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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 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.