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.
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By Lisa M. Campbell, Timothy D. Backstrom and Barbara A. Christianson

On May 1, 2020, the U.S. Environmental Protection Agency granted an experimental use permit (EUP) to Oxitec Ltd. (Oxitec) to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce populations that serve as a vector for a variety of diseases including Zika virus.  The EUP is designed to test the effectiveness of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations in specific locations with monitoring and sampling of the resultant mosquito populations.  These field tests will proceed only after state and local approval, and they are intended as a first step toward potential wider use of genetically modified mosquitoes in the U.S.

Oxitec’s field tests will be conducted, if approved by state and local authorities, over a two-year period in Monroe County, Florida, beginning in summer 2020, and in Harris County, Texas, beginning in 2021.  During these field tests, Oxitec will release into the environment male mosquitoes that have been genetically modified to carry a protein that will inhibit the survival of female offspring.  After males carrying this protein mate with wild female mosquitoes, it is anticipated that only the male offspring will survive to become fully functional adults and that these male offspring will retain the same genetic modification.  This should provide multi-generational effectiveness in reducing the number of adult females in Aedes aegypti mosquito populations in the release areas.

Female mosquitoes are the ones who bite humans and that serve as the vector for blood-borne illnesses.  Since only male mosquitoes will be released into the environment and their female offspring are not expected to survive, EPA does not believe they will pose a health risk to the human population.  EPA anticipates that these modified mosquitoes could be an effective tool in combatting the spread of certain diseases like the Zika virus in light of the growing resistance of mosquito populations to current insecticides.  It is also anticipated that there will be no adverse effects to animals such as bats and fish who consume the genetically modified mosquitoes.

Oxitec is required to monitor and sample the mosquito population weekly in the treatment areas to determine how well the product works for mosquito control and to confirm that the modified genetic traits disappear from the male Aedes aegypti mosquito population over time.  EPA has also maintained the right to cancel the EUP at any point during the 24-month period if unforeseen outcomes occur.

EPA’s decision and the approved permit are available here.


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

On April 29, 2020, the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) released updated guidance to give assistance to facility operators and families on how to clean and disinfect spaces properly. Developed in cooperation with the White House, the updated guidance provides step-by-step instructions for public spaces, workplaces, businesses, schools, and homes, and falls in line with the Opening up America Again guidelines, the three-phased approach, based on the advice of public health experts, to help state and local officials when reopening its economies, getting people back to work, and continuing to protect American lives.

The comprehensive plan was developed in consultation with EPA’s expertise on the safe and effective use of disinfectants against the SARS-CoV-2, the virus that causes COVID-19.  The guidance offers a three-step process for preparing spaces for reopening:

  1. Develop a plan
    • Determine what needs to be cleaned;
    • Determine how areas will be disinfected; and
    • Consider the resources and equipment needed.
  2. Implement the plan
    • Clean visibly dirty surfaces with soap and water;
    • Use the appropriate cleaning or disinfectant product; and
    • Always follow the directions on the label.
  3. Maintain and revise the plan
    • Continue routine cleaning and disinfection;
    • Maintain safe practices; and
    • Continue practices that reduce the potential for exposure.

EPA states that cleaning and disinfecting surfaces is an important, two-step process essential to any effort to reduce the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.

  • Clean:  Use soap and water to remove germs, dirt, and impurities from surfaces. It lowers the risk of spreading infection.
  • Disinfect:  Use disinfectant products to kill germs on surfaces. By killing germs on a surface after cleaning, it can further lower the risk of spreading infection.

EPA has compiled a list of disinfectants for use against SARS-CoV-2, List N: Disinfectants for Use Against SARS-CoV-2, which include ready-to-use sprays, concentrates, and wipes.  EPA emphasizes to follow the product label instructions and safety information, including leaving the product on the surface long enough to kill germs, rinsing off the product to avoid ingesting it, and putting the product out of reach of children right away.

EPA also states that it is important to avoid over-using or stockpiling disinfectants or personal protective equipment, which can result in shortages of critical products needed for emergencies.  In the event that disinfectant products on the EPA list are not available, the guidance provides other techniques for disinfecting surfaces that are as effective in reducing the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.

EPA’s guidance documents are available here.


 
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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.


 
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By Timothy D. Backstrom, James V. Aidala, and Kelly N. Garson

On April 23, 2020, the Supreme Court ruled that pollution traveling indirectly to rivers and streams through groundwater can be covered by the Clean Water Act’s (CWA) permitting requirements.  The case, County of Maui, Hawaii v. Hawaii Wildlife Fund, et al, 590 U.S. (2020), concerned whether pollutants discharged from a point source into groundwater, a non-point source, and then conveyed into navigable waters fall within permitting requirements of the CWA.  In a 6-3 Opinion delivered by Justice Breyer, the Court held that the CWA “requires a permit when there is a direct discharge from a point source into navigable waters or when there is the functional equivalent of a direct discharge.” Slip op. at 15.

Under the CWA, a point source is a discernable conveyance such as a pipeline and other conduit, including wells (the Court notes that wells ordinarily result in discharge of pollutants through groundwater). Slip op. at 13.  The case at issue concerned the County of Maui’s (Maui) operation of a wastewater reclamation facility that collected and partially treated sewage before pumping the treated water into four underground injection wells.  From the wells, the treated water traveled half a mile through groundwater into the Pacific Ocean, a navigable water.  Maui had not obtained a permit for the discharge, and in 2012, several environmental groups brought a citizens’ CWA lawsuit against the county.

The legal question of whether the CWA’s permitting program covers pollution that travels from a point source, like a factory discharge pipe or a containment pond, through groundwater before reaching a downstream water has major implications for industries ranging from agriculture to oil and gas.  The Court’s “functional equivalent” standard for the reach of federal regulation is an interpretation that is narrower than the one sought by environmentalists and endorsed by the Ninth U.S. Circuit Court of Appeals, but the Court declined to defer to the U.S. Environmental Protection Agency’s (EPA) 2019 Interpretative Statement.  84 Fed. Reg. 16810, 16824 (April 2019).

EPA’s Interpretive Statement supported the argument of Maui and the U.S. Solicitor General that if any non-point source lies between the point source and the navigable water, a permit is not required for the release.  Groundwater and non-point pollution that is generated, for instance, by rainwater runoff is not covered by the CWA and is regulated by the states.  The Court rejected this interpretation, posing the question: “If that is the correct interpretation of the statute, then why could not the pipe’s owner, seeking to avoid the permit requirement, simply move the pipe back, perhaps only a few yards, so that the pollution must travel through at least some groundwater before reaching the sea?”  Slip op. at 10.  The Court held that “to follow EPA’s reading would open a loophole allowing easy evasion of the statutory provision’s basic purposes.  Such an interpretation is neither persuasive nor reasonable.” Slip op. at 12.

The Court did not adopt the “fairly traceable” standard supported by the environmental groups and the Ninth Circuit either, as its scope would be too broad, and would interfere too seriously with states’ traditional and intended regulatory authority over groundwater and non-source pollution. Slip op. at 7-8.

The “functional equivalent of a direct discharge” standard will require a permit for discharge from any point source directly into navigable waters, and from point sources when the discharge “reaches the same result through roughly similar means.”  The Court identified seven factors that may be relevant in determining whether the discharge comes “from” a point source:

(1) transit time, (2) distance traveled, (3) the nature of the material through which the pollutant travels, (4) the extent to which the pollutant is diluted or chemically changed as it travels, (5) the amount of pollutant entering the navigable waters relative to the amount of the pollutant that leaves the point source, (6) the manner by or area in which the pollutant enters the navigable waters, (7) the degree to which the pollution (at that point) has maintained its specific identity. Slip op. at 16.

The Court notes that time and distance will be important factors in many (though potentially not all) cases.  For example, a distance of a few feet is concretely within the scope of the permitting requirement; a distance of 50 miles that may take a year for the water and perhaps mixing with other materials before reaching the navigable water is indeterminate.

The Court stated that the “functional equivalent” standard will essentially maintain EPA’s longstanding interpretation of the 1972 water law’s requirements prior to the 2019 Interpretive Statement that sought to narrow its reach.  The Court further acknowledges that the new standard may expand the scope of the CWA as it applies to wells and septic systems, but does not expect an “unmanageable expansion” of the permitting program, and expects that EPA and the states will mitigate harms and initiate a best practices permitting policy, and that judges will exercise discretion mindful of the complexities of indirect discharges.  Slip op. at 18.

Commentary

The decision of the Supreme Court to construe National Pollutant Discharge Elimination System permitting requirements to extend to indirect discharges that originate at a point source but travel through groundwater before reaching navigable waters was not particularly surprising.  Reviewing courts have generally been mindful that completely excluding all discharges to groundwater from permitting might encourage dischargers to use discharges to groundwater to evade otherwise applicable control requirements.  Nonetheless, it was somewhat surprising when the Court created a new “functional equivalence” standard that was not specifically advocated by the litigants.

Although the Court clearly intended to adopt a construction that was less expansive than the “fairly traceable” standard adopted by the Ninth Circuit, EPA and the states will have to determine how the seven potentially relevant factors identified by the Court will be utilized in determining when a permit will be required for indirect discharges.  EPA and the states will also have discretion to determine whether there are other “potentially relevant factors applicable to factually different cases” as anticipated by the Court.  Slip op. at 16.  This case involved deliberate discharges of municipal wastewater to underground injection wells, but future policy disputes and litigation are likely to focus on indirect discharges that are more inadvertent in character.  Activities of particular interest include indirect discharges from agriculture, and indirect discharges from impoundments that have been used to collect coal ash, mining tailings, and other types of industrial waste.

In the absence of Congressional intervention to codify clearly what is required, the courts can only do so much.  The Supreme Court has concluded that Congress could not have intended to create a loophole in the water permitting scheme so large as to encourage deliberate evasion, but it falls now to EPA and the states to determine what sort of indirect discharges are “functionally equivalent” to a direct discharge.  Although the Court has afforded considerable latitude to permitting agencies in deciding how to effectuate the new standard, the decision will most likely lead to a new round of contentious litigation before a policy for permitting of indirect discharges can ultimately be adopted.


 
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By Lisa M. Campbell and Timothy D. Backstrom

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

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

Commentary

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

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

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


 
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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.


 
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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.


 
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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. 


 
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Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another.  Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.


 
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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.”

EPA encourages consumers to review its list of products found at epa.gov/coronavirus for products registered and approved for use against SARS-CoV-2, the coronavirus that causes COVID-19.  The public also can report suspected fraud schemes related to COVID-19 by calling the National Center for Disaster Fraud (NCDF) hotline (1-866-720-5721) or by e-mailing the NCDF at .(JavaScript must be enabled to view this email address).


 
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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.


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

On April 6, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year 2017 (2017 Report).  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2017 Report discusses the completion of tolerance reassessment and describe the status of various regulatory activities associated with reregistration.  The 2017 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA.  The report is available at EPA-HQ-OPP-2014-0125.  Comments can be submitted on or before June 5, 2020.

EPA’s completed product registration actions totaled 255, short of EPA’s goal of 600 actions.  The table below details the actions completed in FY 2017.

Table 1.—Product Reregistration Actions Completed in FY 2017 (as of September 30, 2017)

Actions FY 2017
Product reregistration actions 14
Product amendment actions 113
Product cancellation actions 128
Product suspension actions 0
Total actions 255

EPA also states that there were 4,370 products had product reregistration decisions pending at the end of FY 2017, compared to 4,621 products with product reregistration decisions pending at the end of FY 2016, and 5,133 products with product reregistration decisions pending at the end of FY 2015.  Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”

The number of applications for registration requiring expedited processing (i.e., “fast track” applications) that EPA considered and approved has been more consistent in recent years, with 2,223, 2,422, and 2,574 in 2015, 2016, and 2017 respectively.


 
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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).


 
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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.


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

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

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

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

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

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

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

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


 
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