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, 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, 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 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:

  1. Develop a plan
    • Determine what needs to be cleaned;
    • Determine how areas will be disinfected; and
    • Consider the resources and equipment needed.
  2. 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.
  3. 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.


 

By Lisa M. Campbell and Timothy D. Backstrom

On April 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Wheeler has requested that the Science Advisory Board (SAB) provide feedback on research needs concerning SARS-CoV-2 (the virus that causes COVID-19).  This research is intended to help EPA understand and mitigate the environmental and human health impacts from COVID-19, and identifies EPA research that is already underway as well as new EPA research that has been proposed.  EPA issued detailed charge questions for consideration by the SAB on April 21, 2020.  EPA has requested that any comments on the charge questions be submitted by April 26, 2020.  The SAB will host a public teleconference and audio webcast of the presentation by EPA and the review by SAB on April 30, 2020, from 1:00 P.M. – 5:00 P.M. Eastern Daylight Time.

Some of the research to be reviewed will be funded by the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.  The research includes an evaluation of the efficacy of available disinfectants in killing the COVID-19 virus on different types of those surfaces that may be frequently touched by multiple people, such as in subway cars, door handles, 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 will collaborate with the Centers for Disease Control and Prevention (CDC) on research to evaluate the use of ultraviolet (UV) light, ozone, and steam as solutions for large-scale disinfection.  EPA and CDC will also evaluate whether electrostatic sprayers and foggers used with List N EPA-approved disinfectants are efficacious in killing the virus.

Commentary

Although there are a number of registered disinfectant products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2, that offer antiviral activity against COVID-19, research to identify and to recommend scalable technologies for disinfection of the COVID-19 virus on environmental surfaces is a critical part of a strategy for reducing infection rates in the ongoing pandemic.  Technologies that can control the virus on porous or soft surfaces are important, as is the long-term durability of antiviral treatments and coatings on environmental surfaces.  Nonetheless, while research on disinfection techniques is important, EPA also needs to consider whether there are procedural changes that would help promising antiviral agents and technologies to be brought to market more quickly.

Disinfectants that are sold with antiviral claims must be registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Although there are at present a number of promising new antiviral products in the pipeline, securing a new registration under FIFRA for an antiviral disinfectant would typically take from 18-24 months and it is uncertain how much EPA can accelerate this timetable.  Despite the urgency of the current public health emergency, the only more expeditious alternative to allow distribution and sale of new antiviral products is an emergency exemption under FIFRA Section 18.

Securing an emergency exemption requires that the request be sponsored by a Federal or State agency.  CDC in particular has been unwilling to submit or to sponsor any emergency exemption requests for COVID-19 because it wishes to avoid any perception that it is favoring any specific product or manufacturer.  Although State agencies are likely to be more willing to request emergency exemptions, State-by-State relief is not very well suited to addressing an infection crisis of global proportions.  In addition to conducting research on disinfectant products and technologies, EPA needs to consider whether the current process for obtaining emergency exemptions for antiviral agents could be modified or streamlined to reflect the urgency of the current crisis.


 

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

On April 23, 2020, the U.S. Environmental Protection Agency (EPA) announced it is continuing efforts to provide critical information on surface disinfectant products that can be used against SARS-CoV-2, which causes COVID-19.  EPA states that it now has nearly 400 products that have qualified to be effective against SARS-CoV-2.  EPA also published an overview of its actions and resources related to disinfection against the novel coronavirus.

EPA’s Office of Chemical Safety and Pollution Prevention’s Assistant Administrator Alexandra Dapolito Dunn stated that “EPA is dedicated to its mission of protecting human health and we want all Americans to have access to effective and approved surface disinfectant products,” and emphasized “[w]e also want everyone follow the directions on the product so that we can safely use registered disinfectants and provide critical protection to our families.”

EPA in its announcement stressed when using an EPA-registered surface disinfectant, always follow the product’s directions and:

  • Never apply the product to yourself or others.  Do not ingest disinfectant products. This includes never applying any product on List N directly to food;
  • Never mix products unless specified in the use directions. Certain combinations of chemicals will create highly toxic acids or gases;
  • Wash the surface with soap and water before applying disinfectant products if the label mentions pre-cleaning;
  • Follow the contact time listed for your product on List N.  This is the amount of time the surface must remain visibly wet to ensure efficacy against the virus. It can sometimes be several minutes; and
  • Wash your hands after using a disinfectant. This will minimize your exposure to the chemicals in the disinfectant and the pathogen you are trying to kill.

Additional information on EPA’s disinfectant safety messages is available on EPA’s twitter feeds, @EPA and @ChemSafety.  These channels will be updated with new materials throughout the COVID-19 crisis.

EPA states it is also continuing to add additional chemicals to its list of common inert ingredients. These actions are intended to help address supply chain issues for EPA-registered disinfectants and other pesticides. It allows manufacturers of already-registered EPA products to change the source of listed inert ingredients.


 

By Lynn L. Bergeson and Barbara A. Christianson

On April 22, 2020, Assistant Administrator Alexandra Dapolito Dunn stated, on prerecorded remarks posted by the American Bar Association, that the U.S. Environmental Protection Agency (EPA), after the coronavirus crisis subsides, will review whether some of the current requirements to submit notifications or label amendments are necessary.  Some of these requirements have been suspended as part of EPA’s efforts to hasten the process for disinfectants approved for use against SARS-CoV-2, which causes COVID-19.

EPA modified the requirements to submit a notification or label amendment to increase quickly the number of disinfectants available to fight the novel coronavirus that causes COVID-19.  These steps include a temporary policy EPA updated on April 14, 2020, describing situations in which manufacturers producing disinfectants for use against SARS-CoV-2 can change certain ingredients or sources of those ingredients without the normal requirement to notify EPA.

On the prerecorded remarks, Assistant Administrator Dunn stated as an example, “if a baker is changing its source of flour, we don’t need to know where it’s coming from as long as it’s the same quality and the company maintains its records.”  She also remarked “dropping such ‘administrative hoops’ has helped disinfectant manufacturers get their products to market without putting public health or the environment at risk.”

EPA will proceed with formal rulemaking or another process if EPA decides to modify the requirements to keep the flexibility currently used during the COVID-19 crisis.


 

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

On April 14, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing registrants to notify EPA of certain formulation and manufacturing facility changes and immediately release the product for sale without waiting for EPA approval.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N). 

EPA’s announcement builds on EPA’s temporary amendment to Pesticide Registration (PR) Notice 98-10 announced on March 31, 2020.  Among other changes, the temporary amendment to PR Notice 98-10 streamlines the process for adding additional registered sources of active ingredients to a formulation and setting up an approved pesticide manufacturing establishment.  This enhanced flexibility allows List N with registered sources of active ingredients to be manufactured in those establishments without prior EPA approval. 

EPA’s temporary amendment to PR Notice 98-10 states that registrants may submit a notification to substitute registered sources of active ingredients that are not similar.  If registrants are unable to substitute a similar registered source (similar defined as the active or inert ingredient obtained from the source has the same Chemical Abstracts Service Registry Number (CASRN) and same purity) of the active ingredient, they may use an alternate source but must adjust the inert ingredient to ensure the nominal concentration of the active ingredient in the product does not change.  As long as the nominal concentration of the active ingredient in the product remains the same and adjustments in inert ingredients is limited to water only, this change will be allowed by notification and confirmatory efficacy data will not be required.

Additionally, EPA’s temporary amendment to PR Notice 98-10 will allow registrants to submit a notification to add EPA-registered establishments for formulations having a registered source of the active ingredient and where there are no other changes to the formulation.

EPA states that the changes allowed through notification by this action will not result in any substantive changes to the final pesticide formulations already approved by EPA, and the products’ effectiveness will not be affected and the products’ current precautionary labeling will remain protective.  EPA adds this action will not cause any unreasonable adverse effects to human health and the environment.

EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:

  • A cover letter with a subject line that clearly indicates that this is a “notification per TEMPORARY AMENDMENT TO PR NOTICE 98-10 (April 14, 2020) for EPA Registration No. XXXXXX and [insert product name]”;
  • The active ingredient; and
  • The following certification statement:

[Name of Registrant] is submitting this notification consistent with the provisions of PR Notice 98-10 and [insert section(s) of the Temporary Amendment to PR Notice 98-10 dated April 10, 2020, and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  I confirm that the ingredients statement of this label remains truthful.  I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA.  I further understand that if this self-certification is not consistent with the terms of PR Notice 98-10, the Temporary Amendment 98-10 dated April 10, 2020, and 40 C.F.R. 152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under section 12 and 14 of FIFRA.

Applications must be submitted via the CDX portal.  At this time, EPA is not accepting paper applications.  Once an application is submitted, EPA requests that an email is sent to the Product Manager for the product with the CDX tracking number (CDX _ 2020 _ XXXXXXX).  A registrant may distribute or sell a product modified according to this temporary amendment to PR Notice 98-10 once EPA receives the notification.  Receipt to EPA occurs when the requestor receives a CDX number when submitting the application via the CDX portal.

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

On April 2, 2020, the U.S. Environmental Protection Agency (EPA) announced the addition of new surface disinfectants on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N) that may be used to combat SARS-CoV-2, the novel coronavirus that causes COVID-19.  List N now contains 357 products.  The webpage for List N also now has enhanced functionality to allow users to sort these products by surface type and use site.  EPA states that it continues to expedite the review process for new disinfectants.

Previously, all products on List N had to have either an EPA emerging viral pathogen claim or have demonstrated efficacy against another human coronavirus.  EPA now has expanded List N to include products on EPA’s List G: EPA’s Registered Antimicrobial Products Effective against Norovirus and List L: Products Effective against the Ebola Virus, as these products also meet EPA’s criteria for use against SARS-CoV-2.

EPA has updated List N to include the types of surfaces on which products can be used (e.g., hard or soft) and use sites (e.g., hospital, institutional or residential). Products applied via fogging or misting are now noted in the formulation column.  This additional information allows the public to choose products that are appropriate for their specific circumstances.

Additionally, EPA has updated the Frequently Asked Questions (FAQ) EPA has posted about disinfectants related to coronavirus.  The FAQ update provides new information on pesticide safety, enforcement, and pesticide devices.  It also includes enhanced explanations of why List N products are qualified for use against SARS-CoV-2 and how these products can be used most effectively.

EPA states that it has continued to adapt its processes to ensure the supply of disinfectants keeps pace with demand. EPA recently announced additional flexibility that allows manufacturers of already-registered EPA disinfectants to obtain certain active and inert ingredients from any source of suppliers without prior approval by EPA.  EPA also added 48 additional chemicals to its list of commodity inert ingredients. EPA states that this regulatory flexibility aims to help ease the production and availability of EPA-registered disinfectants.

EPA also is expediting all requests for company numbers and establishment numbers to enable new pesticide-producing establishments to come online as quickly as possible.  

Additional information on EPA’s efforts to address the novel coronavirus is available here.


 
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