Below is an excerpt of a legal update co-authored with Real Estate + Development Group lawyer Eden Yerby.

In companion rulings favoring offshore wind developers and federal agencies, the First Circuit Court of Appeals recently affirmed rulings issued by the District Court (D. Mass.) and dismissed challenges brought by two Vineyard Wind opponents concerning the project’s potential impact on the endangered North Atlantic right whale.[1] In both cases, a panel of the same three judges addressed challenges to the administrative procedures followed by the National Marine Fisheries Service (NMFS) and the Bureau of Ocean Energy Management (BOEM) in issuing a biological opinion and an Incidental Harassment Authorization (IHA) for the project that would directly impact the right whale. In two decisions authored by Judge Kayatta analyzing aspects of the federal permit approval process, the Court ruled that the agencies properly evaluated potential impacts to the right whale and did not violate the authorizing statutes or otherwise act arbitrarily or capriciously. Read the full legal update.

EPA recently issued its long-awaited rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). Along with the rule, EPA issued PFAS Enforcement Discretion and Settlement Policy Under CERCLA. This policy document provides the regulated community with some insight as to how EPA may roll out this rule in practice.

According to the policy document, EPA intends to focus its PFOA/PFOS CERCLA enforcement efforts on “responsible entities who significantly contributed to the release of PFAS into the environment, including parties that manufactured PFAS or used PFAS in the manufacturing process, federal facilities, and other industrial parties.” EPA does not intend to use its CERCLA authority to pursue certain public and other entities, such as:

  • Community water systems
  • Publicly owned treatment works (POTWs)
  • Publicly owned/operated municipal solid waste landfills
  • Publicly owned airports
  • Local fire departments

Based upon how PFAS are being investigated and discovered in the environment, the above entities are often on the front lines of identifying PFAS in the environment. They are also providing important public services. Because of this, EPA intends to focus its enforcement efforts elsewhere.

In considering whether to pursue other parties under CERCLA, EPA will consider a number of factors:

  • Does the entity manufacture PFAS or used PFAS as part of an industrial process?
  • Is the entity is actively involved in the use, storage, treatment, transport, or disposal of PFAS?
  • Does the entity perform a public service role?
  • Is the entity a state, local, or tribal government?

Based on the above factors, it seems clear that EPA intends to focus its PFAS CERCLA enforcement efforts on the manufacturing and industrial sectors. That enforcement activity could very well arise out of contamination discovered in water systems, POTWs, landfills, etc., but it appears EPA will focus on the manufacturing and industrial entities that may have contributed PFAS to the environment.

EPA will also seek to protect the public entities listed above in pursuing CERCLA settlements. For example, when EPA enters into a settlement with a PFAS manufacturer, it may look to secure a waiver of rights to prevent that manufacturer from seeking contribution from certain non-settling parties. EPA may also enter into favorable settlements with the public entities listed above to shield them from lawsuits from other potentially responsible parties.

EPA makes it clear that this enforcement policy applies to CERCLA only. EPA further reserves the right to change this policy as the scientific and legal landscapes evolve. That said, for now, it appears that the manufacturing and industrial communities may find themselves in the crosshairs of CERCLA enforcement.

This post is also being shared on our Manufacturing Law Blog. If you’re interested in getting updates on legal news and perspectives and related business issues that are facing manufacturers and distributors, we invite you to subscribe to the blog.

On May 10, 2024, extensive revisions recently adopted by the Environmental Protection Agency (EPA) to the Risk Management Program (RMP) regulations (40 CFR Part 68) will take effect. The revisions, dubbed by EPA as the “Safer Communities by Chemical Accident Prevention Rule,” reinstate certain Obama-era provisions previously rolled back under the Trump administration. However, the revisions also enlarge some of these provisions and add significant new requirements, including some that reflect the current administration’s focus on climate change and environmental justice.

The revisions require owners and operators of subject facilities to achieve compliance with most of the substantive requirements within three years (i.e., by May 10, 2027). RMP plans must be updated to reflect new applicable requirements and resubmitted to EPA within four years (i.e., by May 10, 2028). For certain other requirements (regarding emergency response field exercises), the compliance deadline is potentially shorter or longer than these three- and four-year periods, depending on the date of the facility’s most recent field exercise.

Once the rule takes effect, court challenges by both business interests and environmental groups are expected. However, given the unknown outcome of such challenges and the breadth and potential costs of the new requirements, potentially impacted facilities should begin assessing the applicability of the revisions now.

Background

The RMP regulations implement Section 112(r) of the 1990 Clean Air Act Amendments (42 U.S.C. 7412(r)), which direct EPA to develop regulations to improve the prevention of chemical accidents at stationary facilities or activities (for brevity, referred to here simply as “facilities”) that use or store “regulated substances” that EPA has identified as presenting the greatest risk of harm from accidental releases. In particular, the owner and operator of a facility with one or more “processes” that manufactures, uses, stores, or handles such a regulated substance in excess of substance-specific threshold quantities must develop and implement a risk management program for all such processes, and document that program in a risk management plan submitted to EPA.

RMP requirements are generally similar to, and in some respects will overlap with, requirements under the Process Safety Management (PSM) program administered by the Occupational Safety and Health Administration (OSHA). However, while OSHA’s PSM regulations focus on workplace safety, the RMP regulations focus primarily on minimizing the public impacts of accidental releases through prevention and emergency response.

Continue Reading EPA Turns Up the Pressure on Chemical Release Prevention and Preparation

Earlier this year, the Connecticut Department of Energy and Environmental Protection (DEEP) released a “Connecticut Environmental Justice Public Participation Guidance Document” (‘the Guidance”) concerning the 2023 amendments to Connecticut’s environmental justice (EJ) statute regarding permitting or other approvals for certain facilities. Although helpful in indicating DEEP’s interpretation of the amended statute (which is not a model of legislative clarity), the Guidance leaves open many questions and raises some new ones. Beyond the Guidance, however, DEEP recently announced a general schedule for developing regulations to implement the most significant part of the amendments: cumulative impact assessments.

Background

Since its adoption in 2009, Connecticut’s EJ statute (Conn. Gen. Stat. § 22a-20a) has applied to “affecting facilities” that are located in or proposed to be located in an “environmental justice community” (both terms defined by the statute) and that apply to DEEP for a new or expanded permit, or to the Connecticut Siting Council for a Certificate of Environmental Compatibility and Public Need. For such facilities, the statute has required applicants to develop and implement a “meaningful public participation plan” and potentially enter into a “community environmental benefit agreement” (CEBA) between the applicant and the host municipality to mitigate potential environmental impacts of the affecting facility.

The 2023 amendments (Public Act 23-202) became effective on October 1, 2023. The amendments primarily do two things: (1) further enlarge applicant obligations concerning public participation, and most significantly, (2) make an assessment of the cumulative impact of “environmental and public health stressors” a new element in reviewing – and potentially denying – “affecting facility” applications. However, the amendments state that the cumulative impact assessment features shall not take effect until DEEP has adopted implementing regulations. The statute also requires DEEP to consult with stakeholders in this effort.

Public Participation Guidance

The recent Guidance addresses only the enhanced public participation features of the 2023 amendments and expressly does not address the cumulative impact assessments. It simply states that the development of the cumulative impact regulations will “take time.” The 2023 amendments also call for DEEP to adopt implementing regulations for the enhanced public participation features. However, the Guidance does not address such regulations or provide a timeline for their implementation.

The Guidance does highlight new requirements regarding public participation and presents DEEP’s integrated understanding of such requirements.  Much of this understanding is straightforward. For example, “affecting facility” applicants must now not only prepare and receive DEEP approval for a “meaningful public participation plan” before filing the application in question but must also prepare and receive DEEP approval for a report regarding the results of such public outreach in order for the application to be deemed sufficient. 

Beyond that, Goal 8 of DEEP’s recently announced “20BY26” plan includes several steps that DEEP plans to take regarding the enhanced public participation under the 2023 amendments, including:

  • Making all EJ public participation plans and CEBAs publicly available, including those that DEEP has previously received.
  • “Produc[ing] other tools … [to] facilitate efficiency and engagement,” such as more guidance to clarify how DEEP permitting and other programs interact with EJ communities, and to highlight opportunities for public participation in DEEP programs. 

While much of the Guidance is relatively straightforward, certain statements appear to range beyond the 2023 amendments. For example, it states that the EJ statute would apply to the addition of a new unit “resulting in [emissions of] fifteen (15) tons or more per year [TPY] of any individual air pollutant.” It is not clear how the 15 TPY threshold, which one may reasonably assume is a reference to the DEEP air permit program for non-major sources in various parts of state regulation  § 22a-174-3a, is consistent with the statute’s restriction of “affecting facility” to include only a “major source” of air pollution. As defined in the 2023 amendments, “major source” means “a major source of air pollution, as defined by the federal Clean Air Act or … [DEEP regulations],” or that has actual or potential emissions exceeding 100 TPY or other applicable Clean Air Act criteria, which typically are far beyond the non-major source thresholds in the DEEP air permit program. 

For another example, the Guidance notes that the EJ statute exempts “minor modifications,” but also states without qualification that the statute applies to an alteration of a facility that “may result in the discharge of any new water, substance or material.” (Emphasis added).  These examples underline that (as it itself notes) the Guidance is not a substitute for the statute itself.

Lastly, the Guidance does not address what DEEP envisions as a “reasonable fee” that the statute authorizes DEEP to charge “affecting facility” applicants to cover the cost of implementing the amended program.

Ultimately, while the Guidance is useful to some degree, the full impact of Public Act 23-202 will not be known until DEEP develops implementing regulations for the enhanced public participation requirements and particularly for cumulative impact assessments. 

Development of Cumulative Impact Regulations

In early March, DEEP announced an overall scheme and schedule for adopting cumulative impact regulations as Goal 7 in DEEP’s “20BY26” plan:

  • Hold “listening sessions” in EJ communities and with regulated parties (throughout 2024).
  • Release a Request for Proposals to develop “the ‘cumulative impacts tool’ that ultimately will give businesses the information that they can rely on to design, from the start, successful permit applications” (early 2024).
  • Propose “a strong but flexible set of rules” for public comment (late 2025). 

Interested parties would be well-advised to watch for opportunities for stakeholder involvement in these efforts as DEEP continues to implement the 2023 amendments. Those who are particularly interested can also sign up to receive DEEP’s Equity and Environmental Justice Newsletter, which includes timely updates on upcoming opportunities and events from DEEP’s Office of Equity and Environmental Justice.

The EPA Office of Inspector General’s (OIG) February 15, 2024, report on EPA’s practices in collecting, retaining, and producing criminal discovery materials in environmental cases found that EPA’s special agents largely adhered to requirements embedded in the due process clauses of the U.S. Constitution, the Brady doctrine, the Jencks Act, and the Federal Rules of Criminal Procedure. While the OIG identified some instances where agents deviated from procedures established by the Office of Criminal Enforcement, Forensics and Training (OCEFT) that could impact discovery during criminal proceedings, such as the use of a personal camera during an investigation, they did not amount to violations of applicable discovery requirements. Based on OIG’s evaluation, OCEFT was advised to review its policies and procedures to determine whether they required updating or whether the establishment of best practices was necessary. Alternatively, OIG recommended periodic training of EPA inspectors and investigators who may support the Government’s prosecution team.

Within EPA, OCEFT sits within the Office of Enforcement and Compliance Assurance (OECA), and both investigate violations of environmental laws and provide technical and forensic services for broader civil and criminal investigations. OCEFT is divided into three divisions: (i) the Criminal Investigation Division, (ii) the Legal Counsel Division, and (iii) the National Enforcement Investigations Center. In a federal investigation of potential environmental crimes, the EPA is considered part of the Government’s prosecution team and is primarily responsible for the investigation component of the process. OCEFT special agents work with the EPA and attorneys at the DOJ and in U.S. Attorney’s Offices. Individual agents are required to provide prosecutors with all potentially discoverable information for prosecutors to evaluate their discovery obligations. While special agents do not make those disclosure determinations, successful prosecutions require that all evidence has been collected in accordance with applicable constitutional and procedural requirements.

OIG’s assessment of OCEFT procedures focused on their application in individual cases to ensure that the Government met its discovery obligations when prosecuting environmental crimes. OIG found no instance where OCEFT agents did not adhere to criminal discovery requirements. It did note, however, circumstances in which agents did not fully apprehend investigative policies and procedures and would benefit from additional training.

The OIG report provides a good overview of EPA’s criminal enforcement procedures and the federal criminal process, generally, as it applies to environmental prosecutions. With OECA head David Uhlmann’s recent Senate confirmation, over two years following his nomination, the EPA now has all of its resources in place to address the agency’s high-priority concerns, including PFAS contamination.

On February 7, 2024, the U.S. Environmental Protection Agency (EPA) released its Final Rule lowering the primary annual National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM 2.5) from the current level of 12 micrograms per cubic meter (μg/m3) to 9 μg/m3.  Once published, the Final Rule is certain to be challenged in court. With that caveat, we summarize below the planned implementation and potential impacts of the new standard on sources of PM 2.5 or PM 2.5 precursor emissions. For more background, see our prior post about EPA’s 2023 proposal to lower the NAAQS and sources of PM 2.5.

Implementation

The Final Rule will take effect 60 days after notice of the Final Rule is published in the Federal Register. As of the date of this post, publication has not yet occurred.

To implement the new PM 2.5 NAAQS, the first step is for each state to develop recommended designations of areas in the state as attainment or nonattainment with respect to the new standard. According to the anticipated timeline in a February 7, 2024 memo from EPA Air chief Joseph Goffman, states would have until February 7, 2025 to submit these recommended designations to EPA. Following EPA review, public comment, and any necessary revisions, designations would be finalized in February 2026. The memo also notes that based on certain Clean Air Act provisions, EPA will initially classify all PM 2.5 nonattainment areas as “Moderate.” Thereafter, any such areas must achieve attainment by the end of the sixth calendar year after the effective date of the designation. EPA expects that 2032 is likely the earliest possible attainment deadline.

Based on 2016-2020 air quality data, and incorporating expected emission reductions from various programs (existing and planned) across the country, EPA projects that more than 99% of counties will attain the tightened annual PM 2.5 standard by 2032. As shown below, the most impacted state per EPA’s 2032 nonattainment projections is California, particularly the Central Valley and southern California. Remaining projected nonattainment areas are highly scattered across the lower 48 states, and include several major urban areas.

Source:  https://www.epa.gov/system/files/documents/2024-02/2024-pm-naaqs-final-2032-projections-map.pdf

However, projections using more recent data – on which EPA has said it expects states to base their attainment designation recommendations – suggest that the 9.0 μg/m3 standard could present much more widespread challenges. According to a recent report by the U.S. Chamber of Commerce (Chamber), average annual PM 2.5 emissions increased significantly from 2019 to 2023 across most of the eastern United States, and most of the country saw significant increases in ambient concentrations of PM 2.5 (as much as 2 to 3 μg/m3) in 2023 due to widespread wildfires.

Using data from 2021-2023, the Chamber considered how counties across the contiguous United States might fare under a 9.0 μg/m3 standard. Counties shown in red on the map below are those which would not meet the new standard, and therefore are vulnerable to a nonattainment designation, even if projected to reach attainment by 2032.  Because of the wildfire-related PM 2.5 spike in many areas of the country in 2023, it is expected that many states will ask EPA to apply its “exceptional events” policy to reduce their attributed PM 2.5 levels and avoid nonattainment designations.

Counties shown in green on the map below are those projected by the Chamber to attain 9.0 μg/m3 with “headroom” to spare (≥3 μg/m3, even before from any downward adjustment under EPA’s “exceptional events” policy).

The remainder of the country, shown in light red, is projected by the Chamber to fall 1 to 3 μg/m3 below the new standard, and would presumably be designated as attainment.  But being designated attainment is one thing; maintaining attainment is another. Absent downward adjustment from EPA’s “exceptional events” policy, PSD permitting authorities will likely be more wary of permitting additional emissions of PM 2.5 or PM 2.5 precursors that consume a significant share of the headroom remaining under 9.0 μg/m3 and, in the aggregate, could lead to a violation of the new NAAQS.

Source: https://www.globalenergyinstitute.org/sites/default/files/2023-11/Chamber PM2.5 Report _ 11.8.23 Final Draft.pdf

Further Potential Impacts

In addition to the potential impacts discussed above, the new NAAQS, once effective, will have an immediate impact on certain pending permit applications for PM 2.5 or PM 2.5 precursors in areas currently designated as attainment under the 12 μg/m3 NAAQS and prior PM 2.5 NAAQS. In such areas, Prevention of Significant Deterioration (PSD) permitting for construction of a new major stationary source or a major modification of an existing stationary source (as defined in EPA and state PSD regulations) under those NAAQS will continue to apply. However, once the Final Rule takes effect, pending, as well as future, PSD permit applicants for a PM 2.5 or a PM 2.5 precursor source will need to incorporate the new standard into their air quality impact analyses. More specifically, applicants will need to demonstrate that their source will not cause or contribute to an exceedance of the 9 μg/m3 NAAQS, as well as the 12 μg/m3 NAAQS and prior standards.

In areas ultimately designated as nonattainment under the new NAAQS, the permitting impacts would be more severe. Under the Clean Air Act, construction of a new major stationary source of PM 2.5 or a PM 2.5 precursor or a major modification of an existing major stationary source would be subject to Nonattainment New Source Review permitting, which requires stringent emission controls and offsetting emission reductions elsewhere at the source or at other sources.  Existing major sources that do not undergo a major modification would be subject to Reasonably Available Control Measures, including Reasonably Available Control Technology (RACM/RACT). 

Other Features of the Final Rule

As in the proposed rule, the Final Rule retains all other existing particulate matter NAAQS (the primary 24-hour PM 2.5 standard and the identical secondary standard; the secondary annual PM 2.5 standard; and the primary 24-hour coarse particulate matter (PM 10) standard and its identical secondary standard). Although EPA solicited comments regarding reducing the 24-hour PM 2.5 primary and secondary standards from the current 35 μg/m3 to as low as 25 μg/m3, the agency determined that the existing standards already provide “appropriate supplemental protection against elevated peak concentrations of fine particles.” In justifying this decision, EPA emphasized its holistic evaluation of the public health protections offered by the full suite of PM standards.

The Final Rule also provides for adjustments to the nationwide PM 2.5 monitoring network, with  an environmental justice focus: when siting monitors, monitoring agencies must consider the proximity of sensitive communities to PM 2.5 emission sources of potential concern.

*          *          *          *          *

This summary highlights some of the many unknowns regarding the new NAAQS at this early stage.  Subject to the outcome of expected legal challenges to the standard, the next few years should clarify its impact on permitting and other regulation of PM 2.5 and PM 2.5 precursor sources.  

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).