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December 08, 2021

EPA Terminates COVID-19 Policies for Disinfectant Notification Mandates

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On Sept. 15, EPA issued a Notice to Manufacturers, Producers, Formulators and Registrants of Pesticide Product announcing plans to reverse measures that increased the availability of disinfectants that can kill COVID-19. An EPA press release accompanying the Notice states: "[i]n 2020, EPA introduced regulatory flexibilities to ensure that critical antimicrobial products remained available as the country responded to the COVID-19 public health emergency. As supply chains have stabilized and disinfectant products expected to kill SARS-CoV-2 (the virus that causes COVID-19) have become consistently available to consumers, the agency has determined that this flexibility is no longer needed…" EPA is granting a one-year grace period, until Sept. 15, 2022, before the termination takes effect.

In spite of flexibility originally granted under 2020 FIFRA policies, EPA has been pushing companies to file amendments that would formalize any supply changes they made under the temporary policy. The Notice states, "[s]ince the Fall of 2020, EPA has also been encouraging registrants to amend their registrations by either submitting a notification or amendment, as applicable to make permanent any changes made using the temporary amendments. Further, EPA is not aware that the supply chain issues that justified the issuance of the temporary amendment continue to persist…"

Specifically, EPA is terminating the policy that allowed makers of disinfectants already registered to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) "List N" of products certified to kill the coronavirus, to quickly seek new sources of certain active ingredients when faced with supply chain disruptions, "without having to first apply for and receive EPA approval." In April 2020, EPA expanded that waiver to allow approved disinfectant manufacturers that use any of eight active ingredients to source the substances from any source without first seeking EPA approval. Then, in May 2020, the agency added isopropyl alcohol as a ninth active ingredient that qualified for flexible sourcing.

In the Sept. 15 Notice, EPA "acknowledges that registrants have made changes in their supply chains based on the temporary amendment, and that registrants require time to make the temporary changes permanent," and writes that the termination will take effect on Sept. 15, 2022. The Notice goes on to state, "[a]fter that date, registrants will not be able to release for shipment formulations produced under the conditions of the temporary amendment without first complying with the registration requirements that were in place prior to the issuance of the temporary amendments…"

Companies that have been taking advantage of EPA's temporary policies will need to evaluate their operations and ensure that they have obtained necessary EPA approvals or changed their business practices by Sept. 15, 2022. Please contact a Clark Hill Environmental & Natural Resources attorney with any questions concerning the Notice or its potential impacts on your business.

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