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April 8 — The Environmental Protection Agency has issued a guidance document clarifying the claims disinfectant makers can and can't make during outbreaks of emerging pathogens.
The guidance is meant to prevent some of the confusion that occurred during the recent Ebola outbreak, when some cleaning industry companies were unsure if they could legally market their products as being effective at killing the virus.
It also creates a way around the EPA's rule preventing companies from making claims that their product can kill a specific microbe without lab studies on that specific microbe. In the case of many new or emerging pathogens, such as Ebola or avian influenza, efficacy tests in a lab could be infeasible or even dangerous.
According to the guidance document, released April 7, companies can market their disinfectant as being able to kill a specific virus if their product has been proven to kill other viruses that are even more difficult to kill.
For example, a company could tout its product as being able to kill the SARS virus, which is relatively easy to disinfect on hard surfaces, if it has been proven effective at killing the norovirus, which is much more resistant to disinfection.
However, the EPA, which regulates antimicrobial disinfectants through its Office of Pesticide Programs, won't allow these efficacy claims to be made on the label of the product. Rather, the claims can only be made in “off-label communications,” such as in technical literature, company websites or on social media.
Chuck Gerba, a microbiologist and virologist at the University of Arizona, said the framework laid out in the guidance document will be a big improvement over what happened during the Ebola outbreak, when the EPA worked in an ad hoc manner with the Centers for Disease Control and Prevention to create a list of approved disinfectant products .
“It’s a good start for the future,” Gerba, who sat on an advisory panel that helped the EPA develop the guidance, told Bloomberg BNA. “Right now, industry is required to test every virus they want to make a claim for. It’s been very frustrating to industry because they feel they have the solutions, but they’re limited to what they can say and recommend.”
Brigid Klein, senior vice president with the Consumer Specialty Products Association, which represents many disinfectant makers, told Bloomberg BNA in an e-mail that her organization is pleased the EPA issued the guidance document but wanted to review its contents more before commenting on it.
The EPA will be accepting public comments on the guidance until May 6 at Regulations.gov under the Docket No. EPA-HQ-OPP-2016-0144.
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A copy of the EPA's emerging pathogen guidance document is available at http://src.bna.com/d0i.
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