An official website of the United States government.

This is not the current EPA website. To navigate to the current EPA website, please go to This website is historical material reflecting the EPA website as it existed on January 19, 2021. This website is no longer updated and links to external websites and some internal pages may not work. More information »

Are pharmaceutical research pilot plants exempt from 311 and 312?

A pharmaceutical research lab contains a pilot plant of its overall operation.  The products manufactured in the pilot plant are not sold, but are distributed to hospitals and other health care facilities for use in continued clinical testing.  Is the pilot plant exempt or must it report its hazardous chemicals under Sections 311 and 312?

In this case, because the pilot plant operation does not manufacture products for sale, the hazardous chemicals would be exempt.  The primary function of the plant is research and testing.