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EPA Expediting Emerging Viral Pathogens Claim Submissions

On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that due to the outbreak of SARS-CoV-2, the coronavirus that causes COVID-19, it is expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants.

EPA states that only claims that do not require review of new efficacy data are being expedited at this time.  Companies can submit these claims as non-Pesticide Registration Improvement Extension Act (PRIA 4) fast-track amendments.  Registrants are asked not to include other label changes typically covered under amendments and notifications as part of the submission to add Emerging Viral Pathogen claims.

EPA requests that registrants include the following information in a letter to ensure the efficient processing of submissions:

  • A subject line that clearly indicates “Emerging Viral Pathogen Claim for SARS-CoV-2”;

  • A request to make emerging viral pathogen claims;

  • A description of how the product meets the eligibility criteria for use against one or more categories of viral pathogens consistent with the guidance;

  • The identification of the virus(es) from the product label that the registrant is using to support the emerging viral pathogen claims and the study ID number (MRID) that supports the claim;

    • Note: EPA recommends using the minimum number of supporting viruses needed for the emerging pathogen claim in order to expedite EPA’s review

  • An up-to-date matrix (Form 8570-35); and

  • A request to add the Terms of Registration outlined in Attachment I of the Emerging Viral Pathogens Guidance.

Registrants should also submit a revised master label with a separate section for emerging viral pathogen claims that includes the generic claim statements identified in Attachment I of the Emerging Viral Pathogens guidance document.

EPA requests that applications are submitted through EPA’s CDX portal and email disinfectantlist@epa.gov with the CDX tracking number (CDX_2020_XXXXXXX) once an application was submitted to expedite the application.

If approved, the product will be added to List N: Disinfectants for Use Against SARS-CoV-2, during the next update to the list, which is scheduled to be updated in the next two weeks.

Additional information is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.

©2020 Bergeson & Campbell, P.C.

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About this Author

Lisa Campbell, Bergeson PC, Federal Insecticide Fungicide Rodenticide Act attorney, TSCA lawyer, environmental statutes legal counsel, regulation compliance law
Partner

Lisa Campbell founded Bergeson & Campbell, P.C. (B&C®) with Lynn Bergeson. Today her practice focuses on many aspects of pesticide and chemical regulation. She counsels clients on a wide range of issues pertaining to exposure and risk assessment, risk communication, and related legal and regulatory aspects of pesticide programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). She also counsels B&C clients on various chemical-specific programs under the Toxic Substances Control Act (TSCA) as well as chemicals regulation and...

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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 seeking a competitive edge in their compliance management.  Ms. Collins holds a Masters in Science degree in Environmental Science and Management and a Bachelor of Science in Biology and Biochemistry from Duquesne University.

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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...

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