EPA v. KREMERS URBAN PHARMACEUTICALS INC (ACO)

Case summary

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 25, 2018 guidance, and reclassify as an area source under the NESHAP for Chemical Manufacturing Area Sources at 40 C.F.R. Part 63, Subpart VVVVVV (Subpart VVVVVV). The ACO requires Kremers to comply with all applicable requirements of the Subpart VVVVVV. Specifically, the ACO requires that Kremers: (1) establish potential HAP limits below 10 tons per year (tpy) for a single HAP and 25 tpy of combined HAPs from the facility; (2) accept an emissions limit of methylene chloride from Kremer?s pharmaceutical manufacturing operations of less than 10,000 pounds per year (lbs/yr) based on use. Kremers will assume all methylene chloride used during the regulated batch process is emitted for purposes of calculating compliance with the limit of 10,000 lbs/yr; (3) maintain monthly records of the number of batches of each pharmaceutical manufacturing operations per month and per alternative provided in 40 C.F.R. ? 63.11496(a)(4) monthly records of associated methylene chloride usage to demonstrate compliance with the emissions limit of 10,000 lbs/yr of methylene chloride; (4) comply with the following work practice requirements: using sight, sound and smell, conduct quarterly visual inspections of equipment to check for leaks while equipment is operating in HAP service; and repair any leaks within 15 days of detection of a leak or shutdown equipment until repairs can be completed; (5) submit the required Initial Notification in accordance with the General Provisions of 40 C.F.R. Part 63, Subpart A; (6) prepare and submit a Notice of Compliance Status report in accordance with the requirements in 40 C.F.R. ? 63.11501(b); (7) submit semi-annual compliance reports in accordance with the requirements in 40 C.F.R. ? 63.11501(d); (8) submit a revised Title V permit application to the State of Indiana that includes the provisions in subparagraphs (1)-(7), above, as required permit terms; and (9) submit an annual report that includes the HAP emission for each source, including all underlying information that supports the calculations, for the past year, for the following two years after the effective date of the ACO. The ACO addresses the violations set forth in the Findings of Violation issued to Kremers on June 29, 2017.

Defendants (1)

• KREMERS URBAN PHARMACEUTICALS INCNamed in settlement

Facilities (1)

• KREMERS URBAN PHARMACEUTICALS INC

  1101 C AVE W, SEYMOUR, IN, 47274-3342

  Registry ID: 110000402421

Statutes cited

• CAA 112D — MACT Standards
• CAA 112H — Work Practices
• CAA 112 — Hazardous Air Pollutants

Enforcement conclusions (1)

• KREMERS URBAN PHARMACEUTICALS INC (ACO)entered 2018-12-26

  Primary law: CAA

Timeline (2 milestones)

• 2018-12-26Final Order Issued
• 2019-01-28Enforcement Action Data Entered