Rhode Island sterilization service company fined $1.5 million
Agreement will result in improved air quality in six states

Washington, DC— The Department of Justice and the U.S. Environmental Protection Agency 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, Rhode Island, 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 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.

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 contributes to ground-level ozone (smog). Ozone can irritate people’s respiratory systems and 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. 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.

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, Maryland, Grand Prairie, Texas, San Diego, California, Coventry, Rhode Island, South Plainfield, New Jersey, and Waukegan, Illinois. The violations are thought to have occurred from at least 1998 until 2003. EPA estimates over 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, New Jersey and Sparks, Nevada facilities.

Cosmed’s supplemental environmental projects include reduction of pollution from municipal diesel vehicles through advanced pollution controls and cleaner diesel fuel in Camden, New Jersey, Lake County, Illinois, and San Diego, California. A project in Dallas, Texas, 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.

Urban areas were chosen in light of the disproportionately high air pollution burden that is typically seen 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 violate clean air standards, we must also ensure that they pay to help alleviate the overall problem.”

Cosmed was a provider of contract sterilization services in the U.S., at one point representing almost one-third of the large sterilization facilities (those using more than 10 tons of ethylene oxide per year). The facilities involved provided sterilization services for a 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 in Baltimore, Maryland, Linden, New Jersey, and Sparks, Nevada.

A copy of the consent decree is online at www.usdoj.gov/enrd/pressroom.htm. The proposed consent decree is subject to a 30-day public comment period and final court approval.