The Environmental Protection Agency ("EPA") announced a proposed rule to amend the new chemicals procedural regulations under TSCA. This proposal follows the 2016 enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the "Lautenberg Act"), which requires EPA to make an affirmative determination on whether each new chemical substance presents an unreasonable risk to human health or the environment under known, intended, or reasonably foreseeable conditions of use. In addition to aligning applicable procedural rules in the Code of Federal Regulations with the requirements of section 5 of TSCA, as amended by the Lautenberg Act, the proposed rule is intended to improve the efficiency of EPA's review processes.
Under the new rule, EPA would be required to make a determination on each premanufacture, significant new use, and microbial commercial activity notice before the submitter may commence manufacturing or processing the chemical substance that is the subject of the notice. The proposed rule additionally clarifies the information to be submitted in premanufacture, significant new use, and exemption notices, in the following categories: physical and chemical properties and environmental fate characteristics; categories of use; details concerning manufacture, processing, and use; worker exposure; environmental releases; and pollution prevention information.
EPA is also proposing changes for low volume exemptions ("LVEs") and low release and exposure exemptions ("LoREXs"). Submitters of exemption notices would not be able to commence manufacture (including import) until EPA has approved the LVE or LoREX notice. Under the proposed rule, PFAS would be categorically ineligible for LVEs and LoREXs. EPA additionally proposes to codify its 1999 PBT policy, meaning that chemical substances under LVE or LoREX review that are determined to be a PBT with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms are ineligible for an LVE or LoREX.
Comments must be received on or before 60 days after the proposed rule's publication in the Federal Register.
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