Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson

On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of a new list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19.  Products on EPA’s “List N: Disinfectants for Use Against SARS-CoV-2” are registered disinfectants qualified for use against SARS-CoV-2 approved through EPA’s Emerging Viral Pathogen Program (Program).  Currently there are 85 products listed that are qualified for use against SARS-CoV-2.  Of note, EPA states that if the directions for use for viruses/virucidal activity of the listed products provide different contact times or dilutions, the longest contact time or most concentrated solution should be used.

EPA issued guidance for the Program in 2016; the guidance was intended to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens.  In the event of an outbreak, companies with pre-approved products can make off-label claims (e.g., technical literature distributed exclusively to healthcare facilities, physicians, nurses, and public health officials; 1-800 consumer information services; company websites (non-label related); social media) for use against the outbreak virus.  These emerging pathogen statements will not appear on marketed (final print) product labels.  Additional information on EPA’s activation of its Emerging Viral Pathogen Program is available on our blog.

Companies with EPA-registered disinfectants that wish to add their products to List N, should provide the information as outlined below to .(JavaScript must be enabled to view this email address).

  1. Ensure that the product has a previously approved emerging viral pathogen claim.
  2. Provide the product name and EPA Registration number.

It is important to note that in releasing today’s list of products, EPA states in red bold font: “Note: There may be additional disinfectants that meet the criteria for use against SARS-CoV-2.  EPA will update this list with additional products as needed.” 

In addition, EPA has updated other lists of antimicrobial products registered with EPA for claims against common pathogens:

  • List B: EPA Registered Tuberculocide Products Effective Against Mycobacterium tuberculosis;
  • List C: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 Virus;
  • List D: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 and Hepatitis B Virus;
  • List E: EPA’s Registered Antimicrobial Products Effective Against Mycobacterium tuberculosis Human HIV-1 and Hepatitis B Virus;
  • List F: EPA’s Registered Antimicrobial Products Effective Against Hepatitis C Virus;
  • List G: EPA’s Registered Antimicrobial Products Effective Against Norovirus;
  • List H: EPA’s Registered Antimicrobial Products Effective Against Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococcus faecalis or faecium (VRE);
  • List K: EPA’s Registered Antimicrobial Products Effective Against Clostridium Difficile Spores; and
  • List M: Registered Antimicrobial Products with Label Claims for Avian (Bird) Flu Disinfectants.

Additional information on EPA’s List of Antimicrobial Products Registered with EPA for Claims Against Common Pathogens is available here.


 

By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson

On January 29, 2020, the U.S. Environmental Protection Agency (EPA) announced that it has activated its Emerging Viral Pathogen Guidance for Antimicrobial Pesticides (Guidance) in response to the discovery of the novel coronavirus (2019-nCoV).  According to the World Health Organization (WHO), coronaviruses cause numerous illnesses, from the common cold to Severe Acute Respiratory Syndrome (SARS).  First identified in Wuhan, China, the 2019-nCoV coronavirus is a new strain that had not been previously seen in humans.

EPA developed its Guidance in 2016 to address emerging pathogens.  Under this Guidance, EPA provides pesticide registrants with a voluntary “two-stage process to enable use of certain EPA-registered disinfectant products against emerging viral pathogens not identified on the product label.”  These pathogens may not be identified on a label because the occurrence of emerging viral pathogens is less common and predictable than established pathogens and because the pathogens are often unavailable commercially and standard methods for laboratory testing may not exist.  EPA’s intent is for the Guidance to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens associated with certain human or animal disease outbreaks.  Registrants with a pre-qualified emerging viral pathogen designation can include an efficacy statement in technical literature distributed to health care facilities, physicians, nurses, public health officials, non-label-related websites, consumer information services, and social media sites.  Additional information on the Guidance is available here and here.

EPA will likely work closely with registrants as they take steps to use these procedures to make claims related to coronavirus.  EPA notes that coronaviruses are enveloped viruses, meaning they are one of the easiest to kill with the appropriate disinfectant product, and thus using such products could help to limit the spread of these viruses.  Registrants that do not meet the criteria set forth in this Guidance yet make claims related to the coronavirus could face enforcement action for selling or distributing misbranded pesticides.  EPA states that it is working closely with the Centers for Disease Control and Prevention (CDC) to identify and address 2019-nCoV in a timely manner and will continue to monitor developments closely.

Information on the coronavirus is available on CDC’s website.


 
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