Kelley Green Law Chemical law, emerging contaminants, and regulatory news and insights Thu, 16 Nov 2023 09:45:10 -0500 60 hourly 1 Breaking News: Supreme Court Stays OSHA COVID-19 Vaccination Standard Thu, 13 Jan 2022 16:14:16 -0500 Just about an hour ago, the Supreme Court reinstated a nationwide stay of OSHA’s temporary emergency standard related to COVID-19, including the vaccination/testing requirements that were scheduled to be enforced starting in February. The court, in an unsigned opinion that appears to have been supported by a 6-3 majority (Justices Breyer, Sotomayor and Kagan dissented), held that the challengers to the rule were likely to succeed on the merits of their argument that the rule exceeded OSHA's statutory authority. Critically, the Court asserted that the OSH Act "empowers the Secretary to set workplace safety standards, not broad public health measures." (emphasis original)
Although Congress has indisputably given OSHA the power to regulate occupational dangers, it has not given that agency the power to regulate public health more broadly. Requiring the vaccination of 84 million Americans, selected simply because they work for employers with more than 100 employees, certainly falls in the latter category.
Accordingly, the standard is no longer enforceable and will not be unless and until the Supreme Court lifts the stay.

It is important to note, however, that OSHA enforcement in this area is likely to continue under the guise of the "general duty clause," which requires employers to provide a workplace "free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees." Accordingly, companies need to assess whether they are, in light of OSHA and other public guidance, taking appropriate steps to protect their employees from the virus.

A copy of the Court’s opinion is available here: 21A244 National Federation of Independent Business v. OSHA (01/13/2022) (

EPA Extends Coronavirus Enforcement Against On-Line Sales of Unregistered Disinfectants Fri, 12 Feb 2021 14:31:40 -0500 Earlier this week, EPA issued another "stop sale" order to Amazon directing the company to take steps to prevent the continued sale "of potentially dangerous or ineffective unregistered pesticides and pesticide devices making illegal and misleading claims, including multiple products that claimed to protect against viruses." The February 9th order adds 70 products to the 30 products identified in a prior June 2020 order issued to Amazon (a similar order also was issued to eBay last spring).

Unregistered pesticides in the e-commerce marketplace pose a significant and immediate health risk to consumers, children, pets, and others exposed to the products,” - Ed Kowalski, Director of the EPA Region 10 Enforcement Compliance Assurance Division

The new order extends the agency's aggressive enforcement actions taken in response to the pandemic, and builds on EPA's ongoing efforts, in conjunction with U.S. Customs and Border Protection, to prevent the import and sale of illegal disinfectant products. Over the last year, EPA also has engaged with Amazon and other e-commerce companies in discussions about policing the third-party sale of illegal disinfectants and other pesticide products on their platforms.

In fact, EPA's focus on on-line sales of pesticide products extends well before the pandemic, and the recent order to Amazon is the third pesticide-related "stop sale" order issued to the company in the last three years. Those efforts are among the agency's highest enforcement priorities in light of the continued spread of the SARS-CoV-2 strain of the coronavirus.

Further information, including an agency press release and copies of the Amazon "stop sale" orders, are available on EPA's website.

Biden EPA Continues Aggressive Enforcement Against Disinfectant Products and UV Devices Claiming to Kill Coronavirus Tue, 09 Feb 2021 17:08:37 -0500 One of the few areas of EPA policy continuity between the Biden and Trump eras is the aggressive enforcement attention being paid to products that claim to fight the SARS-CoV-2 coronavirus.

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.
The updated EPA advisory also highlights agency concerns with products improperly claiming long-lasting anti-viral effects (so-called "residual claims" that a product "provides an ongoing antimicrobial effect beyond the initial time of application, ranging from days to weeks to months"). Such claims only are allowed if approved by EPA and "supported by acceptable studies demonstrating satisfactory residual efficacy," consistent with agency guidance issued in October 2020.

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 ....
In addition, on the litigation front, EPA continues to fight two novel challenges to the scope of the agency's enforcement authority. In the first case (Zuru LLC v. EPA), filed in September, the company is challenging EPA's determination that its cleaning wipes are an unregistered pesticide, and blocking its importation, because the wipes contain an active ingredient found in a number of other EPA-registered disinfectants; of website statements made by third party resellers that the wipes are “disinfectants” and “kill germs"; and the product name “‘Bactive’ implies bacterial fighting properties.”

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.

Cleaning Product Enforcement Challenge Highlights Reach of EPA's Antimicrobial Regulatory Authority Fri, 11 Dec 2020 12:51:45 -0500 For years, EPA has asserted broad authority to regulate products that are labeled or marketed with express or implied pesticidal (including antimicrobial) claims. During the current pandemic, that authority has been exercised aggressively, particularly against products, many of which are imported, that claim or suggest effectiveness in fighting coronavirus and other microbes. A novel litigation challenge to one such EPA enforcement action provides a timely reminder of the extensive scope of the authority claimed by the agency under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

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."

While the parties may reach a settlement, the case is worth keeping a close eye on for its potential to shape the scope of EPA's FIFRA authority as applied to cleaning products and other disinfectants/antimicrobials.

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

EPA Establishes New Expedited Approval Pathways for Long-Lasting Residual Antimicrobial Products Wed, 21 Oct 2020 15:06:37 -0400 As part of the agency's ongoing response to the coronavirus pandemic, EPA has issued new interim guidance outlining the path for expedited approval of products that demonstrate the ability to provide durable residual antimicrobial activity of hard surfaces. Specifically, the guidance establishes registration criteria for two new categories of antimicrobial products: (1) "residual disinfectants" (including liquid spray and other surface treatments), and (2) "supplemental residual antimicrobial products" (including paints, coatings and solid surface materials). EPA is seeking to review and approve registrations for these products at least 1-2 months quicker than the usual agency review time.

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:

Although this product DOES NOT meet EPA’s standards for disinfectants, EPA has determined that, when used with an EPA-registered disinfectant, this product can provide some additional protection against [microorganism(s)] for up to X days. This product DOES NOT achieve the same level of efficacy as an EPA-registered disinfectant; it is only intended to provide supplemental protection between routine applications of EPA-registered disinfectants.”

In addition, companies that register these "supplemental" products must prepare and implement a written stewardship plan that addresses their "proper sale ... distribution, and responsible use." EPA notes that "[u]nlike the conventional antimicrobial products, these products represent unique challenges that require timely feedback to ensure proper use and compatibility in combination with current infection control practices." The plan must include the the following elements:

  • Advertising and promotional materials that clearly and consistently include a disclaimer that the product does not meet EPA’s standards for disinfectants and is intended to supplement the use of EPA-registered disinfectants.
  • Outreach to the infection control community;
  • Customer feedback consisting of product issues/concerns, adverse events, compliance challenges/observations, and contraindications/adverse events gathered through quarterly registrant-initiated surveys, customer complaints, and suggestion boards; and
  • Development of a stewardship website.
EPA currently maintains a list of disinfectants that meet EPA's criteria for efficacy against the SARS-CoV-2 virus ("List N"). While approved "supplemental residual antimicrobial products" are not eligible for List N, they will be added to a separate appendix.

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.

EPA Approves First "Long-Lasting Anti-Viral" for Emergency Use to Fight Coronavirus Mon, 24 Aug 2020 14:44:23 -0400 Today, EPA announced that it has issued the first ever emergency use exemption for a "long-lasting" anti-viral coating. The exemption was granted upon request by the state of Texas to permit use of the coating at American Airlines airport facilities and at two orthopedic clinics in the state.

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.

Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to allow for unregistered uses of pesticides to address emergency conditions. Under such an exemption, EPA allows limited use of the pesticide in defined geographic areas for a finite period of time -- up to one year for public health emergencies -- to address "urgent, non-routine" situations. Emergency exemptions may be requested by State or Federal agencies when an emergency condition jeopardizes public health, the environment, or production of agricultural goods, and inadequate tools exist to address the situation. To grant the exemption, EPA evaluates the safety, durability, and efficacy of the product to ensure it remains effective under the proposed conditions of use, even after repeated contact and treatment with cleaning and disinfection products.

In obtaining the exemption, Allied Bioscience also agreed to pursue a traditional registration (under FIFRA Section 3) by submitting additional data to the agency over coming months. If the full registration process is completed, the product would become available for purchase by members of the public.

EPA also announced that it plans to issue soon information to assist companies interested in obtaining a registration for anti-viral surface coatings.

More information on the Section 18 emergency exemption granted to Texas is available here.

Kelley Drye Legal Download - Cleaning Up: Answers To Common Questions About Disinfectant, Germ, and Virus-Killing Claims Thu, 13 Aug 2020 13:39:26 -0400 Since the start of the pandemic, we have been receiving a lot of questions regarding products claiming to kill or otherwise inhibit viruses, bacteria and other germs. Following on from their recent webinar on this same topic (available here…killing-claims/), partner Kristi Wolff and special counsel Joe Green answer some common questions they have been getting.

Click here to listen to the episode.

Upcoming Webinar: Cleaning Up From 2020: Guidance for Disinfectant, Germ and Virus Killing Claims Tue, 28 Jul 2020 11:47:37 -0400
Join us next Wednesday, July 29 for a webinar covering the basics of germ killing and related product claims. Register Here
COVID-19 has brought a proliferation of products claiming to kill or otherwise inhibit viruses, bacteria and other germs. These products, before they can be legally sold, are heavily regulated by the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and sometimes both. Major enforcement actions are pending against companies making illegal claims or selling unregistered products. Meanwhile, the FTC regulates advertising of many sanitizing products and the agency has pursued enforcement on companies that overstate their products’ germ-killing performance. Discussion topics will include:
  • The regulatory landscape: Who regulates what – EPA, FDA and FTC jurisdiction and requirements
  • What can you say and when can you say it
  • Potential liability and enforcement considerations
  • What to do if you receive a warning letter or other enforcement action
Anyone who is currently making or planning to make pesticide products, microbiology laboratory personnel with efficacy testing responsibilities, manufacturers of sanitizing products including lights, retailers of sanitizing products, anyone new to claims or in need of a refresher should join us for this webinar.

Register Here

Also Join other Kelley Drye webinars such as:
Wednesday, July 22 Selling Online: How to Avoid Flattening the Curve of an Uptick in Website Traffic Register Here
COVID-19 has increased the already dizzying amount of online sales, making the applicable marketing requirements increasingly important. These rules affect not just how companies advertise and promote products and services online, but also how they bill and otherwise interact with consumers before, during, and after a transaction.

This webinar will include practical tips to help companies minimize risk of enforcement and litigation and provide practical guidance. Topics include:

  • Endorsers and Influencers
  • Promotions and Pricing
  • Subscription Plans and “Free” Trials
  • Shipping and Delivery
  • Consumer Reviews and the Consumer Review Fairness Act
  • Customer Service Considerations – how timely refunds and responsiveness can help reduce legal risks
Register Here
July 30 California Consumer Privacy Act (CCPA) for Procrastinators: What You Need To Do Now If You Haven’t Done Anything Yet Register Here
The coronavirus pandemic has put many things on hold, but CCPA enforcement is not one of them. The California Attorney General’s enforcement authority kicked in on July 1, 2020, and companies reportedly have begun to receive notices of alleged violation. In addition, several class actions have brought CCPA claims. Although final regulations to implement the CCPA have yet to be approved, compliance cannot wait.

If you’re not yet on the road to CCPA compliance (or would like a refresher), this webinar is for you.

We will cover:

  • Latest CCPA developments
  • Compliance strategies
  • Potential changes to the CCPA if the California Privacy Rights Act (CPRA) ballot initiative passes
Anyone who has not begun their CCPA compliance efforts or thinks they need a refresher should join us for this webinar.

Register Here

Find replays of our webinars and other key resources on the COVID-19 Response Resource Center.

EPA Cautions Consumers About Ozone Generators, UV Lights, and Other Pesticide Devices Making Coronavirus Claims Thu, 04 Jun 2020 09:00:17 -0400 Amid the flurry of products making coronavirus-related claims, some without legal approval or scientific support, one class of products raises unique questions: so-called "pesticide devices," like ozone generators and ultraviolet (UV) lights, which are instruments that claim to control pests -- including viruses and other germs -- through physical or mechanical means. Unlike chemical pesticides, such 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.

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, unlike some existing surface disinfectant products that have data on file with EPA showing effectiveness against similar viruses, are not eligible under the agency's Emerging Pathogens Policy to make claims related to the coronavirus/SARS-CoV-2 or for inclusion on EPA's "List N" of products deemed to be effective against the virus.

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

FDA and FTC Joint Warning Letters Target Amazon Affiliates Making False COVID-19 Claims Wed, 03 Jun 2020 12:29:14 -0400

Originally posted on Ad Law Access By on May 29, 2020

Earlier this week, federal regulators continued their efforts to combat the spread of products featuring allegedly false and misleading claims that products can diagnose, treat, cure, or prevent COVID-19. In warning letters issued to CBD Gaze, Alternavita,, and Careful Cents LLC, the agencies identify the respective recipients as participants in the Amazon Affiliate program. Amazon Affiliates are marketers who earn commissions by promoting products sold on Amazon. The letters state that the products at issue, which include essential oils, grapefruit seed extracts, cod liver oil, and others, feature false treatment and prevention claims such as the following:

  • CBD Gaze: “Find the best CBD Oil to help fight Coronavirus.”
  • Alternavita: “4 Proven Ways To Protect Yourself Against Coronavirus,” you represent that “Everyone is concerned about Coronavirus and looking for ways to protect themselves,” and then state the following:
“Grapefruit Seed Extract If you want a little extra daily protection GSE is a safe antibiotic . . . [Amazon associate link].”
  • “NATURAL REMEDIES FOR CORONAVIRUS. . .There are plenty of things you can do to boost your immune system and fight off any virus including coronavirus. Here are a few!” … “2. Vitamin D . . . This important vitamin plays a crucial role in immune health. Being deficient in Vitamin D can increase your risk of infection. I recommend this brand of Vitamin D [Amazon associates link] and starting at a minimum dose of 5,000 IU.” [from your website]
  • Careful Cents LLC: “How to Boost Your Immune System Naturally With Essential Oils to Fight Coronavirus” you state: “Can you use essential oils to boost your immune system and fight coronavirus? Yes! Essential oils are one of the best tools to strengthen your immune system naturally . . .”
The letters state that the products are unapproved new drugs and misbranded pursuant to the Food Drug and Cosmetic Act. Causing the introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d). The letters also state that “it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.”

What’s the lesson? The difference between these letters and the warning letters that FDA and the FTC issued earlier this year is that these are targeted not to the company making the product or even the retail platform on which they are sold. They were sent to the middleman marketer, who likely does not produce or possess the product, but who is promoting and profiting from its sale. This is consistent with the FTC’s letters to product influencers in other marketing contexts but is a departure from FDA’s typical enforcement approach. Although we have seen FDA pursue retailers (particularly online ones), FDA has not made pursuit of marketing affiliates a priority. Clearly, regulators want affiliate marketers (Amazon or otherwise) to understand that they are not immune from enforcement if they are making aggressive or unsubstantiated health claims.

EPA Issues Consumer Advisory on Products Claiming to Kill Coronavirus Tue, 02 Jun 2020 10:31:38 -0400 Yesterday, EPA issued another in a series of recent advisories aiming to clarify for consumers and companies what they need to know about disinfectant products claiming to kill the coronavirus. EPA is actively investigating the numerous tips and complaints it continues to receive concerning products marketed with possibly false and misleading coronavirus/COVID-19 related claims.
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.
Products that claim to disinfect and kill or otherwise inhibit viruses, bacteria and other germs must be registered with EPA before they can be sold. A disinfectant cannot make legal claims of effectiveness against a particular pathogen, such as SARS-CoV-2, unless EPA has specifically approved the claim as part of the registration process. Registration requires that any claim be supported by valid test data and an EPA determination that the product works as intended and is safe to use.

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.
Consumers are reminded to follow the label directions for approved disinfectants -- particularly regarding the amount of time the product must remain wet on the surface -- to ensure effectiveness in killing the virus. Use of a disinfectant in a manner inconsistent with label directions can pose safety risks, both from contact with the pesticide and from a false belief that the surface has been cleaned of the pathogen.

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:

EPA Scrutinizing On-Line Sale of Anti-Coronavirus Pesticides Thu, 30 Apr 2020 17:23:42 -0400 The U.S. Environmental Protection Agency (EPA) is focusing substantial enforcement attention on the internet sale of pesticide products marketed with anti-viral claims, particularly those with claims related to coronavirus and COVID-19. EPA is scrutinizing on-line listings of pesticide products to identify and take action against products that are unregistered or which bear unapproved claims.

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

EPA Region 9, which oversees the West coast where a number of these products are imported from Asia and elsewhere, is particularly involved in the effort.

“EPA is vigorously investigating fraudulent disinfectant sales to the public via online marketplaces" - John Busterud, EPA Region 9 Administrator
Among other actions, EPA recently has taken several aggressive steps in furtherance of the initiative against illegal pesticide product sales, including:

• Working with U.S. Customs and Border Protection (CBP) to prevent entry of the unregistered product "Virus Shut Out," which was being imported from Japan and Hong Kong through U.S. ports in Honolulu and Guam.

• In coordination with CBP, seizure of "more than 7,800 illegal products" coming through international mail facilities at the main airports in Los Angeles and San Francisco.

• Meeting and working with U.S. retailers and third-party marketplace platforms to discuss imposter disinfectant products and those that falsely claim to be effective against the novel coronavirus.

• With the Department of Justice, arresting and bringing criminal charges against a Georgia resident for the illegal import and sale through eBay of an unregistered pesticide (Virus Shut Out) with allegedly fraudulent anti-viral claims.

Criminal charges are relatively rare in the environmental context, unless there is some truly intentional fraud or egregious misconduct (such as falsifying reports). While the facts of the case are not as yet fully public, and it is possible there is more to the misconduct in the case, criminal charges are a substantial escalation in the EPA response to the sale of unregistered pesticide products.

EPA Expands List of Approved Coronavirus Disinfectants Fri, 27 Mar 2020 11:26:34 -0400 The U.S. Environmental Protection Agency (EPA) continues to expand the number of surface disinfectants approved for use against coronavirus, announcing the addition of 70 new products to the agency's "List N: Disinfectants for Use Against SARS-CoV-2." This brings the total number of products on the list to over 350. A copy of the current list is available here.

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.


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:

Coronavirus: Does My Disinfectant Work Against the COVID-19 Pathogen? Mon, 16 Mar 2020 17:09:54 -0400 With the ongoing spread of the coronavirus, and as stories of hording Purell and antimicrobial wipes abound, this practitioner* has been inundated recently by questions -- from clients, co-workers, family, and friends -- about what products they can use to disinfect their homes and offices to protect against the coronavirus that causes COVID-19. Unfortunately, there is no shortage of unproven remedies being touted on websites and in mass emails, not to mention the rumor mill. (*Remember, I’m a lawyer practicing in the antimicrobial regulatory field, not a medical doctor!)

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.
EPA is now implementing its "emerging pathogen" policy and has issued a list of disinfectants that the agency believes to be effective against SARS-CoV-2 (the formal name of the novel coronavirus that causes COVID-19). The EPA list is available here. (Note 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.)

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.

Hope this is helpful and that everyone stays healthy and well-sanitized!

Coronavirus Activates EPA Emerging Pathogens Rapid Response Thu, 30 Jan 2020 18:07:07 -0500 In response to coronavirus cases now appearing in the U.S., yesterday, EPA announced that the agency has activated its Emerging Viral Pathogens Guidance for Antimicrobial Pesticides (a copy of which can be found here).

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 good news? According to EPA, "coronaviruses are enveloped viruses, meaning they are one of the easiest to kill with the appropriate disinfectant product."

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.