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Pesticide News Story: EPA Settles with Nation’s Largest Supplier of Hospital Disinfectants

For Release: August 4, 2008

On August 4, EPA Region 2 issued a statement regarding the Agency’s recent settlement with, Lonza Inc., the nation’s largest manufacturer of hospital disinfectants.  Lonza has agreed to develop and implement a nationwide quality assurance program to ensure the effectiveness of the disinfectant products sold by Lonza and its distributors to hospitals and other consumers around the country.

In agreeing to develop and implement this supplemental environmental project (SEP) project, Lonza will evaluate whether or not the companies that formulate its products are doing so safely and legally.  Lonza will inspect the production plants, interview key personnel, and review required documentation.  Only those companies that are found to comply with all regulatory, quality assurance and manufacturing requirements will be permitted to continue to formulate Lonza’s products.  Lonza has until December 2009 to develop and fully implement the SEP.

EPA took this action and Lonza agreed to the SEP because some of the hospital disinfectant products sold by Lonza were not effective when tested by EPA.  They include:  Formula 158 Lemon Disinfectant, Fresh and Clean, and REV.  Formula 158 Lemon Disinfectant and Fresh and Clean did not kill Pseudomonas aeruginosa, and REV did not kill either the Pseudomonas aeruginosa or Staphylococcus aureus, as claimed on the product labels.  Both pathogens can cause infections that can be serious but are generally treatable with antibiotics.

Before any pesticide is sold in the United States, it must go through EPA’s rigorous registration process, dictated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  During this process, companies must provide toxicity, environmental, and other studies and information about the product to ensure that its proper use does not cause any negative human health or environmental effect.  To obtain a registration for a pesticide product making public health claims (e.g., "kills germs," "stops E. coli”), EPA requires specific efficacy data to support the product's public health labeling claims for the patterns of use, and other data to support the product's safety.  The manufacturer is responsible for ensuring that the product will perform according to claims on the label.  EPA also works closely with the manufacturer to make sure the label instructions are as clear as possible.

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