Pfizer pays first fine under new pharmaceutical air rules

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, Connecticut. The company stopped making pharmaceuticals at the plant in January.

The settlement is the first of its type in federal court under Clean Air Act regulations controlling the emissions of hazardous air pollutants from pharmaceutical manufacturing, the U.S. Justice Department and Environmental Protection Agency announced Monday.

The new rules, known as PharmaMACT regulations, impose Maximum Achievable Control Technology, or MACT, standards - industry-specific measures that must be implemented to control hazardous air pollutants in order to prevent harm to human health or the environment.

During its production of pharmaceutical-grade chemicals, Pfizer used substances such as methanol, hydrogen chloride, methylene chloride, MTBE, hexane, toluene, and many others, which are classified by the EPA as hazardous air pollutants under the Clean Air Act.

The alleged violations occurred between October 2002 and December 2005, resulting from a failure of Pfizer`s leak detection and repair program at its Groton plant.

They included a failure to properly conduct pressure tests to identify leaks, repair leaks before start-up, equip open-ended lines with a seal, and document leak tests to establish full compliance with the 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,` said Ronald Tenpas, assistant attorney general for the Justice Department`s Environment and Natural Resources Division.

`We will not wait to enforce the law until after a catastrophe occurs,` he said.

Under the agreement, Pfizer certifies that the violations have been corrected. But the EPA says the violations undermined the agency`s ability to determine compliance, which presented the risk of excess emissions of hazardous air pollutants for leaks that were not timely detected and repaired.

`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,` said Robert Varney, regional administrator of EPA`s New England office.

Pfizer, a publicly traded corporation, with 2007 revenues of $48.4 billion, operates about 80 manufacturing plants worldwide, where it makes healthcare products relating to human and animal health.