Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

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

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

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

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

40 C.F.R. § 166.3.

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

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

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

Commentary

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

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

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


 

By Lisa R. Burchi and Lisa M. Campbell

On September 25, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report Measures and Management Controls Needed to Improve EPA’s Pesticide Emergency Exemption Process that details the results from the its audit done to determine whether EPA has a comprehensive pesticide emergency exemption approval process that maintains environmental and human health safeguards.  Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) allows EPA to “grant federal and state lead agencies the authority to approve -- in certain emergency situations -- the limited application of a pesticide not registered for that particular use.  These short-term pesticide use approvals are called emergency exemptions.”  OIG states that the scope of the audit “focused on the emergency exemption management process and the internal controls necessary to consistently implement and administer it.”  OIG did not “evaluate the science used to review emergency exemptions or the subsequent emergency exemption application decisions.”

OIG’s main criticisms of EPA’s emergency exemption program listed in the report are:

  1. EPA’s Office of Pesticide Programs (OPP) collects human health and environmental data through its emergency exemption application process, including the total acres affected, the proposed and actual quantities of the exempted pesticide applied, and the estimated economic losses but it does not use these data to support outcome-based performance measures that capture the scope of each exemption, to measure the potential benefits or risks of each exemption, or to determine how well the emergency exemption process maintains human health and environmental safeguards.
  2. OPP does not consistently communicate emergency exemption information with its stakeholders.  OPP previously sent a “year in review” letter to states that summarized the emergency exemption activity for that year and provided additional information regarding the emergency exemption process.  OPP has not sent this letter since 2015, however.
  3. There were significant deficiencies in the OPP’s online database management, in its draft Section 18 emergency exemption standard operating procedure and application checklist, and in its reports to Congress and the Office of Management and Budget.

The eight OIG recommendations in the report for the Assistant Administrator (AA) for the Office of Chemical Safety and Pollution Prevention’s (OCSPP) consideration, and OCSPP’s response to those recommendations, are as follows:   

Recommendation 1:  Develop and implement applicable outcome-based performance measures to demonstrate the human health and environmental effects of the EPA’s emergency exemption decisions.

  • OCSPP Response and OIG Resolution:  OCSPP did not agree with this recommendation, stating that development of an outcome-based performance measure for the Section 18 emergency exemption process was neither appropriate nor feasible.  No proposed corrective actions were proposed and this issue remains unresolved. 

Recommendation 2:  Determine which application review performance target for emergency exemption applications the OPP plans to meet, and make that target consistent between its Annual Performance Goal and its internal controls governing the emergency exemption process.

  • OCSPP Response and OIG Resolution:  OCSPP did not agree or disagree with Recommendation 2, but it nevertheless provided a corrective action “to avoid future confusion” and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 3:  Update and prepare the draft standard operating procedure in final that OPP uses to guide the emergency exemption process.

  • OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and provided planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 4:  Develop formal emergency exemption application review procedures that detail specific data collection, management and reporting control steps, and procedures that require specific management controls for accurately and consistently updating the OPP’s Section 18 database.

  • OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and provided acceptable planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 5:  Develop concise emergency exemption application guidance that specifies the minimum requirements of an application submission and is available on the OPP’s Section 18 website.

  • OCSPP Response and OIG Resolution:  OCSPP did not agree or disagree with Recommendation 2, but it nevertheless proposed to:  (1) evaluate how its web resources can be enhanced to respond to this recommendation; and (2) if it determines that enhancements to the Section 18 website are necessary, implement any needed web updates by December 2019.  OIG does not believe the proposed corrective action for this recommendation is sufficient to meet the intent of the recommendation and states this recommendation remains unresolved.

Recommendation 6:  Provide clear guidance to state lead agencies on how and when they can use efficacy data from other state lead agencies to satisfy the emergency exemption application criteria.

  • OCSPP Response and OIG Resolution:  OCSPP did not agree with this recommendation, stating that the only example provided by OIG to support this recommendation represents an extremely rare situation.  No corrective actions were proposed and this issue remains unresolved. 

Recommendation 7:  Expand the data presented in the OPP’s Section 18 database by considering additional data points, such as application acreage requested, actual acreage applied, and registration status of each exempted pesticide.

  • OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and stated it would “consider additional data points, such as application acreage requested, decision documents, and registration status of each exempted pesticide, as OCSPP explores ways to improve the website database and its overall content.”  OCSPP proposed that by December 2019 recommendations would be made to the OPP Director for enhancing the Section 18 database and a memorandum would be provided to the OCSPP AA with a plan for updating the Section 18 database addressing these recommendations.  OIG states that OCSPP did not commit to expanding the data presented in the Section 18 database and, thus, this issue remains unresolved.

Recommendation 8:  Provide an annual update and information summary to state lead agencies to better inform them about any changes to the emergency exemption application-and-review process.

  • OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and stated it would “explore how to provide periodic and useful program updates to applicants.”  OCSPP proposed by that December 2019 it would “work with State Lead Agencies to identify the types of information they may find helpful for periodic updates” and “develop a strategy which details the activities that might be conducted to provide periodic and useful program updates to applicants.”  OIG states that OCSPP found the term “periodic” unclear and stated the issue remains unresolved.

Although several of these recommendations and EPA’s proposals remain unresolved, registrants should monitor for actions to be taken by EPA in response to the OIG Report.