Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA)

The EPA is proposing amendments to the Toxic Substances Control Act (TSCA) procedural regulations for new chemicals in order to increase efficiency, update extant policies, and modernize the New Chemicals Program. Reducing the need for redoing risk assessments, enhancing information in new chemical notices, and requiring EPA approval for low volume and low release and exposure exemptions are among the proposed changes. This action may affect manufacturers of chemicals, petroleum and coal products, and wholesalers of goods. The Toxic Substances Control Act (TSCA) mandates that manufacturers submit a notice 90 days prior to the manufacture or processing of a new chemical substance for a significant new use. The EPA is required to evaluate the notification, determine the probability of an unreasonable risk, and take the necessary actions.

The proposed changes include specifying the process for determining each PMN, SNUN, and MCAN, clarifying the level of detail required for completeness, and addressing PMNs that contain errors or are incomplete. In addition, the proposed changes would require EPA approval for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs), make certain PBTs ineligible, and permit submitters to request suspensions for up to 30 days via oral or email request.

The EPA is taking steps to harmonize procedural regulations with the amended TSCA and to update existing policies. They propose to clarify required information in PMNs, SNUNs, and exemption notices and to enhance review procedures.

The proposed action seeks to reduce redo work by minimizing requests for amendments and clarifying submitter procedures for amending PMNs and SNUNs during the review period. The EPA proposes amendments to the regulations governing LVEs and LoREXs to prevent unreasonable risks during production.

Notifying submitters if a chemical substance becomes subject to a proposed or final SNUR, making PFAS categorically ineligible, codifying the EPA's 1999 PBT policy, and allowing informal review period suspensions of up to 30 days are among the proposed changes. The proposed rule will increase submission and review efficiency, clarify information requirements, and reduce the frequency of amendments and risk assessments.