Keep in mind that List N only includes surface disinfectant products, such as sprays and aerosols. Many other effective disinfection products, including hand sanitizers and body wipes, are regulated by the U.S. Food and Drug Administration (FDA) and do not appear on EPA's list. These FDA-regulated products typically will not include EPA registration information on the product label, as discussed in my post from last week: Coronavirus: Does My Disinfectant Work Against the COVID-19 Pathogen?.

EPA is moving rapidly to expand the number of disinfectant products allowed to make claims of effectiveness against coronavirus under the agency's "emerging pathogens" policy (for more information on the policy, see my prior blog post). While the policy sets a 90-day period for EPA to review requests to add claims against "emerging pathogens" like coronavirus, the agency said yesterday that it has been able, in many cases, to grant approvals within 14 days. The policy, and such expedited review, is premised on the products already having data showing anti-viral efficacy on file with EPA.

In addition, EPA is now allowing companies to source certain "commodity inert ingredients" from different suppliers without first obtaining agency approval. These inactive ingredients, such as sodium chloride and glucose, can readily be obtained from a large number of suppliers without meaningful difference in composition. Typically, companies may only use ingredients from the specific sources identified in the product registration application. Given potential shortages in the supply chain, this added flexibility will help minimize potential disruptions in the production of disinfection products, as well as ease the registration requirements for new products.

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Please see the Kelley Drye COVID-19-Response Resource Center website for daily and up-to-date information about the potential legal and business implications of the evolving pandemic: https://www.kelleydrye.com/Our-Practices/Hot-Topics/COVID-19-Response-Resource-Center.

The good news: According to the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC), coronaviruses are among the class of viruses that are the most easy for many disinfectant products to kill. EPA's "emerging pathogens" policy (more details of which can be found here in my prior blog post) establishes a three-tiered hierarchy of viruses according to how resistant they are to being killed (or "inactivated") by typical disinfectant products. "Enveloped viruses," such as the coronavirus, are in the third tier, meaning that they "are the least resistant to inactivation by disinfection."

The structure of these viruses includes a lipid envelope, which is easily compromised by most disinfectants. Once the lipid envelope is damaged, the integrity of the virus is compromised, thereby neutralizing its infectivity.

Typically, to be registered for use against a specific bacteria or virus, disinfecting/antimicrobial products must submit to EPA test data showing that the product is effective against that particular microbe. EPA's "emerging pathogens" policy was established to allow for the legal use of disinfectants against a novel virus for which no product would as yet have EPA approval and for which test data and methods may not exist. The policy recognizes that a disinfectant that is effective against viruses in the same family as the novel virus, or which are effective against "harder to kill" viruses under the three-tier hierarchy noted above, should be effective against the new pathogen.

So, as a consumer, how does one know if a particular disinfectant for sale at the store (or, perhaps more likely in these quarantine days, for sale on-line) is likely to be effective against SARS-CoV-2? Here are a few things to look for:

(1) Any legal disinfectant product must have an EPA registration number on the product label. Look for "EPA Reg. No." (followed by a series of numbers) in the fine print on the product label, usually near where other manufacturer or distributor information is provided. (Of course, not all registered disinfectants will be effective against the novel coronavirus, but to be legal it must at least have an EPA registration.)

(2) Check to see if that EPA Reg. No. is on the EPA list noted above. However, as EPA is still working through submissions to include specific products on that list, there are others out there that may be effective, but just have not finished the expedited approval process for making coronavirus claims.

(3) Look for "coronavirus" in the list of microbes against which the product has been tested to be effective, as specified on the product label. While no product labels as yet will state effectiveness against the SARS-CoV-2 novel coronavirus, they may have been tested for effectiveness against other coronaviruses (such as SARS and MERS).

(4) While on-product labels are not allowed to carry "emerging pathogen" claims, EPA's policy allows registrants who meet certain criteria to provide information about effectiveness against an emerging pathogen on a product website, in social media, and in communications with health care professionals. If the policy criteria are met, these products can include on such platforms a statement similar to the following:

Product X has demonstrated effectiveness against viruses similar to SARS-CoV-2/the novel coronavirus on hard surfaces. Therefore, Product X can be used against the novel coronavirus when used in accordance with the directions for use against [name of similar supporting virus(es)] on hard surfaces. Refer to the CDC website for additional information.

The voluntary guidance, issued in August 2016, details a process by which companies holding current EPA registrations under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) for certain disinfectant products can promote those products for use against "emerging pathogens," like the coronavirus.

Typically, to be registered for use against a specific bacteria or virus, disinfecting/antimicrobial products must submit to EPA test data showing that the product is effective against that particular microbe. EPA's "emerging pathogens" policy was established to allow for the legal "off-label" use of disinfectants against a novel virus for which no product would as yet have EPA approval and for which test data and methods likely do not exist.

Many of the emerging pathogens of greatest concern are pathogenic viruses, and the ability of some of these viruses to persist on environmental surfaces can play a role in human disease transmission.

- EPA Office of Pesticide Programs, "Update: Coronavirus Cases Trigger EPA Rapid Response" (Jan. 29, 2020)

The guidance establishes a two-step process by which existing registrants first submit a request to EPA for a label amendment adding to their registration a statement of effectiveness against emerging viral pathogens. This may (and, ideally, should) be done prior to an outbreak. If the product meets the eligibility criteria, the agency generally will approve the amendment. Then, in the second stage of the process, when an outbreak of an emerging pathogen occurs, registrants of products with the "emerging pathogen" label amendment may then communicate to the health care community and public that their product may be used against the newly emerged pathogen.

Registrants with such a "pre-qualified emerging viral pathogen designation" can include a statement regarding efficacy against an emerging pathogen "in technical literature distributed to health care facilities, physicians, nurses, public health officials, non-label-related websites, consumer information services, and social media sites."

EPA's emerging pathogens guidance is only triggered after the Centers for Disease Control and Prevention (CDC) "has identified the emerging pathogen and recommended environmental surface disinfection to help control its spread." EPA implements the policy in close coordination with the CDC and reportedly the two agencies are closely monitoring developments with the coronavirus: "Based on what we know right now, the immediate risk to America is low."

More information on the coronavirus is available from the CDC.