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.
Respondent handled and stored, aqueous ammonia in a process at the Facility in quantities exceeding the threshold quantity.
Respondent handled and stored, methylamine gas in a process at the Facility in quantities exceeding the threshold quantity.
Respondent’s failure to submit an RMP regarding the facility is a violation of the regulations at 40 C.F.R. Part 68.
Respondent’s failure to comply fully with the requirements of 40 C.F.R. Part 68 regarding the facility constitute violations of Section 112(r) of the CAA.
Respondent hereby certifies that the facility does not currently have any processes which have regulated substances above RMP threshold quantities.
Respondent agrees to pay a civil penalty in the total amount of $190,000.
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