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EPA Releases Revised Draft Risk Evaluation for PV29 for Public Comment and Peer Review

For Release: October 29, 2020

EPA 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).

After issuing the draft risk evaluation in November 2018, EPA received additional data on PV29 in response to test orders, and the sole U.S. manufacturer of this chemical voluntarily submitted additional information to the agency. EPA used that information to revise the draft risk evaluation. This new data led EPA 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 this new data had a significant impact on EPA’s risk evaluation and ultimately the risk determinations, the agency is providing an opportunity for the public and independent, scientific experts to give input before the risk evaluation is finalized.

EPA will accept public comments on the revised draft risk evaluation in docket EPA-HQ-OPPT-2018-0604 for 30 days.

At the same time, EPA will 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). Biographical sketches of the peer reviewers will be available in the docket. The peer review will focus on charge questions supplied by the agency, and 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. The revised draft risk evaluation is not a final agency action and represents the agency’s current review of the scientific information on this chemical. As with any chemical product, EPA strongly recommends that users carefully follow all instructions on the product’s label/safety data sheet.

View the revised draft risk evaluation and supporting documents.

Background

TSCA is our nation’s primary chemical management law. This law requires EPA to evaluate the risks associated with exposure to existing chemicals using the best available science then take action to reduce or eliminate any unreasonable risks identified. PV29, one of the first ten chemicals to undergo risk evaluation, is a specialty pigment that is primarily used in paints and plastics in the automotive sector.

EPA published the draft risk evaluation for PV29 in November 2018. During the review of the draft risk evaluation by the SACC, uncertainties were identified concerning PV29’s solubility and occupational worker inhalation exposure. In February 2020, EPA issued a test order under section 4 of TSCA to obtain new information to help address the data uncertainties identified during the peer review. This information has been received and incorporated into the revised draft risk evaluation.

Learn more about the risk evaluation process for PV29.