SOCMA has submitted extensive public comments to the U.S. Environmental Protection Agency (EPA) on its implementation of the New Chemicals Review Program
and on its development of approaches for Pre-Prioritization
under the amended Toxic Substances Control Act.
Maintaining the productivity of the New Chemicals program is crucial to SOCMA and its members. While EPA successfully cleared the backlog of new chemical notices that arose after the passage of the Lautenberg amendments, SOCMA members continue to widely report that EPA has unnecessarily impeded the introduction of new chemicals. The increasingly lengthy and precautionary approach taken by EPA has resulted in the Pre-Manufacture Notice (PMN) review process resembling that of a registration program. Such an approach may be appropriate for foods, drugs and pesticides, which are generally excluded from TSCA, but for PMNs this sort of scrutiny does not improve safety. In fact, it ignores the Congressional intent of Section 6 Risk Evaluation of TSCA, the component of the law that provides for a comprehensive risk assessment of a chemical substance, which does not increase length of the review process or level of scrutiny.
EPA's recently published FY18-22 Transformation Strategy notes that one of the Priority Goals is to "Complete TSCA Pre-Manufacture Notice final determinations in accordance with the timelines set forth in the statute." SOCMA's comments identify a number of areas in the New Chemicals program that must be modified to meet this strategic goal.
SOCMA has also submitted comments on the possible approaches for identifying potential candidate chemicals for EPA's prioritization process under TSCA. The TSCA Work Plan in 2014 resulted in various problems, including misinformed stakeholders on what EPA needed and what information EPA was relying on, and to whom relevant information could be given and when stakeholders could expect EPA to act on the work plan. The process to be developed by EPA in 2018 must utilize rigorous quantitative frameworks and objective criteria, as well as provide a screening-level assessment that allows for the rapid evaluation of candidate chemicals.
SOCMA would like to see EPA employ a high-throughput screening and scoring process, one that could be similar to the approach used in Canada's Chemicals Management Plan (CMP), which allowed for the rapid review of 23,000 chemicals on Canada's Domestic Substances List (DSL). Such an approach would guarantee the needs for transparency and stakeholder engagement while ensuring that the public has a clear understanding of potential risk in the candidate pool of chemical substances.
SOCMA hopes the technical, legal and policy recommendations in its comments assist the agency in its ongoing implementation of amended TSCA.