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.
On July 24, the U.S. Environmental Protection Agency (EPA) proposed to designate five chemicals as High-Priority Substances for risk evaluation under the nation’s chemical safety law, the Toxic Substances Control Act (TSCA). If EPA finalizes these designations as proposed, the agency would immediately move forward with the risk evaluation process. According to the current Administration this step is consistent with a commitment to understand and address environmental and toxic exposures to ensure that every community has access to clean air and water while bolstering efforts to make progress on delivering environmental justice and tackling plastic pollution.
The five chemical substances EPA is proposing to designate as High-Priority Substances are:
EPA will accept public comments on the proposed designations for 90 days after publication via docket EPA-HQ-OPPT-2023-0601 at the Regulations.gov page. Upon publication of the Federal Register notice, supporting documents will also be available in the docket.
Chemicals Proposed as High-Priority Substances for Risk Evaluation
All five chemicals were selected from the 2014 TSCA Work Plan, which is a list of chemicals identified by EPA for further assessment based on their hazards and potential for exposure. In proposing these five chemical substances as High-Priority Substances for risk evaluation, EPA had to consider the chemicals’ conditions of use and production volume or changes in conditions of use and production volume over time, impacts to potentially exposed or susceptible subpopulations including children and workers, and the chemicals’ potential hazards and exposures. EPA also considered more specific criteria such as the chemical’s bioaccumulation and environmental persistence and whether the chemical is stored near significant sources of drinking water.
Vinyl chloride is used primarily in the manufacturing and processing of plastic materials such as polyvinyl chloride (PVC), plastic resins, and other chemicals. Many of these materials are used for pipes and insulating materials. This chemical was also involved in the Norfolk Southern train derailment in East Palestine, Ohio. Vinyl chloride is a known human carcinogen and can cause liver, brain, and lung cancer in exposed workers. Short-term exposure to vinyl chloride can also result in other health effects such as dizziness, nausea, and eye and skin irritation. Vinyl chloride exposure can also damage genetic material in cells, which can lead to numerous adverse health effects. In the 1970s, the White House Council on Environmental Quality and EPA officials raised serious concerns about the health impacts of vinyl chloride as an example when the Nixon Administration asked Congress to write a law to ensure chemicals were made and used safely, which led to passage of the “original” TSCA in 1976.
Acetaldehyde is used primarily in the manufacturing and processing of adhesives, petrochemicals, plastic and other chemicals, as well as intermediates for products such as packaging and construction materials. Acetaldehyde is a probable human carcinogen. Specifically, animal studies have shown that exposure to acetaldehyde can result in the formation of nasal and laryngeal tumors. Short-term exposure can also result in health effects such as irritation of the respiratory system and reduced heart function. Data further shows that acetaldehyde exposure can damage genetic material in cells, potentially leading to numerous adverse health effects.
Acrylonitrile is used primarily in the manufacturing and processing of plastic materials, paints, petrochemicals, and other chemicals. Acrylonitrile is a probable human carcinogen and can cause lung and brain cancer in exposed workers. Short-term exposure to acrylonitrile can also result in health effects such as eye, skin, and respiratory irritation. Long-term exposure can result in reproductive effects such as reduced sperm count and developmental effects such as slowed fetal growth.
Benzenamine is used in the manufacturing and processing of dyes and pigments, petrochemicals, plastics, resins, and other chemicals. Benzenamine is a probable human carcinogen and can cause bladder tumors and pancreatic cancer in workers. Long-term exposure to benzenamine can result in a range of adverse health effects such as difficulty in breathing, tumor growth in the spleen, and possible reductions in fetal viability.
MBOCA is used in the manufacturing and processing of rubbers, plastics, resins, and other chemicals. MBOCA is a probable human carcinogen. Specifically, animal studies have shown that exposure to MBOCA can cause liver and urinary bladder cancer. Short-term exposure to MBOCA can result in eye and skin irritation. Data further demonstrates that MBOCA exposure can damage genetic material in cells, potentially leading to numerous adverse health effects.
EPA Prioritization Process
Prioritization is the first step under EPA’s authority to regulate existing chemicals currently on the market and in use. EPA’s proposed designations are not themselves a finding of risk. If EPA finalizes these designations, the agency will initiate risk evaluations for these chemicals to determine whether they present an unreasonable risk to human health or the environment under the TSCA conditions of use (the way the chemical is made and used), which the agency is required to complete within 3-3.5 years. If at the end of the risk evaluation process EPA determines that a chemical presents an unreasonable risk to health or the environment, the agency must begin the risk management process to take action to eliminate these unreasonable risks.
EPA began the process of prioritizing these five chemicals in December 2023 and also announced that it expects to initiate prioritization on five chemicals every year, which will create a sustainable and effective pace for risk evaluations. According to EPA, the agency has continued to improve the prioritization process by investing in cutting-edge software to review more information earlier in prioritization. EPA has also implemented improvements to its systematic review approaches as recommended by the Scientific Advisory Committee on Chemicals (SACC) by incorporating additional data sources such as assessments published by other government agencies to identify potential hazards and exposures, clarifying terminology to increase transparency in the systematic review process, and presenting interactive literature inventory trees and evidence maps to better depict data sources containing potentially relevant information.
EPA has conducted a preliminary screening and technical review of large data sets to more efficiently identify relevant information for prioritization and risk evaluation and can easily flag information that may be useful to retrieve later in the risk evaluation process. As a result, EPA now has a head start on risk evaluations. At this proposed designation stage, EPA has a much fuller understanding of how these chemicals behave in the environment and their potential hazards and exposures than it had at this point in the process in the previous prioritization cycle conducted in 2019. That has also enabled EPA to make considerably more information available to the public a year earlier than occurred for the first 30 chemicals designated for risk evaluation under TSCA. The public will be able to see which studies and what information EPA considered in its screening review for proposed designation and submit any additional information they would like EPA to consider via public comment.
Additional Resources:
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
