Date: Mar 28, 2019
Keller and Heckman partner Herb Estreicher was quoted in a ChemicalWatch article on how the U.S. EPA’s decision to release additional information underlying its TSCA risk evaluation of pigment violet 29 (PV29) has not ended the ongoing controversy around the confidentiality of health and safety data. According to the article, dated March 28, 2019, EPA recently it published information supporting its November 2018 draft evaluation for PV29, including 20 studies submitted to European Chemicals Agency (ECHA) when the substance was registered under REACH (Registration, Evaluation, Authorization and Restriction of Chemicals).
This release of information was in response to public demand for the release of 24 studies that had originally been withheld as confidential business information (CBI). However, despite the release of the documents, there are substantial redactions in the information made public. EPA also published a 10-page document of "summaries" covering ten of the studies, rather than the full versions. The concern is that the public is being forced to rely on a company’s own interpretation of its studies and raises the question of whether the EPA itself has access to the full studies. In an interview, Herb Estreicher told Chemical Watch he found the EPA’s decision to release the studies "very troubling".
"Companies will be reluctant to give EPA REACH studies, fearing loss of data compensation rights," he said. "This will detract greatly from the quality of future TSCA risk evaluations and/or lead to unnecessary duplication of animal testing."