Test Marketing Exemption

TSCA 5(h)(l) authorizes EPA to exempt from PMN and SNURs chemical substances that will be used for test marketing purposes. Unlike the other exemptions discussed infra requiring EPA prior approval, the holder of a TME has a limited time to conduct the test marketing. TME chemicals undergo a shortened 45 day review period and are not subject to user fees. 

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To encourage industry participation in this voluntary pilot project, the Agency has provided regulatory flexibility in the form of certain expedited reviews of PMNs. For purposes of this voluntary pilot project, EPA implemented a program leading to the opportunity for simultaneous submissions of Test Market Exemption applications and PMNs on chemical substances for which the submitter demonstrates the application and use of the P2 Framework or other scientifically acceptable hazard and exposure... 

The PMN process is in many ways the heart of the entire TSCA regulatory program. PMNs, together with applications for exemptions from the PMN rules (the Test Marketing Exemption, Low Volume Exemption, and low release and exposure exemption (LoREX)) are the main way for the EPA to... 

A person who has received a test marketing exemption for a significant new use is exempted from compHance with the SNUR, unless the SNUR specifically overrides this general rule. ... 

C.F.R. 721.45(a). For the test marketing exemption to apply to SNURs, a company that is subject to a SNUR must be able to file a test marketing exemption to avoid the restrictions in the SNUR. See the discussion ir a concerning the application of the LVE, LoREX, and polymer exemptions to SNURs. 

C.F.R. jtjt 725.1, 725.110 and 725.300. Only one test marketing exemption has been approved for a microorganism. See http //www.epa.gov/biotech rule/pubs/submain.htm. 

Many of the exemptions from PMN requirements are applicable to SNURs, but because SNURs cover processors the SNUR rules are adapted to cover processing when required. A person who has received a test marketing exemption for a significant new use ° or has been granted an exemption under TSCA 5(h) (5)is exempt from SNUR requirements. A person who manufactures, imports, or processes a SNUR substance solely for research and development or as an impurity or as a byproduct that is burned as a fuel, disposed of as waste, or from which other substances are extracted for commercial purposes is exempt from SNUR requirements. An importer or processor who imports or processes the substance as part of an article is exempt from the SNUR requirements, but a manufacturer of an article is not." A person who manufactures, imports, or processes a SNUR substance solely for export is exempt from filing a SNUN so long as the substance is labeled as... 

Has the EPA issued a Test Marketing Exemption (TME) for any of the seller s products ... 

Records documenting compliance with all exemptions from PMN requirements that the seller relied upon. The buyer will need to apply for a new Test Marketing Exemption (TME) because the EPA does not consider TMEs to be transferable. The parties can assign Low Volume Exemptions (LVEs), Low Release and Exposure (LoREX) exemptions, and polymer exemptions, but must have the documentation to be able to comply. 

Procedure Number Reg. Alf. 3, Procedure for the Test Marketing Exemption from PMN and SNUR RequirementsProcedwre TME... 

Procedure Number Reg. Atf. 3, Procedures for PMN and SNUR Exemptions Needing EPA Approvals The Test Marketing Exemption Procedure TME Procedure Number Lab. 5, Sampling R D Substances to Third Parties Procedure Sampling... 

Additional substances qualify for exemptions from the PMN requirements. The EPA s PMN form is also used for certain exemption applications and other notifications. The exemption applications that must use the PMN form are the Low Volume Exemption and Low Release and Exposure Exemption. Use of the PMN form is optional for applying for a Test Marketing Exemption. 

Step 5. If the substance is not on the Inventory, the MRC shall determine if the substance is excluded from the definition of chemical substance because it is a pesticide, a food, a nuclear material, or any other substance excluded from TSCA s scope. The MRC shall also determine if the substance is eHgible for an exemption from the PMN requirements because it is to be made for test marketing, in low volumes, is an exempt polymer, or any other type of substance eHgible for an exemption. If the substance is excluded or qualifies for an exemption, no PMN is required see Procedure Number Reg. Aff. 3, Procedure for the Test Marketing Exemption from PMN and SNUR Requirements, Procedure Number Reg. Aff. 4, Procedure for EVE and LoREX Exemptions from PMN Requirements. 

This Procedure applies to the Test Marketing Exemption (TME)from the PMN and SNUR rules. Use of the PMN form to apply for the TME is optional but encouraged and this Procedure assumes use of the PMN form for that purpose. ... 

Third, the submission must be a full PMN, as opposed to an abbreviated exemption notice. Notices for test market exemptions, low volume exemptions or... 

If a new substance is manufactured or imported for test marketing, the Test Marketing Exemption (TME) specified at 40 CFR 720.38 may apply. The Polymer Exemption may apply under conditions defined at 40 CFR 723.250. 

If the chemical in question is not on the Inventory List, then a Pre-Manufacturing Notice (PMN) must be submitted at least 90 days before commencement of manufacture (TSCA Section 5(a)(1)). PMNs are published in the Federal Register, allowing a time period for anyone with adverse data to comment. These PMN notices are usually purged of Confidential Business information (CBl), sometimes omitting even the name of the petitioner. Essentially equivalent to a PMN is the Test Marketing Exemption (TME) for new chemical entities. 

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