On February 8, 2024, the U.S. Environmental Protection Agency (EPA) published two proposed rules in the Federal Register that would expand the EPA’s authority to address certain per-and polyfluoroalkyl substances (PFAS) under the Resource Conservation and Recovery Act (RCRA). These rules would significantly increase the EPA’s and authorized state’s authority to address the release of some of the most common PFAS and require responsible parties to conduct assessments, investigations, and clean-ups.

The first proposed rule, Listing of Specific PFAS as Hazardous Constituents, seeks to add nine PFAS, their salts, and their structural isomers to RCRA’s list of hazardous constituents. It is important to note that this is not the same as a “hazardous waste” listing under RCRA, which would automatically designate substances as “hazardous substances” under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), also known as Superfund.

The nine PFAS listed in the proposed rule are:

  • perfluorooctanoic acid
  • perfluorooctanesulfonic acid
  • perfluorobutanesulfonic acid
  • hexafluoropropylene oxide-dimer acid
  • perfluorononanoic acid
  • perfluorohexanesulfonic acid
  • perfluorodecanoic acid
  • perfluorohexanoic acid
  • perfluorobutanoic acid

The stated purpose of this proposed rule is to bring PFAS into RCRA’s Corrective Action program, which requires that the owner or operator of a facility with a permit or interim permit for the treatment, storage, or disposal of hazardous waste initiate corrective action to protect human health and the environment for all releases of hazardous wastes or hazardous constituents. It also means that the EPA has found that these substances have been shown in scientific studies to have “toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life forms.”

The second proposed rule, Definition of Hazardous Waste Applicable to Corrective Action for Releases from Solid Waste Management Units, seeks to amend the definition of “hazardous waste” and authorize the EPA to require corrective actions to address releases from RCRA-regulated solid waste management units (SWMU) of any substance that meets the statutory definition of hazardous waste — not only substances identified as hazardous waste or constituents in the RCRA regulations. This action is designed to enhance the EPA’s position that it has the authority to use the RCRA Corrective Action program at permitted facilities to address both listed hazardous waste and constituents – including the nine PFAS identified in the first proposed rule – but also other emerging contaminants, such as any of the thousands of other PFAS, if it can be shown that they meet the statutory definition of “hazardous waste.”

Taken together these proposed rules represent an important step forward in the EPA’s PFAS Strategic Roadmap by expanding the EPA’s authority to address releases of the nine listed PFAS (and potentially more) and set the stage for the EPA’s impending proposed rules to designate two PFAS – Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) – as hazardous substances under CERCLA and to establish a national primary drinking water standard for PFAS.

Comments on the listing of the nine PFAS are due April 8, while comments on the expansion of EPA’s RCRA authority are due on March 11.

This article was originally published by ACOEL on December 12.

“Seldom is so ambitious a case filed on so slight a basis.”  Those are words a plaintiff’s lawyer would hate to hear, but that is exactly how the Sixth Circuit Court of Appeals began its opinion rejecting an Ohio firefighter’s attempt to certify a nationwide class of individuals with elevated PFAS in their blood serum.  The parties apparently agreed that at the PFAS blood serum levels proposed, the class would include just about everyone in the United States.

Plaintiff Kevin Hardwick first brought his complaint in the Southern District of Ohio in 2018 against 10 defendants who made PFAS.  (The Court noted early on that “of the thousands of companies that have manufactured chemicals of this general type over the past half century, Hardwick has chosen to sue the ten defendants here.”)  Hardwick asked the court to certify a nationwide class and establish a “science panel” to study the potential causal connection between PFAS exposure and “any injury, human disease, adverse human health impact, and/or a risk sufficient to warrant any personal injury compensation or future diagnostic medical testing, including medical monitoring.”  Hardwick is represented by the same law firm that represented the plaintiffs in the class action for alleged PFAS exposure from DuPont’s Parkersburg, West Virginia facility.  Resolution of that case included the creation of the C8 Science Panel, a group of three scientists who conducted a nearly 10-year epidemiologic study of the health of people allegedly exposed to PFAS surrounding the plant.  Presumably Hardwick is seeking to repeat this on a national level, with the findings of the science panel binding on all the parties.

In March 2022 the Southern District of Ohio certified a class of Ohio residents with PFAS in their blood serum above certain levels – a class which would have included about 11.8 million people.  The defendants petitioned for interlocutory review which the Sixth Circuit granted in September 2022.  The Sixth Circuit issued its 7-page decision on November 27, 2023, vacating the certification order and remanding with instructions to dismiss the case for lack of jurisdiction.

The decision was based on plaintiff’s failure, even at the pleading level, to satisfy the requirements for standing.  More specifically, the Court chose “to begin and end … with the element of traceability.”  The Court found that plaintiff made conclusory allegations as to all ten defendants collectively, with no specificity about how the plaintiff’s injury (here, the presence of PFAS in his blood serum) is traceable to any individual defendant.  The Court also pointed out the plaintiff’s failure to allege that any of the defendants manufactured the 5 PFAS compounds found in his blood, “nor did he allege any plausible pathway by which any of these defendants could have delivered any of these 5 PFAS to his bloodstream.”  The Court therefore concluded that Hardwick “elides rather than meets the Supreme Court’s requirements as to pleadings and traceability.  Hardwick therefore lacks standing to proceed with his claims.”

The Court also noted that the actual injury requirement for standing was also sharply contested.  While this issue was not specifically addressed by the Sixth Circuit, the actual injury requirement is being hotly contested in PFAS litigation around the country, especially in cases where plaintiffs are seeking medical monitoring classes.  For example, earlier this year the New Hampshire Supreme Court held that “increased risk of harm is not an injury for purposes of a negligence action” absent a present physical injury.  But across the Connecticut River in Vermont, plaintiffs can seek medical monitoring under certain circumstances absent a present injury.  And the Second Circuit, in the Hoosick Falls PFAS litigation, held that a present physical injury is required, but that it is sufficient to allege that there is a “clinically demonstrable presence of toxins” in the body or “some physical manifestation of toxin contamination.”  In that case, plaintiffs could demonstrate that they had PFAS in blood serum above the national averages.

For now, there will be no certified nationwide class of PFAS claimants.  And it is still too soon to tell whether PFAS will be the next asbestos.  But PFAS litigation is not going away any time soon.

Below is an excerpt of an article co-authored with Jessica Bardi and Eden Yerby, members of Robinson+Cole’s Coastal + Offshore Resources Industry Team, and published in The Maritime Executive.

Offshore wind (OSW) deployment is a key component of the Biden administration’s renewable energy goals, including the installation of 30 GW of offshore wind capacity by 2030 and 110 GW by 2050.  For perspective, the administration estimates that 30 GW would power over 10 million homes.  The Northeast, with its favorable coastal shelf and prevailing wind conditions, has been at the forefront of offshore wind development in the United States.  While federal and state permitting efforts have advanced on several projects and turbines have started to leave coastal ports for their offshore destinations, other planned installations have stalled recently due to changing economic conditions.  Read the full article.

As we have previously reported, PFAS (per- and polyfluoroalkyl substances) are a class of substances coming under increasing regulatory scrutiny.  As manufacturers ring in the new year they should be aware of two new PFAS reporting requirements that could need careful attention in 2024.

De Minimis Exemption No Longer Available for PFAS Under EPCRA

Certain PFAS have been subject to Toxics Release Inventory (TRI) reporting under the Emergency Planning and Community Right to Know Act (EPCRA) since 2020. This reporting obligation began with an initial list of 172 PFAS, which has since expanded.  That said, only a few dozen facilities submitted TRI reports for PFAS in each of the years since 2020.  EPA followed up with facilities from which it had expected to receive filings, and reported that such facilities had concluded that TRI reporting was not necessary because of the de minimis exemption to TRI reporting.   Under the de minimis exemption, substances present in mixtures in a concentration below 1 percent (or 0.1 percent for carcinogens) could be omitted from TRI reports.  Since PFAS are often present in mixtures in very low concentrations the de minimis exemption essentially allowed almost all PFAS to remain unreported.

By a new rule published on October 31, 2023, EPA designated PFAS subject to TRI reporting as “chemicals of special concern” subject to enhanced reporting requirements.  Because chemicals of special concern are not subject to the de minimis exemption to TRI reporting, and must be reported even in minute concentrations, this change will dramatically increase the amount of PFAS subject to reporting in the 2024 reporting year (2024 TRI filings are due July 1, 2025).

A second PFAS-related change to EPCRA reporting requirements has already gone into effect and might already be impacting your supply chain.  EPCRA requires that certain suppliers of mixtures and/or trade name chemical products must disclose to their customers the presence of any TRI-reportable substance in their products unless such substance is present below the de minimis concentration of 1 percent (0.1 percent for carcinogens).   In the same October 31 final rule, EPA also eliminated the use of the de minimis exemption to supplier notification requirements for any chemicals of special concern (including TRI-reportable PFAS, and also lead, mercury, and other chemicals of special concern).  As a result, manufacturers may soon learn that products in their supply chain contain small concentrations of PFAS that would not have been previously reported or disclosed because they would have been below the de minimis threshold.  This enhanced knowledge would in turn also inform TRI reports for the chemicals of special concern.

TSCA Reporting Rule for Manufacturers and Importers

Under a new PFAS reporting rule promulgated under the Toxic Substances Control Act on October 11, 2023, any entity that manufactured (including imported) PFAS or PFAS-containing articles in any year since 2011 must provide EPA information on PFAS identity, concentration, uses, production volumes, disposal, exposures, and hazards.  The definition of PFAS under TSCA is much broader than under EPCRA (defined by chemical properties rather than a list of substances) and could apply to thousands of different compounds.

It is important to note that TSCA defines manufacturing to include importing.  Furthermore, unlike some other TSCA reporting requirements, the new PFAS reporting rules will apply to finished product “articles” in addition to bulk chemicals, so importers of finished articles are subject to reporting rules for products that might have had PFAS added several steps earlier in the supply chain.  For example, a jacket made from fabric that has been treated with a PFAS-containing water-repellent coating would be considered a PFAS-containing article subject to the reporting rule if imported since January 1, 2011. 

The more complex the item, and the more different components are included, the more opportunities for PFAS-containing components to be present.  Even something simple like a desktop speaker could include wires (potentially sheathed with PTFE), plastic casing (which may have been strengthened with PFAS-imparting processes), and fabric (treated with a PFAS-containing water and stain-repellent coating).  Fortunately, manufacturers and importers are only required to provide the information “known to or reasonably ascertainable” by the filer, and for earlier years in the reporting period, there might be little, if any, information available.  Even so, a careful examination of the supply chain and related records may be required in order to understand your reporting obligations and/or document what information (if any) is known or reasonably ascertainable.

Reporting forms are due within 18 months after the effective date of the rule (i.e., by May 13, 2025) except for small article importers, who must report within 24 months after the effective date (i.e., by November 13, 2025).

The EPA is seeking comments on a newly released, revised guidance document regarding the consideration of environmental justice (EJ) concerns in the rulemaking process. The guidance document updates a 2016 version and incorporates new scientific developments, other EPA guidance, and new priorities and policies.

The guidance document sets forth both analytical expectations for an EJ analysis, as well as technical methods and approaches that can be used to evaluate EJ concerns for a particular action. Under the guidance document, an EJ analysis should seek to answer the following:

  • Baseline: are there existing EJ concerns that are affected by the action for groups of concern?
  • Regulatory options: are these EJ concerns impacted by the regulatory action?
  • Mitigation or exacerbation of impacts: will EJ concerns be exacerbated, mitigated, or unchanged by the regulatory action compared to the baseline?

In analyzing these three questions, the guidance proposes consideration of a variety of methods and approaches, including both quantitative and qualitative data. EPA will consider the impacts of things like exposure to multiple stressors, cumulative exposures, and the susceptibility of a particular population to an adverse health effect (including potential lack of access to healthcare).

While the guidance is directed at EPA and considerations it must undertake when going through rulemaking, it will impact the manufacturing community in a variety of ways. First, a more detailed EJ analysis could delay implementation of a variety of environmental regulations or actions that will impact manufacturers. Second, it may result in the need for manufacturers to provide or generate information to support EPA in its analysis. Further, the continued focus on EJ, and this guidance in particular, will likely result in increased public access to the quantitative and qualitative data that is considered during an EJ analysis.

EPA will be hosting two webinars in December on the revised guidance. Any comments must be received by EPA on or before January 15, 2024.

In a recent report, the Environmental Protection Agency (EPA) Office of Inspector General (OIG) describes steps the EPA should take to increase air monitoring at marine ports and neighboring communities. While not agreeing to adopt all of the OIG’s recommendations, EPA has agreed to assess the air-monitoring network around ports and in near-port communities and to create a plan to enhance the monitoring network to address any gaps that might be identified.

The OIG report follows an unprecedented increase in cargo handled by U.S. ports, which has resulted in a decrease in air quality at several ports. The primary sources of emissions from port operations include ocean-going vessels (OGVs), cargo-handling equipment, and trucks. The OIG initiated an evaluation in 2022 to determine what steps, if any, EPA was taking to address the increase in air pollution.

EPA is authorized by the Clean Air Act (CAA) to regulate emissions from mobile sources, such as OGVs and trucks. The CAA also requires EPA to establish, update, and oversee attainment of National Ambient Air Quality Standards (NAAQS) for certain air pollutants, some of which are commonly present in ambient air at marine ports and in surrounding communities. To reduce emissions from ports, EPA to date has largely relied on voluntary programs to encourage shipping companies, port authorities, and community organizations to adopt cleaner practices. Since 2008, EPA’s Diesel Emissions Reduction Act (DERA) grant program has been the primary means of replacing and retrofitting older, dirtier diesel engines such as those found in various port equipment and associated vehicles. Going forward, EPA also will be distributing $3 billion from the Inflation Reduction Act (IRA) in grant funding to address air quality at ports.

While tools are in place to improve air quality at ports and in neighboring communities, OIG has identified a need for EPA to enhance its air quality monitoring. Among other things, OIG has recommended that EPA develop guidance for using “citizen science” (monitoring data generated by community groups). In addition, OIG has recommended that EPA set quantifiable performance measures for its Ports Initiative, including a plan for establishing emissions baselines. OIG’s push for increased air monitoring and performance measures is time-sensitive as EPA prepares to award IRA funding for planning, procurement, and installation of zero-emissions technology at ports. A summary of OIG’s findings and recommendations are included in its September 21, 2023 report, The EPA Needs to Address Increasing Air Pollution at Ports

In response to the OIG report, EPA has identified corrective actions it will take to evaluate its current air-monitoring network, although EPA has noted that monitoring should not be the sole focus of efforts to evaluate emissions and related air quality and has referred to other tools such as emissions inventories and air quality modeling. OIG has accepted EPA’s response with respect to OIG’s recommendations concerning monitoring, but not with respect to OIG’s recommendations concerning the establishment of performance standards. EPA will continue to work on resolving these issues.

With the coming influx of new IRA grant funding designed to reduce OGV, vehicle, and other marine port emissions and to improve air quality, ports can anticipate heightened focus on their vehicle operations and other emission sources.

Chevron deference is squarely in the U.S. Supreme Court’s crosshairs. The Court has had on its October docket an appeal in Loper Bright Enterprises v. Raimondo, which challenges the long-standing doctrine. First established by the Court in the 1984 Chevron v. NRDC case, the doctrine imposes a two-part test when courts determine whether to defer to an agency’s interpretation of a statute that it administers.  First, lower courts determine whether the statute clearly addresses the question at issue, in which case no deference is afforded to the agency’s interpretation.  If the statute is ambiguous, however, Chevron then instructs lower courts to defer to the agency’s reasonable construction of the statute.

Loper Bright involves the National Marine Fisheries’ interpretation of the Magnuson-Stevens Fishery Conservation and Management Act of 1976 to require commercial fishermen to fund at-sea monitoring programs and a challenge to the agency’s interpretation of the Act as it applies to the fishing companies. The case also squarely frames the question of whether the Court should overrule or clarify Chevron deference.  Because Justice Ketanji Brown Jackson heard arguments in Loper Bright while on the D.C. Circuit, the Court’s newest member recused herself from the appeal.

Likely in order to avoid the risk of a 4-4 tie in what could be a landmark ruling on Chevron deference, on October 13 the Court granted a petition to review Relentless Inc. v. Department of Commerce. The appeal, brought by Seafreeze Fleet LLC, involves a challenge to a similar rule under the National Oceanic and Atmospheric Administration requiring vessel operators to pay for federal observers on their ships. The Seafreeze appeal poses an identical question as to whether the Court should overrule or clarify Chevron.  The Court’s grant of certiorari will allow Justice Jackson to participate in arguments and weigh in on a case that could have substantial implications for administrative law.

A special briefing schedule will allow both cases to be heard in the January 2024 session.

In the Byzantine complexity of the Clean Air Act (CAA), EPA’s “once in, always in” policy regarding hazardous air pollutants (HAP) has been particularly confounding.  And now it’s back in play, through regulatory revisions proposed by EPA in late September.  

EPA’s proposal would prohibit a source from reducing its potential emissions of HAP to below “major source” thresholds (and thus avoiding more stringent regulation) unless the source’s post-reduction emissions of HAP are limited to the level that would have been allowed if the source had remained subject to the “major source” regulation.  In other words, a source may not reduce its potential HAP emissions enough to avoid “major source” controls, and then increase its actual emissions to a level higher than could be emitted with such controls.  In addition, the proposal would require the post-reduction emissions limit to be federally enforceable – that is, enforceable by EPA and by citizen groups under the Clean Air Act’s citizen suit provisions.  The proposed rule would also apply retroactively, back to January 25, 2018 (more on this date below), thus potentially pulling a previously-reclassified source back into “major source” status unless it obtains such a federally enforceable limit. 

Some background:  Under the CAA, a “major source” of HAP is defined as having the potential to emit at least (A) ten tons per year of any substance that the CAA or derivative EPA regulations identify as a HAP; (B) twenty-five tons per year of all HAP in total; or (C) any lower threshold that EPA decides is appropriate for a particular HAP.  A major source of HAP is subject to emission standards that require Maximum Achievable Control Technology (MACT).  By contrast, a non-major source of HAP is subject to standards that EPA to date has typically chosen to make less stringent than MACT (and for some source categories, has not yet adopted).

In effect, EPA’s proposed revisions would partially restore a much-criticized policy – known as “once in, always in” – that EPA announced in 1995 but withdrew in 2018.  The policy stated that if a source ever had the potential to emit HAP above the major source threshold after the first substantive compliance date of an applicable MACT standard, the source is “permanently subject” to the standard, even if the source later reduced its potential to emit HAP to below major source levels.  In other words:  once in, always in.  EPA claimed this policy was compelled by the “language and structure” of the CAA, and an underlying Congressional intent to limit or eliminate HAP emissions generally. 

On January 25, 2018, EPA withdrew the “once in, always in” policy after concluding from further review that it was not consistent with the CAA’s HAP provisions and exceeded EPA’s CAA authority.  Following the withdrawal, EPA promulgated regulations in 2020 (known as the “Major MACT to Area” or “MM2A” rule) to confirm that a source could indeed reclassify itself at any time to non-major HAP status (and for most source categories, thereby avoid MACT) if the source reduced its potential emissions of HAP to below the “major source” levels. 

The pending proposed revisions would add conditions to any such re-classification, by requiring a federally enforceable limit to prevent any subsequent emissions of HAP beyond previously-applicable MACT levels.  As in the original “once in, always in” policy, the preamble to the proposed revisions claims a basis in Congressional intent to limit or eliminate HAP emissions. Also as in the “once in, always in” policy, however, the preamble does not seem to address how the proposed conditions for MM2A reclassification square with the lack of any such conditions in the CAA’s definition of a “major source” of HAP, or with EPA’s available, but unused, CAA authority to adopt or tighten standards for non-major HAP sources if EPA thinks appropriate. 

EPA is taking public comments on the proposed revisions through November 13, 2023. 

The U.S. Environmental Protection Agency (EPA) released an advance notice of proposed rulemaking with a focus on modifying the treatment and handling of “empty” containers and drums under the Resource Conservation and Recovery Act (RCRA). The EPA is soliciting information and requesting comments “to assist in the potential development of non-regulatory and regulatory options that would ensure the proper management of used industrial containers that held hazardous chemicals or hazardous waste, up to and including the drum reconditioning process.”

The EPA is seeking comments on a variety of concepts, including:

  • Eliminating 40 CFR 261.17’s “empty” container exemption;
  • Modifying the requirements for a container to qualify as “empty”;
  • Expanding record-keeping, labeling, and certification requirements for generators;
  • Increasing requirements surrounding rinsate from drums; and 
  • Requiring all drum reconditions to obtain a full RCRA Subtitle C TSDF (Treatment, Storage, and Disposal Facility) permit or receive a variance.

Many of the regulatory changes being proposed in the advance notice would likely have a wide-ranging impact on manufacturers, recyclers, and even commercial operations, in addition to the more obviously impacted waste transporters and treatment, storage, and disposal operations.

The EPA set the comment deadline for September 25, 2023. Comments can be submitted at federalregister.gov.

On May 25, 2023, after more than 15 years of fighting, a couple contesting the Environmental Protection Agency’s assertion of jurisdiction over their residential lot as “waters of the United States” (WOTUS) under the Clean Water Act (CWA) scored a decisive victory in a U.S. Supreme Court decision, Sackett v. EPA. Chantell and Mike Sackett’s property, located near Priest Lake in Idaho, had wetland features but no direct contact with the lake or surface waters flowing into the lake. A road separates their lot from a larger wetland complex that flows into the lake. The U.S. Circuit Court of Appeals for the Ninth Circuit agreed that the EPA could impose CWA §404 permitting obligations on the Sackett’s filling of the wetlands on their land based on a site-specific determination that these and other area wetlands had a “significant nexus” to the chemical, physical, and biological integrity of Priest Lake as “traditional navigable waters.”

But the Supreme Court rejected this use of the “significant nexus” test. Following Justice Scalia’s opinion in the 2006 split decision Rapanos v. United States, the Sackett majority concluded that “navigable waters” are limited to only “relatively permanent, standing or continuously flowing bodies of water … described in ordinary parlance as ‘streams, oceans, rivers, and lakes.’” They held that “adjacent wetlands” regulated under the CWA “dredge and fill” permit program must have a “continuous surface connection” that makes them “indistinguishable” from such traditional navigable waters.

EPA and Army Corps of Engineers administer this CWA program, but have not yet issued any detailed responses. (Updates on the impact of Sackett will be available through the website links provided below.) There is certainly room for debate on the meaning of “indistinguishable” and “continuous surface connections” particularly when flooding or intermittent surface flows occur and where dunes, berms, levees, dams, ditches, culverts, drainage pipes, and other features either prevent or provide for connections between wetlands and traditional navigable waters. Some states and several environmental groups are also evaluating ways in which other programs might be expanded in the wake of Sackett. The decision is expected to curtail the circumstances when CWA §404 permitting applies to utilities, developers, farmers, and landowners conducting construction and filling activities and businesses harvesting timber or extracting other natural resources.

Attorney Melvin’s additional articles and presentations on water and wastewater topics appear in Environmental Law+ blog and other Robinson+Cole publications.