Tag Archive for: EPA

Pesticide Program Update: EPA Seeking Public Nominations for Experts to Serve as Ad Hoc Reviewers for Analysis of Atrazine Ecological Risks

This original announcement was published by the EPA on March 25, 2023. Click here for more information!

 

The U.S. Environmental Protection Agency (EPA) is seeking public nominations of scientific and technical experts for consideration to serve as ad hoc reviewers assisting the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) with the review of the Agency’s analysis and assessment of ecological risk from atrazine use. EPA is also announcing a three-day public virtual meeting on August 22-24, 2023, starting at 10:00 a.m. to approximately 5:00 p.m. EDT on Examination of Microcosm/Mesocosm Studies for Evaluating the Effects of Atrazine on Aquatic Plant Communities.  

Nominations must be submitted on or before April 24, 2023. These nominations will be used to assist the Agency in selecting approximately 8-12 ad hoc reviewers to assist the FIFRA SAP with their review. The review will take place during the August public meeting. Registration information for the meeting will be announced on the FIFRA SAP website in July.  

Individuals nominated for this FIFRA SAP peer review should have expertise in one or more of the following areas: aquatic plant community ecology; aquatic community ecology; plant community ecology; algae community ecology; aquatic plant ecology; aquatic toxicity; ecotoxicity; plant toxicity; algae toxicity; and/or mesocosm experiments. Nominees should be scientists with sufficient professional qualifications, including training and experience, to provide expert comments on the scientific issues for this review.

Prospective candidates for service on the FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate’s employment, stocks and bonds, testimonies, and where applicable, sources of research support. EPA will evaluate the candidates’ financial disclosure information to assess whether there are financial conflicts of interest, appearance of a loss of impartiality, or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for selection and service on the FIFRA SAP. 

Nominations must be submitted to the Designated Federal Official (DFO), Tamue Gibson, MS, via email at gibson.tamue@epa.govDo not email any information you consider to be Confidential Business Information or other information whose disclosure is restricted by statute.  

For additional information, please contact the DFO or view the Federal Register Notice in docket EPA-HQ-OPP-2023-0154.

The FIFRA SAP serves as one of the primary scientific peer review mechanisms of EPA’s Office of Chemical Safety and Pollution Prevention and is structured to provide independent scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues regarding the impact of regulatory actions on human health and the environment. 

Pesticide Program Update: EPA Posts Draft Biological Opinion for Carbaryl and Methomyl for Public Comment

This original announcement was published by the EPA on March 16, 2023. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) is posting and seeking public comment on the National Marine Fisheries Service’s (NMFS) draft biological opinion for the insecticides carbaryl and methomyl. Carbaryl and methomyl are insecticides used on a variety of cropsincluding field vegetables and orchard crops.   

Under the Endangered Species Act (ESA), EPA must ensure that its actions, including many pesticide registration actions, do not jeopardize federally listed endangered or threatened species, or adversely modify their designated critical habitats. When EPA determines in a biological evaluation that use of a pesticide product may affect these species or critical habitats, EPA must initiate formal consultation with NMFS, the U.S. Fish and Wildlife Service (FWS), or both (the Services). In response, the Service(s) may develop a biological opinion that determines whether the pesticide will jeopardize listed species or adversely modify critical habitats.  

In March 2021, EPA completed its final biological evaluations for carbaryl and methomyl. EPA’s biological evaluations made “likely to adversely affect” determinations for 1,640 listed species and 736 designated critical habitats for carbaryl and 1,098 listed species and 736 designated critical habitats for methomyl. A “likely to adversely affect” (LAA) determination means that EPA reasonably expects that at least one individual animal or plant of any listed species may be exposed to these pesticides at a sufficient level to have an adverse effect. This is the case even if a listed species is almost recovered to a point where it may no longer need to be listed. 

EPA initiated formal consultation with the Services upon completing these biological evaluations and, in response, NMFS has developed a draft biological opinion for carbaryl and methomyl.  

Biological opinion and next steps 

The draft biological opinion includes NMFS’s determinations that, under the ESA, use of carbaryl and methomyl is likely to jeopardize some listed species and adversely modify their critical habitats when used as registered. The draft biological opinion contains measures to avoid jeopardy and adverse modification, and to minimize “take,” which is incidental harm of listed species.  

In its draft biological opinion, NMFS evaluated the effects of the use of pesticide products containing carbaryl and methomyl and determined that carbaryl is likely to jeopardize 37 listed species and adversely modify 36 critical habitats. Methomyl is likely to jeopardize 30 listed species and adversely modify 29 critical habitats. These findings cover only NMFS species. FWS will issue its own biological opinion addressing the listed species under their purview.  

The draft biological opinion describes measures to avoid jeopardy, including a flexible list of chemical-specific measures to reduce loading of pesticides into aquatic habitats to protect them from adverse effects of pesticide exposure. It also includes measures to minimize take and impacts to critical habitats, such as the development of ESA educational materials, reporting of label compliance monitoring, and inclusion of label information about ecological incident reporting. 

EPA and NMFS are particularly interested in comments on the draft biological opinion regarding:  

  • additional risk reduction options beyond those described in the biological opinion; 
  • the general feasibility of drift reduction measures based on wind direction; and 
  • runoff and/or spray drift reduction technologies. 

After the 60-day public comment period, EPA will provide NMFS with the comments received and a summary of the comments for consideration before it finalizes the biological opinion. EPA will implement the final biological opinion.   

The biological opinion is available for public comment in docket EPA-HQ-OPP-2023-0144. 

Biological Opinions Available for Public Comment and Links to Final Opinions

EPA Announces Accelerated Action on Four Organophosphate Pesticides Based on Updated Exposure Assessments

This original announcement was published by the EPA on March 15, 2023. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) is announcing an effort to expedite protections on some high-risk uses of four organophosphate pesticides. The Agency is releasing the updated occupational and non-occupational spray drift exposure risk assessments for these four pesticides – diazinon, ethoprop, tribufos and phosmet – several years ahead of the scheduled completion of EPA’s work on these chemicals in order to seek early mitigation prior to completing the standard registration review process.

“The science is clear: some uses of these four pesticides pose a serious health risk to the people that are exposed to them,” said Michal Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. “That’s why we’re taking early action now. While we know there’s still a lot of work to finish our review of these pesticides, today’s announcement helps deliver on our promise to protect farmworkers and uphold our commitment to environmental justice.”

Diazinon, ethoprop, tribufos and phosmet are part of the group of pesticides known as organophosphates. These pesticides are used in both agricultural (e.g., fruit and nut trees, vegetables and herbs, cotton) and non-agricultural settings for a range of purposes. Diazinon and phosmet controls insects, ethoprop controls worms and other soil pests, and tribufos defoliates cotton prior to harvest. These pesticides are currently undergoing registration review, a process that requires EPA to reevaluate pesticides every 15 years to ensure that as the ability to assess risk evolves and as policies and practices change, pesticides continue to meet the statutory standard of causing no unreasonable adverse effects on human health or the environment.

As part of the registration review process, EPA assessed the potential risks to people who mix, load, and apply the four pesticides, farmworkers who work with crops that have been treated with these pesticides, and bystanders who are potentially exposed to spray drift, including families living in agricultural communities.

The Agency identified the following potential risks for each pesticide:

  • The diazinon assessment identified potential risks to workers who mix, load, and apply the pesticide, and to bystanders (including farmworkers) who could be exposed to spray drift.
  • The ethoprop assessment identified potential risks to workers who mix, load, and apply the pesticide, and to bystanders (including farmworkers) who could be exposed to spray drift.
  • The phosmet assessment identified potential risks to workers who mix, load, and apply the pesticide, workers conducting certain post-application activities (e.g., weeding, hand harvesting, or workers re-entering treated areas), and bystanders (including farmworkers) who may be exposed to spray drift.
  • The tribufos assessment identified potential risks to workers who mix, load, and apply the pesticide, and to bystanders (including farmworkers) who may be exposed to spray drift.

Although registration review for these pesticides was not scheduled to be completed until 2025-2026, after recognizing that several of uses of these four pesticides present significant human health risks, EPA is taking accelerated and early action to address these risks. This will allow the Agency to put important protections in place quickly for some high-risk uses of these pesticides, while allowing time to work through the complicated scientific issues that need to be addressed before completing registration review.

EPA is currently meeting with the technical registrants of the four pesticides about early risk mitigation. The types of mitigation under consideration include cancellation of uses and formulation types, prohibition of application methods, increased personal protective equipment for pesticide handlers, spray drift requirements, and new restrictions on when workers can reenter treated fields and perform harvesting and other types of post-application activities. The Agency is asking the registrants to submit label amendments that reflect the necessary risk mitigation measures for each of these four organophosphates and is prepared to expedite label reviews in order to implement the protections as quickly as possible.

The updated exposure risk assessments are now available in the registration review dockets, EPA-HQ-OPP-2008-0351 (diazinon), EPA-HQ-OPP-2008-0560 (ethoprop), EPA-HQ-OPP-2008-0883 (tribufos) and EPA-HQ-OPP-2009-0316 (phosmet) at www.regulations.gov. Given the expedited nature of this effort, the Agency is not taking comment on these assessments. Stakeholders will have an opportunity to comment on the four occupational and non-occupational spray drift risk assessments when the cases progress through the next step of registration review with the proposed interim decision, which will include the full updated human health risk assessment for each. EPA expects to issue the proposed interim decisions in fiscal year 2025 (tribufos) and fiscal year 2026 (ethoprop, diazinon and phosmet).

EPA Finalizes Updates to List of Pests of Significant Health Importance

This original announcement was published by the EPA on March 1, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency has released an updated list of pests of significant health importance. The list identifies the pests that EPA, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA) currently consider to be of significant public health importance.  

The list of pests serves as a useful tool for private and public organizations, including local or state governments, departments of public health, pesticide registrants, and non-governmental organizations when making decisions and planning for future public health actions. Federal law requires that EPA develop and implement programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance.  

Since this list’s original publication in 2002, EPA, CDC, and USDA have identified new vector-borne diseases and pests that were previously considered benign or nuisance pests, but have since been shown to adversely impact public health. The final Pesticide Registration Notice (PRN) adds several new pests (e.g., brown dog tick) and public health impacts (e.g., Zika fever and coronaviruses like SARS-CoV-2). Other pests have been renamed, grouped with similar species or removed altogether. 

Read the final PRN in docket EPA-HQ-OPP-2020-0260 at www.regulations.gov. 

EPA Implements Protections for Endangered Fish Species from Four Pesticides

This original announcement was published by the EPA on February 2, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) has implemented measures to protect 28 federally endangered and threatened (listed) Pacific salmon and steelhead species and their designated critical habitat from the effects of bromoxynil, prometryn, metolachlor, and 1,3-D (also known as telone). Bromoxynil, prometryn, and metolachlor are herbicides used to control grasses and broadleaf weeds, and 1,3-D is a pesticide used in pre-plant soil fumigation. 

Biological Opinions 

In June 2021, after receiving public comments, the National Marine Fisheries Service (NMFS) issued final biological opinions for bromoxynil, prometryn, metolachlor, and 1,3-D. NMFS’s biological opinions found that registered uses of these pesticides do not jeopardize listed salmon and steelhead species or adversely modify their critical habitats. Because use of these pesticides may result in “take” of individuals of listed salmon and steelhead species, the biological opinions also describe measures to minimize the potential for take and any impacts of take. “Take” includes (among other things) unintentionally harming or killing an individual of a listed species. 

Implementation 

EPA has implemented these biological opinions by issuing Endangered Species Protection Bulletins, available on the Bulletins Live! Two website, and approving label amendments to protect listed species, thereby fulfilling its obligations under the Endangered Species Act (ESA) for these pesticides for the listed salmon and steelhead species and their critical habitat.  

The Endangered Species Protection Bulletins for the four pesticides describe geographically specific use limitations to protect listed salmon and steelhead species and critical habitat. The Bulletins include mitigation measures such as no-spray buffers, retention ponds, and vegetated ditches to minimize potential take.  

The amended labeling for bromoxynil, prometryn, metolachlor, and 1,3-D products includes instructions for pesticide users to obtain Bulletins and follow their required mitigation measures. The labeling also includes guidance on how to report ecological incidents associated with pesticide applications, should users observe any. This work aligns with the goals outlined in EPA’s April 2022 ESA Workplan and its November 2022 ESA Workplan Update to provide practical, timely protections for listed species from pesticides. 

Background 

Before NMFS developed these final biological opinions, EPA and NMFS determined that the registered uses of these pesticides have the potential to adversely affect one or more individuals of listed Pacific salmon and steelhead species. The “likely to adversely affect” (LAA) determination means that the Agencies reasonably expect that at least one individual animal or plant, among a variety of listed species, may be exposed to bromoxynil, prometryn, metolachlor, and 1,3-D at a sufficient level to have an adverse effect.  An LAA determination does not necessarily mean that a pesticide registration action will jeopardize a listed species or adversely modify critical habitat. 

 

 

EPA Adjusts Annual Pesticide Registration Maintenance Fee to Meet Statutory Requirements

This original announcement was published by the EPA on January 26, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is notifying pesticide registrants that the Agency has updated its Annual Pesticide Registration Maintenance Fees webpage, including fee tables, to reflect the revised fiscal year 2023 maintenance fee announced on Jan. 13, 2023 

To meet new statutory requirements in the Pesticide Registration Improvement Act of 2022 (PRIA 5), which was signed into law on Dec. 29, 2022, the revised maintenance fee for fiscal year 2023 for each registered pesticide product will be $4,875, increased from the $3,400 level specified in the EPA invoices provided in early December 2022.  

PRIA 5 directs EPA to collect, to the extent practicable, an average amount of $42 million in pesticide registration maintenance fees annually for fiscal years 2023-2027, an increase from the $31 million target under Pesticide Registration Improvement Extension Act of 2018 (PRIA 4). PRIA 5 also specifies that the maintenance fee target is retroactively applicable as of Oct. 1, 2022. The increase in the per product maintenance fee reflects the increase in the annual collection target between PRIA 4 and PRIA 5. 

All registrants with Section 3 pesticide product registrations, including those that were initially registered by a state under Section 24(c), will receive an email to notify them of this change. Registrants who have not yet made a payment under the initial invoicing should utilize the new fee tables, instructions, product listing, and filing forms available on this webpage to submit their full payment and maintenance fee package.   

Registrants who have already made payment to EPA in response to the December 2022 invoicing will need to pay the difference between that initial payment and the updated amount due. After accessing product filing forms and paying the outstanding fee, those registrants should send the new payment receipt and a revised package to maintfee@epa.gov, as shown in the sample maintenance fee package documentA complete package (filing form, product listings, and payment receipt) is not required if the registrant is making a second payment. While the payment receipt and filing form are needed, if the registrant will not be changing any responses for the previously submitted product listing, EPA will reference that document.  

FIFRA section 4(i)(1)(A) specifies that registrants must pay the annual pesticide registration maintenance fee by Jan. 15 of each year. As PRIA 5 was enacted following EPA’s initial invoicing and shortly before the statutory payment deadline, EPA understands that registrants may encounter difficulties with timely payment of appropriate fiscal year 2023 maintenance fees, but encourages registrants to submit the required fee and form to EPA as soon as possible after supplemental invoicing.   

For more information and to access instructions, the maintenance fee filing form, fee tables and product listings grouped by company numbers, please visit the Annual Pesticide Registration Maintenance Fees webpage. Registrants are encouraged to contact EPA at maintfee@epa.gov with any questions or concerns. 

EPA Rebuilds Endocrine Disruptor Screening Program by Soliciting Public Comment on New Approach Methodologies to Screen for Endocrine Effects

This original announcement was published by the EPA on January 19, 2023. Click here for more information!

The U.S. Environmental Protection Agency (EPA) is releasing a draft White Paper for public comment, entitled Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP), that describes validated NAMs that EPA may now accept as alternatives for certain EDSP tests.  

Endocrine systems, also referred to as hormone systems, are found in all mammals, birds, fish, and many other living organisms. These systems are made up of glands located throughout the body, hormones synthesized by these glands and released into the bloodstream or the fluid surrounding cells, and receptors in various organs and tissues that recognize and respond to the hormones. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that EPA screen pesticide chemicals for their potential to cause endocrine disruption and to protect human health from substances with endocrine effects. 

The draft White Paper released today is a key step in EPA’s work to reinvigorate its efforts to meet its requirement for EDSP screening of chemicals and continue to provide transparency of EDSP Tier 1 testing, which is the step in the EDSP that determines the potential for endocrine-disrupting effects and whether there is a need to obtain more data by requiring additional Tier 2 tests. The approaches described in the draft White Paper would accelerate the pace of screening of all chemicals, including pesticide active ingredients, for potential impacts on the endocrine system, add efficiencies and decrease costs in the Agency’s review, and reduce animal testing. By focusing on screening chemicals more efficiently, EPA can also more quickly identify any additional testing needs and regulatory actions to better protect people and communities from pesticides that may impact the endocrine system. 

The draft White Paper presents several NAMs that would allow EPA to screen chemicals faster and more efficiently using alternatives to vertebrate animal testing and other in vitro, or in-the-laboratory, assays. NAMs are defined as any technology, methodology, approach, or combination that can provide information on chemical hazard and risk assessment to avoid the use of animal testing. NAMs are technologies and approaches that have been developed by using advances in molecular, cellular, and computational sciences, which can supplement or replace more traditional methods of testing chemicals — such as animal testing — for potential hazards. Advances in testing can lead to quicker analysis and recognition of chemicals that can affect the development, reproduction, and neurological function of people and animals – which in turn will lead to faster efforts to identify and require the implementation of protections for those who need them. 

EPA values stakeholder input and is taking comment on the draft White Paper. As science evolves, EPA continues to commit to ensuring that its assessment of pesticides more closely, quickly, and effectively evaluates the potential for endocrine effects. 

If EPA finds that data for a particular chemical reveals an effect in humans similar to an effect produced by a naturally occurring estrogen or other endocrine effects, EPA will take action to ensure that any needed protections are implemented.  

EDSP White Paper and Next Steps for the Program 

EPA has invested in the development of NAMs to more quickly screen chemicals for endocrine disruption, reduce the use of vertebrate animal testing, and ensure that pesticide decisions continue to protect human health and the environment.  

The EDSP uses a tiered approach for screening chemicals. Tier 1 screening data is used to identify substances that have potential to interact with the endocrine system. Chemicals that go through Tier 1 screening and are found to exhibit potential to interact with the estrogen, androgen, or thyroid hormone systems will proceed to Tier 2 for testing. 

Tier 2 testing data identifies adverse endocrine-related effects caused by the substance and establishes a quantitative relationship between the dose and that adverse effect. The results of Tier 2 testing will be combined with other hazard information and exposure assessments on a given chemical, resulting in a risk assessment. Risk assessments are used to inform risk mitigation measures, and regulatory decisions concerning chemicals to ensure that people who might be exposed to them are protected.  

The draft White Paper also identifies NAMs for priority setting and weight-of-evidence (WoE) evaluations. Priority setting is important for EPA to test the chemicals posing the greatest risk first, while WoE is the process by which the strengths and weaknesses of a data collection are judged to render an overall conclusion that may not be evident from considering the data individually. WoE is conducted as part of evaluating EDSP Tier 1 screening data to identify the need for Tier 2 testing. 

The current EDSP Tier 1 methods used for screening chemicals for endocrine disruption are expensive, require extensive staff time, and use laboratory animals. Because of the cost (EPA estimated industry costs in conducting a full Tier 1 battery to be approximately $1 million per chemical, largely due to the laboratory animal testing) and time (up to six years) involved in conducting and reviewing the full battery of Tier 1 assays, EPA has only screened a fraction of the thousands of chemicals that are subject to EDSP for their potential endocrine-disrupting effects. These factors delay EPA’s ability to take steps to protect those who may be at risk to these chemicals.  

As described in the draft White Paper, EPA has validated NAMs that, when used alongside traditional approaches to chemical testing, will expedite the Tier 1 screening of thousands of chemicals to assess whether they affect the endocrine system. This work will ultimately speed up the risk assessment process and enable EPA to protect people and their communities faster from potentially harmful endocrine effects.  

These validated NAMs for screening were reviewed in 2014 and 2017 by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) and are now considered validated alternatives to four EDSP Tier 1 assays. The data derived from these validated models and assays may be used to satisfy specified EDSP data needs, depending on a pesticide’s properties. 

Upon publication of the Federal Register notice, public comments on the draft White Paper will be accepted for 60 days in docket ID number EPA-HQ-OPP-2021-0756 at www.regulations.gov. After considering public comments, EPA will issue a finalized document.  

Background 

EPA has considered previous public input in developing this draft White Paper. In 2015, EPA requested comments on its “Endocrine Disruptor Screening Program: Use of High Throughput Assays and Computational Tools,” which describes how EPA planned to incorporate an alternative scientific approach to screen chemicals for their ability to interact with the endocrine system by integrating high throughput assays and a computational model. EPA’s response to comments it received is now available in docket EPA-HQ-OPPT-2015-0305. Additionally, in 2017, EPA held a FIFRA SAP meeting on the potential use of high-throughput screening for chemicals under the EDSP and the androgen receptor pathway model. EPA’s response is now available in docket EPA-HQ-OPP-2017-0214. 

For the entirety of the previous Administration, Presidential budget requests repeatedly proposed to completely eliminate the EDSP. EPA’s focus in the Biden-Harris Administration is to build on the work already done to accelerate the pace and transparency of evaluations done for endocrine disruption. In 2021, EPA also received and responded to 10 recommendations from EPA’s Office of Inspector General (OIG) on the need to make significant improvements to the EDSP and develop an effective system of internal controls. In general, EPA agreed with all of the OIG recommendations, as they are closely aligned with the Agency’s vision for this program. In addition to the issuance of the draft White Paper, EPA is actively working on these recommendations, including those related to List 1 and List 2 chemicals.  

Additionally, last year EPA established the Endocrine Disruptor Science Policy Council, an internal group of EPA scientists who will be working to address EDSP science policy issues. EPA is developing a draft strategic plan that will set the future vision for and direction of the EDSP. 

More information on EDSP and NAMs is available on EPA’s website. 

EPA Re-Invoicing Annual Pesticide Registration Maintenance Fee to Meet Statutory Direction

This original announcement was published by the EPA on January 13, 2023. Click here for more information!

The U.S. Environmental Protection Agency (EPA) is notifying pesticide registrants that the Agency will soon be sending supplemental invoices to reflect the new annual pesticide registration maintenance fee for fiscal year 2023. To meet new statutory requirements in the Pesticide Registration Improvement Act of 2022 (PRIA 5), which was signed into law on December 29, 2022, the revised fee for fiscal year 2023 for each registered pesticide product will be $4,875, increased from the $3,400 level specified in the EPA invoices provided in early December 2022.

PRIA 5 directs EPA to collect, to the extent practicable, an average amount of $42 million in pesticide registration maintenance fees annually for fiscal years 2023-2027. The previous collection target for fiscal year 2023 under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) was $31 million. Additionally, maximum payment caps and small business caps are increased in PRIA 5 and will be reflected in the forthcoming reinvoicing.

All registrants with FIFRA Section 3 and Section 24(c) pesticide product registrations will receive an email to notify them of this change. Registrants will need to access their product filing forms, pay any outstanding portion of the revised maintenance fees, and return completed documents to EPA. If your company has already made payment to the EPA in response to the earlier invoicing, your company will need to provide the difference between that initial payment and the amount owed under the supplemental invoicing. As PRIA 5 was enacted following EPA’s initial invoicing and shortly before the statutory payment deadline of January 17, 2023, EPA understands that registrants may encounter difficulties with timely payment of appropriate fiscal year 2023 maintenance fees, but encourages registrants to submit the required fee and form to EPA as soon as possible after the supplemental invoicing. EPA also encourages registrants to reach out to the Agency with any questions or concerns.

EPA Proposes New Mitigation Measures for Rodenticides, Including Pilot for Protecting Endangered Species

This original announcement was published by the EPA on November 29, 2022. Click here for more information.

EPA Proposes New Mitigation Measures for Rodenticides, Including Pilot for Protecting Endangered Species

Today, the U.S. Environmental Protection Agency (EPA) proposed new measures to protect human health and the environment for 11 rodenticides, including measures to reduce potential exposures to three federally listed endangered and threatened (“listed”) species and one critical habitat.  

This work furthers the goals outlined in EPA’s April 2022 Endangered Species Act (ESA) Workplan and one of the ESA pilots described in its November 2022 update to provide practical, timely protections for listed species from pesticides. 

Each year, rodents cause significant damage to property, crops, and food supplies across the United States. They may also spread diseases, posing a serious risk to public health. Rodenticides are used in residential, agricultural, and non-agricultural settings to control a variety of pests including house mice, Norway rats, roof rats, moles, voles, pocket gophers, prairie dogs, ground squirrels, feral hogs, and mongooses. 

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires EPA to review registered pesticides every 15 years to ensure that, as the ability to assess risk evolves and as policies and practices change, the pesticides continue to meet the statutory standard of causing no unreasonable adverse effects on human health or the environment. When EPA identifies unreasonable adverse effects to human health or the environment, it proposes amendments to pesticide labels to mitigate these risks. During registration review, the Agency also has obligations under the ESA that may result in additional assessments and mitigations.  

Proposed Risk Mitigation Measures 

In 2008, EPA issued a risk mitigation decision (RMD) for 10 rodenticides that represented the Agency’s final decision on the reregistration eligibility of rodenticide products at that time and constituted the Agency’s final action in response to the remand order in West Harlem Environmental Action and Natural Resources Defense Council v. U.S. Environmental Protection Agency. The 2008 RMD included mitigation measures to reduce risks to human health and non-target organisms. For example, EPA implemented minimum packaging size requirements for products on the consumer market (must be in packages one pound or less), prohibited products intended for general consumers (i.e., homeowners or residential consumers) from containing second-generation anticoagulant rodenticides (SGARs), and required tamper- and weather-resistant bait stations for outdoor, above-ground placements where children, pets, and wildlife may be present.  

The proposed interim decisions (PIDs) released today cover three first-generation anticoagulant rodenticides (FGARs), four SGARs, and four non-anticoagulant rodenticides. Strychnine (the 11th rodenticide) was not part of the 2008 RMD but is now included as part of EPA’s registration review of the rodenticide group. 

These PIDs build on the earlier protections by proposing additional mitigation measures based on findings in the 2020 draft human health and ecological risk assessments (DRAs) and feedback submitted during the DRAs’ public comment period. These measures are intended to reduce exposure to non-target organisms such as mammals and birds that may inadvertently consume rodenticides through their prey, or animals that may consume the rodenticide directly. Proposed measures include requiring bait to be placed in tamper-resistant bait boxes to ensure it is contained, and requiring users to collect carcasses of rodents that may have consumed rodenticides to prevent further exposures to non-target organisms that could consume the carcasses. In addition, the PIDs propose that all products, excluding those registered solely for use by homeowners, include label language directing users to access the web-based Bulletins Live! Two and follow the measures contained in any Endangered Species Protection Bulletin(s) for the area in which the user is applying the product.   

Endangered Species Pilot 

The ESA workplan described how EPA is developing early mitigation for a subset of species where EPA predicts a likelihood of a jeopardy or adverse modification finding for one or more of the registration review pilot pesticides if mitigation is not undertaken. One of these pilots is for rodenticides, which will focus on addressing effects to mammals and birds that consume rodenticide bait (primary consumers) and to birds, mammals and reptiles that consume primary consumers (secondary consumers).  

As part of its registration review ESA pilot for the rodenticides, EPA evaluated their potential effects on individuals and populations of Stephens’ kangaroo rat, Attwater’s prairie chicken, and the California condor and its designated critical habitat. EPA’s draft evaluation determined that rodenticide use is “likely to adversely affect” these three species but predicted the proposed mitigations will protect them from likely “jeopardy” (i.e., potential impacts to the survival of listed species) and “adverse modification” of critical habitat. A “likely to adversely affect” determination means EPA reasonably expects that at least one individual animal of any of the three species may be exposed to one or more of the rodenticides at a sufficient level to have an adverse effect.    

EPA’s draft likelihood of jeopardy and adverse modification predictions examine effects of the rodenticides at the species scale (i.e., the population as opposed to an individual of a species). While EPA has made predictions about the likelihood of jeopardy and adverse modification, the U.S. Fish and Wildlife Service (USFWS) is responsible for making the actual jeopardy/adverse modification findings for these species and has the sole authority to do so. 

EPA chose these three listed species because they represent species that may be affected by rodenticides through different routes of exposure, like primary consumption, for example, by Stephens’ kangaroo rat and Attwater’s prairie chicken and secondary consumption, for example, by California condor.

To focus the mitigations where they are most needed while retaining options for rodenticide users, the proposed mitigation measures for the three listed species would be targeted in specific geographic areas most relevant to the species. The PIDs include proposed mitigation measures to be included on the Bulletins Live! Two website for the species and the critical habitat of the California Condor. 

The draft evaluation for the three species and one critical habitat and associated mitigation measures are pilots for other listed species that may be similarly exposed and affected by rodenticides. In developing and applying mitigation measures for these species, EPA recognized that not all rodenticides have the same effects.  

Next Steps  

In addition to describing the pilot and the mitigation measures for the selected species, the PIDs also describe EPA’s plans for expanding those mitigation measures to the other approximately 90 listed species potentially affected by rodenticides. This plan, when finalized, will be known as the Rodenticide Strategy the Agency described in its November 2022 update to its ESA Workplan.  

EPA also intends to make effects determinations for all listed species available in a draft biological evaluation (BE), which the Agency anticipates making available for public comment in November 2023. The BEs will contain EPA’s draft analysis of the potential effects of the rodenticides on listed species and their designated critical habitats and will identify mitigation measures for these species and critical habitats to avoid or minimize exposure from the rodenticides (Rodenticide Strategy). EPA expects to complete the final BE for the rodenticides in November 2024.  

If EPA’s final BE continues to find that rodenticide use is likely to adversely affect listed species or adversely modify their critical habitats, then EPA will initiate formal consultation and share its findings with USFWS, which will use the information in EPA’s BE to inform its biological opinions. If the USFWS determines in its final biological opinions that additional mitigations are necessary to address any jeopardy or adverse modification determination, or to address any incidental take, then EPA will work to ensure that any necessary registration or labeling changes are made.   

The PIDs are now available for public comment in their respective pesticide registration review dockets at www.regulations.gov for 75 days. See the Federal Register notice for more information. After the PIDs, the next step in the registration review process is issuing an interim decision. 

For more information, visit EPA’s rodent control pesticide safety review webpage.

EPA Approves Stronger Plans for Certification of Pesticide Applicators

This original announcement was published by EPA on November 22, 2022. Click here for more information!

The U.S. Environmental Protection Agency (EPA) has approved 13 state and federal agency certification plans that comply with the improved federal standards to enhance worker safety under the 2017 Certification of Pesticide Applicators (CPA) rule.

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires authorities to have an EPA-approved plan to certify applicators of restricted use pesticides (RUPs). To date, of the nation’s 68 certification programs, EPA has reviewed all proposed modified plans and has approved eight plans from states and territories and five from federal agencies, of which all are now starting to be implemented.

In 2017, EPA updated the CPA regulations, setting stronger standards for people who apply RUPs. Improvements include enhancing applicator competency standards to ensure RUPs are used safely, establishing a nationwide minimum age for certified applicators and persons working under their direct supervision, and protection for noncertified applicators by requiring training before they can use RUPs (under the direct supervision of a certified applicator), among others.

The implementation of revised certification programs is crucial to reducing potential RUP exposures to certified applicators and those working under their direct supervision, other workers, the public, and the environment.

The following approved state and territory certification plans meet or exceed the standards mandated in the 2017 CPA rule:

  • Alaska (Alaska Department of Environmental Conservation)
  • California (California Department of Pesticide Regulation)
  • Nebraska (Nebraska Department of Agriculture)
  • New York (New York State Department of Environmental Conservation)
  • Oregon (Oregon Department of Agriculture)
  • Puerto Rico (Puerto Rico Department of Agriculture)
  • Vermont (Vermont Agency of Agriculture, Food and Markets)
  • U.S. Virgin Islands (U.S. Virgin Islands Department of Planning and Natural Resources)

In addition, the following federal agency certification plans meet or exceed the standards mandated in the 2017 CPA rule:

  • U.S. Department of Agriculture, Animal and Plant Health Inspection Services, Plant Protection and Quarantine
  • U.S. Department of Agriculture, Forest Service
  • U.S. Department of Defense
  • U.S. Department of Energy; Bonneville Power Administration
  • U.S. Department of the Interior, Bureau of Land Management

State, territory and tribal authorities with existing plans can continue using those plans until November 4, 2023, consistent with EPA’s recently issued extension (87 FR 50953, August 19, 2022). EPA is working closely with authorities to address challenges in revising their plans and will continue to approve plans on a rolling basis. After November 4, 2023, only authorities with EPA-approved modified certification plans can continue to certify applicators of RUPs.

EPA makes these certification plans available to the public by:

  • Tracking the progress of certification plan reviews and approvals here.
  • Approving certification plans as they are ready and announcing the approvals in batched Federal Register Notices (approximately quarterly).
  • Making all pre-2017 and newly approved certification plans publicly available in EPA’s Certification Plan and Reporting Database (CPARD) here.

Upon publication, the Federal Register Notice will be available in docket EPA-HQ-OPP-2022-0509 at www.regulations.gov.