The Nickel Report

On August 16, 2024, federal agencies released their “Spring 2024” Unified Regulatory Agenda detailing the regulations that they are developing over the next several months as well as long-term actions planned over the next few years.

On September 5, 2024, the US Environmental Protection Agency (EPA) concurrently issued a direct final rule and proposed rule to change the reporting period and submission deadline for its reporting rule for per- and polyfluoroalkyl substances (PFAS) under Section 8(a)(7) of the Toxic Substances Control Act (TSCA).

On July 25, 2024, the US Environmental Protection Agency (EPA) proposed to designate acetaldehyde (CASRN 75-07-0), acrylonitrile (CASRN 107-13-1), benzenamine (CASRN 62-53-3), vinyl chloride (CASRN 75-01-4), and 4,4-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4) as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).

States across the country continue to add to the growing patchwork of restrictions for per- and polyfluoroalkyl substances (PFAS) in products, posing challenges for those who manufacture, distribute, and sell products in the U.S. In 2024 alone, states introduced nearly 250 bills addressing PFAS, including restrictions for PFAS in products. Thirteen states have already enacted laws regulating PFAS in products, including (as previously reported) Minnesota and California. In the past few months, Maine, Colorado, Connecticut, Vermont, and Rhode Island have joined the list, each with its own unique and nuanced set of requirements, deadlines and exemptions. The variations in these state laws presents a complicated compliance matrix, necessitating an informed and strategic approach, particularly for companies navigating the complexities of extensive, global supply chains. Below, we provide our analysis of these new laws that companies selling products in these states should be aware of.

Within the first five months of 2024, the United States Environmental Protection Agency (EPA) finalized two rules under section 6(a) of the Toxic Substances Control Act (TSCA) that would impose extensive bans and restrictions on uses of chrysotile asbestos and methylene chloride. Aside from a 2019 EPA rule prohibiting the manufacturing (including importing), processing, and distributing in commerce of methylene chloride for consumer paint and coating removal, these are the first two broadly applicable risk management rules that EPA has promulgated since Congress amended TSCA in 2016 to manage unreasonable risks to human health or the environment through broad restrictions on existing chemicals.

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 19, 2024, the US Environmental Protection Agency (EPA) released a pre-publication copy of its much-anticipated final rule adding two per- and polyfluoroalkyl substances (PFAS) to the list of “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). The rule will be effective 60 days after publication in the Federal Register.

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.

On February 21, 2024, the US Environmental Protection Agency (EPA) released its final rule adjusting the fees it collects under the Toxic Substances Control Act (TSCA). EPA is required under TSCA Section 26 to review and, if necessary, adjust the fees every three years to ensure that funds are sufficient to defray part of the costs of administering TSCA. While EPA has significantly increased TSCA fees for manufacturers, importers, and processors of chemicals, it has also finalized new, key exemptions from fee requirements. These new fees will be effective on April 22, 2024.

By March 1, 2024, all establishments that produce pesticides, devices, or active ingredients for pesticides must file their annual production reports for the 2023 reporting year pursuant to Section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 7 U.S.C. § 136e(c)(1). Last year, EPA’s Office of Enforcement and Compliance Assurance reminded stakeholders that the agency is poised to take action against companies that violate FIFRA and noted that non-compliance with the requirements related to producing pesticides and devices by EPA-registered establishments is increasing.

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

In 2022 and 2023, the United States Environmental Protection Agency (EPA) proposed five risk management rules under Section 6(a) of the Toxic Substances Control Act (TSCA) imposing restrictions and bans on chemical uses. This is the first group of risk management rules that EPA has published since Congress amended TSCA in 2016, establishing EPA’s process to address “unreasonable risks” identified for certain uses of existing chemicals. These proposed rules provide a roadmap for EPA’s approach to chemical regulation under Section 6(a), establishing the precedent for future regulation.

Companies should anticipate more proposed bans, especially for consumer uses of a chemical, along with significantly lower chemical exposure limits compared to occupational exposure limits. Rigorous workplace requirements, including exposure monitoring, respiratory protection and additional personal protective equipment (PPE) requirements are also expected. And, the absence of industry data on a chemical’s use may lead to more stringent proposed regulation.

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.

EPA finalized a rule effective on August 7, 2023 concerning the treatment of confidential business information (CBI) claims made in Toxic Substances Control Act (TSCA) submissions. Companies who submit any information to EPA under TSCA and want their confidential information to be protected from public disclosure must comply with these new requirements for CBI claims. Failure to follow these procedural requirements can result in EPA’s denial of the confidentiality claims and the information being made public.

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

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 May 3, 2023, EPA released its proposed risk management rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to impose restrictions on the manufacture, import, processing, distribution, and use of methylene chloride, a widely-used solvent in a variety of consumer and commercial applications. This is the first risk management rule proposed by EPA since it issued revised risk determinations last year based on its new “whole chemical approach” and policy for assuming that personal protective equipment (PPE) is not used by workers. It also reflects a substantial expansion of the regulatory prohibitions applicable to a chemical that was already subject to TSCA risk management restrictions, albeit more limited ones, under EPA’s prior framework for risk management actions.

EPA is proposing to prohibit the manufacture, processing, and distribution in commerce of methylene chloride for consumer use; prohibit most industrial and commercial uses of methylene chloride; require a workplace chemical protection program (WCPP) for certain identified conditions of use that are allowed to continue; and provide certain time-limited, critical use exemptions under Section 6(g) of TSCA for uses of methylene chloride that would otherwise significantly disrupt national security and critical infrastructure. Stakeholders have until July 3, 2023 to comment on the proposed rule.

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.

In late February 2023, EPA released for public comment its Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act (“Draft Principles”), which proposes a set of principles for evaluating cumulative risks for chemicals undergoing risk evaluation under the Toxic Substances Control Act (“TSCA”). In conjunction with the Draft Principles, EPA also released its “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate Under the Toxic Substances Control Act,” (“Draft Proposed Phthalates Cumulative Risk Approach”), an approach for applying these Draft Principles to the evaluation of cumulative risks posed by certain phthalates undergoing TSCA risk evaluations. EPA referred to these documents as the “first steps” towards the Agency conducting cumulative risk assessments under TSCA.

In February 2023, the US Environmental Protection Agency (EPA)’s Office of Enforcement and Compliance Assurance (OECA) quietly released a Compliance Advisory “What You Need to Know about Producing, Distributing, or Selling Pesticide Devices.” The advisory follows on the heels of similar advisories and provides information to the regulated community about requirements for pesticide devices under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in order to promote compliance. EPA issued this advisory in response to a “significant increase” in the number of pesticide devices being sold or distributed in the US in which EPA has found “substantial non-compliance” with FIFRA requirements. EPA has also experienced a high volume of inquiries from companies and other regulators seeking clarification about pesticide device requirements. The advisory suggests that EPA remains poised to continue taking enforcement actions against companies that import, distribute or sell pesticide devices that do not comply with FIFRA’s requirements.

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 December 22, 2022, EPA’s Integrated Risk Information System (IRIS) Program released its ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook). EPA began working on the approaches in the IRIS Handbook after a 2011 National Research Council report recommended several improvements to the overall IRIS assessment process. In 2020, EPA released a draft IRIS Handbook for public comment and commissioned a peer review by the National Research Council.

Established in 1985 to ensure Agency-wide consistent toxicity evaluations, IRIS assessments provide chemical toxicity values for noncancer and cancer human health effects resulting from chronic exposure to chemicals. These values are often utilized in EPA regulations under the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). While chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA) require more information and analysis than that provided by an IRIS assessment, IRIS assessments will likely continue to be used to inform TSCA risk evaluations. State agencies and international bodies also rely on IRIS assessments.

On 6 September, the US EPA released its proposed rule to add perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund.

If finalized, these hazardous substance designations could have a significant impact on many industries, from creating new reporting obligations to increased compliance, enforcement and litigation risks related to site cleanup.

Click here to read the full article, published in Chemical Watch.

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.

On June 15, 2022, the United States Environmental Protection Agency (EPA) released drinking water health advisories [1] for certain per- and polyfluoroalkyl substances (PFAS), resulting in the establishment of:

1. Near zero updated interim advisory levels for Perfluorooctanoic acid (PFOA) and Perfluorooctane sulfonic acid (PFOS) that are not only orders of magnitude below previously established levels, but that are also below detectable levels and, notably, were issued in advance of completion of peer review by EPA’s Science Advisory Board (SAB); and
2. Newly issued final advisories at low levels for GenX and PFBS chemicals that have been used as replacement chemicals for PFOA and PFOS.

With the busy holiday shopping season underway, retailers should remain vigilant in their efforts to protect consumers and themselves from the risks of selling potentially unsafe, ineffective or misbranded products in violation of the U.S. Environmental Protection Agency (EPA’s) federal pesticide law, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  As concerns with the spread of COVID-19 and new variants increase over the winter months, consumers are likely to stock up disinfectant products and devices like air purifiers and air filters marketed to reduce the transmission of COVID-19 and other microorganisms.  These products are tightly regulated under FIFRA, and retailers can unwittingly become entangled in regulatory enforcement actions for selling and distributing products that do not comply with EPA’s regulations.  FIFRA extends legal liability not only to the makers of violative products, but also retailers who sell them to consumers, whether or not the retailer was necessarily aware of the violation. In addition to EPA, state agencies also enforce state regulatory requirements applicable to these products.