On December 9, 2024 the U.S. Environmental Protection Agency (EPA) finalized the latest risk management rules for trichloroethylene (TCE) and perchloroethylene (PCE) under the 2016 Toxic Substances Control Act (TSCA) amendments.
TCE is a toxic chemical in products for consumer and commercial use known to cause human health risks even at very small concentrations. Under today’s rule, all uses of TCE will be banned over time (with the vast majority of identified risks eliminated within one year), and safer alternatives are readily available for the majority of uses. These chemicals can be found in industries like dry cleaning, automotive repair and manufacturing.
EPA aims to better protect people from health risks by banning manufacture, processing and distribution in commerce of PCE for all consumer uses and many commercial uses, while allowing some workplace uses to continue only where robust workplace controls can be implemented. PCE and TCE are both nonflammable chlorinated solvents that are volatile organic compounds. PCE can biodegrade into TCE, and PCE may contain trace amounts of TCE as an impurity or a contaminant. The chemicals can often serve as alternatives for each other. For several uses of TCE that will be totally prohibited, there is an analogous use of PCE that can continue safely in perpetuity under workplace controls. Some examples of uses that will be prohibited under the TCE rule, but will continue under the PCE rule include: industrial and commercial use as an energized electrical cleaner, in laboratory use for asphalt testing and recovery, use to make refrigerants and other chemicals, and for vapor degreasing.
Trichloroethylene – TCE Use and Phase Out
TCE is used as a solvent in consumer and commercial products such as cleaning and furniture care products, degreasers, brake cleaners, sealants, lubricants, adhesives, paints and coatings, arts and crafts spray coatings, and is also used in the manufacture of some refrigerants. Safer alternatives are readily available for the majority of these uses.
EPA is finalizing its prohibition on all uses of TCE, most of which will be prohibited within one year, including TCE manufacture and processing for most commercial and all consumer products. This will protect most people who are likely to be exposed to TCE from uses covered by TSCA, including all consumers and workers in many sectors and many communities.
A limited number of uses in the workplace will be phased out over a longer period. Those uses will only continue with required stringent worker protections in place. All TCE uses with longer phaseout timeframes will have worker safety requirements, such as a Workplace Chemical Protection Plan that includes an inhalation exposure limit. The final rule sets a different inhalation exposure limit for airborne TCE than was proposed. This change was made in response to public comments to ensure the limit is feasible to implement and monitor while still reducing risk. EPA estimates that the new inhalation exposure limit would reduce long-term workplace exposure by 97%.
Many of the TCE uses that are continuing for longer than one year occur in highly industrialized settings that can adopt EPA’s new stringent worker protections, such as uses of TCE to clean parts used in aircraft and medical devices, to manufacture battery separators, to manufacture refrigerants, as well as in other transportation, security and defense systems.
For the use of TCE in manufacturing refrigerants, the longer timeframe supports fighting climate change by complementing efforts to phase down climate-damaging hydrofluorocarbons under the bipartisan American Innovation and Manufacturing Act.
All of these uses ultimately will be prohibited, but some of the exemptions associated with longer timeframes are necessary to avoid impacts to national security or critical infrastructure. In addition, some of the timeframes have been adjusted from the proposed rule based on public comment to allow reasonable time for transitioning to alternatives.
Further, to support cleanup activities at sites of past TCE contamination (e.g., Superfund sites), EPA is allowing essential laboratory use and proper disposal of TCE wastewater to continue for 50 years provided worker protections are in place, including the inhalation exposure limit set by today’s rule.
Perchloroethylene – PCE Phase Out
PCE is a solvent that is widely used for consumer uses such as brake cleaners and adhesives, in commercial applications such as dry cleaning, and in many industrial settings. Safer alternatives are readily available for the majority of these uses. EPA is finalizing a 10-year phaseout for the use of PCE in dry cleaning to eliminate the risk to people who work or spend considerable time at dry cleaning facilities. Use of PCE in newly acquired dry-cleaning machines will be prohibited after six months. Compliance dates for machines that are already owned will vary depending on the type of the dry-cleaning machine used, with older types of machines being phased out sooner than newer ones. Many dry cleaners have already begun this transition. This timeline is unchanged from the proposed rule.
EPA’s final risk management rule requires companies to rapidly phase down manufacturing, processing and distribution of PCE for all consumer use and many uses at industrial and commercial workplaces, most of which will be fully phased out in less than three years. For most of the uses of PCE that EPA is prohibiting, EPA’s analysis found that alternative products with similar costs and efficacy to PCE are reasonably available.
The rule also finalizes stringent, achievable controls for continuing uses under a Workplace Chemical Protection Program. These uses generally occur in highly sophisticated workplaces that may be important to national security, aviation and other critical infrastructure, as well as uses that complement the agency’s efforts to combat the climate crisis. These uses include:
In response to public comments on the proposed rule, most workplaces now have 30 months instead of 12 months to fully implement the Workplace Chemical Protection Program. EPA also revised several other aspects from the proposal to strengthen and clarify aspects of the Workplace Chemical Protection Program, including monitoring requirements. EPA also ensured the employees’ designated representatives, such as labor union representatives, have access to occupational exposure monitoring and records.
Additional Information and Resources
On December 4, the U.S. Environmental Protection Agency (EPA) finalized amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA). The Agency aims to ensure new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative, and toxic (PBT) chemicals with potential for human exposure are subject to the full safety review process before manufacture. Under TSCA, EPA reviews the potential risks of new chemicals before they can enter U.S. commerce and, when necessary, putting safeguards in place to protect human health and the environment.
Final Rule Eliminates PFAS and PBT Exemptions
The final rule eliminates eligibility for a low volume exemption (LVE) or low release and exposure exemption (LoREX). Existing regulations allow EPA to grant safety review exemptions for the manufacturing of chemicals with low production quantities, environmental releases or human exposures. These exemptions allowed the chemicals, some of which historically have included some PFAS, to undergo a shorter review instead of the full, robust review prior to manufacture.
Align Federal Regulations with Existing Law
Under TSCA, manufacturers (including importers) and processors must submit premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications. Prior to the 2016 amendments, EPA only made formal safety determinations on approximately 20% of new chemical submissions.
The new law requires EPA to make one of five possible safety determinations on 100% of new chemical submissions before they can enter the market. If EPA determines…
ONE: a new chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, the Agency must take action under section 5(f) to protect against the unreasonable risk.
TWO: the available information is insufficient to allow the Agency to make a reasoned evaluation of the health and environmental effects of the new chemical substance or significant new use, EPA must issue an order under section 5(e). A section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
THREE: in the absence of sufficient information, the manufacture, processing, distribution in commerce, use or disposal of the chemical may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the EPA Administrator, EPA must issue an order under section 5(e). A section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
FOUR: the substance is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the substance, EPA must issue an order under section 5(e). A section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
FIVE: a new chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, the Agency will notify the submitter and the submitter may commence manufacture of the chemical or manufacture or processing for a significant new use notwithstanding any remaining portion of the 90-day review period. EPA will notify the submitter of its decision and publish its findings in a statement in the Federal Register.
This rule amends the regulations by specifying that EPA must make one of the five specified statutory determinations on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing the new chemical substance. The rule also updates the regulations to list the actions required in association with each of those determinations.
The Agency feels these amendments align the regulations with TSCA section 5 requirements to reflect the full extent of new chemicals review, providing consistency and transparency in new chemicals review processes.
Change to Chemicals Review Process
The final rule also makes several other changes to the new chemicals review process, including clarifying the level of detail needed in new chemical notices and amending the procedures for EPA’s review of notices that have errors or are incomplete. EPA is changing its longstanding practice of accepting amended notices that contain information that was known or reasonably ascertainable at the time of the original submission and then accepting a request to suspend the review period. Instead, EPA will now exercise its authority under the regulations to declare the original submission incomplete and restart the review period when the completed submission is received.
Industry will provide complete submissions for review through a new set of information “pick-lists” that will be incorporated into the application form located in EPA’s Central Data Exchange in a phased approach. EPA feels this will help submitters provide all the necessary information, so that EPA can assess risk more quickly and accurately.
This rule will go into effect 30 days after publication in the Federal Register. A prepublication version of the rule is available here.
EPA’s final action, also known as a risk management rule under the Toxic Substances Control Act (TSCA), is the second risk management rule to be finalized using the process created by the 2016 TSCA amendments.
Methylene chloride is used by consumers for aerosol degreasing and paint and coating brush cleaners, in commercial applications such as adhesives and sealants, and in industrial settings for making other chemicals. For example, methylene chloride is used in the production of more climate-friendly refrigerant chemicals.
Since 1980, at least 88 people have died from acute exposure to methylene chloride, largely workers engaged in bathtub refinishing or other paint stripping, even, in some cases, while fully trained and equipped with personal protective equipment. While EPA banned one consumer use of methylene chloride in 2019, use of the chemical has remained widespread and continues to pose [a] significant and sometimes fatal danger to workers. EPA’s final risk management rule requires companies to rapidly phase down manufacturing, processing, and distribution of methylene chloride for all consumer uses and most industrial and commercial uses, including its use in home renovations.
Consumer use [of methylene chloride] will be phased out within a year, and most industrial and commercial uses will be prohibited within two years.
For a handful of highly industrialized uses, EPA has created a Workplace Chemical Protection Program. This workplace chemical protection program has strict exposure limits, monitoring requirements, and worker training and notification requirements that will protect workers from cancer and other adverse health effects caused by methylene chloride exposure.
Uses that will continue under the Workplace Chemical Protection Program are highly industrialized and important to national security and the economy. These are uses for which EPA received data and other information that shows workplace safety measures to fully address the unreasonable risk could be achieved. These uses include:
Additionally, specific uses of methylene chloride required by the National Aeronautics and Space Administration, the Department of Defense, and the Federal Aviation Administration will also continue with strict workplace controls because sufficient reductions in exposure are possible in these highly sophisticated environments, minimizing risks to workers.
Compliance Under the Risk Management Rule
For uses of methylene chloride continuing under the Workplace Chemical Protection Program, most workplaces will have 18 months after the finalization of the risk management rule to comply with the program and would be required to periodically monitor their workplace to ensure that workers are not being exposed to levels of methylene chloride that would lead to an unreasonable risk. In consideration of public comments on the proposal, EPA extended the compliance timeframe to give workplaces ample time to put worker protections in place.
EPA also revised several other aspects from the proposal including ensuring the Workplace Chemical Protection Program applies to the same uses whether they are federal or commercial uses, establishing a de minimis concentration, and provisions to strengthen and clarify aspects of the Workplace Chemical Protection Program such as monitoring requirements.
EPA will also host a public webinar to explain what is in the final rule and how it will be implemented. The agency will announce the date and time in the coming weeks.
For More Information
The U.S. Environmental Protection Agency finalized a rule that strengthens its process for conducting risk evaluations on chemicals under the Toxic Substances Control Act (TSCA). These improvements to EPA’s processes advance the goals of this important chemical safety law, ensure that TSCA risk evaluations comprehensively account for the risks associated with a chemical, and provide a solid foundation for protecting public health, including workers and communities, from toxic chemicals. The rule also includes changes to enhance environmental protections in communities overburdened by pollution, complementing the Administration’s environmental justice agenda.
The 2016 TSCA amendments require that EPA establish a procedural framework rule on the process for conducting chemical risk evaluations. TSCA risk evaluations are the basis for EPA’s risk management rules. Although EPA finalized a risk evaluation framework rule in 2017, that rule was challenged in court. EPA’s final rule includes revisions made to respond to the court’s ruling, as well as several changes to improve EPA’s process for TSCA risk evaluations, including:
EPA announced many of the changes included in the final rule in 2021 and has incorporated them into TSCA risk evaluation activities over the past three years. EPA then proposed a revised procedural framework rule in October 2023 and, after considering public comment on the proposed rule, released today’s final rule. EPA is submitting this document for publication in the Federal Register (FR).
The procedures outlined in the rule apply to all risk evaluations initiated 30 days after the date of publication of the final rule or later. For risk evaluations that are currently in process, EPA expects to apply the new procedures to those risk evaluations to the extent practicable, taking into consideration the statutory requirements and deadlines.
TSCA Risk Evaluation Process
The Risk Evaluation process is the second step, following Prioritization and before Risk Management, in EPA’s existing chemical process under TSCA. The purpose of risk evaluation is to determine whether a chemical substance presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. As part of this process, EPA must (1) evaluate both hazard and exposure, (2) exclude consideration of costs or other non-risk factors, (3) use scientific information and approaches in a manner that is consistent with the requirements in TSCA for the best available science, and (4) ensure decisions are based on the weight-of-scientific-evidence. Learn more about the TSCA risk evaluation process.
Additional Resources
