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.
EPA Announces Its Continued Efforts to Provide Critical Information on Safe Disinfectant Use During COVID-19 Crisis
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:
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.
EPA Remarks That Requirements to Notify EPA of Certain Changes to Disinfectants During COVID-19 May Be Retained
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.
Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.
Lynn and Eric’s conversation focuses on unique “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, Toxic Substances Control Act (TSCA) implementation initiatives, and the impact of tariffs on imports from China on NACD member companies. Eric is an amazing leader of an essential trade association, and this conversation provides insights into his success as President and CEO of NACD.
All Things Chemical™ engages listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space. All Things Chemical™ is available now on iTunes, Spotify, Stitcher, and Google Play Music. Subscribe so you never miss an episode.
Register Now for “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” on April 29, 2020, 12:00 pm (EDT)
Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another. Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.
Department of Justice Arrests Georgia Resident for Selling Illegal Products Claiming To Protect Against Viruses
On April 9, 2020, the Department of Justice (DOJ) announced it had charged a Georgia resident, Rong Sun, a/k/a Vicky Sun with federal criminal charges relating to alleged illegal importation, sales, and mailing of an unregistered pesticide product. EPA also has taken steps to prevent further imports, sales, and distributions of this product within the United States, announcing in its press release that it prevented several shipments of this product from entering U.S. Pacific ports.
The product at issue, Toamit Virus Shut Out, was sold through eBay and made claims to protect individuals from bacteria and viruses and to reduce transmission risk by 90 percent. Claims regarding the product also included the following statement: “In extraordinary times, access to public places and confined spaces will be protected by one more layer and have one more layer of safety protection effect, thus reducing the risks and probability of infection and transmission.” The product was not registered by EPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
DOJ’s Environment and Natural Resources Division is prosecuting the case. EPA’s Criminal Investigation Division, U.S. Immigration and Customs Enforcement’s Homeland Security Investigations, and USPS are investigating this case. This type of collaborative investigative effort among federal agencies can be expected to continue to prevent defrauding victims during this coronavirus pandemic. In its press release announcing the arrest, DOJ stated that it “will take quick action through the Georgia COVID-19 Task Force to put a stop to criminals preying on the public with Coronavirus-related fraud schemes.” EPA Assistant Administrator for Enforcement and Compliance Assurance Susan Bodine stated further: “Reliance on fraudulent products may increase the spread of COVID-19 and exacerbate the current public health emergency.”
EPA Continues Efforts to Increase the Availability of Disinfectant Products for Use Against COVID-19
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:
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.
On April 6, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year 2017 (2017 Report). Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area. The 2017 Report discusses the completion of tolerance reassessment and describe the status of various regulatory activities associated with reregistration. The 2017 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before June 5, 2020.
EPA’s completed product registration actions totaled 255, short of EPA’s goal of 600 actions. The table below details the actions completed in FY 2017.
Table 1.—Product Reregistration Actions Completed in FY 2017 (as of September 30, 2017)
EPA also states that there were 4,370 products had product reregistration decisions pending at the end of FY 2017, compared to 4,621 products with product reregistration decisions pending at the end of FY 2016, and 5,133 products with product reregistration decisions pending at the end of FY 2015. Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”
The number of applications for registration requiring expedited processing (i.e., “fast track” applications) that EPA considered and approved has been more consistent in recent years, with 2,223, 2,422, and 2,574 in 2015, 2016, and 2017 respectively.
California Department of Pesticide Regulation Announces Limited Enforcement Discretion for Licensing Requirements to Support COVID-19 Control for the Next 90 Days
On April 3, 2020, the California Department of Pesticide Regulation (DPR) announced it would allow enforcement discretion by County Agricultural Commissioners (CAC) for licensing and certification requirements for pesticide applicators who perform sanitization services to control the spread of COVID-19.
DPR states in its announcement that, under normal circumstances, a “Pest Control Business (PCB) must always have a Qualified Applicator License (QAL) holder to supervise pest control services. Generally, where a PCB performs sanitization services, the QAL must also be certified in Category A, P, or K” described as follows:
DPR acknowledges that due to Governor Newsom’s March 4, 2020, “Stay at Home” Executive Order, DPR cannot proctor in-person licensing examinations to certify licensees. DPR thus announced that it will use enforcement discretion by allowing “licensed and registered PCBs to perform sanitization services for the control of COVID-19 if they have a designated individual at each business location with a valid QAL in any category” (emphasis added by DPR). DPR specifies that enforcement discretion applies when all of the following conditions are met:
EPA Coordinates with Retailers and Third-Party Marketplace Platforms to Discuss Steps to Protect American Consumers from Fraudulent Coronavirus Disinfectant Claims
On April 3, 2020, the U.S. Environmental Protection Agency (EPA) hosted an interactive telephone call with U.S. retailers and third-party marketplace platforms to discuss imposter disinfectant products and those that falsely claim to be effective against the novel coronavirus, SARS-CoV-2, the cause of COVID-19. EPA hosted the call due to recent complaints on the availability of products with unsubstantiated and potentially dangerous claims of protection against SARS-CoV-2 and has enlisted the help of the retail community to prevent these products from coming to market.
EPA Administrator Andrew Wheeler described the call as “informative and productive,” and stated that “together, we will work diligently to ensure that consumers have access to EPA-approved and verified surface disinfectant products; products that we know to be effective against the novel coronavirus.”
Participants included the Retail Industry Leaders Association (RILA), the National Retail Federation, Walmart, Amazon, and eBay. All expressed commitment to “work closely with trusted suppliers to ensure that all products that they sell meet or exceed all applicable U.S. safety standards and legal requirements” and to “work closely with EPA to remove fraudulent products from the marketplace as soon as possible.” EPA is also coordinating with the U.S. Department of Justice and other federal partners to bring the full force of the law against those selling fraudulent or unregistered products.
Based on tips, complaints, and research, EPA has identified illegal products that are claiming anti-viral, antibacterial, disinfectant, sterilizing, or sanitizing properties but have not gone through EPA’s robust registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and are not legal for sale in the United States. EPA only registers disinfectants that can be used effectively against the novel coronavirus on surfaces. Non-registered products may not effectively eliminate the virus or reduce the spread of the virus and could even be harmful to consumers’ health. Consumers are urged to refer to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N) for EPA-registered disinfectants that EPA has determined to be safe and effective against the novel coronavirus.
The following is a list of some of the unregistered products that have been identified. EPA typically enforces FIFRA through stop-sale orders and penalty actions. EPA provided the following information to ensure that Americans have as much information as possible to help them protect themselves from COVID-19:
Additional information on the recent telephone conference is available here.
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.