Managing risk: what the EPA’s TSCA chemical use bans tell us
August 2024 | SPOTLIGHT | RISK MANAGEMENT
Financier Worldwide Magazine
August 2024 Issue
The US Environmental Protection Agency (EPA) recently issued final risk management rules under the Toxic Substances Control Act (TSCA) banning certain uses of two chemicals: chrysotile asbestos and methylene chloride.
The identity of these two chemicals is less important than the process by which the EPA concluded that the banned uses of these chemicals pose unreasonable risks to human health and the environment, and the nature and intrusiveness of the workplace and other restrictions the EPA has imposed while the bans take effect.
Even if an organisation’s supply chain excludes these chemicals, the administrative process and broad prohibitions the EPA is authorised to impose under the TSCA have enormous commercial implications for all businesses using chemicals, as most do. These rules offer insight into the future of chemical regulation, and this article explains why. As the expression goes: “It ain’t pretty.”
Background
The EPA is required under the TSCA to prioritise, evaluate and manage unreasonable risks from conditions of use of active, high priority existing chemicals. The law’s focus on the potential risks existing chemicals may pose, the chemicals used for decades and on which most manufacturing operations are based, is a foundational goal of the US chemical management programme that was extensively revised in 2016.
The revised law and the EPA’s implementation of it address a key criticism of the original TSCA, namely the conspicuous absence of a systematic mechanism for evaluating existing chemicals and the potential risks they may pose. As there are some 44,000 existing chemicals under the TSCA (not all of them are ‘high priority’), the bipartisan legislation enacted in 2016 requiring exactly what the EPA is doing now was laser-focused on correcting this rather large omission.
Congress identified in the 2016 legislation the first 10 chemicals to be evaluated, all of which were drawn from the 2014 update of the EPA’s ‘Work Plan for Chemical Assessments’ list. Asbestos was at the top of the EPA’s list, given the notoriety the substance achieved under the old TSCA and ongoing tort litigation.
Methylene chloride was equally top of mind, given its broad commercial uses and the chemical’s association with multiple consumer incidents, including fatalities. The EPA restricted consumer uses of methylene chloride for stripping paint and coatings in 2019 and imposed other requirements. While these initial chemical risk evaluations took considerably longer than expected, the EPA issued the final risk management rule for chrysotile asbestos in March 2024 and the final rule for methylene chloride in May.
Overview of final rules
The final asbestos risk management rule prohibits all persons from manufacturing (including import) chrysotile asbestos, including any chrysotile asbestos-containing products or articles, for diaphragms in the chlor-alkali industry and a variety of other uses. Beginning five years after 28 May 2024 (the effective date of the final rule), the rule prohibits all persons from processing, distributing in commerce and commercially using chrysotile asbestos for diaphragms in the chlor-alkali industry, except as explicitly provided otherwise.
“Even if an organisation’s supply chain excludes these chemicals, the administrative process and broad prohibitions the EPA is authorised to impose under the TSCA have enormous commercial implications for all businesses using chemicals, as most do.”
The final rule is quite specific in its application to the three remaining commercial operations in the US processing chrysotile asbestos. The EPA will permit persons to process, distribute in commerce and commercially use chrysotile asbestos for diaphragms in the chlor-alkali industry at two facilities until eight years after the effective date of the final rule, if they meet certain conditions.
The EPA will also permit persons who meet certain criteria to process and distribute in commerce and commercially use chrysotile asbestos for diaphragms in the chlor-alkali industry at another facility until 12 years after the effective date of the final rule, provided that the facility meets certain conditions. The phaseout periods are different, as the entities processing asbestos have very different use profiles, operational needs and transition plans.
There are many other prohibitions and restrictions on other conditions of use on the manufacturing, processing, distribution in commerce and commercial use of chrysotile asbestos. We do not explore them further here, except in general terms. For example, beginning two years after the effective date of the final rule, all persons are prohibited from manufacturing (including importing), processing, distributing in commerce and commercially using chrysotile asbestos, including any chrysotile asbestos-containing products or articles, for use in sheet gaskets for chemical production, except as provided by the EPA. These details are not important for the point being made, namely as of a date certain these uses of this chemical will be banned forever.
For most of the conditions of use the EPA reviewed, where the prohibition on processing and industrial use will take effect in five or more years after the effective date of the rule, the EPA is requiring strict operational controls to limit workplace exposures. This requirement is especially important to understand, as the EPA’s approach is expected to serve as a template for future chemical restrictions. Importantly, owners or operators are required to comply with a very conservative eight-hour existing chemical exposure limit (ECEL). This begins six months after the effective date of the final rule.
Retrofitting a plant to meet this ECEL, and otherwise comply with the final rule, will be costly. This requirement applies to processing and industrial use of chrysotile asbestos in bulk form or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and industrial use of chrysotile asbestos sheet gaskets for titanium dioxide production. Once a facility has completed the phaseout of chrysotile asbestos and no longer uses chrysotile asbestos in its operations, interim requirements like the ECEL no longer apply.
Many may wonder what role the Occupational Safety and Health Administration (OSHA) standards play in this process (OSHA is the federal agency chiefly in charge of regulating workplace risks). For chrysotile asbestos, the EPA’s approach for interim controls is, according to the EPA, aligned with elements of the existing OSHA standard for regulating asbestos.
According to the EPA, the OSHA permissible exposure limit (PEL) and ancillary requirements “have established a long-standing precedent for exposure limit threshold requirements within the regulated community”. The EPA acknowledges that it is applying a much lower ECEL under the final rule than the PEL, but does not elaborate on the obvious dissonance this lack of alignment causes.
The methylene chloride final rule is less complicated. Under it, the EPA prohibits manufacturing, processing and distribution of methylene chloride for all consumer uses, prohibits most industrial and commercial uses of methylene chloride, including paint and coating removers, and, like the asbestos rule, creates strict workplace protections to ensure that for the remaining uses, workers will not be harmed by methylene chloride use. The rule also requires manufacturers, including importers, processors and distributors, to notify companies to whom methylene chloride is shipped of the prohibitions and to maintain records.
Most prohibited uses will be fully phased out within two years. The EPA believes that alternative products with similar costs and efficacy to methylene chloride products are generally available for most prohibited uses. Whether industry agrees is less clear.
Uses that will continue under the strict workplace conditions are highly industrialised and important to national security and the economy. These are uses for which the EPA received data and other information showing that the workplace safety measures could be achieved.
What the rules tell us
The final risk management rules tell us several things. First, the EPA has clear authority to ban uses of chemicals and is prepared to exercise that authority. There are phaseout periods, so companies need not go cold turkey immediately. Bans have hard stops, however, and a few years is no time at all in retooling a product line, identifying alternative substances and reformulating product compositions.
Second, the EPA will impose strict worker protection and other workplace restrictions during the phaseout period and on non-prohibited continuing uses. The EPA has broad authority to impose personal protective equipment (PPE) requirements for workers, enforce workplace exposure limits considerably more stringent than current OSHA PELs, demand downstream notification requirements, and impose worker training and recordkeeping requirements.
These requirements are costly to satisfy and require careful explanation to a workforce perhaps wondering why all these measures are needed now, and what their relevance is to a worker’s health, given past higher workplace exposures. Downstream customers newly advised of chemical restrictions may be asking the same question.
Third, these rules tell us the EPA is of the view that certain uses of these chemicals must be banned because the necessary PPE used during the phaseout period may not be used correctly. This very precautionary approach to risk management is a critically important take-home message. It is worth asking if soon-to-be banned uses of these chemicals may continue to be used safely by complying with the restrictions, why must they be banned at all?
The EPA’s response is the restrictions may not be followed, or PPE may fail, or any number of other ‘what-ifs’ suggest to the EPA that a ban is the only surefire way of preventing unreasonable risk. Under this construction, the EPA will need to ban uses of nearly every substance it reviews under section 6 of the TSCA because it is likely that uses of substances that the EPA reviews over the next several decades will be deemed to pose unreasonable risk from routine, unprotected inhalation or dermal exposures.
These rules reflect how the EPA will manage risks from the existing chemicals the EPA will review under section 6 of the TSCA for years to come. Both final rules have been judicially challenged. Monitoring these litigations will be important, as the challenges are not just about asbestos and methylene chloride. There are plenty more for the EPA to review. The Work Plan Chemical list is the EPA’s roadmap. These are the chemicals the EPA is reviewing now and for the foreseeable future.
Lynn L. Bergeson is managing partner of Bergeson & Campbell, P.C. She can be contacted on +1 (202) 557 3801 or by email: lbergeson@lawbc.com.
Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C), has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act, the Federal Insecticide, Fungicide, and Rodenticide Act, the European Union Registration, Evaluation, Authorization and Restriction of Chemicals regulation, and especially how these regulatory programmes pertain to nanotechnology, industrial biotechnology, synthetic biology and other emerging transformative technologies. Her knowledge of and involvement in the policy process allow her to develop client-focused strategies whether advocating before Congress, the US Environmental Protection Agency, the US Food and Drug Administration, or other governance and standard-setting bodies.
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