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December 30, 2020

EPA Releases Report Compiling Letter Peer Review Comments on Revised Draft Risk Evaluation of PV29

Lynn L. Bergeson Carla N. Hutton

On December 21, 2020, the U.S. Environmental Protection Agency (EPA) announced that a report compiling the letter peer reviewers’ comments on the revised draft Toxic Substances Control Act (TSCA) risk evaluation of C.I. Pigment Violet 29 (PV29) is now available in Docket EPA-HQ-OPPT-2018-0604.  EPA states that it is in the process of reviewing the letter peer reviewers’ comments and will use the feedback received from the peer review and public comments to inform the final risk evaluation.
 
According to EPA, after it issued the draft risk evaluation in November 2018, it received additional data in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  EPA states that these new data led it to revise its analytical approach for evaluating the potential exposure and health effects of PV29.  As a result of this updated analysis, the revised draft risk evaluation now shows unreasonable risk to workers for 11 out of 14 conditions of use.  Because these new data had a significant impact on EPA’s risk evaluation and ultimately the risk determinations, EPA provided an opportunity for the public to give input before issuing the final risk evaluation.
 
EPA notes that it also conducted a letter peer review of the revised draft risk evaluation using independent scientists, including one who has served as a member and several who have served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals (SACC).  The peer review focused on charge questions supplied by EPA.  The report made available December 21, 2020, is the result of this letter peer review.