EPA Announces Initiatives to Improve Efficiency, Worker Protections and Transparency in New Chemical Reviews
Released June 26, 2024
Today, the U.S. Environmental Protection Agency (EPA) is announcing four new initiatives in its review of new chemicals under the Toxic Substances Control Act (TSCA) to improve efficiency, better protect workers and increase transparency.
Under TSCA, EPA must review the potential risks of new chemicals before they enter the U.S. market and, when necessary, put safeguards in place to protect human health and the environment from those risks. EPA continues to improve that process, strengthen those safeguards, and provide more information to the public about its work. In FY23, EPA completed 70% more risk assessments compared to FY22, and has maintained this pace in FY24. Since the beginning of FY23, 60% of FY22 and older back-logged cases and 50% of FY23 cases have been cleared. And since January 2024, cases that support the climate goals of the Inflation Reduction Act have been completed in about a third of the time compared to non-prioritized cases.
Engineering checklist
In May 2024, EPA began implementing an internal engineering checklist to systematically review new chemical submissions and identify potential data gaps at the beginning of the review process. The engineering checklist addresses some of the most common missing information that EPA has identified in submissions, including lack of clarity about the intended end use or process (i.e., how many days per year it is expected to be used), the physical form of the chemical (i.e., is it a spray that could create mist), and the lifecycle of the chemical (i.e., how it is expected to be disposed of).
If any missing information is identified, EPA can proactively notify the submitter of the issue and allow them to provide it before the Agency starts its risk assessment. Waiting to address these data gaps later in the process can require additional work that increases the review time for both the submitter and other submitters whose new chemical reviews are delayed.
Worker protections
When EPA reviews a new chemical submission, one potential outcome is issuing an order under TSCA Section 5(e) that allows the chemical to be manufactured only under the terms of the order. Most TSCA Section 5(e) orders are consent orders that are negotiated between EPA and the notice submitter and use standard “boilerplate” text.
In June 2024, EPA updated the boilerplate language it will use for consent orders to strengthen worker protections and provide further clarity to the text. This update to the boilerplate language requires that workers, including contractors, and their representatives have ready access to information in orders. It also restores and strengthens prior requirements in orders issued before 2020 for hazard communication, labeling, safety data sheets and training. EPA also made a number of housekeeping revisions to the boilerplate that include updating example terms, restoring text, removing extraneous text, adding definitions, and editing for clarity and to improve formatting. EPA encourages stakeholders to review the new boilerplate language and submit input to the Agency.
Updated statistics for new chemical review timelines
Today, EPA will begin including completed “rework” risk assessments when reporting monthly statistics on new chemical reviews. Rework cases occur when supplemental work is required after the initial risk assessment has been completed. This work could include evaluation of new information not provided with the original submission and development of new assessment reports or memos as a result of the submitter later providing new information or questions.
EPA has updated its Statistics for the New Chemicals Program webpage to include a category that lists all completed rework risk assessments since the beginning of 2024. From January to May 2024, EPA completed 218 risk assessments, 26 of which were rework cases representing approximately 12% of all risk assessments completed during that period. This statistic, along with all the other statistics on the webpage, will continue to be updated on a monthly basis.
Reference Library
Today, EPA is launching the New Chemicals Division Reference Library, an index of EPA documents related to the work of the New Chemicals Division. This resource includes guidance documents, compliance advisories, templates, manuals and other materials useful to a variety of stakeholders. These materials were previously available on various webpages across the EPA website, which could make them challenging to locate. By centralizing them in one location, the public will be able to more easily find documents, as well as identify ones they may not have been aware of.
The Reference Library has a search function or can be organized by topic, subtopic, title, publication date or source. The reference library currently contains over 90 entries and will continue to be updated as new materials are developed.