US EPA Finalizes Procedures for Prioritization of Chemicals for Risk Evaluation Under TSCA
On July 20, 2017 the US EPA finalized the procedures for prioritization of chemicals for risk evaluation under the Toxic Substances Control Act (TSCA) as required under the new section 6(b)(1) amendment in the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” passed on June 22, 2016.
The process will include four steps or phases in prioritization. These are as follows: (1) Pre-prioritization, (2) Initiation, (3) Proposed Designation, and (4) Final Designation. As part of this process, and as required by the act, EPA will identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. The initiation phase will require EPA to announce a candidate substance and give the public a 90 day comment period to provide relevant information on the chemical. In the designation step, EPA will be required to screen the chemical substances against multiple criteria specified in TSCA 6(b)(1)(A): hazard and exposure potential of the chemical substance (e.g., persistence and bioaccumulation, potentially exposed or susceptible subpopulations, and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed. Once this screening process is complete, EPA must publish the chemical’s proposed prioritization designation (High-Priority or Low—Priority) as well as any information or analyses used in that designation and again give the public a 90 day period to comment. During the Final Designation step, EPA will make its final designation as to whether the chemical is a High-Priority Substance requiring a risk evaluation. Importantly, designation of a substance as low priority will not preclude EPA from later revising the designation.
Certain chemicals will be treated slightly different during the prioritization process. In particular, when prioritizing metals or metal compounds EPA must use the March 2007 Framework for Metals Risk Assessment of the Office of the Science Advisor. EPA is also to give preference to chemical substances that are listed in the 2014 Update of the TSCA Work Plan for Chemical Assessments that have persistence and bioaccumulation scores of 3 and are known human carcinogens and have high acute and chronic toxicity.
The rule will modify existing 40 CFR 702 and becomes effective on September 18, 2017.
Source: US EPA Finalizes Procedures for Prioritization of Chemicals for Risk Evaluation Under TSCA, 82 FR 33753 (2017).