EPA has released the draft risk evaluation and opened a 60-day comment period
EPA has announced the availability of the draft TSCA risk evaluation for trans-1,2-dichloroethylene and is accepting comments through October 26, 2026.
Under TSCA, the purpose of a risk evaluation is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under its conditions of use, including risks to potentially exposed or susceptible subpopulations, and without considering costs or other non-risk factors.
EPA states that the draft evaluation preliminarily finds that trans-1,2-dichloroethylene presents an unreasonable risk to human health, driven primarily by certain conditions of use analyzed in the draft.
The substance is relevant because it appears in multiple industrial use scenarios
According to EPA’s notice, trans-1,2-dichloroethylene is used as a solvent, reaction product, cleaning agent or degreaser, surface modifier, and processing aid.
Workers and occupational non-users may be exposed through inhalation, workers may also face dermal exposure, consumers may be exposed through inhalation and dermal routes in product use, and environmental releases can occur to air, water, and land.
That makes the draft evaluation relevant not only for chemical suppliers but also for downstream facilities where the substance may be used in cleaning, degreasing, or process-related applications.
EPA is specifically looking for exposure and use information
The notice highlights several areas where EPA is seeking targeted input, including:
- occupational exposure assumptions and the use of exposure controls and PPE;
- the number of facilities involved in vapor degreasing;
- monitoring data relevant to manufacturing as a byproduct;
- information on batch-manufacturing frequency;
- additional PPE information for certain formulation and semiconductor-manufacturing solvent uses; and
- other relevant studies or data sources not identified by EPA.
This means the comment period is not only procedural. It is also a practical opportunity for companies or trade groups with relevant use knowledge to assess whether they have data worth contributing.
The current update is a draft risk-evaluation step, not a final risk-management rule
EPA has not yet issued a final risk evaluation or a TSCA section 6 risk-management rule for this substance.
After reviewing public comments and input from the Scientific Advisory Committee on Chemicals, EPA will issue the final risk evaluation. EPA must then use that evaluation as the basis for its section 6 unreasonable-risk determination.
For compliance teams, the more immediate value is early visibility into EPA’s preliminary finding and the use and exposure information EPA is seeking.
What companies can check
- Determine whether trans-1,2-dichloroethylene is used in cleaning, degreasing, formulation, or process operations at relevant facilities.
- Ask suppliers whether the substance appears in solvents, mixtures, or processing aids tied to medical-device manufacturing or component production.
- Review whether current SDS, material records, and process descriptions are sufficient to identify actual use scenarios.
- Confirm whether occupational exposure control, PPE, and release-management information is already documented.
- Consider whether the company or an industry group should submit data-based comments before October 26, 2026.
For medical-device-related manufacturers, this update is best treated as upstream process and materials intelligence. It does not directly change market-access status today, but it may shape future solvent, process, and supplier decisions if EPA later adopts risk-management action.
Sources
- Primary official sourcetrans-1,2-Dichloroethylene Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment (opens in a new tab)U.S. Environmental Protection Agency
- Supporting sourceAssessing and Managing Chemicals under TSCA (opens in a new tab)U.S. Environmental Protection Agency