EPA's compliance advisory outlines the key requirements applicable to pesticide devices, including:

• Devices must be produced in an EPA-registered establishment and bear an EPA establishment number.

• Devices may not make claims that are false or misleading, including several categories of claims EPA has determined via notice and comment rulemaking are false or misleading.

• Entities importing devices must ensure that appropriate Notices of Arrival are submitted to Customs in connection with each import.

• States may impose their own requirements, and a number of states require pre-market registration of devices.

However, the compliance advisory does not break new ground, and leaves open a number of significant questions, including:

• The precise demarcation between devices and pesticides, including how novel technologies are classified!万博体育app手机登录咨询不讨论先例或提供附加指导,设备制造商在评价产品是否适当归为设备时应该知道这一点。

• What testing or other steps device manufacturers should take to ensure that their devices are safe.

Given EPA's continued focus on this area, as well as the lack of guidance on several key issues, companies should carefully monitor EPA developments and take affirmative steps to minimize the risk of a potential enforcement action.

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.

For the first time ever, EPA has approved a pesticide making residual antiviral claims under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The approval may be a significant boon in the fight against COVID-19, but it also raises several key questions about EPA's broader approach to combatting the novel coronavirus.

EPA's Historic Approach to Residual Antiviral Products

Products that are sold with antiviral claims must typically be registered as pesticides under Section 3 of FIFRA, which can take 18-24 months.  EPA has historically declined to approve products making residual antiviral claims (i.e., claims that a product remains effective against viruses hours, days, or longer after its application), and during the current pandemic has informed applicants that they must develop their own testing protocol in support of such products.  Development of such testing protocols can be a lengthy and expensive process, with EPA taking a year to review the protocols alone.  Once such a protocol is approved, an applicant would then need to generate efficacy data and submit a registration application.While this process helps ensure that robust efficacy data underlies such registrations, it can also limit innovation and hinder EPA's ability to react rapidly to developments like the COVID-19 pandemic.

The Granted Exemptions & Their Significance

In a shift away from its historic approach, on August 24, EPA issued two public health emergency exemptions to the Texas Department of Agriculture.  The exemptions allow Texas to permit an airline and a orthopedics clinic to use a new surface coating that inactivates coronaviruses like SARS-CoV-2 for up to seven days.  The exemptions last one year.     The exemptions were issued pursuant to Section 18 of FIFRA, which authorizes EPA to grant state and federal agencies emergency exemptions for unregistered uses of pesticides to address emergency conditions.  Section 18 exemptions allow applicant agencies to oversee the limited use of an unregistered pesticide in defined geographic areas for a finite time.  Only federal and state agencies can apply for Section 18 emergency exemptions.

Unanswered Questions

This unprecedented use of emergency exemptions creates more questions than answers about EPA's long-term strategy to combat COVID-19 and its plan for residual disinfectant products, including:

How will EPA evaluate data about a residual antiviral product's efficacy?  Texas submitted data demonstrating the coating's success against an EPA approved surrogate coronavirus and bacteria.  However, EPA has not released a summary of such data, a description of the protocol used to generate the data, or an explanation of the standard by which such data will be measured.  Accordingly, what EPA will require for future applicants remains unclear.

How will this impact EPA's issuance of regular registrations for products making residual antiviral claims?  EPA has also not explained how the efficacy data requirements it applied to this Section 18 emergency exemption differed from those applicable to standard Section 3 registrations, other than to explain that the submitted data for this product do not "qualify for registration under section 3."  What additional research is necessary to qualify this surface coating (or similar products) for registration under Section 3 of FIFRA?  Will registration occur on an accelerated timeline, or will EPA continue granting emergency exemptions until the standard registration process is completed?  EPA has indicated that it will provide information on at least some of these issues "in the coming weeks."

What about treated articles?  This emergency exemption addresses only a surface coating that is designed to be regularly re-applied.  To date, EPA has not addressed what efficacy data might be required for articles treated with antiviral products that are designed to last for months or even years.  Will EPA develop an approach for evaluating and registering such products?  EPA's Science Advisory Board found in June that such products could "have high potential in reducing or eliminating exposure to SARS-CoV-2," and thus should be a "high priority area to investigate."

Partly as a result of a 2016 increase in FIFRA penalties, EPA collected an all-time high of over $7 million in publicly-announced penalties in 2018 to date, far exceeding the equivalent figures of $2 million in 2016 and $774,000 in 2015.  The overall number of enforcement cases also remains consistent with past years.

The Trump EPA's continued emphasis on FIFRA enforcement underscores the need for companies to engage with counsel to ensure compliance with FIFRA and avoid the business disruption, brand damage, and significant penalties that can accompany FIFRA violations.

Recent Trends & Data

Covington's analysis of EPA's enforcement data demonstrates that EPA's settlements for FIFRA violations under the Trump administration, when compared to the previous administration, have continued at a similar pace and a higher dollar amount.  EPA publicized 16 settlements in 2017-2018, totaling over $8.5 million in penalties.  By contrast, in 2015-2016, EPA publicized 21 settlements, for a total penalty amount of $2.7 million.

Part of the reason for this jump in penalties is a 2016 EPA rule implementing the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, which increased the maximum penalty for a single FIFRA violation from $7,500 to $19,446.  EPA considers each sale or shipment of a product to be a separate violation subject to a separate penalty, which can quickly lead to substantial penalty amounts.

Our analysis of EPA's enforcement data also shows that EPA's overall number of FIFRA cases remains relatively constant, as demonstrated in Figure 1 below.  Interestingly, EPA's Region 5, long one of the more active regions for FIFRA enforcement, has significantly increased the volume of its enforcement cases, bringing nearly half of the agency's enforcement cases in 2017-2018, as seen in Figure 2.

Recent EPA Actions

Three recent EPA actions illustrate the broad scope of EPA's return to its core mission of FIFRA enforcement.

In the first case, EPA ordered a company to stop nationwide distribution, transport, and sales of a pesticide that was registered with EPA.  The registered version had been manufactured in the United States, but the company had shifted manufacturing to China without obtaining EPA approval or registering the new manufacturing site, resulting in an improperly registered pesticide.

In the second action, two companies reached a settlement with EPA after a water filtration device manufacturer imported pesticidal products without filing the proper EPA notice of arrival forms needed to import a pesticide.

In the third case, a company settled with EPA after selling electronic cleaning products that claimed to kill germs, but were not registered with EPA.  EPA's inspector identified the product by examining the company's website.  This enforcement action is consistent with a broader EPA trend, particularly in the Midwest (EPA Region 5), of bringing enforcement actions against disinfectants that are not registered with EPA, even though those disinfectants may have been approved by a different federal agency, the FDA.

Ensuring FIFRA Compliance

The FIFRA scheme is complex.  For example, even determining whether a product makes a permissible "cleaning" claim or an impermissible "antimicrobial" claim that requires the product to be registered with EPA can be a tricky task.  Likewise, FIFRA's import requirements and the myriad instances where companies must notify EPA of changes to their FIFRA-registered products involve intricate EPA regulations and guidance.

With EPA inspectors now able to identify violations merely by reviewing a website, proactive efforts to ensure compliance are critical in forestalling enforcement actions.  FIFRA enforcement not only poses the risk of penalties but can result in immense damage to a company's brand.  Particularly in light of EPA's return to its "core mission" of bringing FIFRA enforcement cases, it is critical that companies remain vigilant regarding FIFRA compliance issues.