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.
“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.
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. Violations 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.
The consent decree 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.
PharmaMACT regulations impose industry-specific measures that must be implemented to control hazardous air pollutants in order to prevent harm to human health or the environment. The LDAR program sets 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.
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. Pfizer’s Groton facility ceased pharmaceutical manufacturing in January 2008.
“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,” said Ronald J. Tenpas, assistant attorney general for the Justice Department’s environment and natural resources division.
OccupationalHazards.com was unable to reach Pfizer for comment.