By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson

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:

• Lanyards that illegally claim to protect wearers from coronavirus:
  • “Virus Shut Out-Portable Protection Card-Virus Protection and Personal Health (5 PCS)”
  • “Air Sterilization Card Disinfection Lanyard Protection Card Household Outdoor Antibacterial Sterilization Health Care”
• Unregistered disinfectant tablets:
  • “Epidemic prevention Chlorinating Tablets Disinfectant Chlorine Tablets Swimming Pool Instant Disinfection Tablets Chlorine Dioxide Effervescent Tablet Chlorine Disinfectant 100g Cozy apposite Fun Suit”
  • “The Flu Virus Buster, CLO2 Disinfection Sticker, Removable sterilize air purifier, Anti COVID-19, Stop Coronavirus disease infection /Influenza Buster Disinfectant 1 Box/10 Tablets”
• Unregistered disinfectant sprays:
  • “Fullene silver antibacterial solution/24 Hour Defense Hand Sanitizer Disinfectant Spray Against Corona Virus COVID- 19 Kills 99.99% of Germs Bacteria 24 Hours of Lasting Protection Alcohol Free 50ml (1.7 fl. oz.)”
• Unregistered disinfectant wipes:
  • “99.9% Sterilization Wipes/16/32/48/64/96pcs Sterilization Rate of 99% Disinfection Wet Wipes and Paper Napkin Prevention of Coronavirus”

Additional information on the recent telephone conference is available here.

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.

By Lisa M. Campbell and Lisa R. Burchi

On March 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a Press Release to clarify its Temporary Policy released on March 26, 2020, regarding EPA’s enforcement of environmental legal obligations during the COVID-19 pandemic.  A discussion of the Temporary Policy is available on our blog.

The impetus for the Press Release was based, according to EPA, on the “reckless propaganda” by certain news outlets that provided erroneous or exaggerated information about the Temporary Policy, particularly that the Temporary Policy is providing a blanket waiver of environmental requirements or is creating a presumption that the COVID-19 pandemic is the cause of noncompliance. 

EPA’s Press Release outlines certain elements of the Temporary Policy that should not be overlooked:

• The Temporary Policy states that EPA will not seek penalties for noncompliance with routine monitoring and reporting requirements, if, on a case-by-case basis, EPA agrees that such noncompliance was caused by the COVID-19 pandemic.  The Policy is not intended to cover:
  • Exceedances of pollutant limitations in permits, regulations, and statutes.
  • Cases which may involve acute risks or imminent threats, or failure of pollution control or other equipment that may result in exceedances, except in possible circumstances where the facility contacts the appropriate EPA region, or authorized state or tribe, and allows regulators to work with that facility to mitigate or eliminate such risks or threats.
  • Normal operations and maintenance of public water systems and required sampling of vital drinking water supplies. 
• Regulated parties must document the basis for any claim that the pandemic prevented them from conducting that routine monitoring and reporting and present it to EPA upon request. EPA states that it is using this approach to allow EPA to prioritize its resources and respond to acute risks and imminent threats, rather than making up-front case-by-case determinations regarding routine monitoring and reporting requirements.

EPA notes that it expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible, once the COVID-19 threat is over.  EPA states that it plans to lift the measures of the Temporary Policy as soon as normal operations can resume, which may occur sooner in some locations than others.

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

On March 31, 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 manufacturers of certain already-registered EPA disinfectant products to obtain certain active ingredients from any source without prior approval from EPA.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).  EPA announced on March 26, 2020, similar action on certain inert ingredients. 

EPA typically requires disinfectant manufacturers to first apply for and receive EPA approval prior to making a change in the source of the active ingredient.  Under this temporary amendment, however, manufacturers can source certain active ingredients from alternate suppliers by informing EPA.  Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation (i.e., the purity of resulting product from the alternate source falls within the certified limits of the currently registered formulation for which they are making the source change).  EPA states that by allowing manufacturers to obtain certain active ingredients from any source it will help alleviate reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on List N.

The eligible active ingredients are:

• Citric Acid, Chemical Abstracts Service Registry Number (CASRN) 77-92-9;
• Ethanol, CASRN 64-17-5;
• Glycolic Acid, CASRN 79-14-1;
• Hydrochloric Acid, CASRN 7647-01-0;
• Hypochlorous Acid, CASRN 7790-92-3;
• Hydrogen Peroxide, CASRN 7722-84-1;
• L-Lactic Acid, CASRN 79-33-4; and
• Sodium Hypochlorite, CASRN 7681-52-9.

EPA will assess the continued need for and scope of this temporary amendment on a regular basis and will update it if EPA determines modifications are necessary.  EPA will notify the public at least seven days prior to terminating this temporary amendment at www.epa.gov/pesticides.

After the termination date of the temporary amendment, registrants will not be able to release for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula (CSF) or otherwise would have complied with relevant requirements in the absence of this temporary amendment.

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 (Insert date or other citation) for EPA Registration No. XXXXXX and [insert product name]”;
• The active ingredient; and
• The following statement:

[Name of Registrant] is notifying EPA of its intent to use one or more alternate, unregistered sources of active ingredient listed in the TEMPORARY AMENDMENT TO PESTICIDE REGISTRATION (PR) NOTICE 98-10 (Insert date or other citation) in the formulation of EPA Registration No. [xxx-xx].  Each source is chemically identical to (i.e., within the certified limits of) the active ingredients in the Confidential Statements of Formula previously accepted by EPA [insert CSF date(s)]. This self-certification is consistent with the provisions of PR Notice 98-10 and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  Further, 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 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 .(JavaScript must be enabled to view this email address) 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.

Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

In September 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) plans to convene a Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting to discuss New Approach Methodologies (NAM) for organophosphate (OP) pesticides.  EPA states that these NAMs could reduce reliance on default uncertainty factors for human health risk assessment and also reduce animal testing.

Under Administrator Wheeler’s directive to prioritize efforts to reduce animal testing, EPA is developing NAMs based on in vitro techniques and computational approaches that will also provide the opportunity to incorporate information relevant to humans.  OPP states that it is evaluating use of “in vitro data for 16 organophosphate compounds to reduce potentially reliance on default risk assessment uncertainty factors in favor of more refined data-derived factors.”  Human health risk assessment for OP pesticides has recently been focused primarily on potential developmental neurotoxicity, and the Office of Research and Development (ORD) has been working to develop a NAM to evaluate developmental neurotoxicity.  Initial analyses of data derived from neuron cell models have been completed for specific OP pesticides as a case study and, when possible, compared to in vivo results (an in vitro to in vivo extrapolation).

This case study of a NAM for developmental neurotoxicity using OP pesticides will be presented to the FIFRA SAP at the September meeting for its consideration and advice.  EPA will request external review and public comment on this research before implementing NAMs in human health risk assessments.  Additional details, including dates, times and agenda, will be forthcoming at www.epa.gov/sap.

Commentary

EPA has for some time had a general policy that it will try to develop and to implement alternatives to in vivo animal testing.  These alternatives to animal testing are typically based on new in vitro assays and modeling methodologies.  It is interesting that OPP has selected an in vitro NAM to assess developmental neurotoxicity of OP pesticides as a case study, given the controversy surrounding EPA’s use of the default Food Quality Protection Act (FQPA) uncertainty factor for all OP pesticides, which was based primarily on epidemiology data that EPA claimed may suggest a link between chlorpyrifos exposure and developmental neurotoxicity.  Prior to this determination, human health risk assessment for OP pesticides was generally based on expert judgments by EPA that neurotoxicity would not be expected below the established threshold for acetylcholinesterase (AChE) inhibition, and that infants and children are not likely to be more sensitive to neurotoxic effects than adults.  OPP adopted the FQPA determination for all OP pesticides even though it could not determine or propose a mechanism for the presumed developmental neurotoxicity of chlorpyrifos below the threshold for AChE inhibition, or evaluate whether other OP pesticides might share a similar mechanism.  Since the 2015 release of the Literature Review, additional epidemiology studies have become available and a number of concerns regarding the reliability of the epidemiology data have been raised.  EPA has also expressed concerns with the availability and reliability of the epidemiology studies.  These developments bring into question the accuracy and reliability of the Literature Review.

In its announcement, OPP states that the new NAM is intended “to reduce potentially reliance on default risk assessment uncertainty factors,” although it does not state which uncertainty factors may be supplanted or modified.  Standard uncertainty factors which may be implicated include the factor for extrapolating from animal data to human effects (“interspecies variation”), the factor for human variability (“intraspecies variation”), and the default uncertainty factor for potential increased sensitivity of infants and children (“FQPA uncertainty factor”).  The issues may spark additional controversy.  Additionally, even if OPP and the FIFRA SAP conclude that the proposed NAM for developmental neurotoxicity is a viable approach to human health risk assessment for OP pesticides, there are likely to be many related policy issues.  For example, it is unclear whether OPP would be sufficiently confident in the reliability of such an assay to propose cancellation or suspension of affected pesticide products based on a resultant human health risk assessment.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 26, 2020, a temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic.  EPA states that its temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak.  The policy addresses different categories of noncompliance differently.  For example, according to EPA, it “does not expect to seek penalties for noncompliance with routine monitoring and reporting obligations that are the result of the COVID-19 pandemic but does expect operators of public water systems to continue to ensure the safety of our drinking water supplies.”  The policy describes the steps that regulated facilities should take to qualify for enforcement discretion.  To be eligible for enforcement discretion, the policy requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic. 

EPA notes that its policy does not provide leniency for intentional criminal violations of law and that it does not apply to activities that are carried out under Superfund and Resource Conservation and Recovery Act (RCRA) Corrective Action enforcement instruments.  EPA states that it will address these matters in separate communications.  The policy states that it does not apply to imports.  According to the policy, EPA is “especially concerned about pesticide products entering the United States, or produced, manufactured, distributed in the United States, that claim to address COVID-19 impacts.”  EPA “expects to focus on ensuring compliance with requirements applicable to these products to ensure protection of public health.”

The policy will apply retroactively beginning on March 13, 2020.  EPA will assess the continued need for and scope of this temporary policy on a regular basis and will update it if EPA determines modifications are necessary.  To provide fair and sufficient notice to the public, EPA states that it will post a notification on its website at least seven days prior to terminating the temporary policy.

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

On March 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is allowing flexibility to manufacturers of disinfectants and other pesticides to increase the availability of products for use against SARS-CoV-2, the coronavirus that causes COVID-19.  EPA announced that it is allowing manufacturers to obtain certain inert ingredients from different suppliers without EPA approval after manufacturers voiced concern with EPA about challenges they face obtaining inert ingredients with the disruption of the supply chain. 

EPA stated it is allowing applicants submitting registrations or registration amendments to obtain commodity inert ingredients, approximately 280 total as of today, from various sources without having to provide the supplier name and address on its Confidential Statement of Formula (CSF).  EPA, however, notes that only ingredients designated as commodity inert ingredients on its list will be eligible for this reduced CSF reporting.

EPA also announced it is continuing to expedite review of submissions from applicants requesting to add emerging viral pathogen claims to existing registered disinfectant labels.  Claims currently are being approved within 14 days, as resources allow, compared to the typical 90-day review.  EPA has added 70 new surface disinfectants to its List N: Disinfectants for Use Against SARS-CoV-2, which brings the total number of products listed to 351.

Additional information on EPA’s list of commodity inert ingredients is available here. 

Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On March 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the publication of its Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides (Revised Method), a method for conducting Biological Evaluations under the Endangered Species Act (ESA). 

The Revised Method will be used by EPA to evaluate potential risks from pesticides to federally listed endangered and threatened species and to make effects determinations during initial registration and as part of periodic registration review.  The Revised Method allows EPA to include historical usage data that reflects where and how certain pesticides have been applied to make predictions about the future.

The Revised Method includes a three-step process to identify and evaluate the potential risk to endangered species by the assessed pesticide:

^{1 Although Step 2 is conducted at an individual level, consideration is given to the likelihood that an exposure and effect will occur. This step considers the proportion exposed across the landscape/watershed and the distribution of exposure among individuals.}

^{2 This is the determination for listed species. The determination for designated critical habitats is “No Adverse Modification/Adverse Modification.”}

EPA Administrator Andrew Wheeler stated: “EPA’s improved methodology will better protect and promote the recovery of endangered species while ensuring pesticide registration review decisions are conducted in a timely, transparent manner and are based on the best available science.”

EPA has also released for public comment draft Biological Evaluations for carbaryl and methomyl, which were conducted using the final Revised Method.  If EPA determines a pesticide may affect a listed species or its critical habitat, it must consult with the Fish and Wildlife Service and the National Marine Fisheries Service (the Services).  The Services will then issue a Biological Opinion to determine if the population of a species would be adversely impacted and, if so, propose ways to reduce risks.

Comments on the draft Biological Evaluations are due on or before May 18, 2020.  The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2020-0090. 

Commentary

Critics of the new method for doing Biological Evaluations have alleged that the purpose of the changes in this method, and of other recent revisions in ESA procedures, is to reduce the number of formal consultations that must be conducted with the Services.  Such allegations must be evaluated in the context of the severe bottlenecks in the current consultation process created by the limited resources and personnel that are available at the Services to conduct any required consultations and to prepare formal Biological Opinions.  The EPA method for doing Biological Evaluations has always been intended to use worst case assumptions to quickly remove from consideration those pesticides that are unlikely to pose any potential risk to endangered and threatened species, so that the limited resources available for the more extensive assessment triggered by consultation are used efficiently to address the most significant potential hazards.  Worst case assumptions, however, exaggerate the “reasonable worst case” and other more realistic scenarios.  Given the reality of limited review resources, focus on more uncertain risks draws resources away from attention on more certain risks to species.  Eventually the assessment system is expected to include other techniques (example: use of probabilistic models) to refine the analyses to concentrate further regulatory options on the most effective ways to protect species.

The draft BE for carbaryl and methomyl are available here and here.  More information on ESA issues is available on our blog.

By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson

On March 13, 2020, the U.S. Environmental Protection Agency (EPA) released an expanded list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19.  The list contains nearly 200 additional products, including 40 new products that went through EPA’s expedited review process.  While disinfectant products on this list have not been tested specifically against SARS-CoV-2, EPA expects them to be effective against SARS-CoV-2 because they have: (1) demonstrated efficacy against a harder-to-kill virus; (2) qualified for the emerging viral pathogens claim; or (3) demonstrated efficacy against another human coronavirus similar to SARS-CoV-2.

EPA Administrator Andrew Wheeler stated: “During this pandemic, it’s important that people can easily find the information they’re looking for when choosing and using a surface disinfectant.  With this expanded list, EPA is making sure Americans have greater access to as many effective and approved surface disinfectant products as possible and that they have the information at their fingertips to use them effectively.”

EPA also made enhancements to the web-based list to make it more user friendly.  Specifically: (1) the product list has been updated to include the product’s active ingredient and the amount of time the surface should remain wet to be effective against the given pathogen; and (2) users may now sort, search, and print the information on the table and easily view it on a mobile device.

List N, EPA’s list of registered disinfectant products is available here.  EPA’s Frequently Asked Questions about List N is available here.

By Lisa R. Burchi and Barbara A. Christianson

On March 10, 2020, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19).  The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent COVID-19/coronavirus.

The agencies sent the letters to the following companies:

1. Vital Silver;
2. Quinessence Aromatherapy Ltd.;
3. N-ergetics;
4. GuruNanda, LLC;
5. Vivify Holistic Clinic;
6. Herbal Amy LLC; and
7. The Jim Bakker Show.

Each of the seven companies have advertised products as able to treat or prevent COVID-19/coronavirus.  The unapproved products include teas, essential oils, and colloidal silver.

According to FDA, there are no approved vaccines, drugs, or investigational products currently available to treat or prevent the virus.  FDA Commissioner Stephen M. Hahn, M.D. stated: “The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health.  We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one.  The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs are safe and effective for their intended uses.”

The letters state that one or more of the efficacy claims made by the marketers are unsubstantiated and therefore may violate the FTC Act.  The letters advise the recipients to cease immediately making all claims that their products can treat or cure coronavirus. 

FTC Chair Joe Simons stated: “There already is a high level of anxiety over the potential spread of coronavirus.  What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims.  These warning letters are just the first step.  We’re prepared to take enforcement actions against companies that continue to market this type of scam.”

Commentary

FTC and FDA have pledged to continue to monitor social media, online marketplaces, and incoming complaints to ensure these products do not continue to make such claims.  The letters sent emphasize that, if the false claims do not cease, FTC may seek a federal court injunction and an order requiring money to be refunded to consumers and instructing the recipients to notify the FTC within 48 hours of the specific actions they have taken to address FTC’s concerns.

In addition, the FTC recently issued a new consumer blog post with information about how to identify and avoid coronavirus-related scams.  Coronavirus: Scammers follow the headlines notes that scammers are creating websites to sell bogus products, and using fake emails, texts, and social media posts as a ruse to take consumers’ money and obtain personal information.  It then warns consumers of the “red flags” to monitor when shopping for products related to the virus.

EPA also has been active in this area, announcing the release of a new list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19 and also announcing its process for expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants. 

By Lynn L. Bergeson and Carla N. Hutton

As reported in our February 13, 2020 blog item, the U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration.  According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles.  According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days to allow additional time to review the documentation contained in the docket.  The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.”  Comments are now due March 30, 2020.

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

On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that due to the outbreak of SARS-CoV-2, the coronavirus that causes COVID-19, it is expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants.

EPA states that only claims that do not require review of new efficacy data are being expedited at this time.  Companies can submit these claims as non-Pesticide Registration Improvement Extension Act (PRIA 4) fast-track amendments.  Registrants are asked not to include other label changes typically covered under amendments and notifications as part of the submission to add Emerging Viral Pathogen claims.

EPA requests that registrants include the following information in a letter to ensure the efficient processing of submissions:

• A subject line that clearly indicates “Emerging Viral Pathogen Claim for SARS-CoV-2”;
• A request to make emerging viral pathogen claims;
• A description of how the product meets the eligibility criteria for use against one or more categories of viral pathogens consistent with the guidance;
• The identification of the virus(es) from the product label that the registrant is using to support the emerging viral pathogen claims and the study ID number (MRID) that supports the claim;
  • Note: EPA recommends using the minimum number of supporting viruses needed for the emerging pathogen claim in order to expedite EPA’s review
• An up-to-date matrix (Form 8570-35); and
• A request to add the Terms of Registration outlined in Attachment I of the Emerging Viral Pathogens Guidance.

Registrants should also submit a revised master label with a separate section for emerging viral pathogen claims that includes the generic claim statements identified in Attachment I of the Emerging Viral Pathogens guidance document.

EPA requests that applications are submitted through EPA’s CDX portal and email .(JavaScript must be enabled to view this email address) with the CDX tracking number (CDX_2020_XXXXXXX) once an application was submitted to expedite the application.

If approved, the product will be added to List N: Disinfectants for Use Against SARS-CoV-2, during the next update to the list, which is scheduled to be updated in the next two weeks.

Additional information is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.

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

On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of a new list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19.  Products on EPA’s “List N: Disinfectants for Use Against SARS-CoV-2” are registered disinfectants qualified for use against SARS-CoV-2 approved through EPA’s Emerging Viral Pathogen Program (Program).  Currently there are 85 products listed that are qualified for use against SARS-CoV-2.  Of note, EPA states that if the directions for use for viruses/virucidal activity of the listed products provide different contact times or dilutions, the longest contact time or most concentrated solution should be used.

EPA issued guidance for the Program in 2016; the guidance was intended to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens.  In the event of an outbreak, companies with pre-approved products can make off-label claims (e.g., technical literature distributed exclusively to healthcare facilities, physicians, nurses, and public health officials; 1-800 consumer information services; company websites (non-label related); social media) for use against the outbreak virus.  These emerging pathogen statements will not appear on marketed (final print) product labels.  Additional information on EPA’s activation of its Emerging Viral Pathogen Program is available on our blog.

Companies with EPA-registered disinfectants that wish to add their products to List N, should provide the information as outlined below to .(JavaScript must be enabled to view this email address).

1. Ensure that the product has a previously approved emerging viral pathogen claim.
2. Provide the product name and EPA Registration number.

It is important to note that in releasing today’s list of products, EPA states in red bold font: “Note: There may be additional disinfectants that meet the criteria for use against SARS-CoV-2.  EPA will update this list with additional products as needed.” 

In addition, EPA has updated other lists of antimicrobial products registered with EPA for claims against common pathogens:

• List B: EPA Registered Tuberculocide Products Effective Against Mycobacterium tuberculosis;
• List C: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 Virus;
• List D: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 and Hepatitis B Virus;
• List E: EPA’s Registered Antimicrobial Products Effective Against Mycobacterium tuberculosis Human HIV-1 and Hepatitis B Virus;
• List F: EPA’s Registered Antimicrobial Products Effective Against Hepatitis C Virus;
• List G: EPA’s Registered Antimicrobial Products Effective Against Norovirus;
• List H: EPA’s Registered Antimicrobial Products Effective Against Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococcus faecalis or faecium (VRE);
• List K: EPA’s Registered Antimicrobial Products Effective Against Clostridium Difficile Spores; and
• List M: Registered Antimicrobial Products with Label Claims for Avian (Bird) Flu Disinfectants.

Additional information on EPA’s List of Antimicrobial Products Registered with EPA for Claims Against Common Pathogens is available here.

By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a new web portal that is available to the public to search for EPA guidance documents.  The EPA Guidance Portal (Portal) was created under Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” where agencies are to develop a central web portal for the public to review active guidance documents and the ability to request for modification or withdrawal of the guidance documents. 

Information available about each guidance document listed on the Portal includes:

• A concise name for the guidance document;
• The date on which the guidance document was issued;
• The date on which the guidance document was posted to the web portal
• An agency unique identifier;
• A hyperlink to the guidance document;
• The general topic addressed by the guidance document; and
• A summary of the guidance documents’ content.

EPA states that the “guidance documents lack the force and effect of law, unless expressly authorized by statute or incorporated into a contract” and EPA “may not cite, use, or rely on any guidance that is not posted on this web area, except to establish historical facts.”

The portal is broken down by office, including regional offices:

• Office of Air and Radiation (OAR)
• Office of Chemical Safety and Pollution Prevention (OCSPP)
• Office of Enforcement and Compliance Assurance (OECA)
• Office of General Counsel (OGC)
• Office of International and Tribal Affairs (OITA)
• Office of Land and Emergency Management (OLEM)
• Office of Mission Support (OMS)
• Office of Research and Development (ORD)
• Office of Water (OW)
• All EPA Regional offices

Currently, there are a total of 1,735 guidance documents listed under OCSPP.  Within the 1,735 documents, 117 appear to be specific to FIFRA. Examples of guidance documents included in the portal are:

• Inert Ingredients Overview and Guidance;
• Exporting Unregistered Pesticides: Foreign Purchaser Acknowledgement Statements;
• EPA's Regulation of Biotechnology for Use in Pest Management;
• CPARD USER GUIDE: For State Lead Agency (SLA) and Tribal Representatives with Certification Plans (CPs);
• Frequent Questions for the 2018 Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines;
• Pesticide Registration Manual;
• Guidance on FIFRA 24(c) Registrations;
• Design for the Environment Logo for Antimicrobial Pesticide Products;
• Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants;
• Structured Product Labeling (SPL) Draft Implementation Guide with Validation Procedures and User Guide;
• Reregistration and Other Review Programs Predating Pesticide Registration Review;
• FIFRA Pesticides Export Policy: Questions & Answers Issue: Research and Development Pesticides; Active Ingredient Concentrations;
• State FIFRA Issues, Research, and Evaluation Group Final Guidance for State Lead Agencies for the Development and Implementation of Managed Pollinator Protection Plans; and
• E-FAST, Down the Drain Assessment Model.

Under OECA, there are six documents specific to FIFRA.  The guidance documents included in this portal are:

• Compliance Advisory: High Number of Complaints Related to Alleged Misuse of Dicamba Raises Concerns;
• Good Laboratory Practices - Questions and Answers;
• EPA and Association of American Pesticide Control Officials (AAPCO) Advisory Notice on Pesticide-related E-Commerce;
• Fact Sheet on Pesticides Sales in E-Commerce;
• Documents with Questions and Answers on FIFRA Pesticides Export Policy; and
• FIFRA Pesticide Export Policy: Interpretive Guidance: Multilingual Labeling.

Of note, the portal sets forth an option for petitioning EPA to modify or withdraw a guidance document from the Portal by completing an online form.  The required information to submit using the online form is name, email address, unique identifier of the guidance document, the office and/or region, and comments related to the withdrawal or modification of the guidance document.

By Lisa M. Campbell and Lisa R. Burchi

On March 2, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on EPA’s procedures for conducting on-site civil inspections.  This final rule applies to on-site inspections conducted by EPA civil inspectors, federal contractors, and Senior Environmental Employment employees conducting inspections on behalf of EPA. 

This rule is effective March 2, 2020.

This rule explains how EPA inspectors should conduct on-site civil administrative inspections and addresses common elements applicable to on-site civil inspections for compliance with environmental laws. 

The elements of the process for conducting on-site civil inspections, and some EPA guidance regarding each element, is as follows. 

• Timing of Inspections and Facility Notification -- EPA inspectors should generally conduct inspections during the facility's normal work hours and take reasonable steps to work with the facility to agree on a workable schedule for accessing areas for the inspection.
• Inspector Qualifications -- EPA inspectors must hold a valid credential to perform the inspection, which are issued to inspectors that have completed relevant training.
• Obtaining Consent to Enter -- Upon arrival at a facility, EPA inspectors shall present their valid EPA Inspector Credentials to a facility employee, describe the authority and purpose of the inspection, and where possible seek the facilities' consent to enter. Inspectors are required under certain statutes to advise facility personnel that they can deny entry, but EPA may then seek a warrant for entry. 
• Opening Conference -- The EPA inspector shall request an opening conference with available facility representatives or employees, where practicable. The EPA inspector shall discuss the overall objectives of the inspection and may request access to/copies of facility records and request to interview facility employees, as necessary.
• Physical Inspection -- EPA inspectors shall inspect the areas, units, sources and processes relevant to the scope of the inspection. The inspectors will generally document their observations with photos and notes.
• Managing Confidential Business Information (CBI) -- Pursuant to existing statutory and regulatory requirements, inspectors shall complete appropriate, statute-specific, CBI training before managing CBI. The EPA inspectors shall manage all CBI claims made by a facility during an inspection in accordance with 40 CFR part 2, subpart B.
• Interview Facility Personnel -- EPA inspectors may conduct interviews of facility personnel as appropriate. Interviews may include, but are not limited to, the environmental contacts, process operators, contractors, maintenance personnel, process engineers, control room operators, and other employees working in the area(s) of interest.
• Records Review -- Once the records requested by the EPA inspector are assembled, the EPA inspector shall review any records relevant to the facility inspection/field investigation. EPA inspectors may request copies of many different types of records (paper, electronically scanned, downloaded or recorded through other digital storage devices), when appropriate, and record copies of records taken from the facility. An EPA inspector may request records before, during, or after an inspection.
• Sampling -- EPA inspectors may take samples when appropriate. Where applicable and practicable, during the opening conference, the inspector shall offer facility personnel the opportunity to obtain split samples or to collect duplicate samples.
• Closing Conference -- EPA inspectors shall offer a closing conference with available facility employees, as practicable, to discuss any outstanding questions or missing documents and the process for follow up. EPA inspectors may also discuss next steps and how the facility will be contacted on the results of the inspection and identify the appropriate point of contact for further communication and coordination. EPA inspectors may also summarize any potential “areas of concern” identified in the inspection.
• Inspection Reports -- After an inspection, EPA shall share an inspection report with the facility. The content and format of the report may vary depending on the facility, type of the inspection, and the statutory authority upon which the inspection is based.

Commentary

EPA states this rule was issued to fulfill the objectives outlined in Executive Order 13892 (Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication).  In addition to this rule, companies can find more detailed information in EPA’s FIFRA Inspection Manual, most recently updated in August 2019, and available here.