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.
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. § 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 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. § 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. 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.
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.