Kremers owns and operates a pharmaceutical manufacturing facility in Seymour, Indiana. At its facility, Kremers manufactures liquid, capsule, and tablet forms of specialty generic pharmaceutical drugs. Kremers uses solvents that contain hazardous air pollutants (HAP) for its pharmaceutical manufacturing operations, and therefore it is subject to the requirements of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Pharmaceuticals Production 40 C.F.R. Part 63, Subpart GGG (Subpart GGG).
Specifically, Kremers failed to:
(1) control HAP emissions from process vents from all pharmaceutical manufacturing operation at its facility by having undiluted and uncontrolled emission streams containing greater than 50 parts per million by volume HAP;
(2) implement leak detection and repair monitoring for the application equipment used in the pharmaceutical manufacturing operation at its facility; and
(3) identify all points of determination for wastewater streams that required control.
On January 25, 2018, EPA issued a guidance memorandum withdrawing EPA's once in always in policy for the classification of major sources of HAPs under Section 112 of the Clean Air Act. With the new guidance, sources of HAPs previously classified as major sources may be reclassified as area sources at any time so long as the facility limits its potential to emit below major source thresholds.
In August 2018, Kremers asked to avail itself of EPA's January