With 12 Months’ Notice, EPA Bringing Temporary Disinfectant Supply Chain Flexibilities to a Close
- What happened: EPA announced that it will retract the temporary amendments to Pesticide Registration (“PR”) Notice 98-10, originally issued by EPA in March 2020. These amendments were intended to provide regulatory flexibility to relieve supply chain impediments to production of surface disinfectant products intended for use against SARS-CoV-2, as well as food contact surface sanitizer products. On and after September 15, 2022, all such disinfectant and sanitizer products must comply with the registration requirements of PR Notice 98-10 in the absence of the temporary amendments.
- Who’s impacted: Manufacturers, distributors, and importers of surface disinfectant and food contact surface sanitizer products.
- What should companies do in response: Review product formulae and supply chain contracts to ensure compliance with EPA’s regular registration requirements.
- By when: September 15, 2022
In response to the COVID-19 pandemic’s spread in early 2020, the U.S. Environmental Protection Agency (EPA) began implementing a series of policies to provide supply chain flexibility to disinfectant manufacturers faced with nationwide ingredient shortages. Noting that “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,” EPA has determined that these flexibilities will sunset on September 15, 2022. Surface disinfectant manufacturers should review their current supply chains to ensure that, come that day, their products are produced using only active and inert ingredient sources in compliance with EPA’s pre-2020 requirements under PR Notice 98-10.
Since March 2020, EPA has added over 570 disinfectant products to its List N of products effective against SARS-CoV-2. EPA’s latest announcement is consistent with an overall shift away from a prioritization of surface disinfectant approvals over the course of the COVID-19 pandemic. In April 2021, EPA announced that it would no longer expedite registration review of new surface disinfectant products intended for use against SARS-CoV-2. However, the Agency’s latest action does not affect its expedited review of more novel products making residual efficacy claims.
An active ingredient is a chemical in a pesticide product that acts to prevent, destroy, repel, or mitigate a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer. An inert ingredient is any substance or group of similar substances other than an active ingredient that is intentionally included in a pesticide product by its manufacturer. Consistent with the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) and PR Notice 98-10, EPA permits pesticide manufacturers to change the source of an active ingredient to an alternate, registered source by notification only if the new source is chemically “similar” to its current source (i.e., it has the same CAS number and purity), but generally requires that manufacturers apply for and obtain advance EPA approval before changing to a non-similar registered source or an unregistered source of any active ingredient. FIFRA also requires that a pesticide manufacturer submit to EPA information on a product’s composition, including all inert ingredients, when seeking to register a new pesticide or applying for an amended registration if the revision involves a change in formula.
Additionally, manufacturers must generally apply for and obtain EPA approval to add additional EPA-registered establishments to a product’s Confidential Statement of Formula form (EPA Form 8570-4), which a manufacturer would need to do if obtaining an active ingredient from an alternate registered source.
Pandemic-Era Policy Changes
Under its Temporary Amendment to PR Notice 98-10, EPA permitted numerous regulatory flexibilities to registrants of currently registered pesticide disinfectant products on EPA’s List N in order to facilitate production of those products. Those temporary flexibilities included:
- Registrants of products that contain certain “commodity chemicals” as active ingredients may use any similar source of such ingredients—including unregistered sources—upon notification to EPA, without having to first apply for and receive EPA approval of an amendment to their pesticide registration identifying the new source;
- Registrants may use a registered, similar source of any non-commodity active ingredient upon notification to EPA;
- Registrants may use a registered, non-similar source of any active ingredient upon notification to EPA, as long as the nominal concentration of active ingredient in the product remains the same and the requisite adjustment in inert ingredients is limited to water only;
- Registrants may substitute a similar inert ingredient source upon notification to EPA and submission of composition information from the individual inert supplier; and
- Registrants seeking to add the EPA-registered establishments for formulations that have a registered source of active ingredient, and where there are no other changes to the formulation other than those described above, may make such changes by notification.
The above flexibilities also apply to registrants of food contact surface sanitizers containing the active ingredient isopropyl alcohol.
The Return to Normal
With its latest announcement, EPA is providing manufacturers and other registrants of surface disinfectants and food contact surface sanitizers one year’s notice that the above flexibilities will end on September 15, 2022. By that date, registrants should ensure that their products are either produced using sources of active ingredients identified in those products’ approved Confidential Statements of Formula, or otherwise comply with EPA’s relevant registration requirements under PR Notice 98-10.
Visit Beveridge & Diamond’s COVID-19 Resources Page for more information on navigating the global pandemic. Beveridge & Diamond’s Pesticides practice has worked for forty years with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use pesticidal products and devices. We represent large and small companies with an emphasis on entities that invest in research to discover, develop, and defend new technology. Our Pesticides practice helps clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives. If you have any questions, please contact the authors.