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 30, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a Compliance Advisory on ultraviolet (UV) lights claiming to kill or be effective against viruses and bacteria. 

EPA states that the Advisory was issued to provide an explanation to the UV light industry that UV lights are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as pesticide devices when sold or distributed with claims to kill or be otherwise effective against viruses and/or bacteria, unless an exception applies, and must comply with certain statutory and regulatory requirements.  This is the second Compliance Advisory issued by EPA relating to UV light devices, as an Advisory issued in May 2020 entitled “What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19” also addressed in part whether UV light devices could make claims against the coronavirus.

The Advisory reiterates that UV lights sold or distributed with claims that the lights can be used for preventing, destroying, repelling, trapping, or mitigating any pests, which include plants, animals, viruses, bacteria, or other micro-organisms, are regulated by EPA under FIFRA as a device.  UV lights without such claims would not be subject to FIFRA.  According to the Advisory, pesticidal devices are subject to certain regulatory requirements under FIFRA, one of which is a prohibition of false or misleading labeling claims. 

The Advisory answers the following questions:

How do I comply with FIFRA if I am selling or distributing a UV light with pesticidal claims?

  • Devices do not need to be registered by EPA and, therefore, are not subject to a pre-market review by EPA (although some states require devices to be registered). However, federal regulations require devices to be produced in an EPA-registered pesticide producing establishment and there are production reporting requirements; see 40 C.F.R Part 167.
  • Devices must be labeled per federal regulations at 40 C.F.R Part 156. Generally, device labels must include warning and caution statements, directions for use and the EPA establishment number, amongst other label requirements. A description of device label requirements can be found at https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices#labeling.  
  • All claims in connection with the sale or distribution of a device must be true and not misleading. FIFRA Section 12(a)(1)(F) specifically prohibits false or misleading labeling (known as misbranding); this includes claims made in marketing materials and on websites. Examples of misbranding are provided at 40 C.F.R 156.10(a)(5) and include, but are not limited to, false or misleading statements concerning product effectiveness (known as efficacy), claims about product safety, false or misleading comparisons with other pesticides or devices, or any statement directly or indirectly implying that the device is recommended or endorsed by any agency of the Federal Government.  Companies are advised to maintain records, with information and data, to substantiate that claims made in regard to devices are not false or misleading.

In addition to FIFRA requirements, importers of all FIFRA-regulated devices must comply with the U.S. Customs and Border Protection (CBP) regulations set forth at 19 C.F.R. §§ 12.110 -12.117. Regulated entities that are importing UV pesticide devices are advised that the products being imported must be in compliance with FIFRA prior to entry into the United States. The EPA regularly coordinates with CBP to identify and reject violative UV pesticide devices at the port of entry.

Can a UV light be a pesticide requiring EPA registration?

Yes. If the UV light product incorporates a substance or mixture of substances to perform its intended pesticidal purpose, then it is considered a pesticide product, not a device, and must be registered with EPA in accordance with FIFRA Section 3 before it can be lawfully sold or distributed in the United States. 

Are UV lights safe and effective?

Unlike chemical pesticides, EPA does not routinely review the safety or efficacy of UV light devices and, therefore, EPA has not conducted a human health risk assessment to determine the safety of these products. For the same reason, EPA cannot confirm whether, or under what circumstances, UV light devices might be effective against any pest, including viruses and bacteria. The effectiveness of any UV light device will depend on a variety of factors including, but not limited to, the device’s duration of use, distance of the light from the surface intended to be treated, the UV wavelength, the specific pest being targeted, the strength or wattage of the UV light bulb, the age of the UV light bulb, shadow areas or other factors. 

Consumers are advised to use all pesticidal devices ONLY in accordance with the Directions for Use, which are required to appear on the product label. EPA recommends that consumers contact the manufacturer or seller of the pesticidal device directly if they have any questions about how to use the product, the product’s safety, or the product’s efficacy.

What are the compliance concerns related to UV lights?

There may be members of the UV light industry who are unfamiliar with FIFRA and may not be aware of statutory and regulatory requirements. For example, they may be unaware that it is a violation of FIFRA to sell or distribute pesticidal UV light devices that are misbranded or that have not been produced in an EPA-registered establishment. EPA has been receiving complaints that UV light devices may be in violation of FIFRA. These complaints are being reviewed and EPA intends to pursue enforcement, as appropriate. See EPA’s May 2020 compliance advisory on products making claims to kill the coronavirus that causes COVID 19 at https://www.epa.gov/sites/production/files/2020-05/documents/cornavirus-compliance-advisory.pdf and any subsequent updates.

Regulated entities of any size who voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of potential violations may be eligible for a reduction or elimination of any civil penalties that otherwise might apply. To learn more about the EPA’s violation disclosure policies, including conditions for eligibility, please review EPA’s Audit Policy website at https://www.epa.gov/compliance/epas-audit-policy. Most violations can be disclosed and processed via EPA’s automated online “eDisclosure” system - https://www.epa.gov/compliance/epas-edisclosure. Many states also offer incentives for self-policing; please check with the appropriate state agency for more information.

Are you unsure if your product is a device under FIFRA?

EPA has developed a guide concerning pesticide devices that explains what a pesticide device is and how it differs from a pesticide product which requires registration. This guide may be helpful to UV light manufacturers who need to determine if their product is regulated by FIFRA.See https://www.epa.gov/safepestcontrol/pesticide-devices-guide-consumers. If you are still uncertain about whether your UV light product is a device, you may submit a request for a Device Determination from EPA. Instructions for submitting a request can be found at: https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices#obtain.

Discussion

UV light devices are a heightened focus of EPA, whose import and enforcement officials have been reviewing materials (e.g., import documents, websites) related to devices and increasingly bringing enforcement actions against companies for FIFRA violations.  These actions can address circumstances when a pesticide device is not produced in a registered establishment or when the label does not include certain requirement elements, but more recently EPA seems particularly interested in the claims that are being made with regard to these devices and whether those claims are “false and misleading” under EPA’s regulations. 

Ensuring that claims related to the efficacy of the device are not considered by EPA to be “false and misleading” can be especially difficult based on the facts that EPA does not review and approve data that support the claims being made, and also that EPA has not historically provided guidance as to the type of data that it would require to support an efficacy claim for a pesticide device.  This Advisory is interesting to the extent that EPA sets forth various factors to be considered when determining the effectiveness of a UV light device.  These factors include, but are not limited to “the device’s duration of use, distance of the light from the surface intended to be treated, the UV wavelength, the specific pest being targeted, the strength or wattage of the UV light bulb, the age of the UV light bulb, shadow areas or other factors.”  The May 2020 Advisory further states that “UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.”  (Emphasis in original.)  In light of the two advisories, it is critical for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.


 

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.


 

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

On August 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that is believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces for up to seven days.  EPA states that after carefully reviewing the available data and information, it “determined that the product helps to address the current national emergency.”  According to EPA, the product is “expected to provide longer-lasting protection in public spaces, increasing consumer confidence in resuming normal air travel and other activities.”

FIFRA Section 18 authorizes EPA to exempt federal or state agencies from any provision of FIFRA in the event that emergency conditions require such an exemption.  EPA regulations (40 C.F.R. Part 166) specify when state or federal government agencies will be permitted to use unregistered pesticides in response to an emergency.  EPA’s regulations provide that an emergency exists when:

  • There is an “urgent, non-routine” situation requiring the use of a pesticide to control a new pest not previously prevalent in the United States, to control significant risks to health, the environment, beneficial organisms, or endangered species, or to prevent specified types of economic loss; and
  • There is no registered pesticide or economically or environmentally feasible alternate method of control available.

40 C.F.R. § 166.3.

The exemptions granted can be very specific and time-limited; EPA has developed a database so companies can search (by chemical, site, pest, applicant, or date range) to determine if an emergency exemption has been issued and its expiration date.

In this case, EPA approved the Section 18 emergency exemption request for SurfaceWise2 -- a product manufactured by Allied BioScience -- a surface coating that Allied BioScience states inactivates viruses and bacteria within two hours of application and continues to work against them for up to seven days, between regular cleanings.  EPA’s approval will allow Texas to permit American Airlines airport facilities and planes at specific locations and two Total Orthopedics Sports & Spine Clinics to use SurfaceWise2 under certain conditions.  The approved Section 18 emergency requests are effective for one year. As new data emerge, EPA may alter the terms of the product’s emergency uses.

Over the coming months, Allied BioScience will pursue a non-emergency approval under FIFRA Section 3 by submitting additional data to meet EPA’s registration requirements as an antiviral and antibacterial surface coating.  If the full registration process is completed, the product would become available for purchase by members of the public.  SurfaceWise2 is not yet available to the general public because Allied Biosciences has not yet submitted the necessary data to qualify for registration under Section 3 of FIFRA.

Commentary

EPA states that it has not received any other Section 18 applications for products with residual efficacy against coronaviruses like SARS-CoV-2, but that is likely to change following this approval and ongoing activities by companies seeking options for products to use against SARS-CoV-2.  EPA states it will consider any such requests submitted related to the COVID-19 public health emergency, and also anticipates posting information for companies or individuals who are interested in pursuing a FIFRA Section 3 registration for antiviral surface coatings in the coming weeks.

States or federal agencies interested in pursuing a Section 18 emergency exemption request for products that claim residual efficacy against viruses should be prepared to include efficacy data demonstrating that the product is durable and effective against viruses for up to the periods of time after application.  It will be essential to ensure that these data will be deemed sufficient by EPA to determine efficacy and durability, which may require discussion with EPA.  EPA will review the results of these studies to ensure that surface coatings remain effective under the anticipated proposed conditions of use.

Additional information on Section 18 emergency exemption requests and Sars-CoV-2 is available here.


 

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

On August 5, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) against EcoShield LLC (EcoShield) for selling a clip-on badge product called the Eco AirDoctor Portable that claims to sanitize the air of pathogens.  EPA states that the product was being sold and distributed in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because it is an unregistered pesticide making false disinfectant claims.  The SSURO against EcoShield is another in a series of enforcement actions EPA has taken against products that EPA believes are making claims in violation of FIFRA during the COVID-19 public health emergency.  Some of these actions include the Amazon and eBay SSURO and the prevention of importation of the unregistered “Virus Shut Out” pesticide product.  (See our blogs here and here for more information on these two actions.)

Under FIFRA, products that claim to kill or repel bacteria or germs, including disinfectants, are considered pesticides and must be registered with EPA.  EPA will not register a disinfectant until it has been determined that it will not pose an unreasonable risk when used according to the label directions.  In this case, Eco AirDoctor Portable was marketed as a “personal air sanitizer” that users hang from shirts or backpacks.  The product claims to release chlorine dioxide gas to sanitize the air of pathogens.  EcoShield also claimed on its website and social media that the product is a “safe and effective germ-killing agent” and, EPA claims, implies protection against SARS-CoV-2.  EPA also expressed concerns regarding prolonged exposure to and inhalation of chlorine dioxide gas, which EPA states can adversely affect the health of users.

To find EPA-registered disinfectant products that are qualified for use against SARS-CoV-2, please search EPA’s List N, which currently contains 473 products, including products that went through the expedited review process for emerging viral pathogens.

Additional information on EPA enforcement actions on unregistered products is available here.


 

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, Heather F. Collins, M.S. and Barbara A. Christianson

On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA researchers are evaluating a number of commercially available products for potential long-lasting effectiveness against SARS-CoV-2, the novel human coronavirus that causes COVID-19.  This research is being conducted at EPA’s Office of Research and Development's Center for Environmental Solutions and Emergency Response in Research Triangle Park, North Carolina, using surfaces that mimic the high touch points in mass transit trains and stations.

EPA states that it is working directly with New York’s Metropolitan Transportation Authority, North America’s largest transportation network, on evaluating EPA-registered antimicrobial products across New York City Transit to determine their ability to provide effective anti-virus protection over time.

Currently, EPA-registered products that claim long-lasting effectiveness are limited to those that control odor-causing bacteria on hard, non-porous surfaces.  At this time, there are no EPA-registered products that claim long-lasting disinfection.  EPA researchers hope to determine whether antimicrobial products can provide residual disinfection on surfaces over time and how durable the disinfection ability of the product is with normal use, including routine cleaning and natural weathering.  According to EPA, data generated by EPA researchers will inform any regulatory decisions (including the approval and use of these products according to the label) made as part of the pesticide registration process through EPA’s Office of Pesticide Programs.

EPA researchers are also evaluating other possible high-efficiency alternative methods to disinfect, such as ultraviolet light (UV), ozone, and steam, that could be used on public transit systems to keep trains, buses, and facilities clean and safe for passengers.  EPA is additionally studying disinfectant application methods, such as electrostatic sprayers or foggers, that EPA believes are promising.

As part of this effort, EPA has partnered with the Los Angeles County Metropolitan Transportation Authority, the third largest transit agency in the United States, to evaluate a number of new technologies, including UVC lighting and air filtration systems, to combat SARS-CoV-2 on public transit systems.

EPA states that it will make the results of this research available to help inform decisions on the use of longer-lasting disinfection products, including information on the frequency of use to maintain disinfection capabilities over time.

Additional information on EPA’s research on COVID-19 in the environment is available here.


 

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.


 
 < 1 2 3 4 >  Last ›