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 Heather F. Collins, M.S.

The U.S. Environmental Protection Agency (EPA) announced on May 26, 2022, that on Monday, May 23, 2022, it has activated its Emerging Viral Pathogen (EVP) Guidance for Antimicrobial Pesticides (Guidance) in response to monkeypox, which had been considered to be a rare disease caused by infection with the monkeypox virus. According to the U.S. Centers for Disease Control and Prevention (CDC), monkeypox was first discovered in 1958 when two outbreaks of a pox-like disease occurred in colonies of monkeys kept for research, hence the name “monkeypox.” The first human case of monkeypox was recorded in 1970 in the Democratic Republic of Congo during a period of intensified effort to eliminate smallpox. CDC states that its scientists are tracking multiple cases of monkeypox that have been reported in several countries that do not normally report monkeypox, including the United States.

EPA developed its Guidance in 2016 to address emerging pathogens. Under this Guidance, EPA provides pesticide registrants with a voluntary “two-stage process to enable use of certain EPA-registered disinfectant products against emerging viral pathogens not identified on the product label.” These pathogens may not be identified on a label because the occurrence of EVPs is less common and predictable than that of established pathogens and because the pathogens are often unavailable commercially and standard methods for laboratory testing may not exist. EPA’s intent is for the Guidance to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against EVPs associated with certain human or animal disease outbreaks. Registrants with a pre-qualified EVP designation can include an efficacy statement in technical literature distributed to health care facilities, physicians, nurses, public health officials, non-label-related websites, consumer information services, and social media sites. Additional information on the EVP Guidance is available here and here.

The monkeypox virus belongs to the Orthopoxvirus genus in the family Poxviridae and is an enveloped virus, meaning it is one of the easiest to kill with the appropriate disinfectant product. EPA recently developed the new List Q: Disinfectants for Emerging Viral Pathogens (EVPs). Monkeypox virus is a Tier I (enveloped virus); thus, when disinfectants damage their lipid envelope, the virus is no longer infectious. EPA’s List Q currently has 422 disinfectant products for use on Tier 1 viruses.

The EVP Policy for the monkeypox virus expires in May 2023.

Information on the monkeypox virus is available on CDC’s website.


 

By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson

On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced it is implementing a new policy regarding the evaluation and registration of new conventional pesticide active ingredients (AI) to comply further with the Endangered Species Act (ESA) (ESA Policy). EPA also issued a Question and Answer document regarding its ESA Policy. Effective immediately, EPA will evaluate the potential effects of new conventional AIs on federally threatened or listed endangered species (Listed Species) and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary before EPA registers any new conventional AIs. The new ESA Policy will apply to all new conventional AI applications, including applications already submitted to EPA but not yet completed.

Under the ESA, EPA must ensure that its actions are not likely to result in jeopardy or adverse modification of designated critical habitat or Listed Species. To determine whether the action may affect Listed Species and their designated critical habitats, EPA makes one of three types of species-specific effects determinations: No Effect (NE), Not Likely to Adversely Affect (NLAA), or Likely to Adversely Affect (LAA). EPA states that historically it did not “consistently assess the potential effects of conventional pesticides on listed species when registering new AIs.” This, EPA states, “resulted in insufficient protections from new AIs for listed species, as well as resource-intensive litigation against EPA for registering new AIs prior to assessing potential effects on listed species.” EPA believes its new ESA Policy should assist in reducing these types of cases against EPA and improve the legal defensibility of new AIs.

EPA states that under the new ESA Policy, if EPA makes an LAA determination through its analyses of a new conventional pesticide AI, EPA will initiate formal consultation with the Services before granting a new AI registration. As part of its analysis and under its existing authorities, EPA will consider the likelihood that the registration action may jeopardize the continued existence of Listed Species or adversely modify their designated critical habitat and provide its findings to the Services. To determine or predict the potential effects of a pesticide on these species and habitats, EPA will use appropriate ecological assessment principles and apply what it has learned from past effects determinations and the Services’ biological opinions. EPA states it is determining whether any new information would be useful for assessing the potential impacts on Listed Species from a new AI, and it will specifically contact registrants that have a new Al application currently under consideration to discuss whether additional information is necessary for EPA’s ESA assessment for the new conventional AI.

If EPA determines that jeopardy or adverse modification is likely for a designated critical habitat or Listed Species, it will only make a registration decision on the new conventional AI after requiring registrants to implement mitigation measures that EPA determines would likely prevent such jeopardy or adverse modification. If EPA finds that a new AI is likely to affect adversely a Listed Species or its critical habitat, but that a jeopardy or adverse modification is not likely, it may nonetheless require registrants to include mitigation measures as part of their registration and product labeling to minimize the potential effects of incidental take to Listed Species that could result from use of a pesticide. In both situations, formal consultation with the Services would still be necessary, as EPA states final jeopardy or adverse modification determinations must be made by the Services. Regarding timeframes, EPA states in the Q&A that it “strives to complete new AI applications within PRIA timelines,” but will work with affected registrations to “renegotiate” PRIA deadlines if EPA believes additional time will be needed under the ESA Policy.

EPA states that it has prioritized conventional pesticide AIs but that it is continuing to explore applying these new ESA approaches to new biopesticide AIs and new antimicrobial AIs. EPA also is developing a comprehensive strategy to address ESA for pesticides at all stages of the registration process. EPA is currently developing a detailed work plan to outline additional improvements to further its compliance with the ESA, including steps to implement protections for high-risk species more efficiently, provide growers with more flexible mitigation measures, and increase stakeholder engagement.

Commentary

This announcement represents the next attempt by the Office of Pesticide Programs (OPP) to comply with ESA requirements in a way that, as the ESA Policy points out, will be more legally defensible while continuing its work to review and approve new pesticide AIs. In recent years, EPA has tried various arguments, mostly futile, to convince courts that past attempts to comply with ESA were sufficient.

This ESA Policy hints at important changes both in EPA’s past rhetoric regarding compliance and possible changes to the ways ESA assessments have been conducted in the past. On the record, EPA has maintained it complied with ESA when registering a new product. The courts have found this claim unsupported and almost always agreed with groups that challenged that claim. There have been a few exceptions where EPA, while not entirely resolving ESA concerns, had more “up front” consideration of ESA issues. Such earlier attention to resolving any ESA concerns, however, can add significantly to the time spent and data requirements to evaluate and address ESA issues.

Any relatively successful cases over past years complement the renewed and explicit commitment by the Biden Administration with the ESA Policy to attempt to resolve the long-standing problem of establishing a registration process that better addresses ESA issues with, among other things, improved coordination between EPA procedures and the review process (and conclusions) of the Services. Past Administrations have expressed similar rhetoric, but so far, many have tried, and all have failed.

In various forums, EPA has dryly described the efforts generally as -- “EPA is currently developing a detailed work plan to outline additional improvements to further the Agency’s compliance with the ESA.” More importantly, perhaps, and new to the mix is that EPA now has a senior political appointee (Jake Li as Deputy Assistant Administrator of OCSPP) especially tasked to lead efforts regarding the ESA-FIFRA integration process.

For applicants and registrants of new conventional AIs, these revised efforts may lead to some delays in the current expected timeframes to “work out” ESA concerns earlier in the process. And importantly, EPA’s ESA Policy describes how new approvals will include more “up front” mitigation measures designed to protect threatened and endangered species to a sufficient, or at least better, degree -- which appears to be a key change designed to reduce the litigation risks that have dogged new registration decisions in recent years.


 

By Barbara A. Christianson

On November 19, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides indefinitely. EPA states that its EVP guidance for antimicrobial pesticides is a part of the federal government’s pandemic preparedness, allowing manufacturers to provide EPA with data, even in advance of an outbreak, demonstrating that their products are effective against hard-to-kill viruses.

EPA activated its EVP guidance for antimicrobial pesticides for the first time in January 2020 in response to the emergence of SARS-CoV-2. EPA has allowed for expedited review and approval of surface disinfectant products for use against SARS-CoV-2 for more than 12 months, including accelerated review for products seeking to add EVP claims to product labels. To date, EPA has added 591 products with emerging viral pathogens claims to its list of Disinfectants for Coronavirus (List N).

EPA states that registrants must remove EVP claims from consumer messaging no later than 24 months after the original notification of the outbreak, unless directed otherwise by EPA. With this extension, EPA will now provide a notification at least six months before inactivating the EVP guidance for SARS-CoV-2 to allow registrants time to adjust product marketing materials as required.

Additional information on the EVP guidance is available here.


 

By Carla N. Hutton

On November 3, 2021, the U.S. Environmental Protection Agency (EPA), the White House Council on Environmental Quality (CEQ), the U.S. Department of Agriculture (USDA), the U.S. Department of Commerce, and the U.S. Department of the Interior “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3, 2021, press release, on October 15, 2021, all five agencies met as part of the Interagency Working Group (IWG) created under the 2018 Farm Bill to discuss improvements to the consultation process for pesticide registration and registration review under Section 7 of the Endangered Species Act (ESA). EPA states that the group’s first meeting resulted in specific commitments to improve the pesticide consultation process for endangered species and engaging stakeholders, including by capitalizing on the strong interest among stakeholders for a workable process.

According to the press release, the IWG is optimistic about its ability to collaborate on improvements that the Biden Administration can implement. The IWG’s actions focused on improving processes that will contribute to tangible benefits for species conservation and for stakeholders. EPA states that the IWG “is intent to adopt improvements expeditiously and that endure across administrations.” To guide its future work, the IWG has identified the following initial priorities and approaches:

  • Focus on improvements that deliver real world benefits for species conservation, public health, and food production. Examples include:
    • Use pilot projects to begin implementing mitigation measures as part of upcoming pesticide consultations and to demonstrate process improvements;
    • Adopt measures early in the pesticide consultation process to avoid, minimize, and offset the effects of pesticide use on ESA-listed species; and
    • Ensure that mitigation measures are effective and practical to implement;
  • Consider opportunities to engage with stakeholders as an interagency body to complement the stakeholder activities of each agency; and
  • Communicate the IWG’s work to stakeholders in a transparent manner.

EPA states that “[e]ffective endangered species protection cannot be accomplished solely by federal agencies,” but also requires “open and continuous engagement with stakeholders on practical solutions to harmonizing species conservation with pesticide use.” To that end, the IWG plans to hold its first stakeholder listening session in early 2022 and will provide details on the proposed session before the end of 2021.


 

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

On September 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is terminating the Temporary Amendment to Pesticide Registration (PR) Notice 98-10, effective September 15, 2022. EPA states that it is providing 12 months’ notice to registrants before the termination takes effect to give registrants time to adjust their contractual commitments. Registrants must ensure that by September 15, 2022, their product is produced using a source of active ingredient identified in the product’s EPA-approved Confidential Statement of Formula (CSF) or otherwise complies with the requirements of PR Notice 98-10. All notifications submitted to EPA under the temporary process are valid only for the time period of the temporary amendment. After September 15, 2022, registrants “will not be able to release for shipment formulations produced under the conditions of the temporary amendment without first complying with the registration requirements that were in place prior to the issuance of the temporary amendments.”

EPA states that this notice applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (the virus that causes COVID-19) or products that serve as the source of active ingredient for disinfectants on EPA’s List N. This notice also applies to food contact surface sanitizer products containing the active ingredient isopropyl alcohol that are used in the essential role of food manufacturer and preparation.

In 2020, EPA issued temporary amendments to PR Notice 98-10 to ensure that antimicrobial products remained available in response to the COVID-19 public health emergency. According to EPA, supply chains have stabilized and disinfectant products expected to kill SARS-CoV-2 have become consistently available to consumers, so it has determined that this flexibility is no longer needed. When the temporary amendment was issued, EPA stated it would assess the continued need for and scope of the temporary amendment to PR Notice 98-10 on a regular basis and would update it if EPA determined modifications were necessary. EPA stated it would post a notification at www.epa.gov/pesticides at least seven days prior to terminating the temporary amendment. EPA acknowledges in the termination memorandum that registrants require time to make the temporary changes permanent through CSF amendment or notification and therefore is providing 12 months, rather than the seven days guaranteed in the temporary amendment.

The memorandum addressing the termination is available here. Information on the temporary amendments to PR Notice 98-10 are available on our blog.


 

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

On July 8, 2021, the U.S. Environmental Protection Agency (EPA) announced that it issued a Stop Sale, Use or Removal Order (SSURO) to Allied BioScience for its product SurfaceWise2. SurfaceWise2, a residual antimicrobial surface coating, was previously authorized for emergency use in Arkansas, Oklahoma, and Texas to help address the COVID-19 pandemic. Specific use sites included American Airlines aircraft and airport facilities and two orthopedic facilities in Texas. A discussion of these emergency authorizations can be found here.

EPA asserts that the company was marketing, selling, and distributing SurfaceWise2 in ways that were inconsistent with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the terms and conditions of the emergency exemption authorizations, and issued an SSURO that requires Allied BioScience to stop selling and distributing SurfaceWise2 immediately. The SSURO will remain in effect unless revoked, terminated, suspended, or modified in writing by EPA.

Additionally, EPA states that it is revoking SurfaceWise2 emergency exemptions for Arkansas and Texas based on the FIFRA violations that EPA is alleging and scientific concerns regarding product performance. According to EPA, since January, new data became available that led EPA to review comprehensively new and existing information regarding product efficacy. EPA states that its laboratory testing indicates the product’s performance is less reliable under real-world conditions than, presumably, data that EPA previously reviewed may have indicated to EPA, particularly when it is exposed to moisture or abrasion.

In May 2021, EPA received a revocation request from Oklahoma indicating the emergency situation was no longer applicable in the state. EPA stated that it is accepting Oklahoma’s rationale and revoking the state’s emergency exemption on those grounds. This action is in addition to revoking the emergency exemptions for Arkansas and Texas.

Commentary

EPA initially approved in August 2020 the emergency exemptions for SurfaceWise2 for specific locations under Section 18 of FIFRA for use against SARS-CoV-2, the virus that causes COVID-19, on surfaces for up to seven days. In January 2021, EPA announced approval of extensions for the first-ever long-lasting antiviral product for use against SARS-CoV-2, with claims providing residual surface control of coronaviruses, including SARS-CoV-2, for up to 30 days on undisturbed (e.g., not routinely disinfected with List N products) non-porous treated surfaces. These approvals were novel and touted by EPA in its effort to combat the coronavirus. It is not unusual for EPA to issue an SSURO to stop sales for a product that is being marketed, sold, and distributed in a manner inconsistent with its label, but the issuance of an SSURO in this instance is noteworthy given EPA’s prior support of the product. Likewise, the fact that EPA conducted its own efficacy testing on this product is atypical. The implications of EPA’s conducting its own testing of the product could potentially have broader implications for novel antimicrobial products claiming long-term efficacy. Additionally noteworthy is the fact that this case emphasizes again EPA’s view that products intended to combat COVID-19 on surfaces are not in need of emergency or expedited approvals.


 

By Heather F. Collins, M.S.

On April 21, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemptions to the states of Georgia, Minnesota, and Utah permitting the use of BiaXamTM B110-V and BiaXamTM B110-P (BiaXam), adhesive film used as supplemental residual surface coating, in Delta Air Lines planes and facilities in those three states.

According to the EPA Authorizations for Georgia, Minnesota, and Utah (EPA Authorizations), the unregistered product is a transparent adhesive film that contains the unregistered active ingredient, Benzene, 1-(1,1-dimethylethyl)-4-ethenyl-, polymer with ethenylbenzene and 2-methyl-1,3-butadiene, sulfonated (CAS RN 1637665-77-0).  BiaXam is approved for use on indoor hard, nonpliable, nonporous, nonfood-contact surfaces of aircraft, airports, and associated facilities owned or operated by Delta Air Lines, to provide residual control of the SARS-CoV-2, the virus that causes COVID-19.  The adhesive film must be applied by trained applicators to indoor surfaces in airplanes, airports, and related facilities at the Delta Air Lines sites listed on the label.  Prior to application of the BiaXam product, the surface initially must be disinfected using a disinfectant from EPA’s List N – Disinfectants for Use Against SARS-CoV.

The BiaXam film is to be replaced in airplanes at least every 200 days, and in airports and related facilities at least every 100 days. If the film detaches from the surface, degrades, is damaged, becomes irreparably soiled, or its edges or corners begin to peel, the film is to be removed, the surface cleaned and dried using a List N disinfectant, and a new layer of film applied to the surface according to the application instructions on the label.  To maintain protective effect on surfaces that have been treated with BiaXam, only alcohol-based Purell wipes, Matrix Disinfectant/Cleaner #3 (quaternary ammonium based, EPA Reg. No. 1839-168-67026), and Lysol wipes (quaternary ammonium based, EPA Reg. No. 777-114) may be used on film-covered surfaces for routine cleaning and disinfection. The film surface is to be cleaned directly in place and not removed unless replacing. If cleaning products are provided to the public (e.g., airline passengers), only products compatible with BiaXamTM B110-V and BiaXamTM B110-P should be provided.

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 BiaXam product to be used at facilities owned or controlled by Delta Air Lines, Inc., at specific sites in Georgia, Minnesota, and Utah, on indoor hard, nonpliable, nonporous, and nonfood-contact surfaces in airplanes, airports, and other air-travel related facilities owned or controlled by Delta Air Lines, Inc. including, but not limited to:

  • Airplanes: railings, doorknobs/handles, armrests, seatback touch screens, seatbelt buckles, window shades, overhead bins, and overhead control buttons.
  • Airports and other air-travel related facilities: check-in kiosks and counters, gate counters, railings, doorknobs/handles, luggage bins, desks, keyboards, computer mice, touchscreens, printers, badge readers, plastic divider walls, hard nonporous seating, armrests, and elevator buttons.

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 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 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 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.


 
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