Key Takeaways

Delays by the U.S. Environmental Protection Agency (EPA) in processing premanufacture notices (PMNs) under the Toxic Substances Control Act (TSCA) may lessen under final amendments to section 5 published on December 18, 2024. That, at least, is EPA’s hope. The final rule requires up-front submission of detailed information and threatens to reset the 90-day review period at Day 1 if information is submitted later.

The final rule is intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act, improve EPA’s efficiency in the review process, and update the regulations based on existing policies and experience implementing the New Chemicals Program. The final amendments are largely similar to the proposed amendments from 2023.

PMN submitters will face expanded information requirements from those listed in the current PMN form, including submission of detailed information on sites controlled by the submitter, sites controlled by others (such as customers), and categories of intended use.

The final rule also confirms that all new per- and polyfluoroalkyl substances (PFAS) and other persistent, bioaccumulative, and toxic chemicals (PBTs) are ineligible for a low volume (LVE) or low release and exposure (LoREX) exemption. Instead, they must undergo a comprehensive safety review through the PMN process before they can be manufactured. EPA announced the ineligibility of PFAS and PBTs for LVEs and LoREX exemptions as a policy matter in 2021. This final rule cements that policy in regulations.

The final rule amends the regulations in 40 C.F.R. § 723.50 to require explicit EPA approval before manufacturers can commence production under an LVE or LoREX, even after a 30-day review period. The rule specifies that the review period for LVE and LoREX applications begins only after the EPA receives a complete and correct notice. The amendments also require the EPA to make determinations for each premanufacture notice (PMN), significant new use notice (SNUN), and microbial commercial activity notice (MCAN) prior to the submitter commencing manufacturing or processing of the chemical substance.

Additionally, the rule introduces several changes to streamline the new chemical review process, such as clarifying the required detail in new chemical notices and revising the procedures for handling notices with errors or incomplete information. For instance, EPA can declare an original submission incomplete and restart the review period once the completed submission is received.

EPA’s response to public comments on the 2023 proposal is available here.

Final Amendments

Once the amendments take effect, they will, among other changes:

• Require all new PFAS and certain PBTS to go through a thorough safety review before they can be manufactured, making these chemicals categorically ineligible for LVE and LoREX exemptions.
• Clarify that a submitter may not commence production of a new chemical substance until EPA issues a determination (PMNs and SNUNs) or notifies the submitter (LVEs/LoREXs) that manufacture (and processing, if applicable) may begin. This implements section 5(a)(1)(B)(ii) of TSCA as added by the 2016 amendments.
  • The determinations that EPA may make under section 5 have been added to 40 C.F.R. § 720.75(d). The new SNUR provision in § 721.25(d) incorporates those kinds of determination by reference.
• Amend 40 C.F.R. § 720.65(c)(2) to allow EPA to declare a PMN to be “incomplete” if it receives additional information during the review period. “Additional or revised information” during the review period gives EPA good cause to declare a submission incomplete – meaning that the review period has not yet started (i.e., go back to Day 1). This is intended to put the onus on submitters to submit “complete” noticesup front, rather than adding information in response to EPA comments. EPA believes this will enhance efficiency in the section 5 review process.
• Amend 40 C.F.R. § 720.75(b)(2) to allow PMN, SNUN, LVE, and LoREX submitters to request a suspension of the notice review period for up to 30 days orally or in writing, including by e-mail, without the need for a formal, written request submitted to EPA via CDX using e-PMN software.
• Require the submitter to include the following information in its section 5 applications:
  • When the PMN submitter cannot provide the chemical identity because the foreign supplier has claimed it confidential, the review period will not start until the foreign supplier provides that information to EPA. This can be done through a joint submission or a letter of support, and ensures that EPA has all necessary information to evaluate the chemical substance thoroughly.
  • Submitters must provide detailed information regarding the categories of intended use for the new chemical substance.
  • Submitters must provide detailed information about the sites controlled by the PMN submitter where the new chemical substance will be manufactured, processed, or used.
  • Submitters must provide detailed information about sites that are not controlled by them, such as downstream customers, including information that is “reasonably ascertainable.”
  • Submitters are required to provide comprehensive information regarding the physical and chemical properties and environmental fate characteristics of the new chemical substance.
• Require submitters of SNUNs to comply with the PMN information requirements in Part 720, meaning that the PMN information requirements will also apply to SNUNs under § 721.25.
• Require LVE applications to comply with the PMN information requirements in Part 720 under § 723.50(e)(2).
• Amend the review period for LVE and LoREX applications, so the 30-day clock starts only after the EPA has received a complete and correct application. If the application is incomplete or contains errors, the review period will not begin until these issues are resolved.

Commentary

There is uncertainty about whether these amendments will achieve EPA's goals of reducing review times for section 5 applications and decreasing the frequency of amendments and rework of risk assessments. They leave unaddressed numerous issues about EPA’s review of section 5 notices that industry has raised.

The finalized revisions will become effective prior to Inauguration Day on January 17, 2025. Its fate after that is unclear. The Trump administration is expected to issue promptly a regulatory freeze, as it did on taking office in 2017, but the freeze will not apply to rules that have already taken effect. Congress might act to disapprove the rule through the Congressional Review Act. If not, the Trump EPA could amend the rule through notice-and-comment rulemaking. If the rule is challenged on judicial review, EPA could seek voluntary remand to reconsider the rule.