"We will not wait to enforce the law until after a catastrophe occurs," said Ronald J. Tenpas, assistant attorney general for the Justice Department's Environment and Natural Resources Division.
"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," he said.
Pfizer officials released a statement saying that although the company believes the penalty sought by the government was not commensurate with the nature of the alleged violations, it agreed to pay the penalty 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," the company said.
"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," the company said. "Pfizer has no reason to believe, and the government has not asserted, that the alleged deficiencies resulted in any environmental harm."
Officials said the alleged violations occurred between October 2002 and December 2005 and resulted from a failure of Pfizer's leak detection and repair program.
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 startup, equip open-ended lines with a cap or other seal and document leak tests to establish full compliance with the requirements, officials said.
Pfizer certifies in the agreement that the violations have been corrected. But officials said the violations undermined EPA's ability to determine compliance, which presented the risk of excess emissions of hazardous air pollutants from leaks that were not timely detected and repaired.
The Groton facility ceased pharmaceutical manufacturing in January.
A message seeking comment was left with Pfizer.
During its production of pharmaceutical-grade chemicals, Pfizer used substances such as methanol, hydrogen chloride, methylene chloride, MTBE, hexane, toluene and others that the EPA classifies as hazardous air pollutants.
Pfizer, a publicly traded corporation, operates about 80 manufacturing plants worldwide where it makes health care products relating to human and animal health.
