Respondent is the owner and/or operator of a pharmaceutical manufacturing facility which uses ammonia (conc. 20% or greater) ("aqueous ammonia") and methylamine gas in two (2) processes for the manufacture of pharmaceuticals. EPA conducted an inspection of the Facility on or about January 31 , 2014 to assess compliance with 40 C.F.R. Part 68. Respondent subsequently sent a letter dated October 19, 2015 to EPA which provided updated information about the quantities of aqueous ammonia and methylamine at the facility from 2012-2015. Respondent did not submit an RMP to EPA.

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