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, Conn., the Justice Department and Environmental Protection Agency (EPA) announced today. Today’s settlement is the first of its type in federal court under regulations that are designed to control the emissions of hazardous air pollutants from pharmaceutical manufacturing operations.
The consent decree filed in U.S. District Court in Connecticut settles government claims that Pfizer violated the “National Emission Standards for Pharmaceuticals Production” and the “National Emission Standards for Organic Hazardous Air Pollutants for Equipment Leaks,” (PharmaMACT regulations) under the federal Clean Air Act. The PharmaMACT regulations impose “Maximum Achievable Control Technology” (MACT) standards, which are industry-specific measures that must be implemented to control hazardous air pollutants in order to prevent harm to human health or the environment.
The alleged violations, which occurred between October 2002 and December 2005, resulted from a failure of Pfizer’s leak detection and repair (LDAR) program at its former manufacturing plant in Groton. Under the PharmaMACT regulations, the LDAR program set forth various equipment, testing and record-keeping requirements to ensure that any leaks of air pollutants from equipment used in the manufacture of pharmaceutical products are timely detected and repaired. 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 start-up, equip open-ended lines with a cap or other seal, and document leak tests to establish full compliance with the LDAR requirements.
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 EPA as hazardous air pollutants under Section 112 of the Clean Air Act.
“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 J. 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. 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.”
“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 W. Varney, regional administrator of EPA’s New England office.
Under the agreement, Pfizer certifies that the violations have been corrected. However, the violations undermined EPA’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. The Groton facility itself ceased pharmaceutical manufacturing in January 2008.
Pfizer, a publicly traded corporation, incorporated in Delaware, operates about 80 manufacturing plants worldwide where it makes healthcare products relating to human and animal health.
Category: Safety News