Verdant Law is pleased to announce that Phil Moffat gave a presentation on EPA’s new PMN review process at this year’s Product Stewardship Conference. Moffat highlighted EPA’s proposed rule (expected to be released in February 2023) updating date procedural regulation to conform with the Lautenberg amendment, which requires EPA to make affirmative determinations on whether new chemical substances present an unreasonable risk to human health or the environment under known, intended or reasonably foreseen conditions of use. The proposed rule, if implemented, would increase the quality of information initially submitted in a PMN and reduce Agency rework in the risk assessment process, and reduce the Agency’s review time for each PMN.
Additionally, in June 2020, EPA launched a series of webinars working towards its goal of increasing transparency and reducing reworks. The webinars highlight common issues that require EPA to reconduct new chemical assessments (reworks), which substantially delay the Agency in completing PMN reviews.
Moffat also discussed EPA’s recently announced effort to implement a streamlined and efficient process for risk evaluations on chemicals used in electric vehicles, semiconductor, and clean energy sectors with the goal of increasing the nation’s energy security. The effort will focus specifically on mixed metal oxides (MMOs), including new and modified cathode active materials (CAMs).
Also detailed was EPA’s recent decision to discontinue the use of exposure modeling thresholds in the new chemical review process. The change would require completing modeling for all potential exposures that may result from air releases and releases to groundwater from landfills, as opposed to only those above an established threshold under the current policy. EPA believes that the adoption of this new policy will allow for a more comprehensive accounting of all potential air and water releases to ensure any needed protections are in place before a new chemical comes to market.
Lastly, Moffat discussed EPA’s efforts to bring innovative science to the chemical review process detailed in an Agency document TSCA New Chemicals Collaborative Research Effort. The effort includes a multiyear research plan in collaboration with federal agencies such as NIH’s National Toxicology Program. The focus areas of the research include:
- Updating and refining chemical categories.
- Developing and expanding databases containing TSCA chemical information.
- Developing and refining QSAR and predictive models for physical-chemical properties, environmental fate/transport, hazard exposure, and toxicokinetics.
- Exploring was to integrate and apply New Approach Methodologies (NAMS) in new chemical assessments.
- Developing a TSCA new chemicals decision support tool.
If you have questions about the topics of this presentation, please contact Phil Moffat.