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.

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.

This original announcement was published by the EPA on July 6, 2023, Click here for more information.

 

EPA is soliciting applications to implement the Pesticide Residential Inspector Training (PIRT) Program for FY 2024 through FY 2028. Eligible applicants include States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa, federally recognized Indian tribes, Alaska Native Villages, inter-tribal consortia and State and tribal institutions. 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 state/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 August 18, 2023. To apply, go to grant opportunity EPA-HQ-OECA-2023-001 at Grants.gov.