Entities Must Have a Commercial Purpose for Their Activities

Entities Must Have a Commercial Purpose for Their Activities 

PMNs are only required for substances that are manufactured or imported for commercial purposes, which is defined in the regulations to mean to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer or importer. Any amount of manufacture or import, no matter how small, can be for a commercial purpose if it is for commercial distribution, test marketing, product research and development, or use as an intermediate. Byproducts and impurities that have no commercial value are made or imported for a commercial purpose if they are made with or present in a product with commercial value that was made or imported for a commercial advantage, although they may qualify for exemptions from PMN and SNUR requirements. 

Purely academic researchers are not subject to the PMN requirements because the substances they make or import are not made or imported for commercial purposes. However, research that is funded under a contract that anticipates commercialization, or is conducted by a researcher who holds patents or has asserted trade secret rights, is not considered academic.  

As early asl977theEPA had concluded that entities that extracted substances from byproducts were processors and not manufacturers, and were not primarily responsible for listing the extracted substances. 42 Fed. Reg. 64572,64587, comment 55 (Dec. 13,1977). In the final PMN regulations the EPA reversed this by defining manufacturers to include extraction. 40 C.F.R. 720.3(t). 

See the discussion of the research and development exemption from the PMN requirement, infra. 

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