The Nickel Report

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.

TSCA Risk Management Rules and Recent TSCA Proposals to Restrict Uses of Chemicals

Under TSCA Section 6(a), EPA has the authority to impose a wide variety of restrictions on existing chemicals once the agency has determined the chemical presents an unreasonable risk. This includes prohibitions on manufacturing, processing, use, distribution and disposal, as well as setting concentration limits, requiring warnings, testing, recordkeeping and notifications. Section 6(a) directs EPA to consider multiple factors in deciding how to regulate a chemical, including the health effects and magnitude of exposure, environmental effects, benefits of the chemical and the reasonably ascertainable economic consequences of the rule. Importantly, TSCA Section 26 compels EPA to use the best available science in decision-making for risk management rules. EPA is also required under Section 9 of TSCA to coordinate with other federal agencies to reduce the potential for duplicative regulation.

EPA published its first proposed risk management rule for chrysotile asbestos (“Part 1”) on April 12, 2022, followed by methylene chloride on May 3, 2023. Subsequently, proposed rules for perchloroethylene (PCE) and carbon tetrachloride (CTC) were published on June 16, 2023, and July 28, 2023, respectively. EPA released its fifth risk management rule on October 31, 2023, for trichloroethylene (TCE). These substances, other than asbestos, are widely-used solvents in a variety of consumer, industrial and commercial applications.

EPA’s Preferred Risk Management Approach

The five proposed risk management rules indicate that EPA is likely to pursue one of two pathways to address the purported unreasonable risks identified in the risk evaluation process:

1. Complete Ban on All Uses—Potential Phaseouts and Interim Workplace Chemical Protection Programs (WCPPs) Until Bans Take Effect

The proposed risk management rule for chrysotile asbestos proposes banning specific use of the substance, including diaphragms in the chlor-alkali industry, sheet gaskets, oilfield brake blocks, aftermarket automotive brakes and linings, vehicle friction products and other gaskets. The proposed risk management rule for TCE completely bans all uses of the chemical, with phaseouts for uses with specified timeframes. Until the TCE ban takes effect for those limited uses, EPA mandates worker chemical protection requirements, akin to an Occupational Safety and Health Administration (OSHA) workplace standard and an existing chemical exposure limit (ECEL) to limit airborne exposures.

2. Substantial Restrictions, Broad Prohibitions and Rigorous WCPP Requirements

EPA’s proposed risk management rules for methylene chloride, perchloroethylene (PCE) and carbon tetrachloride (CTC) also include detailed WCPPs. EPA has also proposed broad prohibitions on various manufacturing, processing, distribution, disposal and use activities (commercial, industrial and consumer). The table below contains the proposed ECELs, which are well below the OSHA Permissible Exposure Limits (PELs).  

WCPPs proposed for non-prohibited uses share similar elements: stringent exposure monitoring (including initial and periodic monitoring), reducing exposures based on the National Institute for Occupational Safety & Health (NIOSH) hierarchy of controls, respirator selection criteria, dermal protection, downstream notification, worker training and recordkeeping. While EPA states that they have tried to align with OSHA requirements, differences exist, which require companies to reassess current compliance approaches.

Upcoming Risk Management Rules

The table below shows the expected rulemaking timelines for the first 10 chemicals that have completed risk evaluations. As shown below, four proposed rules have been published in the Federal Register for public comment, and EPA is expected to propose rules for other chemistries in 2024.

Regulated industry has a lot at stake with the proposed risk management rules EPA plans to finalize in 2024. If EPA continues the same approach used in the other proposed risk management rules, companies should prepare for more bans on chemical uses, particularly upstream uses like manufacturing, aimed at mitigating downstream risks, and more WCPP requirements and ECELs. Extended phase out periods are likely for chemical uses that EPA considers to be “critical uses” or lacking identified alternatives.

Companies should also expect more EPA requests for information on chemicals undergoing risk evaluation. EPA is particularly interested in information within the last 20 years on personal breathing zone and area monitoring data, process emissions factors, descriptions of commercial worker activities and exposure sources, product formulation and relevant unpublished data. EPA has also said that uncertainty regarding whether the regulated community can comply with an ECEL or prevent workers’ direct dermal contact with a chemical “can influence whether a condition of use is considered to be a candidate for [a] [workplace chemical protection program (WCPP)] or whether [a] prohibition is more appropriate[.]” 

Providing this information is often in companies’ best interest. If companies do not provide data to EPA demonstrating that they can meet EPA’s proposed ECELs for the particular conditions of use for a chemistry which EPA is regulating, EPA will likely propose that the ECEL is not achievable for that condition of use and, thus, conclude that a prohibition is the most appropriate risk management approach.

EPA is also proposing to layer additional workplace regulations on top of existing OSHA standards, prompting concerns expressed by 59 members of Congress in a December 6, 2023, letter to EPA’s Administrator Michael Regan. The concerns focus on EPA’s approach of “banning first, then exempting” uses of a chemical, “usurping” OSHA’s authority to create exposure limits for chemicals, and the lack of public input, peer review and transparency in developing ECELs.

The chemicals team at Hunton Andrews Kurth LLP is available to provide further details on EPA’s TSCA proposals and to answer any questions you may have.