Tag: PFAS

Senate Subcommittee Holds Hearing on Public Health Impacts of PFAS Exposures

On December 5, 2024, the Senate Environment and Public Works (EPW) Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight held a hearing on “Examining the Public Health Impacts of PFAS Exposures.” The Subcommittee heard from the following witnesses (written testimony is not available at this time):

  • Laurel Schaider, Ph.D., Senior Scientist, Environmental Chemistry and Engineering, Silent Spring Institute;
  • Sue Fenton, Ph.D., Director of the Center for Human Health and the Environment, Professor of Biological Sciences, North Carolina State University; and
  • Michael D. Larrañaga, Ph.D., P.E., President and Managing Principal, R.E.M. Risk Consultants, on behalf of the American Industrial Hygiene Association (AIHA).

Schaider testified that there needs to be a comprehensive strategy to address all per- and polyfluoroalkyl substances (PFAS), including fluorinated polymers, as a class. Schaider described how the manufacture of PFAS can expose workers and nearby communities to PFAS and how the disposal of products that contain PFAS can contaminate the environment. Fenton offered a number of suggestions for possible legislation, including: limiting the production and use of PFAS; requiring health insurance companies to pay for PFAS testing in susceptible populations; phasing out PFAS in firefighting foams (FFF); requiring manufacturers to provide standards in purified forms of their PFAS; and requiring PFAS manufacturers to fund the development of safe destruction methods for PFAS. Larrañaga stated that PFAS are part of our critical infrastructure and are used in the manufacture of products such as semiconductors, electronics, medical equipment, pharmaceuticals, herbicides, insecticides, plastics, airplanes, automobiles, and buildings. Larrañaga urged that the use of PFAS be balanced against the risk of alternatives.

The hearing included discussion of the use of PFAS in consumer products, including non-stick pans and waterproof mascara, versus other products, such as cell phones and semiconductors. Schaider stated that the issue is not only non-essential uses of PFAS, as in cookware, but also the lifecycle of products that contain PFAS. There may be environmental contamination in communities where PFAS are manufactured, workers may be exposed during manufacture, and at the end of the lifecycle of the product, the PFAS could end up in a landfill or in emissions when incinerated.

During the hearing, Senator Roger Wicker (R-MS) asked whether all PFAS cause the same level of harm and noted the common definition of PFAS as “any compound containing at least one fully fluorinated carbon atom.” Larrañaga responded that although fluoropolymers contain one fully fluorinated carbon atom, they are less bioavailable than other PFAS of concern. There could be an issue if heating them, but by removing that use from the marketplace, instead of banning all PFAS, there would be no adverse effect to critical infrastructure or defense. Schaider stated that, to her knowledge, no PFAS is completely safe. According to Schaider, newer PFAS replacement chemicals raise many of the same health concerns. Schaider suggested that an essential uses framework could be used to identify where PFAS uses can be reduced immediately.

The hearing included discussion of the best way to move forward. Fenton noted that even for essential uses, there is potential exposure to the waste and that proper disposal is important. According to Fenton, labeling products with intentionally added PFAS would allow consumers to make more informed choices. Subcommittee Chair Jeff Merkley (D-OR) suggested that there may be product categories where labeling is more important because the contamination pathway is more significant. Merkley concluded that Congress should continue to explore how to reduce the risk of PFAS to citizens.

There is much discussion, seemingly everywhere, about PFAS, but no easy answers to the questions the Subcommittee considered. In a perfect world, PFAS would be comprehensively addressed as Schaider recommends, and all the unknowns about disposal, exposure, and toxicity would be known. But we do not live in that world, and many hard questions remain to be answered. The Subcommittee gets points for raising key issues, but did little to move the needle.

All eyes are now on the new kids in town — the incoming Trump Administration and U.S. Environmental Protection Agency (EPA) Administrator-Designate Lee Zeldin. We expect in 2025 a decidedly different focus on PFAS, but beyond this, much remains to be seen.

©2024 Bergeson & Campbell, P.C.
For more on the PFAS, visit the NLR Environmental Energy Resources section

A Guidebook to Lawsuits Over PFAS, or Forever Chemicals

Lawsuits over the effects of per and polyfluoroalkyl substances (PFAS) have become some of the most momentous legal battles since the Big Tobacco lawsuits. PFAS compounds, also known as “forever chemicals,” are used in so many different products that you are almost guaranteed to have one in your home. Since 2000, it has been discovered that these chemicals do not break down, have contaminated numerous water sources in America, that virtually everyone has been exposed to them, and that they carry serious health risks, including several types of cancer.

Already, PFAS manufacturers and other companies that use PFAS in the course of their daily business have paid over $11 billion in PFAS lawsuits, and that is just to mitigate the damage of PFAS exposure by cleaning up contaminated soils and waters. The lawsuits to compensate victims of PFAS exposure are just beginning, and may eclipse this massive total.

What are PFAS Chemicals?

PFAS chemicals are synthetic compounds that have multiple fluorine atoms attached to a chain of alkyl, which includes carbon atoms. There are thousands of different compounds that fall into the category of PFAS chemicals. Importantly, though, the fluorine-carbon bond that is present in all of them is one of the strongest in organic chemistry, with no natural processes for breaking it down. As a result, once a PFAS compound is created, it will continue to be a PFAS compound until something is done to it to break down its chemical structure, like superheating it when it is in water.

What are They Used For?

PFAS chemicals have been used by several major corporations for a variety of applications since they were first used to invent Teflon in 1938. Broadly speaking, PFAS chemicals are extremely useful at resisting, cleaning, or preventing:

  • Heat
  • Water
  • Stains
  • Grease
  • Oil

These broad applications, however, have meant that they have been used in a huge number of specific ways. For example, PFAS chemicals are included in the following products to resist water:

  • Paint
  • Clothing
  • Raincoats
  • Tents
  • Shoes
  • Personal care products, like mascara and sunscreen

As a heat resistant chemical, PFAS compounds are frequently used in:

  • Non-stick cookware
  • Electrical wire insulation
  • Firefighting foam
  • Building materials, including adhesives and insulation

As a stain resistant material, PFAS chemicals have been used in:

  • Carpeting
  • Stain-resistant clothing
  • Window curtains
  • Furniture and varnishing
  • Dental floss
  • Food packaging

PFAS chemicals have also been used as oil- and grease-resistant products, like:

  • Lubricants
  • Hydraulic fluids
  • Pizza boxes and microwave popcorn bags

The practical effect of all of this is that PFAS chemicals are everywhere. There are very few days that you do not interact with one. Worse, because the chemical structure of PFAS compounds do not break down, when they are used or discarded they can contaminate the area around them.

What Have PFAS Chemicals Contaminated?

Virtually everything.

In the early days after PFAS chemicals started to get used for a variety of consumer products, the public and the companies behind the compounds disposed of them with no regard or understanding for the dangers that they were causing.

That lack of understanding by the corporations behind PFAS chemicals, however, began to disintegrate in the 1970s. It was around then that 3M, one of the leading PFAS manufacturing companies, discovered its PFAS chemicals inside fish in local waterways.

Rather than sound the alarm, though, 3M and its competitors continued to dispose of used or unwanted PFAS materials in whatever means they wanted or were most convenient at the time. They burned them, buried them, or dumped them into the water. Some PFAS manufacturers even developed a new firefighting foam, aqueous film forming foams (AFFFs), that relied heavily on PFAS chemicals to put out fires involving airplane jet fuel. Firefighters used this PFAS containing firefighting foam on actual fires at airports and trained with it on controlled fires at airports across the country.

The PFAS chemicals in the foam leeched into the soil and waterways near these airports for decades.

The problem was not discovered, at least not by regulators from the federal government, until 1998. That was when the U.S. Environmental Protection Agency (EPA) learned of an internal study by 3M. In that study, researchers exposed pregnant rats to PFAS materials. Inevitably, the newborn rats died within a few days. Alarmed by the news, the EPA began to investigate in an effort to regulate PFAS.

It was also at this time that a cattle farmer in West Virginia lost his animals to a mysterious health condition. Suspecting that the culprit was a major chemical plant upriver that was owned by PFAS manufacturer DuPont, the farmer sued. Over the next couple of years, the PFAS litigation expanded into a class action of over 3,500 plaintiffs and multiple water districts in the West Virginia region. A temporary settlement was reached in which DuPont would provide $30 million of funding for an independent health and environmental study to address PFAS contamination in the soil and water, the C8 Science Panel.

The findings of this Panel and subsequent studies were dire: There was PFAS contamination virtually everywhere. It was in the soil. It was in the water. It was in the animals that ate plants from the soil and that drank the water. Fish from contaminated waterways had especially high levels of PFAS chemicals in them. And PFAS chemicals were in human beings.

Who Has Been Exposed to Them?

According to one study, 95 percent of Americans had a detectable amount of PFAS chemicals in their blood.

Anyone who is exposed to PFAS chemicals has a risk of ingesting it or it getting into their body some other way – PFAS chemicals are readily absorbed through the skin, and can even get inside your body through your tear ducts. The most common way for your PFAS exposure to become PFAS contamination are:

  • Eating contaminated food or drinking contaminated water
  • Touching anything with PFAS chemicals in it, including clothing and soil
  • Inhaling contaminated dust or air
  • Swallowing anything that has PFAS chemicals in it, like makeup or lipstick
  • Being in contaminated air, which can get into your body through your skin pores and sweat

This means different people are at higher risk of PFAS exposure and contamination than others.

For example, people who live in or near communities that have PFAS industries that emit the chemical into the air are likely to get exposed to the dangerous chemical every single day. Firefighters who use or train with PFAS-heavy AFFF are likely to get severe exposure to the chemical whenever they use the foam, but especially when they use it on a real fire, which burns the chemical and releases it into the air where it is more easily inhaled or absorbed through the skin.

Once they are in your body, PFAS chemicals work their way into your bloodstream. Once there, they pass through your body as your blood circulates. This takes them through all of the organs that handle your blood, including your kidneys and liver. While these organs are responsible for breaking down toxins in your blood, they cannot handle PFAS chemicals. Unless PFAS chemicals are excreted somehow, they will continue to pass through your organs, causing harm to them each time they go by.

Excreting PFAS chemicals seems to be difficult. Studies have found that many people do not excrete PFAS chemicals in their urine very well, though others can do it better. These variations in excretion mean that similar people with similar exposures to PFAS chemicals may have different levels of contamination.

Aside from urinating, the only ways to get PFAS chemicals out of your body are to bleed out contaminated blood and to breastfeed, though breastfeeding just gives the contamination to the newborn child who drinks the milk.

What Health Risks Come With PFAS Contamination?

It is important to know that there is still a lot that researchers have to learn about the health conditions caused by PFAS contamination. Collecting more data may connect new health conditions to high levels of exposure to the chemical, or may even undermine what we think we know at this point.

Right now, though, medical research has found that exposure to toxic PFAS chemicals and high levels of PFAS contamination are associated with higher risks of:

  • Liver damage and cancer
  • Kidney cancer
  • Prostate cancer
  • Testicular cancer
  • Thyroid Disease
  • Fertility problems
  • Pregnancy issues, including:
    • Fetal death
    • Low birth weight
    • Developmental delays in newborns
    • Preeclampsia
    • Hypertension
  • Obesity
  • Hormonal disruption and irregularities
  • Dysfunction in the immune system
  • High cholesterol

Some of these conditions are debilitating. Others may prove to be fatal.

Have There Been Any Settlements?

At this point, the only lawsuits that have been settled by PFAS manufacturers have been those brought by public municipalities and water districts. These class actions and multidistrict litigation (MDL) cases demanded compensation from these companies for the costs of decontaminating soil and upgrading water filtration system to eliminate PFAS from the drinking water.

Already, though, these lawsuits have recovered over $11 billion in settlements.

The first settlement is probably the most telling. This was the West Virginia case that led to the creation of the C8 Science Panel. In 2005, the Panel was created as a part of a temporary settlement that also required DuPont and its spin-off company, Chemours, to pay $71 million and cover the costs of fixing local water treatment facilities.

After the C8 Science Panel began publishing its findings, though, DuPont and Chemours reached a final settlement agreement of $671 million.

Both the settlement and the Panel’s findings led to numerous other studies, as well as to lawsuits by water districts against PFAS manufacturers.

The biggest of these has proven to be the MDL consisting of claims of over 300 water municipalities against the company 3M. This one nearly went to a bellwether trial, settling at the last moment in June, 2023, for between $10.3 billion and $12.5 billion, with the final amount depending on the amount of PFAS contamination that is found in the water. A similar lawsuit against DuPont and its subsidiaries and spin-offs settled soon thereafter for $1.185 billion. More recently, the MDL against Tyco Fire Products, one of the companies behind the firefighting foam AFFF, settled in April, 2024, for $750 million, and the one against BASF settled in May for $316.5 million.

What About Mass Tort Claims?

These massive settlements, totaling over $11 billion, are just to cover the costs of cleaning up the soil and water of the plaintiff municipalities. We have not even begun to recover compensation for the individual victims who have suffered the healthcare issues connected to PFAS exposure and contamination.

Several of these cases are ongoing, though.

Some are being pursued by small groups of plaintiffs against smaller PFAS businesses, like this Connecticut community that is suing a local paper company for contaminating local waterways with PFAS chemicals.

Many more, however, have been consolidated into an MDL in South Carolina. As of July, 2024, it had more than 9,000 claims in it. This MDL, though, is strictly concerned with PFAS exposure from AFFF firefighting foam. However, it does include individual plaintiffs who have suffered actual harm from PFAS exposure, rather than public municipalities. These individual plaintiffs are demanding compensation for their adverse health conditions, medical monitoring, and even for the costs of cleaning up contaminated private property or for the reduction in property values caused by the contamination.

According to PFAS mass tort lawyer Dr. Nick Oberheiden, founding partner of the national law firm Oberheiden P.C., “It seems safe to say that these individual claims for compensation related to PFAS exposure and contamination are going to continue to get filed for decades into the future. One likely outcome is that an MDL will form for non-AFFF specific claims related to medical conditions and property value loss due to PFAS contamination. Victims who have been exposed to PFAS chemicals could then join the MDL and benefit from the expedited process that it entails. If PFAS manufacturers and defendants go bankrupt, we will likely see a trust fund being created, similar to how asbestos manufacturers handled the thousands of cases against them.”

Oberheiden P.C. © 2024
by: Dr. Nick Oberheiden of Oberheiden P.C.
For more news on PFAS Litigation, visit the NLR Environmental, Energy, & Resources section

White House OSTP Releases PFAS Federal R&D Strategic Plan

The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl Substances (PFAS) Federal Research and Development Strategic Plan (Strategic Plan). Prepared by the Joint Subcommittee on Environment, Innovation, and Public Health PFAS Strategy Team (PFAS ST) of the National Science and Technology Council, the Strategic Plan provides a federal strategy and implementation plan for addressing the strategic areas identified in the 2023 Per- and Polyfluoroalkyl Substances (PFAS) Report (PFAS Report). The Strategic Plan is intended to be a companion document to the PFAS Report. The activities described in the Strategic Plan are reviewed through the Office of Management and Budget (OMB) annual budget process and subject to available resources.

Background

As reported in our March 16, 2023, blog item, the PFAS Report provides an analysis of the state of the science of PFAS and information that will be used to direct the development of a federal strategic plan. The PFAS Report focuses on the current science of PFAS as a chemical class, identifies scientific consensus, and portrays uncertainties in the scientific information where consensus is still sought. The PFAS Report identifies four key strategic areas that, when addressed, will generate actionable information to address PFAS: removal, destruction, or degradation of PFAS; safer and environmentally friendlier alternatives; sources and pathways of exposure to PFAS; and toxicity of PFAS. The gaps and opportunities identified in the PFAS Report were used to develop the Strategic Plan.

Strategic Plan

Based on the four strategic areas presented in the 2023 PFAS Report, the PFAS ST identified four strategic goals that will drive federal research and development (R&D) efforts regarding PFAS:

  • Provide relevant, high-quality scientific data that increase the understanding of PFAS exposure pathways to inform federal decisions that reduce risks to human health and the environment;
  • Effectively and equitably communicate federal work and results regarding PFAS R&D through engagement with impacted communities and federal, Tribal, state, and local agencies;
  • Identify research and technologies to address PFAS contamination and mitigate the adverse impacts on communities; and
  • Generate information that facilitates informed procurement decisions by federal agencies, manufacturers, and consumers regarding products that contain or use PFAS and PFAS alternatives to reduce adverse human health and environmental effects.

According to the Strategic Plan, the PFAS ST identified five R&D strategies within the strategic research areas that address the identified knowledge gaps. The R&D strategies and select tasks to achieve the objectives within each strategy include:

  • Understand PFAS exposure pathways to individuals and communities:
    • Further characterize potential PFAS exposures in the built environment, including schools, workplaces, and other indoor/household environments. According to the Strategic Plan, this would include the co-occurrence and use of consumer products and understanding the lifecycle of products with regard to PFAS exposure;
    • Initiate studies regarding PFAS co-exposure and potential interactions with other contaminants (including other PFAS) in environmental samples, such as nano- and microplastics, petroleum constituents, metals, pesticides, and pharmaceuticals;
    • Initiate and continue studies of the physical-chemical properties of PFAS and mixtures of PFAS;
    • Investigate additional pathways and routes of exposure, such as direct contact, dermal absorption, oral ingestion, and inhalation from indoor and outdoor environments (residential, consumer, and occupational exposures); and
    • Develop and support studies of PFAS exposures in indoor environments through collection of dust, air, consumer products, and other media where biomonitoring may also be conducted;
  • Address current PFAS measurement challenges through the development of standards, advanced sampling, and analytical methodologies:
    • Develop and refine analytical methods and data collection methods to evaluate PFAS content, migration, and emissions from consumer, commercial, and industrial products, and their impact on workplace and indoor environments;
    • Develop testing programs and methods related to quantifying PFAS content, migration, and emissions in animal/livestock feed, food and food packaging, indoor exposure (dust, home/office materials), workplace settings, and consumer products; and
    • Develop and validate real-time, rapid, and remote PFAS screening methods using analytical sensors, PFAS proxies, passive sampling devices, and other novel technologies for the detection of PFAS in media;
  • Understand the toxicological mechanisms, human and environmental health effects, and risks of PFAS exposure:
    • Develop scientifically supported classification schemes for PFAS with respect to adverse impacts on human health and the environment;
    • Develop and support research regarding the human toxicity and ecotoxicity testing of PFAS as mixtures with PFAS and other co-occurring chemicals;
    • Support research to understand further the mechanism of action of PFAS toxicity, advance development of adverse outcome pathways, and understand the impact of PFAS mixture toxicities when evaluating cumulative health effects;
    • Develop and support epidemiological studies designed to identify communities near significant sources of PFAS contamination that may have environmental justice concerns, including occupationally exposed populations and populations, communities, and/or lifestages that are more susceptible to PFAS exposure or adverse health outcomes;
    • Explore the development of a federal data-sharing strategy to use interagency toxicological and epidemiological data to determine human health endpoints of concern from PFAS exposure; and
    • Develop classification strategies that enable grouping of PFAS by hazard identification, exposure assessment, and dose-response studies in support of risk assessments;
  • Develop, evaluate, and demonstrate technologies for the removal, destruction, and disposal of PFAS:
    • Continue to support the foundational research that advances technologies for the destruction of PFAS by both thermal and non-thermal approaches;
    • Support the implementation of removal and destruction technologies that apply to discharge and releases at the point of manufacturing; and
    • Develop and implement models to evaluate technology performance, short-term and long-term costs, energy demands, scalability, and the composition of treated materials that are released to the environment;
  • Identify PFAS alternatives and evaluate their human health and environmental effects:
    • Engage with academic and private sector industrial researchers to support the development of novel, less toxic alternative chemistries and processes for sustainable PFAS alternatives;
    • Identify and evaluate critical and essential uses of PFAS within individual agencies and sectors;
    • Develop an interagency-aligned evaluation framework for prioritizing research on specific PFAS alternatives that includes considerations regarding sustainability; performance; viability and timeframe to transition; dependency on foreign sources of materials; criticality of the current product to national security, critical infrastructure, climate change mitigation, and public health; and criticality of the need for a replacement product or process;
    • Support research to advance sustainable manufacturing and circularity of PFAS-based processes and products to preserve current critical and essential uses, which will enable an orderly transition to PFAS alternatives in critical manufacturing sectors that are dependent on PFAS;
    • Develop a database of the current commercial inventory of alternative materials and products with relevant chemical and toxicological information, manufacturer production capacity, and performance comparison of the alternatives to PFAS-containing materials and products; and
    • Continue to assess human health and environmental effects posed by alternative materials and products for use in comparison to other product formulations, including PFAS-containing product formulations.

Commentary

Bergeson & Campbell, P.C. (B&C®) acknowledges that OSTP’s PFAS Strategy may benefit from the U.S. Environmental Protection Agency’s (EPA) regulatory activities under the Toxic Substances Control Act (TSCA) and other initiatives. We provide below representative examples of these activities.

Between 2022 and 2024, EPA issued TSCA Section 4 test orders requiring manufacturers and/or processors to perform various studies on four PFAS (i.e., 6:2 fluorotelomer sulfonamide betaine [6:2 FTSB], trifluoro(trifluoromethyl)oxirane [HFPO], 2,3,3,3-tetrafluoro-2-heptafluoropropoxy) propanoyl fluoride [HFPO-DAF], and 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-Heptadecafluoro-N-(2-hydroxyethyl)-N-methyloctane-1-sulfonamide [NMeFOSE]).

EPA also intends on initiating ten additional TSCA Section 4 test orders per year on PFAS between fiscal year (FY) 2024 and FY 2026 (i.e., October 1, 2024-September 30, 2027). EPA’s activities under TSCA Section 4 may lead to the development of data that provide a better understanding of the human health and environmental effects of specific types of PFAS.

The TSCA Section 8(a)(7) rule on the reporting and recordkeeping of manufacture and import of PFAS will provide additional information on PFAS uses, production volumes, disposal, exposures, and hazards. In addition, EPA’s publication of its updated PFAS category analysis may help frame how to use data on PFAS for which testing has been (or is in the process of being) completed to fill data gaps on related PFAS.

Further, EPA’s Office of Research and Development (ORD) and Office of Land Use and Emergency Management (OLEM) have made significant contributions on analytical methods for detecting PFAS in various media and guidance for destroying and disposing of PFAS and PFAS-containing materials, respectively. The TSCA Section 8(a)(7) information along with EPA’s advancements with identifying PFAS in environmental media may aid with identifying those PFAS and the associated uses that lead to the greatest environmental releases.

Collectively, EPA’s activities on PFAS will advance the objectives of OSTP’s PFAS Strategy. This information may also aid with differentiating the types of PFAS that present the greatest concerns to human health and the environment versus those chemistries that do not. After all, many chemical substances, including pharmaceuticals and pesticides, meet one or more of the existing definitions for PFAS and have clear public health benefits, yet do not present the same concerns as those PFAS that have significant concerns (e.g., perfluorooctanoic acid).

©2024 Bergeson & Campbell, P.C.
For more news on PFAS Federal R&D Strategic Plans, visit the NLR Environmental Energy Resources section.

EPA Delays TSCA PFAS Reporting Deadlines

The Environmental Protection Agency (EPA) just issued a direct final rule amending reporting deadlines for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA).

As described in our prior client alert, EPA finalized a rule last fall that requires entities that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011 to submit a one-time comprehensive report regarding PFAS uses, production volumes, byproducts, disposal, exposures, and environmental or health effects.

Since EPA is still developing its reporting application to collect this data, and it will not be fully functional by November 2024, EPA has bumped back the start of the data submission period from November 12, 2024 to July 11, 2025.

The data submission period now ends on January 11, 2026, except for article importers that are also considered small manufacturers. Their submission period will end on July 11, 2026.

EPA is not proposing any changes to the scope of reporting under TSCA.

©2024 Pierce Atwood LLP. All rights reserved.
For more news on EPA TSCA Reporting, visit the NLR Environmental Energy Resources section.

PFAS CERCLA Expansion Now On Hold

We have regularly reported on the EPA‘s long-anticipated  rule to designate PFOA and PFOS as “hazardous substances” under CERCLA. In April 2024, the EPA also issued an Advanced Notice of Proposed Rulemaking (ANPRM), which aimed to have seven additional PFAS added to the CERCLA list of “hazardous substances.” EPA originally set a deadline of April 2025 to finalize the rule to add seven additional PFAS to CERCLA; however, EPA’s July 2024 Unified Agenda now indicates that the deadline to finalize the rule for the additional seven PFAS is “to be determined.”

The shift in priorities away from an expanded PFAS CERCLA designation is a significant development that anyone follows PFAS regulatory or litigation news.

CERCLA PFAS Scope Designation To Date

On January 10, 2022, the EPA submitted a plan for a PFAS Superfund designation to the White House Office of Management and Budget (OMB) when it indicated an intent to designate two legacy PFAS – PFOA and PFOS – as “hazardous substances” under the Comprehensive Environmental Response, Compensation & Liability Act (CERCLA, also known as the Superfund law). The EPA previously stated its intent to make the proposed designation by March 2022 when it introduced its PFAS Roadmap in October 2021. Under the Roadmap, the EPA planned to issue its proposed CERCLA designation in the spring of 2022. On August 12, 2022, a CERCLA PFAS designation took a significant step forward when the OMB approved the EPA’s plan for PFOA and PFOS designation. This step opened the door for the EPA to put forth its proposed designation of PFOA and PFOS under CERCLA and engage in the required public comment period.

When OMB initially contemplated approving the EPA’s proposed rule, it designated the rule as “other significant”, which meant that the rule was predicted to have costs or benefits less than $100 million annually. However, the OMB received several pieces of feedback expressing concern that such an estimate fa undervalued the impact that such a designation will have. More specifically, the Chamber of Commerce provided its own estimate that the CERCLA designation would have a cost impact of over $700 million annually. As a result, the OMB changed its designation of the EPA’s propose rule to “economically significant”, which triggered the EPA to have to conduct a RIA prior to proposing the PFAS CERCLA designation. Under the RIA, the EPA will have to provide support for its position that a CERCLA designation is justified to achieve EPA goals and to provide support for the contention that such a designation is the least burdensome and most cost-effective way to achieve the EPA’s goals.

Despite the call for a RIA by the OMB, the EPA nevertheless released its final CERCLA designation in May 2024, the significance of which, if it survives legal challenges, will be felt for some time.

Additional CERCLA Designation

In February 2023, the EPA sent a proposed rule to the OMB that states the following:

“EPA plans to publish in the Federal Register an advance notice of proposed rulemaking requesting public input on whether the agency should consider designating as hazardous substances precursors to PFOA and PFOS, whether the agency should consider designating other PFAS as CERCLA hazardous substances and whether there is information that would allow the agency to designate PFAS as a class or subclass.”

The OMB reviewed the proposal and on March 24, 2023, approved the proposal so as to permit the EPA to proceed with publishing the Advanced Notice of Proposed Rulemaking (ANPRM).

On April 13, 2023, the EPA published in the Federal Register an ANPRM that seeks public comment on a proposal to list as “hazardous substances” the following additional PFAS: PFBS, PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and PFDA. The EPA indicated that the seven PFAS were chosen based on available toxicity data for the chemicals.

CERCLA PFAS Designation: Impact On Businesses

Once a substance is classified as a “hazardous substance” under CERCLA, the EPA can force parties that it deems to be polluters to either cleanup the polluted site or reimburse the EPA for the full remediation of the contaminated site. Without a PFAS Superfund designation, the EPA can merely attribute blame to parties that it feels contributed to the pollution, but it has no authority to force the parties to remediate or pay costs. The designation also triggers considerable reporting requirements for companies. Currently, those reporting requirements with respect to PFAS do not exist, but they would apply to industries well beyond just PFAS manufacturers. The CERCLA PFAS scope in any final regulation is therefore critical to numerous industries that were or are downstream users of PFAS.

The downstream effects of a PFOA and PFOS designation would be massive, but a designation of the entire class of PFAS or even various subclasses of PFAS would be potentially unquantifiable in financial magnitude. With over 15,000 PFAS in existence according to the EPA and many of them in continued use to this day, the potential environmental pollution ramifications touch on countless industry types. Companies that utilized PFAS in their industrial or manufacturing processes and sent the PFAS waste to landfills or otherwise discharged the chemicals into the environment will be at immediate risk for enforcement action by the EPA given the EPA’s stated intent to hold all PFAS polluters of any kind accountable. Waste management companies should be especially concerned given the large swaths of land that are utilized for landfills and the likely PFAS pollution that can be found in most landfills due to the chemicals’ prevalence in consumer goods. These site owners may be the first targeted when the PFOA/PFOS designation is made, which will lead to lawsuits filed against any company that sent waste to the landfills for contribution to the cost of cleanup that the waste management company or its insured will bear. However, with a broader PFAS designation a possibility now, there should naturally be concern regarding re-openers in the future for these same sites.

Of course, all of the above are subject now to legal challenges of the final CERCLA designation, which will play out over the next several months. In addition, EPA (and the rest of the country) are now living in a post-Chevron world, which is sure to have significant impacts on challenges to EPA’s intentions with respect to PFAS under CERCLA. It is perhaps for these reasons that EPA recently adjusted its deadline to finalize the expended PFAS CERCLA designation to a status of “to be determined.” This is quite significant and shows to me that EPA is adjusting its resources to prepare for the legal challenges to come, as well as focusing more earnestly on initiatives that it can pass prior to a potential shift in party power in the November 2024 elections.

Conclusion

While it is likely fair to say that almost all significant PFAS initiatives that EPA wishes to undertake will not be pushed forward until after the November election cycle, it is nevertheless of great importance for companies, insurers, and financial world specialists to continue to monitor PFAS developments. Even with a party shift in November, PFAS is unlikely to be wiped off of the map, so to speak, in terms of an environmental issue. The awareness of PFAS issues among media, politicians and citizens is simply too great at this point. In addition, developments that will be critical to monitor because of the impact that they may have on PFAS litigation, which will surely subsume PFAS regulatory impacts if November brings a party power shift.

©2024 CMBG3 Law, LLC. All rights reserved.
For more news on PFAS CERCLA Expansion, visit the NLR Environmental Energy Resources section.

Recent Federal Developments, July 2024

TSCA/FIFRA/TRI

EPA’s Proposed NMP Risk Management Rule Includes Requirements To Protect Workers And Consumers: On June 15, 2024, the U.S. Environmental Protection Agency (EPA) issued a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would protect workers and consumers from exposure to N-methylpyrrolidone (NMP). 89 Fed. Reg. 51134. To address the identified unreasonable risk, EPA proposes to: prohibit the manufacture (including import), processing, distribution in commerce, and use of NMP in several occupational conditions of use (COU); require worker protections through an NMP workplace chemical protection program (WCPP) or prescriptive controls (including concentration limits) for most of the occupational COUs; require concentration limits on a consumer product; regulate certain consumer products to prevent commercial use; and establish recordkeeping, labeling, and downstream notification requirements. Comments are due July 29, 2024. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of the comments on or before July 15, 2024. According to EPA’s June 5, 2024, press release, NMP is used to manufacture and produce many electronics, polymers, agricultural chemicals, and petrochemical products. EPA states that NMP is used in the production of specialized electronics, such as semiconductors and magnet wire, as well as lithium-ion batteries used in a wide variety of applications, including aerospace vehicles and electronic devices. EPA notes that NMP “also has numerous other industrial, commercial and consumer applications, including adhesives and sealants, paints and coatings, paint removers, lubricants, automotive care products, degreasers, cleaning and furniture care products.” For more information, please read the full memorandum.

EPA Announces Final Cancellation Order And Updates To Existing Stocks Provisions For Several Chlorpyrifos Products: On June 25, 2024, EPA announced the issuance of a final cancellation order for Corteva’s chlorpyrifos product “Dursban 50W in Water Soluble Packets” and three Gharda chlorpyrifos products, and an amendment to the existing stocks provisions for two Liberty and three Winfield chlorpyrifos end-use products. EPA also states that it has updated its frequently asked questions about chlorpyrifos. More information is available in our July 2, 2024, blog.

EPA Announces New Initiatives To Improve Efficiency, Worker Protections, And Transparency In New Chemical Reviews: During the June 26, 2024, “TSCA Reform — Eight Years Later” conference, presented by Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health, Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA, provided the keynote address. During her remarks, Freedhoff announced four new initiatives in EPA’s review of new chemicals under TSCA. As later announced by EPA, these initiatives are:

  • Engineering checklist: In May 2024, EPA began implementing an internal engineering checklist to review systematically new chemical submissions and identify potential data gaps at the beginning of the review process.
  • Worker protections: According to EPA, most TSCA Section 5(e) orders are consent orders negotiated between EPA and the notice submitter that use standard “boilerplate” text. In June 2024, EPA updated the boilerplate language to strengthen worker protections and provide further clarity to the text.
  • Updated statistics for new chemical review timelines: On June 26, 2024, EPA began including completed “rework” risk assessments when reporting monthly statistics on new chemical reviews. EPA has updated its Statistics for the New Chemicals Program under TSCA web page to include a category listing all completed rework risk assessments since the beginning of 2024.
  • Reference Library: On June 26, 2024, EPA launched the New Chemicals Division Reference Library, an index of EPA documents related to the work of the New Chemicals Division. It currently contains over 90 entries, and EPA will update it as it develops new materials.

More information is available in our June 26, 2024, blog item. A summary of the conference is available in our July 9, 2024, memorandum.

EPA Postpones Proposed Expansion Of The Safer Choice And DfE Programs: As reported in our July 27, 2023, memorandum, in July 2023, EPA proposed an expansion of the Safer Choice and Design for the Environment (DfE) programs to include certification of additional product categories. According to EPA’s website, “EPA thanks the many commenters for their input. EPA reviewed the comments and understands several categories are of interest to stakeholders and Safer Choice partners. With the 2024 decrease in EPA’s funding, however, EPA is not able to pursue expansion at this time. EPA plans to reconsider the expansion in the future as resources allow.” On June 28, 2024, a summary of comments received on EPA’s proposed expansion was posted in the online docket. More information is available in our July 5, 2024, blog item.

EPA Releases Draft Risk Evaluation For 1,1-Dichloroethane And Draft Hazard Assessment Of 1,2-Dichloroethane For Public Comment And Peer Review: On July 1, 2024, EPA announced the release of the draft risk evaluation for 1,1-dichloroethane and the draft human health hazard assessment supporting the draft risk evaluation for 1,2-dichloroethane (also known as ethylene dichloride) prepared under TSCA. EPA states that it “preliminarily determined 1,1-dichloroethane poses unreasonable risk to human health (of workers) and the environment.” According to EPA, the effects to people from exposure to 1,1-dichloroethane and 1,2-dichlorethane are “kidney and other cancers, as well as harmful non-cancer renal, nasal, immune system, and reproductive effects.” Publication of a notice of availability in the Federal Register will begin a 60-day comment period. More information will be available in a forthcoming memorandum.

Court Vacates TSCA Section 4 Test Order, Grant’s Vinyl Institute’s Petition For Review: On July 5, 2024, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Vinyl Institute, Inc. v. EPA (No. 22-1089). As reported in our May 31, 2022, blog item, on May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit against EPA, seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under TSCA Section 4(a)(2). The court states that “EPA’s non-public part of the administrative record is not part of ‘the record taken as a whole’ subject to our heightened substantial evidence review of TSCA test orders.” According to the court, to the extent EPA relies on non-public portions of the administrative record, it “has failed to provide substantial evidence that meets its statutory mandate.” The court vacated the test order, remanding to EPA to satisfy that mandate with “substantial evidence in the record taken as a whole.” The court also denied VI’s motion to supplement the record “with scientific information it could have — and should have — submitted earlier.” More information is available in our July 10, 2024, blog item.

EPA Publishes Compliance Guide For Final Methylene Chloride Risk Management Rule: On July 10, 2024, EPA published a compliance guide for its final methylene chloride risk management rule issued under TSCA. According to EPA, the compliance guide will help industry, workers, and other interested stakeholders understand and comply with the new regulations to prevent injuries, long-term illnesses, and deaths. EPA also announced that in June 2024, it released a fact sheet on the rule containing information on who is subject to the rule along with a summary of compliance timelines. More information will be available in a forthcoming memorandum.

EPA Grants TSCA Section 21 Petition Seeking Section 6 Rule Prohibiting Three PFAS Found In Fluorinated Plastic Containers: EPA announced on July 11, 2024, that it granted a petition filed a petition under TSCA Section 21 requesting that EPA establish regulations under TSCA Section 6 prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of three per- and polyfluoroalkyl substances (PFAS) formed during the fluorination of plastic containers. EPA “will promptly commence an appropriate proceeding under TSCA Section 6.” According to EPA’s announcement, EPA intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA); and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. More information will be available in a forthcoming memorandum.

EPA’s Spring 2024 Unified Agenda Includes Proposed And Final TSCA, TRI, And PFAS Rules: EPA’s Spring 2024 Unified Agenda, published on July 5, 2024, includes a number of proposed and final TSCA, Toxics Release Inventory (TRI), and PFAS rulemakings. More information on the rulemakings, including links to our memoranda, will be available in an upcoming blog item.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Publishes 2024-2027 Climate Adaptation Plan: EPA announced on June 20, 2024, the release of its 2024-2027 Climate Adaptation Plan, which describes Agency actions to address the impacts of climate change and help build a more climate-resilient nation. Highlights include:

  • Fostering a climate-ready workforce;
  • Building facility resilience;
  • Developing climate-resilient supply chains;
  • Integrating climate resilience into external funding opportunities;
  • Applying climate data and tools to decision making; and
  • Integrating climate adaptation into rulemaking processes.

EPA Amends Standards And Practices For All Appropriate Inquiries: EPA issued a final rule on June 24, 2024, amending the “Standards and Practices for All Appropriate Inquiries” to reference a standard practice recently made available by ASTM International, “a widely recognized standards development organization.” 89 Fed. Reg. 52386. EPA states that it is amending the All Appropriate Inquiries Rule to reference ASTM International’s E2247-23 “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process for Forestland or Rural Property” and allow for its use to satisfy the requirements for conducting all appropriate inquiries under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). In addition, after one year, EPA will remove recognition of the previous version of that standard, ASTM E2247-16, as compliant with the All Appropriate Inquiries Rule. The final rule will be effective August 23, 2024.

EPA Proposes To Remove Affirmative Defense Provisions From Specified NSPS And NESHAP: On June 24, 2024, EPA proposed amendments to several New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act (CAA). 89 Fed. Reg. 52425. Specifically, EPA proposes to remove the affirmative defense provisions associated with violation of emission standards due to malfunctions. According to EPA, it proposes to remove these provisions because they are inconsistent with a D.C. Circuit Court decision that vacated affirmative defense provisions in one of EPA’s CAA regulations, and because EPA finds that the reasoning in the decision applies equally to other CAA rules. Since the court decision, EPA has been removing affirmative defense provisions from CAA rules when they were otherwise revised or amended. EPA states that this action “proposes to remove the remaining affirmative defense provisions more efficiently.” Comments are due August 8, 2024.

PHMSA Amends HMR To Require Real-Time Train Consistent Information In Electronic Form: The Pipeline and Hazardous Materials Safety Administration (PHMSA) published a final rule on June 24, 2024, amending the Hazardous Materials Regulations (HMR) to require railroads that carry hazardous materials to generate in electronic form, maintain, and provide to first responders, emergency response officials, and law enforcement personnel certain information regarding hazardous materials in rail transportation to enhance emergency response and investigative efforts. 89 Fed. Reg. 52956. According to PHMSA, the amendments address a safety recommendation of the National Transportation Safety Board and statutory mandates in The Fixing America’s Surface Transportation Act, as amended by the Infrastructure, Investment, and Jobs Act, and complement existing regulatory requirements pertaining to the generation, maintenance, and provision of similar information in hard copy form, as well as other hazard communication requirements. The effective date of the final rule is July 24, 2024. The voluntary compliance date was June 24, 2024. The delayed compliance date for Class I Railroads is June 24, 2025, and for Class II and III Railroads is June 24, 2026.

EPA Proposes To Extend Compliance Date For Installation Of Certain Variable Refrigerant Flow Systems: On June 26, 2024, EPA proposed to amend a provision of the Technology Transitions regulations promulgated under the American Innovation and Manufacturing Act. 89 Fed. Reg. 53373. The proposed amendment would allow one additional year, until January 1, 2027, solely for the installation of new residential and light commercial air conditioning and heat pump variable refrigerant flow systems that are 65,000 British thermal units per hour or greater using components manufactured in the United States or imported prior to January 1, 2026. According to EPA, the existing January 1, 2026, compliance date for the installation of certain variable refrigerant flow systems “may result in significant stranded inventory that was intended for new construction. EPA is promulgating this action to mitigate the potential for significant stranded inventory in this subsector.” Comments are due July 26, 2024.

PHMSA Requests Feedback On De Minimis Quantities Of Explosives: PHMSA published a request for information (RFI) on June 28, 2024, to solicit information from hazardous materials (HAZMAT) shippers pertaining to what small quantities or low concentrations of explosives they offer for transport appear to present a low risk to life, property, and the environment. 89 Fed. Reg. 54157. PHMSA seeks to determine what small quantities or low concentrations of explosives HAZMAT shippers offer for transport that appear to present a low risk (e.g., negligible severity, remote probability) to life, property, and the environment. PHMSA will use the information to define the focus of a research project investigating the risk of small and/or de minimis quantities of explosive substances and in selecting test samples for PHMSA research and development Contract# 693JK322C00003. Comments are due September 26, 2024. PHMSA states that it will consider comments received after that date to the extent possible.

EPA Determines Current NESHAP For PQBS Source Category Provides “Ample Margin Of Safety”: On July 5, 2024, EPA published a final rule regarding the residual risk and technology review conducted for the NESHAP for the Coke Ovens: Pushing, Quenching, and Battery Stacks (PQBS) source category and the periodic technology review for the Coke Oven Batteries (COB) source category NESHAP. 89 Fed. Reg. 55684. EPA states that it is issuing a final determination that risks due to emissions of hazardous air pollutants (HAP) from the PQBS source category are acceptable and that “the current NESHAP provides an ample margin of safety to protect public health.” The final rule was effective July 5, 2024, except for amendatory instruction 3, which was effective July 15, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register beginning July 5, 2024. The IBR of certain other material listed in the rule was approved by the Director of the Federal Register as of July 13, 2005.

EPA Releases Science-Based Recommendations To Help Reduce Exposure To Contaminants, Including PFAS, In Fish: EPA announced on July 11, 2024, that it issued updated recommendations under the Clean Water Act (CWA) for contaminants that states, Tribes, and territories should consider monitoring in locally caught, freshwater fish. According to EPA, for the first time, it has added several PFAS to the contaminant list alongside lead, three cyanotoxins, a flame retardant, and amphetamine. With this announcement, EPA suggests that states, Tribes, and territories monitor for these contaminants. EPA notes that this update comes after reviewing scientific literature, analyzing data, and seeking external peer review of the Agency’s analysis, and it will help ensure that state and Tribal fish advisories consider the latest science.

FDA

FDA Updates Resources For FSMA Rule: On June 27, 2024, the U.S. Food and Drug Administration (FDA) released additional resources to help industry comply with the Food Traceability Rule, a component of the Food Safety Modernization Act (FSMA). Resources include a template spreadsheet to help fulfill data submission requests and minor revisions to the Food Traceability List. Additional information is available at the link here.

FDA Releases Update For Priority Guidance Topic List: On June 28, 2024, FDA provided an update for its priority guidance topic list, which was released in January. Since January, FDA has issued the following guidance documents:

FDA notes that its “intent is to publish all draft and final guidance topics on the list” but that “modifications in plans may be needed to support emerging issues and Administration priorities.”

FDA Revokes Authorization For Brominated Vegetable Oil: On July 3, 2024, FDA amended its regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. 89 Fed. Reg. 55040. The final rule revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. FDA notes that there are no other FDA authorized uses. The rule is effective on August 2, 2024.

NANOTECHNOLOGY

ECHA Evaluating Function Of EUON; Survey Closed July 3, 2024: The European Chemicals Agency (ECHA) is evaluating the function of the European Union (EU) Observatory for Nanomaterials (EUON). As part of its evaluation, ECHA conducted a survey to collect responses from EUON website visitors and stakeholders. The survey closed July 3, 2024. More information is available in our June 24, 2024, blog item.

ECHA Updates Report On Key Areas Of Regulatory Challenge, Addresses Micro- And Nano-Sized Materials: On June 12, 2024, ECHA announced that it updated its report on key areas of regulatory challenge, providing more detailed information on areas where scientific research is needed to protect human health and the environment from hazardous chemicals. The report addresses micro- and nano-size materials. More information is available in our June 17, 2024, blog item.

NIOSH Highlights NTRC’s Work On Engineering Controls And PPE: On July 1, 2024, the National Institute for Occupational Safety and Health (NIOSH) posted a NIOSH Science Blog item entitled “Celebrating 20 Years of the Nanotechnology Research Center: Highlights from Engineering Controls and Personal Protective Equipment,” part of a series commemorating the 20th anniversary of the Nanotechnology Research Center (NTRC). NIOSH researchers plan to develop a new reliable aerosol testing method that can accurately evaluate the respirator penetration against workplace nanomaterials; evaluate the effectiveness of NIOSH-approved® respirators to determine whether existing respirator guidelines apply to workers exposed to nanomaterials; and compare nanomaterial penetrations determined by direct-reading and elemental carbon analysis methods. More information is available in our July 5, 2024, blog item.

NNI And NNCO Will Hold July 24 Workshop On “Responsible Development, Social Science, And The National Nanotechnology Initiative”: The National Nanotechnology Initiative (NNI) and the National Nanotechnology Coordination Office (NNCO) are convening a July 24, 2024, workshop, “Responsible Development, Social Science, and the National Nanotechnology Initiative: A Workshop to Explore Past and Future Intersections.” The agenda includes a presentation about the recently released “Blueprint for the Use of Social and Behavioral Science to Advance Evidence-Based Policymaking,” introductions to key nanotechnology case studies by federal experts, and flash talks by social scientists. More information is available in our July 3, 2024, blog item.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://www.lawbc.com/brand/bioblog/.

LEGISLATIVE

House Appropriations Committee Approves FY 2025 Interior, Environment, And Related Agencies Appropriations Act: The House Appropriations Committee announced on July 9, 2024, that it approved the Fiscal Year (FY) 2025 Interior, Environment, and Related Agencies Appropriations Act by a vote of 29 to 25. According to the press release, the bill:

  • Ensures chemical and pesticide manufacturers are not overburdened with requirements that would drive business overseas and threaten American competitiveness;
  • Blocks EPA’s car regulations on light, medium, and heavy-duty vehicles;
  • Prohibits EPA from allowing California to require that new small off-road engines, such as lawn care equipment, be zero-emission;
  • Prohibits funds for EPA’s Clean Power Plan 2.0 and regulatory overreach regarding ozone emissions and steam electric power plants;
  • Reduces funding for EPA by 20 percent;
  • Reduces funding for the Council on Environmental Quality to the authorized level of $1 million;
  • Rejects eight of the Administration’s climate change executive orders; and
  • Prohibits agencies from using the Social Cost of Carbon (SCC) in cost-benefit analyses and blocks the Interagency Working Group on Social Cost of Greenhouse Gases.

House Committee Holds EPA Oversight Hearing On July 10, 2024: The House Committee on Oversight and Accountability held a full committee hearing on July 10, 2024, on “Oversight of the U.S. Environmental Protection Agency.” The Committee’s July 3, 2024, press release quotes Committee Chair James Comer (R-KY) as stating: “We know the Biden Administration is overreaching its environmental protection authorities extensively, flouting the limits the Supreme Court set upon them two years ago in West Virginia v. EPA and adopting statutory interpretations that surely will not pass muster under the Court’s recent decision in Loper Bright Enterprises v. Raimondo. The Committee looks forward to holding the agency accountable next week for its efforts to cement Green New Deal and other misguided priorities that have hurt both American businesses and consumers across the country.” More information will be available in a forthcoming memorandum.

MISCELLANEOUS

California Court Grants Injunction To Stop Prop 65 Warnings For Titanium Dioxide In Cosmetic And Personal Care Products: On June 12, 2024, the U.S. District Court for the Eastern District of California (District Court) issued an Order granting a preliminary injunction brought by the Personal Care Products Council (PCPC), which alleged that the California Office of Environmental Health Hazard Assessment’s (OEHHA) requirement for warnings under Proposition 65 (Prop 65) related to titanium dioxide in cosmetics and personal care products violated the First Amendment. The Personal Care Products Council v. Bonta, No. 2:23-cv-01006-TLN-JDP (E.D. Cal. 2024). In its Order, the District Court enjoined the California Attorney General and any private citizen enforcers from enforcing Prop 65’s warning requirement for “cancer as applied to Listed Titanium Dioxide (i.e., titanium dioxide that consists of airborne, unbound particles of respirable size) in cosmetic and personal care products.” The District Court also denied a motion to intervene by Environmental Health Advocates, Inc. (EHA), who had argued it was “an interested party because it is the primary enforcer of Prop 65.” For more information, please read the full memorandum.

Proposition 65: OEHHA Proposes Additional Changes To “Short-Form” Warning Option: On June 14, 2024, the California OEHHA issued a notice proposing additional changes to its Prop 65 Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). The changes proposed now are to the proposed regulations that OEHHA issued on October 27, 2023. The history of these amendments, dating back to January 2021, are set forth in our memorandum available here. Written comments on the proposed changes were due no later than June 28, 2024. More information is available in our July 5, 2024, memorandum.

June 2024 IRIS Program Outlook Released: EPA’s Health and Environmental Risk Assessment (HERA) Program announced on June 27, 2024, the release of the June 2024 Integrated Risk Information System (IRIS) Program Outlook. To maintain transparency, the IRIS Program provides an updated outlook of program activities. The IRIS Program Outlook describes assessments that are in development and projected public milestone dates.

Registration Opens For July Webinars On Minnesota’s PFAS In Products Law; MPCA Publishes Summary Of Comments On CUUs: The Minnesota Pollution Control Agency (MPCA) will hold two public webinars in July to provide updates and answer questions on Minnesota’s PFAS in products law (Amara’s Law), which takes effect in stages between 2025 and 2032:

  • Progress on rule development, July 18, 2024, 10:00 a.m. – 11:30 a.m. (CDT): Join MPCA staff for a presentation on preliminary rule writing for the PFAS in products reporting, fees, and currently unavoidable use (CUU) rules. Registration is open.
  • Information on 2025 prohibitions for retailers and manufacturers, July 25, 2024, 11:00 a.m. – 12:00 p.m. (CDT): This webinar will discuss how the 2025 PFAS in products prohibitions will affect retailers and manufacturers starting January 1, 2025, when 11 categories of consumer products must be free of intentionally added PFAS. Registration is open.

As reported in our January 12, 2024, blog item, MPCA published a request for comments (RFC) on planned new rules governing CUU determinations for products containing PFAS. According to the RFC, the main purpose of the rulemaking is to establish criteria and processes through which MPCA will make decisions on what uses of intentionally added PFAS will qualify as CUUs in products sold, offered for sale, or distributed in Minnesota. Any such determinations must be published by rule by MPCA by January 1, 2032. MPCA has posted a summary of the comments received on the RFC. More information is available in our June 24, 2024, blog item.

Minnesota Department Of Health Highlights Recent Publications On PFAS Bioaccumulation And PFAS In Infant Formula: The Minnesota Department of Health (MDH) recently noted that Health Risk Assessment scientists at MDH have published two articles in the Journal of Environmental Exposure Assessment related to PFAS:

OIRA Will Offer Training Sessions On Effective Participation In The Public Comment Process: As part of its efforts to strengthen public engagement in the federal regulatory process, the Office of Information and Regulatory Affairs (OIRA) in OMB announced on July 10, 2024, that it will offer training sessions on effective public participation in the public comment process. 89 Fed. Reg. 56777. In response to feedback received from the public and as part of its ongoing efforts to strengthen public participation in the regulatory process, OIRA will hold two training sessions on effective participation in the public comment process. During the training sessions, OIRA will describe opportunities to provide comment in the federal regulatory process; how to submit public comments; and how to draft effective public comments. The training sessions will be held on July 18, 2024, from 3:00 p.m. to 3:45 p.m. (EDT) and July 24, 2024, from 5:30 p.m. to 6:15 p.m. (EDT).

CISA Hosts 2024 Chemical Security Seminars On July 11 And 18, 2024: The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is hosting the fully virtual 2024 Chemical Security Seminars on July 11 and July 18, 2024, from 10:00 a.m. – 3:00 p.m. (EDT). The sessions will cover a range of topics related to the security of dangerous chemicals. More information is available in our July 8, 2024, blog item.

Comments On Canada’s Updated Draft State Of PFAS Report And Revised Risk Management Scope Are Due September 11, 2024: The July 13, 2024, Canada Gazette includes a notice announcing the availability of the Updated Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Updated Draft Report) and Revised Risk Management Scope for Per- and Polyfluoroalkyl Substances (PFAS) (Revised Risk Management Scope). The Minister of the Environment and the Minister of Health (the ministers) propose to recommend that the class of PFAS, excluding fluoropolymers, be added to Part 2 of Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). According to the Revised Risk Management Scope, Canada is considering:

  • As a first step, a regulatory instrument under CEPA to restrict PFAS not currently regulated in firefighting foams; and
  • Additional regulatory instrument(s) under CEPA to prohibit other uses or sectors in relation to PFAS. Prioritization for prohibition may be based on factors such as socioeconomic considerations, the availability of feasible alternatives, and the potential for human and environmental exposure.

The Revised Risk Management Scope states that “[v]oluntary risk management actions are also being considered to achieve early results to reduce releases of PFAS, as a complement to the proposed regulatory instruments.” Comments are due September 11, 2024. More information is available in our July 12, 2024, blog item.

©2024 Bergeson & Campbell, P.C.
For more news on Recent Federal Environmental Developments, visit the NLR Environmental Energy Resources section.

U.S. EPA Finalizes Designation of Two PFAS Chemicals as Hazardous Substances Under CERCLA

On April 19, the U.S. Environmental Protection Agency (EPA) released its long-awaited final rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as “hazardous substances” under Section 102(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or “Superfund”) (the “Final Rule”). The designation, which takes effect 60 days after the final rule is published in the Federal Register, will provide expanded investigation and remediation authority to EPA, will provide a powerful tool for private actions under CERCLA, and will trigger additional release reporting requirements. It will also expand enforcement authority in states that regulate CERCLA-designated hazardous substances.

Hazardous Substance Designation of PFOA and PFOS Has Broad Implications for Cleanups and CERCLA Liability

PFOA and PFOS are two specific chemical compounds within a broad group of thousands of manmade chemicals known as per- and polyfluoroalkyl substances (PFAS). EPA focused its regulatory efforts on these two PFAS; however, the vast majority of PFAS remain unregulated under CERCLA even after issuance of the Final Rule.

Designating PFOA and PFOS as hazardous substances triggers numerous requirements. The primary impact of the Final Rule is that it incorporates PFOS and PFOA into CERCLA’s strict, joint and several liability framework. This change grants EPA the power to investigate releases of PFOA and PFOS and compel potentially responsible parties (PRPs), including owners and operators of a property or facility, to remediate releases of PFOA and PFOS through the specific CERCLA enforcement provisions. PRPs also now have a clear private right of action under CERCLA to pursue cost recovery and contribution actions. Additionally, when the Final Rule becomes effective, facilities will be required to immediately report releases of PFOA and PFOS above their designated “reportable quantities,” (currently one pound within a 24-hour period), to the National Response Center and relevant state or tribal authorities.

Furthermore, many states include CERCLA hazardous substances under their cleanup statutes, meaning these states will now be able to require remediation of PFOA and PFOS under state law.

Listing PFOA and PFOS as “hazardous substances” under CERCLA does not make PFOA or PFOS contaminated waste a “hazardous waste” or a “hazardous constituent” under the Resource Conservation and Recovery Act. However, this designation does require the U.S. Department of Transportation to designate PFOA and PFOS as “hazardous materials” for purposes of transport under the Hazardous Materials Regulations.

While the PFOA and PFOS CERCLA Listing is Final, Questions Remain

As noted in our prior article on the proposed rule, EPA’s designation of PFOA and PFOS as “hazardous substances” leaves several questions unanswered.

  • How will EPA’s CERCLA enforcement discretion policy really play out in practice? 

    Concurrently with the publication of the Final Rule, EPA also released a PFAS Enforcement Discretion and Settlement Policy under CERCLA. This enforcement policy captures EPA’s current position that it does not intend to pursue PRPs under circumstances where “equitable factors” do not support doing so. Enumerated circumstances in the policy include so-called “passive receivers” of PFAS, including community water systems and publicly-owned treatment works, publicly-owned municipal solid waste landfills, publicly-owned airports and local fire departments, and farms where PFAS-containing biosolids are applied to the land. However, EPA’s enforcement policy—which is not binding upon the agency and is subject to change at any time—should be viewed with a healthy dose of skepticism among regulated industries, considering the sheer breadth of potential CERCLA liability for these substances, as well as continued Congressional proposals to codify exemptions for passive receivers within the CERCLA statute itself. Notably, the agency’s enforcement position does not in any way prevent private parties from initiating cost recovery or contribution actions under CERCLA.

  • How will regulated industries manage the costs of PFOA and PFOS cleanup?PFAS contamination can be wide-ranging due to several factors unique to the chemicals themselves. Further, unlike remediation technologies for other well-studied contaminants, existing remediation technologies for PFOA and PFOS are nascent at best and are expensive at a large scale. It is therefore often difficult to even estimate accurate cost ranges for PFOA and PFOS cleanups, but costs can easily run into the millions of dollars at complex sites. Although EPA has published interim guidance on PFOA and PFOS disposal methods, and the recently passed Infrastructure Investment and Jobs Act provides $3.5 billion over five years for Superfund cleanups, the methods and money may not go as far as planned if cleanup costs for PFOA and PFOS sites end up exponentially higher.
  • How will EPA handle potential PFOA and PFOS contamination at closed Superfund sites?In response to comments seeking clarification on whether designating PFOA and PFOS will lead to the reopening of closed Superfund sites, EPA stated that the final rule “has no impact” on EPA’s authority to list PFOA and PFOS sites as Superfund sites. EPA’s question-and-answers page—which we note is not a binding statement from the agency—also states that “[d]esignation will not change EPA’s process for listing and/or deleting [National Priorities List (NPL)] sites or evaluating remedies’ protectiveness through five-year reviews, and it will not require PFOA and PFOS sampling at NPL (final or deleted) sites.” While the final rule does not require PFOA and PFOS sampling at closed sites, it does not prevent EPA from ordering sampling at these sites. PRPs who may have long ago stopped budgeting for remedial costs at existing or legacy locations that were remediated years and even decades ago, may find that they are required to revisit these sites where PFOA and PFOS may be present.
  • What cleanup standards will govern PFOA and PFOS remediation?There is a current patchwork of state regulatory standards relating to PFAS, ranging from binding cleanup levels, advisory guidance, or no PFAS standards at all, which may lead to similarly patchwork cleanup standards depending on which standards are applied as an appropriate “applicable or relevant and appropriate requirement” (ARAR) at a specific site. In addition, on April 10, 2024, EPA issued a final rule setting Maximum Contaminant Levels (MCL) for PFOA and PFOS in drinking water at 4.0 parts per trillion (ppt), individually. While these drinking water standards are separate from EPA’s final rule listing PFOA and PFOS as “hazardous substances” under CERCLA, the “hazardous substances” rule notes that the MCL may be an appropriate ARAR for cleanup efforts under CERCLA.
  • What other PFAS will EPA next target under CERCLA?As noted above, PFOA and PFOS are two specific PFAS among thousands of others currently and historically used. Much of the science on the potential health effects of PFAS (both individual chemical compounds and as a class) continues to evolve. In the meantime, EPA has moved to regulate additional types of PFAS under other statutes. For example, as we noted in a previous client alert, EPA recently published a proposed rule listing seven other PFAS compounds as hazardous constituents under RCRA. Some or all of these PFAS may eventually be targets of future CERCLA rulemaking efforts.

Next Steps

The Final Rule will take effect 60 days after it is published in the Federal Register. Affected parties should consider their portfolio of planned, active, and in some cases, closed remediation sites for potential implications, and companies may consider reviewing and updating their hazardous substance reporting and transportation protocols to address PFOA and PFOS as applicable.

© 2024 Foley & Lardner LLP
For more on PFAS, visit the NLR Environmental, Energy & Resources section.

EPA Designates Two PFAS as Hazardous Substances

On April 19, 2024, the U.S. Environmental Protection Agency (EPA) announced that it was designating two common per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as Superfund. As expected, EPA is issuing a final rule to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances. The pre-publication version of the rule is available here.

Once the rule is effective, entities will be required to report releases of PFOA and PFOS into the environment that meet or exceed the reportable quantity. Reporting past releases is not required if the releases have ceased as of the effective date of the rule. EPA will have the authority to order potentially responsible parties to test, remediate, or pay for the cleanup of sites contaminated with PFOA or PFOS under CERCLA.

Massachusetts established reportable concentrations for six PFAS, including PFOA and PFOS, in 2019. The Massachusetts regulations also contain cleanup standards for PFAS contamination in soil and groundwater.

Under Maine law, these substances also are automatically deemed a Maine hazardous substance regulated under the Maine Uncontrolled Hazardous Substance Sites Law. Maine’s PFAS screening levels are available here.

Solid waste facility operators had expressed serious concerns about the prospect of PFOA and PFOS being listed as hazardous substances under CERCLA and have advocated for a narrow exemption. Landfills can be recipients of PFAS-containing waste without knowing it. Similarly, wastewater treatment plant operators feared liability and increased costs if the rule designating PFOA and PFOS as hazardous substances became final.

EPA’s announcement of the final rule came with a CERCLA enforcement discretion policy [PFAS Enforcement Discretion and Settlement Policy Under CERCLA] that makes clear that EPA will focus enforcement on parties that significantly contributed to the release of PFAS into the environment.

The policy states that the EPA does not intend to pursue certain publicly‑owned facilities such as solid waste landfills, wastewater treatment plants, airports, and local fire departments, as well as farms where biosolids are applied to the land. Firefighting foam (aqueous film-forming foam, or AFFF) is known to contain PFAS, and runoff from the use of AFFF has been known to migrate into soil and groundwater.

©2024 Pierce Atwood LLP. All rights reserved.
For more news on EPA PFAS regulations, visit the NLR Environmental, Energy & Resources section.

California PFAS Ban in Products: 6th Largest Global Economy Enters the Fray

We reported extensively on the landmark legislation passed in Maine in 2021 and Minnesota in 2023, which were at the time the most far-reaching PFAS ban in the United States. Other states, including Massachusetts and Rhode Island, have subsequently introduced legislation similar to Maine and Minnesota’s regulations. While we have long predicted that the so-called “all PFAS / all products” legislative bans will become the trend at the state levels, it is significant to note that California, the world’s sixth largest economy, recently introduced a similar proposed PFAS ban for consumer products.

The California proposed legislation, coupled with the existing legislation passed or on the table, will have enormous impacts on companies doing business in or with the state of California, as well as on likely future consumer goods personal injury lawsuits. The California PFAS ban must therefore not be overlooked in companies’ compliance and product development departments.

California PFAS Ban

California’s SB 903 in its current form would prohibit for sale (or offering for sale) any products that contain intentionally added PFAS. A “product” is defined as “an item manufactured, assembled, packaged, or otherwise prepared for sale in California, including, but not limited to, its components, sold or distributed for personal, residential, commercial, or industrial use, including for use in making other products.” It further defines “component” as “an identifiable ingredient, part, or piece of a product, regardless of whether the manufacturer of the product is the manufacturer of the component.”

While the effective date of SB 903’s prohibition would be January 1, 2030, the bill gives the California Department of Toxic Substances Control (“DTSC”) the authority to prohibit intentionally added PFAS in a product before the 2030 effective date. It also allows DTSC to categorize PFAS in a product as an “unavoidable use”, thereby effectively creating an exemption to the bill’s ban, although California exemption would be limited to five years in duration. Similar carve outs were also included in the Maine and Minnesota bans. In each instance, certain information must be provided to the state to obtain an “unavoidable use” exemption. In California, an “unavoidable use” exemption would only be granted if:

  1. There are no safer alternatives to PFAS that are reasonably available.
  2. The function provided by PFAS in the product is necessary for the product to work.
  3. The use of PFAS in the product is critical for health, safety, or the functioning of society.

If a company sells a products containing PFAS in the state of California in violation of the proposed law, companies would be assessed a $1,000 per day penalty for each violation, a maximum of $2,500 per day for repeat offenders, and face possible Court-ordered prohibition of sales for violating products.

Implications To Businesses From The Minnesota PFAS Legislation

First and foremost of concern to companies is the compliance aspect of the California law. The state continues to modify and refine key definitions of the regulation, resulting in companies needing to consider the wording implications on their reporting requirements. In addition, some companies find themselves encountering supply chain disclosure issues that will impact reporting to the state of California, which raises the concern of accuracy of reporting by companies. Companies and industries are also very concerned that the information that is being gathered will provide a legacy repository of valuable information for plaintiffs’ attorneys who file future products liability lawsuits for personal injury, not only in the state of California, but in any state in which the same products were sold.

It is of the utmost importance for businesses along the whole supply chain to evaluate their PFAS risk. Public health and environmental groups urge legislators to regulate these compounds. One major point of contention among members of various industries is whether to regulate PFAS as a class or as individual compounds. While each PFAS compound has a unique chemical makeup and impacts the environment and the human body in different ways, some groups argue PFAS should be regulated together as a class because they interact with each other in the body, thereby resulting in a collective impact. Other groups argue that the individual compounds are too diverse and that regulating them as a class would be over restrictive for some chemicals and not restrictive enough for others.

Companies should remain informed so they do not get caught off guard. Regulators at both the state and federal level are setting drinking water standards and notice requirements of varying stringency, and states are increasingly passing PFAS product bills that differ in scope. For any manufacturers, especially those who sell goods interstate, it is important to understand how those various standards will impact them, whether PFAS is regulated as individual compounds or as a class. Conducting regular self-audits for possible exposure to PFAS risk and potential regulatory violations can result in long term savings for companies and should be commonplace in their own risk assessment.

©2024 CMBG3 Law, LLC. All rights reserved.
For more news on PFAS Ban in California, visit the NLR Environmental, Energy & Resources section.

PFAS MDL Settlements: Red Herrings For Downstream Companies

Leading up to the aqueous film-forming foam (AFFF) MDL litigation bellwether trial in June 2023, questions circulated regularly about the end game for the water utilities that had filed lawsuits alleging PFAS contamination to drinking water. With several hundred utilities with pending lawsuits seeking the costs for technology needed to filter PFAS from drinking water, monitoring wells, testing equipment, disposal costs, etc., and potentially thousands of other water utilities with similar potential lawsuits, the damages seemed astronomical. So, too, did the amount of time it would take to litigate each case to get the water utilities monetary relief. These two competing forces, plus the pressure of an actual trial date looming, led Dupont and 3M to announce PFAS MDL settlements in June 2023. At $1.185 billion by Dupont and between $10.3 billion and $12.5 billion by 3M, with the intention of both settlement funds to resolve all pending and potential water utility claims in the United States, it seemed to many that a resolution had been achieved that would address PFAS in drinking water systems without burdening utility customers or the utilities themselves.

The issue, though, is that over 9,000 water utilities were estimated to be in need of treatment technology to meet the EPA’s newly proposed drinking water standards. The American Water Works Association (AMWA) reminded everyone that their own estimates of the costs of compliance to the EPA’s level would cost utilities over $3.2 billion annually. Even buying into the old joke that lawyers are horrible at math, it does not take long for one to realize the significant gap in the proposed settlement amounts and AMWA’s estimates. Water utilities accepting money under the Dupont and 3M settlement funds are not all going to receive 100% of the necessary funding for remediation. How then will this deficit be resolved?

Water utilities will be reluctant to pass on all of the costs to customers, although pricing increases could provide a stopgap measure for water utilities on top of the MDL settlement funds. State or even federal funding may be available under grant, loan or other programs that can also assist. However, when the dust settles, it is likely that water utilities are going to look to a particular group of parties to pursue damages from – companies that discharged PFAS into waterways that fed into the water utility facilities. Lawsuits already abound nationally filed by private citizens against such companies for property damage, bodily injury and medical monitoring. Why then would water utilities finding themselves in need of significant money to properly treat drinking water not take similar legal action? Couple this with pressure water utilities are starting to receive in the form of finding themselves sued in class action lawsuits by private citizens, and the legal notion of contribution begins to ring very true for water utilities looking to minimize their own damages in such lawsuits and find sources of funding for remediation technology.

Companies that have historically discharged effluent into waterways that feed drinking water supplies must therefore keep all of the above in mind and not be lulled into a false sense of complacency that the Dupont and 3M settlements in the MDL are going to mean the end of PFAS drinking water litigation. I predict quite the opposite.

It is of the utmost importance that businesses along the whole commerce chain that have or believe that they might have used PFAS in certain processes take steps now to understand their PFAS risk. Public health and environmental groups urge legislators to regulate PFAS at an ever-increasing pace. Similarly, state level EPA enforcement action is increasing at a several-fold rate every year. Companies that did not manufacture PFAS, but merely utilized PFAS in their manufacturing processes, are becoming targets of costly enforcement actions at rates that continue to multiply year over year. Lawsuits are also filed monthly by citizens or municipalities against companies that are increasingly not PFAS chemical manufacturers. The only way to manage future risk is to fully understand what that risk picture looks like, and companies would be well-advised to invest in proper diligence for the PFAS risk question.

©2024 CMBG3 Law, LLC. All rights reserved.
For more on PFAS, visit the NLR Environmental, Energy & Resources section.