Drug maker Pfizer has reached a settlement with the US Justice Department over Clean Air Act Violations that occurred at its pharmaceutical plant in Groton, Conn. The settlement, which includes a $975,000 civil penalty, is the first of its kind involving industry-specific standards for airborne emissions during pharmaceutical manufacturing.
In the original complaint, the government charged that Pfizer failed to properly conduct pressure tests to identify leaks and failed to repair leaks, seal open-ended pipes and document leak tests. The alleged violations took place between October 2002 and December 2005. According to the complaint, these violations presented the risk of excess emissions of hazardous air pollutants from the plant.
Until it closed this past January, the Groton plant produced bulk-pharmaceuticals for Pfizer. The manufacturing involved the use of chemicals, including methanol, hydrogen chloride, methylene chloride, MTBE, hexane, toluene and many others, which are classified by Environmental Protection Agency (EPA) as hazardous air pollutants.
“All facilities that produce hazardous air pollutants must carefully adhere to all provisions of EPA’s Clean Air requirements to ensure that we are taking every necessary step to protect human health and our environment,” Robert Varney, regional administrator of EPA’s New England office, said in a statement.
Under the consent decree filed in U.S. District Court in Connecticut, Pfizer certifies the violations have been corrected. But the violations undermined EPA’s ability to determine compliance, the agency said.
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