Pfizer Pays $975K Fine For Air Pollution

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air-pollutionThe drugmaker agreed to pay the civil penalty to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Connecticut, the same town where Pfizer R&D is headquartered.

Why is this noteworthy? The US Department of Justice says the settlement is the first of its type in federal court under PharmaMACT regulations that are supposed to control the emissions of hazardous air pollutants from pharmaceutical manufacturing operations.

The violations, which occurred between October 2002 and December 2005, were associated with the production of bulk pharmaceutical materials, and 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 leak detection and repair requirements.

“This significant penalty, the first in federal court under the PharmaMACT regulations, should send a strong message to the pharmaceutical industry that they must be diligent in detecting and repairing leaks of hazardous substances” Ronald Tenpas, Assistant Attorney General for the Justice Department’s Environment and Natural Resources Division, says in a statement.

“We will not wait to enforce the law until after a catastrophe occurs. Penalties such as this one compel the industry’s close attention and rigorous implementation of the leak detection requirements to prevent the escape of harmful air pollutants that can endanger the public.”

At some point, the Justice Department will post the consent decree on this page. The Groton facility, by the way, ceased pharmaceutical manufacturing in January.

UPDATE: A Pfizer spokesman writes us with this comment: “Pfizer is paying a civil penalty to settle an August 2006 Administrative Order from US Environmental Protection Agency Region 1 alleging violations of the Pharmaceutical Hazardous Air Pollutant Regulation’s leak detection and repair provisions at its former Groton manufacturing facility. Although Pfizer believes that the penalty sought by the government is not commensurate with the nature of the alleged violations, in order to resolve the matter, Pfizer agreed to pay a civil penalty of $975,000.

“The alleged violations involved recordkeeping, administrative and work practice deviations, many of which were self-reported to the agency by Pfizer. When initially notified of the alleged violations, Pfizer took timely steps to enhance the compliance of its program and ensure that the agency’s concerns were addressed. 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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