| How to Effectively Navigate the TSCA New Chemical Notification Process (PSX 2020 On Demand) | |
| Under TSCA, EPA uses a risk-based approach to assess whether a new chemical substance under the conditions of use, presents an unreasonable risk of injury to human health or the environment. In the absence of specific substance data and process details, EPA uses conservative modeling parameters to estimate toxicological, fate and transport, exposure, and release properties. Not providing the appropriate information upfront can result in significant delays in EPA's review process and hence commercialization. If EPA determines there is insufficient information, it may regulate the substance using Consent Orders and Significant New Use Rules (SNURs), which come with restrictions on end uses, exposures, and releases, along with recordkeeping, and notification requirements. This presentation examines EPA's current approach for reviewing new chemicals, provides examples of challenges faced by submitters, offers practical approaches for preparing notifications to facilitate EPA's review and addressing concerns raised by EPA based on its initial review.
Presenter(s): Ashish Deshmukh, PhD, Senior Managing Consultant, Ramboll |
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