EPA v. ELI LILLY AND COMPANY

Case summary

Eli Lilly and Company (Lilly) owns and operates a chemical manufacturing facility at 1555 Kentucky Avenue, Indianapolis, Indiana. The U.S. Environmental Protection Agency issued two Findings of Violation to Lilly: 1) On March 21, 2007 for violating the National Emissions Standards for Pharmaceuticals Production at 40 C.F.R. Part 63, Subpart GGG (the Pharma-MACT); the National Emissions Standards for Organic Hazardous Air Pollutants (HAPs) for Equipment Leaks at 40 C.F.R. Part 63, Subpart H; and EPA Reference Method 21 at 40 C.F.R. Part 60, Appendix A (Method 21) by, among other things, failing to identify all equipment subject to the equipment leak standards of the Pharma-MACT such that it can be distinguished readily from equipment that is not subject and to perform Method 21 monitoring correctly on connectors; and 2) On March 25, 2008 for violating the Pharma-MACT by exceeding the Pharma-MACT process-based annual mass limits and failing to block each open-ended line. EPA discovered these violations through an inspection it conducted from June 19-23, 2006 and through a letter from the Indianapolis Office of Environmental Services and Lilly's Title V compliance reports. EPA referred the case to the Department of Justice on September 11, 2007 and filed a judicial complaint on February 24, 2011. Under this Stipulation and Order of Settlement, Lilly must pay a civil penalty of $337,500. No injunctive relief is required because Lilly demonstrated compliance with the process-based annual mass limit exceedances by reducing emissions through process changes. Lilly demonstrated compliance with the equipment leak standards by investing approximately $400,000 to implement a series of actions evaluating and improving identification of subject components since EPA's June 2006 inspection. Also, Lilly performed a root cause analysis in response to the alleged Method 21 violation.

Defendants (1)

• ELI LILLY AND COMPANYNamed in complaintNamed in settlement

Facilities (2)

• ELI LILLY & COMPANY LILLY TECHNOLOGY CENTER

  1555 S HARDING ST, INDIANAPOLIS, IN, 46221-1873

  Registry ID: 110017392819

• ELI LILLY & COMPANY LILLY TECHNOLOGY CENTER

  1555 S HARDING ST, INDIANAPOLIS, IN, 46221-1873

  Registry ID: 110017392819

Statutes cited

• CAA 112D — MACT Standards

Enforcement conclusions (1)

• ELI LILLY AND COMPANYentered 2011-02-25

  Primary law: CAA

  Federal penalty: $337,500

Timeline (7 milestones)

• 2007-09-11Referred To Dept Of Justice
• 2007-09-14Enforcement Action Data Entered
• 2011-02-24Complaint Filed With Court
• 2011-02-25Final Order Entered
• 2011-02-25Demand for Stipulated Penalties
• 2011-02-25Final Order Lodged
• 2011-03-28Enforcement Action Closed