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Home ⚬ Resources ⚬ US TSCA ⚬ TSCA Risk Management Program: A State of the Union

TSCA Risk Management Program: A State of the Union

9 min read

Introduction

Under the new administration, it is expected that implementation of the Toxic Substances Control Act (TSCA) could be significantly different from past activity. The forecast below describes the major likely impacts for regulation of existing chemicals under TSCA Section 6 in 2025.

To note, there are 3 key stage-gates to the Section 6 assessment process, including the following:

  1. Prioritization
  2. Risk Evaluation
  3. Risk Management

Once an existing substance in the TSCA inventory is prioritized, EPA performs a risk evaluation based on scientific principles and once the evaluation is completed, they must publish a final risk management rule to mitigate any potential risks to human health or the environment associated with the use of the substance.

General Process

A 2016 amendment to TSCA contained in the Frank R. Lautenberg Chemical Safety Act for the 21st Century required EPA to conduct risk evaluations for existing chemical substances. This procedural framework for conducting risk evaluations under TSCA Section 6 was further amended and codified in 2024 via a final rule.

The final rule stated that the TSCA risk evaluation determination process is based on a “whole chemical” approach which considers risks from all types of uses (including those that may be regulated under other legislation) as opposed to solely evaluating the potential risks on a per use basis. Moreover, this approach included an assumption that worker exposure occurs due to lack of or ineffective use of personal protective equipment (PPE). Under the administration, revisions to this requirement via amendments to the TSCA legislation may prove to be difficult. A much more likely scenario would impose restrictions on the use of EPA funding since appropriations for the TSCA program are almost certainly to be reduced under the current administration. In addition, it is expected that there could be a significant reduction in EPA personnel, which would negatively impact both PMN processing and the development of risk evaluations and risk management rules.

The intent is to shift the EPA approach to TSCA implementation by incorporating the following potential changes:

  • Revise the new chemical review regulations to improve and expedite the review process
  • Ensure that risk evaluations are risk-based as opposed to hazard-based like those found in the EPA IRIS assessments
  • Conduct risk evaluations only for exposure pathways that are not regulated by other environmental statutes
  • Apply real-world use of chemicals in the assessment of conditions of use for risk evaluations
  • Revise the proposed framework rule for risk evaluations to assume that workers are using OSHA-required personal protective equipment (PPE) as directed and that these assessments are based on the definitions of ‘‘best available science’’ and ‘‘weight of scientific evidence’’
  • Generate a framework rule for risk management rulemaking to have greater transparency and stakeholder input
  • Limit TSCA fees rule so the amount administered does not include the costs of EPA inefficiency or overreach

Recent Activity for Risk Evaluation and Management in 2024

New High Priority Chemicals Proposed and/or Designated

In December 2024, EPA finalized the designation of five chemicals  as high-priority substances (acetaldehyde, acrylonitrile, benzenamine, vinyl chloride, and MBOCA) with risk evaluations to be ongoing. However,  it is unclear if some or all of these substances will continue to be designated as high-priority substances and, if the designations remain, what the outcomes of the risk evaluations might be.

In regards to vinyl chloride, a draft scope document was published by EPA in January 2025, describing the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations for this chemical.  This information is expected to be incorporated into the EPA’s risk evaluation for vinyl chloride. Although the initial public comment period has closed, additional opportunities for public comment will be available during the risk evaluation process, including a public comment period on the draft risk evaluation.

Also in December 2024, the prioritization process for another five chemicals (4-tert-octylphenol, benzene, ethylbenzene, naphthalene, and styrene). A 90-day public comment period for these five chemical substances was started by EPA that will end with the publication of a proposed designation document in 2025, which will be followed by another 90-day comment period. After the two public comment periods, the designation of these chemicals may be finalized in December 2025.

Ongoing Risk Evaluations for Priority Substances

Risk evaluations of the initial 10 TSCA-regulated existing chemical substances, although nearing final stages if not already having designated risk management rules, may also be reconsidered (i.e., 1,4-dioxane and legacy uses of asbestos). This also includes an evaluation for one of the 20 high-priority substances (TCEP) as well as proposed risk evaluations for formaldehyde, DIDP, DINP, 1,3-butadiene, and 1,1-dichloroethane and a draft human health hazard assessment for 1,2-dichloroethane have also been issued.

However, since all these assessments were conducted using the “whole chemical” approach and assumes workers do not use OSHA-required PPE and considers exposure pathways regulated under different environmental statutes, it is unclear if these evaluations will be abandoned or reevaluated due to ongoing litigation of the whole chemical approach. It is expected that if the EPA publishes final risk evaluations without a “whole chemical” approach, NGOs are expected to seek judicial review of any section 6 orders stating that a particular use does not present an unreasonable risk. Ongoing litigation and additional statutes may help to solidify the EPA’s scientific approach to existing chemicals risk evaluation and hopefully will provide clarity in their approach to assessing chemicals. Additional details on TSCA litigation efforts are included below.

Risk Management Rules for High Priority Chemicals

Three final risk management rules were published in the first half of 2024 and, therefore, not subject to the Congressional Review Act. These rules are currently under judicial review and include:

  • Methylene chloride (5th Circuit)
  • Asbestos part 1 (5th Circuit)
  • Risk evaluation framework regulation (D.C. Circuit)

It is likely that these rules will be remanded based on challenges to the “whole chemical” approach and the lack of PPE assumptions. Reconsideration and reevaluation by the EPA are expected for these rules.

In contrast, four final risk management rules were issued in December 2024 and are in litigation process. These rules include:

  • Trichloroethylene (TCE) (3rd Circuit)
  • Carbon tetrachloride (CTC) (8th Circuit)
  • Perchloroethylene (PCE) (5th Circuit)
  • New Chemical Regulations (9th Circuit)

The status of the TCE final rule may serve as an example of the fate of this set of rules. EPA issued a final rule on January 28, 2025, delaying the effective date of four rules until March 21, 2025, based on President Trump’s January 20, 2025, memorandum entitled “Regulatory Freeze Pending Review.” This delay includes the December 17, 2024, final risk management rule for TCE. The effective dates of these rules would be postponed for 60 days from the date of the memorandum and would apply to any rules published in the Federal Register that had not yet taken effect. Currently, the status of the final TCE rule is under litigation in the federal system. At this time, it is not known if the rule will be abandoned completely or returned to the EPA for reevaluation and/or revision.

Status of Section 6 Activities by Chemical

A summary of the status of the various TSCA Section 6 activities by steps in the risk evaluation process is described in the table below.

Workplace Chemical Protection Program (WCPP)

EPA has also issued a compliance guide for compliance with the Workplace Chemical Protection Program (WCPP) requirements for chemicals regulated under Section 6 of TSCA on January 16, 2025. The compliance guide includes an overview of the typical WCPP requirements required under Section 6(a) rules. This guide is intended for manufacturers (including importers) and processors who distribute, use, or dispose of a regulated chemical that is subject to the WCPP requirements as part of the EPA rulemaking.

The general WCPP requirements include:

  • EPA TSCA occupational exposure limits (Existing Chemical Exposure Limits (ECEL) or EPA Short-Term Exposure Limits (EPA STEL)) and their action levels
  • Occupational exposure monitoring and controls (all applicable routes)
  • Personal protective equipment (PPE), including respirators
  • Exposure control plans
  • Recordkeeping
  • Downstream notifications

In addition to the general requirements, the WCPP specifications given within the risk management rule for a specific chemical must be implemented.

Persistent, Bioaccumulative, and Persistent Substances (PBTs)

The rule for two PBTs (decaBDE and PIP (3:1)) was recently amended with an effective date of January 21, 2025. However, on January 20, 2025, the effective date of this finalized but not-yet-effective rule was postponed by 60 days. In addition, a proposal was directed to delay effective dates of such rules beyond the 60-day period and to consider further action in coordination with the Office of Management and Budget (OMB) “for regulations that raise substantial questions of law or policy.” It should be noted that since the PBT amendments go beyond the October 31, 2024, compliance deadline for several uses of PIP (3:1), some or all of that rule may be allowed to take effect after the 60-day period.

Conclusion

At this time, it is unclear as to how the current EPA will implement TSCA for regulation of existing chemicals in the coming year. However, it is certain that all regulated parties in all industries should anticipate new, modified, or evolving TSCA requirements. These ongoing changes make it necessary to have increased awareness for any TSCA compliance programs in order to monitor updated regulatory developments and incorporate appropriate changes as needed. Affected stakeholders need to ensure they are investing appropriate time and resources into tracking these developments.

If you need assistance navigating TSCA regulatory developments, please contact us at info@h2compliance.com.

 

 

Published February 27th, 2025

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