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 April 14 expanded its formal relaxation of certain FIFRA requirements for pesticides listed on EPA's "List N" of products expected to be effective against the coronavirus.  This expansion builds on EPA's March 30 iteration of this temporary policy, which this blog previously discussed.

Notably, EPA has found "good cause" to take these actions without notice and comment in light of the pandemic, an issue that was not discussed in its March 30 guidance.  EPA also characterizes these revisions as procedural in nature, and so subject to an exception to notice-and-comment rulemaking under the APA—a rationale that would apply regardless of the pandemic.  5 U.S.C.§553(b)表示EPA首次引用此大流行期间的这些例外,并可能预示未来努力快速修改其规则,如果机构认为有必要的话。值得注意的是,EPA引用这些例外,尽管自己的规则需要通知和评论,不包含这些例外。§152.46.

EPA will allow for commodity active ingredients that are not "similar" to the registered active ingredient because their purity differs to be substituted by notification, so long as (1) the nominal concentration of the active ingredient does not change, and (2) any adjustment in inert ingredients to compensate for the change in purity of the active ingredient is limited to water.  Previously, such changes would require EPA approval of an amended pesticide registration.
• Active Ingredients With Different Purities May Be Substituted for Registered Sources of Active Ingredients By Notification. EPA will allow an active ingredient, including non-commodity active ingredients, to be substituted for a non-similar active ingredient (i.e., the same active ingredient with a different purity), so long as (1) the alternate source is registered, (2) the nominal concentration of the active ingredient does not change, and (3) the only change necessary to the inert ingredients is limited to water.  Previously, such changes would require EPA approval of an amended pesticide registration.
• "Similar" Non-Commodity Active & Inert Ingredients May Be Used By Notification.非通货性活性成分 /simational可用通知替换并立即发布销售活性成分源注册后,已注册企业也可生产N列表农药,只要EPA得到通知,产品可在通知提交后立即发售此前,公司不得不等待EPA批准 。

EPA还暗示,必要时开放提供更多灵活性,指出必须确保“美国人继续获取有效经批准的消毒剂,帮助消除COVID-19扩散”。

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.