EPA Speeds Way For New Coronavirus Disinfectants

By Juan Carlos Rodriguez
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Law360 (March 9, 2020, 10:26 PM EDT) -- The U.S. Environmental Protection Agency said Monday that it is speeding up the process to approve manufacturers' claims that their existing disinfectants will kill the new coronavirus.

In an effort to increase the availability of consumer products that can be used to protect against the spreading virus, the EPA said it is activating a special program companies can use to get quicker agency approval to label products as being effective in killing SARS-CoV-2, the virus that causes COVID-19.

According to the EPA, coronaviruses are one of the easiest types of viruses to kill with an appropriate disinfectant used according to directions.

"Today's action will help move disinfectants that are effective against the novel coronavirus to the market more quickly, without diminishing the scope of the review to ensure safety and quality of the product," EPA Administrator Andrew Wheeler said in a statement Monday.

The program allows companies to add "emerging viral pathogens" claims to their already-registered surface disinfectant labels. According to the EPA, companies must describe how their product meets the eligibility criteria for use against one or more categories of viral pathogens and identify the virus or viruses from the existing product label that the company is using to support the emerging pathogen claims.

Under the EPA's program, manufacturers must show the Office of Chemical Safety and Pollution Prevention that their products are effective against viruses harder to kill than the one behind COVID-19. Several products have already been approved, such as Clorox Multi-Surface Cleaner & Bleach and Lysol Clean & Fresh Multi-Surface Cleaner.

The emerging viral pathogen labeling program has been around for some time, said Andrew R. Stewart, counsel at Sidley Austin LLP and a former acting division director in the EPA's Office of Civil Enforcement with experience in matters involving the Federal Insecticide, Fungicide and Rodenticide Act, or FIFRA.

"This is not a brand-new play that EPA is running here," Stewart said. "They have lists [of approved disinfectants] going back that relate to a number of other pathogens, including some other pretty widely known ones that have had these types of outbreaks on cruise ships and the like, such as the norovirus, and even more widely known ones like hepatitis B and C, and HIV."

The EPA said this is the first time the program has been activated since the Obama administration issued the Emerging Viral Pathogens Guidance for Antimicrobial Pesticides in 2016. The guidance was intended to clarify and improve the process by which manufacturers' claims are vetted.

Stewart said even on the accelerated schedule the EPA is operating on, it will still rely on scientific tests to confirm manufacturers' claims.

"This is designed to balance the two goals EPA has here. One is, under the pesticide law, EPA has to ensure that pesticides sold and distributed are safe for the environment and humans. On the other hand, it's got to help deal with emerging pathogens and the implications for public health," he said.

While one part of the agency is vetting new manufacturer claims, Stewart said the enforcement division will be on the lookout for companies that are flouting the law. In the past the EPA watched for problematic products at stores, but he said the advent of online shopping has forced a new approach.

"EPA does a lot of monitoring of internet sales these days," Stewart said. "[Enforcement personnel] can do monitoring of websites to see what products and claims are being made with respect to the coronavirus antimicrobials. And if they see something that's not approved, they could allege the sale or distribution of an unregistered pesticide, or what they call misbranding, which is an improperly labeled product."

The agency said Monday that there are about 30 requests from companies that want to add the emerging viral pathogen claim to their products. The EPA said it can't reveal which companies have requested this expedited review due to confidential business provisions in FIFRA, which governs the program.

The EPA said its normal time frame to review such requests is 90 days, and that it "is working as expeditiously as possible" to review them.

Besides the disinfectant program, the EPA said is monitoring other aspects of the outbreak. The Centers for Disease Control and Prevention says the coronavirus disease is mainly thought to spread between people who are in close contact with one another, and the EPA said it is staying on top of the transmission science to make sure existing regulations for the treatment of public water systems that prevent waterborne pathogens such as viruses from contaminating drinking water are adequate.

In addition, the EPA said it is ready to assist federal, state, tribal and local governments with laboratory support, decontamination approaches and waste management strategies.

"We are in close coordination with all of the government effort to combat the virus," the EPA said.

--Editing by Jill Coffey.

For a reprint of this article, please contact reprints@law360.com.

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