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, Lisa R. Burchi, and Barbara A. Christianson

On October 28, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2018 (2018 Report).  85 Fed. Reg. 68327.  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2018 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration.  The 2018 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA.  The report is available at EPA-HQ-OPP-2014-0125.  Comments can be submitted on or before December 28, 2020.

EPA’s completed product reregistration actions totaled 177, short of EPA’s goal of 400 actions.  The table below details the actions completed in FY 2018.

Table 1.  Product Reregistration Actions Completed in FY 2018 (as of September 30, 2018)

Actions FY 2018
Product reregistration actions 19
Product amendment actions 33
Product cancellation actions 125
Product suspension actions 0
Total actions 177

 

 

 

 

 

 

EPA also states that 4,193 products had product reregistration decisions pending at the end of FY 2018, compared to 4,370 products with product reregistration decisions pending at the end of FY 2017, and 4,621 products with product reregistration decisions pending at the end of FY 2016.  Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”

The number of applications for registration requiring expedited processing (i.e., “fast-track” applications) that EPA considered and approved has been more consistent in recent years, with 2,422, 2,574, and 2,303 in 2016, 2017, and 2018, respectively.


 

By Barbara A. Christianson

On October 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses.  This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes COVID-19.  While traditional disinfectants only kill viruses and bacteria that are on the surface at the time they are used, surfaces treated with residual antimicrobial products kill pathogens that come into contact with the surface days, weeks, or years after the product is applied.

EPA announced in an October 26, 2020, memorandum that it is seeking feedback from the public on the expedited process, design elements for evaluating residual product claims, and the test methods associated with this initiative. 

All comments on the interim guidance must be submitted to Docket Number EPA-HQ-OPP-2020-0529 on or before January 4, 2021. 

The interim guidance documents -- Interim Method for Evaluating the Efficacy of Antimicrobial Surface Coatings, Interim Guidance - Expedited Review for Products Adding Residual Efficacy Claims, and Interim Method for the Evaluation of Bacterial Activity of Hard, Non-Porous Copper-Containing Surface Products -- are available in Docket Number EPA-HQ-OPP-2020-0529.  More information on the interim guidance is available on our blog.


 

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

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.  EPA’s guidance specifies scientific testing requirements for two different types of products:  (1) disinfectants that also provide residual efficacy, and (2) supplemental residual antimicrobial products (e.g., coatings, paints, solid surfaces) that do not meet EPA’s standards for disinfectants but are intended to be used as a supplement to standard List N disinfectants.

In addition to releasing the draft residual efficacy protocols, EPA has also released an updated draft testing protocol for evaluating a copper surface’s ability to kill bacteria and a draft protocol for evaluating the efficacy of antimicrobial surface coatings.  These laboratory testing methods act as a foundation for EPA’s interim guidance to registrants regarding residual effectiveness.

While EPA does not have an approved standard method to support virus claims for these types of products, EPA states that the following information is intended to provide interim guidance on the study design elements necessary to support these types of claims.  EPA states that it may consider other methods or studies to support residual efficacy claims, provided they are scientifically sound.  Applicants are highly encouraged to consult with EPA prior to submitting.  Of significant interest, EPA states that products may make both types of residual claims provided that they are supported by the appropriate data.

Due to lab capacity concerns, EPA plans to consider non-GLP (Good Laboratory Practice) data to support residual claims, provided that the study submission accurately represents how the study differs from the GLP standards in the 40 C.F.R. Section 160.12 statement of non-compliance.  Additional details provided in the EPA guidance on how to qualify products for residual disinfectants or supplemental residual antimicrobial products are briefly outlined below.

Residual Disinfectant Claims

Residual disinfectants must clear a higher standard of efficacy than supplemental residual antimicrobial products.  Residual disinfectant products must be effective within 10 minutes of a virus or bacteria contacting a treated surface and must remain effective for up to 24 hours.  Surfaces treated with residual disinfectants must not require additional cleaning or disinfection during this window.  EPA-approved residual disinfectant products are eligible to be added to List N.  In addition, long-lasting coating products must satisfy all requirements for standard disinfectant claims (non-residual) to be eligible for residual disinfectant claims and must have undergone testing to support standard disinfectant claims.

To support a claim as a residual bactericidal disinfectant, applicants should use EPA’s Residual Self-Sanitization Protocol with the following modifications:

  • Base Bacteria -- Consistent with EPA Guideline 810.2200, Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) should be used to support the case residual disinfectant claim.
  • Conduct testing on three product lots at the lower certified limit (LCL) for each bacterium.  In accordance with the OCSPP 810.2000 Test Guideline, certificates of analysis should be submitted to substantiate the tested concentration.
  • Residual testing to support additional vegetative bacteria is not needed.  Claims can be bridged from the standard disinfectant (non-residual data) for additional bacteria.  For example, if a product has data to support a base disinfectant claim (Staphylococcus aureus and Pseudomonas aeruginosa) and data to support disinfectant claims for additional vegetative bacteria (e.g., Escherichia coli or MRSA), residual data are only needed for the base bacteria, and not additional bacteria, to support residual claims for those vegetative bacteria for which base disinfectant claims are supported.
  • According to the Residual Self-Sanitization Method, durability testing should include 12 wear cycles, consisting of abrasions (alternating wet and dry) and re-inoculations to support a 24-hour residual disinfectant claim.  Each wear cycle consists of four passes (two back and forth) of the abrasion material over the surface followed by re-inoculation.  Additional details can be found in the method.
  • Products should achieve a ≥ 5-log reduction in ≤ 10 minutes ± 5 seconds for qualifying bacteria when compared to the parallel abrasion and re-inoculation controls to support residual disinfectant claims.
  • According to the OCSPP 810.2200 Test Guideline, the performance standard and time to meet the performance standard are consistent with the standards for non-residual disinfectants.
  • At this time, expedited review is limited to residual disinfection claims of 24 hours or less based on data generated in accordance with the re-inoculation and abrasion cycles specified in the referenced protocol.
  1. Residual Virucidal Claims

EPA’s Residual Self-Sanitization Protocol with the modifications below should be used to support residual virucidal claims.  Virucidal efficacy should be assessed consistent with the principles of ASTM E1053 (e.g., recovery, cytotoxicity, neutralization, and calculations), the standard virucidal method detailed in OCSPP 810.2200 Product Performance Test Guideline.

  • To support residual virucidal claims, acceptable non-residual virucidal efficacy (3-log reduction) should be demonstrated for the product at ≤ 10-minute contact time consistent with the OCSPP 810.2200 Product Performance Test Guideline.
  • Residual virucidal data should be generated for the most difficult to kill virus that that the product claims to kill.  Claims for residual effect against the other viruses can be bridged from the non-residual virucidal data supporting the product.  For additional information on selecting the most difficult to kill virus, see EPA’s Emerging Viral Pathogens Guidance.
    • To be considered for List N, virus testing should include a non-enveloped virus or a human coronavirus (SARS-CoV-2 or human coronavirus 229E).
  • Testing on two product lots should be conducted at the LCL.
  • According to the Residual Self-Sanitization Method, durability testing should include 12 wear cycles consisting of abrasions (alternating wet and dry) and re-inoculations to support a 24-hour residual disinfectant claim.  Each wear cycle consists of four passes of the abrasion material over the surface followed by re-inoculation.  Additional details can be found in the method.
  • Products should achieve ≥ 3-log reduction in ≤ 10 minutes ± 5 seconds for the hardest to kill virus when compared to the parallel abrasion and re-inoculation controls to support residual virucidal claims.
    • The performance standard and contact times are consistent with the standard non-residual disinfectants.
  • At this time, expedited review is limited to residual disinfection claims of 24 hours or less based on data generated in accordance with the re-inoculation and abrasion cycles specified in the referenced protocol.
  1. Labeling and additional information (both bactericidal and virucidal)
  • Products are eligible for inclusion on List N following adherence to the Emerging Viral Pathogens guidance or appropriate testing for a qualifying virus (e.g., SARS-CoV-2 or human coronavirus 229E).
  • These products may be used as stand-alone disinfectants and do not need a label disclaimer that they are a “supplement to standard disinfection” since they meet the general criteria for disinfectants (effective in ≤ 10 minutes with appropriate log reductions for bacteria and virus).

Supplemental Residual Antimicrobial Products

Supplemental residual antimicrobial products work within two hours of a virus or bacteria coming into contact with a surface and can remain effective for weeks to years.  These products can supplement, but not replace, routine cleaning and disinfection using products from EPA’s List N:  Disinfectants for Use Against SARS-CoV-2 (COVID-19).  Approved supplemental residual antimicrobial products are not eligible for inclusion on List N, but will be added to a separate List N appendix.

Qualifying antimicrobial surface coatings, films, fixed/solid, and paint products should demonstrate efficacy against vegetative bacteria first before virus claims can be supported.  These products are not required to meet the efficacy standards for disinfectants and can only be approved for use as supplements to standard disinfection. The duration of residual effectiveness claims that EPA will consider for expedited review depends on the type of product, as outlined below.

  1. Antimicrobial Surface Coatings and Films

For these products, EPA states that EPA’s draft Performance of Antimicrobial Surface Coatings on Hard Non-porous Surfaces for qualifying bacteria should be used.  EPA provides the following additional information for products on which virus claims would be added:

  • Test Organisms
    • Bacteria -- Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) are the qualifying bacteria required to support supplemental residual antimicrobial surface claims for the proposed claim duration (e.g., one week, two weeks).
      • Testing should be conducted on three product lots per bacterium at the LCL.
    • To support claims for additional bacteria, testing should be conducted according to the method but with a reduced number of product lots.
      • Two lots of product for each bacterium at the nominal concentration.
    • Viruses -- All viruses for which claims are desired should be tested.  The most difficult to kill virus should be subjected to the durability assessment using coating carriers followed by the efficacy assessment to support the proposed duration (e.g., one week, two weeks).  All other viruses should be tested using coated carriers that were not subjected to the durability procedure.
      • Assessment of virucidal efficacy on the coated carriers should be conducted consistent with ASTM E1053, the standard method specified in EPA’s 810.2200 Efficacy Test Guideline.
      • Two lots of product at the LCL should be tested for the most difficult to kill virus.  Two lots of product at the nominal concentration should be tested for additional viruses.
        • To be considered as a supplement to List N, virus testing should include a non-enveloped virus or a human coronavirus (SARS-CoV-2 or human coronavirus 229E).
  • Stainless steel carriers will be used to support claims for coatings on hard, nonporous surfaces.  Use sites should be limited to hard, non-porous surfaces.  Additional material types (e.g., porous materials or textiles) may be proposed by the registrant upon consultation with EPA prior to submission.
  • The recommended number of abrasions (touches) and cycles of exposure to cleaning or disinfecting chemicals are provided in the method to substantiate durability claims.  The method also specifies the chemical disinfecting solutions to simulate cycles of in-service disinfection and cleaning.  Additional details can be found in the method.
    • Ten cycles of abrasion and/or chemical exposure is equivalent to one week of durability.  The number of cycles can be increased in one-week increments to support claims up to four weeks.
    • If a product is incompatible with one or more of the test chemistries, this should be discussed with EPA in advance and may limit use sites and surfaces depending on the nature of the incompatibility.  EPA does not have a standard method for determining incompatibility.  This may be based on research and development data or known incompatibilities with the coating material, for example.
  • This protocol may be modified for films upon consultation with EPA in advance of submission.
  • If an applicant intends to claim supplemental residual effects longer than four weeks, it should consult with EPA in advance of submission.  EPA states that because the ongoing antimicrobial integrity of coatings and films will not be readily visible, it is important that end users have a reasonable expectation of durability.
  • Products should achieve a 99.9% reduction (3-log) for both bacteria and viruses in comparison to untreated controls within a maximum of two hours but not less than one hour, as EPA is concerned that observations taken before the inoculum has dried (e.g., less than one hour) on the surface may not provide an accurate assessment of the product.
    • The time to achieve performance begins at the time of inoculation.
  1. Antimicrobial Surface Coatings and Films -- Labeling and Additional Information

EPA states that this new category of antimicrobial products should be labeled as supplemental residual antimicrobial surfaces.  EPA provides the following additional information:

  • As these products do not meet the criteria for a disinfectant due to the longer contact time and lower performance standard, claims for residual disinfectant are not acceptable.  As above, contact times for disinfectants are ≤ 10 minutes and with a higher performance standard for bacteria.
  • Products should carry the following prominent label qualifier that they are a supplement to standard disinfection and cleaning:
    • “Although this product DOES NOT meet EPA’s standards for disinfectants, EPA has determined that, when used with an EPA-registered disinfectant, this product can provide some additional protection against [microorganism(s)] for up to X days. This product DOES NOT achieve the same level of efficacy as an EPA-registered disinfectant; it is only intended to provide supplemental protection between routine applications of EPA-registered disinfectants.”
  • For products eligible only for supplemental residual antimicrobial claims, EPA intends to require as a term of registration that the label and labeling state, “This product does not meet EPA’s efficacy standards to qualify as a stand-alone disinfectant.”
  • Although these products will not be eligible for List N, they will be eligible as a supplement to List N (N.1) to reflect that they are supplemental treatments (i.e., not stand-alone disinfectants) and intended for use in combination with List N disinfectants.
  • The following are example acceptable product label claims:
    • “Kills 99.9% of [insert microorganism/s] within two hours of exposure when used as part of a comprehensive infection control program/protocol for up to X days.”
    • “Continuously reduces [insert microorganism/s] within two hours of exposure when used as part of a comprehensive infection control program for up to X days.”
  1. Fixed/Solid Surfaces Including Solid Copper and Other Metals and Solid Impregnated Materials and Paints -- Method Recommendation

EPA states that these products should use EPA’s Draft Copper Surface Protocol for qualifying bacteria.  EPA provides the following additional information for products that wish to have virus claims added.

  • Test Organisms
    • Bacteria -- Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) are the qualifying bacteria used to support supplemental residual surface claims.
      • Testing should be conducted on three product lots per bacterium at the LCL.
    • To support claims for additional bacteria, testing should be conducted according to the method but with a reduced number of product lots.
      • Two lots of product for each bacterium at the nominal concentration.
    • Viruses -- All viruses for which claims are desired should be tested.  The most difficult to kill virus should be subjected to the durability assessment in the copper method, followed by the efficacy assessment.  All other viruses should be tested using test carriers that were not subjected to the durability procedure.
      • Assessment of virucidal efficacy on the coated carriers should be conducted consistent with ASTM E1053, the standard method specified in EPA’s 810.2200 Efficacy Test Guideline.
      • Two lots of product at the LCL should be tested for the most difficult to kill virus.  Two lots of product at the nominal concentration should be tested for additional viruses.
  • The recommended number of abrasions (touches) and cycles of exposure to cleaning or disinfecting chemicals are provided in the method in order to substantiate durability claims.  The method also specifies the chemical solutions to simulate cycles of disinfection and cleaning.
    • As the durability of these types of products can be readily observed, duration claims are not necessary.  This is consistent with currently registered copper-containing surface products and paints.
    • If a product is incompatible with one or more of the test chemistries, this should be discussed with EPA in advance and may limit use sites and surfaces, depending on the nature of the incompatibility.  EPA states that it does not have a standard method for determining incompatibility.  This may be based on research and development data or known incompatibilities with the coating material, for example.
  • This protocol can be modified for other metals or solid impregnated surfaces or paints upon consultation with EPA.
  • Products should achieve a 99.9% reduction (3-log) for both bacteria and viruses in comparison to untreated controls within two hours.
    • The time to achieve performance begins at the time of inoculation.
  1. Fixed/Solid Surfaces Including Solid Copper and Other Metals and Solid Impregnated Materials and Paints -- Labeling and Additional Information

EPA states that these products should be labeled as supplemental residual antimicrobial surfaces.  EPA states the following with regard to these products:

  • As these products do not meet the criteria for a disinfectant due to the longer contact time and lower performance standard, claims for residual disinfectant are not acceptable.
  • Products should carry the following prominent label qualifier that they are a supplement to standard disinfection and cleaning:
    • “Although this product DOES NOT meet EPA’s standards for disinfectants, EPA has determined that, when used with an EPA-registered disinfectant, this product can provide some additional protection against [microorganism(s)] for up to X days. This product DOES NOT achieve the same level of efficacy as an EPA-registered disinfectant; it is only intended to provide supplemental protection between routine applications of EPA-registered disinfectants.”
  • For products eligible only for supplemental residual antimicrobial claims, EPA intends to require as a term of registration that the label and labeling should state, “This product does not meet EPA’s efficacy standards to qualify as a stand-alone disinfectant.”
  • Although these products will not be eligible for List N, they will be eligible as a supplement to List N (N.1) to reflect that they are supplemental treatments (i.e., not stand-alone disinfectants) and intended for use in combination with List N disinfectants.  The following are example acceptable product label claims:
    • “Kills 99.9% of [insert microorganism/s] within two hours of exposure when used as part of a comprehensive infection control program/protocol.”
    • “Continuously reduces [insert microorganism/s] within two hours of exposure when used as part of a comprehensive infection control program.”
  1. Supplemental Residual Antimicrobial Products -- Stewardship Program

EPA intends to require, as a term of registration, that registrants of all supplemental residual antimicrobial products prepare and implement a written stewardship plan designed to support the responsible use of supplemental residual coatings and antimicrobial surface products.  Unlike conventional antimicrobial products, EPA believes that these products represent unique challenges that require timely feedback to ensure proper use and compatibility in combination with current infection control practices.  EPA expects that plans would be submitted for EPA review and approval during the registration process, or shortly thereafter (e.g., within two months after the registration date).  An approvable plan would address the proper sale (including advertising and promotional materials), distribution, and responsible use of the supplemental residual coatings and antimicrobial surface products.  EPA states that plans should include, at a minimum, the following elements:

  • Advertising and promotional materials that clearly and consistently include a disclaimer that the product does not meet EPA’s standards for disinfectants and is intended to supplement the use of EPA-registered disinfectants.
  • Outreach to the infection control community;
  • Customer feedback consisting of product issues/concerns, adverse events, compliance challenges/observations, and contraindications/adverse events gathered through quarterly registrant-initiated surveys, customer complaints, and suggestion boards; and
  • Development of a stewardship website.

EPA states further that “if EPA determines at any time following registration that the Plan is not being adequately or timely implemented or does not effectively ensure the product’s safe and effective use, the registration may be cancelled by the Agency.”  It is not clear from the statement whether EPA intends such a cancellation to be a term of the registration or whether it would be undertaken pursuant to the standard FIFRA cancellation procedures.


 

By Lynn L. Bergeson, Lisa M. Campbell, and Carla N. Hutton

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.  As most know, EPA has not before now provided guidance on how stakeholders can demonstrate to EPA’s satisfaction that their product remains efficacious for periods of time, given the broad diversity of contact opportunities and scenarios.  Importantly, EPA states that pursuant to Title VII of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, it is providing notice of its intention to expedite reviews for addition of residual (i.e., extended or long-lasting) efficacy claims for currently registered or new product registrations that are on EPA’s Disinfectant List N, that would qualify for List N, or products that can be used as a residual supplement to disinfectants on List N.  The guidance specifies scientific testing requirements for two different types of products, supplemental residual antimicrobial products and residual disinfectants.  According to EPA, supplemental residual antimicrobial products work within two hours of a virus or bacteria coming into contact with a surface and can remain effective for weeks to years.  EPA notes that these products can supplement, but do not replace, routine cleaning and disinfection using products from EPA’s List N:  Disinfectants for Use Against SARS-CoV-2 (COVID-19).  Approved supplemental residual antimicrobial products are not eligible for inclusion on List N, but EPA will add them to a separate List N appendix.

In addition to releasing the draft residual efficacy protocols, EPA has also released an updated draft testing protocol for evaluating a copper surface’s ability to kill bacteria and a draft protocol for evaluating the efficacy of antimicrobial surface coatings.  According to EPA, “[t]hese laboratory testing methods act as a foundation for EPA’s interim guidance to registrants regarding residual effectiveness.”

More information will be available in a forthcoming memorandum that will be available on our website.


 

This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below.

This week, I sat down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group.  As a former Assistant Administrator in what is now the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention, Jim has a keen sense of how EPA prepares for and transitions to changes in Administrations.  As we prepare for the November elections, we thought it would be good to check-in with Jim and get a sense of how our colleagues at EPA are faring.  After reviewing key topics in the pesticide world, Jim walks us through how and when pesticide registrants and others in the commercial value chain can prepare for any forthcoming transition, consequential or otherwise.  Jim discusses whether regulated entities can expect policy changes occasioned by a new Administration, regardless of who wins.  Jim also addresses the implications of changes in the Supreme Court in light of Justice Ginsburg’s death. Jim’s insights in these areas is spot on and timely.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2020 Bergeson & Campbell, P.C.  All Rights Reserved


 

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

On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2. 

In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance).  EPA published this Guidance in August 2016, to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels.  The Guidance allows product registrants to make limited off-label claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA that demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2. 

Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2.  List N currently includes 469 products and is updated weekly.  In many cases, EPA states that it was able to approve claims in as little as 14 days.

The 13 products approved include 12 unique products from the manufacturer Lonza and one additional Lysol product from Reckitt Benckiser.  The 13 products approved are:

  • Lonza Formulation S-21 (EPA Reg. No. 6836-75);
  • Lonza Formulation S-18 (EPA Reg. No. 6836-77);
  • Lonza Formulation R-82 (EPA Reg. No. 6836-78);
  • Lonza Formulation S-18F (EPA Reg. No. 6836-136);
  • Lonza Formulation R-82F (EPA Reg. No. 6836-139);
  • Lonza Formulation S-21F (EPA Reg. No. 6836-140);
  • Lonza Formulation DC-103 (EPA Reg. No. 6836-152);
  • Lonzaguard RCS-256 (EPA Reg. No. 6836-346);
  • Lonzaguard RCS-128 (EPA Reg. No. 6836-347);
  • Lonzaguard RCS-128 PLUS (EPA Reg. No. 6836-348);
  • Lonzaguard RCS-256 PLUS (EPA Reg. No. 6836-349);
  • Lonzaguard R-82G (EPA Reg. No. 6836-381); and
  • Lysol® Disinfecting Wipes (All Scents) (EPA Reg. No. 777-114).

Additional information is available here.


 

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

On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of new guidance (Guidance) for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.  This new guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product labels.  The Guidance outlines information that EPA asks registrants to submit to obtain expedited review of their proposed addition of this application method to their labels.

EPA notes that electrostatic spraying has drawn increased interest through the current public health emergency posed by COVID-19 because of the need to disinfect large indoor spaces, such as schools, offices, businesses, and other large areas, or areas with many surfaces.  Unlike conventional spraying methods, electrostatic sprayers apply a positive charge to liquid disinfectants as they pass through the nozzle.  The positively charged disinfectant is attracted to negatively charged surfaces, which allows for efficient coating of hard, nonporous surfaces.

EPA’s Guidance addresses adding electrostatic spray application methods to both new and currently registered disinfectant products that are on EPA’s List N: Disinfectants for Use Against SARS-CoV-2, or that would qualify for List N, and require review under the Pesticide Registration Improvement Extension Act (PRIA 4). 

EPA states that it will expedite the following registration applications:

  • Requests to amend currently registered products, including products on List N, that require review of data under PRIA 4:
    • Current EPA-registered products approved for spray use application methods, already on List N, and the application is supported by the following data and revised label language: 
      • Confirmatory efficacy data conducted with an electrostatic sprayer to bridge from the existing approved claims to application by electrostatic sprayers;
      • A wetness test consistent with MLB SOP MB-31 and a video to demonstrate that the surface remains wet for the duration of the contact time; and
      • The following amendments made to the product label for electrostatic spray use directions:
        • Spray droplet particle size (regardless of the ability to change nozzles that impact particle size) should be limited to a volume median diameter (VMD) ≥40 µm1.
        • Include the contact time and minimum and maximum spray distance from the application equipment to the treated surface that is supported by the efficacy data, and instructions to reapply if the surface dries before the contact time is achieved.
        • Place the electrostatic spray function in the ON position for electrostatic spray models that have the functionality to toggle ON/OFF.
        • Specify that bystanders and pets must not be in the room during application.
      • The following personal protective equipment (PPE) should be specified on the product label as part of the electrostatic spray use directions:
        • For chemicals that have low vapor pressures (less than 1. x 10-4 mm Hg), use N95 filtering face piece respirators or half face respirators with N95 filters.
        • For high vapor pressure chemicals (greater than 1. x 10-4 mm Hg), such as hydrogen peroxide, use half face respirators with chemical specific cartridges and N95 filters.
        • Other PPE, including gloves, clothing, and eye protection is applicable as specified on the approved product label consistent with the acute toxicity profile of the product.
    • Current EPA-registered products approved for spray use application methods for inclusion on List N:
      • For a request to amend currently registered products for inclusion on List N and to specify electrostatic spray as an approved method of application, follow the directions in EPA’s previously announced expedited review of certain PRIA 4 submissions for products intended for use against SARS-CoV-2. Specifically, follow the directions in the “Request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data)” section and include the additional information specified above for electrostatic sprayers as part of the submission. Submission of new efficacy data to add claims to an already EPA-registered product along with the information specified for electrostatic sprayers can be submitted together as a PRIA 4 A570 action for expected expedited review.
      • The submission should include a PRIA 4 fee payment in the amount of $4,023, or small business fee waiver request with the appropriate fee for a PRIA 4 A570 action. EPA states that it will make every effort to complete the review and make a regulatory decision one to two months faster than the standard four-month time frame under PRIA 4.
    • Current EPA-registered products not approved for spray use application methods or for which modified PPE label language is desired for inclusion on List N:
      • If the currently registered product labeling for the active ingredient is not approved for spray use application methods and/or the registrant wants to conduct and submit data to modify the default PPE label language specified above, these data should be submitted as a PRIA 4 code A572 and include the efficacy data, directions for use for electrostatic sprayers, and other documents specified above. EPA states it will make every effort to complete the review and make a regulatory decision one to two months faster than the standard nine-month time frame under PRIA 4.
      • In addition, include the receipt of a PRIA 4 fee payment in the amount of $13,888 for an A572 action, or small business fee waiver request with the appropriate fee for a PRIA 4 A540 action or PRIA 4 A572 action.
  • Requests to add electrostatic spray use directions to a new product that requires the review of data under PRIA 4:

EPA’s Guidance builds on EPA’s previously announced expedited review of certain submissions for products intended for use against SARS-CoV-2.

This guidance is important for many disinfectant products.  Affected registrants or potential registrants should review it carefully. 


 

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

On July 6, 2020, the U.S. Environmental Protection Agency (EPA) announced that it approved amended labels for two products, Lysol Disinfectant Spray (EPA Reg. No. 777-99) and Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127), based on laboratory testing that shows the products are effective against SARS-CoV-2.  These are the first products for which EPA has reviewed laboratory testing data and approved label claims against SARS-CoV-2. 

In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance),  This Guidance was developed in April 2016 to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels.  The Guidance allows product registrants to make limited claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA and demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2. 

Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2.  List N currently includes 431 products and is updated weekly.  In many cases, EPA states that it was able to approve claims in as little as 14 days.

This week, EPA updated the entries for the two Lysol products on List N to indicate they have now been tested directly against SARS-CoV-2.  This is significant since they are the first List N products for which EPA has reviewed laboratory testing data specifically against SARS-CoV-2, and not listed based on EPA’s determination that a product can be used against SARS-CoV-2 because of the product’s effectiveness against a harder-to-kill virus. 

EPA states that it expects to approve such claims for additional List N products in the coming weeks.


 

By Lisa M. Campbell, Timothy D. Backstrom, and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on July 2, 2020, that it has registered NSPW Nanosilver (a new nanosilver formulation) to suppress odor-causing bacteria and algae, fungus, mold, and mildew that can cause deterioration or staining in textiles.  Textiles that may be treated with NSPW Nanosilver include fabrics, sportswear, footwear, linens, and awnings.  NSPW Nanosilver is the active ingredient in the pesticide product POLYGUARD-NSPW MASTER BATCH (Polyguard).  The NSPW Nanosilver in Polyguard will be embedded within beads or pellets of a polymeric material in a “master batch,” and these beads of pellets will then be incorporated into treated textiles through a closed-loop manufacturing process.  EPA states that once the beads or pellets containing NSPW Nanosilver are introduced into this manufacturing process, no beads or pellets can escape into the environment.  EPA also states that the available data indicate that the leach rate of nanosilver from NSPW Nanosilver-treated textiles is below the limit of detection.

The same type of nanosilver was the active ingredient in another product that EPA previously conditionally registered under FIFRA Section 3(c)(7)(C) in 2015.  The U.S. Court of Appeals for the Ninth Circuit issued a decision vacating that conditional registration because the court concluded that the mandatory public interest finding by EPA was not adequately supported by the administrative record.  According to EPA, the new registration for NSPW Nanosilver involves a modified use pattern that will limit exposures compared to the product that received the previously vacated conditional registration.  Based on additional data that the applicant has submitted to support the use pattern as modified, EPA has prepared an updated risk assessment for NSPW Nanosilver and has determined based on that risk assessment that the product as modified meets the standard for an unconditional registration under FIFRA Section 3(c)(5).  Materials supporting this action will be posted in Docket ID EPA-HQ-OPP-2020-0043.

Commentary

Registering any new metallic silver product that satisfies the EPA criteria for classification as nanosilver for use as an antimicrobial pesticide presents special challenges, because EPA has adopted a policy that it will construe each new nanosilver product as a new pesticidal active ingredient.  The predecessor to NSPW Nanosilver (Nanosilva) was granted a conditional registration, a procedure that EPA uses when there are data gaps that must be filled before EPA is ready to make the determinations that would support issuance of an unconditional registration.  EPA may only issue a conditional registration for a product containing a new pesticidal active ingredient when EPA makes a determination that “use of the pesticide is in the public interest,” and the Ninth Circuit Court determined that EPA did not compile an administrative record adequate to support that finding.

Colloidal metallic silver products that meet the definition of nanosilver were first synthesized in the late 19th century.  Some industry stakeholders question whether the differences between different pesticide products that satisfy the EPA definition of nanosilver are sufficiently great to treat each new product as a new active ingredient, but it is also clear that the size and shape of the particles in these products do vary.  In this instance, EPA has determined that the supporting data for the application allow EPA to issue an unconditional registration.  Accordingly, the legal issue on which the Ninth Circuit based its prior decision to vacate the conditional registration for Nanosilva is not pertinent to the current registration decision.  Given the challenge to the prior registration decision, it will be important to monitor any opposition to the newly issued registration.


 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On June 8, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of an existing stocks order under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1) governing further sale, distribution, and use of existing stocks of three reduced volatility dicamba products (XtendiMax®, EngeniaTM, and FeXapanTM) with conditional registrations that were vacated by the June 3, 2020, decision of the Ninth Circuit Court of Appeals in National Family Farm Coalition v. EPA.  EPA explained its action by stating that the existing stocks order would provide “clarity to farmers” in light of the Court decision.  Because EPA believes that vacatur made those stocks of the three dicamba products that were already in channels of trade unregistered pesticides, and the Court’s decision did not specifically address or establish any regimen to govern these unregistered existing stocks, EPA concluded that issuance of an existing stocks order was a practical necessity.  The existing stocks order includes provisions that:  (1) prohibit all sale and distribution of existing stocks of the three vacated dicamba products by the registrants, and by persons other than commercial applicators except for disposal of the products or returning the products to the registrants or their contract agents, (2) allow commercial applicators to use existing stocks of the vacated dicamba products in their possession in a manner consistent with existing labeling until July 31, 2020, and (3) prohibit end users from using existing stocks of the vacated dicamba products in their possession except in a manner consistent with existing labeling and from using such stocks in any manner after July 31, 2020.

Need for an Existing Stocks Order

To understand EPA’s position concerning the need for an existing stocks order for the three dicamba products with registrations vacated by the Ninth Circuit decision, it is important to review the legal status of those existing stocks after issuance of the decision.  In the absence of further EPA action, all stocks of the three dicamba products subject to the vacatur order that were already in channels of trade became unregistered pesticides.  Under FIFRA, as unregistered pesticides, these products could not be distributed or sold, which would prohibit stock of the unregistered products from being returned to the registrants or disposed, absent further EPA action.  Stocks of the three products that were labeled for uses other than soybeans and cotton (the uses extended by the conditional registration decision vacated by the Court) also became unregistered and thus also could not be distributed or sold absent further action by EPA.  Without further action by EPA, stocks of the three products already in the hands of end users could be lawfully used without any kind of restriction because although FIFRA Section 3(a) prohibits sale or distribution of unregistered pesticides, FIFRA does not include any provision prohibiting or limiting use of unregistered pesticides.  Thus, the Court’s vacatur action created a situation in which EPA needed to act expeditiously to establish a rational regimen governing existing stocks of the three dicamba products.  EPA was able to issue an order creating such a regimen because EPA construes the vacatur of the product registrations by Court action as a type of cancellation, which is how EPA has construed vacatur orders in the past.  FIFRA Section 6(a)(1) expressly authorizes EPA to issue orders governing sale, distribution, and use of canceled pesticides.

EPA Policy for Existing Stocks Orders

EPA adopted a policy in 1991 (56 Fed. Reg. 29362) outlining six factors it generally considers in adopting existing stocks orders for canceled pesticides under FIFRA Section 6(a)(1):  (1) the quantity of existing stocks at each level in channels of trade, (2) the risks resulting from use of existing stocks, (3) the benefits resulting from use of existing stocks, (4) financial expenditures users and others have already spent on existing stocks, (5) the risks and costs of disposal or alternative disposition of existing stocks, and (6) the practicality of implementing restrictions on the distribution, sale, or use of existing stocks.  EPA applied this policy to the current situation and determined that “[e]ach of the six factors weighs heavily in support of allowing end users to use existing stocks of these dicamba products that are in their possession.”  Since use of these unregistered pesticides is not otherwise prohibited by FIFRA as discussed above, EPA adopted prohibitions of use of the products not in accordance with the current labeling and of any use after July 31, 2020.  The only action taken by EPA to authorize further use of the three products involved stocks held by commercial applicators, which EPA allowed the commercial applicators to use according to the current labeling until July 31, 2020.

EPA Administrator Wheeler stated, “At the height of the growing season, the Court’s decision has threatened the livelihood of our nation’s farmers and the global food supply. Today’s cancellation and existing stocks order is consistent with EPA’s standard practice following registration invalidation, and is designed to advance compliance, ensure regulatory certainty and to prevent the misuse of existing stocks.”

Three days after EPA issued the dicamba existing stocks order, on June 11, 2020, the Petitioners in the National Family Farm Coalition case submitted a motion requesting that the Court provide emergency relief “to enforce its vacatur” decision and that the Court hold EPA and Administrator Wheeler in contempt.  According to the Petitioners, EPA’s entire rationale for issuing an existing stocks order is based on false premises.  In the Petitioners’ view, existing stocks of the three dicamba products are not “unregistered” because the vacatur order only invalidated certain newly authorized uses, and the existing stocks should not be deemed to be “cancelled” either, although the conditional registration decision for the products has been vacated.  In their motion, the Petitioners also assert that EPA is wrong because, “When read in context, FIFRA clearly prohibits the use of unregistered pesticides.”  In addition to their request that the Court take emergency action to enforce its decision and hold EPA in contempt, the Petitioners also requested that the Court adjudicate their Endangered Species Act (ESA) claims, an action that would require that the Court recall the mandate and issue another decision on the ESA claims it previously declined to reach.

On June 12, 2020, the Court issued an order requiring EPA to file its response to the motion by 5:00 p.m. PDT on June 16, 2020, and the Petitioners to file any reply by 5:00 p.m. PDT on June 18, 2020.

In another development, BASF Corporation and E.I. DuPont de Nemours each filed separate “emergency motions” to intervene in the case on June 12, 2020.  Each company asserts that it was not afforded notice that the Court might take adverse action concerning the registration for its dicamba product until after the decision vacating that registration was issued by the Court.  At this juncture, the Court has not yet indicated whether it will consider these emergency intervention motions or whether it would be willing to allow any further briefing on the merits of the case.

Additional information on the Ninth Circuit Court of Appeals decision is available on our blog.

Commentary

The Court’s June 3, 2020, decision stated, “We are aware of the practical effects of our decision,” but it is not clear from the discussion that follows whether the Court fully considered the chaotic effects of issuing a vacatur decision that did not specifically address the fate of existing stocks of the dicamba products with vacated registrations.  On May 21, 2020, EPA asked for leave to file information on its plans to issue a cancellation order governing existing stocks of products with vacated registrations, but the Court declined to allow that filing.  In any case, it should not have been surprising that EPA would construe its vacatur order as a form of cancellation, because that is what EPA did when the Ninth Circuit previously issued a vacatur order for sulfoxaflor products in 2015.

The Petitioners’ motion rejecting the basic legal premises underlying the EPA existing stocks order reflects a novel view of pesticide registration that is difficult to reconcile with the plain language and established constructions of FIFRA.  Under FIFRA, EPA issues registrations for specific pesticide products, which may be labeled only for those uses that EPA has previously determined meet applicable requirements.  Under FIFRA Section 6(b), EPA can decide that particular uses no longer meet the standard for registration and must be removed from an existing product label, but the only means by which EPA can effectuate that determination is by taking action to cancel any product for which the registrant does not agree to make the necessary changes.  The Court vacated EPA’s conditional registration decision that authorized three registered dicamba products to be labeled for use on dicamba-tolerant soybeans and cotton but did not direct or establish any process for EPA to consider amending the product labeling or restoring the prior registrations.  Under these facts, EPA has concluded that under FIFRA, existing stocks that are labeled for those uses became unregistered pesticide products because the labeling no longer conforms to the product registrations as they have been altered by the Court.  In the absence of an existing stocks order, stocks of the affected products labeled for the disallowed uses could not be lawfully distributed for any purpose, including voluntary recall by the registrant, disposal, or relabeling to remove the disallowed uses.

Despite the assertions by the Petitioners that FIFRA prohibits use of unregistered pesticides, FIFRA has not been construed in this manner.  While it a violation of FIFRA to distribute or sell any pesticide product with labeling that does not conform to a valid registration, FIFRA does not include any similar prohibition on use of an unregistered pesticide.   Thus, in the absence of an existing stocks order, stocks of the three dicamba products with vacated registrations that are already in the hands of end users could be lawfully used without restriction.  This notion is reflected in the provisions addressing end users in the order.  No provision in the order authorizes end users who have the three dicamba products in their possession to do anything.  Rather, the order prohibits end users from using the three products except in compliance with the existing labeling and from using the products at all after July 31, 2020.

Of course, it is not surprising that EPA applied its established criteria for existing stocks orders in the manner that it did.  Representatives of affected growers argued that prohibiting all use of the products in the middle of the 2020 growing season would lead to billions of dollars in damages, at a time when the entire agricultural economy has already been severely impacted by the Covid-19 pandemic.

In addition to arguing that an existing stocks order was necessary to establish a practical regimen governing distribution and use of those stocks of the three dicamba products in channels of trade when the Court’s decision was issued, EPA will likely argue that the Circuit Court lacks jurisdiction to review the existing stocks order.


 
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