In implementing this mandate, EPA is not limiting its review to new claims that product manufacturers have made directly in response to the pandemic. Rather, EPA is considering the totality of marketing claims that appear on product labels and labeling. For companies with products that have been on the market for some time, this means that the Agency is functionally reconsidering longstanding statements that passed muster when reviewed by EPA in the past or may have gone unnoticed.^[v] Where efficacy claims are deemed to be deficient, EPA has alleged that the distribution of the filters and purifiers would constitute a violation of FIFRA Section 12(a)(1)(E), which makes it unlawful for any person to distribute or sell a pesticide product that is misbranded. As a result, affected businesses with existing products must re-evaluate their marketing.

Types of Claims That EPA Is Scrutinizing

The notices of refusal issued by EPA to those companies deemed in violations have not always been accompanied by detailed explanations of the alleged deficiencies. However, it seems that EPA is generally focused on the following types of claims:

• Unqualified or generic claims about a purifier or filter’s ability to kill, capture, or otherwise eradicate “germs,” “viruses,” “bacteria” “mold,” or “fungus” without specifying the species of microorganism on which the product has been tested or data on which such claims otherwise are based.
• Claims that fail to distinguish whether efficacy testing was performed on a virus or a virus surrogate.
• Discrepancies between labels and labeling. In particular, EPA has scrutinized discrepancies between product labels and pamphlets included in product containers and information on company websites. The Agency has taken issue with efficacy claims in online materials that are more aggressive than those on the label or the labeling accompanying a product.
• Claims that a given product or device is more effective than competing brands, without specifying the brands in question.

By focusing on such claims, EPA is signaling that industry must be prepared to support, with hard data, all product efficacy claims regarding regulated pesticide devices. Although EPA is not describing its current mandate as a new policy, its present stance is not entirely aligned with its past regulatory posture, and certain apparent tensions stand to impose considerable burdens on the regulated industry.

In this connection, EPA’s insistence that pest capture claims refer to organisms that were the subject of actual efficacy testing applies even to filters that operate to trap particles based on size regardless of the organic nature of the pest. This is a break from past practice, whereby EPA, for example, found no issue with companies that predicated pest capture claims upon their products meeting the definition of a true HEPA filter (i.e., a high-efficiency particulate absorbing filter that traps at least 99.97 percent of all particles that are 0.3 microns in diameter). Now, even if such companies can demonstrate HEPA efficacy, they are being required to couch their efficacy claims in terms of specific organisms that have been the subjects of efficacy testing. More general claims that such filters capture 99.97 percent of germs, bacteria, viruses, mold, fungus, and other microbial pests with a diameter of 0.3 microns or more are being rejected. This degree of precision seems a priori excessive, and EPA has not clearly articulated why it is necessary in such a scenario.

In the same vein, EPA has required that companies demonstrate that their air filters and purifiers meet a minimum standard of 99.9 percent before claiming that such products are “effective” in removing a given a pest. This 99.9 percent requirement derives from EPA guidance regarding anti-microbial surface disinfectants and non-binding recommendations regarding air sanitizers.^[vi] In short, it appears to be a claim historically grounded in the Agency’s regulation of pesticides, such as surface cleaners and aerosol sprays, as opposed to pest devices.

As these examples demonstrate, EPA is staking out the regulatory gray space under its new mandate to protect the public against potentially misleading claims. Moreover, consistent with its longstanding policy that industry bears the obligation of determining how to comply with legal requirements, EPA is generally refusing to provide what alternate language would be acceptable to correct allegedly deficient claims. Consequently, companies are left to consider whether to make scanty claims to avoid allegations of misbranding, to undertake additional efficacy testing to support more robust claims, or, alternatively, to recast existing claims in a highly technical and detailed fashion, which risks overloading consumers with information and, therefore, may make marketing less effective.

Special Difficulties Presented to Importers

The situation is particularly acute for importers of air filters and purifiers, many of whom placed foreign orders for these devices months before EPA’s initiated its new regulatory scrutiny. Under FIFRA Section 17, pesticide device importers must submit Notices of Arrival to EPA before bringing any shipments into the United States to provide the Agency an opportunity to inspect the shipments, and EPA has recommended that Customs and Border Protection (CBP) refuse entry to products that it has deemed to be misbranded under its current mandate. Accordingly, importers whose products have passed scrutiny in the past, but which are now alleged to be misbranded, must scramble to take corrective action within a narrow timeframe or risk having their products destroyed by CBP pursuant to the procedures in Section 17(c)(1). Under that section, once EPA determines that a device is mislabeled and it recommends refusing entry, CBP “shall cause the destruction of any . . . device refused delivery which shall not be exported by the consignee within 90 days from the date of notice of such refusal.”

Faced with potential impoundment and destruction of their shipments, importers who are forced to relabel their devices are left to choose among potentially unappealing options. Returning products to their points of origin may be prohibitively expensive due to significantly increased shipping costs caused by the pandemic. Shipping the products to different foreign facilities that are closer than the point of origin for relabeling may be an option, but any facility where labeling will occur must have a FIFRA establishment number, as required by FIFRA Section 7 and 40 C.F.R. § 152.200.

Alternatively, importers can elect to pay a penalty in order to relabel the products within the customs territory of the U.S. Currently, the maximum penalty for FIFRA violations is $20,288 per shipment.^[vii] Although in practice EPA may assess a smaller penalty, accepting a penalty offer, even one for less than the maximum, can harm a business’s reputation and can have a detrimental effect on any future enforcement actions.

Conclusion

EPA is adopting an aggressive enforcement posture, which reflects its apparent viewpoint that safeguarding against potentially misleading claims outweighs the risks of further disrupting the supply of air filters and purifiers at a time when such products are in high demand. The Agency’s current stance has important implications for both manufacturers and importers, especially since the Agency is not restricting its enforcement mandate based on whether a given claim has been deemed acceptable in the past. Accordingly, manufacturers and importers may wish to closely review their product claims and reconsider their marketing goals in view of the possibility that EPA will adopt a narrow view regarding the acceptability of efficacy. Pillsbury attorneys, including some who have previously worked at EPA, are experienced in advising companies regarding the regulatory aspects of FIFRA, including requirements pertaining to pesticide device labeling, and can also assist businesses in responding to enforcement under this statute.

^{[i] “Pest” is defined as (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator declares to be a pest.}

^{[ii] Research and Markets Report: United States Air Purifier Market, By Filter Type (HEPA + Activated Carbon, Pre-Filter + HEPA, HEPA and Others (Ion & Ozone, Electrostatic Precipitator, etc.), By End Use, By Distribution Channel, By Region, Competition Forecast & Opportunities, 2015–2026F (June 2021).}

^{[iii] Will EPA take enforcement action against companies making false claims that their disinfectants work against SARS-CoV-2 (COVID-19)? | U.S. EPA}

^{[iv] The Act defines “misbranded” as, among other things, “labeling [that] bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular.” Labels are defined as the written, printed, or graphic matter physically located on a device or its containers or wrappers, while labeling encompasses other written, printed, or graphic matter that accompanies a device or which is referred to on the label or “in literature accompanying the . . . device.”}

^{[v] Unlike pesticides, which must be registered pursuant to FIFRA Section 3, pesticide devices are not required to be registered with EPA prior to sale or distribution.}

^{[vi] What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19 (epa.gov); Office of Chemical Safety and Pollution Prevention (OCSPP) Guideline, 810.2300: Sanitizers for Use on Hard Surfaces—Efficacy Data Recommendations; OCSPP Guideline, 810.2500: Air Sanitizers –Efficacy Data Recommendations.}

^{[vii] 40 C.F.R. § 19.4; EPA, FIFRA Enforcement Response Policy at p. 16, https://www.epa.gov/sites/default/files/documents/fifra-erp1209.pdf}