18138_Authority_Feb

54 The Authority | February 2025 Align Federal Regulations with Existing Law Under TSCA, manufacturers (including importers) and processors must submit premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications. Prior to the 2016 amendments, EPA only made formal safety determinations on approximately 20% of new chemical submissions. Now, the new law requires EPA to make one of five possible safety determinations on 100% of new chemical submissions before they can enter the market. This rule amends the regulations by specifying that EPA must make one of the five specified statutory determinations on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing the new chemical substance. The rule also updates the regulations to list the actions required in association with each of those determinations. These amendments align the regulations with TSCA section 5 requirements to reflect the full extent of new chemicals review, providing consistency and transparency in new chemicals review processes. Improve the Efficiency of EPA’s Review of New Chemical Submissions to Foster Innovation The final rule also makes several other changes to add efficiencies to the new chemicals review process, including clarifying the level of detail needed in new chemical notices and amending the procedures for EPA’s review of notices that have errors or are incomplete. EPA is changing its longstanding practice of accepting amended notices that contain information that was known or reasonably ascertainable at the time of the original submission and then accepting a request to suspend the review period. Instead, EPA will now exercise its authority under the regulations to declare the original submission incomplete and restart the review period when the completed submission is received. This will save time and resources that could instead be spent reviewing complete submissions more quickly. These reforms will also help industry to provide complete submissions for review through a new set of information “pick- lists” that will be incorporated into the application form located in EPA’s Central Data Exchange in a phased approach. Continued on page 65.