Key Contacts
2024 TSCA Review
TSCA Existing Chemicals Evaluation
In final year of the Biden administration, EPA undertook a substantial amount of regulatory activity under the Toxic Substances Control Act (TSCA), especially in last month of 2024, leaving various proposed and final rules for the incoming Trump Administration to implement or reconsider. Under TSCA Section 6(b), EPA published rules and regulations to assess and manage existing chemical substances in each of the three steps of TSCA’s Existing Chemical Evaluation Process: prioritization, risk evaluation, and risk management.
Prioritization
On December 18, 2024, EPA announced that it is initiating the 12-month prioritization process to determine whether five chemicals are either high- or low-priority: 4-tert-Octylphenol, Benzene, Ethylbenzene, Napthalene, and Styrene. TSCA Section 6(b) requires EPA, in the prioritization stage, to designate chemicals as either high-priority or low-priority for risk assessments based on potential hazards to human health and the environment. If the chemical is considered a high-priority substance, EPA must begin the risk evaluation process and applicable public comment periods. Also on December 18, 2024, EPA finalized five chemical substances as high-priority, leaving the responsibility of conducting risk assessments of these chemicals to the incoming Trump administration: Acetaldehyde, Acrylonitrile, Benzenamine, Vinyl Chloride, and 2-Chloroaniline (MBOCA).
Risk Assessment
In 2024, the Biden administration instituted major changes to EPA’s TSCA risk assessment procedures for existing chemicals. As required by the 2016 TSCA amendments, the former Trump administration promulgated a final rule titled, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, (“the 2017 Risk Evaluation Rule”). From 2020-2021, EPA finalized ten chemical risk evaluations following the 2017 Risk Evaluation Rule, which allowed EPA the discretion to issue individual risk evaluations for each condition of use of a chemical substance. During the Biden Administration, EPA withdrew these risk evaluations and announced various policy changes to the TSCA risk assessment procedures. One important policy change, informally referred to as "the whole chemical approach," requires EPA to assess all conditions of use in a single risk determination for the chemical rather than evaluating individual conditions of use separately, for purposes of whether a chemical poses an unreasonable risk.
In May 2024, the Biden Administration published its own final rule, Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA) (“2024 Risk Evaluation Rule”), codifying the Administration's single risk determination approach. Other major policy changes codified in the 2024 Risk Evaluation Rule include the removal of the definitions for "best available science" and "weight of scientific evidence" from the prior rule and the addition of "overburdened populations" to the list of "potentially exposed or susceptible subpopulations” that EPA must consider in its evaluations. Additionally, EPA will no longer assume the use of personal protective equipment (PPE) for workers, to avoid underestimating the risks of occupational chemical exposures. The 2024 Risk Evaluation Rule also expands the scope of risk assessments by requiring EPA to analyze chemical exposure pathways that are already addressed by other statutes, such as the Resource Conservation and Recovery Act (RCRA), the Clean Air Act (CAA), the Clean Water Act (CWA), and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).
Over the past year, EPA published four final chemical risk evaluations using procedures from the 2024 Risk Evaluation Rule: Tris(2-chloroethyl) phosphate (TCEP) (September 2024), Asbestos Part 2 (November 2024), 1,4-dioxane (November 2024), Formaldehyde (December 2024). Actions taken to manage the risks associated with these chemicals will be the responsibility of the Trump administration.
Risk Management Rules
As required by TSCA Section 6(b), EPA issued various risk management rulemakings to address unreasonable risks to health and the environment established through EPA’s risk assessments. In 2024, EPA published final risk management rules for five of the first ten chemicals that the 2016 TSCA Amendments required EPA to evaluate: Asbestos Part 1 (March 2024), Methylene Chloride (April 2024), Carbon Tetrachloride (CTC) (December 2024), Perchloroethylene (PCE) (December 2024), and Trichlorethylene (TCE) (December 2024). These final rules either partially or wholly ban uses of the chemicals and implement enhanced workplace protections for industries engaged in exempted ongoing uses. The rules for Methylene Chloride and Asbestos Part 1, published in the spring of 2024, already face challenges filed in federal court, with oral arguments yet to be scheduled. The most recent rules for CTC, PCE, and TCE, published in mid-December 2024, are likely to face similar legal challenges in the near future. The Trump administration’s response to these rules and their legal challenges remains to be seen; the new administration may decide not to defend the Biden administration’s rules in court or move for voluntary remand so that the EPA may reconsider these rules. It is possible that the Trump administration may also try to delay the implementation of the three most recent rules for CTC, PCE, and TCE, before their effective dates. EPA additionally released three proposed risk management rules in 2024: N-Methylpryrrolidone (proposed June 2024), 1-Bromoproane (proposed July 2024), and C.I. Pigment Violet 29 (proposed December 2024). The incoming Trump administration may reconsider these proposed rulemakings and determine whether they will reach the final rulemaking stage as proposed.
TSCA New Chemicals Program
On December 18, 2024, EPA published a final rule revising its procedures for reviewing new chemicals under TSCA section 5, with the goal of improving the efficiency of the New Chemicals Program. TSCA Section 5 requires EPA to determine whether newly created chemical substances present an unreasonable risk to human health or the environment under known or reasonably foreseen conditions of use. Under the Biden administration, EPA's review of most submissions of new chemicals lasted longer than the statutorily required 90-day review period, creating delays and lack of certainty for regulated industry. This rule takes effect on January 17, 2025.
TSCA Safety Data Reporting Rule
On December 13, 2024, EPA issued a final rule under TSCA Section 8 requiring manufacturers and importers of sixteen chemicals to report data from unpublished health and safety studies to EPA. This rule is intended to inform EPA's decisions under the stages of prioritization, risk evaluation and risk management of chemicals under TSCA. The chemicals subject to this rule include: 2-Chloraniline (MBOCA), 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol), Acetaldehyde, Acrylonitrile, Benzene, Bisphenol A, Ethylbenzene, Naphthalene, Vinyl Chloride, Styrene, Tribromomethane, Triglycidyl Isocyanurate, Hydrogen fluoride, N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD), and 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone). These chemicals are of particular interest to EPA because they are either in the process of prioritization as candidates for high-priority designation for risk evaluation or are expected to be candidates in upcoming years.
TSCA Coordination Efforts Between EPA and OSHA
In recognition of the overlapping chemical regulation efforts of EPA and the Occupational Safety and Health Administration (OSHA), in December 2024, the two agencies entered into a Memorandum of Understanding (MOU) that formalized agency coordination efforts under TSCA Section 6. Under this MOU, EPA and OSHA will share information regarding the TSCA existing chemicals review process as it pertains to chemical hazards in the workplace, communication and outreach materials for stakeholders regarding EPA and OSHA rules that regulate the same chemical hazards, enforcement activity and inspections of potential violations where mutual agency interest exists, and protocols to ensure the confidentiality of information exchanged between the agencies. EPA and OSHA intend for this MOU to facilitate workplace health and safety protections for workplaces utilizing existing chemical substances regulated under TSCA and the Occupational Safety and Health Act and to improve implementation efforts by both agencies.
