By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) released on December 20, 2019, an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  EPA discussed the updated document, “TSCA New Chemical Determinations:  A Working Approach for Making Determinations under TSCA Section 5,” at a public meeting on December 10, 2019.  EPA states that the updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

• The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
• Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
• In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
• The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
• The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

• Additional clarification and detail throughout;
• General guiding principles and concepts for making determinations;
• Decision-making logic and key questions that EPA must address; and
• Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses.  Upon publication in the Federal Register, EPA will accept comment on the updated document for 45 days in docket EPA-HQ-OPPT-2019-0684 at https://www.regulations.gov.  More information will be available in a forthcoming memorandum that will be posted on our website.