The U.S. Environmental Protection Agency (EPA) has historically used its civil enforcement authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to pursue most penalties associated with the distribution and sale of unregistered pesticide products and devices. However, facing unprecedented concerns about potential risks to the American public associated with the use of unregistered, fraudulent, or ineffective disinfectants during the COVID-19 pandemic, EPA appears to be prioritizing its criminal enforcement in this area, as well. Regulated industry and other stakeholders should consider if EPA’s expanded use of its criminal enforcement authority over the last year may augur a deeper shift in the Agency’s approach to FIFRA violations, with potential implications that continue beyond the pandemic itself.
- Anyone in the chain of sale or distribution of an unregistered or misbranded pesticide product may be subject to civil enforcement or, in the case of “knowing” violations, criminal prosecution under FIFRA.
- Citing an “onslaught” of FIFRA violations during the COVID-19 pandemic in 2020, EPA prioritized enforcement against “persons hoping to cash in on the fear of the novel coronavirus by making fraudulent claims that their products or devices kill that virus.”
- According to EPA, in fiscal year 2020 the Agency took 447 FIFRA civil enforcement actions and opened approximately 60 criminal cases related to suspected or confirmed unlawful sales or distributions of unregistered or misbranded pesticides or devices that have made claims of efficacy against SARS-CoV-2. These five dozen criminal cases – although still only a small percentage relative to EPA’s FIFRA civil enforcement activity over the same period – appear to reflect a meaningful spike in the Agency’s use of its FIFRA criminal enforcement authority in a single year.
Pesticides products must be registered by EPA.
Disinfectant sprays, wipes, and other products that are intended to kill or reduce microbes such as bacteria and viruses on surfaces or objects, or in the air or water, are considered pesticides, and are regulated under FIFRA. Unless otherwise exempted, pesticide products must be registered by EPA before they may be sold or distributed. FIFRA § 3(a)(1)(A). As part of the registration process, applicants must generate data to demonstrate that their products are effective for all claimed uses and do not present unreasonable risks to people or the environment.
EPA also reviews each pesticide product label before issuing a registration. In the case of COVID-19, claims that pesticide products kill or mitigate SARS-CoV-2 must be substantiated and accepted by EPA. On March 5, 2020, EPA began publishing “List N,” representing a list of EPA-registered disinfectant products that meet EPA’s criteria for use against SARS-CoV-2. This list continued to expand over the last year; at the time that this article was published, there were 567 pesticides products on List N. Over the ensuing months, EPA also issued a series of temporary FIFRA registration policies designed to ease supply chain disruptions and expedite certain approval processes for registered disinfectant products.
At the same time, however, the Agency also expressed serious concerns about what it identified as a growing number of unregistered disinfectant products making unsubstantiated and potentially dangerous claims of protection against COVID-19. FIFRA prohibits the sale or distribution any pesticide that is unregistered or misbranded. FIFRA § 12(a)(1)(A); 12(a)(1)(E). A product is misbranded if it is labeled in a manner that is false or misleading, or if it is advertised or otherwise sold with claims that differ substantially from those accepted by EPA as part of the product’s registration. Significantly, distribution or sale of an unregistered or misbranded pesticide is a violation of FIFRA, even if claims made about the product are arguably true or provable.
On April 28, 2021, EPA updated its disinfectant policy to align with more recent CDC guidance indicating that the risk of being infected with COVID-19 by touching contaminated surfaces is low. At the same time, EPA announced that it would be shifting resources toward the evaluation of “novel products,” such as those that inactivate airborne SARS-CoV-2. These products may include, for example, certain ultra-violet (UV) lights, ozone generators, and antimicrobial air purifiers that make claims to reduce airborne SARS-CoV-2 and which may be subject to FIFRA regulation as “pesticidal devices.” Devices are not subject to FIFRA registration requirements, but their production, distribution, and claims are still closely regulated by EPA.
Criminal penalties can result from “knowing” violations of FIFRA.
While FIFRA authorizes both civil and criminal penalties, as a matter of historical practice criminal enforcement under FIFRA has been relatively limited, and generally focused on cases involving highly toxic substances or incidents of actual and serious harm to human health or wildlife.
Under FIFRA § 14(a)(1), a registrant, commercial applicator, wholesaler, dealer, or
other distributor may be assessed a civil penalty of up to $20,358 per violation. In addition, FIFRA § 14(b)(1) makes the “knowing” violation of any provision of FIFRA subject to criminal penalties consisting of fines and/or imprisonment. Criminal misdemeanor penalties under FIFRA may be assessed up to $50,000 for registrants, applicants, or producers, and up to $25,000 for commercial applicators or other persons. In addition, violators may face imprisonment for up to one year. FIFRA § 14(b)(1)(A), (B). FIFRA’s sole criminal felony penalty applies to any pesticide product registrant “who, with intent to defraud, uses or reveals information relative to formulas of products.” FIFRA § 14(b)(3). The penalties associated with this crime include incarceration up to three years and fines up to $10,000.
According to EPA’s FIFRA Inspection Manual, “[t]he primary factor distinguishing a criminal case from a civil case is the INTENT of the VIOLATOR” (emphasis in original). As explained by EPA, an environmental crime is committed when the violator either “intends” to commit an unlawful act, or intentionally engages in the prohibited conduct and “should know or has full knowledge that the act is prohibited by law or regulation.” EPA acknowledges that environmental crimes are not usually committedly with the specific purpose of harming people or the environment, but instead often involve “putting personal financial gain over public health and safety.”
Individuals that violate FIFRA provisions can also be charged with federal crimes of conspiracy (18 U.S.C. § 371), mail fraud (18 U.S.C. § 1341), or wire fraud (18 U.S.C. § 1343). On top of federal enforcement actions, states can also enforce their own pesticide acts in connection with false, misleading, or unapproved COVID-19 claims on labels, potentially creating multiple layers of enforcement and liability.
Prior to the COVID-19 pandemic, EPA pursued FIFRA criminal investigations relatively infrequently, and usually only if the alleged crime was primarily associated with highly toxic pesticides or actual harm to human health or environment. Consistent with EPA’s general guidelines requiring EPA to target “the most significant and egregious violators,” investigators usually pursued FIFRA criminal cases based on significant environmental harm (i.e., actual harm, or threat of harm, to human health or the environment) as well as culpable conduct or where a highly toxic pesticide is used.
- In 2016, TERMINIX LP and TERMINIX USVI entered a plea agreement for illegal application of a pesticide. TERMINIX used a pesticide containing methyl bromide, a highly toxic chemical banned from indoor use since 1984, in a resort in St. John’s, U.S. Virgin Islands. The application of the pesticide resulted in the poisoning a family of four that was vacationing at the resort and led to permanent neurological damage and disabilities. The defendants paid $10 million in fines, including $8 million in criminal fines and the branch manager of the TERMINIX USVI was sentenced to 12 months in prison.
- In 2012, a man sold an unregistered pesticide that contained 61 times the amount of brodifacoum allowed by EPA. Under FIFRA, brodifacoum may only be used by licensed professions and is not approved for direct consumer use; however, the man packaged the chemical in small vials of a blue-green liquid which one woman mistook for medicine, ingested, and became severely ill. The man and his friend sold more than 4,500 individual packages of misbranded pesticide products to undercover agents resulting in a multiagency investigation where 12 arrests were made and thousands of packaged of unregistered and misbranded products were seized. The man pled guilty to violating FIFRA by distributing and selling at least 2,010 unregistered or unauthorized pesticide packages. He was sentenced to 12 months of probation and restitution of $1,200 to dispose of the pesticides seized. The man’s friend also pleaded guilty. The friend was sentenced to 12 months of probation, 200 hours of community service, restitution of $1,200 to dispose of the pesticides seized, and a $3,000 fine.
- In 2012, Scotts Miracle-Gro Company (“Scotts”) was sentenced to pay a $4 million criminal fine and millions more in civil penalties for its illegal application of insecticides to wild bird food products that were toxic to birds. In addition, Scotts also pleaded guilty to falsifying pesticide registration documents, distributing pesticides with misleading and unapproved labels, and distributing unregistered pesticides. A Scotts’ manager was sentenced to three months’ incarceration for two felony counts: having made a material false statement and having submitted falsified documents to EPA.
EPA Heightened FIFRA Criminal Enforcement During the COVID-19 Pandemic
Unlike the criminal cases noted above, which have generally been linked to incidents involving actual death or injury, EPA’s heightened use of its FIFRA criminal enforcement authority over the last year appears to more broadly capture cases involving concerns about potential harm. While the efficacy of public health antimicrobial pesticides is always subject to heightened scrutiny under FIFRA, this apparent shift appears closely connected to the unprecedented concerns surrounding COVID-19.
Since the pandemic reached the United States last year, EPA has repeatedly expressed concern about potential risks to consumers using unregistered disinfectants, “as they may be ineffective against the virus that causes COVID-19” and “jeopardize our collective efforts to protect public health.” While directing the public to EPA’s list of approved disinfectant products with demonstrated efficacy against SARS-CoV-2 (known as “List N”), the Agency also explained that it was “vigorously investigating fraudulent disinfectant sales to the public via online marketplaces.”
EPA’s prioritization of enforcement against these products was rapid and intense. In March 2020, EPA’s Criminal Investigation Division began working remotely to investigate and open cases against distributors of unregistered pesticides that claim to kill COVID-19 or SARS-CoV-2. EPA also launched the “COVID-19 Fraud Initiative,” focusing on the “illegal sale and distribution of pesticide products that either have no active, nor effective ingredients, or contain restricted or banned ingredients.”
In May 2020, EPA issued a detailed Compliance Advisory, warning that it would take enforcement actions against pesticides products distributors that made unapproved or potentially false or misleading claims regarding COVID-19. The Advisory noted that EPA had received “a steady stream of tips/complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices,” noting that these “tips and complaints are being actively reviewed and efforts are being made to identify violative products.”
In particular, EPA expressed concern “with pesticide and pesticide device products sold online on e-commerce platforms that are fraudulent, counterfeit, and/or otherwise ineffective.” EPA also emphasized its coordination with the U.S. Department of Justice, U.S. Customs and Border Protection, and other federal agencies “to bring the full force of the law against those selling or otherwise distributing violative products.”
Accordingly, a relatively large number of FIFRA criminal charges were brought over the last year. For example:
- In May 2020, a Georgia woman pleaded guilty to violating FIFRA by selling an unregistered pesticide, “Virus Shut Out,” that was claimed to protect against viruses like COVID-19. She was charged with illegally importing and selling an unregistered pesticide—and mailing a prohibited item—while claiming that the illegal pesticide would help protect individuals from viruses and reduce transmissions by 90%. While she faced up to one year in prison and a $100,000 fine, the woman was ultimately sentenced in June 2020 to two years’ probation and a fine of $650.
- In August 2020, a Maryland man was charged with federal mail fraud and fraudulently selling unregistered and misbranded pesticides that were claimed to kill COVID-19. The man is alleged to have: purchased pesticides products from an unnamed seller on Facebook Marketplace, relabeled the products with unsubstantiated claims that they kill COVID-19, and sold the wrongly labeled products on eBay. If convicted, the man will face a maximum sentence of 20 years in federal prison and $250,000 in fines for mail fraud as well as up to one year in federal prison and $25,000 in fines for violating FIFRA.
- In November 2020, online retailers in Queens, New York, were charged in November 2020 for selling COVID-19 killing “Virus Shut Out,” which they advertised on their company’s Facebook page.  If convicted, the defendants face up to one year in prison.
- In December 2020, a Quincy, Massachusetts man pleaded guilty to distribution and sale of an unregistered pesticide where he had listed a product known as “Toamit Virus Shut Out,” a lanyard that users were to wear around their necks to protect themselves from viruses and bacteria, on eBay. Again, here the charging statutes provide for a sentence of up to one year of imprisonment and a fine of up to $25,000.
- In May 2021, a San Diego firm and its owner pleaded guilty to charges relating to the unlawful importation, sale, and mailing of an unregistered pesticide product marketed as a killer of airborne viruses like COVID-19. The product contained sodium chlorite, a flammable substance, and was described as an air purifier instead of a pesticide. As part of the plea agreements, the defendants agreed to a total financial penalty of $556,443, which included forfeiture of the proceeds from the sale of the illegal product, restitution for the unpaid duty and the cost of disposing of product that was not sold, and an additional fine.
In Pursuing Multiple FIFRA Criminal Matters over the Last Year, EPA has Signaled the Seriousness with which it Views False or Misleading Disinfectant Product Claims
EPA’s collaborative approach to investigating and criminally prosecuting unregistered and fraudulent products that claim to act against COVID-19 reflects its heightened concern about these types of products. As the pandemic continues to evolve and EPA shifts its resources to the evaluation of devices and other novel products that claim to inactivate airborne SARS-CoV-2, it remains to be seen how the Agency’s criminal enforcement efforts may evolve under the Biden administration. Even as EPA’s historic FIFRA criminal enforcement has focused primarily on cases involving highly toxic pesticides or actual serious harm to human health or wildlife, the dozens of criminal cases opened during the pandemic suggest an expanded use of the Agency’s criminal enforcement authority under circumstances involving wider public health concerns, even in the absence of a specific incident involving actual harm.
It is too early to predict if EPA’s expanded use of its FIFRA criminal enforcement authority over the last year will reach beyond the Agency’s focus on COVID-19 claims. Regardless, pesticide and device distributors must always ensure that their products are properly labeled and, if required, registered by EPA. All product claims must also be substantiated and avoid false or misleading statements. Pesticides claiming to act against SARS-CoV-2 must be on EPA’s List N. Although the harms associated with uses of unregistered or fraudulent disinfectant products have not yet been quantified, recent trends suggest that EPA is now more prepared to pursue criminal enforcement under FIFRA when animated by wider public health concerns, even under circumstances that do not directly involve incidents of actual death or injury.
 EPA Enforcement Annual Results FY 2020.
 Products that are used as disinfectants and sanitizers for skin are not regulated by EPA under FIFRA. Instead, they are regulated as drug products by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act (FFDCA).
 FIFRA Enforcement Response Policy (Dec. 2019), as adjusted to account for inflation according to Civil Monetary Penalty Inflation Adjustment, 85 Fed. Reg. 83818 (Dec. 23, 2020). Under FIFRA § 14(a)(2), a private applicator or other person may be assessed a penalty of up to $3,011 for each violation occurring after a Notice of Warning (“NOW”) or a citation for a prior FIFRA violation is issued. For a first offense, private applicators may be assessed a civil penalty of up to $1,940.
 Private applicators or any “other person not included” in the categories described above, on the other hand, who “knowingly violate” any provision of FIFRA, are subject to misdemeanor penalties of up to $1,000 in fines, 30 days imprisonment, or both. Id.
 Even though registrants must support efficacy claims for every registered pesticide product with product performance data, EPA has generally waived the requirement to submit those data during the registration process unless the pesticide product bears a claim to control pest microorganisms “that pose a threat to human health and whose presence cannot readily be observed by the user.” 40 C.F.R. § 158.400(e)(1).