Lonza Misled Public, Has to Set Up Assurance Program
Through a recent settlement between the U.S. Environmental Protection Agency and Lonza Inc., the nation's largest manufacturer of hospital disinfectants, consumers will know what they are buying.
In March 2007, EPA charged Lonza with making false claims about the effectiveness of its products against microbial pests. As a result, Lonza has agreed to develop and implement an unprecedented nationwide quality assurance program to ensure that the quality and efficacy of the disinfectant products that are sold to hospitals around the country are up to par, according to an Aug. 4 press release.
"When a person uses a disinfectant, she should be able to wholeheartedly trust that that disinfectant is doing what the label claims," said Alan J. Steinberg, regional administrator. "Lonza misled the public, but EPA is turning this situation into a positive by overseeing this quality assurance program and sending a message to others that these deceptive actions will not be tolerated."
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.
However, some of the hospital disinfectant products that Lonza sold under false pretenses were 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 labels. Both pathogens can cause infections that can be serious, but are often treatable with antibiotics.
Lonza's Supplemental Environmental Project (SEP), the first of its kind nationwide, is designed to secure significant environmental and public health protection and improvements. In agreeing to develop and implement this project, Lonza will evaluate whether companies that formulate its products are doing so safely and legally and will inspect the plants, interview key personnel, and review required documentation. 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 Lonza's products. Lonza has until December 2009 to develop and fully implement this project.