Merck & Co., Inc. Settlement

(Washington, DC - September 28, 2011) The U.S. Environmental Protection Agency and the U.S. Department of Justice today announced that Merck & Co. has agreed to pay a $1.5 million civil penalty to settle alleged violations of federal environmental laws at its pharmaceutical manufacturing facilities in Riverside and West Point, Pa.

On this page:

• Overview of Facility
• Background
• Violations
• Health and Environmental Effects
• Injunctive Relief
• Pollutant Reductions
• Civil Penalty
• Comment Period
• Contact

Overview of Facility

Merck & Co., Inc. (Merck) is a global healthcare company Which manufactures pharmaceutical products. This case addresses violations at the Riverside and West Point, Pennsylvania facilities.

Background

EPA conducted a multimedia inspection of the Riverside facility in February 2006 as part of an initiative focused on facilities using methylene chloride. In January 2008, Merck sold Riverside to Cherokee Pharmaceuticals, a wholly-owned subsidiary of PRWT Services, Inc. Merck corrected violations prior to the sale. Merck reacquired the facility in September 2010.

On June 13, 2006, the West Point facility discharged potassium thiocyanate that caused extensive fish kills and resulted in the Philadelphia Water Department temporarily closing its Schuylkill River drinking water intake.

This discharge was the subject of a separate enforcement action that included installation of comprehensive controls at the facility. At the request of the Pennsylvania Department of Environmental Protection, EPA conducted a multimedia inspection in November 2006. All identified violations were corrected during or shortly after the 2006 inspection.

Violations

Merck failed to implement preventive measures as required under several significant federal environmental statutes, thereby compromising the integrity of EPA's regulatory programs.

These violations include, among other things permit violations under the:

• Clean Air Act
• Clean Water Act
• Resource Conservation and Recovery Act
• Stratospheric Ozone Protection Regulations (Ozone Regulations)
• Pharmaceutical Maximum Achievable Control Technology standards (Pharmaceutical MACT)
• Notification requirements under the Emergency Planning and Community Right-To-Know Act and the Comprehensive Environmental Response, Compensation and Liability Act

Overall, these violations resulted from Merck's failure to maintain adequate records and to communicate with federal, state, and/or local governments. While this case does not involve grave environmental damages, Merck failed to take measures that, due to good luck, did not result in a major environmental mishap.

Health and Environmental Effects

Merck's violations did not contribute to adverse health and environmental effects because the violations involved mainly failure to maintain adequate records, rather than harm to the environment.

Injunctive Relief

There is no injunctive relief associated with this case because Merck has corrected all identified noncompliance.

Pollutant Reductions

There are no pollutant reductions associated with this settlement as the majority of violations were record-keeping and were corrected during or shortly after the 2006 inspections.

Civil Penalty

Merck will pay a civil penalty of $1.5 million to the United States within 30 days of the entry of the Stipulation.

Comment Period

The proposed judicial Stipulation, filed in the U.S. District Court for the Middle District of Pennsylvania, is not subject to a comment period.

Contact:

Caroline B.C. Hermann
U.S. EPA
Office of Civil Enforcement
Special Litigation and Projects Division
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(202) 564-2876
Caroline Hermann ([email protected])