The EPA Needs to
Determine Whether
Seresto Pet Collars Pose
an Unreasonable Risk to
Pet Health

February 29, 2024 | Report No. 24-E-0023


-------
Report Contributors

Gabby Fekete
Gila Goldstein
Steve Hanna
Lauretta Joseph
Jim Kohler

Gaida Mahgoub
Barry Parker
Alii Phillips
Michael Wilson

Abbreviations

C.F.R.	Code of Federal Regulations

EPA	U.S. Environmental Protection Agency

FDA	U.S. Food and Drug Administration

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

IDS	Incident Data System

OIG	Office of Inspector General

OPP	Office of Pesticide Programs

U.S.C.	United States Code

VICH	Veterinary International Conference on Harmonization

Key Definitions

Companion Animal Safety Study:
Environment:

Pesticide Incident:

Registration Review:

Unreasonable Adverse
Effects to the Environment:

Cover Image

A picture of pets. (EPA image)

A report intended to demonstrate an adequate margin of safety
if a pesticide product is overused.

The water, air, land, and all plants and man and other animals
living therein and their interrelationships.

Any exposure or effect from a pesticide's use that is not
expected or intended.

A review that FIFRA section 3(g)(1)(A) requires the EPA to
conduct for every pesticide no later than 15 years after the
pesticide's initial registration.

Any unreasonable risk to humans or the environment, taking
into account the economic, social, and environmental costs and
benefits of the use of any pesticide.

Are you aware of fraud, waste, or abuse in an
EPA program?

EPA Inspector General Hotline

1200 Pennsylvania Avenue, NW (2431T)
Washington, D.C. 20460
(888) 546-8740
(202) 566-2599 (fax)

OIG.Hotline@epa.qov

Learn more about our OIG Hotline.

EPA Office of Inspector General

1200 Pennsylvania Avenue, NW (2410T)
Washington, D.C. 20460
(202) 566-2391
www.epaoiq.gov

Subscribe to our Email Updates.

Follow us on X (formerly Twitter) @EPAoiq.
Send us your Project Suggestions.


-------
At a Gla

24-E-0023
February 29, 2024

The EPA Needs to Determine Whether Seresto Pet Collars Pose an
Unreasonable Risk to Pet Health

Why We Did This Evaluation

To accomplish this objective:

The U.S. Environmental Protection
Agency Office of Inspector General
conducted this evaluation to determine
whether the (1) EPA's response to
reported pesticide incidents involving
Seresto pet collars provides assurance
that the collars can still be used without
posing unreasonable adverse effects to
human health and the environment and
(2) EPA adhered to pesticide
registration requirements in its approval
of Seresto pet collars, specifically
toxicological data requirements in
40 C.F.R. part 158. This evaluation is
the result of multiple OIG Hotline
complaints.

As of August 2023, the EPA was
reviewing the active ingredients,
flumethrin and imidacloprid, in Seresto
pet collars, pursuant to Federal
Insecticide, Fungicide, and Rodenticide
Act requirements. The Act mandates
that the EPA determine whether a
pesticide "will not generally cause
unreasonable adverse effects on the
environment."

To support this EPA mission-related
effort:

•	Ensuring the safety of chemicals.

To address this top EPA
management challenge:

•	Safeguarding the use and disposal
of chemicals.

What We Found

The EPA's response to reported pesticide incidents involving Seresto pet collars has not
provided assurance that they can be used without posing unreasonable adverse effects to
the environment, including pets. While the EPA's Office of Pesticide Programs adhered to
the toxicological data requirements in 40 C.F.R. part 158 in its initial approval of Seresto
pet collars, it has not adhered to the pesticide registration review process for the active
ingredients flumethrin and imidacloprid in the Seresto pet collars. The Office of Pesticide
Programs did not conduct or publish domestic animal risk assessments, which it had
committed to doing in the work plans for these two pesticides; continues to use an
inadequate 1998 companion animal safety study (Guideline 870.7200); and lacks standard
operating procedures and a measurable standard to help determine when domestic animal
pesticide products pose unreasonable adverse effects to the environment, as required by
the Federal Insecticide, Fungicide, and Rodenticide Act.

Additionally, the EPA's Pesticide Incident Reporting System and reporting process do not
capture adequate data that the EPA needs to assess unreasonable adverse effects of pet
products. The EPA requested that current and former Seresto pet collar registrants provide
more than the required aggregate reporting of pet incident data because of the Agency's
concerns about the numerous reports of adverse incidents it had received. In July 2023, the
EPA reported that it completed a review of Seresto pet collar-related incident reports and
said that, in many of the death-related incidents, critical details were missing, preventing
the Agency from determining the cause of the deaths. The EPA worked with the current
Seresto product registrant to take measures, and the EPA limited its approval of Seresto
pet collar registrations to five years. While the EPA will continue to evaluate Seresto
incidents over that period, the Office of Pesticide Programs needs to prioritize several
areas for improvement to ensure that pesticide products do not pose unreasonable adverse
effects to pets.

Pet collars containing pesticides continue to be used without
assurance that there are no unreasonable adverse effects on
the environment, including pets.

Recommendations and Planned Agency Corrective Actions

We make eight recommendations to assist the EPA in determining whether Seresto pet
collars can be used without posing unreasonable adverse effects in pets. The EPA
generally agreed with Recommendations 2, 3, 5, 6, 7, and 8, which are resolved with
corrective actions pending. Recommendation 4 is also resolved with corrective actions
completed. The EPA did not agree with Recommendation 1, which remains unresolved.

Address inquiries to our public
affairs office at (202) 566-2391 or
OIG.PublicAffairs@epa.gov.

List of OIG reports.


-------
OFFICE OF INSPECTOR GENERAL

U.S. ENVIRONMENTAL PROTECTION AGENCY

February 29, 2024

MEMORANDUM

SUBJECT: The EPA Needs to Determine Whether Seresto Pet Collars Pose an Unreasonable Risk
to Pet Health
Report No. 24-E-0023

FROM:

Sean W. O'Donnell



Jl

TO:

Michal liana Freedhoff, Assistant Administrator
Office of Chemical Safety and Pollution Prevention

This is our report on the subject evaluation conducted by the U.S. Environmental Protection Agency
Office of Inspector General. The project number for this evaluation was QSRE-FY22-0120. This report
contains findings that describe the problems the OIG has identified and corrective actions the OIG
recommends. Final determinations on matters in this report will be made by EPA managers in
accordance with established audit resolution procedures.

The Office of Chemical Safety and Pollution Prevention is responsible for the issues discussed in this
report.

In accordance with EPA Manual 2750, your office completed corrective actions for Recommendation 4.
Your office also provided acceptable corrective actions and estimated milestone dates for
Recommendations 2, 3, 5, 6, 7, and 8. These recommendations are resolved with corrective actions
pending. A final response pertaining to these recommendations is not required; however, if you submit
a response, it will be posted on the OIG's website, along with our memorandum commenting on your
response.

ACTION REQUIRED

Recommendation 1 is unresolved. EPA Manual 2750 requires that recommendations be resolved
promptly. Therefore, we request that the EPA provide us within 60 days its responses concerning specific
actions in process or alternative corrective actions proposed on the recommendation. Your response will
be posted on the OIG's website, along with our memorandum commenting on your response. Your
response should be provided as an Adobe PDF file that complies with the accessibility requirements of
section 508 of the Rehabilitation Act of 1973, as amended. The final response should not contain data

To report potential fraud, waste, abuse, misconduct, or mismanagement, contact the OIG Hotline at (888) 546-8740 or OIG.Hotline@epa.gov.


-------
that you do not want to be released to the public; if your response contains such data, you should identify
the data for redaction or removal along with corresponding justification.

We will post this report to our website at www.epaoig.gov.

To report potential fraud, waste, abuse, misconduct, or mismanagement, contact the OIG Hotline at (888) 546-8740 or OIG.Hotline@epa.gov.


-------
Table of Contents

Purpose	1

Background	1

Seresto Pet Collars, Pet Deaths, and Human Incidents	1

Initial Registrations and Pesticide Registration Review Process	3

Responsible Offices	5

Scope and Methodology	6

Prior Report	7

Results	7

The OPP Did Not Conduct Domestic Animal Risk Assessments as Part of Registration
Review or Expressly Determine Whether the Seresto Pet Collar Poses an

Unreasonable Risk to Pet Health	8

Data Used for Initial Pesticide Registration Are Not up to International Standards	10

IDS Data Are Inadequate to Determine Unreasonable Adverse Effects	11

Additional Concerns Raised over the EPA's Oversight of Pet Products	13

Recommendations	14

Agency Response and OIG Assessment	14

Status of Recommendations	16

A Agency Response	17

B Distribution	26

24-E-0023	i


-------
Purpose

The U.S. Environmental Protection Agency Office of Inspector General initiated this evaluation to
determine whether the (1) EPA's response to reported pesticide incidents involving Seresto pet collars
provides assurance that the collars can still be used without posing unreasonable adverse effects to
human health and the environment and (2) EPA adhered to pesticide registration requirements in its
approval of Seresto pet collars, specifically toxicological data requirements in 40 C.F.R. part 158. This
evaluation responds to multiple hotline complaints that we received.

Top Management Challenge Addressed

This evaluation addresses the following top management challenge for the Agency, as
identified in OIG Report No. 24-N-0008. The EPA's Fiscal Year 2024 Top Management
Challenges, issued November 15, 2023:

• Safeguarding the use and disposal of chemicals.

Background

Seresto Pet Collars, Pet Deaths, and Human Incidents

Seresto pet collars are intended for use on dogs that are at least seven weeks old and cats that are at
least ten weeks old. The pet collars work by releasing two active ingredients: the pesticides flumethrin
and imidacloprid. Pesticides are used on animals to control fleas, ticks, mosquitoes, and other pests.

Federal law generally requires that pesticides distributed and sold in the United States be registered by
the EPA. Imidacloprid was originally registered by the EPA in the 1990s. The Seresto pet collar and
flumethrin were registered by the EPA in March 2012.1 Nine years later, in March 2021, news media
reported that over 1,500 pets had died and many more had fallen ill while using Seresto pet collars.
Furthermore, from 2012 through 2022, the EPA received more than 100,000 incident reports related to
Seresto pet collars. By November 2022, the EPA had received more than 2,500 pet death incident
reports and nearly 900 human pesticide incident reports regarding Seresto pet collars.

As a result of the March 2021 media coverage, the U.S. House of Representatives Committee on
Oversight and Government Reform, which is now the Committee on Oversight and Accountability,
Subcommittee on Economic and Consumer Policy launched an investigation. The subcommittee
reviewed EPA emails and documents regarding the dangers posed by the Seresto pet collars. In 2022,
the subcommittee released a report of its investigation, which outlined the EPA's awareness of these
incidents and the potential harm caused by the collars and the EPA's own conclusion after an
independent review conducted in 2016 that the collars "probably or possibly" caused 45 percent of the
reported pet deaths. On July 13, 2023, the EPA reported that it completed a review of Seresto pet

1 The EPA is responsible for ensuring that all pesticides, including flea and tick products, sold in the United States
do not cause unreasonable adverse effects when they are used according to label directions.

24-E-0023

1


-------
collar-related incident reports and announced that it was requiring the implementation of additional
measures for Seresto pet collars. According to the Agency's website, the EPA determined that Seresto
pet collars continue to meet the EPA's standards under FIFRA.2 The EPA limited this registration
approval to five years.3 The EPA made its determination after completing its review of Seresto pet collar
incidents and identifying the need for more detailed incident reporting and public outreach. The EPA's
review found that many of the 1,400 Seresto pet collar incident deaths reported to the EPA from 2016
through 2020 lacked critical details, preventing the Agency from determining the causes of the deaths.
Additionally, in some incidents with moderate or severe clinical signs, removal of the collar seemed to
alleviate symptoms or reapplication of the collar coincided with a reoccurrence of symptoms. Based on
these findings, the registrant of Seresto pet collars agreed to implement new mitigation measures
including:

•	Adding label warnings on common adverse effects that have been reported, along with
instructions to remove the collar if those effects occur and on how to report the incident.

•	Requiring the registrant to report incident and sales data on an annual basis and provide
additional information about incidents whenever possible.

•	Improving the quality of data reported when receiving reported incidents from consumers.
Figure 1 provides a timeline of events related to the Seresto pet collars.

Figure 1: Seresto pet collar timeline

Initial registration for Seresto pet collar.

Emails show EPA officials raised concerns
about Seresto but were rebuffed by supervisors.

March: The EPA staff raised concerns to
management through prepared briefings. No
action was taken by management.

June: The House subcommittee held a
hearing called "Seresto Flea and Tick Collars:
Examining Why a Product Linked to More than
2,500 Pet Deaths Remains on the Market."

J 2012)

The EPA's independent analysis of Health
Canada Pest Managements Regulatory Agency
study concludes that 45 percent of reported pet
deaths "probably or possibly" caused by collar.

July: The EPA met with the registrant to discuss
improved product safety measures; the registrant
did not agree to make the changes.

March: The House Subcommittee on Economic
and Consumer Policy launched investigation injo
the collar.

June: The House subcommittee publicly issues
its investigative staff report.

July: The EPA completed a review of Seresto collar incidents and identified the need for more detailed incident
reporting. The EPA adjusted the regulatory requirements for the registration of Seresto pet collars to incorporate
additional necessary mitigation that will aid in the Agency's continued review of this product. This registration will

be a time-limited registration of five years.

Source: OIG analysis of EPA information. (EPA OIG image)

2	U.S. EPA, EPA Requires Additional Mitigation Measures for Seresto Pet Collars (July 13, 2023).

3	This is different from the normal FIFRA registration review time frame, which is 15 years for an unconditional

registration of a pesticide.

24-E-0023

2


-------
What is a pesticide incident?

The EPA defines a pesticide incident as any exposure or effect from a pesticide's use that is not expected or intended.
Pesticide incidents may involve humans, wildlife, plants, domestic animals, and bees

Initial Registrations and Pesticide Registration Review Process

Under FIFRA, as amended, 7 U.S.C. §§ 136—136y, the EPA must generally register pesticides that are
distributed or sold in the United States. Section 3(c)(5) of FIFRA establishes the statutory standard under
which the EPA may unconditionally register a pesticide. The toxicological data required to register a
pesticide product under FIFRA are identified in 40 C.F.R. part 158. When the EPA has determined that no
"unreasonable adverse effects on the environment" will result from the sale or distribution of a
pesticide product, it grants the applicant a license, or registration, to legally sell and distribute the
product in the United States. After the initial registration is issued, pursuant to section 6(a)(2) of FIFRA,
registrants must continue to report any adverse incident data regarding the pesticide to the EPA.
Pursuant to section 3(g) of FIFRA, the EPA reviews each registered pesticide at least every 15 years to
ensure that each pesticide can carry out its intended functions without creating unreasonable adverse
effects on the environment. This requirement is referred to as the pesticide registration review process.
The EPA's Office of Pesticide Programs, or OPP, within the Office of Chemical Safety and Pollution
Prevention, oversees the initial registration process and the pesticide registration review process.

Initial Registration Process

To issue an initial registration for a pesticide, the EPA reviews the chemical, toxicological, and efficacy
data that FIFRA requires the applicant to submit with the application. The EPA uses these data to
conduct a risk assessment to evaluate the pesticide's potential to harm humans, wildlife, fish, and plants
and to contaminate surface water or groundwater through leaching, runoff, and spray drift. The EPA
also, as part of the initial registration process, evaluates and approves the pesticide's label to ensure
that appropriate directions for use and safety measures are listed. The pesticide label is meant to
provide clear directions for the effective use of the product while minimizing the risks to human health
and the environment. To use a pesticide in a manner inconsistent with its labeling is a violation of
federal law.

For any pesticide whose "use will result in exposure to domestic animals through, but not limited to,
direct application," which we subsequently refer to as a pet product in this report, the applicant must
develop and submit, as part of the toxicological data required pursuant to 40 C.F.R. part 158, a
companion animal safety study. The purpose of the companion animal safety study is to demonstrate an
adequate margin of safety if a pet product is misused. To guide the development of companion animal
safety studies, the EPA issued Guideline 870.7200, Companion Animal Safety, in August 1998. The data
from the companion animal safety study feed into the domestic animal risk assessments that the OPP
conducts to quantify any risks to pet health. Data from the companion animal safety study also inform
how the pet products should be labeled.

24-E-0023

3


-------
Reporting Requirements After the Initial Registration

After the EPA issues an initial registration for a pesticide, section 6(a)(2) of FIFRA requires the registrant
to continue to report to the EPA any information regarding unreasonable adverse effects on the
environment. Pesticide incident reports help provide the EPA with robust information on effects and
consequences, ensuring that the registered pesticide can continue to be used without posing
unreasonable adverse effects.

In 1996, pursuant to section 6(a)(2), the EPA established a rule for registrants to report information
regarding unreasonable adverse effects of pesticides after their initial registrations. Among other
reporting requirements, the rule mandates that registrants report aggregate data on a quarterly basis
for domestic animal pesticide incidents. To house the data submitted in response to this rule, the OPP
created an internal system called the Incident Data System, or IDS. The OPP includes information in the
IDS about each incident for which there is a claim of either an adverse effect involving humans, plants,
or wild and domestic animals or detection of pesticides in water. The IDS records the number of
incidents reported for the quarter and the severity of the incidents, such as minor symptoms (minimally
bothersome), moderate (more pronounced, more prolonged, or a more systemic nature than minor
symptoms), or major (life threatening or resulting in residual disability). While the registrants determine
and submit the classification of the incident to the EPA, the OPP manually inputs the incident data it
receives into the IDS, and there is no consistent method for the EPA's collection of the data.

The OPP reports that it takes a two-pronged approach to incident data:

•	Fully use all available incident information possible, recognizing the strengths, weaknesses, and
limitations associated with each data source.

•	Work to improve incident information used for decision-making.

Pesticide Registration Review Process

In addition to assessing reported incident data, the EPA is to review each registered pesticide no later
than 15 years after its initial registration, pursuant to section 3(g)(1)(A) of FIFRA. The purpose of this
review is to determine whether the pesticide continues to perform its intended functions without
unreasonable adverse effects on the environment. FIFRA provides the EPA with broad authority to
establish or modify data needs and timing for individual pesticide registration actions to achieve
statutory and program objectives.

When conducting the pesticide registration review, the EPA is to assess a wide variety of potential
human health and environmental effects associated with the use of the pesticide. The EPA may also
require additional data to conduct a new risk assessment.

The EPA is to initiate a registration review by establishing a public docket for a pesticide registration
review case and opening the docket for public comment. A docket is a collection of documents and other
materials that an agency makes available for public comment and that are used in a rulemaking or other

24-E-0023

4


-------
agency action. The docket for a pesticide registration review includes a preliminary work plan that
summarizes the information the EPA has on the pesticide and the anticipated path forward. The EPA
publishes a notice in the Federal Register announcing the availability of the docket and providing the
public with a comment period of at least 60 days. The EPA then considers the information received
during the comment period to develop a final work plan. If the EPA determines that it needs more
information from the registrant, it issues a data call in notice. Next, the EPA publishes another Federal
Register notice announcing its proposed decision or proposed interim decision, and it provides the public
with another comment period of at least 60 days. After considering any comments on its proposed
decision, the EPA issues an interim or final registration review decision, including an explanation of any
changes made since the proposed decision and a response to any significant comments received during
the public comment period. Figure 2 summarizes the registration review process.

Figure 2: Registration review process

A

Source: EPA information. (EPA image)

*After publication, the EPA generally holds a 60-day public comment period.

EPA Authority to Cancel Pesticide Registrations

The EPA is responsible for assessing any changes that have occurred since the last registration decision
to determine whether the pesticide still satisfies the statutory standard for registration, and the EPA
considers any new information on the pesticide to decide whether a new risk assessment is needed.
If, based on information provided by the registrant after an initial registration or obtained as part of the
EPA's pesticide registration review process, the EPA determines that the pesticide does pose
unreasonable adverse effects, the EPA can take action to protect human health and the environment,
including pets. Under section 6(b) of FIFRA, the EPA may cancel a pesticide registration when existing
risks related to its use are unacceptable and registrants have not made changes to the registration to
address the unacceptable risks.

Responsible Offices

The U.S. Food and Drug Administration, or FDA, regulates animal drugs, feeds and foods, and devices, as
well as most animal health products. The FDA regulates orally administered pet pesticide products as
drugs, while the EPA regulates products topically applied to the skin, such as flea and tick collars, as
pesticides.

The OPP regulates the sale, distribution, and use of all pesticides in the United States. The OPP's Health
Effects Division is responsible for assessing pesticide exposure and risks to humans. The EPA's annual
appropriated budget for fiscal year 2022 was $9.56 billion. The Office of Chemical Safety and Pollution
Prevention's fiscal year 2022 budget was $254.4 million, or roughly 2.7 percent of the EPA's total
budget. The fiscal year 2022 budget for the OPP was $83.1 million, or about 0.87 percent of the EPA's

24-E-0023

5


-------
total budget. According to the OPP, since fiscal year 2005 when the office had around 808 full-time
employees, it has declined in staff from year to year and had 575 full-time employees by the end of
fiscal year 2022.

Scope and Methodology

We conducted this evaluation from May 2022 to September 2023 in accordance with the Quality
Standards for Inspection and Evaluation published in December 2020 by the Council of the Inspectors
General on Integrity and Efficiency. Those standards require that we perform the evaluation to obtain
sufficient and appropriate evidence to support our findings.

We reviewed the EPA's pesticide registration process and data requirements; pesticide incident
reporting process; and relevant statutory and regulatory requirements. We also reviewed the June 2022
staff report findings of a 16-month investigation into the safety of the Seresto flea and tick collars by the
House of Representatives Committee on Oversight and Reform Subcommittee on Economic and
Consumer Policy.4 We interviewed OPP senior leadership to determine roles and responsibilities for pet
product regulation and to understand historical management decisions related to Seresto collars. We
reviewed OPP documents and information, including the EPA's website and relevant documents on the
additional mitigation measures it is requiring for Seresto pet collars published in July 2023, and the joint
FDA and EPA white paper titled A Modern Approach to EPA and FDA Product Oversight, published in
February 2023. Throughout this report we use the phrase "adverse effects" as it relates to FIFRA in a
variety of ways. This is consistent with the EPA's use in describing FIFRA's applicability in determining
whether a pesticide can cause unreasonable adverse effects on the environment. FIFRA defines the
phrase "unreasonable adverse effects on the environment" to mean, in part, "any unreasonable risk to
man or the environment."5 The phrase is used in a variety of ways throughout FIFRA and in EPA
materials discussing FIFRA. Examples of how the EPA and FIFRA use this phrase include:

•	"Will not generally cause unreasonable adverse effects on the environment."6

•	"Any unreasonable risk to man or the environment."7

•	"Unreasonable adverse effects on human health or the environment."8

•	"Unreasonable adverse effects to human health or the environment."9

4	House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy,
Seresto Flea and Tick Collars: Examining Why a Product Linked to More Than 2,500 Pet Deaths Remains on the
Market, June 2022.

5	7 U.S.C. § 136(bb).

6	7 U.S.C. § 136a(c)(5)(D). See also EPA website. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
Federal Facilities, Basics of FIFRA, last updated on March 7, 2023.

7	7 U.S.C. § 136(bb). See also EPA website. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal
Facilities, Basics of FIFRA, last updated on March 7, 2023.

8	EPA website. Pesticide Registration Manual: Introduction, last updated February 6, 2023.

9	EPA website. Pesticide Registration Manual: Introduction, last updated February 6, 2023.

24-E-0023

6


-------
•	"EPA is responsible for ensuring that all pesticides, including flea and tick products, sold in the
United States do not cause unreasonable adverse effects."10

•	"EPA must determine that the pesticide presents no unreasonable adverse effects to humans
and the environment."11

Prior Report

Although not specific to pet incidents, the OIG previously reported on deaths related to pesticide
exposure and the IDS in EPA OIG Report No. 17-P-0053. Additional Measures Can Be Taken to Prevent
Deaths and Serious Injuries From Residential Fumigations, issued December 12, 2016. This report found
that the "EPA lacks a consolidated incident database that allows the OPP to conduct oversight of
incidents, analyze incident trends, and make necessary recommendations to address identified issues."
Below we provide details on this continuing deficiency of pesticide incident reporting.

Results

The EPA's response to reported pesticide incidents involving Seresto pet collars has not provided
assurance that the collars can still be used without posing unreasonable adverse effects to the
environment, including to pets. The OPP adhered to the toxicological data requirements in 40 C.F.R.
§ 158 for the initial registration of the Seresto pet collar, including conducting the required human
health risk assessment. Also, pursuant to section 3(g)(1)(A) of FIFRA, the OPP initiated the pesticide
registration review process for flumethrin and imidacloprid.12 However, the OPP did not adhere to some
aspects of the pesticide registration review process. Specifically, the OPP did not conduct domestic
animal risk assessments for either flumethrin or imidacloprid as it had committed to do in initial and
final work plans for both pesticides. Furthermore, according to a long-tenured EPA scientist we
interviewed, the EPA's 1998 Guideline 870.7200 for companion animal safety studies is inadequate, and
the OPP lacks standard operating procedures and a methodology to help determine when pet products
may pose unreasonable adverse effects to the environment.

Pursuant to section 6(a)(2) of FIFRA, the EPA has collected and input incident data regarding the Seresto
pet collar into the IDS. However, the EPA's IDS does not capture all the data that the Agency needs to
assess unreasonable adverse effects of pet products. According to the EPA's website on pet collar
products, the EPA requested additional information from the current and former registrants of the
Seresto pet collar on unreasonable adverse effects. Also, the EPA's lack of action in response to reported
incident data does not provide assurance to the public that the Seresto pet collars do not pose
unreasonable adverse effects to the environment, including pets. The OPP needs to prioritize several
areas for improvement to ensure that pet products do not pose unreasonable adverse effects to pets.

10	EPA website, EPA's Regulation of Flea and Tick Products, last updated on July 13, 2023.

11	EPA website. Introduction to Pesticide Incidents, last updated on July 27, 2023.

12	According to 40 C.F.R. section 155.42(a), "A registration review case will be composed of one or more active
ingredients and all the products containing such ingredient(s)."

24-E-0023

7


-------
The OPP Did Not Conduct Domestic Animal Risk Assessments as Part of
Registration Review or Expressly Determine Whether the Seresto Pet Collar
Poses an Unreasonable Risk to Pet Health

The OPP adhered to the toxicological data requirements in 40 C.F.R. part 158 for the initial registration
of the Seresto pet collar. The OPP has not, however, adhered to the pesticide registration review
process for flumethrin and imidacloprid. Specifically, the OPP has not determined whether flumethrin
and imidacloprid pose an unreasonable risk to pet health and did not conduct the domestic animal risk
assessment that it had committed to do in initial and final work plans for both pesticides.

The EPA's pesticide registration review regulations at 40 C.F.R. § 155.58(b)(1) require the Agency in the
proposed registration review decision to state its proposed findings with respect to the FIFRA standard
and the basis for the findings. Further, when the OPP makes its registration review decision, the OPP is
obligated under 40 C.F.R. § 155.58(a) to provide the public with an explanation of how it came to its
decision through a notice in the Federal Register.

The preliminary work plan that the EPA included in the registration review dockets for both flumethrin
and imidacloprid specified that the Agency would conduct domestic animal risk assessments. The final
work plan for both pesticides also included language reiterating the need for or the Agency's
commitment to conducting domestic animal risk assessments.13 Pursuant to 40 C.F.R. § 155.53(b)(1), if,
as part of a pesticide's registration review, the Agency finds that a new assessment of a pesticide is
needed, it will conduct the new risk assessment, either based upon existing data or information or after
gathering additional data or information. Therefore, once the Agency concluded that a domestic animal
risk assessment was necessary for each pesticide, it was obligated to conduct those assessments.
Nevertheless, neither registration review docket included the risk assessments for public comment.
Similarly, neither pesticide's proposed interim decision included any domestic animal risk assessment
results for public comment. Instead, the OPP issued its:

• Flumethrin Proposed Interim Registration Review Decision Case Number 7456 in

September 2019 for public comment without determining whether pet products containing
flumethrin pose a risk to pet health. After it reviewed the public comments, the OPP issued its
Flumethrin Interim Registration Review Decision Case Number 7456 in March 2020 without
determining whether pet products containing flumethrin pose a risk to pet health.

13 In the flumethrin preliminary and final works plans, the Agency indicated that it planned to conduct a risk
assessment regarding "domestic animals" as part of the flumethrin registration review. In the imidacloprid
preliminary work plan, the Agency indicated that a "companion animal risk assessment, including an analysis of pet
incidents, will be part of the registration review of imidacloprid," whereas in the final work plan it indicated that
such a risk assessment "will be required to support registration review." For purposes of this report, we use the
phrase "domestic animal risk assessment" to refer to both "domestic animal" and "companion animal" risk
assessments.

24-E-0023

8


-------
•	Imidacloprid Proposed Interim Registration Review Decision Case Number 7605 in January 2020
for public comment without providing any domestic animals risk assessment results.14

The OPP's directors and scientists with whom we spoke stated that the OPP does not have the expertise
and resources to conduct domestic animal risk assessments to support the registration review process.
The OPP also does not have a standard operating procedure detailing how to conduct domestic animal
risk assessments, even though the U.S. Government Accountability Office's GAO-14-7Q4G, Standards for
Internal Control in the Federal Government, referred to as the Green Book and issued in
September 2014, instructs federal managers to design and implement appropriate procedures to fulfill
their program's responsibilities.

Moreover, the EPA has no measurable standards in place regarding domestic animal risk assessments.
This means that, even if the EPA had conducted the domestic animal risk assessments as part of the
flumethrin and imidacloprid registration review process, there is no standard, objective way for the
Agency to determine whether the pesticides pose an unreasonable risk to pet health. We identified
examples of measurable standards that other agencies use for their domestic animal risk assessments
and that the EPA uses for its human health risk assessments:

•	Disproportionality analysis: According to an FDA division director, the FDA uses a
disproportionality analysis to evaluate its adverse incident reporting on approved drugs. This
analysis uses a large database of products and incidents to identify when a product may have a
higher-than-expected frequency of incidents.

•	Establishment of an adverse incident rate: The Canada Pest Management Regulatory Agency
disapproved the registration of the Seresto pet collar because it has an adverse incident rate
greater than one in 10,000 collars sold.

•	Human health risk assessment approach: The OPP uses four steps to conduct human health risk
assessments: (1) hazard identification, (2) dose-response assessment, (3) exposure assessment,
and (4) risk characterization.

The OPP is not limited to the above examples and could develop any scientific technique that establishes
a measurable standard for when the risk to pet health is unreasonable. Such a standard would align with
the Government Accountability Office's instruction to federal managers to implement program
objectives designed to meet the requirements of applicable laws and regulations whose performance
can be measured and assessed.

14 We note that the OPP, in its response to the draft report in Appendix A, states, "On July 13, 2023, OPP released a
comprehensive scientific review of Seresto pet collars, 'Canine and Feline Adverse Event Review for the Seresto
Collar (EPA Reg No. 11556-155),' that is equivalent to the OIG-identified need for a 'domestic animal risk
assessment for Seresto products." (Footnote omitted.)

24-E-0023

9


-------
Data Used for Initial Pesticide Registration Are Not up to International Standards

The OPP Needs to Update Its Guideline for Companion Animal Safety Studies

The OPP evaluates pet products using data that are not up to international standards. In July 2008, the
Veterinary International Conference on Harmonization, or VICH, adopted updated guidelines for margin
of safety studies, which were captured in VICH GL43, Target Animal Safety for Veterinary
Pharmaceutical Products. The FDA implemented the updated margin of safety guidelines in April 2009.
The EPA has not done the same. Therefore, while the EPA's 1998 Guideline 870.7200 is the relevant
protocol for pesticide registrants to follow when conducting companion animal safety studies, as
specified in 40 C.F.R. part 158, that EPA guideline is outdated. For example, although Guideline 870.7200
states that the EPA's intent is to harmonize efforts between the EPA and the FDA, as of March 2023, the
OPP has not updated the 1998 guideline to align with the 2008 VICH GL43. Staff we interviewed
indicated that this was not a priority and noted that the EPA is not a member of VICH.

A long-tenured EPA scientist told us that the EPA's 1998 Guideline 870.7200 does not allow for accurate
measurements of a margin of safety for rates of release from pet collars. This EPA scientist also told us
that Guideline 870.7200 was based on FDA protocols from the late 1990s. The scientist described this as
a "glaring weakness" that has become publicly obvious with the Seresto pet collar incidents. More
efficient, advanced, and accurate methods for ensuring a margin of safety have been developed.

The EPA is aware of the need to incorporate the latest science into its domestic animal risk assessments.
On February 17, 2023, the EPA and the FDA jointly issued a white paper on how best to update their
respective oversight responsibilities in alignment with each agency's expertise. The white paper notes
that "[scientific advances in products administered topically to animals have highlighted the need for
robust animal safety evaluation and consistent regulatory standards for these products."

Section 3(c)(2)(A) of FIFRA directs the EPA to "publish guidelines specifying the kinds of information
which will be required to support the registration of a pesticide and shall revise such guidelines from
time to time." The purpose of a companion animal safety study is to demonstrate an adequate margin
of safety if the product is misused. The OPP conducted its companion animal safety study for the initial
registration of the Seresto pet collar based on data collected via an outdated protocol. Additionally, the
OPP's managers indicated that there were no plans as of March 2023 to update the EPA's 1998
Guideline 870.7200 or to revise the required data requirements for pet products.

The OPP Does Not Require the Premarket Clinical Testing of Pet Products

The OPP does not have a pet product data requirement compelling the registrant to conduct and submit
premarket clinical testing data. The FDA established this process in its May 2001 VICH-GL9 Good Clinical
Practice. Clinical testing, which provides data on health impacts, is an integral way to find out whether a
new pesticide is safe and effective. Clinical testing to assess hazards to humans and domestic animals
may be derived from a variety of tests. The FDA requires pet product manufacturers to conduct and
submit premarket clinical testing, including a premarket clinical trial of approximately 200 animals. The

24-E-0023

10


-------
OPP has not developed or issued a registration data requirement for any premarket clinical testing to
assess the risk to pets for a pet product's initial registration. The data that the OPP uses to evaluate the
risk to pet health posed by a pet product are therefore not as robust as those used by the FDA or as
required by international standards. As a result, the OPP's decision to issue an initial registration for a
new pet product may not be adequately informed, which puts the health and well-being of pets exposed
to the product at risk of unreasonable adverse effects.

IDS Data Are Inadequate to Determine Unreasonable Adverse Effects

The OPP does not capture adequate data to allow the EPA to determine when unreasonable adverse
effects are occurring or when further analysis of incidents associated with a domestic animal product is
needed. While the IDS captures data on pet incidents received pursuant to FIFRA section 6(a)(2), it does
not capture information about the species affected or any narrative information regarding exposure
scenarios or symptoms.

For Seresto pet collar incidents, the EPA directed registrants to provide more than the required
aggregate reporting of pet incident data maintained in the IDS. In April 2021, the EPA sent letters to the
current and former registrants of the Seresto pet collar because of concerns about the numerous
reports of adverse incidents that the Agency had received. The letters reiterated the registrants' legal
duty under FIFRA to provide information regarding unreasonable adverse effects, including adverse
reactions and deaths, for the registered pet products. In addition, the EPA required the registrants to
submit sales data. The EPA provided registrants with a detailed, categorized list of information to report.
In one category, the EPA specified that "[a]ll available sales data and detailed/enhanced incident data
for Seresto collars" should be reported. The EPA also requested that registrants provide the incident
information in electronic format using the EPA's reporting template.

EPA staff raised additional concerns to us about incident reporting and noted:

•	The IDS is unreliable. The regulations regarding IDS reporting do not adequately define data
needs. There is underreporting, and data quality is suspect.

•	A standard system and methodology for pet incident process evaluation do not exist, and the
Agency should have these to more efficiently review and analyze pet incidents.

•	The OPP does not have any guidance or standard operating procedures to evaluate and
interpret pet incident data to incorporate into risk assessments.

Pesticide incident reporting is a long-standing problem for the EPA. Table 1 notes deficiencies identified
in various sources over a period of 16 years.

24-E-0023

11


-------
Table 1: Examples of deficiencies in the pesticide incident reporting process

Year

Source

Noted deficiencies

2007

The EPA, OPP Report on Incident
Information: The Baseline, 2007

"While IDS reports are broad in scope, the system does
not consistently capture detailed information about
incident events, such as occupational exposure
circumstances or medical outcome."

"In most cases data going into IDS is not validated or
verified, though some reports are collected from calls to
contract poison control centers."

2016 EPA OIG ReDort 17-P-0053. Additional "The EPA lacks a consolidated incident database that

Measures Can Be Taken to Prevent Deaths allows the OPP to conduct oversight of incidents, analyze
and Serious Injuries From Residential incident trends, and make necessary recommendations to
Fumigations, December 12, 2016 address identified issues."

2018

EPA OIG Report 18-P-0080. EPA Needs to
Evaluate the Impact of the Revised
Agricultural Worker Protection Standard on
Pesticide Exposure Incidents, February 15,
2018

"[Incidents must be manually entered into the IDS, the
IDS maintains inconsistent information of different levels
of quality and verifiability, and incidents are submitted
from various sources. The IDS is also stand-alone and
unable to communicate with other databases."

2020 Internal EPA Briefing, Proposed Seresto - Submitted FIFRA section 6(a)(2), "Data Shortcoming":
Flumethrin + Imidacloprid Mitigation "Details of the incident are not provided, making

identifying any mitigation difficult."

2021

Internal EPA Briefing, Seresto and EPA's
Regulation of Pet Products

The OPP's IDS: Pet Incident Data Challenges/Limitations:

•	"Aggregate reporting of pet incidents lacks narrative
information on individual incidents

•	Pet information, including species, sex, health status

•	Nature of Exposure

•	Clinical Signs"

2022 Congressional subcommittee report, Seresto "EPA must improve its data collection to better understand
Flea and Tick Collars: Examining Why a the risks posed by the pet products it regulates."

Product Linked to More than 2,500 Pet
Deaths Remains on the Market, House
Committee on Oversight and Reform,

Subcommittee on Economic and Consumer
Policy, June 2022

Source: OIG review of relevant documents. (EPA OIG table)

The June 2022 congressional subcommittee staff report details a 16-month investigation into the safety
of Seresto pet collars, which found that the EPA knew the pesticide incident reporting process had
enduring deficiencies. The report also restated deficiencies from the EPA's own 2007 report, OPP Report
on Incident Information: The Baseline (2007). The subcommittee's staff report stated:

Despite acknowledging these key flaws over a decade ago, the agency's reporting
system has not been updated since 1997. The incident data that EPA received on
the Seresto collar exemplifies the structural shortcomings of the agency's
reporting system.

24-E-0023

12


-------
The EPA's continued lack of action to address long-standing deficiencies in incident reporting prevents
the Agency from effectively assessing whether pet products cause unreasonable adverse effects or
further incident analysis is needed to make a determination of unreasonable adverse effects.

Additional Concerns Raised over the EPA's Oversight of Pet Products

While the OPP has a clear organizational structure for reviewing human health and ecological data, it is
unclear where the responsibility for reviewing domestic animal health and safety data resides. The OPP
lacks accountability for conducting domestic animal risk assessments and analyzing incident data,
limiting the EPA's ability to ensure that pet products do not pose unreasonable adverse effects to pets.
Office of Management and Budget Circular No. A-123, Management's Responsibility for Enterprise Risk
Management and Internal Control, requires federal managers to implement the Government
Accountability Office's Green Book, including establishing an organizational structure, assigning
responsibility, and delegating authority to achieve the entity's objectives.

Interviews with Agency scientists identified a lack of oversight and undefined responsibilities for
evaluating domestic animal health and safety for pet products. Interviewees expressed the following
concerns:

•	There is no designated office for the oversight of pet safety and pet health. The

OPP's Registration Division has some responsibility when it comes to reviewing companion
animal safety studies. For a nonpet product pesticide, the OPP's Health Effects Division would
complete the risk assessment, but that risk assessment would focus on human health exposure,
not pet exposure.

•	The OPP has an Environmental Fate and Effects Division and a Health Effects Division but has no
division dedicated to pets. The Environmental Fate and Effects Division is responsible for
ecological risk assessments, not domestic animal risk assessments.

•	The OPP does not have any guidance or standard operating procedures to evaluate and
interpret pet incident data to incorporate into risk assessments.

•	According to an OPP senior manager, within the OPP, there is a lack of veterinary expertise and
ability to evaluate and interpret the data requirements for pet safety.

•	An OPP senior staff member observed that the EPA does not have an advocate for pet health.

One director described to us the need for more program resources and said, "[T]hey lost 30 [full-time
equivalent staff] and without additional funding, are projected to lose an additional 30." Another
director echoed these concerns about declining resources and said that attrition has outpaced the
OPP's ability to hire.

24-E-0023

13


-------
Recommendations

We recommend that the assistant administrator for Chemical Safety and Pollution Prevention:

1.	Issue amended proposed interim registration review decisions for both flumethrin and
imidacloprid that include domestic animal risk assessments for the two pesticides, written
determinations on whether the Seresto pet collar poses unreasonable adverse effects in pets,
and an explanation of how the Office of Pesticide Programs came to its determinations. Allow
for public comment by placing these documents in the applicable registration review dockets.

2.	Implement standard operating procedures on how to conduct domestic animal risk assessments
for the active ingredients in pet products to support pesticide registration review decisions.

3.	Implement a measurable standard to determine when a pet product poses unreasonable
adverse effects in pets to support the pesticide registration review decision.

4.	Update the EPA's Guideline 870.7200, Companion Animal Safety, as necessary, to be consistent
with the Veterinary International Conference on Harmonization Guideline GL43, Target Animal
Safety for Veterinary Pharmaceutical Products.

5.	Establish and implement an additional data requirement for the premarket clinical testing of pet
products that is consistent with the Veterinary International Conference on Harmonization
Guideline GL9, Good Clinical Practice.

6.	Assess what incident information is needed from registrants of pet products to determine when
the EPA should take mitigation measures or other actions. Require pet product registrants to
report that information to the EPA.

7.	Establish policies and procedures that result in consistent implementation of mitigation
measures to address unreasonable adverse effects or conduct additional analysis to determine
whether a pet product is causing unreasonable adverse effects.

8.	Update the EPA's Incident Data System to capture the additional data that the EPA identifies
from the recommendations above to allow the EPA to adequately assess incident reports and
make timely decisions on when to take action.

Agency Response and OIG Assessment

Appendix A includes the Office of Chemical Safety and Pollution Prevention's response to our draft
report. The office also provided technical comments, which we reviewed and used to make appropriate
changes for the final report. The Office of Chemical Safety and Pollution Prevention generally agreed
with Recommendations 2, 3, 5, 6, 7, and 8 and provided corrective actions with estimated completion
dates. We consider these recommendations resolved with corrective actions pending.

24-E-0023

14


-------
We note that, with respect to Recommendation 5 the EPA, in its response to our draft report, discussed
its view that regulatory jurisdiction over pet collars and other topical pet products should be transferred
from the EPA to the FDA and detailed steps it has taken to effect such a transfer. The EPA notes that it
agrees that premarket testing could be useful, and that the FDA considers the premarket clinical testing
in their guidance for new animal drugs. Given the EPA's agreement with the need for premarket testing
and the potential transfer of some responsibilities to the FDA, we consider the Agency's proposal to
include steps in the Standard Operating Procedure mentioned in Recommendation 2 to perform
literature searches for pre-market clinical trials to meet the intent of Recommendation 5

Recommendation 4, regarding the need to update the EPA's companion animal safety guidelines, as
necessary, to be consistent with international standards, was an issue identified in our interviews with
staff of the Office of Chemical Safety and Pollution Prevention. In its response, the Office of Chemical
Safety and Pollution Prevention stated that it reviewed both the VICH's and the EPA's guidelines after
receiving our draft report. It concluded that it would not be appropriate to update the EPA's guidelines
because "the scope of GL43 applies to all veterinary drugs administered by all routes, not just the topical
or dermal routes as is the case with the companion animal products that EPA registers." It considered
the recommendation to be "sufficiently addressed" without further corrective actions. Since the EPA
conducted the additional review and determined that a change was not needed, we consider
Recommendation 4 completed as of the date of the Office of Chemical Safety and Pollution Prevention's
response to the draft report.

The Office of Chemical Safety and Pollution Prevention did not agree with Recommendation 1, which
advised issuing amended proposed interim registration review decisions. It instead described alternative
actions, which the Agency previously outlined in its July 13, 2023 memorandum determining that
Seresto pet collars continue to meet the EPA's standards under FIFRA. However, these alternative
actions do not meet the intent of Recommendation 1. The Agency's response to the draft report states,
"As this was not a registration review action, OPP did not follow the procedural steps of the registration
review process nor did it place the documents in the registration review docket or make them available
for public comment." The Agency further stated, "Overall, OPP determined that, with the mitigation
measures, the use of these collars would meet EPA's standards of no unreasonable adverse effects
under FIFRA." However, the Agency did not provide a detailed rationale for this statement, nor did it
provide any support for the allowance of an equivalent alternative to a registration review under FIFRA.
In the July 2023 memorandum, the Office of Chemical Safety and Pollution Prevention made no express
conclusions as to whether Seresto pet collars posed unreasonable adverse effects, and the office did not
include opportunities for public comment, which is inconsistent with the Agency's and the OPP's public
involvement practices. The importance of public involvement and the EPA's commitment to
transparency in its interactions with the public were recently highlighted by the EPA in the October 2023
Meaningful Involvement Policy, the EPA Scientific Integrity Policy, the OPP's "Pesticide Program Public
Involvement Opportunities" webpage. and the "Opportunities to Participate in Pesticide Reevaluation"
webpage. Recommendation 1 remains unresolved.

24-E-0023

15


-------
Status of Recommendations

Rec. No.

Page No.

Recommendation

Status*

Action Official

Planned
Completion
Date

1

14

Issue amended proposed interim registration review decisions for both
flumethrin and imidacloprid that include domestic animal risk
assessments for the two pesticides, written determinations on whether
the Seresto pet collar poses unreasonable adverse effects in pets, and
an explanation of how the Office of Pesticide Programs came to its
determinations. Allow for public comment by placing these documents in
the applicable registration review dockets.

U

Assistant Administrator
for Chemical Safety and
Pollution Prevention



2

14

Implement standard operating procedures on how to conduct domestic
animal risk assessments for the active ingredients in pet products to
support pesticide registration review decisions.

R

Assistant Administrator
for Chemical Safety and
Pollution Prevention

12/12/25

3

14

Implement a measurable standard to determine when a pet product
poses unreasonable adverse effects in pets to support the pesticide
registration review decision.

R

Assistant Administrator
for Chemical Safety and
Pollution Prevention

12/12/25

4

14

Update the EPA's Guideline 870.7200, Companion Animal Safety, as
necessary, to be consistent with the Veterinary International Conference
on Harmonization Guideline GL43, Target Animal Safety for Veterinary
Pharmaceutical Products.

C

Assistant Administrator
for Chemical Safety and
Pollution Prevention

11/27/23

5

14

Establish and implement an additional data requirement for the
premarket clinical testing of pet products that is consistent with the
Veterinary International Conference on Harmonization Guideline GL9,
Good Clinical Practice.

R

Assistant Administrator
for Chemical Safety and
Pollution Prevention

12/12/25

6

14

Assess what incident information is needed from registrants of pet
products to determine when the EPA should take mitigation measures or
other actions. Require pet product registrants to report that information to
the EPA.

R

Assistant Administrator
for Chemical Safety and
Pollution Prevention

12/12/25

7

14

Establish policies and procedures that result in consistent
implementation of mitigation measures to address unreasonable adverse
effects or conduct additional analysis to determine whether a pet product
is causing unreasonable adverse effects.

R

Assistant Administrator
for Chemical Safety and
Pollution Prevention

12/12/25

8

14

Update the EPA's Incident Data System to capture the additional data
that the EPA identifies from the recommendations above to allow the
EPA to adequately assess incident reports and make timely decisions on
when to take action.

R

Assistant Administrator
for Chemical Safety and
Pollution Prevention

6/28/24

* C = Corrective action completed.

R = Recommendation resolved with corrective action pending.
U = Recommendation unresolved with resolution efforts in progress.

24-E-0023

16


-------
Agency Response

Appendix A



iSB/

%

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

WASHINGTON, D.C. 204G0

MEMORANDUM

SUBJECT:

FROM:

TO:

Response to Draft Report entitled "The EPA Meeds to Determine Whether
Seresto Pet Collars Pose a Risk to Pet Health/ Project No. OSRE-FY22-0120.

Michal Freedhoff, Ph.D.
Assistant Administrator

Sean W. O'Donnell
Inspector General

MICHAL
FREEDHOFF

Digitally signed by MtCHAL
FREEDHOFF

Date 2023.1127 17:20:45
-05'00'

This memorandum responds to the U.S. Environmental Protection Agency (EPA) Office of Inspector
General's (OIG) September 27, 2023, Draft Report entitled "The EPA Needs to Determine Whether
Seresto Pet Collars Pose a Risk to Pet Health."

I. General Comments:

The Office of Chemical Safety and Pollution Prevention (OCSPP) appreciates the OIG's effort in
evaluating whether:

•	EPA's response to reported pesticide incidents involving Seresto pet collars provides assurance
that the collars can still be used without posing unreasonable adverse effects to human health
and the environment, and

•	EPA adhered to pesticide registration requirements in its approval of Seresto pet collars,
specifically toxicologicai data requirements in 40 C.F.R. part 158.

OCSPP partially agrees with OIG's conclusions and recommendations. However, the Draft Report
identifies several recommendations that the OCSPP is unable to implement without significant changes
in expertise, resources, time, funding, and regulations. In addition, the Draft Report did not appear to
consider the results of the extensive multi-year re-evaluation of Seresto products that EPA released in
July 2023 nor the Food and Drug Administration (FDA)-EPA jurisdictional whitepaper released in

24-E-0023

17


-------
February 2023, as these documents were not included in the Scope and Methodology section of the
report, which lists the materials the OIG evaluated.

OCSPP remains committed to improving protections for pet health and is already implementing changes
to its regulatory processes based on the robust review of Seresto. OCSPP agrees with the OIG that the
Office of Pesticide Programs (OPP) adhered to the toxicological data requirements in its initial approval
of Seresto, that a Standard Operating Procedure (SOP) can be developed to better assess pet health
risks going forward, and that the Incident Data System (IDS) currently lacks detailed information on pet
incidents. OCSPP does not agree with the Draft Report's conclusions that OPP did not determine
whether Seresto pet collars can be used without posing unreasonable adverse effects to pets and did
not do a domestic animal risk assessment for Seresto.

Over the past several years, OPP 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. Due to
the number of Seresto-related incidents reported to OPP, in April 2021 EPA sent a letter1 pursuant to
section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and 40 CFR Part 159 to
the registrant of Seresto pet collars, reiterating its statutory requirement to report incidents associated
with the products and to provide additional data on reported adverse effects of Seresto pet collars. This
additional information was more extensive than what is routinely reported by pesticide product
registrants to EPA's Incident Data System (IDS). OPP completed its extensive review of over 120
documents in July 2023, which included adverse event reports from 2016-2020, toxicology and
pharmacokinetic studies, and assessments conducted by the registrant. OCSPP has also been engaged in
a multi-year collaboration between EPA and FDA which resulted in the creation of the February 2023
whitepaper titled "A Modern Approach to EPA and FDA Product Oversight." The whitepaper outlines
challenges with OPP's current approach to pet product regulation and recommends improvements to
the process, which include a transfer of jurisdiction for some pet products to FDA.

OCSPP's Technical Comments, which we respectfully request remain internal to EPA, were provided to
the OIG on 10/27/23. OCSPP appreciates the OIG staffs willingness to meet with OCSPP staff to discuss
this Draft Report in multiple meetings. OCSPP continues its commitment to work to improve its process
for evaluating pet health. What follows are discussions of OPP's Seresto scientific review, regulatory
actions, long-term pet product oversight plans, and specific responses to the OIG's recommendations in
the Draft Report.

OPP's Scientific Review of Seresto

On July 13, 2023, OPP released a comprehensive scientific review of Seresto pet collars, "Canine and
Feline Adverse Event Review for the Seresto Collar (EPA Reg No. 11556-155),"2 that is equivalent to the
OIG-identified need for a "domestic animal risk assessment" for Seresto products. In this report, and
with the help of FDA scientists, OPP reviewed the companion animal studies submitted in support of the
collar registration, the toxicological data set on the two active ingredients (imidacloprid and flumethrin),
available data on the rate that the active ingredients are released from the collar, and the reported
adverse event data. During this extensive 2-year effort, EPA consulted with FDA's Center for Veterinary

1	Information Concerning Seresto Collars That Must Be Reported Pursuant to FIFRA Section 6(a)(2);
https://www.regulations.gov/document/EPA-HQ-OPP-2021-0625-00Q2

2	Canine and Feline Adverse Event Review for the Seresto Collar (EPA Reg No. 11556-155);
https://www.regulations.gov/document/EPA-HQ-OPP-2021-0625-0Q15

24-E-0023

18


-------
Medicine (FDA CVM, hereafter referred to as FDA) on this review and incorporated methodologies often
utilized in FDA's adverse event reviews.

OPP's scientific review of Seresto-related incident reports identified the need for more detailed incident
reporting in order to inform future regulatory efforts and public outreach. EPA analyzed all incidents
that reported deaths related to the use of Seresto. This included 1,400 deaths reported to EPA from
2016-2020, which represent 2% 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 pet, 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
significant non-lethal incidents, such as neurological symptoms. In some incidents with moderate or
severe clinical signs, removal of the collar seemed to alleviate symptoms and/or reapplication of the
collar coincided with a reoccurrence of symptoms. Additional details can be found in OPP's scientific
review.3

OPP's Seresto Regulatory Actions

On July 13, 2023, OPP also released "EPA's Memorandum in Support of the Regulatory Decision for PNR
1427 (Seresto Pet Collar, EPA Reg. No. 11556-155)"4, which includes a summary of OPP's scientific
review5 and the benefits of Seresto compared to similar alternative products to control fleas and ticks.6
The regulatory rationale also includes a section titled "Rationale for Final Regulatory Decision and Risk
Mitigation," describing how OPP determined that the Seresto collars meet the FIFRA approval standard
based on additional mitigation the registrant has agreed to implement.

Based on the considerations in the documents listed above, the Agency adjusted the regulatory
requirements for Seresto pet collars and incorporated additional risk mitigation measures on the
product label in July 2023. The registrant is now required to submit enhanced data for all incidents going
forward, including specific reported clinical signs, detailed pet information (e.g., species, age, breed,
medical conditions, etc.), and detailed case narratives. Additionally, material that was considered
deficient in the science review—including critical details on death incidents, adequate case follow up on
any reported deaths, and information on a pet's health status prior to collar application—is now also
required in the incident reporting to improve OPP's incident evaluations. The Seresto registrant is also
required to provide detailed sales data, data on annual incident rates and severity, and any incidents in
other countries where the collars are sold. To alert veterinarians and consumers of potential risks, the
terms of continued registration require the registrant to include label warnings on Seresto products that
describe common adverse effects that have been reported, along with instructions to remove the collar

3	Canine and Feline Adverse Event Review for the Seresto Collar (EPA Reg No. 11556-155);
https://www.regulations.gov/document/EPA-HQ-OPP-2021-0625-0Q15

4	EPA's Memorandum in Support of the Regulatory Decision for PNR 1427 (Seresto Pet Collar, EPA Reg. No. 11556-
155); https://www.regulations.gov/document/EPA-HQ-OPP-2021-0625-0Q13

5	Canine and Feline Adverse Event Review for the Seresto Collar (EPA Reg No. 11556-155);
https://www.regulations.gov/document/EPA-HQ-OPP-2021-0625-0Q15

6	Usage, Benefits, and Impacts of Potential Mitigation for Seresto Pet Protection Collars Containing Imidacloprid
(PC Code 129909) and Flumethrin (PC Code 036007); https://www.regulations.gov/document/EPA-HQ-OPP-2Q21-
0625-0004

24-E-0023

19


-------
if those effects occur and instructions on how to report the incident. The registrant also must develop an
outreach program to communicate more effectively with veterinarians and the public on the risks of
using the product and other similar pesticides on pets. To reduce the risk of strangulation, the registrant
must evaluate potential changes to the emergency release mechanism of Seresto collars to prevent
death by strangulation or choking. The Seresto registration was split into two registrations, one for cats
and one for dogs, to help with future incident comparisons across products. The Seresto registration was
also time-limited to 5 years so the newly enhanced incident data can be monitored during this period
and so EPA can decide whether to continue the registration or to modify/cancel it after 5 years.

Overall, OPP determined that, with the mitigation measures, the use of these collars would meet EPA's
standards of no unreasonable adverse effects under FIFRA. Specifically, the Seresto Cat registration
notice (EPA Registration # 11556-191) states, "This product is unconditionally registered in accordance
with FIFRA section 3(c)(5)" and the Seresto Dog label amendment letter (EPA Registration # 11556-155)
states, "The application referred to above, submitted in connection with registration under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable under FIFRA Section
3(c)(5) subject to the following conditions...," both dated July 13, 2023.7,8

Long Term Solutions to Pet Product Oversight

In addition, OPP would like to acknowledge the multi-year collaboration between EPA and FDA to create
the February 2023 whitepaper titled "A Modern Approach to EPA and FDA Product Oversight."9 While
the Draft Report includes one quote from this document, indicating that scientific advances have
highlighted the need for more robust animal safety evaluation and consistent regulatory standards for
topical pet products, the Draft Report does not discuss one of the main points of the whitepaper
concerning challenges with EPA's current approach to pet product regulation. These challenges include:
misalignment of each agency's expertise with the products it regulates, differences in the agencies'
resources and infrastructure to assess animal safety and product incidents, advancement in scientific
understanding on how products work, and a lack of clarity among the public about which agency has
jurisdiction over which products.

Additionally, the February 2023 whitepaper discusses a modernized approach for better regulation of
these products, specifically the transfer from EPA to FDA of approximately 600 topically administered
products for external parasites on animals, including pet collars. This transfer would better align
regulation of these products with FDA's expertise and resources on animal products, which far exceed
EPA's. OPP manages approximately 18,000 active pesticide registrations, of which only several hundred
control external parasites on pets and other animals. OPP only has two veterinarians—neither of whom
were hired to work on these types of products full time and have been pulled away from their other
duties to help evaluate pet products. By contrast, FDA's CVM has many veterinary medical officers and
other staff with expertise to assess these products more comprehensively.

One way to accomplish this transfer could be through legislative changes. This past year, EPA and FDA
have jointly met several times with Congressional staff on the House Energy and Commerce, House
Agriculture, Senate Health, Education, Labor, and Pensions, Senate Environment and Public Works, and

7	Label for Seresto Cat (11556-191); https://www3.epa.gov/pesticides/chem search/ppls/011556-00191-
20230713.pdf

8	Label for PNR1427 INSECTICIDE/Seresto Dog (11556-155);

https://www3.epa.gov/pesticides/chem search/ppls/011556-00155-20230713.pdf

9	EPA and FDA Modernized Approach to Oversight of Certain Products; https://www.regulations.gov/docket/EPA-
HQ-QPP-2023-0103

24-E-0023

20


-------
Senate Agriculture Committees. The agencies also provided technical assistance to these Congressional
committees at their request. Additionally, the agencies briefed the White House's Council on
Environmental Quality on the proposed transfer. These efforts further highlight EPA and FDA's approach
to finding long-term solutions to regulating pet products.

II. OCSPP's Response to the Recommendations:

Recommendation 1: Issue amended proposed interim registration review decisions for both flumethrin
and imidacloprid that include domestic animal risk assessments for flumethrin and imidacloprid; written
determinations on whether the Seresto pet collar poses unreasonable adverse effects in pets; and an
explanation of how the Office of Pesticide Programs came to its determinations. Allow for public
comment by placing these documents in the applicable registration review dockets.

• OCSPP Response 1: OPP's July 13, 2023 actions satisfy this recommendation.

On July 13, 2023, OPP released a comprehensive scientific review10 of Seresto pet collars (the
only pet product with both imidacloprid and flumethrin), which is equivalent to a "domestic
animal risk assessment." OPP also released "EPA's Memorandum in Support of the Regulatory
Decision for PNR 1427 (Seresto Pet Collar, EPA Reg. No. 11556-155)"11 that includes a section
titled "Rationale for Final Regulatory Decision and Risk Mitigation," which describes how OPP
came to its determinations. OPP's written determination that, with additional risk mitigation
measures incorporated, the use of these collars continued to meet EPA's standards of no
unreasonable adverse effects under FIFRA was also publicized on July 13, 2023.12

OPP used the registration review process to address risks to pets in the March 2020 Flumethrin
Interim Registration Review Decision13, but OPP also worked outside of registration review to
more quickly obtain from the registrant the additional Seresto product and incident information
evaluated in OPP's scientific review.14 As this was not a registration review action, OPP did not
follow the procedural steps of the registration review process nor did it place the documents in
the registration review docket or make them available for public comment. However, OCSPP
placed documents supporting the July 2023 regulatory decision in a separate public docket.15 In
addition, in July 2021, OPP requested public comment on a petition from the Center for

10	Canine and Feline Adverse Event Review for the Seresto Collar (EPA Reg No. 11556-155);
https://www.regulations.gov/document/EPA-HQ-OPP-2021-0625-0Q15

11	EPA's Memorandum in Support of the Regulatory Decision for PNR 1427 (Seresto Pet Collar, EPA Reg. No. 11556-
155); https://www.regulations.gov/document/EPA-HQ-OPP-2021-0625-0Q13

12	See the Seresto Cat registration notice (EPA Registration # 11556-191) stating, 'This product is unconditionally
registered in accordance with FIFRA section 3(c)(5)" and the Seresto Dog label amendment letter (EPA Registration
# 11556-155) stating, "The application referred to above, submitted in connection with registration under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable under FIFRA Section 3(c)(5)
subject to the following conditions...", both dated July 13, 2023.

13	Flumethrin Interim Registration Review Decision;
https://www.regulations.gov/document/EPA-HQ-OPP-2016-0031-0Q36

14	Information Concerning Seresto Collars That Must Be Reported Pursuant to FIFRA
section 6(a)(2); https://www.regulations.gov/document/EPA-HQ-OPP-2021-0625-00Q2

15	Docket EPA-HQ-OPP-2021-0625 at regulations.gov

24-E-0023

21


-------
Biological Diversity16 to cancel Seresto collars and suspend the collars pending cancellation. OPP
received and reviewed more than 5,400 public comments and, in July 2023, responded by
denying the Petitioner's request to cancel and suspend the Seresto registration based on OPP's
July 2023 regulatory decision.17 Finally, EPA contacted our stakeholders, posted updates on
EPA's website, and addressed questions from the public after issuing its findings on Seresto on
July 13, 2023.

Recommendation 2: Implement standard operating procedures on how to conduct domestic animal risk
assessments for the active ingredients in pet products to support pesticide registration review decisions.

•	Proposed Corrective Action 2: OCSPP agrees to develop standard operating procedures to
evaluate risk to pets from the active ingredients in pet products.

•	Target Completion Date: December 12, 2025.

Recommendation 3: Implement a measurable standard to determine when a pet product poses
unreasonable adverse effects in pets to support the pesticide registration review decision.

•	Proposed Corrective Action 3: OCSPP agrees to establish a methodology to determine when a
pet product needs further investigation to ensure the product does not pose unreasonable
adverse effects to pets and to include it in the SOP mentioned under Recommendation 2.

•	Target Completion Date: December 12, 2025.

Recommendation 4: Update the EPA's Guideline 870.7200, Companion Animal Safety, to be consistent
with the Veterinary International Conference on Harmonization Guideline GL43, Target Animal Safety
for Veterinary Pharmaceutical Products.

•	OCSPP Response 4: Since receiving the Draft Report, OPP compared EPA's Guideline 870.7200
with the Veterinary International Conference on Harmonization Guideline GL43. EPA's 870.7200
requires more animals (n=6) compared to GL43 (n=4) per group. While GL43 does describe
additional laboratory safety study designs, they are not relevant to companion animals. The
scope of GL43 applies to all veterinary drugs administered by all routes, not just the topical or
dermal routes as is the case with the companion animal products that EPA registers, and GL43
includes not just companion animals but also food-producing animals. OCSPP has determined
that it would not be appropriate to update EPA's Guideline 870.7200 to be consistent with GL43.
Therefore, OCSPP considers this recommendation to be sufficiently addressed and is accordingly
not providing additional corrective actions.

Recommendation 5: Establish and implement an additional data requirement for the premarket clinical
testing of pet products that is consistent with the Veterinary International Conference on Harmonization
Guideline GL9, Good Clinical Practice.

•	Proposed Corrective Action 5: OCSPP agrees premarket clinical testing could be useful in
evaluating potential risks to pets. FDA considers premarket clinical testing as part of their

16	Center for Biological Diversity April 2021 Petition to Cancel Seresto Collar;
https://www.regulations.gov/document/EPA-HQ-OPP-2021-0409-00Q2

17	Petition to Cancel Registration of PNR1427 (Brand Name Seresto) under the Federal Insecticide, Fungicide, and
Rodenticide Act; Reg. No. 11556-155; https://www.regulations.gov/document/EPA-HQ-QPP-2021-0409-0287

24-E-0023

22


-------
substantial evidence of effectiveness guidance for new animal drugs in their Guidance for
Industry #85 (VICH GL9). However, as this is not required for any other EPA products,
establishing and implementing a new data requirement would require substantial resources,
additional expertise, and increased funding. These challenges further support the transfer of
veterinary products from EPA to FDA. For example, a resource-intensive rulemaking would be
needed to establish a new data requirement, and guideline writing and a Scientific Advisory
Panel (SAP) are needed to establish the methods by which to conduct the testing, all of which
would likely take more than 5 years. Additionally, as FDA has GL9 in place to evaluate premarket
clinical testing, it would be inefficient for EPA to replicate a similar data requirement while EPA
and FDA continue to find a long-term solution, as described in their whitepaper, to regulating
these products.

Therefore, as a corrective action that can be implemented in a timelier fashion with our current
resources, OCSPP will include steps in the SOP mentioned in Recommendation 2 to perform
literature searches for pre-market clinical trials, which could include data generated for product
registration in other countries.

• Target Completion Date: December 12, 2025

Recommendation 6: Assess what incident information is needed from registrants of pet products to
determine when the EPA should take mitigation measures or other actions. Require pet product
registrants to report that information to the EPA.

•	Proposed Corrective Actions 6a and 6b: OCSPP agrees with this recommendation. OPP has
previously evaluated what additional incident information would be useful to improve OPP's
ability to identify and mitigate potential risk concerns to pets. Templates are available for pet
product companies to use in reporting the sales and incident data to supplement data collected
in IDS.18 Further, during the extensive review of the Seresto incidents, OPP identified additional
incident reporting information that could enhance future incident evaluations. As part of the
Seresto 5-year time limited registration established in July 2023, the Seresto registrant must
report this enhanced incident information annually. To address other pet products, as Corrective
Action 6a, OCSPP will update the website to include additional guidance on collecting incident
data that was identified during the Agency's extensive review of the Seresto incidents and is
described in the registration conditions for the Seresto collars.19,20 As Corrective Action 6b,
OCSPP will develop a plan to require pet product registrants to report this incident information
to the EPA.

•	Target Completion Date: For Corrective Action 6a, June 28, 2024. For Corrective Action 6b,
December 12, 2025.

18	Incident and sales data templates; https://www.epa.gov/pesticides/use-standardized-templates-report-pet-
spot-incidents-conclusion-pilot-and-implementation

19	Registration condition #5: Label for Seresto Cat (11556-191);
https://www3.epa.gov/pesticides/chem search/ppls/011556-00191-20230713.pdf

20	Registration condition #6: Label for PNR1427 INSECTICIDE/Seresto Dog (11556-155);
https://www3.epa.gov/pesticides/chem search/ppls/011556-00155-20230713.pdf

24-E-0023

23


-------
Recommendation 7: Establish policies and procedures that result in consistent implementation of
mitigation measures to address unreasonable adverse effects or conduct additional analysis to
determine whether a pet product is causing unreasonable adverse effects.

•	Proposed Corrective Action 7: OCSPP agrees to establish policies and procedures that result in
consistent implementation of mitigation measures, as appropriate, to address unreasonable
adverse effects or conduct additional analysis to determine whether a pet product is causing
unreasonable adverse effects, and to include this in the SOP mentioned under Recommendation
2.

•	Target Completion Date: December 12, 2025.

Recommendation 8: Update the EPA's Incident Data System to capture the additional data that the EPA
identifies from the recommendations above to allow the EPA to adequately assess incident reports and
make timely decisions on when to take action.

•	Proposed Corrective Action 8: In July 2023, OCSPP took a major step to increase the
transparency of IDS by releasing 10 years of pesticide incident data on its website and to
continue to make this data available going forward.21 The numerous incidents related to
Seresto contributed to OCSPP's decision to share these data sets. Sharing this information also
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 overburdened
populations. These data sets 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. Most reports also provide information on the location of the incident,
the pesticide product, and a brief description of the incident(s). While EPA's IDS is the main
repository of incident reports for pesticide products, OPP has developed other methods of
obtaining additional information for pets to improve OPP's ability to make timely decisions.
These additional data, including incident information and sales data, are captured in OPP's
official document repository system, Documentum. As discussed under Proposed Corrective
Action 6, OCSPP already has templates for registrants to report any additional information
missing from data collected through IDS.22 OCSPP will update the website to include additional
guidance on collecting incident data that was identified during the Agency's extensive review of
the Seresto incidents, as described above in Proposed Corrective Action 6.

•	Target Completion Date: June 28, 2024.

cc: All OCSPP DAAs

Edward Messina, Director, OPP

Michael Goodis, Deputy Director of Programs, OPP

Leo Gueriguian, Acting Deputy Director for Management, OPP

Charles Smith, Division Director, OPP/RD

Elissa Reaves, Division Director, OPP/PRD

Timothy Kiely, Deputy Director, OPP/PRD

Daniel Rosenblatt, Deputy Director, OPP/RD

21	https://www.epa.gov/pesticides/epa-posts-pesticide-incident-data-publiclv

22	Incident and sales data templates; https://www.epa.gov/pesticides/use-standardized-templates-report-pet-
spot-incidents-conclusion-pilot-and-implementation

24-E-0023

24


-------
Jennifer Saunders, Acting Associate Director, OPP/RD

Cathryn Britton, Chief, OPP/PRD/RMIBV

Paul Di Salvo, Acting Chief, OPP/RD/IVB1

Kerry Leifer, Chief, OPP/RD/CITAB

Lauretta Joseph, OIG

Steve Hanna, OIG

Gila Goldstein, OIG

Jim Kohler, OIG

Gaida Mahboub, OIG

Barry Parker, OIG

Alii Phillips, OIG

Michael Wilson, OIG

Janet L. Weiner, OCSPP Senior Audit Liaison
Susan Perkins, OCFO

24-E-0023

25


-------
Appendix B

Distribution

The Administrator

Deputy Administrator

Chief of Staff, Office of the Administrator

Deputy Chief of Staff for Management, Office of the Administrator
Agency Follow-Up Official (the CFO)

Assistant Administrator for Chemical Safety and Pollution Prevention
Agency Follow-Up Coordinator
General Counsel

Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs

Director, Office of Continuous Improvement, Office of the Chief Financial Officer
Director, Office of Pesticide Programs, Office of Chemical Safety and Pollution Prevention
Deputy Director for Programs, Office of Pesticide Programs, Office of Chemical Safety and
Pollution Prevention

Deputy Director for Management, Office of Pesticide Programs, Office of Chemical Safety and

Pollution Prevention
Deputy Assistant Administrator for Chemical Safety and Pollution Prevention
Deputy Assistant Administrator for Pesticide Programs, Office of Chemical Safety and
Pollution Prevention

Deputy Assistant Administrator for Management, Office of Chemical Safety and Pollution Prevention
Director, Office of Pollution Prevention and Toxics, Office of Chemical Safety and Pollution Prevention
Deputy Director, Office of Pollution Prevention and Toxics, Office of Chemical Safety and

Pollution Prevention
Office of Policy OIG Liaison
Office of Policy GAO Liaison

Audit Follow-Up Coordinator, Office of the Administrator

Senior Audit Advisor, Office of Chemical Safety and Pollution Prevention

Audit Liaison, Office of Pollution Prevention and Toxics

24-E-0023

26


-------
Whistleblower Protection

U.S. Environmental Protection Agency

The whistleblower protection coordinator's role
is to educate Agency employees about
prohibitions against retaliation for protected
disclosures and the rights and remedies against
retaliation. For more information, please visit
the OIG's whistleblower protection webpaae.

Contact us:

Congressional Inquiries: OIG,CongressionalAffairs(5)epa.gov

Media Inquiries: OIG.PublicAffairs@epa.gov

'line EPA OIG Hotline: OIG.Hotline@epa.gov

Web: epaoig.gov

Follow us:

X (formerly Twitter): (5>epaoig

Linkedln: linkedin.com/company/epa-oig
YouTube: /outube.corn/epaoig


-------