Hospital Disinfectant Firm Forced to Implement Quality Assurance Program

A recent settlement between the U.S. Environmental Protection Agency and Lonza Inc., the nation's largest manufacturer of hospital disinfectants, has resulted in an unprecedented nationwide quality assurance program that EPA says will ensure that the quality and efficacy of disinfectant products sold to hospitals around the country are up to par. In March 2007, EPA charged Lonza with making false claims about the effectiveness of its products against microbial pests. As a result, the company has agreed to develop and implement a Supplemental Environmental Project (SEP), which EPA says is the first of its kind nationwide.

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. During this process, companies must provide health studies and environmental information about the product to ensure that its proper use does not cause any negative human or environmental effects. It is incumbent upon the manufacturer to ensure that its product lives up to its claims. If EPA decides to register the product, it grants the manufacturer an EPA registration number, which is listed on the product. EPA also works closely with the manufacturer on the label language, to make sure it is clear and as specific as possible about how the product may be used.

In this case, however, some of Lonza's hospital disinfectant products were sold under false pretenses and did not kill pathogens as claimed on the labels, EPA said. Now, in agreeing to develop and implement the SEP, Lonza will evaluate whether or not the companies that formulate its products are doing so safely and legally, and will inspect the plants, interview key personnel, and review required documentation. According to the agreement, only those companies that are found to be in sync with the criteria of regulatory, quality assurance, and manufacturing compliance will be permitted to continue to formulate the company's products. Lonza has until December 2009 to develop and fully implement this project.

For more information about pesticides, their health effects, and how they should be used and disposed of, call the National Pesticide Information Center at 1-800-858-PEST, or visit www.epa.gov/region02/pesticides.

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