Posted on December 16, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
On December 15, 2022, the U.S. Environmental Protection Agency (EPA) announced a redesign and updates to the statistics web page for the New Chemicals Review Program. According to EPA, the update includes additional information and metrics on the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA), increasing transparency for the public, the regulated community, and other stakeholders.
According to EPA, before TSCA was amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), EPA issued formal risk determinations for approximately 20 percent of new chemical submissions. EPA states that in 80 percent of the cases, EPA dropped the chemical from further review, which under the prior law would allow the manufacturer to take the chemical to market.
Under the Lautenberg Act amendments, EPA is required to make an affirmative determination on all new chemical notices submitted under TSCA, “substantially increasing the Agency’s workload.” EPA notes that despite the “dramatic increase in responsibility,” its budget for the TSCA program has remained essentially flat over the past six years.
To address resource limitations, EPA has taken several significant steps over the past year to create a sustainable program that follows the science and the law. EPA states that the redesigned and updated web page represents another important step in that process. EPA will update the data displayed on the enhanced web page monthly. According to EPA, the data show that EPA “continues to make positive progress on reviewing new chemicals and managing risks to human health and the environment. With more funding and resources, EPA could further increase the efficiency, effectiveness and transparency of its work.”
More Detailed Breakdown of New Chemical Submissions
EPA states that the web page now contains month-by-month counts of new chemical submissions, completed risk assessments, and completed risk management actions for all notices and exemptions, allowing users to track monthly progress on EPA’s new chemicals workload.
EPA notes that the new monthly statistics table “shows recent improvement in EPA’s ability to conduct risk assessments efficiently -- in October and November, EPA completed 99 risk assessments, more than double from the prior two-month period.” According to EPA this progress “is a result of EPA’s aggressive recruitment and training for scientists with relevant experience and background to conduct risk assessments and efforts to continuously improve the program’s review process and procedures.”
Additionally, new tables and graphs on the web page visualize new chemicals submission trends and changes from fiscal years (FY) 2010-2022. Previously, the web page included a count of the total number of completed actions since the 2016 TSCA amendments, but it did not break this information down by FY.
Status Tracker for New Chemical Exemptions
The revised web page now also includes a tracker for other applications submitted to the New Chemicals Program, including low volume exemptions (LVE), low release and low exposure exemptions (LoREX), test market exemptions (TME), TSCA environmental release applications (TERA), and Tier II exemptions for microorganisms (Tier II). EPA notes that previously, the web page only included this kind of tracking for premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN).
According to EPA, exemptions represent over 50 percent of the new chemical notices submitted to EPA. EPA states that the new tracker “makes it easy for users to monitor the number of active exemption cases currently under review by EPA and their review status, giving stakeholders greater insight into the status of a significant portion of the program’s workload.”
Information on the New Chemicals Review Process
The new web page provides greater detail about the new chemicals review process, including explanations of each step of the review process for notices and exemptions. Also new to the web page is an explanation of the factors that EPA considers when triaging new chemical submissions for review. EPA states that these factors include the date of receipt of submission, statutory and regulatory deadlines, the level of effort needed to rework potentially some or all of the risk assessment, and the applicability of new approaches that EPA has developed to standardize reviews for certain new chemicals. EPA states that providing this information helps submitters understand how EPA manages its large workload within limited resource constraints and helps them submit complete notices in the order that matters most for their business.
Other New Chemicals Improvements
EPA states that the New Chemicals Program has taken several steps this year to enhance the review process for new chemicals, resulting in 480 risk assessments completed and 447 risk management actions issued in FY 2022. These efforts include:
- Launching innovative approaches to reviewing new biofuels and mixed metal oxides (MMO) used in new and modified cathode active materials (CAM), which have helped increase the program’s capacity by standardizing the review process for these chemicals;
- Conducting an outreach initiative consisting of several webinars with stakeholders to explain how EPA evaluates engineering data for new chemical submissions, with the goal of preventing common issues that contribute to delays in new chemical reviews and stretch limited resources;
- Developing a multi-year collaborative research program with the Office of Research and Development (ORD) and other federal entities to bring innovate science to new chemical reviews before they can enter the marketplace; and
- Aggressively recruiting, onboarding, and training new staff to conduct risk assessments and developing new policies, guidance, and standard operating procedures.
We applaud EPA’s efforts to improve the efficiency and transparency of its operations. We appreciate that EPA is working hard, with too few resources and staff, and welcome these enhancements to the EPA website.