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EPA Releases Documents Detailing Scope of Risk Evaluations for First Ten Chemical Substances, as Required by TSCA

On July 7, 2017, the EPA published a notice in the Federal Register announcing its release of documents detailing the scope of the risk evaluations that will be conducted for the first ten chemical substances to undergo initial risk evaluations under the Toxic Substances Control Act (TSCA), as required by the Frank R. Lautenberg Chemical Safety Act (LCSA) (also known as the 2016 TSCA Amendments). The risk evaluations are intended to determine whether the chemical substances present an unreasonable risk of injury to human health or the environment, and the scope of the evaluations includes hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations that the EPA expects to consider. The EPA’s notice directly implements the 2016 TSCA Amendments’ mandate to publish scope documents for each of the first ten chemical substances designated to undergo risk evaluation. The first ten chemical substances were designated by the EPA for the initial risk evaluations required by the 2016 TSCA Amendments in a notice published in the Federal Register on December 19, 2016 (81 Fed. Reg. 91,927), at which time the risk evaluation process for each of the chemicals began. They are:
  • Asbestos,
  • 1-Bromopropane,
  • 1,4-Dioxane,
  • Carbon Tetrachloride,
  • Cyclic Aliphatic Bromide Cluster (HBCD),
  • Methylene Chloride,
  • N-Methylpyrrolidone (NMP),
  • Pigment Violet 29,
  • Tetrachloroethylene (also known as perchloroethylene), and
  • Trichloroethylene (TCE).
The docket ID numbers for the first ten chemical substances’ scope documents are identified in the Federal Register notice. The EPA notes that the timeframe for the development of the first ten chemical substances’ scope documents was very compressed. Furthermore, the first ten chemicals were not subject to prioritization, the process through which the agency expects that it will collect and screen much of the relevant information about chemical substances that are subject to the risk evaluation process in the future. The EPA states that it therefore had limited ability to process all the information gathered during scoping for the first ten chemicals and was unable to provide an opportunity for public comment on drafts of the scope documents, as it intends to do for future scope documents. As a result, the EPA states that the scope documents for the first ten chemical substances are not as refined or specific as it anticipates future scope documents will be. Therefore, as an additional interim step before the publication of the draft risk evaluations for the first ten chemical substances, the EPA will publish and take public comment on problem formulation documents for each of the first ten chemicals in order to refine the current scopes. The EPA expects to publish the problem formulation documents mid-January 2018, approximately six months after the publication of this notice announcing the availability of the scope documents. Source : Scopes of the Risk Evaluations To Be Conducted for the First Ten Chemical Substances Under the Toxic Substances Control Act; Notice of Availability, 82 Fed. Reg. 31,592 (notice published July 7, 2017).

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