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June 25, 2008

Compliance penalty

Pfizer Pays Fine For Air Pollution

Drugmaker resolves charges that it violated federal Clean Air Act

Glenn Hess

Pfizer has agreed to pay a $975,000 civil penalty to resolve allegations that it violated the Clean Air Act at its former manufacturing facility in Groton, Conn.

In a consent decree filed in the U.S. District Court for the District of Connecticut, the Department of Justice (DOJ) says the alleged violations, which occurred between October 2002 and December 2005, resulted from a failure of Pfizer's leak detection and repair program.

DOJ charged that Pfizer failed 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 regulatory requirements.

"This significant penalty should send a strong message to the pharmaceutical industry that they must be diligent in detecting and repairing leaks of hazardous substances," says Assistant Attorney General Ronald J. Tenpas.

During its production of pharmaceutical-grade chemicals, Pfizer used substances such as methanol, hydrogen chloride, and methylene chloride, which are classified by EPA as hazardous air pollutants under the Clean Air Act. The Groton plant ceased pharmaceutical manufacturing in January 2008.

Pfizer says it believes the penalty is excessive based on the nature of the alleged infractions, but it agreed to pay the fine to resolve the matter. "The alleged violations involved record keeping, administrative, and work practice deviations, many of which were self-reported to the agency by Pfizer," according to a statement issued by the company.

"When initially notified of the alleged violations, Pfizer took timely steps to enhance the compliance of its program and ensure that EPA's concerns were addressed," the company says. "Pfizer has no reason to believe, and the government has not asserted, that the alleged deficiencies resulted in any environmental harm."

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