Regulatory DevelopmentsDecember 20, 2016
The U.S. Environmental Protection Agency (EPA) is scheduled to publish in the December 21, 2016, Federal Register a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA). Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow. As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain procedural requirements, and this rulemaking removes the regulations specifying those procedures. The final rule will be effective when published in the Federal Register.
The final rule removes 40 C.F.R. Part 750, Subpart A (the general procedural requirements for rulemaking under TSCA Section 6, including the requirement for a hearing). Subpart A detailed hearing-related procedures, as well as the content and timing of EPA’s notices and its record. The final rule also removes similar provisions from the procedural rules in subparts B and C for exemptions from the prohibitions in TSCA Section 6(e) applicable to polychlorinated biphenyls.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act amends many sections of TSCA, including TSCA Section 6. While EPA must take action against unreasonable risks presented by chemical substances or mixtures, its duties under TSCA Section 6 have been significantly modified to include specific deadlines and procedures for prioritizing chemicals for risk evaluations, conducting the risk evaluations, and promulgating regulations to address unreasonable risks that it identifies. EPA states that notably, once unreasonable risks have been identified through a risk evaluation, TSCA Section 6(c)(1) now requires EPA to issue a proposed rule to address the risks no later than one year after the final risk evaluation is published, and the final rule must be issued no later than two years after the final risk evaluation is published, subject to the limited extension authorized by TSCA Section
The final rule states that to the extent Subpart A simply reflected administrative requirements of TSCA and the Administrative Procedure Act (APA), new TSCA and APA will continue to apply on their own terms. According to EPA, Section 6 as amended prescribes considerably more procedure than the previous version of TSCA. To the extent Subpart A goes beyond the current statutory requirements, EPA “believes that the layering of additional procedural requirements by regulation is both unnecessary to ensure a transparent rulemaking process with robust public participation and not well-suited to the rapid throughput required by the law. EPA also believes the requirements are in some respects outdated with respect to current technology.”
The final rule appears to amend the Section 6 procedural requirements such that they align with the amended requirements under new TSCA. While the procedural simplifications in new TSCA were a useful change that should better enable regulatory action on existing chemicals, EPA will need to exercise care in its future rulemaking to meet the procedural requirements that remain in Section 6, as well as satisfy the relevant provisions in Section 26.