King Pharmaceuticals LLC (King) will pay $2.2 million and take measures to comply with the Clean Air Act to resolve alleged violations of the Clean Air Act (CAA) at its pharmaceutical manufacturing facility located in Bristol, Tenn., announced the Department of Justice, the U.S. Environmental Protection Agency (EPA), and the Tennessee Department of Environment and Conservation (TDEC).
From the $2.2 million civil penalty, $1.1 million will be paid to the United States and $1.1 million will be paid to TDEC. From TDEC’s $1.1 million penalty, $650,000 will be applied to a TDEC state project for homeowners. The settlement also 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 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 TDEC state project calls for implementation of a program dedicated to providing financial assistance to low-to-moderate income homeowners in making improvements to residential housing focused on weatherization, insulation and energy efficiency. This project will focus on the reduction of energy usage and decreasing emissions associated with the generation of electricity or use of fossil fuels in home heating. TDEC plans to use existing local programs in the Bristol area to identify and channel assistance to eligible homeowners.
“This settlement will protect public health and the environment by requiring additional hazardous air pollution controls at the pharmaceutical facility in Bristol,” said Robert G. Dreher, Acting Assistant Attorney General for the Justice Department’s Environment and Natural Resources Division. “This significant civil penalty should send a strong signal to the pharmaceutical industry regarding our commitment to enforce PharmaMACT.”
“Upholding the public health benefits of the Clean Air Act is a critical responsibility of EPA,” said Beverly H. Banister, Acting Deputy Regional Administrator of EPA’s Southeastern office. “This settlement will result in better management practices that will ultimately lead to greater protection of public health and the environment for the citizens of Bristol.”
“The Tennessee Department of Environment and Conservation is pleased the proposed settlement could be reached in this litigation to address air emissions and permitting requirements, and that the facility will move forward to meet those requirements,” said TDEC Commissioner Bob Martineau. “Additionally, the state project included in the settlement will promote emission reductions by reducing the energy needs of low-income residents in the area.”
King began pharmaceutical manufacturing operations at the Bristol facility in 1993. King was acquired by Pfizer Inc. in 2011, becoming a wholly owned subsidiary of Pfizer. On May 29, 2013, UPM Pharmaceuticals announced that it will acquire the Bristol facility. The sale of the facility will not affect the injunctive relief required by the settlement. The alleged violations were discovered during a May 2006 inspection and subsequent investigation by EPA and TDEC. The United States and the state of Tennessee jointly brought the complaint.
The Department of Justice filed the complaint and lodged the consent decree contemporaneously on behalf of EPA in the U.S. District Court for the Eastern District of Tennessee today. Notice of the lodging of the consent decree will appear in the Federal Register allowing for a 30-day public comment period before the consent decree can be entered by the court as a final judgment. It is available on the Justice Department website at www.usdoj.gov/enrd/Consent_Decrees.html.