Today, the U.S. Environmental Protection Agency (EPA) announced a redesign and updates to the statistics webpage for the New Chemicals Review Program. 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. The new information and features will help users understand EPA’s new chemicals review process, throughput, and trends, while highlighting the progress the program has made despite ongoing resource challenges.
“EPA is committed to building a culture of transparency and today’s update is a significant step towards improving transparency in our review of new chemicals,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “The newly enhanced webpage gives users an extensive look at the new chemical review process and provides a clear snapshot of the progress made by the program’s dedicated career staff to ensure public health and environmental protections.”
TSCA requires EPA to review the potential risks of new chemicals before they enter the U.S. marketplace and, when necessary, put safeguards in place to protect human health and the environment. Before TSCA was amended in 2016, EPA issued formal risk determinations for approximately 20% of new chemical submissions. In 80% of 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 2016 amendments, EPA is required to make an affirmative determination on all new chemical notices submitted under TSCA, substantially increasing the Agency’s workload. Despite the dramatic increase in responsibility, the budget for the TSCA program has remained essentially flat over the past six years.
To address resource limitations, EPA has taken several steps over the past year to create a sustainable program that follows the science and the law. Today’s action represents another important step in that process. Data displayed on the enhanced webpage will be updated monthly. 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
The webpage 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.
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. 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 webpage visualize new chemicals submission trends and changes from FY 2010-2022. Previously, the webpage included a count of the total number of completed actions since the 2016 TSCA amendments, but it did not break this information down by fiscal year.
Status tracker for new chemical exemptions
The revised webpage now also includes a tracker for other applications submitted to the New Chemicals Program, including Low-Volume Exemptions (LVEs), Low Release and Low Exposure Exemptions (LoREXs), Test Market Exemptions (TMEs), TSCA Environmental Release Applications (TERAs) and Tier II Exemptions for Microorganisms (Tier IIs). Previously the webpage only included this kind of tracking for Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs) and Microbial Commercial Activity Notices (MCANs).
Exemptions represent over 50% of the new chemical notices submitted to EPA. 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 webpage 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 webpage is an explanation of factors that EPA considers when triaging new chemical submissions for review. These factors include the date of receipt of submission, statutory and regulatory deadlines, the level of effort needed to potentially rework some or all of the risk assessment, and the applicability of new approaches EPA has developed to standardize reviews for certain new chemicals. 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
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 (MMOs) used in new and modified cathode active materials (CAMs), 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 ORD and other federal entities to bring innovate science to new chemical reviews before they can enter the marketplace.
- Aggressively recruiting, onboarding and training new staff to conduct risk assessments and developing new policies, guidance and standard operating procedures.
Original source can be found here.
