On July 24, 2025, U.S. Environmental Protection Agency (EPA) approved a Test Marketing Exemption (TME) under section 5(h)(1) of the Toxic Substances Control Act (TSCA) for a confidential new chemical substance (TME Application No. T-24-0001).
While the specific identity of the chemical remains protected as confidential business information, the Federal Register notice outlines key criteria of the exemption, which provide a helpful refresher for chemical companies considering testing market conditions for a new chemical.
A TME allows a manufacturer to introduce a new chemical into commerce for a limited test marketing period without the regulatory burden of undergoing TSCA Premanufacture Notification (PMN), a cumbersome process by which EPA thoroughly evaluates risks associated with new chemicals prior to introduction into commerce. The purpose of the TME is to first allow companies the opportunity to evaluate customer interest and performance in realistic market settings.
In approving TME Application No. T-24-0001, the EPA concluded that the proposed use - manufacture and use as a raw material in the production of esters - did not pose unreasonable risk, based on review of available health and environmental data. The exemption includes several conditions typical of TMEs. The company is limited to producing no more than 50 tons of the substance per year. The exemption is effective for a period of 365 days, beginning with the first date of manufacture. The chemical must be fully consumed during its intended use. Each shipment must be accompanied by a bill of lading stating that its use is limited to those approved by the TME. The manufacturer must maintain records for at least five years, including production quantities, shipment dates and destinations, and copies of associated shipping documents. Importantly, the EPA retains the authority to modify or revoke the exemption if new information suggests the chemical may present an unreasonable risk.
For companies contemplating a TME, the regulatory pathway offers an opportunity to explore market potential while deferring the time and expense of full PMN review. However, applicants must be prepared to submit detailed information upfront, including health and environmental effects data, projected production volume, number and identity of customers, exposure scenarios, marketing plans, and safety data sheets. Deviations from approved terms, such as exceeding volume cap or distributing to unapproved recipients, could result in enforcement or revocation of the exemption.
This latest TME approval provides a clear example of the EPA’s expectations for test marketing under the TSCA exemption. While the process offers flexibility for early-stage market exploration, it comes with strict conditions and oversight. Companies considering a TME should prepare thoroughly, maintain complete documentation, and remain vigilant in complying with all recordkeeping requirements.
