October 18, 2021

Volume XI, Number 291

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October 18, 2021

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EPA Announces Sunset of Temporary Disinfectant Supply Chain Flexibilities

On September 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is terminating the Temporary Amendment to Pesticide Registration (PR) Notice 98-10, effective September 15, 2022. EPA states that it is providing 12 months’ notice to registrants before the termination takes effect to give registrants time to adjust their contractual commitments. Registrants must ensure that by September 15, 2022, their product is produced using a source of active ingredient identified in the product’s EPA-approved Confidential Statement of Formula (CSF) or otherwise complies with the requirements of PR Notice 98-10. All notifications submitted to EPA under the temporary process are valid only for the time period of the temporary amendment. After September 15, 2022, 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.”

EPA states that this notice applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (the virus that causes COVID-19) or products that serve as the source of active ingredient for disinfectants on EPA’s List N. This notice also applies to food contact surface sanitizer products containing the active ingredient isopropyl alcohol that are used in the essential role of food manufacturer and preparation.

In 2020, EPA issued temporary amendments to PR Notice 98-10 to ensure that antimicrobial products remained available in response to the COVID-19 public health emergency. According to EPA, supply chains have stabilized and disinfectant products expected to kill SARS-CoV-2 have become consistently available to consumers, so it has determined that this flexibility is no longer needed. When the temporary amendment was issued, EPA stated it would assess the continued need for and scope of the temporary amendment to PR Notice 98-10 on a regular basis and would update it if EPA determined modifications were necessary. EPA stated it would post a notification at www.epa.gov/pesticides at least seven days prior to terminating the temporary amendment. EPA acknowledges in the termination memorandum that registrants require time to make the temporary changes permanent through CSF amendment or notification and therefore is providing 12 months, rather than the seven days guaranteed in the temporary amendment.

The memorandum addressing the termination is available here. Information on the temporary amendments to PR Notice 98-10 are available on our blog.

©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 263
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About this Author

Healther Collins, Regulatory Consultant, Bergeson and Campbell, health and safety compliance
Regulatory Consultant

Heather F. Collins, M.S., Regulatory Consultant with Bergeson & Campbell, P.C. has nearly two decades of experience developing, implementing, and managing environmental, health, and safety (EH&S) compliance for global chemical and chemical product companies.  Her prodigious skills in developing biocide and pesticide registration and compliance strategies, safety data sheet authoring, and dangerous goods management, coupled with her keen awareness of the financial and temporal pressures of the marketplace make her an excellent resource for clients...

724-524-1860
Barbara Christianson, Bergeson & Campbell, P.C., Paralegal
Paralegal

Barbara Christianson has worked at Bergeson & Campbell, P.C. (B&C®) for over a decade, honing her experience in the industries that Bergeson & Campbell serves. As a paralegal, Ms. Christianson supports Bergeson & Campbell's professional staff with a broad range of detail-oriented, oftentimes deadline-driven activities.

Ms. Christianson plays a key role in coordinating and providing detailed quality control review of documents and submissions and has significant experience using industry-specific software programs. She...

202-557-3807
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