EPA has released a draft risk evaluation and opened a comment period
EPA has announced the availability of a draft risk evaluation for 1,2-dichloropropane under the Toxic Substances Control Act (TSCA). The notice was published on September 4, 2026, and comments are due by November 3, 2026.
Under TSCA, a risk evaluation examines 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 identified as relevant by EPA. The evaluation is conducted without consideration of costs or other non-risk factors.
EPA’s preliminary finding is limited to the draft evaluation stage
EPA’s draft evaluation preliminarily identifies unreasonable risk to human health under certain conditions of use for 1,2-dichloropropane. The notice does not establish a final risk-management measure, a significant new use rule, a ban, or a reduction requirement.
EPA will consider public comments and input from the Scientific Advisory Committee on Chemicals before issuing a final risk evaluation. The final evaluation will then provide the basis for EPA’s TSCA section 6 unreasonable-risk determination and any subsequent risk-management action, if applicable.
Why the update may matter to medical-device manufacturers
The notice identifies conditions of use including processing as a reactant, laboratory chemical use, and cleaning and furnishing care products. These categories may overlap with facility-level cleaning, maintenance, laboratory, or process activities, depending on the actual materials used at a company site.
For medical-device manufacturers, the relevant question is whether 1,2-dichloropropane appears in a solvent, mixture, cleaning product, process material, or supplier operation connected with manufacturing. The notice itself does not identify particular medical-device product lines as affected. Companies should therefore treat the connection as conditional on actual use, import, processing, or distribution—not as an automatic product-level obligation.
What companies can check now
- Review chemical inventories, purchasing records, and current SDS files for 1,2-dichloropropane and related mixtures.
- Check cleaning, maintenance, laboratory, and process descriptions at facilities supporting imaging equipment, IVD instruments, electrical components, or cable-related operations where the substance may be present.
- Ask suppliers whether the substance is used in supplied solvents, mixtures, formulations, or upstream processing, and whether the SDS and composition information are current.
- Record the relevant conditions of use, worker exposure controls, PPE, ventilation, and release-management practices so the company can assess whether the draft’s scenarios resemble its operations.
- Consider whether the company or an industry association has data-based information that should be submitted before the November 3, 2026 comment deadline.
For now, this is an early-warning and information-gathering step. Affected teams can use the comment period to improve material visibility and prepare for a possible later TSCA risk-management process without treating the draft as a current ban or market-access restriction.
Sources
- Primary official source1,2-Dichloropropane 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 sourceRisk Evaluations for Existing Chemicals under TSCA (opens in a new tab)U.S. Environmental Protection Agency