The rule, originally proposed in January 2023, is part of a larger effort by the Biden Administration to effectuate their PFAS Strategic Roadmap and regulate the chemicals. EPA last updated the list of PFAS subject to the TRI reporting program in July 2022.

The additional nine PFAS were added pursuant to the Fiscal Year 2020 National Defense Authorization Act (“NDAA”), which sets forth several mechanisms by which additional PFAS can be added to the list of reportable chemicals. Pursuant to the NDAA, EPA must review confidential business information (“CBI”) claims before adding PFAS to the TRI list if the chemical is subject to a claim of protection from disclosure. After review, EPA determined that the following four PFAS are no longer confidential and thus added them to the TRI:

• Alcohols, C8-16, γ-ω-perfluoro, reaction products with 1,6-diisocyanatohexane, glycidol and stearyl alc. (2728655-42-1);
• Acetamide, N-[3-(dimethylamino)propyl]-, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs. (2738952-61-7);
• Acetic acid, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs., 2-hydroxypropyl esters (2744262-09-5); and
• Acetamide, N-(2-aminoethyl)-, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs., polymers with N1,N1-dimethyl-1,3-propanediamine, epichlorohydrin and ethylenediamine, oxidized (2742694-36-4).

Additionally, the NDAA automatically adds PFAS to the TRI upon the Agency’s finalization of a toxicity value. EPA finalized toxicity values for the following chemicals in December 2022, thus adding them to the TRI:

• PFBA (375-22-4);
• Perfluorobutanoate (45048-62-2);
• Ammonium perfluorobutanoate (10495-86-0);
• Potassium perfluorobutanoate (2966-54-3); and
• Sodium perfluorobutanoate (2218-54-4)

Now, a total of 189 PFAS chemicals are subject to TRI reporting requirements. The addition of these nine PFAS is effective on January 1, 2023. Accordingly, facilities that manufacture, process or otherwise use any of these chemicals from that date forward must report releases and other waste management activities involving the substances for the 2023 reporting year (reports are due July 1, 2024). Hence, facilities should be tracking the use of these chemicals now. Required PFAS reporting for TRI Reporting Year 2022 is due on July 1, 2023.

According to the TRI Analysis, in 2021, 44 facilities reported managing 1.3 million pounds of PFAS as waste, compared to 800,000 pounds reported in 2020. While most such waste is recycled, facilities reported 108,000 pounds in releases of PFAS containing waste, significantly more than the roughly 20,000 pounds of releases reported in 2020. Unsurprisingly, the hazardous waste management sector accounted for nearly 80 percent of these releases, primarily through regulated landfills, and the boost is largely attributable to one facility. Direct releases to the environment are a fraction of the reported numbers.

The spike in these numbers is likely attributable to updated reporting requirements required by the 2020 National Defense Authorization Act, which mandated PFAS reporting starting in 2021 (for the 2020 reporting year). Specifically, new reporting requirements under this Act included the addition of four PFAS to the list of 172 PFAS reported for 2020. EPA admits in the Analysis that the increase in PFAS managed as waste in 2021 is primarily due to reporting for one PFAS, perfluorooctyl oxide, one of the four chemicals added to the list for 2021.

In the Agency’s Press Release, EPA opines that

“Because PFAS are used at low concentrations in many products, this rule [to eliminate the de minimis exemption] would ensure covered industry sectors and federal facilities that make or use TRI-listed PFAS will no longer be able to rely on the de minimis exemption to avoid disclosing their PFAS releases and other waste management quantities for these chemicals.”

It certainly appears that EPA is poised to eliminate the exemption in its anticipated final rulemaking on the matter.

Many industry stakeholders, however, emphasize that the de minimis exemption is necessary to make the TRI program more workable in practice by limiting the need for reporting entities to hunt for information on miniscule amounts of substances that generally pose little to no risk.

If adopted, the proposed National Primary Drinking Water Regulation (NPDWR) would set legally enforceable individual Maximum Contaminant Levels (MCLs) for two of the best known PFAS compounds, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), at 4.0 parts per trillion (ppt). 4.0 ppt is understood as the current laboratory detection limit for PFOA and PFOS, and signals that EPA intends for the limits to be set at the most stringent possible level. If adopted at 4.0 ppt, the MCLs for PFOA and PFOS would be the most restrictive in the nation, and states and U.S. territories will be required to adopt MCLs at or below the same standard within two years.

EPA also proposes using a risk-based standard for mixtures of four additional PFAS compounds in drinking water: perfluorohexane sulfonic acid (PFHxS), hexafluoropropylene oxide dimer acid (HFPO-DA) and its ammonium salt (also known as a GenX chemicals); perfluorononanoic acid (PFNA); and perfluorobutane sulfonic acid (PFBS).^[1] For these compounds, the regulation would require use of a formula to determine if any mixture of these chemicals in drinking water, taken together, has a “Hazard Index” (HI) score of 1.0 or greater, which indicates potential risk of adverse health effects.

To understand how all three of these proposed standards would impact their operations, public water systems should immediately review past sampling results to determine whether they exceed the proposed limits. Public water systems should also begin planning and evaluating costs to comply, despite the lack of an immediate deadline to do so, with the proposed standards.

SDWA also requires the Administrator of the EPA to propose a maximum contaminant level goal (MCLG) simultaneously with the NPDWR.^[2] The MCLG is a non-enforceable public health goal that represents a level at which no known adverse health effects are expected to occur. Because EPA determined PFOA and PFOS are likely carcinogenic to humans, the agency proposes MCLGs of 0.0 ppt. The proposed MCLG for any mixture of PFNA, PFHxS, PFBS, and GenX Chemicals is HI 1.0.

The proposed rule is the latest in a series of actions EPA is taking to address PFAS pollution. In March 2021, pursuant to its “PFAS Strategic Roadmap: EPA’s Commitments to Action,” EPA issued a final determination to regulate PFOA and PFOS as contaminants under SDWA. As mandated by SDWA, the proposed rule comes 24 months after determination.^[3] Once published in the Federal Register, the public will have the opportunity to provide verbal or written comments to EPA on the proposed rule.^[4] Following the public comment period, EPA expects to issue the final regulation by the end of 2023. It is important for any entity that seeks to modify or influence the proposed standards to fully participate in EPA’s administrative process.

If adopted, in concert with EPA’s pending proposed rule to list PFOA and PFOS as hazardous substances under the federal Comprehensive Response, Compensation, and Liability Act (CERLCA), the MCLs for PFOA and PFOS may be expected to be adopted into remedial actions performed pursuant to CERCLA. In addition, in states and/or U.S. territories that employ federal and state MCLs as a driver for remediation cleanup standards, EPA’s promulgation of the MCLs for PFOA and PFOS may affect remedial activities required under state environmental remedial programs, such as state equivalents of CERCLA.

EPA is authorized to promulgate an NPDWR under SDWA based on its determination that these six PFAS may have adverse health effects, occur in public water systems with a frequency and at levels of public health concern, and that, in the sole judgment of the Administrator, their regulation presents a meaningful opportunity for health risk reduction for persons served by public water systems.^[5] EPA anticipates that, if fully implemented, the rule will prevent thousands of deaths and reduce tens of thousands of serious PFAS-attributable illnesses.

[1] In the proposed rule, EPA issues a preliminary regulatory determination to regulate PFNA, PFHxS, PFBS, and GenX Chemicals.

[2] SDWA 1412(a)(3); 42 U.S.C. 300g-1(a)(3).

[3] SDWA 1412(b)(1)(E); 42 U.S.C. 300g-1(b)(1)(E).

[4] EPA, in its proposal, specifically requests comment on whether water systems should be permitted to apply to the relevant state agency for monitoring waivers and whether the identification of possible alternatives to traditional vulnerability assessments should be considered to identify risk.

[5] SDWA 1412(b)(1)(A); 42 U.S.C. 300g-1(b)(1)(A).

When the 2021 TRI data were published last year, those following the ever evolving world of PFAS were initially surprised to see such a small PFAS presence represented. Indeed, of the 75,890 total entries reported to TRI for all chemicals in 2021 (from nearly 21,000 facilities), EPA received merely 92 PFAS reporting forms on 46 different PFAS from 45 facilities. This information seems even more jarring considering that approximately 650 PFAS are currently in commerce (though only 172 are currently subject to TRI reporting) from about 120,000 facilities.

The reason for this gap was the vast employment of an aptly named “de minimis” exemption, a long-standing TRI policy that allows facilities to ignore amounts of substances in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens). The Agency has signaled since 2020 that it planned to do away with the exemption for PFAS, and the December 5 proposal follows through on that pledge.

In announcing the rule, EPA asserted that it “would ensure that covered industry sectors and federal facilities that make or use TRI-listed PFAS will no longer be able to rely on the de minimis exemption to avoid disclosing their PFAS releases and other waste management quantities for these chemicals.”

By removing this reporting loophole, we’re advancing the work set out in the Agency’s PFAS Strategic Roadmap and ensuring that companies report information for even small concentrations of PFAS. We will make this information available to the public so EPA and other federal, state and local agencies can use it to help best protect health and the environment.

EPA Administrator Michael Regan

The Agency and several environmental organizations have argued in the past that the so-called “reporting loophole” of the de minimis exemption allows facilities to avoid reporting releases of potentially significant amounts of TRI-listed chemicals, thereby diminishing public trust, obfuscating transparency, and keeping community members in the dark about chemicals they believe to be hazardous to human health. The Sierra Club alongside other organizations, for example, have sued EPA claiming that the exemption is not statutorily permitted. The case, National PFAS Contamination Coalition, et al. v. EPA, is currently pending in the United States District Court for the District of Columbia.

However, as pointed out by the reporting community of industry stakeholders, the de minimis exemption helps make the TRI program more workable in practice by limiting the scope of substances for which reporting is required and not requiring companies to chase down information on miniscule amounts of substances present at trace quantities that generally pose little to no risk.

For certain chemicals of “special concern” – such as mercury, dioxins, lead, and other “persistent, bioaccumulative, and toxic” substances – EPA previously has eliminated availability of the exemption, as well as the TRI short-form (Form A) reporting option. The proposed rule would add PFAS to the category of chemicals of “special concern.”

In order to ensure that downstream users are informed of the presence of “special concern” chemicals in mixtures and products they purchase, the proposed rule also would make the exemption unavailable for supplier notification requirements.

Released on October 11th, the paper, “Presumptive Contamination: A New Approach to PFAS Contamination Based on Likely Sources” (published in Environmental Science & Technology Letters), aims to fill existing data gaps by positing that

[I]n the absence of high-quality data to the contrary, PFAS contamination is probable near facilities known to produce, use, and/or release PFAS, and to protect public health, the existence of PFAS in these locations should be presumed until high-quality testing data is available.

(1) Fluorinated aqueous film-forming foam ("AFFF") discharge sites: military sites, airports, firefighting training sites, and "high-hazard flammable liquid fire" sites such as those associated with oil and gas extraction, petroleum refineries, bulk storage facilities, and chemical manufacturing, as well as railroad crashes.

(2) Industrial facilities that produce or use PFAS: Identified largely through the limited scope of facilities that reported PFAS use under the U.S. Environmental Protection Agency ("EPA") Toxic Release Inventory ("TRI") program.

(3) Sites related to PFAS-containing waste: Including PFAS-contaminated effluent and sludge from wastewater treatment plants ("WWTPs"), as well as solid waste disposal sites.

The authors note that "State and federal agencies can use a presumptive contamination approach to identify and prioritize locations for monitoring, regulation, and remediation."

The information from this study is particularly notable on the heels of EPA's August 2022 proposal to add two PFAS chemicals (PFOA and PFOS) to the list of hazardous substances under the Superfund program. Clearly, the magnitude of PFAS contamination in the United States is extraordinary, and raises the potential for thousands of clean up actions (and regulatory enforcement) at sites across the country.

This is the second year that PFAS, known more colloquially as the “forever chemicals” due to their persistence and years-long degradation process, have made an appearance on the TRI, a publicly available database containing information on toxic chemical and waste management activities in the U.S. Their inclusion is relatively new, only being added to the TRI by the 2020 National Defense Authorization Act (“NDAA”).

The information filed for 2021 indicate that the 45 facilities managed over 1.3 million pounds of production-related PFAS waste during the year. These numbers seem odd given that approximately 650 PFAS are currently in commerce (though only 172 are subject to TRI reporting) from about 120,000 facilities that involve merely the handling and/or potential release of PFAS. Though you should seldom trust your lawyers with math, we can confidently say here that these numbers are just not adding up.

The explanation for this gap, though, is simple. The rules allow facilities to disregard certain levels of listed toxic chemicals in mixtures or products that they use. Under this aptly named “de minimis” exception, facilities are not required to report to the TRI certain minimal concentrations of chemicals in the materials they process. Though PFAS are persistent, their quantities in products are often below the de minimis reporting threshold.

EPA has signaled on several different occasions that they intend to eliminate the de minimis exception for PFAS in a forthcoming rulemaking. First, in the Agency’s October 2021 PFAS Strategic Roadmap, EPA stated its intent to categorize PFAS as a “Chemical of Special Concern,” thereby removing its eligibility for de minimis status. Just a few months ago, EPA signaled how it might go about doing that. When EPA published the 2021 TRI dataset last week, it again indicated that it “plans to enhance PFAS reporting under the TRI by proposing a rulemaking this fall that would, among other changes, remove the eligibility of the de minimis exemption for PFAS. If finalized, this proposal would also make unavailable the de minimis exemption with regard to providing supplier notifications to downstream facilities for PFAS and certain other TRI chemicals.” Just three weeks ago, EPA added five new PFAS to the TRI as well.

Indeed, the heat is on for EPA to act on PFAS. The Agency is making $1 billion available in grant funding to help communities struggling with PFAS contamination, and has recently updated its Health Advisories on four PFAS chemicals commonly found in drinking water, food packaging and cosmetics. That money comes from the Infrastructure Investments and Jobs Act, which in total, authorizes $5 billion for the Agency to reduce PFAS in environmental justice communities. This newfound financial support, combined with Congressional interest and widespread public scrutiny, all support the Agency’s move towards expanding PFAS reporting requirements and, more generally, the Agency’s aggressive stance towards mitigating PFAS.

It certainly appears that the days of PFAS eligibility under the de minimis exception are coming to a close. And, with that, we can expect a dramatically expanded TRI report in coming years.

The NDAA set forth several mechanisms by which additional PFAS were to be added to the TRI list of reportable chemicals, including issuance of a final toxicity value or significant new use rule ("SNUR") for a substance, or addition of a PFAS substance to the "active" TSCA Inventory. Pursuant to that authority, EPA added the following three chemicals to TRI based on adoption of a final toxicity value in April 2021:

• Perfluorobutane sulfonic acid (“PFBS”) CASRN 375-73-5)
• Perfluorobutanesulfonate (CASRN 45187-15-3)
• Potassium perfluorobutane sulfonate (CASRN 29420-49-3)

For these four PFAS, first TRI reports will be due to EPA by July 1, 2023, for calendar year 2022 data.

A fifth PFAS -- another with an extra-long chemical name (CASRN 65104-45-2) -- was added to the TRI list as it was determined to be covered by a SNUR issued in July 2020 for long-chain PFAS. Oddly, because the chemical met the terms of a 2020 SNUR, this PFAS was deemed to be "officially" added to the TRI list as of January 1, 2021, meaning that it was subject to reporting for the 2021 calendar year (reports that were due July 1, 2022). EPA does not address if it actually expected a facility to report by this past July 1 for a chemical not added publicly to the TRI list until issuance of a rule that becomes effective August 17, 2022.

The TRI listings are the latest in an ever-growing range of Agency actions to address PFAS. It is clear that the list of TRI-reportable PFAS will steadily expand as EPA continues to issue SNURS and finalize more and more toxicity values. The Agency has recently issued updated Health Advisories for four PFAS chemicals commonly found in drinking water, cosmetics and food packaging, and is also making $1 billion available in grant funding to help communities dealing with PFAS contamination. The grant money is allocated through the Infrastructure Investments and Jobs Act, which in total, authorizes $5 billion for the Agency to reduce PFAS in drinking water in communities facing disproportionate impacts of water contamination. This, combined with increased Congressional support and heightened public attention to PFAS and environmental issues in general, positions EPA deftly for more opportunities to address PFAS.

In a decision issued the final day of the Supreme Court’s 2022 term, the Court sided with West Virginia and other States that had challenged the Environmental Protection Agency’s (“EPA’s” or “the Agency’s”) ability to regulate greenhouse gases. The Court’s decision limits EPA’s authority pursuant to the Clean Air Act (“CAA”), which as discussed below, may implicate changes to executive branch agencies’ ability to regulate more broadly.

Preliminary Challenges in the District Courts Regarding the EPA’s Authority Pursuant to the Clean Air Act

This case arises from differing interpretations of a section of the Clean Air Act—Standards of Performance for Existing Sources—that gives the EPA the authority to adopt regulations “under which each State or tribe shall submit to the [EPA] a plan which,” in part “establishes standards of performance for any existing source[s]” that “contribute[] significantly to . . . air pollution which may reasonably be anticipated to endanger public health or welfare.”[1]

Pursuant to this section of the CAA, in 2015 the Obama Administration issued the Clean Power Plan (“CPP”), which established national carbon-dioxide emission rate requirements for coal- and gas-fired plants.[2] These limits could only be met through the use of outside-the-fenceline emissions reductions measures, such as transitioning to renewable energy. The CPP then gave States and tribes some flexibility to create their own plans for adopting enforceable emissions limits so long as State-wide emissions complied with the CPP’s State-specific emission caps.

In October of 2015, West Virginia filed suit in the U.S. Court of Appeals for the D.C. Circuit (“D.C. Circuit”) against the EPA to halt implementation of the plan.[3] In February of 2016, in a very rare move, the Supreme Court stayed the implementation of the CPP while it was still under review by the D.C. Circuit.[4] Then, in 2018, while the challenges to the CPP were still pending, the Trump Administration adopted the Affordable Clean Energy Act (“ACE”), which effectively repealed the CPP.[5] ACE required less stringent emissions reduction ranges than the CPP. These limits were based on inside-the-fenceline controls which were usually already being met by plants through market-based switches from coal to natural gas. ACE also extended the deadlines for State compliance with emissions’ standards.

Between 2020 and 2021, environmental groups, States, power utilities, trade associations for renewable energies, and coal mine operators challenged ACE in the D.C. Circuit.[6] Petitioners that included environmental groups challenged ACE’s failure to enact more stringent emissions limits based on outside-the-fenceline emissions reductions and trading. Industry groups and States—including West Virginia and 18 other States—questioned whether Congress, through this provision of the CAA, had given EPA the authority to issue rules “capable of reshaping the nation’s electricity grids and unilaterally decarbonize[e] virtually any sector in the economy.”[7] On January 19, 2021, the day before President Biden’s inauguration, the D.C. Circuit vacated the ACE rule and remanded the rule to the Agency. The court held that the CPP was permissible under the CAA because the outside-the-fence controls only informed the stringency of the CPP’s emissions limits but did not restrict States from adopting alternate approaches to meet the CPP’s proscribed limits. Moreover, the court found that ACE’s longer deadlines for federal and state compliance were “arbitrary and capricious,” and therefore, unlawful pursuant to the Administrative Procedure Act.

Arguments Before the Supreme Court

West Virginia and others petitioned the Supreme Court for certiorari of the D.C. Circuit’s decision in April 2021, and on October 29, 2021 – in the midst of the Biden EPA’s efforts to promulgate a replacement for the ACE and CPP rules – the Court granted certiorari. Among West Virginia’s arguments, was that the CPP’s approach amounted to an improper assertion of EPA jurisdiction over power generation and transmission policy, and that EPA’s ability to control the nation’s energy policy through GHG gas regulations would have vast economic and political impacts that implicate a legal doctrine known as the “major questions doctrine.”[8]

The EPA argued that the CPP did not require outside-the-fenceline controls, it merely based the stringency of the State emissions limits on those controls.[9] Per the Agency, even though emissions trading is common in the power sector, States were free to adopt whatever compliance methods they wanted to ensure compliance with the CPP’s proscribed limits. In other words, the agency was not requiring a certain method of operation. The flexibility given to the States, the EPA argued, meant that the Court’s review was not governed by the major questions doctrine. The Agency further pointed out that in 2019, the power sector largely achieved the emissions limitations included in the CPP on their own without enacting major industrial changes. Therefore, EPA reasoned, the CPP’s limitations did not have large practical consequences that would trigger the major questions doctrine.

The Supreme Court’s Decision

In a 6-3 ruling with Justice Roberts writing for the majority, the Supreme Court held that the CAA does not grant EPA authority to set nationwide emissions guidelines for GHGs that would “force a nationwide transition away from the use of coal.” Pointing to the major questions doctrine, the Court reasoned that the EPA, through the CPP, had asserted jurisdiction over national energy policy generally by effectively prescribing the means of power generation rather than setting emissions limits that individual power generating facilities could achieve using inside-the-fenceline measures. This broad reshaping of national energy policy from higher emitting sources to lower-emitting or renewable sources would have large-scale political and economic impacts that were not clearly authorized by Congress in the CAA. Thus, while the CAA confers EPA authority to regulate GHG emissions, it does not grant the EPA authority to reshape national energy policy toward lower-emitting or renewable energy sources. The Court found it unlikely that Congress would leave such a significant decision to the EPA’s discretion through the vague and ambiguous CAA text that the EPA cited as its authority for the CPP. The Court did not rule on whether the EPA can regulate emissions outside-the-fenceline, leaving that question open for debate.

Implications

This decision further establishes the current Court’s skepticism towards agencies citing longstanding statutes as the bases for significant new regulatory authority. Justice Kagan, in dissent, criticized the majority for “announc[ing] the arrival” of the major questions doctrine.[10] While often implied in decisions rejecting agencies’ jurisdictional claims, this doctrine has never before been explicitly used by the majority to justify a holding. Because so many rules and policy changes – environmental or otherwise – are now undertaken by executive branch agencies using long-existing statutory authority, and not through Congress’ conferral of new statutory authority to agencies, the Court’s reliance on the major questions doctrine could portend further limits on other executive agency rules.

This decision, while limited to the CAA provision on which EPA claimed authority for the CPP, will plainly require the EPA to substantially rework its approach to addressing GHG emissions from power plants, which in 2020 contributed 25% of all national GHG emissions. The decision also poses implications for the Biden-Harris Administration’s climate change agenda more broadly. While the Supreme Court in Massachusetts v. EPA confirmed that the CAA gives EPA authority to regulate GHGs, it did not decide that the EPA could do so through any means.[11] Given that Congress last amended the CAA in 1990 and is unlikely to do so again anytime soon, other GHG regulations that the EPA may attempt to promulgate could raise similar questions about the breadth and scope of authority Congress delegated in the CAA decades ago. Additionally, the Court’s reliance on the “major questions doctrine” may provide a basis for aggressive challenges to any significant federal agency action based on long-held statutory authority.

Summer associate Sophie Miller assisted in the preparation of this post.

In the last two weeks, the Environmental Protection Agency (“EPA”) has taken two major steps forward on its regulation of the “forever chemicals,” per- and polyfluoroalkyl substances (“PFAS”), to advance implementation of its PFAS Roadmap, released in October 2021. Specifically, EPA (1) established drinking water health advisory limits for four widely-studied PFAS; and (2) issued an order requiring manufacturers of a particular PFAS to conduct studies of that PFAS, or provide specified toxicity data.

The PFAS Roadmap set out a three-pronged approach to their regulation: First, research the chemicals and their exposure pathways; Second, restrict PFAS output through regulation; and Third, require remediation of PFAS contamination. (For an overview of the PFAS Roadmap, see: EPA Plan Changes PFAS Outlook for Companies, Regulators.)

Exposed communities, manufacturers, owners of affected properties, drinking water suppliers and state agencies should all take note of EPA’s progress, as it directly impacts the ongoing efforts to fill the scientific gap, stop exposure pathways, and clean up the large swaths of natural resources—including drinking water—that have suffered PFAS-related impacts.

Set Health Advisory Levels for Certain PFAS

In perhaps the most significant step EPA has taken to regulate PFAS thus far, on June 15, 2022, EPA issued drinking water health advisories for four PFAS. Health advisories are not enforceable limits, but serve to inform state and federal regulators of the concentration at which detrimental health effects will occur, whether for chronic or short-term exposure, and will be used as the basis for EPA’s establishment of enforceable standards. EPA is expected to propose enforceable drinking water standards, known as Maximum Contaminant Levels (“MCLs”) under the federal Safe Drinking Water Act, by the end of 2022, with a final rulemaking expected by the end of 2023.

A 2016 health assessment of PFOS and PFOA, both legacy PFAS, set a health advisory at a combined level of 70 ppt.[1] The recently revised interim health assessments, based upon a review of toxicity studies, are orders of magnitude lower: 0.004 ppt for PFOA and 0.02 for PFOS. These updated health advisories for PFOA and PFOS have lowered significantly based on epidemiological human studies showing that the most sensitive non-cancer effect for PFOA and PFOS was suppressed vaccine response in children. While EPA has indicated that PFOA is likely a human carcinogen and PFOS is a suspected human carcinogen, it is continuing to evaluate cancer risk concentrations, so the published interim levels are not intended to indicate safe levels for cancer risk at this time. Due to their classification as a suspected and likely human carcinogen, however, the drinking water MCL will likely be set at the detection limit of 4 ppt.[2]

Final health assessments for two next-generation PFAS—Gen X and PFBS—have been set at 10 ppt for GenX and 2,000 ppt for PFBS. These assessments were based on mice studies that indicated health effects for GenX, including effects to the liver, kidney, immune system, development, and cancer; and health effects for PFBS, including the thyroid, reproductive system, developing fetus, and kidneys. Cancer risk concentration, while cancer from oral exposure of GenX is suggested, has also not been established for GenX or PFBS.

Issued TSCA Order to Research PFAS

While PFOA, PFOS, GenX and PFBS, have peer-reviewed science on which to base health advisories, EPA is also looking to expand scientific data on less-studied PFAS, and issued an order requiring companies to undertake those studies. On June 6, 2022, EPA issued an order (the “Order”) to four manufacturers[3] of a particular PFAS chemical—a surfactant used in fire-fighting foam and floor finishes, ordering that they test or provide testing information regarding the chemical. Consistent with EPA’s PFAS Roadmap that laid out a national PFAS testing strategy aimed at developing a greater understanding of PFAS, in furtherance of developing protective regulations, this is the first such order EPA has issued regarding PFAS.

In issuing this Order, EPA relied on its authority under Section 4(a)(2) of the Toxic Control Substances Act (“TSCA”), which is the law that provides EPA the authority to regulate the manufacturing of chemical substances and mixtures. The Order concerns the PFAS 6:2 Fluorotelomer sulfonamide betaine (“6:2 FTAB”) and the named manufacturers include The Chemours Co., DuPont de Nemours, Inc., National Foam, Inc., and Johnson Controls, Inc. The Order specifically directs the recipients to provide testing on (1) the physical-chemical properties of 6:2 FTAB and (2) the health effects associated with inhalation of the chemical.

EPA chose 6:2 FTAB for testing because of the amount manufactured each year and its similarity to other untested PFAS. A large volume of 6:2 FTAB is manufactured each year, thereby potentially exposing a significant number of workers to the chemical. Based on what EPA does know about 6:2 FTAB, the results of the toxicity data it receives may provide a better “understanding of the human health effects of 503 additional PFAS with similar structures . . . .”[4] This Order is just the first in a series of testing orders EPA plans to issue in the coming months. There are twenty-three additional PFAS that EPA identified as needing additional toxicity data and having a known manufacturer it could look to for that data.

Next Up on EPA’s PFAS Roadmap

EPA still has a number of actions coming out this year on PFAS, including:

Summer 2022	Continued meetings being held by the Office of Management and Budget on the proposed rule to designate PFOA and PFOS as hazardous substances under RCRA and CERCLA; and Initiate first national study of PFAS in fish tissue in U.S. lakes.
Fall 2022	Publish a proposed rule to establish a national primary drinking water regulation for PFOA and PFOS; Publish multi-laboratory validated analytical method for 40 PFAS; Complete studies on PFAS discharges in the following industries: electrical and electronic components, textile mills, and landfills; and Evaluate mitigation options for PFAS air emissions.
Winter 2022	Finalize new PFAS reporting under TSCA Section 8; and Reduce PFAS discharges by including limits in Clean Water Act permits.

The most recent actions—publishing health assessments and ordering further study—are on track with EPA’s plan to regulate thousands of PFAS chemicals. Despite the individual actions taken on particular PFAS, EPA will likely take a categorical approach to regulation moving forward. The announcement this week of health assessments for PFOS and PFOA at just a small fraction of the prior levels is an indicator of drinking water MCLs at detection limits, and continued toxicity testing outcomes indicating significant health effects in humans.

Communities impacted by contaminated water that previously fell below the thresholds needed under various agreements to qualify for bottled water may now be eligible to receive bottled water. Companies involved with manufacturing PFAS chemicals anywhere in their product lines should consider whether to phase out use of the chemicals and evaluate remediation exposure before they are named responsible parties. And states and municipalities dealing with widespread contamination of their natural resources should consider assessing their damages at the currently feasible detection limits, as regulatory levels will be equal to or approaching such limits, and should store samples for further testing as analytical methods improve.

While PFAS are subject to a lower reporting threshold (100 pounds per year) than most other TRI-listed substances (the typical thresholds are 25,000 pounds for manufacturing and processing activities, and 10,000 pounds for "otherwise use"), the de minimis exemption allows facilities to disregard certain minimal concentrations of the chemicals in the materials they process. In adding PFAS to the TRI list in June 2020, EPA retained the availability of the de minimis exemption for PFAS — which is 0.1% for perfluorooctanoic acid (PFOA) (due to its cancer classification), and 1% for all other PFAS. Accordingly, the quantity of PFAS in mixtures that contain less than the de minimis concentration do not need to be counted towards the reporting threshold or in release calculations.

Because PFAS are used at low concentrations in many products, the elimination of the de minimis exemption will result in a more complete picture of the releases and other waste management quantities for these chemicals.

- U.S. EPA Press Release, March 3, 2022

Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) requires facilities that manufacture, process or otherwise use TRI-listed chemicals to file annual reports (by July 1) with EPA providing details about their pollution prevention and waste management activities, including releases, of TRI chemicals during the prior calendar year. In June 2020, EPA officially added 172 PFAS to the list of chemicals reportable each year under the TRI program, with subsequent additions to that list, including four new listings in January 2022 for perfluorobutane sulfonic acid (PFBS), potassium perfluorobutane sulfonate, and two chemicals named only by their numeric chemical identifiers: Chemical Abstracts Service registry number (CASRN) 203743-03-7 and CASRN 65104-45-2.

The first reports for PFAS were filed with EPA by the July 1, 2021, deadline for the 2020 reporting year.

EPA's summary report of the 2020 TRI data states that 38 facilities reported for PFAS activities during 2020, managing 800,000 pounds of the chemicals with 9,000 pounds released. Predictably, half of the reports were filed by the chemical manufacturing industry sector, with 11 others from the hazardous waste management sector. The reports addressed 43 different PFAS, most commonly PFOA, perfluorooctanesulfonic acid (PFOS), and hexafluoropropylene oxide dimer acid (HFPO-DA). Of the quantities of PFAS released, over 90 percent were disposed of on site (55%) or transferred off site for disposal (36%), and, therefore, not directly released to the environment. Nine percent of reported "releases" were in the form of water discharges (5%) and air emissions (4%).

A copy of EPA's 2020 TRI National Assessment Report is available on the agency's website.

Originally finalized this past January, the PBT rules immediately drew widespread criticism, particularly with regard to PIP (3:1) and the broad prohibition on the processing, import, and other distribution in commerce of components and products containing the substance, initially scheduled to come into effect on March 8, 2021. PIP (3:1) is a widely used plasticizer and flame retardant that is present in a wide range of components, particularly electronics including cell phones, laptop computers, wiring harnesses, and other equipment used across a broad spectrum of industries. With only limited exemptions in the current PBT rule, many companies were faced with a major compliance dilemma that could prevent access to and import of critical parts or materials. In response, EPA adopted a "no action assurance" policy that paused enforcement of certain provisions of the PIP (3:1) rule for six months. In September, EPA further extended the enforcement pause until March 8, 2022.

Now, EPA is proposing a further extension until October 31, 2024 of the compliance deadline for the provisions related to PIP (3:1) in articles.

EPA is proposing to further extend the compliance dates related to articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) to ensure supply chains for key consumer and commercial goods are not disrupted.

- EPA Press Release, October 21, 2021

The latest proposed rule seeks to further extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, along with associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles.

In the proposal, EPA describes specific kinds of information the agency is seeking to support finalizing the proposed compliance date extension, including:

• Specific uses of PIP (3:1) in articles throughout their supply chains;
• "Concrete steps taken" to identify, test, and qualify substitutes for those uses;
• Specific product certifications that would require updating (such as flammability standards);
• An estimate of the time that would be required to remove the substance; and
• Documentation of specific needs for replacement parts, including the service life of the equipment and the identification of any applicable regulatory requirements for the assurance of replacement parts.

The provisions of the January 2021 rules remain in effect while EPA works on the new rulemaking effort, with the exception of PIP (3:1) as noted above.

Further information on the proposed PIP (3:1) rulemaking is available at EPA's website.

Last June, EPA issued an initial list of 160 PFAS for inclusion in the TRI program pursuant to a mandate in the National Defense Authorization Act for Fiscal Year 2020 ("NDAA"). The NDAA also requires addition to the TRI list of PFAS that subsequently are the subject of other agency actions, such as a Toxic Substances Control Act (TSCA) significant new use rule (SNUR), designation as an active TSCA substance, or agency adoption of a final toxicity value. The three new PFAS each were included within the scope of a June 2020 SNUR.

Based on the NDAA criteria, it is expected that EPA soon will add perfluorobutane sulfonic acid (PFBS) to the TRI list, after the agency released an updated toxicity assessment for the substance in April. EPA's regulatory agenda anticipates further expansion of the TRI PFAS list in the future.

The internal EPA planning document (recently obtained and released by Inside EPA) includes a number of noteworthy changes under consideration, though lacks additional explanation or detail, including:

• "Develop option for annual CDR reporting for priority chemicals": CDR currently requires manufacturers and importers of chemicals to report on-site production and downstream use and exposure information to EPA every four years. It is unclear whether the plan refers to (as some accounts have suggested) "optional" facility reporting on an annual basis or -- more likely in this author's view -- development of a rulemaking "option" for OPPT to establish mandatory annual CDR reporting for certain chemicals of high interest;
• Expansion of TRI reporting to additional industry sectors, including, specifically, Natural Gas Processing;
• Expanding the list of PFAS chemicals subject to TRI reporting; and
• Enhanced CDR and TRI data analysis to support environmental justice (EJ) and TSCA chemical prioritization initiatives.

In keeping with the Biden Administration's focus on environmental justice, the plan alludes to a greater emphasis on utilizing the CDR/TRI data to identify underprivileged communities (e.g., "conduct TRI/EJ mapping projects") and the chemicals that pose heightened risks to those communities.

A copy of the OPPT strategic plan is available here.

The five chemicals subject to the PBT rules include:

• Phenol, isopropylated phosphate (3:1) (PIP (3:1))
• Decabromodiphenyl ether (DecaBDE)
• 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)
• Hexachlorobutadiene (HCBD)
• Pentachlorothiophenol (PCTP)

With the prohibition entering into effect on March 8, and only limited exemptions in the current rule, many companies were faced with a major dilemma in that compliance could prevent access to and import of critical parts or materials.

Stakeholders note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging. They assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles. It was not EPA’s intent during the development of the rule to have such a broad disruptive impact.

- U.S. EPA Press Release, March 8, 2021

In addition, EPA is initiating a 60-day comment period seeking input on both the PIP (3:1) compliance issues and whether the PBT rules sufficiently reduce exposure to the five chemicals, with a particular re-examination of exposures to potentially exposed or susceptible subpopulations, and the environment, and whether additional or alternative measures should be considered.

The EPA press release, with links to additional information, is available here.

While EPA has long prioritized enforcement of the rules governing antimicrobial products (disinfectants and the like), the current pandemic has elevated that focus substantially, particularly against products that claim or suggest effectiveness in fighting coronavirus and other microbes. Some of the more high-profile actions over the last year have targeted on-line sales of products (often imports) that are not registered with EPA to make antimicrobial claims, as required by the Federal Insecticide Fungicide and Rodenticide Act (FIFRA).

In a January 2021 update to a COVID-related compliance advisory first issued in May 2020, EPA reiterated its aggressive enforcement stance, with an emphasis on internet product sales:

EPA is receiving a steady stream of tips/complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices. These tips and complaints are being actively reviewed and efforts are being made to identify violative products. EPA intends to pursue enforcement against products making false and misleading claims regarding their efficacy against the coronavirus. EPA is particularly concerned with pesticide and pesticide device products sold online on e-commerce platforms that are fraudulent, counterfeit, and/or otherwise ineffective. EPA is also coordinating with the U.S. Department of Justice, U.S. Customs and Border Protection, and other federal partners to bring the full force of the law against those selling or otherwise distributing violative products.

EPA's updated advisory also expands on, and somewhat shifts, the agency's discussion of pesticide "devices" (e.g., UV lights, ozone generators, and other instruments that use physical or mechanical means to control pests, including viruses and other germs) that claim to kill the coronavirus. Unlike chemical pesticides, devices are not required to be registered by EPA and, therefore, are not scrutinized by the agency to ensure they are safe to use or work as intended. [Note that devices must meet other EPA requirements, including being labeled with an “EPA Establishment Number” to identify the facility at which the device was produced, and not being marketed with "false or misleading" claims.] While EPA does not review efficacy data for these products, manufacturers must have on file adequate substantiation for the claims they make. Interestingly, the May 2020 advisory noted that "devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses." This language has been replaced in the January 2021 advisory with a more general reminder that

[M]aking false or misleading labeling claims about the safety or efficacy of a pesticidal devices is prohibited and could result in the issuance of a Stop Sale, Use, or Removal Order and penalties ....

The second case, Tzumi Innovations v. EPA, filed in December, similarly involves objections to EPA's designation of the company's hand wipes (typically for use on the human body and an FDA-regulated product) as an unregistered pesticide and a threatened Stop Sale, Use, Or Removal Order (SSURO). EPA filed a new brief in that case on February 3 asserting that the matter is not ripe for review and, substantively, that the wipes are properly considered pesticides because they are being marketed for use on surfaces.

Both challenges provide a reminder of the extensive scope of EPA's FIFRA authority, including over products that do not explicitly make antimicrobial claims, but imply such effectiveness through other statements or based on the presence of certain active ingredients. For a more detailed discussion, see my prior blog post.

A copy of EPA's updated COVID Compliance Advisory "What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19" is available here.

Zuru, LLC, filed suit in September alleging that EPA incorrectly declared their product, Bactive Heavy Duty Cleaning Wipes, to be an unregistered "pesticide" and blocked its import into the United States. The crux of the case is that Zuru asserts that it does not make any "disinfectant or other pesticidal claims" for the product, which it says is labeled only "as intended for use in heavy duty cleaning of nonporous surfaces to fight the presence of dirt, grease, and common messes."

For several reasons, however, EPA contends that the cleaning wipes are pesticide products regulated under FIFRA. In particular, the agency argues that the wipes fall under EPA's FIFRA authority because they contain an active ingredient (chlorhexidine digluconate) found in a number of other EPA-registered disinfectants. Moreover, while no express pesticidal claims are made on the product packaging, EPA alludes to statements made on-line by third party resellers that the wipes are "disinfectants" and "kill germs." The agency also contends that the very name "'Bactive' implies bacterial fighting properties."

The case, for which EPA earlier this week was granted a 10-week extension to respond, provides compelling lessons for companies that sell cleaning products to keep in mind, including:

(1) The scope of FIFRA is not limited to express pesticidal claims made on the product label or in marketing materials. In determining whether a product is "intended for a pesticidal purpose," EPA will look beyond express claims to examine whether labeling, ingredients, marketing materials, and even the product name imply pesticidal intent.

(2) EPA can regulate a product for which no pesticidal claims are made if it contains a substance that "has no significant commercially valuable use other than as a pesticide." This is the core issue in the Zuru case, in which the company argues that the ingredient at issue also has separate value as a cleaning agent.

(3) Sometimes, an ingredient or product becomes commonly associated with "pesticidal" purposes, such that EPA asserts regulatory authority over it even absent other express or implied pesticidal claims. The classic example, from decades ago, is Avon's Skin So Soft lotion that was not overtly marketed as a pesticide, but became commonly associated in the public mind with mosquito repellency. Third party website testimonials and the statements of product resellers, such as in the Zuru case, may be cited as evidence of pesticidal intent based on public perception.

(4) Product names and logos can be considered to be "pesticidal" claims. This seems to be a major hurdle for Zuru in its case, as the agency asserts regarding the term "Bactive."

The case is Zuru, LLC v. EPA, et al., in the United States District Court for the District of Columbia.

The CDR rule requires manufacturers (including importers) of chemical substances listed on the TSCA Chemical Substance Inventory to report data on chemical manufacturing, processing, and use every four years. The information collected through the CDR program, according to the agency, "helps EPA understand exposure to these chemicals and screen and prioritize chemicals to identify and evaluate potential human health and environmental effects."

The report requires submission of detailed on-site production and downstream industrial and consumer use information for substances manufactured or imported in quantities of 25,000 pounds or more. The current reporting cycle began June 1 and was scheduled to close on November 30. The new reporting deadline is January 29.

Additional information on CDR reporting is available at EPA's website.

Historically, traditional disinfectant or sanitizer products that receive EPA registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) provide a relatively quick kill of the vast majority of bacteria, viruses or other microbes on the surface at the time of application, but are subject to immediate recontamination as soon as they are touched. In recent years, a number of products have emerged with the ability to provide more durable antimicrobial activity that lasts beyond the immediate application to the surface. The demand for such long-lasting disinfectants and sanitizers has spiked in recent months in light of the pandemic.

EPA's new policy responds to this increased demand and is the first-ever guidance that specifically outlines the data requirements for approval of such "residual" antimicrobials. For the new category of "residual disinfectants," products must kill 99.9% of bacteria or 99.999% of viruses within 10 minutes of application and continue providing such efficacy for at least 24 hours.

In contrast, "supplemental residual antimicrobial products" do not meet the quick kill time standard for a "disinfectant" but provide at least a 99.9% microbial reduction within 2 hours, and continue to be effective over weeks, months or years. EPA considers these products to be "supplemental" in that they provide beneficial microbial reductions on the treated surface during the time between routine cleaning and disinfection practices. Products receiving this type of registration must bear the following qualifying language:

In conjunction with the new guidance, EPA also released draft residual efficacy testing protocols, an updated draft testing protocol for evaluating the ability of copper surfaces to kill bacteria, and a draft efficacy protocol for antimicrobial surface coatings.

The new guidance is effective now but subject to amendment after a 60-day comment period, which runs through December 11th. A copy of the guidance is available here.