- U.S. EPA is continuing to regulate and prevent sham COVID-19 products and devices from entering the market under FIFRA.
- EPA's distinction in regulating pesticide substances versus pesticide devices can cause confusion, but can be addressed if companies take proactive steps to ensure their product's compliance with the requisite legal framework, and self-report when in doubt.
As noted in our prior alerts, available here and here, U.S. EPA has made it a priority during the ongoing COVID-19 pandemic to target sham pesticides and products falsely claiming to prevent infection from COVID-19, using its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).1 Notably, and in addition to regulating pesticide substances, e.g., biocidal and antimicrobial products used on surfaces to kill microbes or viruses—including the novel Coronavirus—as well as hand sanitizers and related products, FIFRA also regulates pesticide "devices." FIFRA defines pesticide "devices" as: “any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than humans and other than bacteria, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides) when sold separately.”2 Put differently, a pesticide device works by physical means (such as electricity, light or mechanics) and does not contain a substance or mixture of substances to perform its intended pesticidal purpose.3
Unlike substances, pesticide devices are not required to be registered by the EPA. As such, neither efficacy claims nor device-safety warranties are reviewed by the EPA. Common examples include purification devices, air purifiers, fly paper, and handheld bug zappers. In fact, some pesticide devices are not regulated by EPA at all. For example, any device that depends more upon the performance of the user than the performance of the device itself to be effective (such as a fly swatter) is not regulated.
Pesticide "Substance" Versus Pesticide "Device"
The use of the terms “substance” and “mixtures of substances” in the definition of pesticide highlights a key distinction between pesticides and devices: If a product contains a substance that is intended to prevent, destroy, repel, or mitigate a pest or constitutes a plant regulator, defoliant, desiccant, or nitrogen stabilizer, then the product is considered to be a pesticide and, in general, will require registration with EPA; in contrast, as noted above, a pesticide device works by more physical means as opposed to containing a pesticide substance or mixture of substances in order to perform its task.
Although pesticide devices have not garnered as much scrutiny from the EPA as their pesticide product counterparts (i.e. pesticide substances and mixtures), pesticide devices are still regulated in that “false or misleading claims” cannot be made about the effectiveness or safety of the devices. For instance, if a manufacturer makes such claims about a device, they must have scientific data to back it up. Regulated devices must also obtain an EPA establishment number.4 This is particularly important in the context of antimicrobial pesticide devices that claim to disinfect, sanitize, and/or sterilize items or ambient air. Because microbial pests are not visible to the naked eye, users generally cannot evaluate the actual performance of the device. Therefore, the device may be "misbranded" if its labeling bears any statement, design, or graphic representation which is false or misleading."5 Distribution or sale of a misbranded device is prohibited under FIFRA.6
Of course, both imported pesticides and devices must always be produced at an EPA-registered establishment, display EPA-required labeling statements, and be accompanied by a Notice of Arrival when entering the United States. Unregistered pesticides may only be imported under limited circumstances specified in EPA’s regulations, and remain subject to EPA’s production, labeling, and notification requirements. EPA has not relaxed these requirements during the pandemic; to the contrary, EPA has emphasized that illegal pesticide imports remain an enforcement priority at this time.
Mitigation of EPA Enforcement Actions Through Self-Disclosure
Without question, EPA’s distinction between pesticide substances and devices has caused confusion in the pesticide community. Because pesticide devices are not registered with EPA and because their efficacy claims are not affirmatively reviewed by the Agency, pesticide-device manufacturers have no means of seeking advance approval for making emerging viral pathogen claims. Indeed, no pesticide devices appear on EPA’s List N.7
Accordingly, companies may be unaware that they are manufacturing a product that is subject to FIFRA, since the sale or distribution of a device that generates a pesticide substance may trigger registration and/or regulatory requirements. In light of this issue, EPA is working to clarify its pesticide device regulatory scheme.
Notwithstanding this confusion, there is hope for companies grappling with the murky distinction: EPA’s self-disclosure system may mitigate potential enforcement actions for manufacturers, importers, distributors and retailers of pesticide products and devices who believe they may have violated FIFRA. EPA’s self-disclosure protocol provides for penalty mitigation or reduction for companies who self-report past noncompliance found through auditing.8
To be eligible for such benefits, companies must meet the following threshold requirements:
- Systematic discovery of the violation through an environmental audit or the implementation of a compliance management system.
- Voluntary discovery of the violation was not detected as a result of a legally required monitoring, sampling or auditing procedure.
- Prompt disclosure in writing to EPA within 21 days of discovery or such shorter time as may be required by law. Discovery occurs when any officer, director, employee or agent of the facility has an objectively reasonable basis for believing that a violation has or may have occurred.
- Independent discovery and disclosure before EPA or another regulator would likely have identified the violation through its own investigation or based on information provided by a third- party.
- Correction and remediation within 60 calendar days, in most cases, from the date of discovery.
- Prevent recurrence of the violation.
- Repeat violations are ineligible, i.e., the specific (or closely related) violations have occurred at the same facility within the past 3 years or those that have occurred as part of a pattern at multiple facilities owned or operated by the same entity within the past 5 years; if the facility has been newly acquired, the existence of a violation prior to acquisition does not trigger the repeat violations exclusion.
- Certain types of violations are ineligible such as those that result in serious actual harm, those that may have presented an imminent and substantial endangerment, and those that violate the specific terms of an administrative or judicial order or consent agreement.
- Cooperation by the disclosing entity is required.
In sum—if past behavior is any indicator—EPA will continue to expedite review of certain products intended for use against COVID-19, while also taking swift enforcement action against potential FIFRA violators, regardless of whether the violations relate to pesticide substances and mixtures, as opposed to pesticide devices. Accordingly, companies would do well to adhere to the regulatory guidelines, and self-report when in doubt.
1 As noted in our prior alert, FIFRA defines a “pesticide” as: (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest; (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant; and (3) any nitrogen stabilizer. (7 U.S.C. § 136, subd. (u).) FIFRA defines a “pest” broadly to include “any insect, rodent, nematode, fungus, weed, or 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 animals).” This broad definition also includes products that kill viruses and microbes.
2 7 U.S.C. § 136, subd. (h).
5 7 U.S.C. § 135, subd. (q)(1)-(2); see also 40 C.F.R. § 156.10 (a)(5) [examples of statements EPA considers to be "misbranded"].
7 List N, available here, is an EPA list of products that meets EPA's criteria for use against SARS-CoV-2, the virus that causes COVID-19.