Although Congress has indisputably given OSHA the power to regulate occupational dangers, it has not given that agency the power to regulate public health more broadly. Requiring the vaccination of 84 million Americans, selected simply because they work for employers with more than 100 employees, certainly falls in the latter category.

It is important to note, however, that OSHA enforcement in this area is likely to continue under the guise of the "general duty clause," which requires employers to provide a workplace "free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees." Accordingly, companies need to assess whether they are, in light of OSHA and other public guidance, taking appropriate steps to protect their employees from the virus.

A copy of the Court’s opinion is available here: 21A244 National Federation of Independent Business v. OSHA (01/13/2022) (supremecourt.gov).

While EPA has long prioritized enforcement of the rules governing antimicrobial products (disinfectants and the like), the current pandemic has elevated that focus substantially, particularly against products that claim or suggest effectiveness in fighting coronavirus and other microbes. Some of the more high-profile actions over the last year have targeted on-line sales of products (often imports) that are not registered with EPA to make antimicrobial claims, as required by the Federal Insecticide Fungicide and Rodenticide Act (FIFRA).

In a January 2021 update to a COVID-related compliance advisory first issued in May 2020, EPA reiterated its aggressive enforcement stance, with an emphasis on internet product sales:

EPA is receiving a steady stream of tips/complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices. These tips and complaints are being actively reviewed and efforts are being made to identify violative products. EPA intends to pursue enforcement against products making false and misleading claims regarding their efficacy against the coronavirus. EPA is particularly concerned with pesticide and pesticide device products sold online on e-commerce platforms that are fraudulent, counterfeit, and/or otherwise ineffective. EPA is also coordinating with the U.S. Department of Justice, U.S. Customs and Border Protection, and other federal partners to bring the full force of the law against those selling or otherwise distributing violative products.

EPA's updated advisory also expands on, and somewhat shifts, the agency's discussion of pesticide "devices" (e.g., UV lights, ozone generators, and other instruments that use physical or mechanical means to control pests, including viruses and other germs) that claim to kill the coronavirus. Unlike chemical pesticides, devices are not required to be registered by EPA and, therefore, are not scrutinized by the agency to ensure they are safe to use or work as intended. [Note that devices must meet other EPA requirements, including being labeled with an “EPA Establishment Number” to identify the facility at which the device was produced, and not being marketed with "false or misleading" claims.] While EPA does not review efficacy data for these products, manufacturers must have on file adequate substantiation for the claims they make. Interestingly, the May 2020 advisory noted that "devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses." This language has been replaced in the January 2021 advisory with a more general reminder that

[M]aking false or misleading labeling claims about the safety or efficacy of a pesticidal devices is prohibited and could result in the issuance of a Stop Sale, Use, or Removal Order and penalties ....

The second case, Tzumi Innovations v. EPA, filed in December, similarly involves objections to EPA's designation of the company's hand wipes (typically for use on the human body and an FDA-regulated product) as an unregistered pesticide and a threatened Stop Sale, Use, Or Removal Order (SSURO). EPA filed a new brief in that case on February 3 asserting that the matter is not ripe for review and, substantively, that the wipes are properly considered pesticides because they are being marketed for use on surfaces.

Both challenges provide a reminder of the extensive scope of EPA's FIFRA authority, including over products that do not explicitly make antimicrobial claims, but imply such effectiveness through other statements or based on the presence of certain active ingredients. For a more detailed discussion, see my prior blog post.

A copy of EPA's updated COVID Compliance Advisory "What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19" is available here.

Accordingly, EPA recently issued an advisory that cautions:

Please note that ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.

Pesticide devices, though not subject to registration, are subject to other EPA requirements. For example, while devices will not have an "EPA Registration Number," they are required to be labeled with an "EPA Establishment Number" to identify the facility at which the device was produced. In particular, any claims made for devices may not be false or misleading, and, therefore, manufacturers should have data on file to substantiate any claims. It is possible, therefore, that a device could be effective against coronavirus, and legally could make such claims, though companies should be prepared to defend the statements. To do so, companies should look carefully at the criteria for claim approval in EPA's Emerging Pathogens Policy.

EPA is actively pursuing enforcement in regard to illegal coronavirus claims, further information on which can be found at https://www.epa.gov/enforcement/covid-19-enforcement-and-compliance-resources.

Last week, the agency issued a press release announcing that it is advising companies that support on-line marketplaces, such as Amazon, "that unscrupulous dealers are using their platforms to sell illegal disinfectant products." In the announcement, EPA Administrator Andrew Wheeler asserted that the agency "takes our responsibility to protect Americans from fraudulent surface disinfectants seriously." Likewise, Susan Bodine, EPA Assistant Administrator for Enforcement and Compliance Assurance (OECA), emphasized that “unregistered disinfectants can put consumers at risk, as they may be ineffective against the virus that causes COVID-19."

“EPA is working hard to stop the sale of these illegal products" - Susan Bodine, OECA