During the COVID-19 pandemic, governments have recognized an urgent need to ensure effective surface disinfectants, hand sanitizers, and other products that can be used against SARS-CoV-2 are available to the public. While certain restrictions have been eased to help maintain the supply and availability of these products, these products remain strictly regulated by federal and state agencies in the United States. Disinfectant product manufacturers, as well as retailers, importers, and other distributors, are responsible for compliance with prohibitions against the distribution or sale of unregistered, misleading, or mislabeled products. The U.S. Environmental Protection Agency (EPA) in particular has identified this as an area of enforcement priority and expects producers and distributors alike to ensure that any products making anti-coronavirus claims are in compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This article offers ten brief tips that producers and distributors of disinfectants should always keep top of mind, and especially in the midst of the ongoing pandemic.
1. Know the Law and How it Applies to Your Activity
FIFRA prohibits the distribution or sale of any pesticide that is not registered with EPA, including many products that make or imply anti-viral or bacterial claims. Surface disinfectants, wipes, and other products that are intended for use to kill, reduce, or mitigate coronavirus on objects, surfaces, or in the air or water will generally be regulated under FIFRA and require registration as pesticide products. EPA requires approval in advance of any sale or distribution of these products. EPA must also approve all labeling claims and regulates pesticide production, packaging, import, and advertising.
Generally, pesticide manufacturers are responsible for registering their products under FIFRA, but anyone in a supply chain that sells or distributes an unregistered pesticide may be independently liable for violating the law. This may include small or large retailers, website marketplace operators, importers, and other partners throughout the supply chain.
2. Understand the Regulatory Status of Your Product
Under FIFRA, a pesticide is defined to include “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating” most microbial pests, which covers a wide variety of surface disinfectants, sanitizers, and other antimicrobial products. FIFRA also regulates “devices,” which are also intended to act against microbial pests, but work by physical means and do not incorporate an antimicrobial substance. Pesticide devices can include UV lights, water treatment units, and air purifiers.
EPA determines pesticidal intent based on an evaluation of express and implied claims, as well as the product’s commercially valuable use and the distributor’s actual and constructive knowledge of consumer use. When determining a product’s regulatory status, EPA will consider label claims as well as statements found in product brochures, websites, and other marketing materials.
Pesticides must be registered by EPA before they may be distributed or sold. Devices do not require registration, but are subject to important FIFRA production, import, and labeling requirements and, like pesticides, must not be marketed with any false or misleading claims.
3. Pay Very Close Attention to EPA Policy Updates
EPA has issued policies temporarily reducing certain notification and approval requirements to help address supply chain concerns and expedite certain changes to ingredients in registered disinfectant products. As the pandemic continues, EPA may decide to keep these temporary policies permanently in place or issue new policies.
Approved sanitizers and disinfectants can be found on EPA’s List N, which should be checked periodically for updates. In an unusual step, EPA has also issued cleaning and disinfecting guidance to the American public, recommending the use of certain unregistered substances when EPA-approved products are unavailable. However, the sale and distribution of unregistered pesticides remains a violation of FIFRA. (For more information on List N, please see our alert available here.)
EPA has also developed a fast track review process to speed up approval of anti-coronavirus claims in connection with certain registered disinfectant products and has provided flexibility for manufacturers to substitute certain commodity inert and active ingredients to bring registered products to the marketplace more quickly. Care should be taken to understand how EPA’s registration processes are being modified, which FIFRA requirements remain in place, and the timeframes in which these policies remain in effect. Closely monitor for updates as additional policy statements may be forthcoming as the pandemic response unfolds.
4. Watch Out for Unapproved Products and Claims
Expect regulatory agencies to be vigilant in pursuing violations of pesticide regulations, particularly those related to the import and distribution of unregistered pesticides making anti-coronavirus claims. In certain instances, EPA’s policy provides that advertisements for approved products may include anti-coronavirus claims, but those same claims may still be prohibited on product labels. EPA recently advised U.S. retailers, third-party marketplace platforms, and other technology operators regarding its concerns about sales of unregistered disinfectant products on and through those platforms.
Pesticides eligible for EPA’s “minimum risk” exemption are not subject to FIFRA registration requirements, but they cannot make any antimicrobial public health claims. General purpose cleaning products do not require registration unless pesticidal or antimicrobial claims are made in connection with their distribution or sale; on the other hand, any claims to act against coronavirus, or to “disinfect,” “sanitize,” or “sterilize,” are presumptively pesticidal and may only be used if approved by EPA in connection with a registered pesticide. Nevertheless, EPA has recommended use of certain unregistered “alternative disinfectants” when registered products are not available.
It is also helpful to work with trusted suppliers to ensure compliance with applicable regulatory requirements. Producers, distributors, and retailers should refer to EPA’s List N, which identifies the registered products that meet EPA’s criteria for coronavirus claims. As noted above, devices do not require registration but remain subject to EPA’s standards for false or misleading claims and, among other things, must be produced at EPA-registered establishments.
5. Ensure Full Compliance with Pesticide Import Requirements
Imported pesticides and devices must always be produced at an EPA-registered establishment, bear 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 a specific enforcement priority at this time.
6. Don’t Forget the States
In addition to EPA registration under FIFRA, a pesticide must also be registered in each U.S. state before it may be sold or distributed in that jurisdiction. Some states parallel the federal requirements, but other states may impose different standards. In some cases, products that are exempt from federal registration requirements (like devices) may still be subject to registration in particular states. States are also not required to follow EPA’s modified registration policies due to the pandemic, although many are taking similar steps to help expedite disinfectant registration processes.
7. Keep In Mind FDA’s Separate Requirements for Hand Sanitizers
Hand sanitizers and other products intended to act against viruses or other microbes in or on the human body are exempt from EPA regulation under FIFRA and are instead subject to FDA regulation as drugs. During the pandemic, FDA is not enforcing some of its requirements for certain aqueous solution hand sanitizers that contain ethanol or isopropyl alcohol as active ingredients, but only if such products meet specific formulation and production criteria established under FDA’s policy. For example, formulas must be consistent with World Health Organization (WHO) recommendations, and any ethanol in the product must also be denatured consistent with Alcohol and Tobacco Tax and Trade Bureau (TTB) requirements. In addition, such products must be produced at FDA-registered facilities and be labeled consistent with FDA-prescribed requirements.
FDA’s temporary hand sanitizer policy has been updated on several occasions since it was originally released and care should be taken to ensure compliance with its most recent iteration.
8. Make a Plan for Disinfecting the Workspace as Employees Return to Work
States are beginning to slowly increase the number of businesses that can open or expand their operations. As employees return to work, make a plan for cleaning and disinfecting the workspace. FIFRA prohibits use of any registered pesticide in a manner inconsistent with its label, and care should be taken to ensure that EPA-approved product labels are understood and followed by employees and staff. Ensure the staff have access to the proper and effective products and that these products are stored and used as required.
9. Maintain Good Recordkeeping
As we are getting used to the “new normal” it seems like everyone, including regulators, can easily understand the need for enforcement discretion and flexibility. However, this may not be the case in two or three years. Maintaining good records is critical to ensure you can later explain decisions made in the midst of the crisis.
10. Get Advice If You Need It
FIFRA requirements can be confusing, particularly now as EPA and FDA continue to adjust and update their policies to provide disinfectant manufacturers and consumers with flexibility during the pandemic. Understanding the law, applicable regulatory requirements, and the scope of flexibility allowed will always be your best approach whenever producing or selling disinfectants and sanitizers, whether during the COVID-19 response or at any other time.