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 Kelly N. Garson
On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment. The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19.
DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My Doctor Suggests LLC and GP Silver LLC. The complaint alleges that defendants began fraudulently promoting and selling various silver products in early 2020 with claims that the silver products would treat and prevent COVID-19. Some of the alleged false and misleading claims made by defendants include that having silver particles in the bloodstream would block the virus from attaching to cells, that silver would “usher” the virus out of the body, and that silver would destroy all forms of viruses and protect against COVID-19.
The U.S. Food and Drug Administration (FDA) issued a statement on the Utah case that “FDA will continue to help ensure those who place profits above the public health during the COVID-19 pandemic are stopped” and that FDA is “fully committed to working with the Department of Justice to take appropriate action against those jeopardizing the health of Americans by offering and distributing products with unproven claims to prevent or treat COVID-19.”
The enforcement action will be prosecuted in a coordinated action by the U.S. Attorney’s Office for the District of Utah and the DOJ Civil Division Consumer Protection Branch, with the assistance of the FDA’s Office of Criminal Investigations and Office of the Chief Counsel. In addition to the TRO, prosecutors obtained a separate court order temporarily freezing the defendants’ assets in order to preserve the court’s ability to grant effective final relief and to maintain the status quo. A hearing on the DOJ’s request for a preliminary injunction is set for May 12, 2020. If the case proceeds to trial, the government will need to prove its allegations to obtain a permanent injunction against the defendants.
In another case, DOJ announced on April 17, 2020, that the United States District Court for the Southern District of Florida issued a TRO to halt the sale of an unapproved and potentially dangerous industrial bleach product being marketed as a “miracle” treatment for COVID-19. The FDA and the U.S. Federal Trade Commission (FTC) had issued a warning letter to the defendant, Genesis II Church of Health and Healing, on April 8, 2020. According to the FDA, oral ingestion of the defendant's product called the Miracle Mineral Solution can cause nausea, vomiting, diarrhea, and severe dehydration. The FDA and the FTC have issued nearly 40 separate warning letters in 2020 to companies selling unapproved or misbranded products with claims to prevent or to treat COVID-19.
Particulate elemental silver and silver salts can be effective antimicrobial agents, and numerous products containing these active ingredients are currently registered for various antimicrobial uses. The U.S. Environmental Protection Agency, along with other federal agencies, are working to ensure that necessary reviews and approvals of legitimate products intended to address COVID 19 are as expeditious as possible. Products that need these regulatory reviews and approval, but that are marketed without them, are and will likely continue to be a current enforcement focus.
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.
By Kelly N. Garson and Barbara A. Christianson
On April 24, 2020, the U.S. Environmental Protection Agency (EPA) and U.S. Customs and Border Protection (CBP) announced that the agencies prevented a significant number of shipments of illegal health products from entering the Los Angeles International Airport (LAX) and the San Francisco International Airport (SFO).
The products at issue were not registered with EPA, including Virus Shut Out products. EPA previously announced on March 25, 2020, that EPA and CBP had prevented several shipments of Virus Shut Out from entering U.S. Pacific Ports. The announcement noted that because the product is not registered, EPA had not evaluated its safety and efficacy against viruses. Additionally, its label does not contain directions for its use in English as required by law, and on-line advertisements for the product contain misleading claims about its safety and effectiveness. The Department of Justice charged a Georgia resident with federal criminal charges relating to the illegal importation, sales, and distribution of Virus Shut Out, or Toamit Virus Shutout, on April 9, 2020, discussed in our earlier blog item.
Following the shipment denial on March 25th, EPA notified Amazon, and Amazon removed the product from its marketplace. EPA has been in communication with several retailers to ensure that these products are removed from their online marketplaces and asking for monitoring for products with illegal pesticidal claims.
In an effort to curb illegal pesticide products during the pandemic crisis, EPA has been working with CBP to identify and seize illegal products imported from Japan and Hong Kong through International Mail Facilities (IMF) in Los Angeles and San Francisco, and CBP has as a result of this effort seized a large number of products.
EPA Administrator Andrew Wheeler states “EPA is increasing the number of approved disinfectants on the market while taking action to prevent dishonest actors from selling fraudulent and illegal items that do nothing to protect Americans from the coronavirus.” This has included EPA’s expedited review of submissions for companies to add Emerging Viral Pathogen claims to registered surface disinfectants.
EPA has released an expanded list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the novel coronavirus that causes COVID-19. List N contains nearly 400 products that have qualified to be effective against SARS-CoV-2.
Additional information on EPA’s efforts to discover and protect against fraudulent products is available on our blog.
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.
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.
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.
The full podcast episode is available to stream online, where listeners can also find the recent podcast “COVID-19, FIFRA, and EPA — A Conversation with Lisa Campbell” Additional updates on chemical regulatory activity related to COVID-19 can be found on B&C’s Pesticide Law and Policy Blog® and on the Regulatory Developments page of B&C's website, including these recent updates:
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.
By Lisa R. Burchi
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.”
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.