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U.S. EPA settles with Irvine, Calif. company to ensure safe handling of pesticides

Release Date: 05/20/2014
Contact Information: Nahal Mogharabi, 213-244-1815, mogharabi.nahal@epa.gov

“Companies must understand that it is illegal to sell pesticides that have not been registered with the EPA,” said Jared Blumenfeld, EPA’s Regional Administrator for the Pacific Southwest. “Safe handling of pesticide products depends on critical information displayed on their approved labels.”

In 2012, EPA found that the company failed to submit required production reports for a registered pesticide distributed under the brand name “STERRAD Hydrogen Peroxide Cassettes.” Small sealed containers, called cassettes, about the size of a smartphone, containing the active ingredient hydrogen peroxide are inserted into a machine used to sterilize equipment. These cassettes were distributed to laboratories or veterinary clinics without an EPA-approved label and failed to list physical and chemical hazards as required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

The Food and Drug Administration regulates systems used to sterilize “critical” or “semi-critical” medical devices for use in humans. Critical devices, such as surgical forceps, come in contact with blood or tissue, while semi-critical devices, such as endoscopes, contact broken skin or mucus membranes. Products used for the sterilization of other equipment, such as equipment in veterinary clinics and laboratories, are considered pesticides under FIFRA and must be registered and bear labels accepted by EPA.

Advanced Sterilization also sold and distributed “STERRAD Hydrogen Peroxide Boosters,” another sterilization insert, without registering it as a pesticide. In addition to the illegal distributions, and the failure to submit a required production report for 2011, the company filed incomplete and erroneous production reports for 2008-2010. Production reports provide information on company activities including the types and amounts of pesticides in production and distributed. The company has since provided the amended reports to EPA.

Advanced Sterilization Products is a Division of Ethicon, Inc., a subsidiary of Johnson & Johnson Company. The company is no longer selling the cassettes or boosters for pesticidal use.

Under FIFRA, EPA labels should include directions for use and precautionary statements which are designed to minimize the risks associated with the product, including the required use of personal protective equipment such as protective eyewear and gloves, designed to minimize contact with the product. Consumers are required to follow pesticide label directions for proper use and should look for the EPA registration number printed on product labels.

For more information on pesticides, please visit: https://www.epa.gov/pesticides

For more information on FIFRA and its enforcement, please visit: https://www.epa.gov/oecaagct/lfra.html