On June 27, 2022, EPA announced its TSCA New Chemical Engineering Initiative. EPA seeks to increase efficiency and transparency in the new chemical review process by inviting stakeholders to learn more about how the agency evaluates submitted information. EPA plans to focus the initiative specifically on issues surrounding “engineering” information, including, but not limited to, occupational exposures and environmental releases.
The initiative has been launched in response to significant delays in new chemical reviews. Frequently, submitters will provide additional information after the safety review process of a chemical under Section 5 of the Toxic Substances Control Act (TSCA) has already begun. When EPA receives this additional information, it must revise its risk assessment (known as a “rework”) which causes delays in completing its review process and finalizing its risk assessment. In an analysis of previous cases, EPA determined that an individual case may be reworked anywhere from one to five times, delaying the process at least several months.
EPA will be conducting a series of webinars providing an in-depth look at how the Agency analyzes submissions, including EPA’s written methodology of how its conducts analysis. EPA intends to present case studies to stakeholders to further demonstrate what it considers acceptable in submissions. Webinars will also communicate EPA’s considerations in evaluating qualitative claims or quantitative data, particularly in circumstances in which they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER). Webinars will also discuss EPA’s considerations in evaluating information about sites that are not controlled by the submitter.
The kick-off meeting for the series was held on July 27, 2022. The meeting detailed background on rework analysis, causes of reworks, examples of rework cases, and general observations. EPA will be releasing information including the dates for two additional webinars in this fall.