Test Marketing Exemption (TME) for New Chemical Review under TSCA
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Under section 5 of TSCA, EPA established an exemption for certain chemicals that are manufactured (including imported) for test marketing. The purpose of the test marketing exemption is to enable potential PMN submitters to focus on customers' acceptance of a chemical substance, and the probable demand for a product in a market where it will be competing with other goods.
For a substance to qualify as a TME substance, all procedural and recordkeeping requirements must be met as found at 40 CFR section 720.38 and section 720.78.
EPA will review TME applications in 45 days.
After the expiration of a TME period as described in a previously granted TME application, a TME substance may continue to be used for TME activities, prior to the expiration of a 90-day Premanufacture Notification (PMN) review period for a "new" chemical substance, under two conditions:
1) The only on-going activities for the TME substance are distribution or use, that is, no additional manufacture of a TME substance may occur after the termination of the TME period.
2) Production volume and the name of the recipient of the distributed TME material was accounted for in the TME application.
After EPA makes a final determination on the PMN, residual TME material may be used for non-exempt commercial purposes, as well as for R&D activities. A Notice of Commencement (NOC) may not be submitted until the first non-exempt commercial manufacture of a new chemical substance after EPA makes a final determination on the PMN.
The availability of residual test-marketing material should generally be minimal. Based on the nature of the TME application, persons applying for the test-marketing exemption are asked to provide the Agency with the maximum quantity of the chemical substance which the applicant will manufacture or import for test marketing purposes. Therefore, the manufacturer should not produce more than the maximum quantity of the chemical substance necessary for the test-marketing activities.
EPA is concerned that the simultaneous submission of a TMEA and a PMN for the same substance might represent an effort by the submitter to obtain PMN review of a chemical substance in 45 days, rather than the 90 days provided by section 5(a) of the Toxic Substance Control Act (TSCA). To discourage such an approach, EPA will closely examine simultaneous submissions to determine if genuine test marketing activity is involved; if it is not, the application will be denied.
Regarding the issue of simultaneous TME and R&D activity, the Agency agrees that a company may co-produce both R&D and TME material in a given batch, and then separate the R&D material for R&D uses. However, since the use of a "new" chemical substance for a R&D purpose is considered a separate commercial activity from that of test marketing, records of the manufacture of the "new" substance must clearly indicate the intended production volume allocated for each activity. 40 CFR section 720.78 specifically requires you to maintain records of the disposition of R&D materials. In addition, production of any materials intended for test marketing purposes cannot commence until the Test Marketing Exemption Application (TMEA) has been granted by the Environmental Protection Agency (EPA).
Note: For TMEAs, the e-PMN software does not validate any data beyond PMN page 3 to allow you more flexibility in filling out the exemption. The rest of the TMEA information can be entered into the form in one of three ways:
- Fill out the applicable fields in the PMN pages 4-13;
- Enter the TMEA information in the cover letter; or
- Enter the TMEA information as an attachment.