EPA Launches Improvement in CDX to Increase Efficiencies for New Chemicals Submitters

For Release: March 31, 2020

Beginning March 2020, EPA is implementing a pop-up notice in CDX to notify submitters of the use of defaults in the absence of information. Providing this added notification will increase efficiencies in the new chemicals program by helping companies ensure that their premanufacture notice (PMN) submissions are accurate and complete. The accuracy and completeness of the notice form improves timeliness of the new chemical review by reducing or eliminating the need to request additional information and revisions of the risk assessment.

The pop-up informs submitters that 40 CFR 720.45 and 720.65(c)(1)(vi) require submitters to provide information on the notice form or indicate that it is not known or reasonably ascertainable and that the lack of information in the notice may result in EPA using default values in the New Chemical review process, as described in the “Points to Consider” document.  The pop-up will be displayed after the log-in page until the submission is final.

For more information on submitting a PMN to EPA, visit https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/filing-pre-manufacture-notice-epa.