The EPA’s Office of Pollution Prevention and Toxics has updated its guidance document, Points to Consider When Preparing TSCA New Chemical Notifications, as part of its efforts to improve implementation of the amended Toxic Substances Control Act (TSCA). The guidance is intended to provide new chemical submitters with information on:
New chemical submitters that provide the Agency with comprehensive data will likely see their products brought to the marketplace more quickly and less expensively than those that do not provide the Agency with everything it needs.
Causes for Delay
The EPA has identified two basic scenarios that often lead to delays in reviewing notifications in the New Chemical Review process:
Notifications that lack detail typically result in follow-up or additional interaction with submitters, adding time to the New Chemical Review process. If the submitter provides additional information, EPA states that it will generally conduct additional analyses and/or re-evaluate the notification in light of the additional information. In an effort to ensure that notifications are not delayed, EPA “encourages submitters to review and to consult this document while preparing their notifications, so they understand the utility of submitting complete information with the original submission.”
According to EPA, if submitters fail to submit the required information when they complete and file their notifications, EPA may declare the notice to be incomplete and the review period will not begin. EPA states that if sufficiently specific information is lacking, it “typically makes conservative assumptions, which oftentimes lead to the practice of delayed reviews and frequent suspensions while submitters work with the Agency to provide and/or develop additional information.” The guidance is intended to reduce the frequency of such delays.
The guidance lists the following possible determinations that EPA will reach under TSCA Section 5(a)(3):
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