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In Precedent-Setting Case, Maker of "Antibacterial" Hospital Products Settles With EPA; EPA Warns Consumers of Unsubstantiated Germ-Killing Claims

Release Date: 11/09/1998
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(#98153) New York, N.Y. -- Safetec of America, Inc., the Buffalo, New York- based maker of medical products, has agreed to pay a $100,500 penalty for violating the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the U.S. Environmental Protection Agency (EPA) announced today. In 1996 and 1997, Safetec sold four of its products as disinfectants without registering the products as pesticides with EPA as required under FIFRA.

The products -- "Speedy Cleanz," "Yellow Z," "Red Z," and "EZ Cleans Hard Surface Wipes" -- had been marketed to hospitals, medical supply companies, schools, airlines and other companies and organizations as disinfectants, or as fluid absorbents and solidifiers with disinfectant properties. Labels on the products included phrases such as "effective against 35 pathogenic organisms" and "addresses the concerns of blood-borne pathogens while leaving the area clean and fresh." These claims implied that the products killed germs and prevented infection -- claims that can only be made if products are properly tested and registered with EPA, which regulates all products used as pesticides on surfaces.

"EPA hopes that the actions we have taken against Safetec and other companies will stem the recent wave of products making unsubstantiated disinfectant claims," said Jeanne M. Fox, EPA Region 2 Administrator. "Manufacturers and consumers should be aware that unless a product is registered as a pesticide with EPA, it is not formally recognized as effective. People and institutions should not buy products claiming to disinfect surfaces unless an EPA registration number appears on the label."

EPA is concerned that institutions will use unregistered products that make anti-microbial claims in the expectation that they will disinfect or sanitize. If the products failed to disinfect, people could be injured, and the institution might be held responsible. In an effort to greatly reduce this risk to public health, EPA has pursued and will continue to pursue enforcement actions against several other companies for making such claims.

In addition to paying the $100,500 civil penalty, Safetec of America will remove pesticidal claims from labels, literature and information about the fluid absorbers and solidifiers. Safetec will also tell its distributors about the changes, and will remove its name from lists of alternative waste treatment technologies, since these lists include a number of legitimate pesticides and disinfectants.

For more information contact:

Nina Habib Spencer, Press Office
EPA Region 2
290 Broadway
NY, NY 10007-1866
Voice: 212-637-3670 FAX: 212-637-5046 E-Mail: habib.nina@epamail.epa.gov