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October 29, 2020

EPA Releases Revised Draft TSCA Risk Evaluation for PV29 for Comment

Lynn L. Bergeson Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on October 29, 2020, that it is releasing a revised draft risk evaluation for C.I. Pigment Violet 29 (PV29) for public comment and peer review under the Toxic Substances Control Act (TSCA).  EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  According to EPA, these new data led EPA to revise its analytical approach for evaluating the potential exposure and health effects of PV29.  EPA’s updated analysis, reflected in the revised draft risk evaluation, now shows unreasonable risk to workers for 11 out of 14 conditions of use.  EPA states that because the new data had a significant impact on its risk evaluation and ultimately the risk determinations, it is providing an opportunity for the public and independent scientific experts to give input before the risk evaluation is prepared in final.
EPA will publish a Federal Register notice on October 30, 2020, beginning a 30-day comment period.  During the public comment period, EPA states that it will also conduct 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 will focus on charge questions supplied by EPA, and EPA states that “the public is encouraged to focus their comments on those issues as well.”
EPA will use feedback received from the letter peer review and public comment process to inform the final risk evaluation.  EPA notes that the revised draft risk evaluation is not a final agency action and represents its current review of the scientific information on PV29.  As with any chemical product, EPA “strongly recommends that users carefully follow all instructions on the product’s label/safety data sheet.”