Register for Upcoming Webinar on EPA’s Research and Regulation of Pesticidal Air Treatment Devices

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

 

Sept. 6, 1-2:30 p.m. ET

Register today for a free webinar about pesticidal air treatment devices featuring EPA’s Dr. Katherine Ratliff and Aline Heffernan.

Hosted by EPA’s Office of Air and Radiation, this webinar will provide an overview of EPA’s:

  • Role in regulating pesticidal air cleaning and treatment devices;
  • Research on the effectiveness of these technologies against infectious aerosols;
  • Work on developing standardized test methods.

Register Here for Webinar

Audio for this webinar is available through GoTo Webinar only. Upon joining the webinar, connect to audio using your computer’s microphone and speakers (VoIP) or via telephone (not toll-free) and PIN.

Featured Speakers

Katherine Ratliff, Ph.D., Office of Research and Development

Dr. Ratliff is a physical scientist and principal investigator in EPA’s Homeland Security Research Program. She uses models, lab, and field-scale studies to develop strategies for remediating environmental contaminants and leads EPA’s research to evaluate the efficacy of air treatment technologies against airborne pathogens. Dr. Ratliff received her B.A. in Earth and Environmental Sciences from Vanderbilt University and a Ph.D. in Earth and Ocean Sciences from Duke University.

Aline Heffernan, MPH, Office of Chemical Safety and Pollution Prevention

Aline Heffernan is the regulatory advisor in EPA’s Antimicrobials Division, where she is the chair of the Device and Federal Insecticide, Fungicide and Rodenticide Act Jurisdiction workgroup. She previously was the division’s SARS-CoV-2 review coordinator to help determine which antimicrobials were effective in killing the virus that causes COVID-19. Heffernan received her undergraduate degree from the State University of New York at Geneseo and her master’s in public health from the State University of New York at Albany.

EPA Registers New Active Ingredient Pyraclonil

This original announcement was published by the EPA on August 24, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) has registered two pesticide products containing the new active ingredient pyraclonil to control weeds in water-seeded rice in California. EPA’s registration decision includes measures to protect non-target organisms, including federally threatened and endangered (listed) species and their designated critical habitats.

In addition to the registration decision, EPA has finalized the biological evaluation for this pesticide under the Endangered Species Act (ESA). Today’s action furthers the goals outlined in EPA’s April 2022 ESA Workplan by identifying potential effects to listed species, implementing necessary mitigation, and initiating the consultation process with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) prior to registration.

Background on Pyraclonil

EPA has approved two products containing pyraclonil: a technical product that can be used to formulate other products and an end-use product that is formulated as a dust-free granule that can be applied aerially to flooded rice paddies. The end-use product is registered for pre- and early post-emergence control of grass, sedge, and broadleaf weeds in water-seeded rice in California only. Notably, it may help control barnyardgrass and watergrass, two problematic weed species for rice growers in the state. Generally, weeds are important to control because they compete with rice plants for valuable nutrients and sunlight, potentially reducing yield if left uncontrolled.

Pyraclonil is also expected to be a useful addition to Integrated Pest Management and Weed Resistance Management programs for water-seeded rice in California due to its efficacy and new mode of action. Rice producers in this area can use pyraclonil in rotation with other herbicides to reduce the potential spread of herbicide resistance.

EPA’s Human Health and Ecological Risk Assessments

Before issuing this registration decision, EPA assessed whether exposures to these products would cause unreasonable adverse effects to human health and the environment, as required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Based on EPA’s human health risk assessment, there are no human health risk concerns from the registered uses of pyraclonil. However, EPA’s ecological risk assessment identified several risks of concern for the environment, including risks to aquatic plant species, listed and non-listed freshwater fish, listed and non-listed estuarine and marine invertebrates, and listed mammals.

EPA’s Final Biological Evaluation

The Agency also evaluated the effects of the proposed registration on listed species and critical habitats. EPA’s final effects determination found that pyraclonil is likely to adversely affect (LAA) 12 listed species and 10 critical habitats.

An LAA determination means that EPA reasonably expects that at least one individual animal or plant, among a variety of listed species, may be exposed to pyraclonil 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. The likely “take,” which includes unintentional harm or death, of even one individual of a listed species, is enough to trigger such a determination. As a result, there are often a high number of LAA determinations. An LAA determination, however, does not necessarily mean that a pesticide is putting a species in jeopardy.

EPA further refined its analysis for the species and critical habitats where it made LAA determinations to predict the likelihood that pyraclonil use could lead to a future jeopardy finding for certain listed species or adverse modification finding for critical habitats. These predictions examine effects of pyraclonil at the species scale (as opposed to one individual of a species). EPA’s draft biological evaluation predicted that, without additional mitigation, the proposed uses of pyraclonil would present a likelihood of jeopardy for two listed species (Sacramento River winter-run Chinook Salmon and Central Valley spring-run Chinook Salmon). EPA predicted no likelihood of adverse modification to critical habitats.

Mitigations

Based on these findings, the applicant has added the following mitigations to their labeling:

  • A water holding period in treated rice paddies after pyraclonil is applied to minimize pyraclonil off-site movement to non-target areas in which listed species live; and
  • Practices to 1) prevent water seepage from treated rice paddies through berms and levees, and 2) minimize overspray of pyraclonil granules onto berms and levees.

The applicant has also revised product labeling to include a requirement that users check the Bulletins Live Two! website to identify whether there are any areas where the pesticide cannot be used. Currently, there are no geographically-specific user restrictions, however, the Services may determine these mitigations are necessary during their review.

With these mitigations in place, EPA’s final biological evaluation predicts that the use of pyraclonil will not result in unreasonable adverse effects to non-target organisms or present a likelihood of jeopardy to these species.

Next Steps

Since EPA’s final biological evaluation found that pyraclonil is likely to adversely affect some listed species and critical habitats, EPA has initiated formal consultation and shared its findings with the Services.

During formal consultation, the Services use the information in EPA’s final biological evaluation (i.e., the final effects determination, predictions of the likelihood of jeopardy/adverse modification, and EPA’s mitigations to avoid jeopardy and minimize take) to inform their biological opinions. While EPA has made predictions about the likelihood of jeopardy and adverse modification as part of its biological evaluation, the Services are responsible for making the final jeopardy/adverse modification findings and have the sole authority to do so. If the Services determine in their 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 with the registrant to ensure that any necessary registration or labeling changes are made.

The registration decision and final biological evaluation are available in docket EPA-HQ-OPP-2020-0004 at www.regulations.gov.

EPA Announces the Implementation of Mitigation Measures for Insecticide Malathion to Protect Endangered Species

This original announcement was published by the EPA on August 23, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is taking action to protect endangered and threatened species by implementing the U.S. Fish and Wildlife Service’s (FWS) nationwide final biological opinion (BiOp) for the insecticide malathion. The malathion BiOp is the first nationwide BiOp issued by FWS to cover all registered uses of a pesticide across the United States and its territories. Its implementation represents the final stage in the Endangered Species Act (ESA) consultation for malathion and is the culmination of a collaborative process over more than seven years involving EPA, FWS, the U.S. Department of Agriculture, pesticide registrants and other stakeholders.  Today, EPA is implementing this BiOp by issuing Endangered Species Protection Bulletins, available on the Bulletins Live! Two website, and approving malathion label amendments to incorporate measures to protect listed species. 

Malathion is an organophosphate insecticide commonly used to control foliage and soil insect pests. It is used in the agricultural production of a wide variety of food and feed crops to control many types of insects such as aphids, leafhoppers, and Japanese beetles, as well as by home gardeners for outdoor residential uses including vegetable gardens, fruit trees, and a variety of ornamentals. Malathion-containing pesticide products also have significant public health benefits when used in pest control programs for controlling mosquito-borne illnesses. Malathion was one of the initial pilots chosen by EPA to help develop ESA consultation processes for FIFRA actions and to incorporate recommendations from the National Academy of Sciences.  Malathion was the subject of litigation, and the timing associated with EPA’s consultation was dictated by that litigation.   

Under the ESA, EPA is responsible for ensuring that its actions—including many pesticide registration actions—do not jeopardize listed species or destroy or adversely modify their designated critical habitats. EPA completes a biological evaluation (BE) to assess the risk of a pesticide to listed species. In January 2017, EPA released the BE for malathion, which determined–given malathion’s large number of labeled uses—that the registered uses of malathion have the potential to adversely affect one or more individuals of most (>90%) federally threatened or endangered (listed) species. In its BE, EPA determines if an individual of a species may be affected or not. If EPA determines that a species may be affected, then EPA uses additional information to determine if pesticide is Not Likely to Adversely Affect (NLAA) or is Likely to Adversely Affect (LAA) an individual of a species or critical habitat. If EPA makes a LAA determination, as it did with malathion for many listed species, EPA must engage in formal consultation with the Services. Practically, the LAA threshold for a BE is very conservative as the likely “take” of even one individual of a species triggers LAA (even if that species is almost recovered).   

The Service(s) then may develop a BiOp that, among other things, determines whether the pesticide is expected to jeopardize listed species or destroy or adversely modify critical habitat, and if so, requires measures to protect these listed species and critical habitats. Such measures are identified through the consultation process, which involves EPA, the Services, USDA, the pesticide applicants, and other stakeholders. 

FWS’s draft BiOp for malathion identified 78 listed species that could be jeopardized by how malathion was used before the consultation process. The final BiOp specifies agreed-upon mitigation measures including no spray zones, reductions in application rates and number of applications, and other changes to the labels that, once implemented, avoid jeopardy and adverse modification of critical habitat. Registrants involved in the consultation agreed to implement these measures by modifying their product labels, which now contain directions on how to apply the pesticide in accordance with the FWS BiOp.  

Additionally, mitigation measures that are only applicable near a species’ habitat are available on EPA’s Bulletins Live! Two website, an online system that describes geographically specific pesticide use limitations to protect listed species and their designated critical habitats. 

FWS determined that the new mitigation measures, once implemented, will adequately reduce the potential effects of malathion products on listed species. These measures will not only protect listed species but also reduce exposure and ecological effects more broadly wherever malathion is used. 

After consultations between the EPA, NMFS, FWS, and the malathion registrants and with input from USDA, the FWS and NMFS issued “no jeopardy” BiOps that were finalized on February 28, 2022, and June 30, 2022, respectively. The Services came to a “no jeopardy” determination based on mitigation measures that were identified during the consultation process.  

EPA is also working to implement the National Marine Fisheries Service’s nationwide final BiOp for malathion, chlorpyrifos and diazinon by the BiOp implementation date of December 30, 2023. The newly approved amended malathion labels include changes necessary to comply with both BiOps, but only the FWS Bulletins are currently available in Bulletins Live! Two. Registrants have submitted requests to amend their product labeling to include the necessary mitigation measures to address spray drift and runoff, as well as guidance on how to report ecological incidents associated with pesticide applications, should users observe any. EPA reviewed these amendments and approved the amended labeling.  

For additional information on the FWS BiOp and the NMFS BiOp for malathion, visit EPA’s website. The registration review process for malathion is ongoing, with the Proposed Interim Decision, proposing any additional necessary mitigations for comment, expected to be completed by the end of this year. 

EPA Amended Request for Applications for Cooperative Agreement for the Pesticide Inspector Residential Training (PIRT) Program

This original announcement was published by the EPA on August 10, 2023. Click here for more information.

 

EPA has amended the request for applications to implement the Pesticide Inspector Residential Training (PIRT) Program for FY 2024 through FY 2028. The amendment includes updates to the list of eligible entities and an updated closing date of September 1, 2023. Eligible applicants include states, public nonprofit institutions/organizations (includes institutions of higher education and hospitals), other public institutions/organizations, federally recognized lndian Tribal governments, U.S. territories and possessions (includes institutions of higher education and hospitals), Native American organizations (includes lndian groups, cooperatives, corporations, partnerships, associations).  

Under this program, EPA will provide financial assistance on an annual basis to carry out a pesticide inspector residential training program. This pesticide-related training is intended for inspectors, scientists, supervisors, and managers of pesticide regulatory programs from states/tribes and U.S. territories working under FIFRA Cooperative Agreements with EPA throughout the United States. 

The Agency expects to provide an estimated $500,000 annually, depending on the Agency’s budget, for a total of up to $3,000,000 for five years (FY 2024 through 2028). EPA also expects to provide a onetime additional allocation of $500,000 at the start of the grant.   

EPA must receive proposals through Grants.gov no later than 11:59 p.m. Eastern Time on September 1, 2023. To apply, go to grant opportunity EPA-HQ-OECA-2023-001 at Grants.gov.  

EPA Posts Resources on Rule to Accelerate Use of Plant-Incorporated Biotechnologies to Protect Against Pests 

This original announcement was published by the EPA on August 4, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIPs) exemption rule. These resources are available on EPA’s public website, https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated-0 and include the following:

  • Fact sheet and background information on PIPs rule
  • Examples of genetic modifications that are exempt under the rule
  • Description of how to submit a self-determination or a request for EPA confirmation of exemption under the rule
  • Sample documents for submitting a self-determination or request for confirmation

The PIPs Exemption Final Rule went into effect on July 31, 2023.

Background

In May 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting two categories of plant-incorporated protectants (PIPs) created using genetic engineering from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). This rule ensures that human health and the environment are protected while reducing costs for the regulated community, consistent with the September 2022 Executive Order 14081 on Advancing Biotechnology. The rule may also result in increased research and development activities, commercialization of new pest control options for farmers, and reduced use of conventional pesticides.

The final rule reflects the biotechnological advances made since 2001, when the Agency first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements, but did not at that time exempt PIPs created through biotechnology. Specifically, the final rule exempts PIPs derived through genetic engineering from FIFRA registration and FFDCA tolerance requirements in cases where the PIPs are essentially equivalent to those exempted by the 2001 rule.

The rule contains conditions for exempting:

1) PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption; and

2) Loss-of-function (LoF) PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect. For this category of PIP, biotechnology developers can make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.

EPA also indicated in the preamble to the rule that EPA would consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements and expanding the categories of PIPs that are allowed the option to self-determine and do not require EPA confirmation of eligibility for the exemption.

The resources mentioned above, as well as the final rule and additional information, including EPA’s response to comments, are available on EPA’s website https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated-0.

EPA Seeks Public Comments to Ensure Information on Bilingual (Spanish) Pesticide Labels Reaches the Hands of America’s Farmworkers

This original announcement was published by the EPA on August 3, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is seeking public comments on how to make bilingual pesticide labeling accessible to farmworkers. As part of the Pesticide Registration Improvement Act of 2022, safety and health portions of pesticide product labels are required to be translated into Spanish. EPA wants input from stakeholders including labor groups, agricultural retailers, individual farmers and farmworkers and more on how to successfully set up an implementation plan that will ensure pesticide label information reaches America’s farmworkers to help prevent pesticide exposure and assist in addressing long-standing environmental justice issues.

Spanish is the primary language of communication for most American farmworkers. EPA is seeking the public’s input to create a strategy to share bilingual (Spanish) pesticide labels with farmworkers and account for communication challenges (such as lack of internet or cell service) in the nation’s farm fields. Specifically, EPA is seeking information on outreach and communication approaches, engagement methods, cultural perspectives, technology considerations, partnerships, and potential environmental justice matters.

Help EPA make pesticide product labels accessible to farmworkers by providing your feedback in public docket EPA–HQ–OPP–2023–0270, Pesticide Registration Improvement Act Bilingual Labeling Requirements: Making Bilingual Pesticide Labeling Accessible to Farmworkers on or before Monday, August 21, 2023. By improving access to bilingual (Spanish) pesticide labels, EPA hopes the implementation plan will increase knowledge, information sharing, and the safety of our nation’s farmworkers.

For general inquiries, email: OPPbilinguallabels@epa.gov.

EPA Posts Pesticide Incident Data Publicly

This original announcement was published by the EPA on July 27, 2023. Click here for more information.

 

WASHINGTON (July 27, 2023) — Today, the U.S. Environmental Protection Agency (EPA) took a major step to increase transparency by posting 10 years of pesticide incident data on its website. Sharing this information advances EPA’s commitment to environmental justice and aligns with EPA’s Equity Action Plan by expanding the availability of data and capacity so the public and community organizations can better understand pesticide exposures, including exposures to vulnerable populations.

This action also advances the President’s transparency goal of ensuring that the public, including members of communities with environmental justice concerns, has adequate access to information on federal activities related to human health or the environment, as charged in Executive Order 14096, Revitalizing Our Nation’s Commitment to Environmental Justice for All.

The data sets, which pull information from EPA’s Incident Data System (IDS), allow users to access raw data on pesticide exposure incidents such as the incident date, the reason for the report (e.g., adverse effect, product defect), and the severity of the incident. It may also provide information on the location of the incident, the pesticide product, and a description of the incident(s). EPA has not verified the raw data for accuracy or completeness, so users should be aware of this limitation before drawing any conclusions from the data.

“People have the right to know when accidental pesticide exposures or other incidents are reported to the Agency,” said EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “It is particularly critical to share how pesticides may have impacted our most vulnerable populations, including children and farmworkers.”

EPA considers a pesticide incident as any exposure or effect from a pesticide’s use that is not expected or intended. Pesticide incidents may involve people, domestic animals (e.g., pets or livestock), wildlife, or the environment (e.g., air, soil, water, plants). Reporting a pesticide incident provides EPA with additional information on the effects and consequences of exposures to pesticides affecting people and the environment.

EPA receives information about pesticide incidents from a variety of sources. The incident reports contained in IDS include data from:

  • pesticide manufacturers (registrants), as they are required to submit reports of unreasonable adverse effects from their products;
  • reporting by the public through other entities (including state regulators for pesticide enforcement);
  • information submitted when individuals send an email directly to EPA;
  • the National Pesticide Information Center (NPIC); and
  • the American Association of Poison Control Centers.

Prior to today’s action, EPA generally only provided incident information to the public when responding to requests under the Freedom of Information Act (FOIA) or as an incident summary as part of EPA’s pesticide registration review process. EPA has made these data accessible to expand the public’s access and understanding of pesticide incidents and pesticide-related illness. Releasing these data is responsive to many long-standing requests to share incident data with farmworker organizations and public health officials.

EPA has made the last 10 years of incident data accessible because incident data older than 10 years may not reflect pesticide product labels currently on the market due to label changes that may occur during registration review. EPA plans to update the data monthly going forward.

Background on EPA’s Review and Use of Incident Data

EPA completes a periodic review of pesticide registrations — including pesticide incidents — at least every 15 years to ensure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. EPA’s analysis may result in label changes to address any identified risks of concern. As mentioned above, this process is known as registration review.

During registration review, EPA conducts human health and environmental assessments to ensure that pesticides will not cause unreasonable adverse effects to human health or the environment. Human health risk assessments evaluate the nature and probability of adverse health effects occurring in people who may be exposed to chemicals in their daily activities (e.g., from food and water they consume, air they breathe, contact at work, or other activities). Ecological risk assessments evaluate how a pesticide is expected to move through and break down in the environment, and whether potential exposure to the pesticide will result in unreasonable adverse effects to wildlife and vegetation.

In addition, incident reports, both those submitted to the Agency and those available in open literature, can help EPA determine whether pesticides have adequate use directions and restrictions, protective safety equipment requirements for farmworkers and/or pesticide applicators, and any other necessary mitigation measures to reduce risk to humans and the environment.

Background on the Incident Data System

EPA is making two data sets public. The first data set contains incidents that were submitted to EPA with a description of the incident (e.g., who was involved, how it happened, and where the incident occurred). The second data set contains incidents that were submitted in aggregate to the Agency. Aggregate incidents are submitted in bulk, as outlined in the Agency’s PR Notice 98- 3 and only contain information on the product and the severity of the incident, with no narrative description. For either data set, a single submission may contain one or more incidents.

EPA is publishing these data sets to increase transparency to the public, but the Agency does not currently have the resources to answer individual questions about its content.

It is important to recognize that the data sets contain raw data that have never been reviewed for their validity or modified to facilitate public review. The Agency did not design the incident reporting system to cover only information known to be valid, and as such, cannot guarantee the accuracy, completeness, or adequacy of the contents of the data sets. People who download and use the data should exercise caution in drawing conclusions from the data.

For incident reports that contain personally identifiable information, EPA has made every effort to remove this information before making the records public. EPA will continue to redact this information as it updates the data sets each month.

To learn more, view the data sets and/or visit our About the Incident Data System webpage that explains how to search the data sets.

EPA Releases Draft Strategy to Better Protect Endangered Species from Herbicide Use

This original announcement was published by the EPA on July 24, 2023. Click here for more information.

Strategy aims to increase efficiencies while supporting farmers, herbicide users with continued use of important pesticide tools  

Contact: EPA Press Office (press@epa.gov)

WASHINGTON (July 24, 2023) – Today, the U.S. Environmental Protection Agency (EPA) released the draft Herbicide Strategy for public comment, a major milestone in the Agency’s work to protect federally endangered and threatened (listed) species from conventional agricultural herbicides. The Strategy describes proposed early mitigations for more than 900 listed species and designated critical habitats to reduce potential impacts from the agricultural use of these herbicides while helping to ensure the continued availability of these important pesticide tools.

“Ensuring safe use of herbicides is an important part of EPA’s mission to protect the environment,” said Deputy Assistant Administrator for Pesticide Programs for the Office of Chemical Safety and Pollution Prevention Jake Li. “This strategy reflects one of our biggest steps to support farmers and other herbicide users with tools for managing weeds, while accelerating EPA’s ability to protect many endangered species that live near agricultural areas.”

The Strategy released today is part of EPA’s ongoing efforts to develop a multichemical, multispecies approach to meeting its obligations under the Endangered Species Act (ESA). EPA’s traditional chemical-by-chemical, species-by-species approach to meeting these obligations is slow and costly.  As a result, EPA has completed its ESA obligations for less than 5% of its actions, creating legal vulnerabilities for the Agency, increased litigation, and uncertainty for farmers and other pesticide users about their continued ability to use many pesticides. The Strategy — which is primarily designed to provide early mitigations that minimize impacts to over 900 listed species — is one of EPA’s most significant proposals to help overcome these challenges.

EPA focused the Strategy on agricultural crop uses in the lower 48 states because hundreds of millions of pounds of herbicides (and plant growth regulators) are applied each year, which is substantially more than for non-agricultural uses of herbicides and for other pesticide classes (e.g., insecticides, fungicides). Additionally, hundreds of listed species in the lower 48 states live in habitats adjacent to agricultural areas. The proposed mitigations in the Strategy would address the most common ways that conventional agricultural herbicides impact these listed species.

EPA expects that the Strategy will increase the efficiency of future ESA consultations on herbicides with the U.S. Fish and Wildlife Service (FWS), which has authority over most listed species that could benefit from the proposed mitigations. Under the Strategy, EPA proposes to identify and begin mitigating for potential impacts even before EPA completes ESA consultations. These early mitigations should expedite EPA’s ability to fully comply with the ESA by reducing impacts to listed species before EPA conducts most of its ESA analysis. Adopting mitigations earlier will also allow EPA and FWS to far more efficiently use their resources in ESA consultations.

The Strategy’s proposed mitigations reflect practices that can be readily implemented by growers and identified by pesticide applicators and that provide flexibility for growers to select the mitigations that work best for them. The Strategy also gives credit to landowners who are already implementing certain measures to reduce pesticide runoff. For example, existing vegetated ditches and water retention ponds will qualify for credits that reduce the need for additional mitigation. Similarly, the Strategy would require less mitigation on flat lands, which are less prone to runoff, and in many western states, which typically experience less rain to carry pesticides off fields. The Strategy also describes how the Agency could add other mitigation practices to the menu of mitigation options in the future, particularly to incorporate emerging technology or new information on the effectiveness of specific practices.

Draft Herbicide Framework Document

The draft framework document includes a discussion of both the proposed scope of the Herbicide Strategy and the proposed decision framework to determine the level of mitigation needed for a particular conventional agricultural herbicide. The draft framework document also includes examples of how the proposed herbicide mitigation would apply to some of the herbicides for which EPA has conducted case studies as well as EPA’s proposed implementation plan.

The draft herbicide framework and accompanying documents are available in docket EPA-HQ-OPP-2023-0365 for public comment for 60 days.

In its ESA Workplan and ESA Workplan Update, EPA outlined this and other ESA initiatives to develop early mitigations that provide listed species with practical protections from pesticides. The Strategy complements those other initiatives, such as targeted mitigations for listed species particularly vulnerable to pesticides and Interim Ecological Mitigations that EPA has begun incorporating under the Federal Insecticide, Fungicide, and Rodenticide Act. The draft framework describes how EPA would apply the mitigations in the Strategy compared to mitigations in the other initiatives.

Visit EPA’s website to learn more about how EPA’s pesticide program is protecting endangered species.

EPA Requires Additional Mitigation Measures for Seresto Pet Collars

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

 

Today, the U.S. Environmental Protection Agency (EPA) is requiring the implementation of additional measures for Seresto pet collars. The new measures will alert veterinarians and consumers of potential risks and provide more information about how to prevent and report adverse reactions from Seresto collars. The new measures will also improve the quality of adverse incident data reported to EPA to aid in the continued review of this product.

EPA conducted an extensive analysis of incident and other data, with the assistance of the Food and Drug Administration (FDA). From this analysis, EPA concluded that these collars continue to meet EPA’s standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). However, with the implementation of today’s mitigations, EPA expects to receive higher quality data in the coming years. EPA has approved Seresto collar registrations for five years to allow for the continued evaluation of incident reports, which could result in further regulatory action in the future.

Background

Seresto collars offer flea and tick prevention for dogs and cats, as well as lice control for dogs. This use is important because fleas and ticks are considered significant public health pests that can transmit many serious diseases, such as Lyme disease and Rocky Mountain spotted fever, to pets and humans.

Under FIFRA, EPA is required to consider the benefits, as well as the risks, of the use of a pesticide. In addition to its protection against several serious public health pests, Seresto works for up to 8 months per collar, is available without the need for a prescription, and is relatively easy to apply compared to other flea and tick products. For cats and dogs, there are very few flea and tick collar alternatives that can be used for such a prolonged time.

Over the past several years, EPA has been improving its method for considering pet product-incidents, such as those reported for Seresto collars, in the pesticide registration and re-evaluation process. As part of this effort, and due to the number of Seresto-related incidents reported to EPA, the Agency began an in-depth review of the incidents of Seresto collars in 2021.

EPA has reviewed an extensive set of data it required Elanco, the current registrant of Seresto collars, to submit and reviewed the many incidents reported to EPA’s Incident Data System to determine whether the collars may contribute to an elevated number of pet-related incidents. Throughout the review process, EPA consulted with FDA, which regulates similar products for cats and dogs, including flea and tick products that are ingested. EPA used information gathered during this review process to make its determination about the product.

EPA’s Risk Findings and New Measures to Reduce Risk

EPA’s scientific review of Seresto-related incident reports identified the need for more detailed incident reporting and public outreach. EPA analyzed all incidents that reported death for Seresto. This included 1,400 deaths reported to EPA from 2016-2020, which represent 2 percent of all Seresto incidents reported for these years. In many of the death-related incidents, critical details of the incident were often missing, preventing the Agency from determining the cause of the death.

The only reported deaths that were found to be “probably” or “definitely” related to Seresto product use were associated with mechanical strangulation or trauma caused by the collar, often associated with a failure of the release mechanism.

For all other deaths, EPA did not identify cases with a probable or definite association between collar use and death, often due to other factors impacting the animal, such as an existing medical condition. In addition, the rate of deaths reported for Seresto was similar to that for other pet products reviewed.

EPA also analyzed all non-lethal incidents, such as neurological symptoms. In some incidents with moderate or severe clinical sign removal of the collar seemed to alleviate symptoms and/or reapplication of the collar coincided with a reoccurrence of symptoms. Based on these findings, Elanco, the registrant of Seresto, has agreed to implement the following measures:

  • To alert veterinarians and consumers of potential risks, the terms of continued registration require Elanco to include label warnings on Seresto products that describe common adverse effects that have been reported, along with instructions to remove the collar if those effects occur and instructions on how to report the incident. Elanco also must develop an outreach program to more effectively communicate with veterinarians and the public on the risks of using the product and other similar pesticides on pets.
  • To improve the quality of data reported when receiving reported incidents from consumers, Elanco must pursue additional information to the greatest extent possible to ensure that complete details of each event are captured. This information includes whether the pet had any pre-existing conditions or previous history of the reported condition. The Seresto collar registration has also been split into two registrations, one for cats and one for dogs, to make comparison of incident data across products easier in the future. Elanco must report incident and sales data to EPA on an annual basis.
  • To reduce the risk of strangulation, Elanco must evaluate potential changes to the emergency release mechanism of Seresto collars to prevent death by strangulation or choking. The company must submit a report detailing the data and analysis collected and performed in pursuit of this effort within one year. Based on this evaluation, EPA may require a modified release mechanism for the Seresto collar.
  • To allow for the continued evaluation of reported incidents, EPA has limited its current approval of Seresto collar registrations to five years. EPA will continue to evaluate Seresto incident data over that period.

Elanco must implement the new registration requirements by the next printing of Seresto pet collar labels, which must occur in the next 12 months. To learn more, read EPA’s decision document, EPA’s scientific review document, or EPA’s frequent Q&As.

EPA Denies Petition to Cancel and Suspend Seresto Pet Collars

Based on the Agency’s scientific review of incident data, EPA is denying a 2021 petition from the Center for Biological Diversity (CBD) that requests the cancellation of Seresto collars and the suspension of Seresto collars pending cancellation. EPA received and reviewed more than 5,400 comments on the petition. Read EPA’s full response to the petition and public comments.

EPA and FDA Continue to Discuss Pet Product Jurisdiction

EPA and FDA jointly released a whitepaper in February 2023 that outlines an updated approach to clarify regulatory oversight of certain animal products to better align with each agency’s expertise. One aspect of that proposed modernized approach includes a process for transferring oversight of flea and tick pet products, such as Seresto collars, from EPA to FDA.

The agencies started discussing a modernized approach to product oversight years before the current review of Seresto collars. However, EPA’s review of Seresto pet-related incident reports has highlighted that, as compared to FDA, EPA has less expertise and resources (staff, infrastructure, and funding) to evaluate animal safety and conduct ongoing monitoring of marketed products. Read the whitepaper to learn more.

Safety Tips for Using Pet Collars

EPA encourages pet owners to discuss with their veterinarian when flea and tick control is needed for their pets and which type of control product they should use. Pet owners should read the entire label before using the recommended product and follow all directions carefully, as well as monitor the pet after treatment.

EPA understands and shares the public’s concerns about reported incidents with Seresto pet collars. Pets are part of the family in many American households and the Agency is committed to following the science and the law as we work on this issue and pursue our mission. Learn more about how to use these products safely.

EPA Seeks Nominations for the Pesticide Program Dialogue Committee

This original announcement was published by the EPA on July 12, 2023. Click here for more information.

 

EPA is accepting nominations for membership on the Pesticide Program Dialogue Committee (PPDC). Established in 1995, the PPDC is a diverse group of stakeholders chartered under the Federal Advisory Committee Act to provide feedback to EPA on various pesticide regulatory, policy, and program implementation issues.

To maintain a broad representation of members for the PPDC, nominees will be selected from among the following:

  • Federal, state, local and tribal governments;
  • Pesticide industry and trade associations;
  • Pesticide users;
  • Grower and commodity groups;
  • Environmental and public interest groups;
  • Farm worker organizations;
  • Public health organizations;
  • Animal welfare groups; and
  • Academia.

Nominations must be emailed or postmarked no later than August 10, 2023, and can be submitted by email to the Designated Federal Official (DFO) listed below with the subject line “PPDC Membership” or by mail to:

Jeffrey ChangPPDC Designated Federal OfficerOffice of Pesticide ProgramsU.S. Environmental Protection Agency1200 Pennsylvania Ave. NWWashington, DC 20460 

For additional information, read the Federal Register notice on nominations for the PPDC or contact the DFO, Jeffrey Chang (chang.jeffrey@epa.gov) or call (202) 566-2213.

Learn more about the PPDC.