GlobalChem: EPA 'Moving Fast' to Get TSCA Back on Track

Chemical industry experts sat down at the recent annual Global Chemical Regulations Conference and Exhibition (GlobalChem) with Shari Barash, the director of the U.S. Environmental Protection Agency's (EPA) New Chemicals Division in the Office of Pollution Prevention and Toxics (OPPT) to discuss updates to the agency's implementation of the Toxic Substances Control Act (TSCA) Section 5. TSCA Section 5 requires manufacturers or processors of chemicals to notify the EPA at least 90 days in advance before using a chemical in a way that is considered a significant new use (SNU) by the agency, with potential restrictions including prohibitions, labeling, safety data sheet (SDS) requirements, and quantity limits.

The New Chemicals Division is responsible for reviewing all new chemicals before they can enter the U.S. marketplace, ensuring they do not pose unreasonable risks to human health or the environment. After the Frank R. Lautenberg Chemical Safety for the 21st Century Act amended TSCA in 2016 with tighter mandates - including affirmative determinations and expanded assessments for “reasonable foreseen” uses of chemicals - the program has experienced growing complexity and workload, leading to a backlog in the chemical review process.

Industry Critiques of TSCA

Joining Barash on the panel were Caroline Tuckhorn, associate director of chemical management at the American Chemistry Council (ACC); Wayne Kennedy, director of product stewardship and regulatory affairs at NewMarket Corporation; and Michael Boucher, partner at Steptoe LLP. The panelists shared their thoughts on the increase in TSCA Section 5 orders and Significant New Use Rules (SNURs) used by the EPA to manage risks associated with new chemical submissions. While these mechanisms help fulfill the EPA's statutory obligations, which is a base-level requirement EPA representatives stressed at GlobalChem, they have introduced new compliance and commercialization hurdles that, in the view of the panelists, put a greater burden on manufacturers operating within complex supply chains.

The panelists stressed that the challenge is not necessarily regulatory leniency, but that companies need predictability and transparency in the regulatory process. Companies have adjusted by conducting more rigorous internal modeling and screening before even submitting chemicals for EPA review, extending timelines and raising costs of research and development due to possible delays. As Kennedy noted, “If a chemist comes to you and says they've got a product they'd like to launch at the end of the year, it doesn't matter whether it's in the U.S. or China or wherever, that's just not realistic in the world we live in today.”

Boucher pointed out that while the EPA's use of Section 5 orders has become the norm, the process of aligning those orders with SNURs remains inconsistent. Because SNURs often differ from the original order and can limit distribution or add compliance obligations, companies must proactively manage risk and develop clear commercialization strategies. The complexity and lack of synchronization between orders and SNURs continue to raise concerns about fairness, especially when newer, potentially safer chemistries face stricter scrutiny than older substances already in the TSCA inventory.

To help companies better navigate possible issues with TSCA, the panelists also expressed the need for the EPA to revive the Sustainable Futures training program, an EPA-led initiative that educated stakeholders on chemical screening models and regulatory expectations by allowing producers to use similar screening models that the EPA uses to check their chemicals before submitting them for review. The panelists praised the framework for providing clarity on what the EPA looks for in a submission and stated that improved training and more accessible modeling tools would not only accelerate safer product development but also enhance transparency and collaboration with the agency.

Streamlining TSCA

Barash shared that the New Chemicals Division has made significant progress in addressing the agency's backlog and modernizing the review process. In FY 2024, the agency completed 501 risk assessments, up from 271 in FY 2022, and is on pace to exceed that total in FY 2025, averaging 46 assessments per month. The EPA also reported a 70% reduction in cases that were part of what Barash called a “static backlog,” or cases that were older than FY 2022. As of early April 2025, there are 399 pending new pre-manufacture notices (PMN) and 126 low-volume exemptions (LVEs) in the backlog that are beyond their initial review periods.

Barash also shared that the division is launching new initiatives to tackle the backlog, including a new LVExpress program, which aims to clear 80 LVEs in the backlog by 31 May 2025. This would be done using dedicated “Tiger Teams” and support from computational toxicology tools to better organize the backlog and simplify the review process. Barash also highlighted $17 million invested in IT system upgrades, which is expected to significantly improve submission processing, transparency, and data exchange. Part of that investment supports the new Cheminformatics Modules, developed in collaboration with EPA's research division, that will further increase the speed of human health assessment and help reduce the backlog of cases.

Other improvements include an updated checklist to reduce rework, expanded training materials for industry submitters, better access to emissions scenario documents, and a revitalized training program modeled after the former Sustainable Futures initiative. In a procedural shift, the EPA is now prioritizing first-in, first-out case handling and has streamlined its SNUR process, cutting timelines by more than 20%. Since the third quarter of FY 2024, the EPA has published 10 proposals for 283 chemicals and two final rules for 37 chemicals, with more expected to come before the end of FY 2025.

Acknowledging the long-standing challenges in TSCA, she emphasized the agency's commitment to delivering timely, science-based decisions while maintaining transparency and engagement with stakeholders. Barash also stressed the steps the New Chemical Division is taking to protect confidential business information (CBI) while the systems are being upgraded. “We have all hands on deck and involvement all the way up through the chain of leadership, ensuring timely case throughput,” she said, ending her portion of the panel.

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