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On December 3, 2024, the United States Environmental Protection Agency (EPA) finalized the amendment of the new chemical procedural regulations under the Toxic Substances Control Act (TSCA). These amendment will improve the efficiency of EPA's reviewing process and align with the 2016 bipartisan TSCA Amendment under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and update the regulations based on existing policies and experience implementing the New Chemicals Program.
How are new chemical regulations structured?
New chemical regulations under TSCA Section 5 are codified in Title 40, Chapter I, Subchapter R of the Code of Federal Regulations (CFR), which include:
Regulations pertaining to Pre-manufacture Notices (PMNs), which are codified at 40 CFR part 720;
Regulations pertaining to Significant New Use Notices (SNUNs), which are codified at 40 CFR part 721;
Regulations pertaining to Low Volume Exemptions (LVEs) and Low Release and Low Exposures (LoREX) Exemptions, which are codified at 40 CFR part 723; and
Regulations pertaining to Microbial Commercial Activity Notices (MCANs) and microorganism-related exemptions, which are codified at 40 CFR part 725.
Who may be affected by this Amendment?
Manufacturers, importers, and processors of a new chemical substance or chemical substance for a significant new use may be affected by this amendment.
Overview of the Finalized Amendment
EPA is promulgating amendments to the current LVE and LoREX regulations as follows:
submitters may not commence manufacture until EPA has approved the LVE or LoREX notice;
EPA may proactively inform LVE and LoREX holders if the chemical substance that is the subject of the LVE or LoREX becomes subject to a SNUR and the chemical identity is CBI, or if it is listed on the confidential portion of the TSCA Inventory;
new PFAS are categorically ineligible for these exemptions; and
certain PBT chemical substances are ineligible for these exemptions.
Similar to the prior notice requirement to the LVE and LoREX regulations, the amendments also specify that EPA must make the five statutory determinations on each PMNs, SNUNs, MCANs received before the submitter may commence manufacturing or processing of the chemical substance. These changes are made to conform to the regulations to the 2016 Lautenberg Amendment to ensure that chemicla substances under PMNs, SNUNs, MCANs and exemptions will not present an unreasonable risk.
In addition, EPA is finalizing amendments that will clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN, or exemption notice in order for the notice to be considered complete. The extra sets of detailed information include:
physical and chemical properties and environmental fate characteristics
categories of use
related to where and how the chemical substances will be manufactured, processed or used
worker exposure
environmental releases
pollution prevention information
Other important amendments are summarized below:
amend regulations regarding how EPA acknowledges the receipt of a notice to account for the pre-screen process;
align the process for correcting errors in the notice with the existing process for incomplete submissions;
clarify that new information about a chemical substance under EPA review must be submitted electronically via CDX;
allow PMN, SNUN, LVE and LoREX submitter to request for a suspension of the notice review period for up to 30 days.
This final rule shall takes effect 30 days after date of publication in the Federal Register.
The pre-publication version (not the official version) can be accessed here.
To know more about chemical management under TSCA, visit CL's dedicated Chempedia on TSCA.
