The Nickel Report

With the busy holiday shopping season underway, retailers should remain vigilant in their efforts to protect consumers and themselves from the risks of selling potentially unsafe, ineffective or misbranded products in violation of the U.S. Environmental Protection Agency (EPA’s) federal pesticide law, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  As concerns with the spread of COVID-19 and new variants increase over the winter months, consumers are likely to stock up disinfectant products and devices like air purifiers and air filters marketed to reduce the transmission of COVID-19 and other microorganisms.  These products are tightly regulated under FIFRA, and retailers can unwittingly become entangled in regulatory enforcement actions for selling and distributing products that do not comply with EPA’s regulations.  FIFRA extends legal liability not only to the makers of violative products, but also retailers who sell them to consumers, whether or not the retailer was necessarily aware of the violation. In addition to EPA, state agencies also enforce state regulatory requirements applicable to these products.

Background

FIFRA requires that pesticide products with claims to kill microorganisms such as viruses (including SARS-CoV-2) be registered with EPA so that EPA can review the data supporting the claims and approve the claims prior to sale and distribution.  Pesticidal devices that work by  physical or mechanical means to kill or trap a pest such as air purifiers, air filters and UV lights containing similar claims do not require EPA registration, but they are still subject to FIFRA’s production, labeling, packaging and import/export requirements. Additionally, some states require registration of pesticide devices.  However, if those same products contain chemical substances to kill or trap a pest and make pesticidal claims, EPA registration may be required. Both pesticides and devices must be produced in EPA-registered production establishments and cannot contain false or misleading label claims or omit information required under the FIFRA labeling regulations (which constitute “misbranding” violations).

Since 2020, EPA has prioritized its regulatory and enforcement efforts on pesticides and devices that claim to be effective against SARS-CoV-2, the virus causing COVID-19.  Earlier this year, EPA released a compliance advisory to the public after receiving complaints concerning pesticide products and devices—particularly products sold online—bearing false claims for efficacy against SARS-CoV-2.  In its advisory, EPA warned consumers that some pesticide products and devices on the market may contain efficacy claims that have not been approved by EPA and, therefore, may present a safety risk.  EPA later announced its intent to pursue enforcement against these products by issuing penalties and/or stop-sale orders. At the same time, many states have also increased enforcement activities focused on pesticide products and devices, with state inspectors targeting retail stores for pesticide compliance inspections.

EPA advised consumers to look for the EPA registration number on a disinfectant product label and check the number against EPA’s List N, EPA’s database of disinfectant products expected to kill SARS-CoV-2, to confirm that the product meets EPA’s criteria for use against SARS-CoV-2.  EPA also cautioned consumers about devices containing potentially false or misleading SARS-CoV-2 claims.  Because devices are not on EPA’s List N, it is more challenging for consumers to know if a device is effective against the spread of SARS-CoV-2.  EPA released guidance to the regulated community reminding device manufacturers of their FIFRA obligations.  For instance, EPA released a compliance advisory to the UV light industry last year explaining that UV lights that claim to kill viruses and bacteria must comply with the FIFRA production establishment/recordkeeping requirements and labeling requirements.  EPA also provided guidance this year on what efficacy claims are appropriate for UV light devices.

Retailers must be ever watchful about the pesticide products and devices they sell (particularly products with SARS-CoV-2 claims), as they could be subject to severe penalties for violations of EPA’s pesticide laws for selling misbranded pesticides and devices.  Civil penalties can be as high as $20,528 for each violation, and criminal penalties for knowing violations can be as high as $25,000 and/or one year imprisonment.

Because violations are assessed on a per-sale or shipment basis, penalties can quickly add up to hundreds of thousands to millions of dollars.  For example, in 2020, EPA settled an enforcement action with a manufacturer and seller of home appliances for FIFRA violations resulting in almost $7 million in penalties.

EPA has also issued criminal enforcement actions against individuals who sold products that purported to kill SARS-CoV-2 but were not properly registered with EPA or contained claims not approved by EPA.  Some recent criminal sentences have ranged from six months of home confinement to 24 months of probation.

EPA has also used its authority to issue stop-sale orders to retailers.  Last year, EPA issued stop sale orders to retailers for selling unregistered and misbranded pesticides and devices with false or misleading SARS-CoV-2 claims.

For devices, there have been a number of recent enforcement actions concerning devices that do not have proper FIFRA labels.  In the past six months alone, EPA has issued over 20 notices of refusal of admission and/or entered into consent agreements to settle violations for devices imported into the United States without labels that contain the required EPA establishment number, directions for use, caution statements, or warning statements.  These products, which EPA deemed to be misbranded under FIFRA, included UV sanitizers and sterilizers, UV lamps, germicidal lamps, mineral ionizer purifier systems, air purifiers, and water treatment products.  EPA also determined that some of these products contained false and misleading statements or the claims were not substantiated with data, which also constitutes misbranding.

The following EPA enforcement examples against importers illustrate examples of claims the Agency found to be false and misleading:

• On October 4, 2021, EPA Region 8 issued a Notice of Refusal of Admission informing the Bureau of Customs and Border Protection that certain UV lamps should be denied entry because they contained false and misleading claims. The claim referenced in the notice were from an intended use statement saying that the intended use of the product was “Domestic UV lamp for the inactivation of viruses and cysts in household water.”
• On September 14, 2021, EPA Region 5 entered into a consent agreement with a company for importing thousands of units of misbranded devices from China that contained safety claims (“safe for kids”) and false or misleading comparisons with other pesticides or devices (“rather than relying on poisonous chemicals, Buzz-B-Gone Zap uses purple LEDs to lure mosquitoes”).
• On August 24, 2021, EPA Region 4 entered into a consent agreement with a company to assess penalties for misbranding violations when the company imported 360 ozone generators. EPA determined that, “after further discussions with representatives of [the company], it was found that efficacy studies had not been conducted on the ozone generators to back up the ‘sanitizing’ claims found on the product label.”
• On June 2, 2021, EPA Region 8 issued a Notice of Refusal of Admission informing the Bureau of Customs and Border Protection that certain water dispensers should be denied entry because they contained “UV Sterilizer” claims, and “review of the product’s labeling, marketing, and provided materials demonstrate[d] that such a claim is not substantiated” and, therefore, misbranded.

With EPA’s enforcement activities targeted at pesticides and devices, retailers should be aware of their potential legal liability for selling products in violation of FIFRA and implement measures to identify and investigate products that raise red flags.

Questions Retailers Should Ask Themselves

Legal counsel for retailers and retail product compliance managers should ask themselves the following questions to help reduce their companies’ risk of violating FIFRA:

1. Does the product contain pesticidal claims on the label?

A first step that retailers can take to identify if they have a potential issue is to review product labels for the products they sell and identify if a product contains pesticidal claims.  “Pesticidal claims” are claims that a product prevents, destroys, repels, kills or eliminates a “pest.”  Pests include microorganisms such as viruses and bacteria on surfaces (as opposed to microorganisms on or in humans and animals, which are regulated by the FDA) as well as insects, weeds and rodents.  Even if a product is not intended by the manufacturer to be sold or used as a pesticide, if it contains claims on the product label or other advertising material that are considered to be pesticidal claims, then it is a pesticide or a pesticide device and is regulated by EPA.  Even the product name itself can be a pesticidal claim.  Further, if a product is a “treated article” (a product that is treated with a pesticide to protect the product itself, which does not require FIFRA registration), but it contains public health claims (such as claims that the product kills SARS-CoV-2), it requires FIFRA registration.

1. If the product contains pesticidal claims on the label, does the label also display an EPA registration number and/or EPA establishment number?

One quick way that retailers can spot problematic products is to see if products with pesticidal claims also display an EPA registration number (for pesticides) and an EPA establishment number (for pesticides and pesticide devices) on the label.  EPA assigns registration numbers to products it approves, and assigns numbers to establishments that have been approved to produce pesticides and devices.  If the product does not contain either number, it could be misbranded in violation of FIFRA.  This is also a warning that the product may be being sold as an unregistered pesticide or produced at an unregistered establishment in violation of FIFRA.

1. Does the product label make any claims not approved on the EPA-approved label?

Even if a pesticide is registered with EPA or produced in an EPA-registered establishment, it can be misbranded if it bears efficacy claims that are not approved by EPA.  Further, advertising materials are not permitted to substantially differ from the claims approved with the product’s registration.

Retailers can check a pesticide product’s EPA-approved label by reviewing EPA’s Pesticide Product and Label System website and search the product name, manufacturer, or registration number.  The EPA-approved label will list all of the potential claims that the manufacturer can make on the product label.  If the product sold in a store or online contains label claims not approved by EPA (e.g., if the product claims to kill viruses or bacteria not included on the EPA-approved label), it is misbranded in violation of FIFRA.

1. Are the claims made on the label overly broad? Do they contain safety claims?

A product can be misbranded in violation of FIFRA if the label contains any statement, design, or graphic representation that is “false or misleading.”  EPA’s label regulations provide examples as to what statements can be false or misleading. These examples include false or misleading statements about the efficacy of the product or device, statements that imply that the pesticide or device is endorsed by a federal agency, and false or misleading comparisons with other pesticides or devices.  EPA also considers safety claims to be “false and misleading.”

Retailers should be weary of pesticide products and devices that contain claims that assert that a product is “safe,” comparative claims, or claims that the product is endorsed by EPA.  Further, in recent guidance to the UV light industry, EPA clarified that it does not support “generic” efficacy claims on devices (such as the claim “effective against most viruses, spores and cysts”).  EPA considers these claims to be “false and misleading” unless they are “appropriately qualified on labeling and supported by the product’s efficacy testing.”

1. Have we obtained appropriate compliance assurances from our product supplier?

It is critical for retailers to sell products from trusted suppliers who are familiar with product regulatory requirements.  Retailers should review their existing contracts with suppliers and determine if they contain provisions that require suppliers to provide appropriate assurances and certifications that the products comply with applicable federal and state laws, and that the suppliers agree to indemnify the retailer in the event of noncompliance.  Retailers should ensure that pesticide products and devices not only comply with FIFRA requirements, but state pesticide regulations as well.  States require pesticide registration in addition to federal pesticide registration.  Certain states also require that devices be registered in the state, even though devices do not need to be registered with EPA.

EPA has publicized enforcement actions against companies for selling unregistered pesticides or misbranded pesticides and devices.  Enforcement actions include civil penalties, criminal penalties, and stop sale orders.  Given that FIFRA imposes strict liability on the entire supply chain for pesticide products and devices, retailers should also proactively stay informed about  EPA enforcement actions in order to avoid suppliers who continue to supply products to retailers in violation of a stop sale order, cancellation or suspension.