U.S. EPA Proposes Amendments to New Chemicals Regulations

By John Kowalski, senior regulatory specialist, Supply Chain team, UL Solutions

On May 26, 2023, the U.S. Environmental Protection Agency (EPA) published a proposed rule to amend the new chemicals regulations under the Toxic Substances Control Act (TSCA).  According to EPA, “These amendments are intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016, improve the efficiency of EPA’s review processes, and update the regulations based on existing policies and experience implementing the New Chemicals Program.”  More specifically, the proposed amendments would:

• Specify that EPA must make one of five statutory determinations on each Premanufacture Notice, Significant New Use Notice, and Microbial Commercial Activity Notice;
• Update the regulations to list the actions required in association with each of those determinations;
• Eliminate eligibility for low volume and low release and exposure exemptions for new per- and polyfluoroalkyl substances (PFAS) and other persistent, bioaccumulative, and toxic (PBT) chemicals;
• Clarify the level of detail needed in new chemical notices;
• Amend the procedures for EPA’s review of notices that have errors or are incomplete;
• Add a new set of information “pick-lists” to the notice form in EPA’s Central Data Exchange; and
• Streamline the process for submitters to request suspension of the review period for 30 days via oral or written request if more time is needed by the submitter.

The proposed rule, when finalized, will impact U.S.-based companies that manufacture or import new chemicals, as well as those that undertake significant new uses of existing chemicals.  It may also impact foreign companies that export products to the United States.  EPA is accepting public comments on the proposed rule until July 25, 2023.

Recommended action items

• Review the proposed rule; and
• Consider submitting comments.

Source

Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA); Proposed Rule