Clean Air Act Enforcement in the Pharmaceutical Industry - Major Pharmaceutical Company to Pay $2.2 Million to EPA to Resolve Violations

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On June 28, 2013, King Pharmaceuticals LLC (“King”) agreed to pay a $2.2 million fine and take measures to comply with the Clean Air Act (CAA) to resolve alleged failures to comply with major source requirements at its pharmaceutical manufacturing facility located in Bristol, Tennessee.

The settlement requires the facility to demonstrate compliance with CAA National Emission Standards for Pharmaceuticals Production (PharmaMACT regulations) and to apply for a Title V permit. The EPA’s PharmaMACT regulations impose “Maximum Achievable Control Technology” (MACT) standards, which are industry-specific measures that must be implemented to control hazardous air pollutants.

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