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Feds Accuse Teva of Polluting Missouri

ST. LOUIS (CN) - A Teva Pharmaceuticals plant polluted Missouri's air and water with hazardous wastes, the United States claims in Federal Court.

Missouri also sued Teva, alleging a slew of environmental violations at its plant in Mexico, Mo. Teva makes antibiotics and other drugs and operates a wastewater treatment plant in Mexico, 130 miles northwest of St. Louis

The state and federal governments accuse Teva of violating the Clean Air Act, the Missouri Air Conservation Law, the Clean Water Act, the Missouri Clean Water Law, the Resource Conservation and Recovery Act and the Missouri Hazardous Waste Management Law..

"Teva was required to manage the affected wastewater streams by reducing total HAPs [hazardous air pollutants] by at least 95 percent," the complaint states.

"Teva made a faulty determination that its wastewater treatment plant was achieving the required 95 percent HAP destruction efficiency. In fact, Teva's actual HAP destruction efficiency was well below the required 95 percent. Therefore, between at least February 2004 and June 2010, Teva violated Subpart GGG both by failing to control HAPs in its wastewater and by failing to properly calculate the destruction efficiency of its treatment plant."

Teva is accused of failing to monitor its emissions properly, among other things.

"In at least June 2007, Teva failed to cap open ended lines subject to the LDAR [lead detection and repair] requirements," the complaint states. "Specifically, 40 C.F.R. § 63.1255(d) requires that '[e]ach open-ended valve or line shall be equipped with a cap, blind flange, plug, or a second valve.' This cap, blind flange, plug, or second valve 'shall seal the open end at all times except during operations requiring process fluid flow through the open-ended valve or line, or during maintenance or repair.' In June 2007, EPA inspectors observed approximately 20 open-ended lines not equipped with a cap, blind flange, plug, or second valve.

"Teva is required to identify all equipment valves, connectors, instrumentation systems, and other specified equipment that are intended to operate in organic hazardous air pollutant service for 300 hours or more during the calendar year within an affected source. 40 C.F.R. § 63.1255(a)(7). To comply with this requirement, Teva must ensure that the equipment 'can be distinguished readily from equipment that' is not subject to the LDAR requirements. During the 2007 inspection, EPA determined that Teva had failed to adequately identify approximately 35 pieces of equipment that were subject to the requirements and identified approximately 20 pieces of equipment that were not physically present at Teva's Mexico Facility. Teva also failed to monitor that the 35 pieces equipment omitted from its drawings for leaks as required by the regulations.

"The regulations at 40 C.F.R. § 63.1255(c)(5)(iv) state that each pump with a dual

mechanical system that includes a barrier fluid system is exempt from LDAR monitoring requirements if, inter alia, the pump is checked by visual inspection each calendar week for indications of liquids dripping from the pump seal. 40 C.F.R. § 63.1255(g)(3) requires that the weekly visual inspection be documented and that Teva maintain the documentation for a period of two years. At the time of EPA's inspection in 2007, TEVA did not have any records of their visual inspection of at least pumps P-617 and P-606.

"Teva also failed to identify and monitor approximately 250 components from the

regenerative thermal oxidizer (RTO) in the LDAR program from at least April 5, 2004, until December 12, 2006. TEVA stated in its January 30, 2007, Periodic Report that it failed to include 250 components associated with the RTO system collection headers in its LDAR monitoring program. TEVA did not monitor these components until December 12, 2006. Two pieces of equipment were found to be leaking during the first LDAR monitoring event.

"Further, in 2006 and 2007, Teva located approximately 13 leaking valves, but

failed to complete the repairs as required by the regulations. Under 40 C.F.R. § 63.1251, 'repaired' means that: 1) the equipment is adjusted/altered to eliminate the leak, and; 2) unless otherwise specified in § 63.1255, monitored to verify that emissions are below the appropriate leak definition. In order to satisfy the second prong of the 'repaired' definition, 40 C.F.R. § 63.1255(e)(7)(iii) requires TEVA to monitor leaking valves within 3 months of repair. A review of TEVA's LDAR monitoring database revealed that TEVA failed to monitor repaired valves within 3 months of repair. TEVA recorded the date that the valve was leaking and also recorded the date the valve was repaired below the applicable leak definition. However, TEVA failed to monitor at least 7 valves within 3 months of the repair date. Accordingly, those valves were not 'repaired' as required by the regulations.

"From at least October 21, 2002, to at least June 15, 2007, TEVA failed to monitor

'difficult to monitor valves' at the required frequency. Pursuant to 40 C.F.R. § 63.1255(f)(3), equipment, including valves, designated as 'difficult to monitor' must have a written plan that requires monitoring of the equipment at least once per calendar year or on the periodic monitoring schedule otherwise applicable to the group of processes in which equipment is located, whichever is less frequent. Teva identified as 'difficult to monitor' valves from a group of processes that were subject to monthly monitoring. Therefore, these valves were required to be monitored on an annual basis. Once TEVA placed valves on the difficult to monitor list, it improperly took them out of its LDAR monitoring program, and monitoring did not occur past that date. As a result, TEVA failed to monitor 11 difficult to monitor valves between January 1, 2004, and approximately September 2008."

The plaintiffs seek an injunction and penalties of $10,000 penalty per day per violation.

Teva, one of the 10 largest pharmaceutical companies in the world, reported $20.3 billion in sales in 2012, according to the company website.

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