Largest Hospital Disinfectant Maker Must Comply with EPA Standards, Or ElseAug 6, 2008 | Parker Waichman LLP
The Environmental Protection Agency (EPA) feels that “Consumers should never have to second-guess information on product labels” and in a legal settlement between it and the country’s largest hospital disinfectant maker, the EPA won.
In March 2007, Lonza, Inc. was charged by the EPA with making false claims about the efficacy of its disinfectant products' ability to fight microbials. In the settlement, Lonza 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 EPA report. “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.”
The EPA states that, “Before any pesticide is sold in the U.S., 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 health studies and environmental information about the product to ensure that its proper use does not cause any negative human or environmental effects.” The onus is on the manufacturer to ensure that its product meets product claims. It is at the discretion of the EPA to determine if the product will be registered. If so, the EPA will provide an EPA registration number. That number is then listed on the product. The EPA then collaborates with the manufacturer on label language, ensuring language is both clear and specific.
Some of Lonza’s hospital disinfectant products were “sold under false pretenses” says the EPA and include Formula 158 Lemon Disinfectant, Fresh and Clean, and REV. Despite label claims, the Formula 158 product did not kill Pseudomonas Aeruginosa; the REV product did not kill either the Pseudomonas Aeruginosa or Staphylococcus aureus. Aeruginosa and Staphylococcus aureus can cause serious infections and Staphylococcus aureus is the bacteria that has mutated to form the often deadly MRSA—Methillin-Resistant Staphyloccus Aureus—outbreak that is on the rise and occurring worldwide. According to Center of Disease Control and Prevention (CDC) figures for 2005, nearly 19,000 people died in the U.S. from MRSA infections and an additional 94,000 were seriously sickened. Patients surviving MRSA often require amputations to cure the infections.
Lonza’s agreement to implement a Supplemental Environmental Project (SEP)—which must be developed and fully implemented by December 2009—is considered the first of its kind in the United States. The Project’s intent is to “secure significant environmental and public health protection and improvements,” said the EPA. By “agreeing to develop and implement” SEP, Lonza will evaluate if those companies that formulate its products are in legal compliance and meet safety criteria. Lonza will also inspect manufacturing “plants, interview key personnel, and review required documentation,” according to the EPA. Those manufacturers deemed in compliance with regulatory, quality assurance, and manufacturing criteria will be permitted to “formulate Lonza’s products.”