Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

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

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:

  • Category A allows PCBs to perform sanitization or disinfection in residential, industrial, or institutional (RII) use settings such as hospitals, schools, or prisons;
  • Category P allows PCBs to perform microbial pest control in RII use settings; and
  • Category K allows PCBs to perform health related pest control services under a government-sponsored program.

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:

  1. The professional sanitization service is performed for COVID-19 control and only during the next 90 days.
  2. The PCB without the specific QAL license category notifies the CAC in writing with an explanation for why the sanitization work is necessary.
  3. Examples of necessary work may include situations in which the PCB is the only licensee registered to do business in the county or where other properly licensed PCBs are unavailable to perform COVID-19-related work.
  4. The QAL holder ensures that all applicators applying antimicrobials are properly trained and are in strict compliance with label directions and all other applicable laws and regulations.

The announcement states that those who wish to obtain more information should contact Joe Marade, DPR’s County/State Liaison, at .(JavaScript must be enabled to view this email address).


 

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:
  • 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:

Topic Step 1 Step 2 Step 3
Assessment Biological Evaluation Biological Evaluation Biological Opinion
Scale Individual and Field Individual and Field/Landscape/Watershed1 Population and Landscape/Watershed
Determination No Effect/May Affect Not Likely to Adversely Affect/Likely to Adversely Affect No Jeopardy/Jeopardy2

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.


 
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