U.S. EPA has released a discussion paper laying out its ideas for identifying candidate chemicals for risk prioritization under the Toxic Substances Control Act. The agency has also scheduled a workshop for Monday, December 11 to discuss those ideas.
Last years major amendment to TSCA [the Frank R. Lautenberg Chemical Safety for the 21st Century Act] requires the agency to eventually evaluate the risks posed by existing chemical substances. The Act requires the agency to initially prioritize chemicals by designating them as either high-priority or low-priority for risk assessment. High priority chemicals must move immediately into a Risk Evaluation phase, while low-priority chemicals essentially escape any further review for the foreseeable future. The risk evaluation must take no longer than 3.5 years to complete. If unreasonable risks are identified EPA has 2 to 4 years to address those risks by promulgating applicable risk management measures.
TSCA requires EPA to prioritize at least 20 high- and at least 20 low-priority chemicals within 3.5 years of the new Act's adoption—approximately the end of December 2019. The Act also requires EPA to identify an initial set of ten chemicals for risk evaluation—a task EPA completed last December [see EPA Names First Ten Chemicals and Proposes First Chemical Ban Under New TSCA, December 23, 2016]. These chemicals were designated separately outside of the prioritization procedure and thus are in addition to the 40 chemicals to be prioritized by the end of 2019.
Earlier this year EPA finalized a rule for prioritizing chemicals for evaluation (the "Prioritization Rule"). In its initial proposal for that rule EPA included a proposed "Pre-Prioritization Process" under which EPA would select candidate chemicals for future prioritization. During the comment period several commenters suggested that EPA more clearly explain the criteria it would use for selecting candidate chemicals and how the public would be involved in the selection process. Consequently, in the final version of the Prioritization Rule EPA dropped the proposed Pre-Prioritization Process and pledged to initiate a stakeholder process to better involve interested parties in developing a final version of that Process.
The publication of the discussion paper and the December 11 workshop are the first steps in developing this process. The discussion paper, which runs more than 100 pages, lays out six possible approaches and tools for identifying candidate chemicals for prioritization:
• Incorporating TSCA Work Plan Methodology: This approach would utilize lessons learned by EPA in establishing its 2014 Update to the TSCA Work Plan. The initial ten chemicals selected for review (see above) were required to be selected from chemicals identified in the Work Plan.
• Using Canada's Chemical Management Plan (CMP): This approach would utilize lessons learned and tools developed under the CMP to identify candidate chemicals.
• Safer Chemical Ingredients List (SCIL): This approach describes the SCIL and discuses how it might be used for chemical identification.
• Functional Category Approach Based on Use and Exposure Potential: This approach would identify a group of chemicals with similar functional use in industrial applications or in commercial or consumer products.
• Functional Category Approach Based on Chemical Structure and Function: This approach would group chemicals based on a chemical’s structure and physiochemical properties to achieve a particular function at the chemical level.
• Integration of Traditional and New Approach Methods (NAM): This approach uses a software tool and databases containing information from traditional and NAM to focus EPA's efforts on those chemicals that present hazard or exposure potential.
Each of these various approaches will be discussed at the December 11 workshop, which will be held in Washington D.C. Interested parties who pre-register will have access at remote locations.
EPA will utilize comments from this workshop, on the discussion paper, and on the proposed Prioritization Plan in identifying the final approach or approaches that will be selected. The agency expects to complete this process by June of next year.
|EPA Names First Ten Chemicals and Proposes First Chemical Ban Under New TSCA||Dec 23, 2016|
|publication of the discussion paper||Nov 14, 2017|