EPA Proposes Rules to Regulate Significant New Chemical Uses

On December 2, 2024, the U.S. Environmental Protection Agency (EPA) proposed new Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemicals previously addressed in premanufacture notices (PMNs). The SNURs mandate a 90-day advance notification to EPA before manufacturing or processing these substances for activities classified as significant new uses. This notification allows EPA to evaluate and determine the conditions for such uses. Manufacturing or processing for these purposes cannot begin until EPA completes its review and makes a formal determination. Comments must be received on or before January 2, 2025.

Proposed Rule Under TSCA Section 5:

EPA has introduced significant updates to its chemical regulations. Key highlights include:

1. Mandatory Determination Before Manufacturing
   • EPA must now issue a determination for each Pre-Manufacture Notice (PMN), Significant New Use Notice (SNUN), or Microbial Commercial Activity Notice (MCAN) before manufacturing or processing can begin.
   • The rule outlines five possible determinations and associated actions.
2. Enhanced Information Requirements
   • Amendments clarify the level of detail required in PMNs, SNUNs, and exemption notices for completeness.
3. Updated Review Procedures
   • New procedures address errors, incomplete submissions, and amendments made during the review period for PMNs and SNUNs.
4. Changes to LVE and LoREX Regulations
   • EPA approval is now mandatory before manufacturing under Low Volume Exemption (LVE) and Low Release and Exposure Exemption (LoREX) notices.
   • PFAS and certain PBTs are categorically ineligible for these exemptions.
   • EPA can notify exemption holders when their substance becomes subject to a Significant New Use Rule (SNUR), even if the chemical identity is confidential.
5. Simplified Suspension Requests
   • Submitters can request up to 30-day suspensions of TSCA Section 5 notices via oral or email requests.
6. Efficiency Improvements
   • Clarifications in chemical notice requirements and streamlined review procedures aim to improve the new chemicals review process.

These amendments, which incorporate feedback on the proposed rule published on May 26, 2023, will enhance transparency and efficiency in EPA’s regulatory processes.

EPA Proposes Updated Rules for 17 PFAS Under TSCA

On November 29, 2024, the U.S. Environmental Protection Agency (EPA) issued a supplemental notice of proposed rulemaking (SNPRM) to revise its December 2022 proposed significant new use rules (SNURs) for 17 per- and polyfluoroalkyl substances (PFAS). These PFAS, which are subject to premanufacture notices (PMNs) and TSCA Orders, require stricter oversight.

The proposed SNURs mandate that manufacturers or processors notify EPA at least 90 days before initiating any significant new use of these PFAS. Activities cannot proceed until EPA completes its review, issues a determination, and takes appropriate action.

Because these PFAS are not listed on the TSCA Inventory and lack ongoing uses, EPA is proposing to designate any manufacture or processing as a significant new use to enable risk evaluation.

Public comments on the proposal will be accepted until December 30, 2024.