By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. In June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions. EPA has posted the meeting slides online.
During the webinar, EPA presented an example of a rework case. According to EPA, from its analysis, it observes that:
- Information on material balance parameters, environmental releases, environmental release media, and engineering controls cause nearly 80 percent of all rework;
- In most cases, companies provide additional information that deviates from EPA model defaults and assumptions; and
- Companies often lack understanding on what information is needed for a Section 5 engineering assessment, including the level of detail needed to support their statements relating to environmental release and worker exposure.
As noted in the meeting slides, EPA plans to hold two additional webinars in fall 2022 that will cover:
- How EPA evaluates quantitative and qualitative information, with examples on the level of detail needed to support the submitted information to be accepted by EPA; and
- The types of information commonly missing in Section 5 submissions, how EPA evaluates environmental release information on sites not controlled by the submitter, and their impact on engineering assessment.
More information is available in our July 28, 2022, memorandum.