Nearly two years after the start of the COVID-19 pandemic, indoor air quality and safety are still common concerns for Americans. In homes and workplaces, the demand for air filters and purifiers is growing rapidly-the U.S. Environmental Protection Agency (EPA or the agency) uses these products as a killer under the Federal Insecticide, Fungicide, and Rodenticide Act. Insect agents are regulated, but there are some exceptions (FIFRA) because they can remove bacteria and viruses in the air. [i] Specifically, the total market for air filters and purifiers in 2020 is 2.9 billion U.S. dollars, and is expected to exceed 4.3 billion U.S. dollars by 2026. [ii] The concern that the EPA has cited is that consumers may be exposed to misleading claims about the efficacy of such products in minimizing exposure to COVID. To this end, the agency issued a notice on its website in April 2021, [iii] announcing that it will use its powers under FIFRA to review product labels and online marketing materials to ensure that devices entering U.S. commerce do not The provisions of Section 2(q)(1)(A) of the labeling regulations will be mislabeled within the scope of its meaning. [iv]
In performing this task, EPA's review is not limited to new claims made directly by product manufacturers in response to the pandemic. Instead, EPA is considering all marketing statements that appear on product labels and labels. For companies whose products have been on the market for a period of time, this means that the agency is functionally reconsidering long-term statements that have passed the EPA review or may not have been noticed in the past. [v] The efficacy statement is considered to be a claim by the EPA that the distribution of filters and purifiers will violate Article 12(a)(1)(E) of FIFRA, which makes it illegal for anyone to distribute or sell mislabeled pesticide products of. Therefore, affected companies with existing products must reassess their marketing.
Types of claims that EPA is reviewing
The denial notices issued by EPA to companies deemed to be in violation of the regulations do not always include a detailed explanation of the alleged defect. However, the EPA seems to generally focus on the following types of claims:
By focusing on such claims, the EPA signals that the industry must be prepared to support all product efficacy claims related to regulated pesticide equipment with hard data. Although the EPA does not describe its current mission as a new policy, its current position is not entirely consistent with its past regulatory posture, and certain obvious tensions will place a considerable burden on regulated industries.
In this regard, EPA insists that the pest capture statement refers to the organism that is the subject of actual efficacy testing, and even applies to filters that capture particles based on their size, regardless of the organic nature of the pest. This breaks past practices. For example, the EPA found that if the company complies with true HEPA filters in its products (that is, it can capture at least 99.97 percent of all particles with a diameter of 0.3 microns). Now, even if these companies can prove the efficacy of HEPA, they are required to express their efficacy claims based on specific organisms that have become the subject of efficacy testing. More generally, this filter can capture 99.97% of bacteria, bacteria, viruses, molds, fungi and other microbial pests with a diameter of 0.3 microns or larger. This precision seems to be excessive a priori, and the EPA has not clearly stated why it is necessary in this case.
Similarly, the EPA requires companies to certify that their air filters and purifiers meet the 99.9% minimum standard before claiming that such products are "effective" to remove specific pests. This 99.9% requirement comes from the EPA's guidelines on antimicrobial surface disinfectants and non-binding recommendations on air disinfectants. [vi] In short, it seems that it is historically based on the agency's declaration of pesticides (such as surface cleaners and aerosols), rather than a pest device.
As these examples show, EPA is delineating regulatory gray space under its new mandate to protect the public from potentially misleading claims. In addition, in line with its long-term policy that the industry has an obligation to determine how to comply with legal requirements, EPA generally refuses to provide acceptable alternative language to correct so-called defect claims. Therefore, the company has to consider whether to make a small number of claims to avoid false brand accusations, conduct additional efficacy tests to support more reliable claims, or reformulate existing claims in a highly technical and detailed manner, which may make consumers Overburdened with information, it may reduce the effectiveness of marketing.
Special difficulties faced by importers
The situation is particularly serious for importers of air filters and purifiers, many of whom have placed orders for these devices months before the EPA initiates a new regulatory review. According to Article 17 of FIFRA, importers of pesticide equipment must submit a notice of arrival to EPA before bringing any goods into the United States, in order to provide the agency with an opportunity to inspect the goods, and EPA has advised Customs and Border Protection (CBP) to refuse imports According to its current authorization, the product is deemed to be mislabeled. As a result, its products have passed inspections in the past, but now importers accused of mislabeling must scramble to take corrective measures within a short period of time, otherwise their products may be subject to Article 17(c)(1). According to this section, once the EPA determines that the equipment is mislabeled and recommends refusal of entry, CBP "will result in the destruction of any ... equipment refusal to deliver, and the consignee shall not export within 90 days from the date of receipt of the refusal notice."
Faced with potential seizure and destruction of goods, importers who are forced to relabel can only choose among potentially unattractive options. Due to the significant increase in transportation costs caused by the pandemic, the cost of returning products to their original place of origin can be prohibitively high. Transporting the product to a different foreign facility closer to the place of origin for relabeling may be an option, but according to FIFRA Section 7 and 40 CFR § 152.200, any facility that requires labeling must have a FIFRA corporate number.
Alternatively, the importer can choose to pay a fine to relabel the product in the U.S. customs zone. Currently, the maximum fine for violating FIFRA is US$20,288 per batch. [vii] Although in practice the EPA may evaluate smaller fines and accept fines, even if they are below the maximum limit, they will damage the company’s reputation and adversely affect any future enforcement actions.
The EPA is taking an aggressive enforcement stance, which reflects its obvious view that when such products are in high demand, the risk of preventing potentially misleading claims is greater than the risk of further interrupting the supply of air filters and purifiers. The agency’s current position is of great significance to both manufacturers and importers, especially since the agency has not restricted its enforcement tasks based on whether a given claim was deemed acceptable in the past. Therefore, given that the EPA may adopt a narrow view of the acceptability of efficacy, manufacturers and importers may wish to carefully review their product claims and reconsider their marketing goals. Pillsbury’s lawyers, including some who have previously worked for EPA, have extensive experience in advising companies on FIFRA supervision, including requirements related to the labeling of pesticide equipment, and can also assist companies in responding to the regulations under the regulations. law enforcement.
[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 microorganisms (except Viruses, bacteria or other microorganisms are on or inside living people or other living animals), and the administrator declares them to be harmful organisms.
[ii] Research and market report: US air purifier market, by filter type (HEPA activated carbon, pre-filter HEPA, HEPA and others (ion and ozone, electrostatic precipitator, etc.), by end use, by distribution channel, by Regions, competition forecasts and opportunities, 2015-2026F (June 2021).
[iii] Will EPA take enforcement actions against companies that falsely claim that their disinfectants can fight SARS-CoV-2 (COVID-19)? | US Environmental Protection Agency
[iv] The Act defines "mislabelling" as, among other things, "a label with any statement, design or graphic representation related to it or its ingredients, which are false in any particular respect Or misleading.” Labels are defined as written, printed, or graphic materials that are physically located on the device or its container or packaging, and labels include other written, printed, or graphic materials that accompany the device or are mentioned in the label or “document”. Graphic materials accompany... equipment. "
[v] Unlike pesticides that must be registered under Article 3 of FIFRA, pesticide equipment does not need to be registered with EPA prior to sale or distribution.
[vi] What do you need to know about products that claim to kill the coronavirus that causes COVID-19 (epa.gov); Office of Chemical Safety and Pollution Prevention (OCSPP) Guidelines, 810.2300: Disinfectants for hard surfaces— —Efficacy data recommendations; OCSPP guideline, 810.2500: Air disinfectants—Efficacy data recommendations.
[vii] 40 CFR § 19.4; EPA, FIFRA law enforcement response policy, see page 10. 16. https://www.epa.gov/sites/default/files/documents/fifra-erp1209.pdf
Disclaimer: Due to the general nature of this update, the information provided here may not be applicable in all situations, and action should not be taken without specific legal advice based on specific circumstances.
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