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By Lynn L. Bergeson and Margaret R. Graham

On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment.  Links and short summaries are provided below.

EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the first ten chemicals to be evaluated under the Toxic Substances Control Act (TSCA) and present refined conceptual models and analysis plans that describe how EPA expects to evaluate the risks and that they are an important interim step prior to completing and publishing the final risk evaluations by December 2019.  Comments on the problem formulation documents will be due 45 days after these documents are published in the Federal Register.  The problem formulation documents are:

  1. Asbestos
  2. 1-Bromopropane (1-BP);
  3. Carbon Tetrachloride;
  4. 1,4-Dioxane;
  5. Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
  6. Methylene Chloride;
  7. N-Methylpyrrolidone (NMP);
  8. Perchloroethylene;
  9. Pigment Violet 29; and
  10. Trichloroethylene (TCE).

EPA states the systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information.  Comments will be due 45 days after publication in the Federal Register.  Also included on the systematic review web page is EPA’s Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations.  

For asbestos, EPA is proposing an asbestos SNUR for certain uses of asbestos (including asbestos-containing goods) that would require manufacturers and importers to receive EPA approval before starting or resuming manufacturing, and importing or processing of asbestos.  EPA states that this review process, the first such action on asbestos ever proposed, would provide EPA with the opportunity to evaluate the intended use of asbestos and, when necessary, take action to prohibit or limit the use.  Comments will be due 60 days after publication in the Federal Register.

More information on the first ten chemical evaluations is available on our blog.  A more detailed analysis will be available next week on our regulatory developments webpage.