAS on the TRI to forgo reporting requirements if their mixtures or products contained less than 1% concentration of a listed PFAS. For PFOA, however, the concentration limit is set at .1%. The proposed rule eliminates this exception by proposing to list all 180 PFAS on the TRI list as chemicals of special concern, rendering such PFAS ineligible for the de minimis exception. EPA seeks to eliminate this exception because, in its view, too “many facilities contacted claimed the de minimis exemption as a reason for not reporting.” Therefore—by design—EPA’s proposed rule will increase reporting requirements and regulatory scrutiny for companies that use any of the 180 PFAS on the TRI list.
EPA is not the only agency that took significant actions on PFAS in 2022. As a part of the Biden-Harris Administration’s “whole-of-government” effort to address PFAS, several agencies joined EPA in using their regulatory might to restrict the use of PFAS. Some examples include: (1) the Food and Drug Administrations’ testing of PFAS in the food supply, including voluntary recalls of canned clams from China due to PFOA; (2) the Department of Homeland Security’s initiative to investigate and remediate PFAS, including an inventory of PFAS use and prior releases at its facilities; (3) the Federal Aviation Administration’s elimination of the use of firefighting foam containing PFAS for training purposes; and (4) and the Department of Energy’s PFAS Strategic Roadmap.
Collectively, EPA’s actions over the last year—as well as its actions prior to 2022—create an environment of increased regulatory scrutiny and compliance costs. One estimate suggests that the CERCLA designation alone could cost regulated entities over $700 million annually. Greater scrutiny and costs, however, are not the only effects of EPA’s actions. The risk of litigation and the accompanying liability over PFAS—especially for historic users of PFAS—continues to grow at an increasing pace. For example, DuPont, Corteva, and Chemours have jointly committed $4 billion dollars to cover the liabilities associated with their past use of PFAS chemicals.
The liability arising from the ever-growing regulatory web around PFAS may cause companies to consider whether to follow 3M out of the PFAS business. Late in 2022, 3M announced that it would exit the PFAS manufacturing business and end the use of PFAS in its products by the end of 2025. 3M’s decision to exit the PFAS market resulted—at least in part—on the EPA’s regulatory emphasis on PFAS, especially in drinking water. Although 3M’s decision caused a stir, it is a reasonable one given that it has been plagued by its PFAS liabilities for years. One analysis has identified at least 3,508 lawsuits against 3M over its PFAS products dating back to 2015. Some of these suits have produced gigantic settlements. In 2018, for example, 3M settled a lawsuit brought by the State of Minnesota over its PFAS discharges into the environment around the Twin Cities for $850 million. More recently, in 2022, 3M entered into an Administrative Order on Consent to address PFAS contamination found in drinking water in the vicinity of 3M’s Cordova, Illinois facility and agreed to take actions around one of its facilities in Belgium that could cost up to $855 million.
3M’s exit from the PFAS business will not, however, cut off its PFAS liabilities. 3M still faces thousands of claims over the use of its PFAS in aqueous firm-forming foam (or AFFF) in a multidistrict litigation based in the United States District Court for the District of South Carolina. Some estimates price 3M’s total PFAS liability between $10 to $30 billion.
An overwhelming majority of businesses using or manufacturing PFAS are not 3M. However, the 3M example shows that time and EPA’s regulatory actions work together to expand PFAS liabilities—as well as compliance costs—for those entities that have used or manufactured PFAS. Therefore, such entities should work to understand their use of PFAS and create a plan to comply with forthcoming regulations—such as effluent limitations—and minimize its potential liability for environmental contamination, personal injury, and property damage.
In the section that follows, we summarize EPA’s actions over the last year.
Summary of EPA’s Key Actions on PFAS
Key cleanup related actions
- Advance Notice of Proposed Rulemaking (NPRM) to Designate PFOA and PFOS as Hazardous Substances under CERCLA (August 2022)
On August 26, 2022, EPA issued a historic Notice of Proposed Rulemaking (NPRM) to designate PFOA and PFOS as CERCLA Hazardous Substances. This proposed rule is the first time EPA has used its authority under CERCLA Section 102(a) to designate a specific substance as a hazardous substance. The Proposed Rule will implement reporting requirements for PFOA and/or PFOS releases and will expose entities to CERCLA liability for releases of these two chemicals. The comment period ended on November 7, 2022. EPA anticipates issuing its final rule designating PFOA and PFOS as Hazardous Substances under CERCLA by August 2023. EPA may also initiate the process of designating other PFAS chemicals as CERCLA hazardous substances by the end of 2023.
- Addition of 5 PFAS to the Regional Screening Level Tables (May 2022)
EPA utilizes Screening Levels (SLs) for chemical contaminants to promote consistency at superfund sites nationwide. SLs are not cleanup standards, but instead identify contamination and inform agencies whether additional investigation or a removal action is warranted at a particular site. The Regional Screening Level (RSL) Tables contain risk-based screening levels based on the latest toxicity values and default exposure assumptions. RSLs also include risk-based Soil Screening Levels (SSLs) aimed at groundwater protection. Regional Removal Management Levels (RMLs) for Chemical Contaminants are based on the same methodology as RSLs.
On May 18, 2022, the EPA added five additional PFAS substances to the lists: PFOA, PFOS, PFNA, PFHxS, and GenX. EPA originally listed PFBS in 2014. The current screening and removal levels for PFAS chemicals are summarized in the table below:
Key drinking and clean water actions
- Interim PFOA and PFOS Health Advisory (HAs) and Issue GenX and PFBS HAs (June 2022)
Under the Safe Drinking Water Act (SDWA), EPA can issue HAs for contaminants not subject to national primary drinking water regulations when it believes that those contaminants may cause adverse health effects over time. Based on its authority under the SDWA, on June 21, 2022, EPA published its interim PFOA and PFOS HAs, revising the 2016 HAs for these chemicals and the final HAs for GenX and PFBS HAs:
- Draft Recommended Aquatic Life Ambient Water Quality Criteria (WQC) for PFOA and PFOS (May 2022)
Under the Clean Water Act (CWA), EPA must develop WQC for “determining when water has become unsafe for people and wildlife using the latest scientific knowledge.” When based on aquatic life, the WQC sets the recommended limit by identifying “how much of a chemical can be present in surface water before it is likely to harm plant and animal life” due to “short-term and long-term exposure.” EPA issues WQC through recommendations that are not considered regulations or legally binding. However—like the HAs—many states rely on EPA’s WQC recommendations to adopt their own standards.
Based on its CWA authority, on April 28, 2022, EPA issued its Draft Recommended Aquatic Life Ambient WQC for PFOS and PFOA (Draft Recommended WQC):
EPA published the Draft Recommended WQC on the federal register on May 3, 2022. The comment period ended on July 5, 2022. As of this writing, the final recommendation has yet to be issued.
- Memorandum Addressing PFAS in Federal and State Issued National Pollutant Discharge Elimination System (NPDES) Permits (April and December 2022)
Under the CWA, EPA has the authority to issue permits for the discharge of pollutants into the waters of the United States. EPA can delegate its authority to issue such permits to the states. On April 28, 2022, EPA issued its Memorandum on Addressing PFAS Discharges in EPA-Issued NPDES Permits and Expectations Where EPA is the Pretreatment Control Authority (April NPDES Memo). Several months later, on December 6, 2022, EPA issued its Memorandum on Addressing PFAS Discharges in NPDES Permits and Through the Pretreatment Program and Monitoring Programs, a companion memorandum to the April memorandum that updates that memorandum and provides guidance for states that issue federal permits (December NPDES Memo). Both memoranda detail terms that EPA seeks to include in NDPES permits to “restrict the discharge of PFAS” and allow for the collection of “comprehensive information on the sources and quantities of PFAS discharges.” These collection efforts will inform EPA’s effluent limitation guidelines, which will be issued in 2023 and 2024.
- Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) (December 2021)
Under the SDWA, EPA must issue a list of unregulated contaminants to be monitored in certain public water systems throughout the United States. The monitoring helps EPA collect occurrence data for the listed contaminants and informs its future regulatory determinations, including the development of national primary drinking water regulations.
Based on this authority, on December 27, 2021, EPA issued UCMR 5, a final agency rule. UCMR 5 requires certain public water systems (roughly 10,331 systems) to collect national occurrence data for 29 different PFAS and lithium.
EPA plans to use the occurrence data to inform its “regulatory determinations and risk-management decisions.” UCMR 5’s five-year cycle runs from January 2022 through December 2026.
Key chemical safety actions
- Removal of PFAS from Approved Inert Ingredient List for Pesticide Products (December 2022)
EPA has created a list called the Inert Ingredient List, which list all the inert ingredients permitted for pesticides used in food, rodent control, ornamental plants, fragrances, and other non-food products. Inert ingredients are substances which are not an active ingredient in a product, but rather an additive or “other ingredients.” Inert ingredients often include emulsifiers, solvents, carriers, aerosol, propellants, fragrances, and dyes.
On December 14, 2022, EPA issued a notice removing 12 PFAS chemicals from the current list of inert ingredients approved for use in pesticide products. By removing these PFAS from the Approved Inert Ingredient List, EPA prevents them from being included in pesticides. If any pesticide manufacturer wishes to use the above PFAS, it is required to submit data to EPA including information regarding the chemical’s potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity, as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative.
- Removal of Two PFAS Primarily Used in Pesticides from the Safer Choice Program (March 2022)
EPA’s Safer Choice Program certifies products that use chemicals known to have the lowest hazard compared to other chemicals to encourage the adoption of safer consumer products and to reduce, eliminate, and prevent pollution at its source. As part of EPA’s Safer Choice Program, EPA maintains a Safer Chemical Ingredients List that identifies chemicals—arranged by functional-use class—which the Safer Choice Program has evaluated and determined to be safer than other traditional chemical ingredients. Since 2012, the list has included two PFAS primarily used in pesticides.
On March 16, 2022, EPA indicated it will remove the final two PFAS from the Safer Chemical Ingredients list. Any product which had been previously certified by Safer Choice Program but contained the two final PFAS to be removed from the list, must be reformulated. Alternatively, companies who make these products can submit data to the EPA indicating why these PFAS should remain on the Safer Ingredients List.
- Proposed Rule on Changes to Reporting Requirements for PFAS and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting (December 2022)
Each year, EPA requires certain facilities to submit toxic release inventory data to the EPA via the TRI. The 2020 National Defense Authorization Act (NDAA) added certain PFAS to the list of chemicals required to be reported to the TRI in 2021. The NDAA also established a reporting threshold for PFAS, and EPA codified the NDAA provision but allowed facilities to forgo reporting de minimis PFAS concentrations (<1% concentration, except for PFOA for which the concentration was set at 0.1%.). On December 5, 2022, EPA proposed a rule to enhance the reporting of PFAS data to the TRI, which eliminated the de minimis concentrations exception. The comment period ends on February 23, 2023.
Key scientific research actions
- Develop PFAS detections methods (2018 to present)
EPA has developed detection methods for PFAS concentrations in air, water, and soil. The table below outlines the detection methods that EPA has published thus far:
- Develop PFAS-related databases (Ongoing)
EPA has developed several publicly available databases and tools related to PFAS. On January 5, 2023, EPA released its PFAS Analytic Tools webpage that provides information on PFAS across the country, including PFAS manufacturing, releases, and facilities potentially handling PFAS. On June 7, 2022, EPA launched its PFAS Treatment Database, which contains over 2,000 records from 80 sources documenting the viability of utilizing different thermal processes to treat PFAS. Other databases that have been developed over the years include EPA’s Drinking Water Treatability database, CompTox Chemicals dashboard, and ECOTOX Knowledgebase.
Key enforcement actions
- EPA’s Information Requests (January and June 2022)
EPA has authority under the Clean Water Act, CERCLA, and SDWA to issue information requests to persons and corporations to investigate the use and impact of PFAS. In January 2022, EPA issued specific information requests to several manufacturers of PFAS, including Chemours Company, Corteva, Inc., and DuPont de Nemours, Inc., asking for information on current and past PFAS production, management, and disposal practices at 24 different facilities. Based on information collected from these requests, EPA will determine its follow-up action.
On July 13, 2022, the Office of Science and Technology Policy (OSTP) issued a voluntary Notice of Request for Information from all interested parties to identify data gaps in the research and development of PFAS. EPA plans to use the comments submitted to inform a strategic plan for Federal coordination of PFAS research and development and to “(i) identify cost effective alternatives to PFAS that are designed to be safer and more environmentally friendly; (ii) methods for removal of PFAS from the environment; and (iii) identify methods to safely destroy or degrade PFAS.” Several other agencies have similarly issued information requests to manufacturers or uses of PFAS. For example, the FDA issued a request for information on the food contact uses of fluorinated polyethylene, which can be used as a chemical barrier for chemicals such as PFAS, to ensure safety.
This article is provided for informational purposes only—it does not constitute legal advice and does not create an attorney-client relationship between the firm and the reader. Readers should consult legal counsel before taking action relating to the subject matter of this article.