Dec. 6 Public Meeting on New Chemicals Review Program:
EPA provided updates on the Agency’s progress on its implementation of the TSCA New Chemicals Review Program. Numerous industry stakeholders expressed concern with the timeliness of PMN reviews, and EPA indicated that it is working toward becoming compliant with the 90/180 day review deadline. EPA also indicated that it does not intend to fold exemptions into the process for PMNs. Much discussion also centered on EPA’s expanding use of SNURs. EPA indicated that where it has concerns with reasonably foreseen conditions of use (COU), but not with intended use, EPA will be assessing whether the chemical substance should be addressed with a SNUR in lieu of a consent order. There was spirited debate regarding what constitutes reasonable foreseeability, whether evaluation of risk should consider probable or possible COU, and how the provision of additional chemical information can refine EPA’s evaluation to avoid a SNUR. Jeff Morris, EPA’s OPPT Director, confirmed that he is currently reviewing every new chemical notification decision to ensure a clear and consistent approach to the reviews. The meeting materials can be found on EPA's website.
Dec. 11 Public Meeting on Approaches for Pre-Prioritization:
EPA reviewed six possible approaches for identifying potential candidate chemical substances for EPA’s prioritization process under TSCA. These approaches included applying and refining the methodology used to screen chemicals in the 2014 TSCA Work Plan; adapting the high through-put screening methods in Canada's Chemical Management Plan (CMP); using the EPA's Safer Chemicals Ingredients List for identification purposes; using a "functional category approach" that identifies groups of chemicals with similar functional use in industrial applications or in commercial or consumer products; using a functional category approach based on the evaluation of similar chemical properties and physical structures; and integration of traditional and New Approach Methods (NAMs) such as in vitro, in chemico, and in silico to inform risk screening. EPA emphasized that these pre-prioritization processes could be adapted in part, in whole, or not at all, and that an iterative approach with stakeholder input will be necessary. EPA also noted that it seeks to balance the need for transparency with the need to avoid approaches that could lead to public misperception on risks of identified candidate chemicals. A published process for pre-prioritization is anticipated in June 2018, to be finalized by March 2019. The meeting materials can be found on EPA's website.
Open Comment Period on New Chemicals and Pre-Prioritization:
EPA has opened the docket for public input on both the New Chemical Review Program (comments due January 20, 2018) and on Approaches for Pre-Prioritization (comments due January 25, 2018).
TSCA Small Manufacturer Definition:
EPA has decided that an update to the existing size standards for small manufacturers and processors currently used to determine which small businesses are exempt from reporting regulations under TSCA Section 8(a) is warranted. A future revision to the size standards will occur by a subsequent rulemaking with opportunities for public consultation. SOCMA will be closely engaged in this activity as EPA proceeds with the rulemaking process.