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.

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.

On April 12, 2022, the United States Environmental Protection Agency (EPA) announced a sweeping proposed ban on ongoing uses of chrysotile asbestos, the only form of asbestos known to still be imported into the United States. EPA’s proposed ban is the first risk management rule issued under the Toxic Substances Control Act (TSCA) since the 2016 Lautenberg Act overhauled the statute to give EPA new powers to review and regulate existing chemicals.

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.

8.18.2021 EPA Finalizes Hazard Assessments for Two Fuel Additives (ETBE and tert-Butanol):

On August 18^th, EPA finalized the long-awaited hazard assessments for both Ethyl Tertiary Butyl Ether (ETBE) and tert-Butyl Alcohol (tert-Butanol).  ETBE was previously added to gasoline to increase its octane levels. It is still registered with EPA for use as a fuel additive, but it is not used currently in the United States.  tert-Butanol is one of the primary metabolites of ETBE and has also been used as a fuel oxygenate. It is also used for other purposes including as a solvent and as a dehydrating agent.

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.

A flurry of asbestos-related activity in the last weeks of 2020 will require the United States Environmental Protection Agency (EPA) to devote significant regulatory attention to asbestos in 2021.  The incoming Biden Administration will need to address these Toxic Substances Control Act (TSCA) developments, and the scope of that response will determine whether regulatory implications extend beyond asbestos to other chemical substances.