Pfizer To Pay Fine for PharmaMACT Violations

Washington, DC (June 23)-Pfizer (New York) has agreed to pay $975,000 in civil penalties to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Connecticut, according to a release by the US Department of Justice (DOJ).

The consent decree filed in the US District Court in Connecticut settles government claims that Pfizer violated the “National Emissions Standards for Pharmaceutical 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 designed to control hazardous air pollutants.

The alleged violations occurred between October 2002 and December 2005, according to DOJ. The violations 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 specifies various equipment, testing, and record-keeping requirements to ensure that any leaks of air pollutants for equipment used in pharmaceutical manufacturing are timely detected and repaired. The specific violations, associated with bulk-pharmaceutical production, included the following: a failure to properly conduct pressure tests to identify leaks; repair leaks before start-up; equip open-ended lines with a cap or seal; and document leak tests to establish full compliance with LDAR programs.

“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 DOJ’s Environment and Natural Resource Division, in a DOJ release.

DOJ specified that during its production of pharmaceutical-grade chemicals, Pfizer used substances such as methanol, hydrogen chloride, methylene chloride, methyl tertiary-butyl ether, hexane, and toluene, which are classified by the Environmental Protection Agency as hazardous air pollutants under the Clean Air Act.

Under the consent decree, Pfizer certified that the alleged violations were corrected. The Groton facility ceased manufacturing in January 2008, according to DOJ.

Read the full text of the consent decree.