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Searle Pharmaceutical Manufacturer Settles with EPA on Charges It Violated Regs to Prevent Air Releases

Release Date: 05/01/2002
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(#02034) New York, N.Y. -- Puerto Rico-based Searle, Ltd. has settled with the U.S. Environmental Protection Agency (EPA ) on charges it violated federal regulations designed to prevent releases to the air of volatile organic compounds from containers and equipment used to manage hazardous waste. Searle, a subsidiary of the Swiss chemical company Monsanto Enterprises Syrl, has operated a manufacturing plant at State Road 140 Km. 64.4 in Barceloneta, Puerto Rico since 1998. Two inspections and information later provided by the company led the agency to identify the violations, which involved tanks, valves and pumps used to store and transport hazardous waste. Searle will pay $95,000 to settle the case.

“Our regulations were put into place to ensure that companies like Searle do not release toxic chemicals into the environment from their equipment,” said Jane M. Kenny, EPA Regional Administrator. “Volatile organic compounds evaporate into the air very easily, can be harmful to people and play a major role in the formation of smog. It is essential that companies that have these chemicals in their waste follow EPA regulations very carefully to ensure that they don’t escape into our environment.”

As part of its day-to-day pharmaceutical manufacturing processes, Searle produces hazardous waste containing volatile organic compounds (VOCs). Companies like Searle often use a system of pipes to transport the waste around their facilities, and tanks and containers to store the waste before it is treated or disposed of. EPA regulations issued under the Resource Conservation and Recovery Act (RCRA) – the federal law governing how hazardous waste is handled – require that tanks and equipment carrying hazardous waste containing VOCs not allow the chemicals to be released into the air. The violations EPA alleged involved equipment used by Searle to manufacture the active ingredient in an arthritis medication. Specific charges included: not determining the maximum vapor pressure of the hazardous waste in four 2,000-gallon tanks and four 500-gallon tanks before filling them with the waste for the first time; failing to inspect the same four 2,000-gallon tanks annually to ensure that their roofs and closure devices had no defects that could allow hazardous waste to escape; not consistently performing monthly leak detection tests on 773 valves and 32 pumps through which hazardous waste is transported; and not conducting weekly visual inspections of the pumps to ensure that they were not leaking VOC-containing hazardous waste.

The enforcement action against Searle resulted from EPA Region 2's ongoing efforts to inspect large facilities to determine whether they are in compliance with RCRA air emission regulations.

Searle Ltd. has until May 2, 2002 to pay the $95,000 penalty. The company has also agreed to comply with all federal RCRA requirements regarding the management of hazardous wastes containing VOCs.