Pfizer pays clean air fine
Pharma Compliance Alert, July 2, 2008
Pfizer became the first pharmaceutical company to pay a fine under the PharmaMACT, a 2000 law designed to control the emissions of hazardous air pollutants from pharmaceutical manufacturing operations.
Pfizer agreed to pay a $975,000 civil penalty to resolve allegations it violated the Clean Air Act at its former manufacturing plant in Groton, CT between October 2002 and December 2005, according to a Department of Justice (DOJ) release. Pfizer shut down the plant in January.
During its production of pharmaceutical-grade chemicals, Pfizer used substances such as methanol, hydrogen chloride, methylene chloride, MTBE, hexane, toluene, and many others, classified by the Environmental Protection Agency as hazardous air pollutants. The alleged violations resulted from a failure of Pfizer’s leak detection and repair (LDAR) program.
The specific violations included failure to:
- Properly conduct pressure tests to identify leaks
- Repair leaks before start-up
- Equip open-ended lines with a cap or other seal
- Document leak tests to establish full compliance with the LDAR requirements
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