EPA Finalizes TSCA Reform Framework Rules

On July 20, 2017, EPA published in the Federal Register two final rules intended to begin implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which significantly reformed the Toxic Substances Control Act (TSCA). The two final rules are the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act, 82 Federal Register 33753 (Prioritization Rule) and Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act, 82 FR 33726 (Risk Evaluation Rule). A third TSCA framework rule—the TSCA Inventory Notification (Active/Inactive) Requirements rule (Inventory Rule)—has not yet been published in the Federal Register, although a pre-publication version was released in June 2017 (we previously reported on all three proposed rules here). Together, these three rules will help the Agency implement the extensive reforms set out in motion by the Lautenberg Act.

The Prioritization Rule and the Risk Evaluation Rule will become effective on September 18, 2017. Upon publication of the Active/Inactive Final Rule in the Federal Register - which EPA has indicated will become effective upon publication - a 180-day clock will be triggered for affected manufacturers, and affected processors must comply within 420 days of publication.

Finally, EPA published the notice of availability of Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations, a guidance document intended to assist stakeholders with developing and submitting their draft risk evaluations, and has uploaded draft scoping documents for the first ten chemicals for which EPA is required to perform risk evaluations under the Lautenberg Act to its website (EPA's initiation of the risk evaluation for these ten chemicals was previously discussed here).

Prioritization Rule

Under the Lautenberg Act, EPA is required to establish a risk-based screening process and criteria to designate chemicals as High or Low-Priority Substances. The Prioritization Rule establishes this process. The rule incorporates the definitions of "High-Priority Substance" and "Low-Priority Substance" directly from the Act, and, as required by the Act, dictates that a substance be designated as a "High Priority substance" if, after an extension of the public comment period, "information remains insufficient to enable the proposed designation of the chemical substance as a Low-Priority Substance." 40 C.F.R. § 702.9(e).

As a reminder, under the Lautenberg Act, the Agency is required to designate at least 20 High Priority and Low...