EPA Accelerates Review of New Chemicals used in Low Volumes and Slashes Backlog of these Submissions

Released August 11, 2025

Today, the U.S. Environmental Protection Agency (EPA) is announcing the results of an effort dedicated to accelerating the review of Low Volume Exemptions (LVEs) in the Toxic Substances Control Act (TSCA) New Chemicals Program. Thanks to several process improvements implemented by the Trump Administration, EPA completed risk assessments for 106 LVEs in just two months and increased the average number of LVE risk assessments, which are often the most time-consuming part of the review process, from 15 per month to 53 per month, an increase of over 250%. The agency also decreased the number of LVEs under review for greater than 30 days (“backlogged”) by more than 23%.  

Under the Trump Administration, EPA recognizes that improving the review process for new chemicals is critical to advancing the agency’s core mission of protecting human health and the environment, boosting our country’s economy, powering innovation and ensuring regulatory certainty for U.S. manufacturers. Consistent with Pillar 3 of Administrator Zeldin’s Powering the Great American Comeback initiative which is centered around Permitting Reform and continued commitment to finding efficiencies, EPA developed a process using existing resources to ensure LVEs that were sitting in the backlog for many months were reviewed by EPA assessors and received a preliminary decision to either grant or deny the exemptions. These improvements will ensure that these new chemistries can come to market in a way that is both timely and protective of human health and the environment.  

Certain categories of low-volume chemicals—chemicals manufactured at 10,000 kilograms/year or less—are exempt from full premanufacture notice (PMN) review under TSCA section 5. TSCA regulations for chemicals submitted as LVEs provide EPA with a 30-day review period, as compared to the 90-day review period for chemicals submitted using a PMN. Over the past four years, EPA accumulated a backlog of LVE notices that did not get reviewed in the 30-day period.  

At the end of March, EPA identified 79 LVEs waiting for review and established a dedicated team of risk assessors. EPA completed the risk assessments and made preliminary decisions for all 79 cases during April and May. Eighty percent of these LVEs have received final decisions from EPA and the remaining 20% are awaiting information from the submitter before a final decision can be made. EPA also completed risk assessments for an additional 27 LVEs during this time with 106 total LVE risk assessments completed over two months, for an average of 53 per month. This effort contributed to a decrease in the number of backlogged LVEs.  

EPA implemented several process improvements that resulted in these successes. For example, grouping similar cases, designating discipline-specific expediters, and using just-in-time communication helped to gain speed and efficiencies. Furthermore, EPA recorded detailed data on assessor timeliness and identified periods of down time that can be shortened or eliminated, resulting in more opportunities for additional efficiency gains in the future. EPA will continue making improvements to decrease the review time for LVEs, ultimately with the target of assigning an assessor and completing the review within 30 days.