As reported in our December 20, 2019, blog item, 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.” On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated document and beginning a 45-day comment period. 85 Fed. Reg. 99. Comments are due February 18, 2020.
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. More information is available in our December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”