WASHINGTON (March 22, 2019) - Today, the U.S. Environmental Protection Agency (EPA) is announcing the release of 24 studies on Pigment Violet 29 (PV29) used by EPA to develop the draft risk evaluation under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act (TSCA).

"We are committed to being transparent with information on chemicals, as we work to develop risk evaluations under TSCA," said EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Alexandra Dapolito Dunn.

The companies that submitted the studies had claimed the documents as confidential business information.  Robust summaries of the studies were provided to the public along with the draft risk evaluation on November 15, 2018.  Since that time, those companies have revised their confidentiality claims, dropping most of them.  Following Agency regulations, EPA has reviewed the remaining claims of confidential business information and determined that the information is entitled to confidential treatment.  That information has been redacted from the studies publicly released today.

The release of these studies does not change the Agency=E2=80™s proposed "no unreasonable risk" determination as concluded in the draft risk evaluation published in November.  EPA previously submitted the complete, unredacted versions of the studies to the TSCA Science Advisory Committee on Chemicals (SACC) to use in their peer review of the draft risk evaluation.

The newly released studies can be found at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/draft-risk-evaluation-pigment-violet-29 and next week will  also be in the Supporting Documents folder of docket EPA-HQ-OPPT-2018-0604 on www.regulations.gov.

EPA will shortly be announcing the date to reopen the comment period on the draft risk evaluation in light of these newly released studies.  The peer review panel on PV 29, canceled due to the lapse in appropriations, is in the process of being rescheduled.

Learn more about EPA's risk evaluation of PV29: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-pigment-violet-29-anthra219-def6510.

Background.  PV29 is a chemical used as a colorant, primarily in inks, paints, coatings, and plastics.  In December 2016, EPA selected PV29 as one of the first ten chemicals to undergo risk evaluation under amended TSCA.  In June 2017, the Agency released a scoping document for PV29 including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations EPA expected to consider in its risk evaluation. EPA further refined the scope of the risk evaluation in June 2018 by issuing and taking public comment on a problem formulation document. Draft risk evaluations for the remaining nine chemicals will be released for public comment over the coming months. EPA plans to issue final risk evaluations for the first ten chemicals by December 2019.

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