Taken together, EPA's recent actions are significant and provide opportunities for companies to develop novel products that could have significant public health benefits. But they also highlight that significant uncertainty remains in this area, which presents risks that companies must carefully navigate to ensure regulatory compliance.
- Residual Antimicrobial Products
EPA's guidance regarding residual antimicrobial products sets out a new framework governing products that seek to make claims of residual efficacy against viruses or bacteria. This is significant: in the wake of the COVID-19 pandemic, the ability to use a product to kill viruses and bacteria on a surface not only at the time of application, but for weeks, months, or even years thereafter, has the potential for significant public health benefits. EPA had provided interim guidance in October 2020, but is now providing more detailed guidance and a test method. EPA's new guidance distinguishes between three categories of residual products: (1) residual disinfectants, (2) antimicrobial surface coatings and films, and (3) fixed/solid surfaces, such as copper, or other impregnated materials.
Residual disinfectants are essentially standard disinfectants demonstrating residual efficacy, and may make claims that they "kill" microbes for up to 24 hours after application.Coatings and films cannot make "kill" claims, and instead must contain disclaimer language, including the statement that the product is not a disinfectant but "can provide some additional protection against microorganism(s)] for up to X days." Fixed/solid surfaces and impregnated materials—for example, a copper door knob—may make claims such as the following: "kills 99.9% of [insert microorganism/s] within 1-2 hours of exposure when used as part of a comprehensive infection control program/protocol."
For second and third categories of products (surface coatings and fixed surfaces), a "stewardship plan" must be included as a condition of registration. The stewardship plan must address "the proper sale (including advertising and promotional materials), distribution, and responsible use of the supplemental residual coatings and antimicrobial surface products." EPA suggests that plans could include elements such as outreach to infection-control specialists regarding product efficacy and appropriate use!万博体育app手机登录development of a website to convey accurate information about the product and to "correct any false or misleading third-party statements or publications," and participating in regular meetings with EPA and others to discuss the product.
In requiring a stewardship plan, EPA is signaling that it intends to closely monitor these products, likely in part out of concerns that end users may view these products as a substitute for standard disinfection and thus not take adequate precautions. By making the registrations conditional on implementation of a stewardship plan, EPA has the ability to cancel the registration in a more streamlined fashion as compared to an unconditional registration.
Accordingly, companies developing products for which a stewardship plan will be required will need to carefully develop and robustly implement their stewardship plan, to mitigate the risk of a potentially abrupt registration cancellation.
Companies interested in developing these types of products, or adding claims to existing products, will need to generate appropriate data and secure registration with EPA (and the states) before making these claims. Applicants may also need to develop and secure EPA approval of test methods if they wish to make differing claims or seek to use products on use-sites not within the scope of EPA's guidance (for example, EPA's guidance for surface coatings and fixed surfaces does not cover porous surfaces). Ultimately, while this guidance provides a significant amount of information regarding these product categories, numerous questions remain about how EPA will implement it.
- Air Sanitization & Indoor Air Quality
The registration of the first product approved to kill both viruses and bacteria in the air (rather than just bacteria) is also significant: EPA has now approved a product that can kill 99.9% of viruses in the air if used as directed, and so there is now an opportunity for pesticides to be developed to directly combat the spread of viruses in the air. That said, significant challenges likely remain in developing products that are both effective and easy to use to treat the air. That is demonstrated by the instructions for the approved product, which may pose some practical issues—they call for closing or covering "all doors, windows, air vents and returns" in the room, spraying for 30 seconds, and then leaving the room for 12 minutes. The instructions also note that there is "no residual effect after room is reopened." Still, this product provides a novel use, and may pave the way for other types of registered pesticides that kill airborne viruses and bacteria.
As to the other category of EPA-regulated products that are intended to kill viruses or bacteria in the air—pesticide devices—EPA has not provided additional guidance. However, on October 5, 2022, EPA's Office of Radiation and Indoor Air requested comment regarding indoor air quality matters, and announced its intent to "promote and advance the widespread adoption of actions that lead to improvements in indoor air quality .... to help mitigate disease transmission (e.g., COVID-19)." Among other issues on which EPA seeks comment are (1) what the federal government can do to help improve "ventilation, filtration, and air cleaning practices to reduce the risk of disease transmission," (2) whether and how to develop a building recognition program relating to "ventilation, filtration, and air cleaning," and (3) "qualitative or quantitative features could be helpful in assessing or describing ventilation, filtration, and air cleaning parameters in a building." Because many of these cleaning and filtering technologies are pesticide devices, stakeholders may want to submit comments to EPA, which are due by December 5, 2022.
The easing of the coronavirus pandemic in the United States, with 67.7% of adults having at least one vaccine shot, provides the Biden Administration's EPA with a unique opportunity to take stock of its pandemic response and consider any potential policy improvements that could be made. This post focuses on two particular issues: (1) EPA's regulation of pesticide devices, including in particular indoor air quality-related devices, and (2) treated articles.
Pesticide Devices
The Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") regulates both pesticide devices and pesticides. Pesticide devices operate by physical or mechanical means, and EPA has concluded that ultraviolet ("UV") lights and various types of air cleaning machines are pesticide devices, if claims to kill microbes or other pests within FIFRA's jurisdiction are made. Under FIFRA, devices are subject to fewer requirements than pesticides—for example, unlike pesticides, devices are not subject to pre-sale review and approval by EPA. Instead, EPA's principal substantive regulation of devices is premised on its authority to take action regarding "misbranded" devices. 7 U.S.C.万博体育app手机登录§ 136j. EPA interprets the misbranding requirement as mandating that a device be safe and effective for its claimed use and that devices not bear any false or misleading labeling—including efficacy claims that are not adequately substantiated.
While EPA requires sellers of devices to not make false or misleading efficacy claims, EPA has provided little guidance to industry regarding what efficacy data or other substantiation is adequate to support such efficacy claims. Indeed, in an April 12, 2021 letter addressing UV lights, EPA declined to provide detail regarding the type of substantiation it believes is appropriate for UV lights, other than to note that "[i]f claims are made against specific pathogens, EPA maintains that testing of the device against those pathogens on the specific substrate (e.g., E.coli on cloth) is necessary to substantiate those claims." Likewise, EPA has cautioned consumers about devices claiming to be effective against SARS-CoV-2, but has not provided guidance on what efficacy substantiation is required for such products.
This lack of guidance is in tension with recommendations by public health authorities that such devices may be important tools to combat the pandemic. For example, the CDC has indicated that upper-room UV light systems "can be used to control SARS-CoV-2 as a useful ventilation tool to consider in reducing the spread of infectious pathogens." Yet an entity marketing such a system would have little guidance as to what type of efficacy data might satisfy EPA, or what data EPA considers necessary to substantiate any given claim.
With the easing of the pandemic, EPA now has an opportunity to consider, in a non-emergency context, whether and how it can provide guidance to both regulated parties and consumers regarding appropriate efficacy claims and substantiation. There may well be significant challenges associated with such guidance, given the different types of devices and the fact that their effectiveness could potentially change depending on the environment in which they are used. Nevertheless, EPA plainly could develop some guidance (e.g., safe harbor specifications, generalized guidance regarding certain efficacy claims and data requirements, efficacy claims it views as impermissible or data it views as unreliable), and nothing prohibits the Agency from doing so after soliciting input from stakeholders via a public notice and comment process.
Treated Articles
Treated articles are products that are treated with an EPA-approved antimicrobial pesticide to kill microbes (e.g., a shower curtain treated to resist mildew). Under longstanding EPA regulations and guidance, claims for such treated articles are limited to claims to protect the article itself. 40 C.F.R.万博体育app手机登录§ 152.25(a), PR Notice 2000-1. Thus, claims to kill disease-causing bacteria or viruses may not be made in connection with treated articles. Instead, to make such claims, an entity must "register the article as a pesticide product," which is a lengthy, complex, and costly process. PR Notice 2000-1. Unlike pesticide devices, this class of products is subject to full-blown regulation under FIFRA.
Based on publicly-available information, EPA has registered few, if any, articles with claims to kill disease-causing bacteria or viruses. One of the few examples emerged earlier this year, when EPA announced that certain copper alloys used in hard surfaces (e.g., a doorknob) was the first such product registered to make antiviral claims. EPA has also provided draft guidance for hard-surface antimicrobial coatings. But for many other types of products, EPA has not developed test protocols or other guidance indicating what sort of data (efficacy, safety etc.) would be adequate.
It is not difficult to imagine the potential utility of such products, both now and in any future pandemic—especially a pandemic where surface transmission is a significant disease vector.manbext网页版For example, treatment of high-contact surfaces (e.g., public transit seats, light switches) could potentially provide significant public-health benefits, assuming efficacy, safety, and durability can be ensured.
To be sure, there may be significant challenges and questions associated with developing such products. But that is all the more reason for EPA to implement a process to work through these issues sooner rather than later.
Conclusion
EPA has played a key role in regulating antimicrobial products throughout the SARS-CoV-2 pandemic, and in expediting a variety of approval processes to provide immediate assistance in combatting the pandemic. Now that the pandemic appears to have abated, EPA could consider giving thought to lessons learned from this pandemic, including how to provide a broader suite of antimicrobial tools to combat the next pandemic, while ensuring that those products are in fact safe and effective for use.
EPA on March 31 provided a formal relaxation of certain FIFRA requirements for pesticides listed on EPA's "List N" of products expected to be effective against the coronavirus. This temporary policy relaxes requirements to receive EPA approval of changes in sources of certain common active ingredients—such as ethanol, hydrogen peroxide, and citric acid—in response to "reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on EPA's List N."
Previously, EPA's PR Notice 98-10 required EPA to receive prior notice of any change in the source of an active ingredient, even if the new source was substantially similar to the previous source. The notification process allowed EPA 30 days to disapprove the modification, and the notifying registrant could not offer the modified product for sale until 60 days elapsed or it received express approval from EPA.
In its new guidance document, EPA has relaxed these requirements for eight specific active ingredients, when used for products included on List N. These active ingredients are commonly-used commodity substances, such as ethanol and hydrogen peroxide. So long as the "substantially similar" requirements of PR Notice 98-10 are satisfied, registrants may sell List N products using alternative sources of active ingredients immediately after providing notice to EPA, even if those ingredients are from an unregistered source, so long as this guidance remains in effect. EPA has indicated it may make further changes to this new policy on an as-needed basis, but will provide at least seven days' notice before terminating the policy.
Registrants will still need to ensure, among other requirements, that (1) the new source has the same certified limits as the original, and (2) that if the new source has an inert ingredient or an impurity of toxicological significance, the new source has the same upper certified limit for that substance.
This guidance marks the second formal relaxation of certain FIFRA requirements in response to the COVID-19 pandemic, after last week's similar relaxation of requirements relating to inert ingredients (which was not limited to List N products). These developments signal that EPA is willing to consider providing flexibilities to registrants due to the "critical need for available disinfectants during the current COVID-19 pandemic," so long as those flexibilities "will not cause any unreasonable adverse effects to human health and the environment."
Finally, EPA has indicated it may consider adopting this approach more broadly going forward. EPA's notice indicates that the agency "may consider a permanent modification to PR-Notice 98-10 with respect to the use of commodity chemicals as sources of active ingredients in pesticide products," after providing notice and an opportunity for public comment.
This aspect of EPA's guidance is consistent with its recent enforcement actions. EPA on March 25 issued its first press release publicizing a FIFRA enforcement action during the coronavirus pandemic, with the agency explaining that it prevented several shipments of an unregistered pesticide that claimed to mitigate viruses from entering the country. In its press release, EPA emphasized that the agency "will not tolerate companies selling illegal disinfectants and making false or misleading public health claims during this pandemic crisis." This enforcement action is likely to be the first of many, given the importance of disinfectant products to combatting the COVID-19 pandemic.
EPA's guidance and enforcement activity underscore the importance of companies continuing to ensure compliance with FIFRA requirements, as well as requirements established by state regulators. Key FIFRA requirements include:
- Ensuring that all products for which pesticidal claims are made, including claims to mitigate viruses, are registered as pesticides with EPA;
- Not deviating from EPA-approved language on the product's label;
- Carefully reviewing all advertising and marketing claims to confirm that they do not "differ substantially" from EPA-approved claims for the product!万博体育app手机登录 评估EPA新病毒病原体政策和产品演化指南EPA建立了一个快速评审过程,即产品已有足够数据时,根据该政策批准产品。