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Pesticide Registration

Section 18 Emergency Exemption Requests and Coronavirus (COVID-19)

Section 18 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorizes EPA to exempt state and federal agencies from provisions of FIFRA and allow unregistered uses of pesticides to address emergency conditions. Under such an exemption, EPA allows limited use of a pesticide in defined geographic areas for a finite time, once EPA confirms that the situation meets that statutory definition of "emergency condition."

On Friday, January 15, 2021, EPA issued emergency exemptions to Georgia and Tennessee allowing them to use 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.

On Tuesday, January 19, 2021, EPA issued emergency exemptions to Oklahoma and Arkansas allowing the use of SurfaceWise2 in American Airlines airport facilities and planes in those states. Previously, on Monday, August 24, 2020, EPA had issued  emergency exemptions to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a product with residual efficacy against coronaviruses like SARS-CoV-2. 

On Wednesday, April 21, 2021, EPA issued emergency exemptions to Georgia, Minnesota, and Utah allowing the use of BIAXAM, a supplemental residual surface coating, in Delta Air Lines planes and facilities in those three states.

BIAXAM

How can this product be used? What are its label claims and directions for use?

BIAXAM is an adhesive film that can be applied by trained applicators to a range of hard, non-porous surfaces like gate counters, seat backs, overhead storage, and touch screens.

Laboratory testing data submitted by the applicant  indicates BIAXAM kills 99.999% of SARS-CoV-2 particles that land on the film within two hours. Based on differences in cleaning and disinfection frequency and protocols used in airport terminals vs airplanes, it remains effective for up to 100 days on airport surfaces and up to 200 days on airplane surfaces. It is allowed for use in Delta Air Lines planes and airline facilities in Georgia, Minnesota, and Utah.

This product supplements, but does not replace, routine cleaning and disinfection. Always follow CDC, state and local public health guidelines, including wearing masks, good ventilation, social distancing, hand washing, and cleaning surfaces.

Read the CDC's science brief on surface transmission of SARS-CoV-2. See EPA's fact sheet on best practices for cleaning and disinfecting during the COVID-19 pandemic.

Where can this product be used?

BIAXAM can be used in Delta Air Lines aircraft and airline facilities in Georgia, Minnesota, and Utah on hard, non-pliable, non-porous surfaces that don't come into contact with food. This includes (but is not limited to):

  • Airplane surfaces like armrests, seatback touch screens, seatbelt buckles, window shades, overhead bins, and overhead control buttons, and
  • Airport surfaces like check-in kiosks and counters, gate counters, railings, desks, touchscreens, armrests, and elevator buttons.

How does EPA know that this product can be used without safety concerns?

EPA does not expect BIAXAM to pose any health risks. Exposure to BIAXAM is expected to be minimal.

Because of its chemical properties, BIAXAM does not easily transfer from surfaces onto skin when touched. EPA is not allowing BIAXAM to be applied to surfaces that are expected to come into contact with food.

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Grignard Pure

How can this product be used? What are its label claims and directions for use?

Grignard Pure forms a mist with activity against airborne SARS-CoV-2 that contains the active ingredient triethylene glycol (TEG), an ingredient commonly used in fog machines for concerts and theater productions. The product may only be applied by trained professionals through a building’s HVAC system or using portable devices positioned strategically in an indoor space.

Use of this product does not eliminate the need for critical precautions like mask wearing and social distancing. Always follow CDC, state and local public health guidelines.

Grignard Pure may be non-visible, or you may see a light haze. 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.

Where can this product be used?

This product can be applied by a trained professional in certain indoor spaces in Georgia and Tennessee where high occupancy, poor ventilation, or other factors make it challenging to follow public health guidance and maintain appropriate social distancing. Areas of particular concern include breakrooms, locker rooms, bathrooms, lobbies, elevators, eating areas, and food preparation areas within:

  • Health care facilities (e.g., hospitals, nursing homes, medical offices, dental offices), but not in resident / in-patient rooms, emergency rooms including waiting areas, operating rooms, or intensive care units; 
  • Intrastate buses, trains, and subways;
  • Food processing (NAICS 311) but not food services (NAICS 722);
  • Indoor spaces within buildings, including government facilities, where people are conducting activity deemed essential by the state and allowed by the state pesticide agency, unless excluded above.

How does EPA know that this product works?

Based on a review of laboratory testing data, EPA expects that when used as directed, Grignard Pure will continuously inactivate 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. 

How does EPA know that this product can be used without safety concerns?

EPA reviewed all available data on this product’s safety and concluded that it does not pose any health risks of concern.

The product may cause temporary irritation to sensitive individuals. If you experience eye, nose or throat irritation (including dry eyes or a sore throat), leave the treated area. Get fresh air either outside or in another room.

EPA does not expect any elevated risks for children or the elderly. In general, people with asthma or other respiratory sensitivities may be more likely to experience respiratory irritation.

EPA has also evaluated this chemical in the past during the registration review of its active ingredient, triethylene glycol (TEG).

Will EPA conduct ongoing monitoring to ensure this product’s safety?

Any unexpected adverse effects related to the use of this product must be immediately reported to EPA as required under the terms of the FIFRA Section 18 emergency exemption approval. This information helps inform the terms of use under which EPA allows this product to be used in the future.

How will I know if I’m entering a space treated with Grignard Pure?

The label requires that signs be posted at every entrance to areas treated with Grignard Pure.

Do I still need to wear a mask and practice social distancing in a space treated with Grignard Pure?

Yes. Grignard Pure does not eliminate the need for critical precautions like mask wearing and social distancing. Always follow CDC, state and local public health guidelines.

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SurfaceWise2

How can this product be used? What are its label claims and directions for use?

SurfaceWise2 can be used in American Airlines airport facilities and planes in the states of Texas, Oklahoma, and Arkansas. It can also be used in Texas in two Total Orthopedics Sports & Spine Clinics. This product provides residual efficacy against coronaviruses like SARS-CoV-2. 

SurfaceWise2 – a product manufactured by Allied BioScience – is a surface coating made wholly in the U.S. that inactivates viruses and bacteria within two hours of application. The product’s label provides directions for application by applicators trained using electrostatic sprayers.

This product is not a replacement for routine cleaning and disinfection with products from EPA’s List N: Disinfectants for Use Against SARS-CoV-2, the virus that causes COVID-19. EPA recommends that facilities continue to follow the cleaning and disinfection recommendations from the Centers for Disease Control and Prevention (CDC). Please note that according to the CDC, while “it may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes,” the virus is thought to spread mainly through close contact between individuals.

How long are the emergency exemptions? What’s the next step for getting this product on List N?

The approved Section 18 emergency requests for SurfaceWise2 are effective in TX, AR, and OK until August 24, 2021. As new data emerge, EPA may alter the terms of the product's emergency uses. 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. However, EPA’s current understanding is that the company intends to complete the necessary research and apply for registration. If the full registration process is completed, the product would become available for purchase by members of the public and may be eligible to be included as a supplement to EPA’s List N.

What type of data would need to be submitted to EPA for Section 18 Emergency Exemption Requests related to products with residual efficacy against COVID-19?

EPA has released interim guidance for companies or individuals who are interested in pursuing a FIFRA Section 3 registration for antiviral surface coatings.

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 both durable and effective against viruses in their applications. For example, antiviral efficacy should be assessed using methods that account for conditions expected to exist in settings where the products will be used, such as surfaces that are exposed to physical touches/abrasion and treated in combination with other cleaning products and disinfectants.

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Section 18 Request Process

Has EPA received other Section 18 Emergency Exemption Requests related to COVID-19?

Section 18 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorizes EPA to exempt state and federal agencies from provisions of FIFRA and allow unregistered uses of pesticides to address emergency conditions. Under such an exemption, EPA allows limited use of a pesticide in defined geographic areas for a finite time, once EPA confirms that the situation meets that statutory definition of "emergency condition."

EPA will consider any requests submitted related to the COVID-19 public health emergency. Please note that only state and federal agencies can submit Section 18 requests.

Can other states submit Section 18 Emergency Exemption Requests related to COVID-19?

Other states can submit Section 18 Emergency Exemption Requests to EPA. Typically, EPA evaluates these requests within 45 days, assessing whether the criteria for an emergency are met and the if product meets the required standards for safety and efficacy. Read more.

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