The Nickel Report

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 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.

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 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.

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

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.

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 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

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 December 29, the chemicals program at EPA closed out 2021 by proposing revisions to its risk determinations for the Cyclic Aliphatic Bromide Cluster (HBCD), a solvent used as a flame retardant and wetting agent which has not been manufactured in the United States in nearly five years. In doing so, the Biden EPA made good on its June 2021 promise to revisit risk determinations previously made during the Trump Administration in accordance with the Toxic Substances Control Act (TSCA). The draft “revisions” represent a significant shift from EPA’s prior approach to existing chemical risk evaluation and foreshadow increased regulatory and litigation risk for all companies—not just those whose operations may have historically involved HBCD.

In a dramatic announcement last week, EPA suggested that if companies import, manufacture, or process a finished good for commercial sale, and that product is not a pesticide, not a firearm, not a tobacco product, and not a food, food additive, drug, cosmetic, or device, they will need to know all chemicals contained in those products. We explain more about this below.

EPA has traditionally declined to extend most of its chemical regulations to finished goods, which are known as “articles” under the Toxic Substances Control Act (TSCA), on the grounds it would be enormously difficult for importers of complex consumer products to determine the chemical identity of each chemical substance in these products. Industry stakeholders have generally supported this approach and have long taken the position that supply chains are too complex to expect finished product manufacturers to be aware of all chemicals in those products.

On January 26, 2021, a coalition of advocacy groups and prominent asbestos plaintiffs’ experts launched two challenges to “Part 1” of the asbestos risk evaluation recently released by the United States Environmental Protection Agency (EPA).  EPA concluded in Part 1 that 16 of the 32 “conditions of use” analyzed pose an “unreasonable risk” to human health, but advocacy groups have criticized EPA for only addressing risks associated with chrysotile asbestos and excluding review of other fiber types.  Now, those groups have teamed up on a pair of legal challenges that could force EPA to revisit its Part 1 asbestos risk evaluation, which could delay risk management regulations.

On November 9, 2020, EPA’s Office of Research and Development (ORD) released its long-awaited draft handbook that details the office’s process for developing chemical hazard assessments for its Integrated Risk Information System (IRIS) Program. The ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) gives useful insight into ORD’s process to develop its IRIS assessments, which provide important toxicological information that federal and state environmental agencies consider when making regulatory and cleanup decisions under multiple statutory programs. EPA will accept comments on the draft handbook and charge questions until March 1, 2021.

Companies that manufacture or import products containing one or more of 20 common chemicals may soon be required to disclose those activities and pay fees to offset the United States Environmental Protection Agency’s (EPA) review of those chemicals under the Toxic Substances Control Act (TSCA). In December 2019, EPA finalized its list of 20 high-priority chemicals for risk evaluation and potential regulation under TSCA:

• Formaldehyde, a chemical commonly used in building products and as a preservative;
• Five phthalates used as plasticizers in products like plastic pipes, toys, food packaging, cosmetics and medical/dental products (BBP, DBP, DEHP, DIBP and DCHP) and one chemical used to make phthalates (phthalic anhydride);
• Three flame retardants (TBBPA, TCEP and TPP) and a chemical sometimes used in the manufacture of flame retardants and fire extinguishers (ethylene dibromide);
• A fragrance additive found in perfumes, cosmetics and other consumer products (HHCB, also known as galaxolide);
• Seven chlorinated solvents found in products like cleaning solutions, paint thinners and glues (1,1-dichloroethane, 1,2-dichloroethane, 1,2-dichloropropane, o-dichlorobenzene, p-dichlorobenzene, trans-1,2-dichloroethylene and 1,1,2-trichloroethane); and
• A chemical used to manufacture synthetic rubber (1,3-butadiene).

In December 2018, an article in this blog flagged a petition for EPA rulemaking under the Toxic Substances Control Act (TSCA) that, if denied, had the potential to set up precedent-setting litigation on citizens’ ability to use the courts to require EPA action under TSCA. Now, nearly a year later, the scenario that article described is coming true. In a challenge to EPA’s denial of that petition, a federal district court is poised to decide what constitutes a petition for issuance of a new rule as opposed to one for amendment of an existing rule—and in the process, to decide when a court may cast aside deference to EPA and undertake its own evaluation independent of the Agency’s record and conclusions.

On March 15, 2019, the House Subcommittee on Environment and Climate Change held a hearing titled, “Protecting Americans at Risk of PFAS Contamination & Exposure.” The hearing examined approaches to eliminate or reduce environmental and health risks to workers and the public from per- and polyfluoroalkyl substances (PFAS).

A pending petition for rulemaking under the Toxic Substances Control Act (TSCA) could represent the latest test of the scope of TSCA’s citizen petition provisions. Denial of this petition would tee up a precedent-setting court battle addressing citizens’ ability to force EPA to exercise its TSCA section 8 authority to require chemical data reporting. And while the petition on its face is focused on requiring additional information collection, it could have important implications for EPA’s implementation of TSCA’s amended provisions regarding regulation of existing chemicals under section 6.

This summer, EPA sparked public outrage with its proposed “significant new use” rule, or SNUR, addressing certain commercial uses of asbestos. Publications like Rolling Stone, Newsweek and The Daily Beast criticized EPA for loosening its regulations to pave the way for asbestos to be reintroduced to the market, allowing asbestos-containing construction materials to be used in homes and other buildings again for the first time in decades. National figures like Senator Brian Schatz and Chelsea Clinton drew attention to the proposal while condemning the Agency for increasing public exposure to this well-known carcinogen.

There’s just one issue: EPA’s proposed action does the opposite of what these critics claim. The SNUR would impose substantial new prohibitions on the listed uses of asbestos—which currently are not regulated by EPA at all—while giving EPA the necessary legal “hook” to restrict or even ban these uses outright in the unlikely event that a company actually tries to resume them.

How can news reports have gotten it so backward?

On May 9, the White House released its Spring 2018 update to EPA’s regulatory agenda. Agency watchers quickly dove into the document to check the status and timelines for high-profile rulemakings and gain insights on the Trump administration’s priorities. But aside from any revelations about the administration’s own initiatives, this latest document was also notable for showing just how much EPA’s regulatory agenda can be driven by forces outside of the executive branch.

On February 7, 2018, US Environmental Protection Agency (EPA) Administrator Scott Pruitt signed a proposed rule to establish user fees to defray EPA’s costs of administering its responsibilities under the Toxic Substances Control Act (TSCA), as amended by the 2016 Frank Lautenberg Chemical Safety for the 21^st Century Act (Lautenberg Act). EPA estimates in the proposed rule that it will collect about $20.05 million per year in user fees, not counting any user fees associated with manufacturer-requested risk evaluations, which would range from $1.3 million to $2.6 million per evaluation.

Last year, President Obama signed into law the amended Toxic Substances Control Act (TSCA). Congress made substantial changes with respect to how both existing and new chemical substances are regulated. Some of these changes are significant and will have a direct impact on US chemical manufacturers, importers, distributors and users. However, the US did not attempt to mimic the EU’s REACH Regulation.

This article provides a high-level comparison of the main building blocks of the two regimes, bringing out the main similarities and differences between them. Of course, these are two different jurisdictions and no direct comparison can be completely valid, but it is worth making the comparison nonetheless, because many companies operate across both regions and because other jurisdictions have mimicked REACH in their regulatory reform, whereas the US has chosen not to.

Environmental and public-health groups have taken issue with the EPA’s rule establishing procedures for chemical risk evaluations under the revised Toxic Substances Control Act (TSCA), which allows the EPA to exclude certain conditions of use when assessing whether a chemical presents unreasonable risks. These groups fear the exclusions could provide a “loophole” allowing some chemical risks to go unaddressed. But putting those concerns aside, should companies affected by the rule actually want to take advantage of these exclusions? Are they really beneficial to regulated industries? Or do they risk undermining one of the primary goals that companies sought to gain by supporting TSCA reform—federal preemption of overlapping state restrictions?

Last year Congress directed the US Environmental Protection Agency (EPA) to review new chemicals by a new process. A major question for manufacturers and consumers is whether EPA can do this within a reasonable time period without unnecessarily getting in the way of innovation.

Since enactment of the Lautenberg Act amending the Toxic Substances Control Act (TSCA) in June 2016, the pace of EPA’s review of new chemicals has slowed dramatically. While EPA’s pre-enactment new chemicals program handled around 1,000 premanufacture notifications (PMNs) annually, EPA estimates that a backlog of about 600 new chemicals had built up by January 2017, which created a substantial concern in the regulated community.

In June 2016, Congress did something it had not done in over a quarter century: it enacted comprehensive, bipartisan revisions to a major environmental statute. More specifically, it substantially overhauled the Toxic Substances Control Act, or TSCA, a law that was first passed in 1976 and was widely considered to be in need of an update. The TSCA reform law, also known as the Lautenberg Act, expands EPA’s role in reviewing new chemical substances; gives EPA new authority to require testing of chemicals; and directs EPA to prioritize, evaluate and regulate the risks from existing chemicals. It also imposes strict deadlines on EPA for carrying out its new duties under TSCA.

And EPA has apparently taken these deadlines to heart.