This week’s post is authored by Emilee Mooney Scott and is also available on Robinson+Cole’s Environmental Law + blogThank you to Emilee for contributing. Emilee is a partner in the firm’s Environmental, Energy + Telecommunications Group, focusing her practice on a variety of environmental compliance and transactional matters, including emerging contaminants.

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).

This post is also being shared on our Environmental Law + blog. If you’re interested in getting updates on timely and thoughtful developments in the environmental, health and safety (EH+S) and energy landscapes, we invite you to subscribe to the blog.

This week’s post is authored by Emilee Mooney Scott and is also available on Robinson+Cole’s Environmental Law + blog. Thank you to Emilee for contributing. Emilee is a partner in the firm’s Environmental, Energy + Telecommunications Group, focusing her practice on a variety of environmental compliance and transactional matters, including emerging contaminants.

In mid-March EPA released its proposal for the first set of Maximum Contaminant Levels (MCLs) under the Clean Water Act for per- and polyfluoroalkyl substances (PFAS).  In contrast to non-enforceable health advisory levels introduced in 2016 and revised in 2022, MCLs constitute enforceable drinking water standards that will impact drinking water utilities and industry nationwide.  The proposal for enforceable drinking water standards marks the latest step in the evolution of PFAS from an emerging contaminant to a contaminant subject to enforceable regulations. 

The proposed rule sets standards for six PFAS compounds as follows:

*More information on how the Hazard Index will be calculated is available in an EPA fact sheet.

The proposed MCLs follow lifetime health advisory levels for PFOA, PFOS, GenX and PFBS issued by EPA in the summer of 2022.  The health advisory levels for PFOA and PFOS are 0.004 parts per trillion, which is a level that cannot yet be reliably detected in laboratories.  While the 4 ppt proposed MCL for PFOA and PFOS is low relative to the levels in place for other constituents, it is at least detectable using current technology.

In the preamble to the proposed rule, EPA indicated that no safe level for PFOA and PFOS has been identified.  Therefore, EPA is setting the non-enforceable, health-based Maximum Contaminant Level Goal (MCGL) at zero for both PFOA and PFOS.  Given that EPA requires the MCLs to be set “as close as feasible” to the MGCLs, the regulated community should be aware that EPA may move to further lower the limits for PFOA and PFOS as technology improves.   

EPA has scheduled a public hearing on the proposed MCLs for May 4, 2023.  Interested participants may register to speak by April 28, 2023 through the EPA event website.

We are also tracking a number of other PFAS-related developments, including that in August 2022, EPA released a proposed rule that would designate PFOA and PFOS as CERCLA hazardous substances.  A number of states (including California and Maine) have passed laws banning the use of PFAS in certain applications. 

The State of California has always been a leader in regulating chemical ingredients contained in products sold in the state (think Prop 65), and it has turned its sights towards per- and polyfluoroalkyl substances (PFAS). There are already laws on the books banning the sale or distribution of PFAS-containing food packaging and children’s products, and requiring disclosure of PFAS in cookware. California recently added to the list of products that must be PFAS-free within its borders, passing two new laws banning the use of PFAS in certain textiles and cosmetic products.

Under the newly passed AB 1817, beginning on January 1, 2025, “no person shall manufacture, distribute, sell, or offer for sale in the state any new, not previously used, textile articles that contain . . . PFAS.”  Textile articles include, among other things:

  • Apparel
  • Furnishings
  • Towels
  • Napkins
  • Shower curtains
  • Handbags and backpacks

Manufacturers of textile articles must use the “least toxic alternative” when removing PFAS from these products, including using an alternative design. Manufacturers will also be required to provide a “certificate of compliance” to persons selling or distributing their products within the state, which must be signed by an “authorized official of the manufacturer,” stating that the textile article does not contain PFAS.

AB 1817 exempts “outdoor apparel for severe wet conditions” from the PFAS ban; however, if such products contain PFAS, they must be labeled “Made with PFAS chemicals,” including in any online listings for sale.

In addition to textile products, California also recently banned the use of PFAS in cosmetics. Under AB 2771, beginning on January 1, 2025, “no person shall manufacture, sell, deliver, hold, or offer for sale in commerce any cosmetic product that contains intentionally added PFAS.” Cosmetic products include any article intended to be applied to the human body for “cleansing, beautifying, promoting attractiveness, or altering the appearance.”

PFAS is considered to be “intentionally added” when a manufacturer adds PFAS for functional or technical effect on the product, or when PFAS are an intentional breakdown product of another added chemical.

With these two new laws, California is continuing the trend in regulating, requiring reporting, or outright banning products containing PFAS. Manufacturers should continue to take notice of these laws and how they might impact their products – both in the State of California and potentially beyond.

Earlier this month, EPA set new lifetime health advisories for four per- and poly-fluoroalkyl substances (PFAS) – in some instances at levels lower than those that can be detected through laboratory testing. The new health advisories are listed below:

PFASHealth Advisory (in parts per trillion)
PFOA (perflurooctanoic acid)0.004 ppt
PFOS (perfluorooctane sulfonic acid)0.02 ppt
GenX (hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt)10 ppt  
PFBS (perfluorobutane sulfonic acid and its potassium salt)2,000 ppt

EPA’s previous health advisories for PFOA and PFOS were 70 ppt (individually or combined), so these new, interim advisories are significantly lower. The advisories for GenX and PFBS are completely new. And all are getting attention.

The health advisories are not enforceable standards; however, in EPA’s own words, they “provide technical information that federal, state, and local agencies can use to inform actions to address PFAS in drinking water, including water quality monitoring, optimization of existing technologies that reduce PFAS, and strategies to reduce exposure to these substances.” Indeed, some states adopted drinking water regulations based on EPA’s now outdated 70 ppt health advisory for PFOA and PFOS.

According to EPA, it reviewed over 400 human epidemiological and animal toxicity studies in determining the health advisories for PFOA and PFOS. GenX and PFBS have not been as extensively studied to date, and those advisories appear to be based only on animal toxicity studies. EPA acknowledged that, for PFOA and PFOS, the levels are set at “near zero” and “below EPA’s ability to detect at this time.” However, it claims that new science and a consideration of lifetime exposure (including PFAS exposure from sources other than drinking water) support “aggressive” action.

EPA plans to develop a proposed National Drinking Water Regulation for PFOA and PFOS by the end of 2022. This proposed regulation will include a Maximum Contaminant Level (MCL), which is almost certain to be well above the health advisories EPA just established for these compounds. If adopted, the MCL for PFOA and PFOS would become an enforceable standard for drinking water. EPA also indicated that it is considering actions to address other PFAS, or groups of PFAS, beyond PFOA and PFOS.

As we previously reported, EPA published a PFAS Action Plan in 2019 designed to enhance and improve data gathering, regulatory development, enforcement, and communication related to per- and polyfluoroalkyl substances (PFAS). EPA continues to make progress implementing the PFAS Action Plan and is working on a more formal framework for addressing PFAS under the Clean Water Act. In the meantime, EPA’s Office of Water recently issued an interim strategy for addressing PFAS in National Pollutant Discharge Elimination System (NPDES) permits.

The interim strategy makes a number of recommendations for the consideration of PFAS in the NPDES permit program. Some of these recommendations involve gathering and sharing information, but others may directly impact permit requirements.

According to the interim strategy, permit writers should consider incorporating requirements for monitoring PFAS at facilities where PFAS are expected to be present in wastewater discharges. Specifically, PFAS may be incorporated into an NPDES permit in the absence of monitoring data if, “because of the raw materials stored or used at the facility, products or byproducts of the facility operation, or available data and information from similar facilities, the permit writer has a strong basis for expecting that the pollutant could be present in the discharge.” Under the interim strategy, NPDES permits may also incorporate best management practices to control or abate a PFAS discharge.

The interim strategy also suggests consideration of PFAS in stormwater permits. In situations where PFAS are expected to be present in stormwater, permit writers may consider monitoring requirements as well as stormwater pollution controls specific to PFAS.

The interim strategy recommends the ongoing information sharing on the development of PFAS requirements in NPDES permits. It also calls for the development of a compendium to compile practices, trends, and developments to address PFAS in NPDES permits around the country.

As of now, EPA has not provided much detail as to what may give it a “strong basis” to expect PFAS to be present in a discharge such that PFAS can be incorporated into an NPDES permit. Based on the language quoted above, however, it appears EPA may use not only information about the actual facility subject to the NPDES permit, but also information from similar facilities to make that determination. We will continue to follow these developments as the interim strategy is rolled out.

Earlier this year, we wrote about EPA’s PFAS Action Plan, the agency’s blueprint for addressing contamination and protecting public health from per- and polyfluoroalkyl substances (PFAS). The PFAS Action Plan, released in February 2019, details a number of actions EPA plans to take with regard to PFAS, including time frames for implementation. EPA has been making some progress towards implementation, albeit not always on the timeline set forth in the Plan. Below are a few updates since February:

Toxics Release Inventory (TRI) Listing for PFAS 

Yesterday, EPA published notice that it is considering a rule to add PFAS compounds to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act. This listing would require certain industry sectors to annually report releases of these chemicals. The purpose of the TRI program is to provide the public with information, or, as EPA puts it, “A Right to Know, A Basis to Act.”

The published notice seeks comment from the public as to whether PFAS compounds should be included in the TRI. Specifically, EPA seeks input on:

  • which PFAS compounds should be evaluated for inclusion;
  • whether PFAS compounds should be listed individually or in categories;
  • the appropriate reporting thresholds; and
  • the human health and environmental toxicity, persistence, and bioaccumulation of PFAS.

The public comment period ends on February 3, 2020.

Regulation of PFAS Under the Safe Drinking Water Act (SDWA)

In the PFAS Action Plan, EPA committed to proposing regulatory determinations for PFOA and PFOS—two of the most common PFAS compounds—by the end of 2019. These regulatory determinations are the first step under the SDWA towards the development of Maximum Contaminant Levels (MCLs). EPA is still moving towards this goal, but the draft regulatory determinations are not likely to be released for public comment until early 2020.

Monitoring for PFAS

EPA intends to test for PFAS compounds during the next round of unregulated contaminant monitoring under the SDWA. The purpose of this monitoring is to collect data for contaminants that are suspected to be in drinking water but do not yet have established health-based standards under the SDWA. During the last round of monitoring, EPA tested for six PFAS compounds. EPA may look to expand that list, and it also plans to use newer sampling methods to detect compounds at lower minimum reporting levels than previously possible. The list of contaminants for the next round of testing is expected to be released in 2020.

Earlier this year, we wrote about EPA’s PFAS Action Plan, the agency’s blueprint for addressing contamination and protecting public health from per- and polyfluoroalkyl substances (PFAS). The PFAS Action Plan, released in February 2019, details a number of actions EPA plans to take with regard to PFAS, including time frames for implementation. EPA has been making some progress towards implementation, albeit not always on the timeline set forth in the Plan. Below are a few updates since February:

Toxics Release Inventory (TRI) Listing for Certain PFAS Compounds 

Yesterday, EPA published notice that it is considering a rule to add PFAS compounds to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act. This listing would require certain industry sectors to annually report releases of these chemicals. The purpose of the TRI program is to provide the public with information, or, as EPA puts it, “A Right to Know, A Basis to Act.”

The published notice seeks comment from the public as to whether PFAS compounds should be included in the TRI. Specifically, EPA seeks input on:

  • which PFAS compounds should be evaluated for inclusion;
  • whether PFAS compounds should be listed individually or in categories;
  • the appropriate reporting thresholds; and
  • the human health and environmental toxicity, persistence, and bioaccumulation of PFAS.

The public comment period ends on February 3, 2020.

Regulation of PFAS Under the Safe Drinking Water Act (SDWA)

In the PFAS Action Plan, EPA committed to proposing regulatory determinations for PFOA and PFOS—two of the most common PFAS compounds—by the end of 2019. These regulatory determinations are the first step under the SDWA towards the development of Maximum Contaminant Levels (MCLs). EPA is still moving towards this goal, but the draft regulatory determinations are not likely to be released for public comment until early 2020.

Monitoring for PFAS

EPA intends to test for PFAS compounds during the next round of unregulated contaminant monitoring under the SDWA. The purpose of this monitoring is to collect data for contaminants that are suspected to be in drinking water but do not yet have established health-based standards under the SDWA. During the last round of monitoring, EPA tested for six PFAS compounds. EPA may look to expand that list, and it also plans to use newer sampling methods to detect compounds at lower minimum reporting levels than previously possible. The list of contaminants for the next round of testing is expected to be released in 2020.

On Valentine’s Day, EPA showed a little love for per- and polyfluoroalkyl substances (PFAS), announcing a sweeping plan to address PFAS contamination and protect public health. PFAS are a group of man-made chemicals that have been gaining a lot of attention, as described in our 2019 outlook. EPA Acting Administrator Andrew Wheeler announced the PFAS Action Plan in a press conference yesterday, calling it “the most comprehensive, cross- agency action plan for a chemical of concern ever undertaken by the Agency.” The Action Plan is 72 pages, but Acting Administrator Wheeler focused on five key elements, described below:

  1. Work Towards the Development of MCLs for PFOA and PFOS

EPA will propose regulatory determinations for PFOA and PFOS—two of the most common PFAS compounds—by the end of 2019. These regulatory determinations are the first step under the Safe Drinking Water Act (SDWA) towards the development of Maximum Contaminant Levels (MCLs). EPA has not set a time frame for the actual development of the MCLs, instead citing to the timing and procedures required by the regulatory process (including public comment). While EPA committed to issuing regulatory determinations for these two specific compounds, it will continue to evaluate the need to follow this same process for other PFAS compounds.

  1. Continue PFAS Enforcement Efforts

Despite the fact that EPA has not established an MCL for any of the PFAS compounds, it intends to continue enforcement efforts based on the current drinking water advisory of 70 parts per trillion. EPA has already brought eight enforcement actions based on this advisory, and it is assisting state agencies in dozens of other enforcement actions based on state PFAS standards. EPA has also started the regulatory process towards classifying PFOA and PFOS as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), a listing that will allow EPA (and private parties) broader enforcement authority.

  1. Expand PFAS Monitoring Efforts

More data means better understanding, and EPA plans to make use of its authority to expand PFAS monitoring to help guide its decision-making process. EPA plans to propose that PFAS be included in the next round of monitoring under the Unregulated Contaminant Monitoring Program in the SDWA. EPA may also use the Toxic Substances Control Act to require reporting of certain PFAS releases and potentially prohibit the use of certain PFAS compounds.

  1. Expand Scientific Research into PFAS Compounds

EPA plans to use research efforts to “close the gap” on a number of PFAS issues, including:

  • What are the human health and environmental effects?
  • What are significant sources of PFAS in the environment?
  • How do PFAS compounds move through the environment?
  • How can we effectively remediate PFAS?
  • What are the costs of PFAS remediation?

EPA plans to evaluate these issues not only for more common PFAS compounds like PFOA and PFOS, but also for emerging PFAS risks, such as GenX.

  1. Develop PFAS Risk Communication Toolbox

EPA will work with federal, state, tribal, and local partners to develop a comprehensive risk communication toolbox to ensure that PFAS messaging to the public is clear and consistent.

Because the Action Plan is just that—a plan—we will continue to track EPA’s progress. States continue to take a leading role in regulating PFAS, but the new EPA Action Plan now provides a road map for federal action.

This week’s post includes an excerpt from our co-authored article PFAS will be increasing concern for manufacturers in year ahead,” published in the Hartford Business Journal’s Economic Forecast issue on January 8, 2024.

PFAS — perfluoroalkyl and polyfluoroalkyl substances — have been on the scene for years now, but we expect to see exponential growth in all things PFAS in 2024.

Governmental and private party PFAS investigations have significantly increased and, as they say, when you look for PFAS, you find them.

PFAS have been detected in a significant number of public drinking water systems, wastewater treatment facilities, private wells, surface water bodies, fish tissues and elsewhere, both in Connecticut and nationally.

Federal and state governments are also increasingly requiring manufacturers and distributors to report whether there are any PFAS in the products they make, use or distribute.

All of this investigation and reporting will lead to increased governmental and regulatory knowledge and awareness of the presence of PFAS in the environment and in a wide variety of products.

With this increased knowledge comes increased regulatory, scientific and legal action.

The Environmental Protection Agency (EPA) has made addressing PFAS exposure a federal enforcement priority for 2024-2027. In addition, EPA plans to list two PFAS compounds, perfluorooctanoic acid and perfluorooctanesulfonic acid, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act.

This will significantly increase the EPA’s ability to require PFAS investigations across the country. And when PFAS are found, remediation typically must occur to minimize public exposure.

Increased knowledge of the presence and potential harms associated with PFAS has increased litigation around the country. This litigation trend will continue to grow as we become more and more aware of the ubiquity of these compounds.

This week’s post includes an excerpt from our co-authored article PFAS will be increasing concern for manufacturers in year ahead,” published in the Hartford Business Journal’s Economic Forecast issue on January 8, 2024.

There are a lot of trends that we could identify for corporate compliance / litigation, but the one that stands out for me relates to contracts – the lifeblood for many of our clients. 

COVID-19 exposed the weaknesses in our global supply chains and in the business-to-business contracts that drive the entire system.

Manufacturers need to review their long-term agreements or standard terms and conditions if they sell “purchase order to purchase order.”

Most manufacturers are on high alert for business and/or legal terms that can significantly impact their margins, legal rights, etc.

What has changed in the past few years that will only increase in 2024? The rise in the use of contractual templates.

Companies — big and small — are looking for ways to make their contracting process more “efficient,” and thus, everyone is pulling out a template that has been approved up the chain of command.

These templates are filled with contractual clauses — some that make sense and others that do not. These templates also contain clauses that often have no relevance to the actual contractual negotiation that is going on.

Templates have made contracts longer in length — not shorter. And, because of all the extraneous language and clauses that are included to make the template effective, the negotiations are dragging on for months.

Time will tell if the manufacturing industry moves away from the templates to get deals done quicker in 2024 and beyond.