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Pfizer to Pay $975,000 for Alleged Clean Air Violations at Connecticut Facility
Date:6/23/2008

WASHINGTON, June 23 /PRNewswire-USNewswire/ -- The pharmaceutical company Pfizer Inc. has agreed to pay a $975,000 civil penalty to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Conn., the Justice Department and Environmental Protection Agency (EPA) announced today. Today's settlement is the first of its type in federal court under regulations that are designed to control the emissions of hazardous air pollutants from pharmaceutical manufacturing operations.

The consent decree filed in U.S. District Court in Connecticut settles government claims that Pfizer violated the "National Emission Standards for Pharmaceuticals Production" and the "National Emission Standards for Organic Hazardous Air Pollutants for Equipment Leaks," (PharmaMACT regulations) under the federal Clean Air Act. The PharmaMACT regulations impose "Maximum Achievable Control Technology" (MACT) standards, which are industry-specific measures that must be implemented to control hazardous air pollutants in order to prevent harm to human health or the environment.

The alleged violations, which occurred between October 2002 and December 2005, resulted from a failure of Pfizer's leak detection and repair (LDAR) program at its former manufacturing plant in Groton. Under the PharmaMACT regulations, the LDAR program set forth various equipment, testing and record-keeping requirements to ensure that any leaks of air pollutants from equipment used in the manufacture of pharmaceutical products are timely detected and repaired. The specific violations, associated with the production of bulk pharmaceutical materials, included a failure to properly conduct pressure tests to identify leaks, repair leaks before start-up, equip open-ended lines with a cap or other seal, and document leak tests to establish full compliance with the LDAR requirements.

During its production of pharmaceutical-grade chemicals, Pfizer used substances such as methano
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SOURCE U.S. Department of Justice
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