While EPA has long prioritized enforcement of the rules governing antimicrobial products (disinfectants and the like), the current pandemic has elevated that focus substantially, particularly against products that claim or suggest effectiveness in fighting coronavirus and other microbes. Some of the more high-profile actions over the last year have targeted on-line sales of products (often imports) that are not registered with EPA to make antimicrobial claims, as required by the Federal Insecticide Fungicide and Rodenticide Act (FIFRA).

In a January 2021 update to a COVID-related compliance advisory first issued in May 2020, EPA reiterated its aggressive enforcement stance, with an emphasis on internet product sales:

EPA is receiving a steady stream of tips/complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices. These tips and complaints are being actively reviewed and efforts are being made to identify violative products. EPA intends to pursue enforcement against products making false and misleading claims regarding their efficacy against the coronavirus. EPA is particularly concerned with pesticide and pesticide device products sold online on e-commerce platforms that are fraudulent, counterfeit, and/or otherwise ineffective. EPA is also coordinating with the U.S. Department of Justice, U.S. Customs and Border Protection, and other federal partners to bring the full force of the law against those selling or otherwise distributing violative products.

EPA's updated advisory also expands on, and somewhat shifts, the agency's discussion of pesticide "devices" (e.g., UV lights, ozone generators, and other instruments that use physical or mechanical means to control pests, including viruses and other germs) that claim to kill the coronavirus. Unlike chemical pesticides, devices are not required to be registered by EPA and, therefore, are not scrutinized by the agency to ensure they are safe to use or work as intended. [Note that devices must meet other EPA requirements, including being labeled with an “EPA Establishment Number” to identify the facility at which the device was produced, and not being marketed with "false or misleading" claims.] While EPA does not review efficacy data for these products, manufacturers must have on file adequate substantiation for the claims they make. Interestingly, the May 2020 advisory noted that "devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses." This language has been replaced in the January 2021 advisory with a more general reminder that

[M]aking false or misleading labeling claims about the safety or efficacy of a pesticidal devices is prohibited and could result in the issuance of a Stop Sale, Use, or Removal Order and penalties ....

The second case, Tzumi Innovations v. EPA, filed in December, similarly involves objections to EPA's designation of the company's hand wipes (typically for use on the human body and an FDA-regulated product) as an unregistered pesticide and a threatened Stop Sale, Use, Or Removal Order (SSURO). EPA filed a new brief in that case on February 3 asserting that the matter is not ripe for review and, substantively, that the wipes are properly considered pesticides because they are being marketed for use on surfaces.

Both challenges provide a reminder of the extensive scope of EPA's FIFRA authority, including over products that do not explicitly make antimicrobial claims, but imply such effectiveness through other statements or based on the presence of certain active ingredients. For a more detailed discussion, see my prior blog post.

A copy of EPA's updated COVID Compliance Advisory "What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19" is available here.

Zuru, LLC, filed suit in September alleging that EPA incorrectly declared their product, Bactive Heavy Duty Cleaning Wipes, to be an unregistered "pesticide" and blocked its import into the United States. The crux of the case is that Zuru asserts that it does not make any "disinfectant or other pesticidal claims" for the product, which it says is labeled only "as intended for use in heavy duty cleaning of nonporous surfaces to fight the presence of dirt, grease, and common messes."

For several reasons, however, EPA contends that the cleaning wipes are pesticide products regulated under FIFRA. In particular, the agency argues that the wipes fall under EPA's FIFRA authority because they contain an active ingredient (chlorhexidine digluconate) found in a number of other EPA-registered disinfectants. Moreover, while no express pesticidal claims are made on the product packaging, EPA alludes to statements made on-line by third party resellers that the wipes are "disinfectants" and "kill germs." The agency also contends that the very name "'Bactive' implies bacterial fighting properties."

The case, for which EPA earlier this week was granted a 10-week extension to respond, provides compelling lessons for companies that sell cleaning products to keep in mind, including:

(1) The scope of FIFRA is not limited to express pesticidal claims made on the product label or in marketing materials. In determining whether a product is "intended for a pesticidal purpose," EPA will look beyond express claims to examine whether labeling, ingredients, marketing materials, and even the product name imply pesticidal intent.

(2) EPA can regulate a product for which no pesticidal claims are made if it contains a substance that "has no significant commercially valuable use other than as a pesticide." This is the core issue in the Zuru case, in which the company argues that the ingredient at issue also has separate value as a cleaning agent.

(3) Sometimes, an ingredient or product becomes commonly associated with "pesticidal" purposes, such that EPA asserts regulatory authority over it even absent other express or implied pesticidal claims. The classic example, from decades ago, is Avon's Skin So Soft lotion that was not overtly marketed as a pesticide, but became commonly associated in the public mind with mosquito repellency. Third party website testimonials and the statements of product resellers, such as in the Zuru case, may be cited as evidence of pesticidal intent based on public perception.

(4) Product names and logos can be considered to be "pesticidal" claims. This seems to be a major hurdle for Zuru in its case, as the agency asserts regarding the term "Bactive."

The case is Zuru, LLC v. EPA, et al., in the United States District Court for the District of Columbia.

Historically, traditional disinfectant or sanitizer products that receive EPA registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) provide a relatively quick kill of the vast majority of bacteria, viruses or other microbes on the surface at the time of application, but are subject to immediate recontamination as soon as they are touched. In recent years, a number of products have emerged with the ability to provide more durable antimicrobial activity that lasts beyond the immediate application to the surface. The demand for such long-lasting disinfectants and sanitizers has spiked in recent months in light of the pandemic.

EPA's new policy responds to this increased demand and is the first-ever guidance that specifically outlines the data requirements for approval of such "residual" antimicrobials. For the new category of "residual disinfectants," products must kill 99.9% of bacteria or 99.999% of viruses within 10 minutes of application and continue providing such efficacy for at least 24 hours.

In contrast, "supplemental residual antimicrobial products" do not meet the quick kill time standard for a "disinfectant" but provide at least a 99.9% microbial reduction within 2 hours, and continue to be effective over weeks, months or years. EPA considers these products to be "supplemental" in that they provide beneficial microbial reductions on the treated surface during the time between routine cleaning and disinfection practices. Products receiving this type of registration must bear the following qualifying language:

In conjunction with the new guidance, EPA also released draft residual efficacy testing protocols, an updated draft testing protocol for evaluating the ability of copper surfaces to kill bacteria, and a draft efficacy protocol for antimicrobial surface coatings.

The new guidance is effective now but subject to amendment after a 60-day comment period, which runs through December 11th. A copy of the guidance is available here.

In granting the exemption, EPA determined that the coating (SurfaceWise2, manufactured by Allied BioScience):

Inactivates viruses and bacteria within two hours of application and continues to work for up to seven days.

Consistent with the agency's Emerging Pathogens Policy (for more details see my prior post), Allied BioScience supported the claims with data demonstrating the coating’s efficacy against a human coronavirus similar to SARS-CoV-2, as well as bacteria. EPA expects products that are effective against other human coronaviruses will also be effective against SARS-CoV-2.

Traditional disinfectants typically work within 10 minutes of application but do not provide residual effectiveness against contamination when touched after cleaning. EPA emphasized that the product is intended to fight viruses that land on a surface between regular cleanings, and that the product is not intended to be a replacement for routine cleaning and disinfection practices. This caveat is akin to similar language provided in EPA registrations granted to antimicrobially active surface materials over the past decade, such as copper alloys surface materials, which are intended to reduce microbial loads between regular cleanings of the surface.

EPA has embarked on a multi-faceted initiative to study the potential for a variety of disinfectant products to provide "long-lasting residual efficacy" and to speed approval of such products.

Accordingly, EPA recently issued an advisory that cautions:

Please note that ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.

Pesticide devices, though not subject to registration, are subject to other EPA requirements. For example, while devices will not have an "EPA Registration Number," they are required to be labeled with an "EPA Establishment Number" to identify the facility at which the device was produced. In particular, any claims made for devices may not be false or misleading, and, therefore, manufacturers should have data on file to substantiate any claims. It is possible, therefore, that a device could be effective against coronavirus, and legally could make such claims, though companies should be prepared to defend the statements. To do so, companies should look carefully at the criteria for claim approval in EPA's Emerging Pathogens Policy.

EPA is actively pursuing enforcement in regard to illegal coronavirus claims, further information on which can be found at https://www.epa.gov/enforcement/covid-19-enforcement-and-compliance-resources.

For some of these products, those claims have not been reviewed or accepted by EPA and, therefore, may present a risk to consumers, and healthcare providers in particular.

Earlier this year, EPA issued a list of disinfectants ("List N") that meet the agency's criteria for use against the coronavirus (SARS-CoV-2, the strain of coronavirus that causes COVID-19). While the surface disinfectant products on List N have not been tested specifically against SARS-CoV-2, they are expected to work against the virus because they demonstrate efficacy against other viruses that are deemed harder-to-kill or another similar strain of coronavirus.

Please note that just because the product label states that it kills “99.5% of viruses,” this does not necessarily mean that it will kill coronavirus.

See my prior post on EPA enforcement activity in this area, as well as a more detailed description of EPA's approval policy for products deemed effective against SARS-CoV-2.

EPA's advisory is available here. List N can be found at: www.epa.gov/ListN.

Last week, the agency issued a press release announcing that it is advising companies that support on-line marketplaces, such as Amazon, "that unscrupulous dealers are using their platforms to sell illegal disinfectant products." In the announcement, EPA Administrator Andrew Wheeler asserted that the agency "takes our responsibility to protect Americans from fraudulent surface disinfectants seriously." Likewise, Susan Bodine, EPA Assistant Administrator for Enforcement and Compliance Assurance (OECA), emphasized that “unregistered disinfectants can put consumers at risk, as they may be ineffective against the virus that causes COVID-19."

“EPA is working hard to stop the sale of these illegal products" - Susan Bodine, OECA

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.

Last February's settlement of an enforcement action against Amazon for the sale of unregistered or misbranded pesticides is seen as a model for future agency actions, as well as a warning to other companies selling pesticides on-line. The settlement included a $1.2 million civil penalty and, perhaps most importantly, the company's agreement to develop an on-line training course (in English, Spanish and Chinese) on pesticide regulations and policies that is now mandatory for all entities selling pesticides on the website. Amazon also implemented a more aggressive monitoring program for illegal pesticides, including a sophisticated computer-based screening system supported by trained staff.

In announcing the Amazon settlement, EPA noted a particular concern that "[n]on-English speaking members of the public are at increased risk from ... pesticides that are illegal in the U.S. but have long been used throughout Asia. These populations’ familiarity with these products make it more likely they will order them from online sources such as Amazon."

Another likely target for on-line sales enforcement is the marketing of antimicrobial "treated articles" with unregistered "public health" claims. "Treated articles" are products that incorporate additives to provide protection against bacteria that cause odors, staining, or degradation of the product itself. Such products must make clear that the antimicrobial treatment does not protect the customer from bacteria or other microbes, and may not make claims, explicit or implied, about protection of human health (“public health claims”). In practice, the line can be fuzzy and companies often cross it (particularly by failing to properly qualify their "product protection" claims).

EPA's final enforcement priority guidance is scheduled for release in June, after a short public comment period after the draft is issued in April. Additional information on EPA's February 2018 settlement with Amazon is available here.