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March 25, 2019

EPA Releases 24 Study Reports Used to Develop the Draft Risk Evaluation for C.I. PV 29

Lynn L. Bergeson

On March 22, 2019, the U.S. Environment Protection Agency (EPA) issued a memorandum stating that it was releasing 24 studies in the Colour Index (C.I.) Pigment Violet (PV) 29 docket (Docket No. EPA-HQ-OPPT-2018-0604) that were reviewed by EPA to develop its Draft Risk Evaluation for C.I. PV 29.  EPA states that these studies are being made available to the public prior to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) expert panel peer review of the draft risk evaluation.  That entirety of the reports was originally erroneously claimed to be confidential business information (CBI), therefore, the reports were not included in the public docket previously.   Fifteen of the study reports have been released without any redactions while nine reports were partially redacted.  EPA provides a full list of the studies and their confidential status in the memorandum.  The 24 study reports represent the following disciplines:  #1-17 Human Health; #18-20 Environmental Hazard; #21-22 Environmental Fate, and #23-24 Physical Chemical properties.  Twenty of the 29 studies made available in the dockets were summarized in the European Chemicals Agency’s (ECHA) registration dossier for C.I. PV 29; EPA refers to them as “robust summaries” and states that it has compared the information contained in the robust summaries against the information contained in the study reports for accuracy.  They were posted to the docket in November 2018.