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 31, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing manufacturers of certain already-registered EPA disinfectant products to obtain certain active ingredients from any source without prior approval from EPA.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).  EPA announced on March 26, 2020, similar action on certain inert ingredients

EPA typically requires disinfectant manufacturers to first apply for and receive EPA approval prior to making a change in the source of the active ingredient.  Under this temporary amendment, however, manufacturers can source certain active ingredients from alternate suppliers by informing EPA.  Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation (i.e., the purity of resulting product from the alternate source falls within the certified limits of the currently registered formulation for which they are making the source change).  EPA states that by allowing manufacturers to obtain certain active ingredients from any source it will help alleviate reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on List N.

The eligible active ingredients are:

  • Citric Acid, Chemical Abstracts Service Registry Number (CASRN) 77-92-9;
  • Ethanol, CASRN 64-17-5;
  • Glycolic Acid, CASRN 79-14-1;
  • Hydrochloric Acid, CASRN 7647-01-0;
  • Hypochlorous Acid, CASRN 7790-92-3;
  • Hydrogen Peroxide, CASRN 7722-84-1;
  • L-Lactic Acid, CASRN 79-33-4; and
  • Sodium Hypochlorite, CASRN 7681-52-9.

EPA will assess the continued need for and scope of this temporary amendment on a regular basis and will update it if EPA determines modifications are necessary.  EPA will notify the public at least seven days prior to terminating this temporary amendment at www.epa.gov/pesticides.

After the termination date of the temporary amendment, registrants will not be able to release for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula (CSF) or otherwise would have complied with relevant requirements in the absence of this temporary amendment.

EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:

  • A cover letter with a subject line that clearly indicates that this is a “notification per TEMPORARY AMENDMENT TO PR NOTICE 98-10 (Insert date or other citation) for EPA Registration No. XXXXXX and [insert product name]”;
  • The active ingredient; and
  • The following statement:

[Name of Registrant] is notifying EPA of its intent to use one or more alternate, unregistered sources of active ingredient listed in the TEMPORARY AMENDMENT TO PESTICIDE REGISTRATION (PR) NOTICE 98-10 (Insert date or other citation) in the formulation of EPA Registration No. [xxx-xx].  Each source is chemically identical to (i.e., within the certified limits of) the active ingredients in the Confidential Statements of Formula previously accepted by EPA [insert CSF date(s)]. This self-certification is consistent with the provisions of PR Notice 98-10 and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  Further, I confirm that the ingredients statement of this label remains truthful.  I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA.  I further understand that if this self-certification is not consistent with the terms of PR Notice 98-10 and 40 C.F.R. 152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under section 12 and 14 of FIFRA.

Applications must be submitted via the CDX portal.  At this time, EPA is not accepting paper applications.  Once an application is submitted, EPA requests that an email is sent to .(JavaScript must be enabled to view this email address) with the CDX tracking number (CDX _ 2020 _ XXXXXXX).  A registrant may distribute or sell a product modified according to this temporary amendment to PR Notice 98-10 once EPA receives the notification.

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


 

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

On March 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is allowing flexibility to manufacturers of disinfectants and other pesticides to increase the availability of products for use against SARS-CoV-2, the coronavirus that causes COVID-19.  EPA announced that it is allowing manufacturers to obtain certain inert ingredients from different suppliers without EPA approval after manufacturers voiced concern with EPA about challenges they face obtaining inert ingredients with the disruption of the supply chain. 

EPA stated it is allowing applicants submitting registrations or registration amendments to obtain commodity inert ingredients, approximately 280 total as of today, from various sources without having to provide the supplier name and address on its Confidential Statement of Formula (CSF).  EPA, however, notes that only ingredients designated as commodity inert ingredients on its list will be eligible for this reduced CSF reporting.

EPA also announced it is continuing to expedite review of submissions from applicants requesting to add emerging viral pathogen claims to existing registered disinfectant labels.  Claims currently are being approved within 14 days, as resources allow, compared to the typical 90-day review.  EPA has added 70 new surface disinfectants to its List N: Disinfectants for Use Against SARS-CoV-2, which brings the total number of products listed to 351.

Additional information on EPA’s list of commodity inert ingredients is available here

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


 

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

On March 13, 2020, the U.S. Environmental Protection Agency (EPA) released an expanded list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19.  The list contains nearly 200 additional products, including 40 new products that went through EPA’s expedited review process.  While disinfectant products on this list have not been tested specifically against SARS-CoV-2, EPA expects them to be effective against SARS-CoV-2 because they have: (1) demonstrated efficacy against a harder-to-kill virus; (2) qualified for the emerging viral pathogens claim; or (3) demonstrated efficacy against another human coronavirus similar to SARS-CoV-2.

EPA Administrator Andrew Wheeler stated: “During this pandemic, it’s important that people can easily find the information they’re looking for when choosing and using a surface disinfectant.  With this expanded list, EPA is making sure Americans have greater access to as many effective and approved surface disinfectant products as possible and that they have the information at their fingertips to use them effectively.”

EPA also made enhancements to the web-based list to make it more user friendly.  Specifically: (1) the product list has been updated to include the product’s active ingredient and the amount of time the surface should remain wet to be effective against the given pathogen; and (2) users may now sort, search, and print the information on the table and easily view it on a mobile device.

List N, EPA’s list of registered disinfectant products is available here.  EPA’s Frequently Asked Questions about List N is available here.


 

By Lisa R. Burchi and Barbara A. Christianson

On March 10, 2020, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19).  The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent COVID-19/coronavirus.

The agencies sent the letters to the following companies:

  1. Vital Silver;
  2. Quinessence Aromatherapy Ltd.;
  3. N-ergetics;
  4. GuruNanda, LLC;
  5. Vivify Holistic Clinic;
  6. Herbal Amy LLC; and
  7. The Jim Bakker Show.

Each of the seven companies have advertised products as able to treat or prevent COVID-19/coronavirus.  The unapproved products include teas, essential oils, and colloidal silver.

According to FDA, there are no approved vaccines, drugs, or investigational products currently available to treat or prevent the virus.  FDA Commissioner Stephen M. Hahn, M.D. stated: “The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health.  We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one.  The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs are safe and effective for their intended uses.”

The letters state that one or more of the efficacy claims made by the marketers are unsubstantiated and therefore may violate the FTC Act.  The letters advise the recipients to cease immediately making all claims that their products can treat or cure coronavirus. 

FTC Chair Joe Simons stated: “There already is a high level of anxiety over the potential spread of coronavirus.  What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims.  These warning letters are just the first step.  We’re prepared to take enforcement actions against companies that continue to market this type of scam.”

Commentary

FTC and FDA have pledged to continue to monitor social media, online marketplaces, and incoming complaints to ensure these products do not continue to make such claims.  The letters sent emphasize that, if the false claims do not cease, FTC may seek a federal court injunction and an order requiring money to be refunded to consumers and instructing the recipients to notify the FTC within 48 hours of the specific actions they have taken to address FTC’s concerns.

In addition, the FTC recently issued a new consumer blog post with information about how to identify and avoid coronavirus-related scams.  Coronavirus: Scammers follow the headlines notes that scammers are creating websites to sell bogus products, and using fake emails, texts, and social media posts as a ruse to take consumers’ money and obtain personal information.  It then warns consumers of the “red flags” to monitor when shopping for products related to the virus.

EPA also has been active in this area, announcing 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 and also announcing its process for expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants. 


 

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

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 .(JavaScript must be enabled to view this email address) 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.


 

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.


 

By Lisa R. Burchi and Margaret R. Graham

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) issued guidance to registrants on the process for making claims against emerging viral pathogens not on EPA-registered disinfectant labels (Guidance).  A draft of this guidance was issued in April 2016 and comments were sought at that time.  More information concerning the draft guidance is available in our blog item EPA Combats Emerging Pathogens Through Updating Guidance for Antimicrobial Pesticide Products.

The current Guidance document, which EPA states “provides general guidance to registrants that can be used to identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens,” includes changes incorporated following EPA’s review of the three public comments received in response to that draft.  

The Guidance retains the voluntary two-stage process, but amends the first stage as indicated:

  • In the first stage, which may be performed prior to any outbreak, registrants with an eligible disinfectant product may submit a request, via label amendment or during the registration of a new product, to control a specific emerging viral pathogen to add a designated statement to the master label and additional terms to the product registration.  If the product meets the eligibility criteria suggested in this Guidance, [EPA] generally will approve the amendment.  Approval of the amendment would include additional terms and conditions of registration regarding how the designated statement may be published and communicated.

In its response to comments document, EPA responded to several comments, including:

  • Changes were made to EPA’s mandated non-label statements to remove certain language that could be considered redundant.
  • EPA is developing a coordinated process with the Centers for Disease Control and Prevention for the purpose of providing a more standardized and consistent approach to emerging viral pathogen outbreaks.  Once this process is established, the agency expects to consult with the U.S. Department of Agriculture to develop a similar approach.
  • The Guidance document allows for the addition of emerging pathogen claim language to the master label during the new product registration process if the product is eligible.  Additional language has been added to multiple locations in the Guidance document to clarify that the process is appropriate for new product registrations.
  • EPA “may consider allowing use of additional modes of claim communication under future versions of this Guidance document, however, hangtags and other promotional materials are not authorized at this time.  Because the statements authorized under this Guidance are pesticidal claims that do not meet the FIFRA registration criteria, it is essential that these off-label claims are not made outside of an emerging pathogen outbreak as described in the Guidance. Accordingly, the Guidance limits these off-label claims primarily to communications outlets that are wholly within the registrant’s control (800 numbers, social media and websites) from which the off-label claims can be immediately removed. Hangtags and other promotional materials directed towards general consumers are largely out of the registrant’s control once the products enter the chain of commerce, and may persist long after the period during which the off-label claims are authorized.”

EPA also notes that this Guidance document “provides general guidance to EPA, pesticide registrants, applicants for pesticide registrations, and the public.  This guidance is not binding on EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice.”


 

By Lisa M. Campbell and Lisa R. Burchi

In response to the increasing concerns regarding emerging viral pathogens that are not on U.S. Environmental Protection Agency (EPA)-registered disinfectant labels, EPA announced on April 7, 2016, that it was updating its Guidance regarding emerging viral pathogens.  Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is authorized to evaluate the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health.  Many believe that the process under which registrants can identify “effective disinfectant products for use against emerging pathogens,” and the process for EPA to “permit registrants to make limited claims of their product’s efficacy against such pathogens,” have not been clear and efficient.  EPA notes, for example, that “[emerging] pathogens are often unavailable commercially, and standard methods for laboratory testing may not have been developed,” such that it “can be difficult to assess the efficacy of EPA-registered disinfectants against such pathogens in a timely manner and to add these viruses to existing product registrations.”

EPA hopes that its Guidance will “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.

EPA’s new draft Guidance document, Draft Guidance to Registrants:  Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels, describes “a voluntary two-stage process to enable the use of certain EPA-registered disinfectant products against these emerging viral pathogens, uses not previously identified on the product label”:

  • First Stage:  This stage may be performed prior to any outbreak. EPA summarizes the first stage as follows:  “registrants with an eligible disinfectant product may submit a request, via label amendment, to add a designated statement to the master label and additional terms to the product registration.  If the product meets the eligibility criteria suggested in this Guidance, [EPA] generally will approve the amendment.  Approval of the amendment would include additional terms and conditions of registration regarding how the designated statement may be published and communicated.”
  • Second Stage:  This stage would occur only during a human or animal disease outbreak caused by an emerging virus.  EPA summarizes this stage as follows:  “In this stage, registrants of products with the previously mentioned label amendment and terms of registration would be allowed to use the designated statement in off-label communications intended to inform the user community/public that the disinfectant product(s) may be used against the specific emerging viral pathogen.  These off-label statements can inform the public about the utility of these products against the emerging pathogen in the most expeditious manner and can be more easily removed once the outbreak has ended than statements on a label.”

Comments related to clarity of this Guidance will be accepted until May 6, 2016.  For more information, please see our memorandum EPA Announces Updated Guidance for Antimicrobial Pesticide Products Intended to Combat Emerging Pathogens.


 
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