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EPA Releases First Draft Chemical Risk Evaluation Under TSCA
Today, the U.S. Environmental Protection Agency (EPA) completed another major Toxic Substances Control Act (TSCA) milestone by releasing the draft risk evaluation for Pigment Violet 29 (PV29), one of the first ten chemicals undergoing risk evaluation under TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).
‰??EPA has made tremendous progress fulfilling our new responsibilities for existing chemicals under the amended Toxic Substances Control Act,‰?? said EPA Acting Administrator Andrew Wheeler. ‰??Releasing the first draft risk evaluation conducted under this new authority shows that the Agency is delivering on its promise to meet the statutory deadlines and ensure the safety of chemicals currently on the market.‰??
Upon publication of the Federal Register notice, the draft risk evaluation for PV29 will be available for public comment for 60 days in docket EPA-HQ-OPPT-2018-0604 on www.regulations.gov. With this action, the Agency will be providing the public with an opportunity to submit their feedback on the conclusions, findings, and determinations in the draft risk evaluation. EPA will use feedback received from the public to inform the final risk evaluation.
The draft risk evaluation will also undergo peer review by the Science Advisory Committee on Chemicals (SACC) shortly. The SACC, the new Federal Advisory Committee required under TSCA, will provide scientific advice, information, and recommendations to EPA on chemicals regulated under TSCA.
PV29 is a chemical used as a colorant, primarily in inks, paints, coatings, and plastics. 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 planned 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.
EPA has already met critical initial deadlines from the Lautenberg Act, including issuing the framework rules on existing chemicals prioritization, risk evaluation, and the existing chemicals inventory by the first-year anniversary of the Act on June 22, 2017.
On the second-year anniversary of the Lautenberg Act, EPA issued:
‰?¢ Mercury Use Reporting Rule with deadlines and requirements to assist in updating the inventory of mercury supply, use, and trade in the United States.
‰?¢ Alternative Testing Strategy to promote the development of alternative test methods to reduce vertebrate animal testing. On March 7, 2018, EPA released the draft strategy for public comment.
‰?¢ Guidance on Generic Names.
‰?¢ Policy on Assigning Unique Identifiers to chemicals and applying those identifiers to other information concerning the same chemical.
‰?¢ Guidance on Expanding Confidential Business Information (CBI) access to states, tribes, and local governments; health and environmental professionals; and first responders.
On September 27, 2018, EPA issued a final Fees Rule to provide funding for Lautenberg Act implementation, including risk evaluations and reviewing CBI.
Finally, also in September 2018, EPA released the approach it anticipates using to identify chemicals that could be included in the next group of risk evaluations under TSCA while looking for input from the public on which chemicals should be prioritized for risk evaluation and which chemicals may be low priorities under TSCA.
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