EPA Eyes Long-Lasting Disinfectants as Next Step in Fight Against COVID-19
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As the coronavirus pandemic rages on, the Environmental Protection Agency has continued to expand the number of disinfectant products available for use in controlling viruses on surfaces. Most recently, the Agency announced it is taking steps to put long-lasting disinfectants to the test in the fight against COVID-19. We previously published an Advisory on the process for making EPA-approved disinfectant claims for antimicrobial products that can be used against SARS-CoV-2 (the cause of COVID-19). EPA went a step further on October 14, 2020 and released long-awaited interim guidance regarding expedited review for applications to add residual efficacy claims to products intended for use against the novel coronavirus, SARS-CoV-2. These residual efficacy claims would allow products to boast "extended" or "long-lasting" antimicrobial effectiveness beyond the initial application, even in between regular cleaning of treated surfaces. Moreover, EPA has pledged to make every effort to expedite review of applications for permission to market such products. Although EPA's interim guidance is immediately effective, the agency will accept and consider comments on it if received before the January 4, 2021 deadline.
Background on EPA's Announcement
EPA's interim guidance is intended to make public and standardize the criteria EPA will apply when considering and approving applications for products the Agency will acknowledge as being effective against pathogenetic microorganisms even beyond the initial application of the product.
Stakeholders have been eagerly awaiting EPA's guidance on residual claims because of the potentially significant impact of "long-lasting" products in the fight against coronavirus, especially in high-touch environments. The interim guidance follows EPA's announcement of two emergency public health exemptions under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to the Texas Department of Agriculture for the use of Allied Bioscience's SurfaceWise2 to treat SARS-CoV-2 on surfaces for up to seven days. Such emergency exemptions are generally valid for only one year and are issued to a federal or state agency when EPA determines that "emergency conditions exist which require such exemption" from EPA's normal registration process for such products.1 These exemptions further increased companies' interest in marketing more "long-lasting" products that might make people feel more secure in certain environments, such as schools and airlines.
While it is not clear whether EPA applied the criteria in the newly released guidance when evaluating and granting the emergency exemption for the use of SurfaceWise2, going forward, those applying for new registrations and amended registrations for products to be sold with residual efficacy claims should generate and submit data that conform with the requirements in the new interim guidance to take advantage of expedited review.
What You Need to Know
As noted, the interim guidance went into effect on the day of publication; however, the Agency may revise the interim guidance after the close of the 60-day comment period.2 Entities developing new products that are within the scope of the Agency's interim guidance should consider taking advantage of this opportunity to prepare and submit timely comments.
The interim guidance sets forth the study design elements necessary to support bactericidal and virucidal residual efficacy claims for two major categories of products that will qualify for expedited review: (1) disinfectants that also provide residual efficacy, including products that are already on EPA's Disinfectant List N and products that would qualify for List N,3 and (2) supplemental residual antimicrobial products that do not meet EPA's disinfectant standard but are intended to be used as a supplement to List N disinfectants, such as paints and coatings. Those study design elements are discussed below. While EPA may consider other scientifically sound methods or studies to support residual efficacy claims, applicants should follow all of the requirements listed in the guidance to put themselves in a better position to get expedited review. Significantly, products can only make a residual claim for viruses if they meet both the performance standard for the bactericidal residual claim and the virucidal residual claim.
Residual Disinfectant Claims: For residual disinfectant claims, qualifying products must meet several stringent requirements. First, products must satisfy all requirements for standard disinfectant claims (i.e., nonresidual) and have undergone testing to support claims of efficacy against SARS-CoV-2 or a virus that is equally difficult to kill. In short, the product must either already be on List N or qualify for inclusion on List N. Unlike the supplemental residual products discussed below, residual disinfectant claims can only be made for products that can be used as stand-alone disinfectants (i.e., effective in 10 minutes or less and achieving the appropriate log reductions for bacteria and virus). Second, for both the residual bactericidal and virucidal disinfectant claims, products must generally adhere to EPA's existing Residual Self-Sanitization Protocol, with a few modifications. The main criteria for supporting residual efficacy claims are summarized in the following table:
Table 1: Residual Disinfectant Claims
|Meet EPA's standard for disinfection efficacy||Yes|
|Duration of residual claim||24 hours or less|
|Durability assessment||Abrasion (12 wear cycles of four passes of the abrasion material over the surface, alternating wet and dry, and re-inoculations to support a 24-hour claim)|
|Performance standard for bacteria for residual claim||5-log reduction (99.999% reduction)|
|Performance standard for viruses for residual claim||3-log reduction (99.9% reduction)|
|Time to meet performance standard||<10 minutes + five seconds or less for qualifying bacteria and/or the hardest-to-kill virus|
Supplemental Residual Claims: Qualifying products that are not stand-alone disinfectant products, but are capable of being used in conjunction with standard disinfection practices, can qualify for a supplemental residual efficacy claim. To qualify for this type of claim, products must meet a host of requirements. First, the supplemental product must demonstrate efficacy against vegetative bacteria before virus claims can be supported. Second, EPA's interim guidance sets out different requirements depending on the type of supplemental product. For example, for the bactericidal claim, antimicrobial surface coatings and films should use EPA's draft method for Performance of Antimicrobial Surface Coatings on Hard Non-porous Surfaces for qualifying bacteria. In contrast, fixed or solid surfaces, including solid copper and other metals and solid impregnated materials and paints, should use EPA's Draft Copper Surface Protocol for qualifying bacteria. Lastly, EPA intends to require as part of registration that registrants of all supplemental residual antimicrobial products prepare and implement a written stewardship plan to support the responsible use of these products. EPA explains that it imposed this requirement because, unlike conventional antimicrobial products, supplemental products require timely feedback to ensure proper use and compatibility in combination with current infection-control practices. The interim guidance sets forth what EPA plans to require of registrants, including an approvable plan that addresses the proper sale, distribution, and responsible use of the supplemental residual coatings and antimicrobial surface products. The following table summarizes the elements of EPA's recommendations for supplemental products to make residual efficacy claims against SARS-CoV-2:
Table 2: Supplemental Residual Antimicrobial Claims
|Element||Criteria for Coatings and Films||Criteria for Fixed (solid and paints)|
|Meet EPA's standard for disinfection efficacy||No; but must demonstrate efficacy against vegetative bacteria and show efficacy against viruses for which claims will be made.||No; but must demonstrate efficacy against vegetative bacteria and show efficacy against viruses for which claims will be made.|
|Duration of residual claim||Weeks (10 cycles of abrasion and chemical exposure is equivalent to one week of durability, for up to a claim of four weeks). For claims of greater than four weeks, applicants must consult with EPA in advance of submission.||Years (Given the durability of these types of products can be readily observed, duration claims are not necessary).|
|Durability assessment||Abrasion & Chemical||Abrasion & Chemical|
|Performance standard for bacteria for residual claim||3-log reduction (99.9% reduction)||3-log reduction (99.9% reduction)|
|Performance standard for viruses for residual claim||3-log reduction (99.9% reduction)||3-log reduction (99.9% reduction)|
|Time to meet performance standard (from time of inoculation)||One to two hours||One to two hours|
Application for Registration: EPA's interim guidance sets forth procedures for submitting applications for new product registrations and to request amendments to labels of currently registered products.
For amending registered products to add a residual efficacy claim, EPA will consider expedited review of applications under the following situations: (1) the currently registered product labeling is approved only for sanitizer claims or the labeling is approved with no public health claims; (2) the currently registered product labeling is approved for broad spectrum or hospital nonresidual disinfection and virucidal claims; or (3) the currently registered product labeling is approved for broad spectrum or hospital nonresidual disinfection claims with no virucidal claims. For requests for new product registrations, applicants should follow the instructions in EPA's previously announced expedited review of certain Pesticide Registration Improvement Act (PRIA) submissions for products intended for use against SARS-CoV-2. Applicants should be careful to follow the correct instructions depending on whether they are attempting to register new products that are intended to be formulated from registered or unregistered technical or manufacturing use products.
Why EPA Is Doing This
The normal review time for new antimicrobial registrations and amendments requiring efficacy data in support of public health claims can be lengthy. EPA released this interim guidance to provide clear direction to potential applicants and hopefully expedite reviews for the addition of residual efficacy claims to novel products intended for use against SARS-CoV-2. Under the PRIA timelines, decision review generally takes four months for amendments and up to 24 months for new or similar registrations. EPA hopes to cut one to two months off of the normal PRIA timeframe for applicants who follow the interim guidance properly. However, EPA is clear throughout the interim guidance—applications that do not meet all criteria listed may not qualify for expedited review. Thus, applicants making submissions for residual efficacy claims are well advised to provide all information specified in the guidance or to confer with EPA well in advance concerning any potential deviation.
Long-lasting disinfectants could be critical in the fight against COVID-19 and be helpful tools in the effort to safely reopen schools, restaurants and other public spaces. However, sellers of such products should proceed with caution before making any "long-lasting" or similar claims until supported by reliable data that has been submitted and approved by EPA. While the Agency's interim guidance is effective immediately, stakeholders should consider providing feedback to EPA for making any critical revisions or clarifications during the 60-day comment period. The deadline to provide comments is January 4, 2021. While applicants who consult first with EPA might eventually persuade EPA that alternative test methods are sufficient to demonstrate and support their proposed residual efficacy claims, interested parties should note that they may not enjoy the benefits of expedited review unless they comply with the standards set forth in the interim guidance. We will continue to monitor developments regarding the regulatory landscape for disinfectant (or related) products that can be used in the fight against the virus that causes the COVID-19 health crisis.
© Arnold & Porter Kaye Scholer LLP 2020 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
Our previous Advisory describes the process to be added to EPA's Disinfectant List N. List N currently has more than 500 disinfectants authorized to make claims for use against SARS-CoV-2.