First, under federal law, disinfectants that kill viruses on surfaces are regulated as “pesticides” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which is enforced by the U.S. Environmental Protection Agency (EPA). Second, employers have a legal duty under the Occupational Safety and Health Act (OSH Act) to protect workers from hazards introduced into the workplace, including hazardous chemicals. Compliance with the requirements enforced by EPA and the Occupational Safety and Health Administration (OSHA) is made more difficult given that agency guidance is rapidly changing in response to the pandemic.
Our team tracks these developments daily and routinely fields questions from employers on how to navigate this evolving legal situation. Read on for a high-level overview of the FIFRA and OSH Act frameworks and best practices when using disinfectants in the workplace.
For more information on these topics, listen to our recent webinar on “How to Protect Employees and Manage Business Risk During COVID-19.” The event page and webinar recording is available here.
The FIFRA Regulatory Framework
FIFRA requires that all pesticides (with very limited exceptions) must be registered with the EPA before they are sold or distributed. EPA’s premarket review and approval usually requires laboratory data demonstrating safety and efficacy against a specific “pest,” which includes bacteria and viruses. Given that SARS-CoV-2, the novel coronavirus that causes COVID-19, was an emerging viral pathogen, lab-testing was not a viable option at the start of the pandemic. Instead, EPA activated for the first time its “Emerging Viral Pathogen” guidance, which provides the agency with a process for reviewing and approving efficacy claims for already-registered disinfectant products against emerging viral pathogens if the registrant can show that the product is effective against similar or harder-to-kill viruses.
EPA also developed List N, a living list that catalogs the products EPA has reviewed and given approval to make limited efficacy claims against SARS-CoV-2. EPA has also begun to approve on-label claims of efficacy against the novel coronavirus, as registrants test their products directly on the virus. Disinfectants approved for on-label claims remain on List N, so it remains a definitive resource for companies looking to procure EPA-reviewed disinfectants for use against the novel coronavirus.
EPA also regulates pesticide devices under FIFRA. Pesticide devices work by physical means, rather than chemical means, to target pests, including bacteria and viruses. Some of the more common pesticide devices are germicidal ultraviolet lights and ozone generators. While devices are not registered with EPA, there are still other FIFRA requirements that device manufacturers must satisfy. Importantly, pesticide devices claiming efficacy against the novel coronavirus are not reviewed by EPA and will not appear on List N. However, devices may still be effective against SARS-CoV-2, and device manufacturers must have laboratory data files demonstrating that efficacy to comply with FIFRA.
In that regard, it is crucial that employers are aware that disinfectant products are regulated under FIFRA and mindful of EPA’s List N. EPA has authority to investigate and bring civil administrative enforcement actions against sellers and distributors of unregistered pesticide products or violative pesticide devices. FIFRA empowers EPA to impose significant penalties and take other actions such as issuing stop sale, use, or removal orders. In general it is not unlawful under FIFRA to use an unregistered pesticide product, but companies can unwittingly violate federal pesticide law by distributing unregistered pesticides in the U.S. This includes attempts to procure unregistered pesticides from overseas and import them into the country.
The OSH Act Regulatory Framework
The first step in determining any applicable OSH Act requirements is establishing whether a proposed disinfectant is classified as a health or physical hazard under the OSHA Hazard Communication Standard (29 C.F.R. §1910.1200). Such hazards may include eye, face, mouth, nose, and skin irritation and/or burns; respiratory distress from vapors; and poison if ingested. If the disinfectant poses such hazards, the employer has a duty to protect its employees by providing them with appropriate and effective personal protective equipment. OSHA requires each chemical manufacturer and distributor to provide a Safety Data Sheet for all hazardous chemicals that it produces or ships. The Safety Data Sheet identifies the hazards of the chemical and provides guidance for its safe use and handling. These safeguards must be integrated into the employer’s workplace procedures and employee training program.
Five Best Practices for Using Disinfectants in the Workplace
- Develop an official company policy for cleaning practices and disinfection protocols that reflects EPA and Centers for Disease Control and Prevention guidance. This written policy should be implemented and reviewed routinely, especially as agency guidance is continually being fine-tuned during the pandemic. Your company policy should identify disinfectants that are being used, and the policy should accurately and fully incorporate the legally binding requirements found on both the disinfectant labels and in Safety Data Sheets.
- List N is the best reference for sourcing disinfectants. List N is a complete, real-time catalog of all pesticide products EPA has assessed for efficacy against the novel coronavirus. In light of EPA’s catalog of disinfectants approved for use against SARS-CoV-2, employers should be wary of bad actors looking to cash in on a crisis. Unfortunately, the COVID-19 pandemic has been a veritable “gold rush” for unscrupulous individuals and companies selling products and devices with bogus or unapproved claims of efficacy against SARS-CoV-2. In fact, EPA and the Department of Justice have investigated a number of cases involving unregistered pesticides, some of which have resulted in criminal prosecution. This is why List N remains the best and most complete resource for sourcing EPA-reviewed and approved products.
- The “label is the law.” Under FIFRA, EPA reviews and approves all label language for registered pesticide products. Employers using disinfectants as part of their cleaning and disinfection plans need to incorporate the label instructions for using the product, including the application method, use sites, surface contact times, and storage and disposal requirements. It is unlawful under FIFRA to use a pesticide product inconsistent with label instructions. For products on List N that have not been approved for on-label claims of efficacy against the novel coronavirus, EPA will specify which on-label directions should be followed.
- Request Safety Data Sheets from disinfectant suppliers. If a disinfectant distributor or manufacturer has not provided you with a Safety Data Sheet, you should request one in order to review the chemical hazards and safe handling and use guidance and impart that information to your employees. If the chemical is hazardous, you will need to provide appropriate personal protective equipment to protect your employees.
- Be aware of evolving “gray areas” in federal pesticide law.
- Long-lasting efficacy – Typically, EPA-registered surface disinfectants kill viruses at the time of application and do not provide “long-lasting” efficacy (also called residual efficacy). Residual efficacy is continuous inactivation of viruses over the course of hours to months. Recently, however, EPA has released guidance and protocols for reviewing and approving products with long-lasting-efficacy claims. To date, EPA has provided emergency approval for a residual efficacy product to be used in a limited number of states and a few specific industries. Beyond that, EPA has approved copper alloy as a supplemental residual antimicrobial product, meaning that it can supplement the use of List N disinfectants when incorporated into surfaces. But as of this writing, EPA still has not fully approved any residual disinfectants that can provide continuous efficacy as a substitute for List N disinfectants.
- Pesticide devices – As discussed above, pesticide devices such as germicidal ultraviolet lights and ozone generators can claim efficacy against SARS-CoV-2 but will not appear on List N because they are not registered with EPA prior to sale or distribution. If sourcing pesticide devices, we recommend using them as supplements to other disinfectants found on List N. We also recommend asking the device manufacturer about the specific data packet they have prepared to support efficacy claims. Any pesticide devices that were not manufactured in an EPA-registered establishment (which is required to be displayed on the device label) are a red flag.
- Antiviral air disinfection – EPA’s List N currently covers products approved for use on surfaces (i.e., hard nonporous surfaces and porous surfaces). Understandably, there is increasing interest from registrants and employers in pursuing review and approval of products capable of offering antiviral air disinfection. To date, EPA has granted emergency approval for only one product that claims to offer antiviral air disinfection, but this applies in only two states. EPA is still in the process of applying protocols for evaluating these products on a wider and more permanent basis.
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.
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