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.
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 M. Campbell, Heather F. Collins, M.S., and Barbara A. Christianson
On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2.
In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance). EPA published this Guidance in August 2016, to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels. The Guidance allows product registrants to make limited off-label claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA that demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2.
Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2. List N currently includes 469 products and is updated weekly. In many cases, EPA states that it was able to approve claims in as little as 14 days.
The 13 products approved include 12 unique products from the manufacturer Lonza and one additional Lysol product from Reckitt Benckiser. The 13 products approved are:
- Lonza Formulation S-21 (EPA Reg. No. 6836-75);
- Lonza Formulation S-18 (EPA Reg. No. 6836-77);
- Lonza Formulation R-82 (EPA Reg. No. 6836-78);
- Lonza Formulation S-18F (EPA Reg. No. 6836-136);
- Lonza Formulation R-82F (EPA Reg. No. 6836-139);
- Lonza Formulation S-21F (EPA Reg. No. 6836-140);
- Lonza Formulation DC-103 (EPA Reg. No. 6836-152);
- Lonzaguard RCS-256 (EPA Reg. No. 6836-346);
- Lonzaguard RCS-128 (EPA Reg. No. 6836-347);
- Lonzaguard RCS-128 PLUS (EPA Reg. No. 6836-348);
- Lonzaguard RCS-256 PLUS (EPA Reg. No. 6836-349);
- Lonzaguard R-82G (EPA Reg. No. 6836-381); and
- Lysol® Disinfecting Wipes (All Scents) (EPA Reg. No. 777-114).
Additional information is available here.
By Lisa M. Campbell, Heather F. Collins, M.S., and Barbara A. Christianson
On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of new guidance (Guidance) for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19. This new guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product labels. The Guidance outlines information that EPA asks registrants to submit to obtain expedited review of their proposed addition of this application method to their labels.
EPA notes that electrostatic spraying has drawn increased interest through the current public health emergency posed by COVID-19 because of the need to disinfect large indoor spaces, such as schools, offices, businesses, and other large areas, or areas with many surfaces. Unlike conventional spraying methods, electrostatic sprayers apply a positive charge to liquid disinfectants as they pass through the nozzle. The positively charged disinfectant is attracted to negatively charged surfaces, which allows for efficient coating of hard, nonporous surfaces.
EPA’s Guidance addresses adding electrostatic spray application methods to both new and currently registered disinfectant products that are on EPA’s List N: Disinfectants for Use Against SARS-CoV-2, or that would qualify for List N, and require review under the Pesticide Registration Improvement Extension Act (PRIA 4).
EPA states that it will expedite the following registration applications:
- Requests to amend currently registered products, including products on List N, that require review of data under PRIA 4:
- Current EPA-registered products approved for spray use application methods, already on List N, and the application is supported by the following data and revised label language:
- Confirmatory efficacy data conducted with an electrostatic sprayer to bridge from the existing approved claims to application by electrostatic sprayers;
- A wetness test consistent with MLB SOP MB-31 and a video to demonstrate that the surface remains wet for the duration of the contact time; and
- The following amendments made to the product label for electrostatic spray use directions:
- Spray droplet particle size (regardless of the ability to change nozzles that impact particle size) should be limited to a volume median diameter (VMD) ≥40 µm1.
- Include the contact time and minimum and maximum spray distance from the application equipment to the treated surface that is supported by the efficacy data, and instructions to reapply if the surface dries before the contact time is achieved.
- Place the electrostatic spray function in the ON position for electrostatic spray models that have the functionality to toggle ON/OFF.
- Specify that bystanders and pets must not be in the room during application.
- The following personal protective equipment (PPE) should be specified on the product label as part of the electrostatic spray use directions:
- For chemicals that have low vapor pressures (less than 1. x 10-4 mm Hg), use N95 filtering face piece respirators or half face respirators with N95 filters.
- For high vapor pressure chemicals (greater than 1. x 10-4 mm Hg), such as hydrogen peroxide, use half face respirators with chemical specific cartridges and N95 filters.
- Other PPE, including gloves, clothing, and eye protection is applicable as specified on the approved product label consistent with the acute toxicity profile of the product.
- Current EPA-registered products approved for spray use application methods for inclusion on List N:
- For a request to amend currently registered products for inclusion on List N and to specify electrostatic spray as an approved method of application, follow the directions in EPA’s previously announced expedited review of certain PRIA 4 submissions for products intended for use against SARS-CoV-2. Specifically, follow the directions in the “Request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data)” section and include the additional information specified above for electrostatic sprayers as part of the submission. Submission of new efficacy data to add claims to an already EPA-registered product along with the information specified for electrostatic sprayers can be submitted together as a PRIA 4 A570 action for expected expedited review.
- The submission should include a PRIA 4 fee payment in the amount of $4,023, or small business fee waiver request with the appropriate fee for a PRIA 4 A570 action. EPA states that it will make every effort to complete the review and make a regulatory decision one to two months faster than the standard four-month time frame under PRIA 4.
- Current EPA-registered products not approved for spray use application methods or for which modified PPE label language is desired for inclusion on List N:
- If the currently registered product labeling for the active ingredient is not approved for spray use application methods and/or the registrant wants to conduct and submit data to modify the default PPE label language specified above, these data should be submitted as a PRIA 4 code A572 and include the efficacy data, directions for use for electrostatic sprayers, and other documents specified above. EPA states it will make every effort to complete the review and make a regulatory decision one to two months faster than the standard nine-month time frame under PRIA 4.
- In addition, include the receipt of a PRIA 4 fee payment in the amount of $13,888 for an A572 action, or small business fee waiver request with the appropriate fee for a PRIA 4 A540 action or PRIA 4 A572 action.
- Requests to add electrostatic spray use directions to a new product that requires the review of data under PRIA 4:
- New product formulated with a registered source of active ingredient(s):
- New product formulated with an unregistered source of active ingredient(s):
EPA’s Guidance builds on EPA’s previously announced expedited review of certain submissions for products intended for use against SARS-CoV-2.
This guidance is important for many disinfectant products. Affected registrants or potential registrants should review it carefully.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA researchers are evaluating a number of commercially available products for potential long-lasting effectiveness against SARS-CoV-2, the novel human coronavirus that causes COVID-19. This research is being conducted at EPA’s Office of Research and Development's Center for Environmental Solutions and Emergency Response in Research Triangle Park, North Carolina, using surfaces that mimic the high touch points in mass transit trains and stations.
EPA states that it is working directly with New York’s Metropolitan Transportation Authority, North America’s largest transportation network, on evaluating EPA-registered antimicrobial products across New York City Transit to determine their ability to provide effective anti-virus protection over time.
Currently, EPA-registered products that claim long-lasting effectiveness are limited to those that control odor-causing bacteria on hard, non-porous surfaces. At this time, there are no EPA-registered products that claim long-lasting disinfection. EPA researchers hope to determine whether antimicrobial products can provide residual disinfection on surfaces over time and how durable the disinfection ability of the product is with normal use, including routine cleaning and natural weathering. According to EPA, data generated by EPA researchers will inform any regulatory decisions (including the approval and use of these products according to the label) made as part of the pesticide registration process through EPA’s Office of Pesticide Programs.
EPA researchers are also evaluating other possible high-efficiency alternative methods to disinfect, such as ultraviolet light (UV), ozone, and steam, that could be used on public transit systems to keep trains, buses, and facilities clean and safe for passengers. EPA is additionally studying disinfectant application methods, such as electrostatic sprayers or foggers, that EPA believes are promising.
As part of this effort, EPA has partnered with the Los Angeles County Metropolitan Transportation Authority, the third largest transit agency in the United States, to evaluate a number of new technologies, including UVC lighting and air filtration systems, to combat SARS-CoV-2 on public transit systems.
EPA states that it will make the results of this research available to help inform decisions on the use of longer-lasting disinfection products, including information on the frequency of use to maintain disinfection capabilities over time.
Additional information on EPA’s research on COVID-19 in the environment is available here.
By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson
On July 6, 2020, the U.S. Environmental Protection Agency (EPA) announced that it approved amended labels for two products, Lysol Disinfectant Spray (EPA Reg. No. 777-99) and Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127), based on laboratory testing that shows the products are effective against SARS-CoV-2. These are the first products for which EPA has reviewed laboratory testing data and approved label claims against SARS-CoV-2.
In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance), This Guidance was developed in April 2016 to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels. The Guidance allows product registrants to make limited claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA and demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2.
Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2. List N currently includes 431 products and is updated weekly. In many cases, EPA states that it was able to approve claims in as little as 14 days.
This week, EPA updated the entries for the two Lysol products on List N to indicate they have now been tested directly against SARS-CoV-2. This is significant since they are the first List N products for which EPA has reviewed laboratory testing data specifically against SARS-CoV-2, and not listed based on EPA’s determination that a product can be used against SARS-CoV-2 because of the product’s effectiveness against a harder-to-kill virus.
EPA states that it expects to approve such claims for additional List N products in the coming weeks.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
On May 15, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is issuing its third temporary modification to Pesticide Registration (PR) Notice 98-10 to include food-contact surface sanitizer products containing the active ingredient (AI) isopropyl alcohol. This new temporary amendment permits all the registration modifications outlined in the March and April modifications, while also expanding the criteria for the types of products that qualify for the provisions of this amendment.
EPA states that this temporary, time-limited amendment to PR Notice 98-10, dated May 11, 2020, will extend some of the supply chain flexibilities to products used in the food manufacture and preparation industries. Specifically, this temporary amendment expands these flexibilities to manufacturers of food-contact surface sanitizer products containing isopropyl alcohol and adds isopropyl alcohol to the list of AIs commodity chemicals allowed to be changed by notification in order to use any similar source to produce List N registered disinfectant products.
According to EPA, these isopropyl alcohol sanitizer products are not to be applied directly to food. Instead, they are used to sanitize equipment and surfaces used in food manufacturing and food preparation.
EPA intends for these flexibilities to increase the availability of products for use against the SARS-CoV-2. This third temporary modification to PR Notice 98-10, according to EPA, is in response to feedback from the food manufacture and preparation industries that are experiencing challenges acquiring sanitizers for use in production facilities processing low-moisture products like cereal, flour, and industrial baked goods.
Additional information on submission information for registrants is available at Temporary Amendment to PR Notice 98-10 and on our blog.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
The Science Advisory Board (SAB) of the U.S. Environmental Protection Agency (EPA) announced that it will convene the Chartered SAB meeting on May 20, 2020, to review and discuss the draft report prepared by the SAB COVID-19 Review Panel. The draft report, SAB Technical Review of EPA’s Identification of Research Needs to Address the Environmental and Human Health Impacts of COVID-19, was funded by the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. This research was conducted to assist EPA in its understanding of the environmental and human health impacts from COVID-19 and to identify EPA research already underway as well as new EPA research that has been proposed. The research included an evaluation of the efficacy of available disinfectants in killing SARS-CoV-2, the virus that causes COVID-19, on different types of surfaces that may be frequently touched by multiple people, such as in subway cars, door handles, and railings. Areas of particular interest include the efficacy of disinfection methods in controlling the virus on porous materials and soft surfaces, and the efficacy of products that claim to offer residual or long-term control of the virus.
EPA issued detailed charge questions for consideration by the SAB on April 21, 2020, and the SAB hosted a public teleconference and audio webcast of the presentation by EPA and the review by SAB on April 30, 2020.
Additional information on the forthcoming Chartered SAB meeting is available here.
By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
On May 12, 2020, the U.S. Environmental Protection Agency (EPA) announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19.
EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the SARS-CoV-2. These actions include requests to amend currently registered products that require a review of efficacy data and applications for new pesticide product registrations that would qualify for List N for use against SARS-CoV-2. This process does not replace the review process of all other submitted antimicrobial products.
EPA states that it also may consider expedited review of new active ingredients (AI) or new uses for currently registered AIs (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces).
The following submissions may qualify for expedited review:
Amendments for Currently Registered Products
- A request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data);
- A request to add a new unregistered source of a non-commodity active ingredient (active ingredient not listed in the May 11, 2020, Temporary Amendment to PR Notice 98-10) to a product’s Confidential Statement of Formula; and
- A request that involves changes to a product’s formulation that requires EPA to review confirmatory efficacy data. Confirmatory efficacy data are a reduced set of data used to support certain changes in formulation to a registered product.
New Products – formulated with currently registered AIs that are contained in disinfectant and/or sanitizer pesticide products approved for use in residential, commercial, institutional, and industrial settings.
- A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with a registered source of active ingredient(s); and
- A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with an unregistered source of the active ingredient(s).
Additional information on EPA’s requirements and process for submissions to be considered for expedited review is available here.
EPA also announced the availability of its new List N Tool: COVID -19 Disinfectants, a new web-based application (app) that allows smart phone users and others to access List N to identify disinfectant products that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.
For several months, EPA has provided the public with List N, which currently lists 410 surface disinfectant products that meet EPA’s criteria for use against SARS-CoV-2. EPA is now making available the data from the List N webpage on a browser-based web app that allows users to identify the disinfectant products best suited for their needs. Users can search by use site (e.g., home, business, health care, etc.), surface type (e.g., hard, non-porous surfaces like countertops; porous surfaces like fabrics), contact time (i.e., the time the product needs to be visibly wet), EPA registration number, AI(s), or product name.
By Lisa M. Campbell, Timothy D. Backstrom and Barbara A. Christianson
On May 1, 2020, the U.S. Environmental Protection Agency granted an experimental use permit (EUP) to Oxitec Ltd. (Oxitec) to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce populations that serve as a vector for a variety of diseases including Zika virus. The EUP is designed to test the effectiveness of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations in specific locations with monitoring and sampling of the resultant mosquito populations. These field tests will proceed only after state and local approval, and they are intended as a first step toward potential wider use of genetically modified mosquitoes in the U.S.
Oxitec’s field tests will be conducted, if approved by state and local authorities, over a two-year period in Monroe County, Florida, beginning in summer 2020, and in Harris County, Texas, beginning in 2021. During these field tests, Oxitec will release into the environment male mosquitoes that have been genetically modified to carry a protein that will inhibit the survival of female offspring. After males carrying this protein mate with wild female mosquitoes, it is anticipated that only the male offspring will survive to become fully functional adults and that these male offspring will retain the same genetic modification. This should provide multi-generational effectiveness in reducing the number of adult females in Aedes aegypti mosquito populations in the release areas.
Female mosquitoes are the ones who bite humans and that serve as the vector for blood-borne illnesses. Since only male mosquitoes will be released into the environment and their female offspring are not expected to survive, EPA does not believe they will pose a health risk to the human population. EPA anticipates that these modified mosquitoes could be an effective tool in combatting the spread of certain diseases like the Zika virus in light of the growing resistance of mosquito populations to current insecticides. It is also anticipated that there will be no adverse effects to animals such as bats and fish who consume the genetically modified mosquitoes.
Oxitec is required to monitor and sample the mosquito population weekly in the treatment areas to determine how well the product works for mosquito control and to confirm that the modified genetic traits disappear from the male Aedes aegypti mosquito population over time. EPA has also maintained the right to cancel the EUP at any point during the 24-month period if unforeseen outcomes occur.
EPA’s decision and the approved permit are available here.
By Heather F. Collins, M.S. and Barbara A. Christianson
On April 29, 2020, the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) released updated guidance to give assistance to facility operators and families on how to clean and disinfect spaces properly. Developed in cooperation with the White House, the updated guidance provides step-by-step instructions for public spaces, workplaces, businesses, schools, and homes, and falls in line with the Opening up America Again guidelines, the three-phased approach, based on the advice of public health experts, to help state and local officials when reopening its economies, getting people back to work, and continuing to protect American lives.
The comprehensive plan was developed in consultation with EPA’s expertise on the safe and effective use of disinfectants against the SARS-CoV-2, the virus that causes COVID-19. The guidance offers a three-step process for preparing spaces for reopening:
- Develop a plan
- Determine what needs to be cleaned;
- Determine how areas will be disinfected; and
- Consider the resources and equipment needed.
- Implement the plan
- Clean visibly dirty surfaces with soap and water;
- Use the appropriate cleaning or disinfectant product; and
- Always follow the directions on the label.
- Maintain and revise the plan
- Continue routine cleaning and disinfection;
- Maintain safe practices; and
- Continue practices that reduce the potential for exposure.
EPA states that cleaning and disinfecting surfaces is an important, two-step process essential to any effort to reduce the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
- Clean: Use soap and water to remove germs, dirt, and impurities from surfaces. It lowers the risk of spreading infection.
- Disinfect: Use disinfectant products to kill germs on surfaces. By killing germs on a surface after cleaning, it can further lower the risk of spreading infection.
EPA has compiled a list of disinfectants for use against SARS-CoV-2, List N: Disinfectants for Use Against SARS-CoV-2, which include ready-to-use sprays, concentrates, and wipes. EPA emphasizes to follow the product label instructions and safety information, including leaving the product on the surface long enough to kill germs, rinsing off the product to avoid ingesting it, and putting the product out of reach of children right away.
EPA also states that it is important to avoid over-using or stockpiling disinfectants or personal protective equipment, which can result in shortages of critical products needed for emergencies. In the event that disinfectant products on the EPA list are not available, the guidance provides other techniques for disinfecting surfaces that are as effective in reducing the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
EPA’s guidance documents are available here.