US EPA Proposes New Rules Under TSCA for Chemicals

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 mandate that manufacturers notify the EPA at least 90 days before producing or processing these chemicals for any newly proposed significant use.

Proposed Rule Details

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

Potentially Affected Entities/h3>

Entities potentially affected by these rules include manufacturers or processors of certain chemical substances, such as those in the chemical manufacturing and petroleum refinery industries. Exporters of substances subject to SNURs need to notify the EPA only once for the first export to a specific country.

Costs

Submitting a Significant New Use Notice (SNUN) is estimated to cost $26,700 for large companies and $11,000 for small companies. These costs cover the preparation and submission of the SNUN, including registration on the EPA's Central Data Exchange (CDX) and user fees. Large companies pay a user fee of $19,020, while small companies 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 for Determining Significant New Use

The EPA assesses several factors to determine if a chemical substance's use is a significant new use:

- The projected volume of manufacturing and processing.
- The extent to which a new use changes the type or form of exposure to humans or the environment.
- The extent and duration of exposure to humans or the environment.
- The anticipated manner and methods of manufacture, processing, distribution in commerce, and disposal.

Submission Requirements

Submitting a Significant New Use Notification (SNUN) requires completing EPA Form No. 7710-25 using e-PMN software and following the procedures outlined in 40 CFR 720.40 and 721.25. The e-PMN software is accessible electronically at [EPA's Reviewing New Chemicals under TSCA](https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca).
The proposed SNURs by the EPA aim to ensure the safe and controlled use of chemical substances deemed not likely to present an unreasonable risk, thereby protecting human health and the environment.