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 Lara A. Hall, MS, RQAP-GLP and Heather F. Collins, M.S.

On March 17, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final guidance document entitled "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis" (EPA 705-G-2020-3722; Docket ID: EPA-HQ-OPP-2016-0093) that expands the potential for data waivers for acute dermal studies to single technical active ingredients (AI) used to formulate end-use products. This new guidance builds upon the final guidance for waiving acute dermal toxicity tests for pesticide formulations published by EPA on November 9, 2016, and is an example of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by 2035.  EPA states that this guidance is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources.

The new final guidance document also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both end-use product formulations and technical chemicals in 2017. 

In developing the new guidance, EPA states that the Office of Pesticide Programs (OPP) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) conducted a retrospective analysis of rat acute oral and acute dermal LD50 studies for 249 AIs across numerous chemical classes and toxicity categories in the EPA pesticide categorization scheme.  The overall purpose of this analysis was to address the utility of the acute dermal toxicity study for single AIs in pesticide labeling, such as the signal word and precautionary statements. Fumigants and rodenticides were excluded from this retrospective analysis based on their physical state and/or anticipated exposures to them. EPA concluded that:

  • For 67 percent of the 249 technical chemicals, the results of both oral and dermal acute toxicity studies fall within the same Toxicity Category; 
  • For 32 percent of the chemicals, the oral study falls within a lower (i.e., more protective) Toxicity Category;
  • Thus, for 99 percent of the chemicals in the analysis, if the dermal study had not been available and labeling had been based only on the Toxicity Category for the oral acute toxicity study, the labeling requirements would have been equally or more protective; 
  • For the two remaining chemicals (less than 1 percent), factors other than the dermal acute toxicity may influence labeling requirements; and
  • The acute dermal toxicity studies provide little to no added value in regulatory decision making. 

EPA states that it believes the retrospective analysis fully supports the conclusion that waivers may be granted for acute dermal toxicity studies for pesticide technical chemicals, except for fumigants and rodenticides.  Waivers may be accepted for fumigants and rodenticides on a case-by-case basis with appropriate scientific rationale. EPA maintains the ability to request acute dermal toxicity data on a case-by-case basis, but states that it anticipates granting the waiver in most cases.

Additional information on EPA’s efforts to reduce animal testing is available here.


 

By Lynn L. Bergeson and Carla N. Hutton

On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469).  EDF v. EPA, No. 4:21-cv-03-BMM.  On January 11, 2021, the Environmental Defense Fund (EDF), Montana Environmental Information Center (MEIC), and Citizens for Clean Energy (CCE) filed suit against EPA, claiming that the January 6, 2021, final rule was unlawful and that EPA’s decision to make the final rule effective on publication was unlawful.  On January 27, 2021, the court granted summary judgment to the plaintiffs, finding that EPA did not provide good cause to exempt the final rule from the Administrative Procedure Act’s (APA) 30-day notice requirement.  The court stated that “EPA’s decision to make the Final Rule immediately effective on publication was ‘arbitrary, capricious’ and ‘otherwise not in accordance with law.’”  In its January 31, 2021, motion, EPA states based on the court’s conclusion that the final rule constitutes a substantive rule and that EPA “lacked authorization to promulgate the rule pursuant to its housekeeping authority.”  According to EPA, where EPA lacked the authority to promulgate the final rule, “remand without vacatur would serve no useful purpose because EPA would not be able to cure that defect on remand.”  EPA notes that because the final rule was in effect for less than a month, and it had not applied the rule in any circumstance while the rule was in effect, “there would be no disruptive consequences in remanding and vacating the rule.”

Prior to EPA’s motion to vacate and remand the final rule, on January 20, 2021, President Joe Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.  According to the EO, it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.”  The EO directs all executive departments and agencies to review immediately and, as appropriate and consistent with applicable law, take action to address the promulgation of federal regulations and other actions during the Trump Administration that conflict with the Biden Administration’s national objectives, and to commence work immediately to confront the climate crisis.  The EO calls for the heads of all agencies to review immediately “all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to,” the Biden Administration’s policy.  For any identified actions, the EO directs the heads of agencies to “consider suspending, revising, or rescinding the agency actions.”  In addition, for certain specified agency actions, the EO states that the head of the relevant agency “shall consider publishing for notice and comment a proposed rule suspending, revising, or rescinding the agency action within the time frame specified.”  The specified agency actions include EPA’s January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”

As reported in our January 11, 2021, memorandum, the origin of EPA’s January 6, 2021, final rule is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program.  We predicted that the final rule would likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C®) Forecast 2021 memo).  With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations.


 

By Lisa M. Campbell and Heather F. Collins, M.S.

On January 19, 2021, 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 states of Oklahoma and Arkansas, permitting American Airlines to use SurfaceWise2, believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces, in specific airport facilities and planes.  EPA also has revised the terms of use for SurfaceWise2 for all current emergency exemptions. 

EPA’s initial emergency exemption for the state of Texas issued on August 24, 2020, specified that the product remained effective for seven days.  According to its updated labels for all three states, EPA has now approved claims that SurfaceWise2 provides residual surface control of the coronavirus SARS-CoV-2 on surfaces that are undisturbed for up to 30 days.  The updated labels state “When used in accordance with the directions for use, SurfaceWise®2 provides residual surface control of coronaviruses, including SARS-CoV-2, for up to 30-days on undisturbed (e.g., are not routinely disinfected with List N products) non-porous treated surfaces.” 

Of note, EPA also states in its announcement that SurfaceWise2 should be reapplied every time surfaces are disinfected to ensure continuous product performance as exposure to prolonged wetness may adversely impact the efficacy of the product.  The updated labels state in the Directions for Use that the user must “Reapply SurfaceWise®2 after surfaces are disinfected to ensure continuous product performance” and “Do not expose SurfaceWise®2 to prolonged wetness as this may adversely impact the efficacy of the product.”

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.  SurfaceWise2 is 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 30 days, on undisturbed non-porous treated surfaces.  EPA’s approvals will allow Texas, Oklahoma, and Arkansas to permit American Airlines airport facilities and planes at specific locations identified on the label and two Total Orthopedics Sports & Spine Clinics in Texas to use SurfaceWise2 under certain conditions.  The approved Section 18 emergency requests are effective for one year. This public health exemption will expire August 24, 2021.  As new data emerge, EPA may alter the terms of the product’s emergency uses, as it did with the modifications discussed here. 

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


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On January 19, 2021, the U.S. Environmental Protection Agency (EPA) announced it will issue an Advance Notice of Proposed Rulemaking (ANPRM) to solicit information on the current pesticide exemption provision process.

EPA announced that it is considering whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPRM would be due on or before 90 days after publication of the ANPRM in the Federal Register in docket ID number EPA-HQ-OPP-2020-0537.  Although the issuance of this proposed rulemaking has been paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies, should it proceed, it will be important for stakeholders to review carefully.  Discussed below are the issues raised in the ANPRM for stakeholder consideration.

EPA states it is seeking public input on:

  • Whether programmatic changes are necessary to ease state regulation of federally exempt products; and
  • Whether EPA should consider adding any new classes of pesticidal substances for exemption.

Specific questions posed include the following:

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
  2. Are these factors appropriate for EPA to consider in determining whether a substance should be exempted from FIFRA regulation via the minimum risk exemption?
  3. Are there other factors that should be considered?  Please explain how these factors should be weighed in a minimum risk determination.
  4. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  5. Are there other pesticidal substances or systems (e.g., peat), that EPA should consider adding as a new class at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?
  6. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
  7. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and the labeling changes, made it easier to identify specific chemicals used in minimum risk pesticide products?
  8. Are there state challenges to implementing the minimum risk program you would like to share with EPA?  Do you have suggestions for improvements to the program to address these issues?

Commentary

In the ANPRM, EPA states it is soliciting information that will help determine if any changes in the regulations should be made.  The ANPR does not contain specific possible changes to FIFRA exemptions.  EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  Given the change in Administrations and the current “pause” on issuance of this proposed rulemaking, it is unclear whether EPA will issue this proposal, and if so whether EPA will take further steps regarding the exemption after reviewing the comments received.  Should EPA proceed to issue the ANPR, it will provide an opportunity for stakeholders to submit comments on these issues, and companies should consider identifying challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

It is noteworthy that EPA received a petition from the Consumer Specialty Products Association in 2006 requesting that EPA address issues related to efficacy claims for Section 25(b) products and that EPA promised to address this petition by rulemaking or other avenues.  The potential for changes to the Section 25(b) requirements thus is not a new concern for EPA, and it will be important to monitor this issue.


 

By Lisa M. Campbell and Heather F. Collins, M.S.

On January 15, 2021, 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 states of Georgia and Tennessee permitting the use of an air treatment product, Grignard Pure, in health care facilities, intrastate transportation, food processing facilities, and indoor spaces within buildings -- including government facilities -- where people are conducting activity deemed essential by the state.  According to the EPA Authorizations for Georgia and Tennessee (EPA Authorizations), Grignard Pure forms a mist with activity against airborne SARS-CoV-2, the virus that causes COVID-19.  It contains the active ingredient triethylene glycol (TEG), an ingredient commonly used in fog machines for concerts and theater productions. 

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.

EPA’s approval will allow the Grignard Pure product to be applied in Georgia and Tennessee in certain indoor spaces where adherence to current public health guidelines is impractical or difficult to maintain.  The areas where it can be used under the exemption include breakrooms, locker rooms, bathrooms, lobbies, elevators, eating areas, and food preparation areas within health care facilities, intrastate transportation, food processing facilities, and indoor spaces within buildings.  According to the EPA Authorizations, Grignard Pure may only be applied by trained professionals through a building’s HVAC system or using portable devices positioned strategically in an indoor space.  Additionally, the label states that use of Grignard Pure does not eliminate the need for critical precautions like mask wearing and social distancing.  Signs must be posted to indicate that a space is being treated and to advise that the product may cause temporary irritation to sensitive individuals.

Based on a review of laboratory testing data, EPA states that it expects that when used as directed, Grignard Pure will inactivate continuously 98 percent of airborne SARS-CoV-2 particles. Grignard Pure was tested against a surrogate virus that is harder to kill than SARS-CoV-2.

The approved Section 18 emergency requests are effective for one year.  Any unexpected adverse effects related to the use of this product must be reported immediately to EPA as required under the terms of the FIFRA Section 18 emergency exemption approval.


 

By Jason E. Johnston

On November 6, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register that makes several changes to “Crop Group 19:  Herbs and Spices Group.”  85 Fed. Reg. 70976.  The original proposed rule, which was published on August 27, 2019 (84 Fed. Reg. 44804), was created in response to a petition developed by the International Crop Grouping Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4).  EPA received comments from eight entities and revised the original proposed rule in response to those comments.

The major components of the new rule are a revision of the commodity definition for marjoram; the addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19:  Herbs and Spices Group” with two new expanded crop groups, “Crop Group 25:  Herb Group” and “Crop Group 26:  Spice Group.”  Recognizing that the existing combined Crop Group 19 Herbs and Spices Group limited the establishment of crop group tolerances, EPA created the two new separate crop groups to benefit herb and spice growers.  EPA states that the anticipated economic benefit of the new crop groups is estimated to be a cost savings of $51.8 million annually.

The crop groups in the final rule include even more commodities than those listed in the proposal.  Crop Group 25 includes 418 herb commodities directly and 25 indirectly through the modification of the definition of edible flowers in 40 C.F.R. Section 180.1. Crop Group 26 includes 205 spice commodities.  The final rule specifies all commodities in the new crop groups and the subgroups therein (i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup.  The effective date of the final rule is January 5, 2021.


 

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

On November 4, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment.  85 Fed. Reg. 70146.

EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service, develops and implements programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance.  According to EPA, the list serves as a tool for private and public organizations, including local or state governments, departments of public health, pesticide registrants, and non-governmental organizations, when making decisions and plans about future public health actions.

Since this list’s original publication in 2002, new vector-borne diseases have been identified and pests that had been previously thought of as benign or nuisance pests have been found to impact adversely public health.  EPA, CDC, and USDA collaborated to update the list to incorporate significant changes regarding vector-borne diseases and related research, and eliminate gaps or ambiguities in the current pests list.

EPA states in the notice that the draft Pesticide Registration (PR) Notice 2020-X more precisely describes both the pests and expected public health impacts and adds several new pests (the brown dog tick) and public health impacts (Zika fever and coronaviruses like SARS-CoV-2) and that other pests have been renamed or grouped with similar species or removed altogether (hobo spider).

Draft PR Notice 2020-X describes the groups of pests and their potential impact on public health as follows:

  • Arthropods: The listed arthropods may cause asthma or trigger allergies, contaminate food, irritate skin, cause direct injury, or carry diseases such as epidemic typhus, trench fever, epidemic relapsing fever, malaria, encephalitis (St. Louis, Eastern, Western, West Nile, and LaCrosse), yellow fever, dengue fever, and many others.
  • Vertebrates: The listed organisms have the potential for direct human injury and can act as disease reservoirs for rabies and other diseases. The rats and mice include those that spread rodent-borne diseases and contaminate food for human consumption.
  • Microorganisms and acellular particles:  This category includes listed bacteria, fungi, protozoans, viruses, virusoids, and prions. The microorganisms and acellular particles listed in this category cause diseases such as COVID-19, cholera, meningitis, Legionnaire’s Disease, and many others.

The complete list of pests is identified in draft PR Notice 2020-X in Appendix A.

EPA states that the list does not affect the regulatory status of any registration or application for registration of any pesticide product.

Comments on the draft PR Notice are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2020-0260.


 

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

On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  85 Fed. Reg. 69307.

The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting that chitosan be added to the list of active ingredients eligible for EPA’s minimum risk exemption, followed by an April 4 2019, amended petition seeking also to add chitosan to the list of inert ingredients eligible for the minimum risk exemption.  EPA on August 20, 2020, issued a Federal Register notice stating that a draft regulatory document on this issue had been forwarded to the U.S. Department of Agriculture (USDA).  EPA states that no comments were submitted on that notice by USDA or any other person.  EPA also forwarded the draft to the FIFRA Scientific Advisory Panel for review, but according to EPA, the Panel “waived review of this proposed rule, concluding that the proposed rule does not contain scientific issues that warrant scientific review by the Panel.”  On October 8, 2020, EPA again announced it was considering adding chitosan to the list of active ingredients allowed for use in minimum risk pesticides and provided a pre-publication version of the proposed rule.

EPA states in the November 2, 2020, Federal Register notice regarding the proposed rule: “Based on all the information available to the Agency, there are low risk concerns for human health or the environment if chitosan is intended for use as a minimum risk pesticide.”  According to EPA, adding chitosan to this list may save stakeholders time and money through waived FIFRA registration requirements for certain products containing chitosan.  Specifically, EPA estimates the cost savings of avoiding the application process (e.g., guideline studies, registration fees) to be up to $116,000 initially and approximately $3,400 per year thereafter for each new product.

Comments on EPA’s proposal to add chitosan to its list of active ingredients for use on minimum risk pesticides are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2019-0701.   EPA states that it is currently deferring a decision regarding the amended petition to add chitosan to the list of inert ingredients permitted in minimum risk pesticides.

Additional information on chitosan is available on our blog.


 

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 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.


 
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