In response to a release of chlorine gas at the facility, EPA conducted an inspection on January 31, 2014. EPA's subsequent evaluation of that release showed the Respondent's response had been appropriate, and there were no violations as a result of the release. However, during and following the inspection, there were indications of possible risk management program violations with respect to processes using other CAA regulated chemicals at the facility. As a result, EPA determined that additional information was needed regarding the regulated chemicals (in addition to chlorine) stored at the facility. The facility used aqueous ammonia and methylamine gas in two processes for the manufacture of pharmaceuticals. After analyzing the inspection results, EPA spoke to and met with facility representatives several times and sent two information requests to the Respondent, one in 2015 and a supplemental one in 2016 regarding compliance with Section 112(r) of the CAA. The results of EPA' s investigation showed violations of the requirements of 40 C.F.R. Part 68 (primarily involving the failure to submit a risk management plan (RMP) to EPA), in that regulated substances, including aqueous ammonia and methylamine gas, were present in processes at the facility in amounts above the regulatory threshold at specific times during the period from 2010 to 2014.
RMP regulated substances are no longer present in processes at the facility above the threshold quantities, so the facility is no