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Agreement Will Result In Improved Air Quality In Six States

WASHINGTON, D.C. - The Department of Justice and the U.S. Environmental Protection Agency today announced the first nationwide settlement of a Clean Air Act enforcement action for violations of the federal standards for ethylene oxide emissions from sterilization facilities. The settlement was reached with the Cosmed Group, Inc., (Cosmed), headquartered in Jamestown, R.I., which sterilizes products for the food and medical industries. EPA investigations found violations of ethylene oxide Maximum Achievable Control Technology (MACT) requirements at six of the eight sterilization facilities in Rhode Island, New Jersey, Maryland, Illinois, Texas, and California.

Under the consent decree, lodged today in the U.S. District Court for the District of Rhode Island, Cosmed will pay a $500,000 civil penalty and spend an additional $1 million to perform supplemental environmental projects that will improve air quality in urban areas. Cosmed also will complete environmental audits at all eight of its current and former facilities, and establish an environmental management system that will help ensure that the company fully complies with environmental regulations in the future at its three remaining facilities.

“This case underscores both the importance of enforcement of EPA’s MACT standards to protect the public health and the value of coordinated national environmental enforcement efforts to address widespread violations at multiple facilities owned by the same company,” said Acting Assistant Attorney General Kelly A. Johnson, for the Justice Department’s Environment and Natural Resources Division. “The Department of Justice is committed to taking vigorous, nationwide enforcement action to ensure that companies make compliance with the MACT standards a top priority.”

Ethylene oxide is a probable human carcinogen that may cause serious reproductive harm, irritate the lungs, and damage the liver and kidneys. In addition, as a volatile organic compound, ethylene oxide also contributes to the formation of ground-level ozone (smog). Ozone can irritate people’s respiratory systems, causing coughing and throat irritation. More seriously, exposure to ground level ozone can aggravate asthma and damage lung cells, and may cause permanent lung damage. These effects can be worse in children and people with respiratory ailments such as asthma. Cosmed uses an ethylene oxide gas-based sterilization process at its facilities. EPA regulates these facilities to prevent emissions of unsafe levels of ethylene oxide into the atmosphere from the facilities’ sterilization and aeration chambers.

“Because of the risks associated with exposure to ethylene oxide, it is essential that facilities comply with regulations for this toxic air pollutant,” said Phyllis P. Harris, Principal Deputy Assistant Administrator of EPA’s Office of Enforcement and Compliance Assurance. “Through active oversight and enforcement of these regulations, we are working to ensure that all citizens breathe cleaner air.”

The complaint, filed with the consent decree, alleges that Cosmed violated the MACT standards-part of EPA’s National Emissions Standards for Hazardous Air Pollutants-in failing to install pollution control equipment in a timely manner, failing to measure its ethylene oxide emissions, and failing to submit required reports to EPA for its six facilities in Baltimore, MD; Grand Prairie, TX; San Diego, CA; Coventry, RI; South Plainfield, NJ; and Waukegan, IL. The violations are thought to have occurred from at least 1998 until 2003. EPA estimates that more than 30 tons of excess emissions of ethylene oxide were emitted from the Coventry, South Plainfield and Waukegan facilities combined. No excess emissions were found at the other facilities, and no violations were alleged at the Linden, NJ, and Sparks, NV, facilities.

Cosmed’s supplemental environmental projects include projects to reduce pollution from municipal diesel vehicles through the use of advanced pollution controls and cleaner diesel fuel in the urban areas of Camden, NJ; Lake County, IL; and San Diego, CA. A project in Dallas, TX, will convert gasoline-powered school buses to run on propane, a cleaner burning fuel. Collectively, these projects will eliminate approximately 235 tons of air pollution in their first three years, including some toxic air pollutants that pose serious health concerns. Urban areas were chosen as the locations for these projects in light of the disproportionately high air pollution burden that is typically experienced by populations in urban areas.

“An important part of this settlement is that the company will pay to help ease air pollution in urban neighborhoods, which are those most often damaged by industrial pollution,” U.S. Attorney Robert Clark Corrente said. “As we pursue those who are alleged to have violated clean air standards, we must also ensure that they pay to help alleviate the overall problem.”

Cosmed was a major provider of contract sterilization services in the United States, at one point representing almost one-third of the large sterilization facilities (those using more than 10 tons of ethylene oxide per year) regulated by EPA. The Cosmed facilities involved in this action provided sterilization services for a diverse range of products including medical devices, pharmaceuticals, packaging, cosmetics, seeds, and food ingredients. Cosmed sold its five medical device sterilization facilities to STERIS in January 2005. It continues to own and operate three facilities that provide sterilization for other products in Baltimore, MD; Linden, NJ; and Sparks, NV.

A copy of the consent decree lodged today is available on the Department of Justice website at: http://<>

The proposed consent decree is subject to a 30-day public comment period and final court approval. For more information about the settlement, go to: