US EPA Proposes New Rules Under TSCA for Chemicals with Significant New Use

The Environmental Protection Agency (EPA) is proposing Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemicals previously reviewed in premanufacture notices (PMNs). These chemicals have been deemed "not likely to present an unreasonable risk" under TSCA. The SNURs require notification to EPA at least 90 days before manufacturing or processing any of these chemicals for a newly proposed significant use.

Proposed Rule:

Under TSCA, EPA must make a determination and take necessary action prior to the manufacture or processing of a new chemical substance or for a significant new use. A SNUR is not a risk determination itself but requires notification for “significant new uses” so that EPA can review and assess the risk. Following EPA's review of a pre-manufacture notice (PMN), a Microbial Commercial Activity Notice (MCAN), or a Significant New Use Notice (SNUN) under TSCA Section 5, it may take appropriate action. Manufacturers must await EPA's review and decision before commencing manufacturing or processing for a significant new use.

Potentially affected entities may include manufacturers or processors of one or more subject chemical substances such as chemical manufacturing and petroleum refineries. For exporters of substances subject to SNURs, a single notification to EPA is required for the first export to a specific country.

Costs:

Submitting a Significant New Use Notice (SNUN) has an estimated cost of $26,700 for large companies and $11,000 for small companies. These costs cover preparation and submission of the SNUN, including registration on EPA's Central Data Exchange (CDX), along with payment of user fees. Large companies pay a user fee of $19,020, while small companies, as defined in 13 CFR 121.201, pay a reduced fee of $3,300 per fiscal year.

The total expenses for export notification will vary based on the requirements of the chemical and the number of countries involved.

Factors assessed while determining that the use of a chemical substance is a significant new use include:

• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the extent and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacture, processing, distribution in commerce, and disposal of a chemical substance.

Submission of Significant New Use Notifications (SNUNs) requires completion of EPA Form No. 7710-25, which is generated using e-PMN software, and compliance with the procedures outlined in 40 CFR 720.40 and 721.25. The e-PMN software can be accessed electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

This proposed rule is assigned Docket Number EPA-HQ-OPPT-2021-0228. It was notified to the World Trade Organization (WTO) on April 9, 2024. The deadline for submitting comments is May 8, 2024.