The Nickel Report

Back in October of 2023, we provided a list of “Frequently Asked Questions” and answers regarding the US Environmental Protection Agency’s (EPA’s) final reporting rule for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). As of May 8, 2024, many companies are facing a one-year countdown to the deadline for submitting their reports to EPA. To help you prepare for this impending deadline, we are providing a second installment of “Frequently Asked Questions” and answers about EPA’s rule.

On April 10, 2024, the U.S. Environmental Protection Agency (EPA) released a pre-publication copy of its final rule to establish limits on six per-and-polyfluoroalkyl substances (PFAS) in drinking water under the Safe Drinking Water Act (SDWA). The rule will be effective 60 days after publication in the Federal Register.

EPA’s plans to investigate – and eventually establish limits on and liability for – PFAS in wastewater discharges and biosolids crossed a significant milestone on January 31, 2024, with the completion of two new analytical methods to detect these ubiquitous contaminants. The most significant of the two is Method 1633, which provides a standardized quantitative method for laboratories to detect 40 different PFAS compounds, at very low levels, in wastewater, surface water, groundwater, soil, biosolids, sediment, landfill leachate, and fish tissue. Method 1621 is a low-cost screening method for the presence of fluorine-containing organic compounds, which could lead to use of the more sensitive Method 1633 to further characterize any PFAS in the sample. EPA’s public statements provide no timeline for seeking approval of these methods for PFAS monitoring of wastewater discharges as part of 40 C.F.R. Part 136, but a Method Update Rule is likely to be proposed before the end of the year.

EPA has big plans for the PFAS data that these two new methods will generate.

On February 1, 2024, EPA released two proposed rules under the Resource Conservation and Recovery Act (RCRA) that will advance EPA’s PFAS Strategic Roadmap. These two actions would subject certain PFAS—and potentially other emerging contaminants—to RCRA corrective action and may also be a precursor to EPA listing certain PFAS as hazardous waste under RCRA. Once published in the Federal Register, comments on the Definition Rule will be due in 30 days, and comments on the PFAS Hazardous Constituent Rule will be due in 60 days.

In December 2023, federal agencies released their “Fall 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals that could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s chemical regulatory team has provided analyses of these upcoming regulatory actions:

• EPA’s Recent Release of its “Fall 2023” Regulatory Agenda: Upcoming PFAS-Related Actions
• EPA’s Recent Release of its “Fall 2023” Regulatory Agenda: Upcoming Toxic Substances Control Act (TSCA) Actions

On October 17, 2023, the California Attorney General (AG) Rob Bonta released an enforcement advisory letter to manufacturers, distributors, and sellers of food packaging and cookware detailing how he intends to enforce AB 1200, a law which: 1) bans the sale of regulated per- and polyfluoroalkyl substances (PFAS) in food packaging in California, and 2) requires disclosure and labeling of chemicals on a “designated list,” including PFAS, that are present in the food contact surface or the handle of cookware products sold in California. Because the individual laws do not provide specific enforcement mechanisms, this announcement is the first time the AG’s office has articulated the authorities it plans to use to enforce these laws. The enforcement advisory letter provides a clear warning to the regulated community, from manufacturers to importers to distributors and retailers, that California will be enforcing its PFAS laws. Similar advisories could be issued in the future for California’s other laws restricting PFAS in juvenile products, textiles, and cosmetics.

On October 11, 2023, the US Environmental Protection Agency (EPA) released its long-awaited final rule imposing detailed reporting requirements on entities that have manufactured or imported per- and polyfluoroalkyl substances (PFAS) for commercial purposes at any time since January 1, 2011. Notably, the reporting rule also applies to importers of articles containing PFAS, which could include many consumer, industrial, and commercial products, and requires reporting on PFAS as a component of a mixture. The rule does not have any exclusions for PFAS that are impurities, byproducts, used in commercial research and development (R&D), or only present in a mixture or article in trace amounts. And, unlike many state PFAS reporting laws, this reporting rule is not limited to only intentionally added PFAS.

The US Environmental Protection Agency (“EPA”) recently finalized its long-anticipated National Enforcement and Compliance Initiatives (“NECIs”) for fiscal years 2024 through 2027, naming six “priority areas” on which EPA’s Office of Enforcement and Compliance Assurance (“OECA”) will focus its enforcement efforts and direct additional resources. In his first significant action since being confirmed by the Senate on July 20, 2023, OECA Assistant Administrator David Uhlmann issued a memorandum on August 17, 2023 to the EPA Regional Administrators, advising of the six NECIs. He stated that over the next four years EPA will “address the most significant public health and environmental challenges, protect vulnerable and overburdened communities, and promote greater compliance with our environmental laws.”

As states across the country develop laws addressing per- and polyfluoroalkyl substances (PFAS), a patchwork of requirements has begun to emerge, creating challenges for those who manufacture, distribute, and sell products around the country. In 2023, over 200 bills were introduced addressing PFAS, including restrictions for PFAS in products. This trend is expected to continue.

In June 2023, federal agencies released their “Spring 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals which could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s regulatory team have provided analyses of these upcoming regulatory actions:

• EPA’s Spring 2023 Unified Regulatory Agenda—Upcoming PFAS-Related Actions
• EPA’s Spring 2023 Regulatory Agenda—Upcoming TSCA Actions

While liability for PFAS—per- and polyfluoroalkyl substances, also known as “forever chemicals”—may be an emerging issue, the availability of insurance coverage for these and similar liability claims is not. “Commercial general liability,” or CGL, insurance was specifically designed to cover claims made by a company’s customers or customers of customers for resulting bodily injury and property damage. PFAS claims fit this bill. 

Continue reading this article on the Hunton Insurance Recovery Blog.

In May 2023, Minnesota’s Governor Walz signed into law HF 2310, which bans the sale of certain products containing “intentionally added” per- and- polyfluoroalkyl substances (PFAS) in 2025 and then all products in 2032, and also establishes reporting requirements for products containing PFAS starting in 2026. Following Maine’s lead, Minnesota has now become the second state in the country to pass a broad ban on PFAS-containing products sold in the state. While reporting requirements apply to product manufacturers, the bans on sale, offer for sale, or distribution in the state apply to “persons,” including retailers. Companies who manufacture products for sale (and who sell) products in the state of Minnesota will need to prepare to assess the presence of PFAS in their supply chains in order to comply with these new requirements.

On March 29, 2023, the US Environmental Protection Agency (EPA) published in the Federal Register its long-awaited proposed rule to restrict certain per- and polyfluoroalkyl substances (PFAS) in drinking water under the Safe Drinking Water Act (SDWA). This action is part of EPA’s whole-of-agency approach in its PFAS Strategic Roadmap and is expected to directly affect 66,000 public water systems across the country. Comments on the proposal are due on May 30, 2023. EPA will also hold a public hearing on May 4, 2023 to receive stakeholder input on this important rulemaking.

The Maine Department of Environmental Protection (DEP) recently released a long anticipated proposed rule that would implement the procedures for Maine’s 2021 law[1] requiring manufacturers to submit notifications to DEP for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS) sold in the state. Stakeholders will have until May 19, 2023, to provide comments on the proposal.

While Maine’s notification requirements went into effect on January 1, 2023, the proposed rule provides critical details on the applicability and procedures for notifications. Many manufacturers who received extensions from the January 1, 2023 notification deadline will be interested in reviewing the details of this proposal. The proposed rule provides important clarifications about the notification requirements, including:

In January 2023, federal agencies released their “Fall 2022” Regulatory Agendas that provide roadmaps for upcoming and long-term regulatory actions on chemicals that could have significant implications for the regulated community. These agendas make clear that the Biden Administration continues to prioritize regulatory actions to address per- and polyfluoroalkyl substances (PFAS) across multiple agencies. And the US Environmental Protection Agency (EPA) also continues to implement numerous regulatory initiatives to assess and mitigate chemical risks under the strengthened Toxic Substances Control Act (TSCA).

Hunton’s chemical regulatory team has provided analyses of these upcoming regulatory actions:

• EPA’s “Fall 2022” Regulatory Agenda – Upcoming PFAS-Related Actions
• EPA’s “Fall 2022” Regulatory Agenda – Upcoming Toxic Substances Control Act (TSCA) Actions

A Question Every Retailer Must Be Prepared to Answer

Per- and polyfluoroalkyl substances (PFAS) have taken center stage. The Biden administration’s regulatory agenda plans numerous revisions to environmental regulations to address this broad class of pervasive substances. While the US Environmental Protection Agency grapples with implementing these initiatives, states are aggressively forging ahead with their own plans. Laws targeting PFAS in various products have taken effect and will continue to take effect in many states, representing a striking expansion from typical state regulations addressing environmental PFAS contamination from firefighting foam and other sources.

On January 12, 2023, the US Environmental Protection Agency (“EPA”) published its proposed National Enforcement and Compliance Initiatives ("NECIs”), soliciting public comment on the Agency’s potential Initiatives for fiscal years 2024 through 2027. These NECIs will guide EPA’s Office of Enforcement and Compliance Assurance (“OECA”) in its enforcement efforts over the next four years by focusing resources on “serious and widespread environmental problems where federal enforcement can make a difference.” Unsurprisingly, the identified NECIs build off EPA’s FY2022 Enforcement Results (on which we recently reported) and reflect OECA’s overarching goal: “to protect human health and the environment by holding polluters accountable and compelling regulated entities to return to compliance.”

On August 26, 2022, the US Environmental Protection Agency (EPA) released a pre-publication copy of its much-anticipated proposed rule adding perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). EPA asserts that this regulatory escalation of PFOA and PFOS will facilitate faster cleanup of contaminated sites and reduce exposures to these “forever chemicals.” If finalized, these hazardous substances designations will have significant and immediate impacts on many industries, from creating new reporting obligations to increased compliance, enforcement, and litigation risks related to site cleanup. EPA’s efforts involving PFOA and PFOS fall within the broader, whole-of-agency approach to addressing PFAS first announced in its PFAS Strategic Roadmap and represent its first ever exercise of its authority under CERCLA section 102(a) to designate a hazardous substance.

On July 28, 2022, the US Environmental Protection Agency (EPA)  published the 2021 Toxics Release Inventory (TRI) preliminary dataset that provides public access to data about chemical releases, waste management, and pollution prevention activities that took place in calendar year 2021 at more than 20,000 federal and industrial facilities across the country. The 2021 preliminary dataset, which for the second year includes reporting on per- and polyfluoroalkyl substances (PFAS) added to the TRI by the 2020 National Defense Authorization Act (NDAA), has not yet undergone the complete TRI data quality process. EPA plans to publish the quality-checked dataset in October 2022, at which time it will be the basis for the 2021 TRI National Analysis interpreting the information and examining trends that is expected to be published in early 2023. Companies should bear in mind that information collected under the TRI program can be used not only to inform regulatory action, but also as a basis for enforcement by EPA and citizen suits.

Does your company manufacture, process, distribute, use, or dispose of fluorinated high-density polyethylene (HDPE) containers and similar plastics? If so, it may be time for supply chain and process reviews aimed at identifying and eliminating possible per- and polyfluoroalkyl substance (PFAS) contamination.

In January, EPA obtained data that some mosquito control pesticides contained detectable levels of certain PFAS.  In a joint investigation with the State of Massachusetts, EPA found that fluorinated high-density polyethylene (HDPE) containers containing a mosquito control pesticide were leaching PFAS into the product. Now, EPA is testing different brands of fluorinated containers to determine whether they contain and/or leach PFAS and has asked the states with existing stocks of these pesticides to discontinue use as EPA evaluates the issue. Information on the EPA activities can be found here. EPA also began working with USDA and FDA to get a better understanding of the use of fluorinated polyethylene containers for pesticides and other products.