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

On May 12, 2020, the U.S. Environmental Protection Agency (EPA) announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19.

EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the SARS-CoV-2.  These actions include requests to amend currently registered products that require a review of efficacy data and applications for new pesticide product registrations that would qualify for List N for use against SARS-CoV-2.  This process does not replace the review process of all other submitted antimicrobial products.

EPA states that it also may consider expedited review of new active ingredients (AI) or new uses for currently registered AIs (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces).

The following submissions may qualify for expedited review:

Amendments for Currently Registered Products

  • A request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data);
  • A request to add a new unregistered source of a non-commodity active ingredient (active ingredient not listed in the May 11, 2020, Temporary Amendment to PR Notice 98-10) to a product’s Confidential Statement of Formula; and
  • A request that involves changes to a product’s formulation that requires EPA to review confirmatory efficacy data. Confirmatory efficacy data are a reduced set of data used to support certain changes in formulation to a registered product.

New Products – formulated with currently registered AIs that are contained in disinfectant and/or sanitizer pesticide products approved for use in residential, commercial, institutional, and industrial settings.

  • A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with a registered source of active ingredient(s); and
  • A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with an unregistered source of the active ingredient(s).

Additional information on EPA’s requirements and process for submissions to be considered for expedited review is available here

EPA also announced the availability of its new List N Tool: COVID -19 Disinfectants, a new web-based application (app) that allows smart phone users and others to access List N to identify disinfectant products that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19. 

For several months, EPA has provided the public with List N, which currently lists 410 surface disinfectant products that meet EPA’s criteria for use against SARS-CoV-2.  EPA is now making available the data from the List N webpage on a browser-based web app that allows users to identify the disinfectant products best suited for their needs.  Users can search by use site (e.g., home, business, health care, etc.), surface type (e.g., hard, non-porous surfaces like countertops; porous surfaces like fabrics), contact time (i.e., the time the product needs to be visibly wet), EPA registration number, AI(s), or product name.


 

By 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.


 

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.


 

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.


 

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, 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 Timothy D. Backstrom

On February 3, 2020, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of an interim registration review decision for glyphosate.  EPA previously issued a proposed interim registration review decision (PID) for glyphosate for comment in April 2019.  At the time EPA issued the glyphosate PID for comment, EPA also issued a draft human health risk assessment and a preliminary ecological risk assessment for glyphosate.  After reviewing the comments received concerning these assessments, EPA has not made any revisions to either assessment.  EPA has determined that there are no dietary, residential, bystander, or occupational human health risks of concern associated with glyphosate use.   EPA has also determined that there are some potential risks to plants, birds, mammals, and invertebrates from glyphosate use, but that these can be appropriately mitigated by label changes requiring enforceable spray drift management measures and adding a warning concerning the potential hazards to non-target organisms.  EPA also has proposed some new measures to manage the development and spread of herbicide-resistant weeds.  EPA has generally retained the proposed labeling changes identified in the PID, except for some modest adjustments to the proposed language concerning droplet size restrictions and swath displacement restrictions for aerial applications, and removal of spray drift advisory language for airblast application.

Despite considerable publicity recently concerning purported carcinogenic risks for glyphosate, including allegations that human exposure to glyphosate can be linked to non-Hodgkin's lymphoma, EPA has determined that glyphosate is not likely to be a human carcinogen and has steadfastly adhered to this basic conclusion.  EPA made this determination for glyphosate after convening a meeting of the FIFRA Scientific Advisory Panel (SAP) to evaluate the carcinogenic potential of glyphosate in 2016.

The general purposes of the PID process are to allow EPA to move forward with aspects of the registration review process that are essentially complete, and to adopt interim risk mitigation measures, even though some of the actions required prior to a final registration review decision are not yet complete.  As in the case of most recent PIDs, EPA states that it has not yet made a complete determination concerning potential effects or any required consultation for glyphosate under the Endangered Species Act (ESA), nor has it made a determination for glyphosate under the Endocrine Disruptor Screening Program (EDSP).  In addition, EPA is considering a pending petition to prohibit preharvest use of glyphosate on oats, and to reduce the tolerance for glyphosate in oats, that was filed in 2018 by the Environmental Working Group and others.  This petition is predicated on the potential carcinogenicity of glyphosate.  Finally, EPA is still evaluating the question of whether additional data will be needed to evaluate properly the potential effects of glyphosate use on pollinators.  

More information on glyphosate and EPA’s interim registration review decision is available here.

Commentary

EPA's interim registration review decision for glyphosate is predicated on EPA's prior determination that the best available scientific data do not substantiate the claims that glyphosate may be a human carcinogen.  As discussed above, the potential carcinogenicity of glyphosate was thoroughly evaluated by the FIFRA SAP in 2016.  EPA's determination after that review that glyphosate is not a carcinogen has also been supported by other pesticide regulatory authorities.  Nonetheless, EPA's view conflicts with a cancer classification decision for glyphosate by the World Health Organization (WHO), and with some recent tort case decisions that were based on the premise that there is a credible linkage between glyphosate exposure and human cancer.  EPA recently announced that it would not permit or approve any cancer warning statements for inclusion in glyphosate labeling (including any statements that may be required pursuant to California's Prop 65) because EPA believes that such statements are false or misleading and would therefore cause the pesticides to be "misbranded."

It appears probable there will be continued litigation based on the purported carcinogenicity of glyphosate, along with various proposals to ban or restrict glyphosate use.  The pending petition to restrict use of glyphosate on oats that was filed by EWG, et al., is expressly predicated on the potential carcinogenicity of glyphosate, so it appears probable that this petition will ultimately be denied by EPA.  Nonetheless, unless WHO decides to reverse or modify its classification determination, or the courts determine that the recent tort awards for glyphosate users cannot be scientifically substantiated, the battles over the claimed carcinogenicity of glyphosate may persist for years.

More information on glyphosate issues is available on our blog under keyword glyphosate.


 

By Timothy D. Backstrom and James V. Aidala

On December 18, 2019, the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) issued for comment a Proposed Interim Decision (PID) in the ongoing registration review process for each of the three registered triazine herbicides: atrazine, propazine, and simazine.  EPA will allow 60 days for comment on each of these triazine PIDs, but the specific comment deadline will only be established after EPA has published notice concerning the proposed interim decisions in the Federal Register.  EPA can utilize an “interim registration review decision” under 40 C.F.R. Section 155.56 whenever it is not yet ready to complete the registration review process, but EPA has nonetheless completed sufficient review to determine that new or interim risk mitigation measures are needed or that additional data or information should be submitted to complete the review.  For each of the three triazine herbicides, EPA is proposing to impose specific risk mitigation measures for particular registered uses to mitigate potential health and environmental risks.  For each triazine herbicide, EPA is not yet ready to make a final registration review decision because EPA has not made findings in the Endocrine Disruptor Screening Program (EDSP) or an effects determination under the Endangered Species Act (ESA).  Several key factors that will affect the final registration review decision for each of the triazine herbicides are discussed below.

Common Factors for Triazine Risk Assessment

There are several common factors to consider with regard to the triazines risk assessment.  These include:

  1. Atrazine, propazine, and simazine are all included in the chlorotriazine chemical class.  EPA has determined that these three herbicides, along with three specific chlorinated metabolites, share a common mechanism of toxicity, so human health risks from all of these substances are being assessed by EPA together through one cumulative triazine risk assessment. The contribution of each product to aggregate human risk differs because of somewhat dissimilar use patterns. The combining of risks resulting from use of each triazine means, however, that it may be necessary for EPA to coordinate the ultimate registration review decisions for the three active ingredients.
  2. As part of the ecological risk assessment for each triazine herbicide, EPA plans to make an effects determination for potentially vulnerable species under the ESA, which in turn will determine whether it is necessary for EPA to consult with the Fish and Wildlife Service or the National Marine Fisheries Service (the Services) concerning potential impacts of each active ingredient and relevant metabolites on endangered or threatened species.  Atrazine, propazine, and simazine are all included in a stipulated settlement between the parties in Center for Biological Diversity et al. v. EPA et al. No. 3:11 cv 0293 (N.D. Cal.), and EPA agreed in that stipulated settlement to set August 14, 2021, as the deadline for EPA to make a nationwide effects determination for each active ingredient, and to request any required consultation with the Services, under ESA Section 7(a)(2).
  3. EPA states that the predominant human health effect of concern for all three of the triazine herbicides and their chlorinated metabolites is potential suppression of the luteinizing hormone (LH) surge, which is considered to be both a neuroendocrine and a developmental effect.  Atrazine and simazine were both included on List 1 for screening testing under the EDSP required by the Food Quality Protection Act (FQPA) amendments.   All of the required Tier 1 screening assays for each of these substances are complete and have been evaluated by EPA, but EPA has not yet made human health or environmental findings under the EDSP.  The EDSP screening testing has not been completed yet for propazine.

Risk Mitigation Measures

Each PID proposes specific risk mitigation measures intended to address potential human and environmental risks identified by the EPA risk assessments.

For atrazine, the PID includes the following measures to mitigate aggregate human risk:

  • Reduce the permissible application rates for use of granular and liquid formulations on residential turf.
  • Require additional personal protective equipment (PPE) and engineering controls for certain uses.
  • Restrict aerial applications to liquid formulations only.
  • Limit backpack sprayer applications to landscape turf to spot treatment only.
  • Prohibit pressurized handgun application to certain commodities.

To mitigate ecological risks, the atrazine PID proposes to require various spray drift reduction measures, to add a non-target advisory statement to labeling, and to adopt a nationwide stewardship program.

For propazine, the PID proposes to cancel the greenhouse use to mitigate aggregate human risk.  Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.

For simazine, the PID includes the following measures to mitigate aggregate human risk:

  • Cancel simazine use on residential turf.
  • Require additional PPE and engineering controls for certain uses.
  • Limit pressurized handgun applications to certain commodities to spot treatment only.

Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.

Commentary

In each of the PIDs for the triazine herbicides, EPA has focused its efforts on adopting mitigation measures which should be efficacious in reducing human and ecological risks without materially impairing the availability of the products in question for key agricultural uses.  In some instances, the PID documents explicitly state that the product registrants have agreed to proposed changes.  An EPA Pesticide Program Update dated December 19, 2019, that discusses the interim decision for atrazine includes statements of support from several grower groups.


 

By Timothy D. Backstrom

On December 5, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced the availability of a revised interim registration review decision for use of sodium cyanide in the M-44 predator control device.  The M-44 device is a restricted use pesticide (RUP) and may be used only by certified applicators in compliance with specific mandatory restrictions set forth on the label.  Although the registration review process for sodium cyanide remains pending, EPA has decided to issue an interim decision for the M-44 device now to adopt new label restrictions intended to mitigate potential risks.  The revised interim decision adopts two new restrictions and also modifies certain existing restrictions, which EPA states "will reduce the potential for unintended impacts on humans, pets, and other non-target animals.”

The M-44 predator control device uses a spring-loaded ejector to fire a capsule containing a single lethal capsule of sodium cyanide.  The M-44 is used by livestock producers to control predators (primarily coyotes) that kill sheep, goats, and cattle.  Registrations for the M-44 device are currently held by the U.S. Department of Agriculture, and by five individual States (South Dakota, Texas, Montana, Wyoming, and New Mexico) where livestock predation has been a particular problem.

New or revised restrictions that will be incorporated in the approved labeling for the M-44 device include:

  • Requiring a 600-foot buffer zone around residences where an M-44 cannot be used (except for a cooperating landowner who has given written permission).
  • Requiring that the applicator notify occupants of all residences within a 0.5 mile radius (by face-to-face communication, person-to-person telephone communication, door hanger, or certified mail) prior to an M-44 placement.
  • Increasing from 50 feet to 300 feet the distance from designated public paths and roads where M-44 use is prohibited.
  • Requiring two elevated warning signs placed 15 feet from the M-44 device and facing the most likely directions of approach, instead of one elevated sign placed 25 feet from the device.

Commentary

Livestock producers and State departments of agriculture contend that the M-44 device is essential to limit economic losses resulting from predation, which reportedly amount to hundreds of millions of dollars annually.  In contrast, wildlife advocates have strongly opposed any continued use of the M-44 device.  In 2017, WildEarth Guardians and the Center for Biological Diversity petitioned EPA to suspend and cancel all registrations for M-44 capsules, but EPA concluded that the petition did not contain substantial new information and denied the petition in 2018.  Although the new and modified label restrictions adopted by EPA in the interim decision for the M-44 device are not likely to satisfy opponents, these changes should nonetheless reduce the likelihood that humans, pets, or other non-target species will be exposed to the M-44 capsules or the toxin they contain.


 

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

On October 1, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the that fees under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) were increased by five percent for pesticide applications received on or after October 1, 2019.  The five percent increase is on fee amounts established by Public Law 116-8, which became effective on March 8, 2019.  The revised fees will remain in effect until September 30, 2021.

The fee schedule provided in PRIA 4 identifies the registration service fees and decision times organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA.  EPA presents the schedules as 19 tables, organized by OPP Division and by type of application or pesticide subject to the fee, and lists the registration service fee for actions received in fiscal years 2020 and 2021.  Applicants must submit fee payments at the time of application.  EPA will reject any application that does not contain evidence that the PRIA 4 fee has been paid.

The revised fee schedule for PRIA 4 fiscal years 2020 and 2021 is available on EPA’s website.  More information on the PRIA 4 legislation is available on our blog under key word PRIA.


 
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