[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]




 
                     SERESTO FLEA AND TICK COLLARS:

                   EXAMINING WHY A PRODUCT LINKED TO

                      MORE THAN 2,500 PET DEATHS

                         REMAINS ON THE MARKET

=======================================================================

                                HEARING

                               before the

              SUBCOMMITTEE ON ECONOMIC AND CONSUMER POLICY

                                 of the

                         COMMITTEE ON OVERSIGHT
                               AND REFORM

                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             JUNE 15, 2022

                               __________

                           Serial No. 117-87

                               __________

      Printed for the use of the Committee on Oversight and Reform
      
      
      
      
 [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]      
      
      
      


                       Available on: govinfo.gov
                         oversight.house.gov or
                             docs.house.gov
                             
                             
                             ______                       


             U.S. GOVERNMENT PUBLISHING OFFICE 
47-806PDF            WASHINGTON : 2022                             
                             
                             
                             
                             
                             
                   COMMITTEE ON OVERSIGHT AND REFORM

                CAROLYN B. MALONEY, New York, Chairwoman

Eleanor Holmes Norton, District of   James Comer, Kentucky, Ranking 
    Columbia                             Minority Member
Stephen F. Lynch, Massachusetts      Jim Jordan, Ohio
Jim Cooper, Tennessee                Virginia Foxx, North Carolina
Gerald E. Connolly, Virginia         Jody B. Hice, Georgia
Raja Krishnamoorthi, Illinois        Glenn Grothman, Wisconsin
Jamie Raskin, Maryland               Michael Cloud, Texas
Ro Khanna, California                Bob Gibbs, Ohio
Kweisi Mfume, Maryland               Clay Higgins, Louisiana
Alexandria Ocasio-Cortez, New York   Ralph Norman, South Carolina
Rashida Tlaib, Michigan              Pete Sessions, Texas
Katie Porter, California             Fred Keller, Pennsylvania
Cori Bush, Missouri                  Andy Biggs, Arizona
Shontel M. Brown, Ohio               Andrew Clyde, Georgia
Danny K. Davis, Illinois             Nancy Mace, South Carolina
Debbie Wasserman Schultz, Florida    Scott Franklin, Florida
Peter Welch, Vermont                 Jake LaTurner, Kansas
Henry C. ``Hank'' Johnson, Jr.,      Pat Fallon, Texas
    Georgia                          Yvette Herrell, New Mexico
John P. Sarbanes, Maryland           Byron Donalds, Florida
Jackie Speier, California            Vacancy
Robin L. Kelly, Illinois
Brenda L. Lawrence, Michigan
Mark DeSaulnier, California
Jimmy Gomez, California
Ayanna Pressley, Massachusetts

                      Russ Anello, Staff Director
               Jonathan Misk, Subcommittee Staff Director
                    Amy Stratton, Deputy Chief Clerk

                      Contact Number: 202-225-5051

                  Mark Marin, Minority Staff Director
                                 ------                                

              Subcommittee on Economic and Consumer Policy

                Raja Krishnamoorthi, Illinois, Chairman
Katie Porter, California,            Michael Cloud, Texas, Ranking 
Cori Bush, Missouri                      Minority Member
Jackie Speier, California            Fred Keller, Pennsylvania
Henry C. ``Hank'' Johnson, Jr.,      Scott Franklin, Florida
    Georgia                          Andrew Clyde, Georgia
Mark DeSaulnier, California          Byron Donalds, Florida
Ayanna Pressley, Massachussetts
Shontel M. Brown, Ohio

                         C  O  N  T  E  N  T  S

                              ----------                              
                                                                   Page
Hearing held on June 15, 2022....................................     1

                               Witnesses

Panel 1

Faye Hemsley & Omarion Hemsley, owners of dceased pet
    Oral Statement...............................................     6
Thomas Maiorino, owner of deceased pet
    Oral Statement...............................................     7

Panel 2

Jeffrey Simmons, President and Chief Executive Officer, Elanco 
  Animal Health
Oral Statement...................................................     9

Nathan Donley, Ph.D., Environmental Health Science Director, 
  Center for Biological Diversity
Oral Statement...................................................    10

Karen McCormack, Former Scientist, Policy Analyst, and 
  Communications Officer, Office of Pesticide Programs (ret.), 
  Environmental Protection
  Agency
Oral Statement...................................................    12

Carrie Sheffield, Senior Policy Analyst, Independent Women's 
  Voice
Oral Statement...................................................    13


Written opening statements and statements for the witnesses are 
  available on the U.S. House of Representatives Document 
  Repository at: docs.house.gov.

                           INDEX OF DOCUMENTS

                              ----------                              

  * No additional documents were submitted for this hearing.



                     SERESTO FLEA AND TICK COLLARS:


                   EXAMINING WHY A PRODUCT LINKED TO


                       MORE THAN 2,500 PET DEATHS


                         REMAINS ON THE MARKET

                              ----------                              


                        Wednesday, June 15, 2022

                  House of Representatives,
                 Committee on Oversight and Reform,
              Subcommittee on Economic and Consumer Policy,
                                                   Washington, D.C.
    The subcommittee met, pursuant to notice, at 1:35 p.m., in 
room 2154, Rayburn House Office Building, Hon. Raja 
Krishnamoorthi (chairman of the subcommittee) presiding.
    Present: Representatives Krishnamoorthi, Porter, Bush, 
Johnson, DeSaulnier, Brown, Cloud, Keller, Franklin, Clyde, and 
Donalds.
    Mr. Krishnamoorthi. The committee will come to order.
    Without objection, the chair is authorized to declare a 
recess of the committee at any time.
    I welcome everyone to today's hearing, the title of which 
is ``Seresto Flea and Tick Collars: Examining Why a Product 
Linked to More Than 2,500 Pet Deaths Remains on the Market.''
    I now recognize myself for an opening statement.
    At the inaugural hearing of this subcommittee in 2019, I 
noted it was created to focus on economic opportunity and 
fairness, consumer health and safety, and the overall quality 
of life. That's why our activities included investigations into 
price gouging in the shipping and food sectors, the infant 
formula shortage, neurotoxins in baby food, workplace 
harassment, the youth vaping epidemic, and, especially relevant 
now, inflation and rising prices.
    Today we're delving into the question of consumer safety, 
as well as overall quality of life, by examining why a product 
linked to numerous pet deaths and other negative side effects 
remains on the market. That product is Elanco Corporation's 
Seresto flea and tick collar.
    Today, our subcommittee has released its report on the 
Seresto collar and how both Elanco and the EPA, which regulates 
the Seresto collar, failed to address Seresto's known and 
deadly risks. As early as 2015, just a few years after the 
collar entered the U.S. market, an EPA investigation found that 
among similar products the Seresto collar, quote, ``ranked No. 
1 by a wide margin in terms of total incidents, major 
incidents, and deaths,'' even after factoring in companies' 
relative sales.
    Those findings weren't enough to drive the makers of the 
Seresto collar or the EPA to act. But, in 2016, Canada's 
equivalent of the EPA, known as the PMRA, concluded, based on a 
review of the same American data available to the EPA, that the 
collar posed too great a risk to pets and their owners to be 
ever sold in Canada.
    Unfortunately, even as the death count rose, the EPA 
allowed Seresto to remain on the market here without even so 
much as requiring additional warning labels that regulators 
mandated in places ranging from Australia to Colombia to the 
European Union.
    The companies that manufactured the Seresto collar, first 
Bayer Animal Health and then later Elanco, were also aware of 
the risks, the incidents, and the deaths. But they too failed 
to act.
    Instead, they hired third-party industry insiders to 
conduct so-called ``independent reviews'' of the incident data, 
which ended up protecting their $300 million a year market but 
ended up endangering pets. So, the Seresto collar stayed the 
same, and so did the consequences.
    Today, we'll hear from witnesses who can speak about the 
Seresto collar, the failures of Bayer, Elanco, and the EPA, and 
the real costs of their collective choices. We'll also hear 
from the families of pets that wore the collars and suffered 
the ultimate consequences.
    As our witnesses today will testify, there is no perfect, 
risk-free way of keeping our pets safe from every possible 
source of harm. That's the sad reality. But it is still 
possible to do all we can to protect the health and well-being 
of every pet.
    Sadly, our investigation has found evidence that the EPA 
and Elanco have failed to live up to that standard. That's why 
today I'm calling on the EPA to initiate Notice of Intent to 
Cancel proceedings, which will ensure that a comprehensive 
review of Seresto and its risks is undertaken to determine what 
must be done.
    And, in the meantime, to protect pets from further harm, 
I'm renewing my call for Elanco to do what the EPA cannot do 
immediately, and that's to institute a voluntary recall of the 
Seresto collar until comprehensive safety testing can be 
completed.
    Now, folks, this particular collar has caused 100,000 
incidents reported to the EPA and over 2,500 pet deaths 
reported to the EPA. The steps that we are asking for today are 
crucial because it's important to protect our pets and our 
families too.
    I now call upon my distinguished colleague, Mr. Cloud, for 
his opening statement.
    Mr. Cloud. Thank you, Chairman.
    This is the first hearing of the Economic and Consumer 
Policy Subcommittee this year, and we've been in session for 52 
days this year, and our first hearing is on pet collars.
    And I do realize that our pets are a huge part of our 
lives. They enrich our families. They provide companionship. 
For my kids, they have helped foster responsibility and 
compassion and care, important ethics we need in our society. 
Just recently, our family mourned the loss of our guinea pig, 
Biscuit. And so, pets are a huge part of our family lives.
    But I have to admit that when I saw that this was going to 
be on the agenda for this week, I could not help but be 
concerned, especially coming from south Texas, about the 
thousands, tens of thousands of human lives that have passed 
away due to fentanyl and due to an open border and due to the 
policies of this administration to continue to aid and abet 
cartels.
    And I realize that this is the Economic and Consumer Policy 
Subcommittee, and so I think about economic policy happening 
right now and where the minds of the American people are.
    Gas is now averaging $5 a gallon nationwide for the first 
time in history. We have not had a hearing.
    Inflation is at a 40-year high. We have not had a hearing.
    The American people cannot find baby formula. We still 
haven't had a hearing.
    I've mentioned fentanyl is killing Americans, especially 
our teens, at unprecedented rates. We have not had a hearing.
    Biden's systemic elimination of the safe and secure border 
he inherited has led to the worst humanitarian and national 
security crisis in this country's history. We have not had a 
hearing this term.
    We could talk about how inflation is affecting the cost of 
owning a pet, including the increased costs of food, toys, 
accessories, but we're not talking about that either.
    Instead, we're holding a hearing on the pet collar, which 
fights fleas and ticks. And as any pet owner knows, flea and 
tick management is an essential part of pet care, but I'm not 
sure it's an essential part of congressional oversight, 
especially when we take in mind where the American people are 
at.
    And, frankly, I've talked to a number of people in my 
district and others who live in other parts of the country, and 
they are really surprised that this has risen to one of the top 
priorities of Congress at this time and juncture.
    The subcommittee Republicans would rather explore efforts 
to help American consumers during these trying times. We would 
gladly have joined the chairman in holding a hearing on the 
shortage of baby formula.
    Moreover, we have welcomed the chance to explore TikTok's 
troubling practice of showing dangerous content to minors, an 
investigation that you all started last year.
    In fact, it's now come to light that teenagers are using 
TikTok and other social media platforms to purchase illicit 
drugs, including, unknowingly in many cases--in most cases--
fentanyl, while social media platforms are also using it to 
recruit young people into the gig economy of human trafficking. 
A hearing on that crisis could be incredibly important.
    And on the subject of our Nation's youth, CDC bureaucrats 
have actively pursued an agenda to close schools during the 
pandemic instead of following the science, damaging our 
children's financial, mental, physical, emotional, and also 
their learning for years to come. But we still have not had a 
hearing.
    Americans are facing incredible economic issues which 
require us as elected officials to listen and to respond.
    I do appreciate the fact that our pets play an important 
part of our lives. We should be kind to animals, and we should 
teach our children to do the same.
    But I do care immensely more about the human lives that we 
were elected to serve, and right now we have troubling economic 
times, with many families having to decide between food and 
fuel, with many families who saved up their entire lives to 
buildup a life savings, thinking they might have enough to make 
it by month to month, only finding out that inflation has put 
an unbearable demand on meeting those needs.
    These are important things and, frankly, where the minds of 
the American people are right now.
    And I have to say, as someone who was sent here to serve 
the American people, I know that the American people are 
bewildered that we're having this hearing, and that this is one 
of the top topics in Congress right now with where we're at. 
And I know the people who elected me to serve would prefer we 
be spending time on other important issues at this juncture.
    And so, with that, I would move to adjourn.
    Mr. Donalds. Mr. Chair, a question has been called as a 
motion from the vice chairman. What's going on?
    Mr. Krishnamoorthi. Thank you, Mr. Donalds.
    The gentleman has moved to adjourn, and the motion is not 
debatable.
    All those in favor of the motion to adjourn, say aye.
    Those opposed, say no.
    In the opinion of the chair, the noes have it, and the 
motion to adjourn is not agreed to.
    Mr. Keller. Could we do that again? I thought I only heard 
one no.
    Mr. Cloud. Request a recorded vote.
    Mr. Krishnamoorthi. OK. Very good.
    A recorded vote has been requested. We will pause while we 
will get the clerk out.
    [Discussion off the record.]
    Mr. Donalds. Mr. Chairman, it's already been about, what, a 
minute and a half? Where's the clerk? Is the clerk on lunch and 
not here today?
    Mr. Krishnamoorthi. The clerk is on the way, Mr. Donalds. 
Thank you.
    Mr. Donalds. Is the clerk sitting in a side office just 
hanging out? I mean, come on, Mr. Chairman.
    OK. America, we don't really get a lot of answers up here. 
Don't be surprised.
    Mr. Cloud. Could we alternatively provide a teller from 
each side to count the votes?
    Mr. Keller. There's not enough people to vote no.
    Mr. Cloud. There aren't that many of us.
    Mr. Keller. I'm virtually, and I only heard one no during 
the whole call.
    Mr. Cloud. Perhaps staff from each side could.
    Mr. Donalds. All right. Parliamentary question, Mr. 
Chairman. If we don't have enough members to vote here and the 
clerk is not here, how do we convene a hearing in Congress 
without a quorum?
    Mr. Keller. Yes.
    Ms. Porter. Madam Chair, how am I recorded?
    Mr. Keller. You're not recorded because we didn't call the 
roll yet.
    Mr. Cloud. Point of information. Does this require a clerk 
or is this a matter of personal preference?
    Mr. Krishnamoorthi. Yes, the clerk is required for a vote.
    [Discussion off the record.]
    Mr. Clyde. Mr. Chairman, by chance is the clerk 
teleworking?
    Mr. Krishnamoorthi. Sorry? Say that again, please.
    Mr. Clyde. Is the clerk teleworking perhaps today?
    Mr. Krishnamoorthi. The clerk is teleworking?
    Mr. Clyde. Teleworking. Yes, teleworking. Is that the 
holdup?
    Mr. Krishnamoorthi. I don't know, Mr. Clyde. I think she's 
on the way. Thank you.
    Mr. Clyde. OK. Thank you.
    Mr. Keller. They're rounding up members.
    [Discussion off the record.]
    Mr. Krishnamoorthi. OK. Madam Clerk, will you please call 
the roll on this motion to adjourn?
    The Clerk. Mr. Krishnamoorthi?
    Mr. Krishnamoorthi. No.
    The Clerk. Mr. Krishnamoorthi votes no.
    Ms. Porter?
    Ms. Porter. No. Ms. Porter votes no.
    The Clerk. Ms. Porter votes no.
    Ms. Bush?
    Ms. Bush. Bush votes no.
    The Clerk. Ms. Bush votes no.
    Ms. Speier?
    [No response.]
    The Clerk. Mr. Johnson?
    Mr. Johnson. Johnson votes no.
    The Clerk. Mr. Johnson votes no.
    Mr. DeSaulnier?
    Mr. DeSaulnier. DeSaulnier votes no.
    The Clerk. Mr. DeSaulnier votes no.
    Ms. Pressley?
    [No response.]
    The Clerk. Ms. Brown?
    Ms. Brown. Brown votes no.
    The Clerk. Ms. Brown votes no.
    Mr. Cloud?
    Mr. Cloud. Yes.
    The Clerk. Mr. Cloud votes yes.
    Mr. Keller?
    Mr. Keller. Yes.
    The Clerk. Mr. Keller votes yes.
    Mr. Franklin?
    Mr. Franklin. Aye.
    The Clerk. Mr. Franklin votes yes.
    Mr. Clyde?
    Mr. Clyde. Yes.
    The Clerk. Mr. Clyde votes yes.
    Mr. Donalds?
    Mr. Donalds. Yes.
    The Clerk. Mr. Donalds votes yes.
    Mr. Krishnamoorthi. Does any member wish to change his or 
her vote? If not, the clerk will report.
    The Clerk. On this vote, we have five yeas and six nays.
    Mr. Krishnamoorthi. The question is not agreed to.
    Now I recognize our witnesses for their opening statements. 
I would like to introduce our witnesses first. We will have two 
witness panels today. I'll introduce the first panel now. The 
witnesses on this panel will not entertain questions following 
their testimony.
    Our first witnesses are Ms. Faye Hemsley and her son, Mr. 
Omarion Hemsley, owners of the now deceased Tigger, a terrier 
mix.
    Our second witness is Mr. Thomas Maiorino, owner of the now 
deceased Rooney, his family's rescue dog.
    I will begin by swearing in the witnesses.
    Please raise your right hands.
    Do you swear or affirm that the testimony you are about to 
give is the truth, the whole truth, and nothing but the truth, 
so help you God?
    Let the record show that the witnesses answered in the 
affirmative.
    Without objection, each of your written Statements will be 
made part of the record.
    With that, Ms. Hemsley and Mr. Hemsley, you are now 
recognized to provide your testimony.

        STATEMENT OF FAYE HEMSLEY, OWNER OF DECEASED PET

    Ms. Hemsley. My name is Faye Hemsley and I live in 
Huntingdon, Pennsylvania. I am the mother of two boys, Omarion 
and William.
    I care deeply about animals and try to help them when I 
can. I regularly rescue dogs in my community.
    Around 2008, I adopted a cute black and brown terrier mix 
that we named Tigger. Tigger became part of our family and 
regularly played with me and my children and the other dogs 
that we had. Tigger also would cuddle with me. We all loved 
Tigger.
    In January 2020, I purchased a Seresto collar for Tigger. 
Because Seresto collars are expensive, I didn't purchase any 
Seresto flea collars for the other three dogs I had at the 
time.
    Tigger was also lively and never suffered from any serious 
health problems, and so I put the Seresto collar around his 
neck to ward off fleas and ticks.
    At first Tigger appeared fine. However, Tigger's head began 
to droop, and he did not have the same amount of energy he once 
did.
    So after that, Tigger died in my son Omarion's arms when he 
was preparing to take Tigger for a walk. Tigger had a Seresto 
collar around his neck at the time of his death.
    None of my other three dogs had the Seresto collar, and 
none of my other dogs got sick and died. I'm convinced that it 
was the Seresto collar that killed Tigger and that he did not--
--
    [Witness crying.]
    I'm sorry.
    I'm convinced it was the Seresto collar that killed Tigger 
and if he did not have the collar, Tigger would still be alive 
today.
    I read about an article about other dogs, other pets having 
suffered the same injuries because of the Seresto collar. As a 
result, I hired a lawyer.
    I never can bring Tigger back, but I hope that by speaking 
here today, I can help other pets and their owners avoid what 
Tigger went through.
    Thank you for giving me the opportunity to tell you about 
my experience with Seresto collars and what happened to Tigger. 
We miss him every day and his cuddles he gave us.
    Mr. Krishnamoorthi. Thank you, Ms. Hemsley. We are so sorry 
for your loss.
    I now recognize Mr. Maiorino.
    You may provide your testimony.

      STATEMENT OF THOMAS MAIORINO, OWNER OF DECEASED PET

    Mr. Maiorino. Thank you, Mr. Chairman and members, for 
hearing us about this important issue.
    My name is Thomas Maiorino. I reside in Mount Laurel, New 
Jersey, with my wife, Monica. I am the father of three boys. My 
youngest son, Robert, turned 12 in 2011. After years of asking 
for a dog, he wore us down, and we decided to rescue a dog from 
a southern shelter for my son's birthday.
    After researching online, we adopted a mixed breed mutt 
that Robbie and his two older brothers named Rooney. Rooney 
swiftly became a loved member of our family. A bit 
rambunctious, she was just what a 12-year-old boy needed. She 
loved to run and chase anything that moved in the yard.
    By all measures, we took great care to ensure Rooney had a 
healthy and happy life. We took her on daily walks, sometimes 
three a day, hikes on park trails. We monitored her diet and 
made sure she was seen by the veterinarian as needed and she 
received all of her shots.
    Because she was a bit rambunctious and we lived in a wooded 
area where there's a lot of wildlife, we were constantly 
concerned about the problems of fleas and ticks. We consulted 
with a veterinarian after getting Rooney to determine the best 
way to protect her against this.
    We used a variety of prevention methods for the first few 
years. And when we changed veterinarians in approximately 2013 
or 2014, the new veterinarian strongly recommended that we use 
the Seresto flea and tick collar based on all of our options.
    We heeded that advice and purchased Seresto collars from 
our local PetSmart. The collars were intended to provide 
protection for up to eight months.
    We noticed that after affixing the collar to Rooney's neck, 
she began to itch and at first had that treated and later 
tested for allergies. We took Rooney to the vet several times 
during 2018 seeking to find the cause for the ever-increasing 
itching.
    After several visits and multiple medications, they were 
unable to determine the cause, and we switched to a specialist 
in 2019 to seek further assistance where they provided allergy 
shots and other medications to address the worsening itching 
and related symptoms.
    Rooney's behavior then became more erratic as the months 
wore on. She began licking her paws so feverishly they would 
bleed. She also developed patches, bleeding patches on her 
stomach.
    Ultimately, in October 2020, Rooney suffered a horrendous 
grand mal seizure in the presence of myself and my wife. The 
damage done by the seizure was irreversible. She was a shell of 
her former self. And, ultimately, the family decided the most 
humane thing would be to put Rooney to sleep at the age of 
nine.
    In early March 2021, I read an article online about Seresto 
pet collars resulting in the deaths of 1,700 pets without any 
warnings from the EPA or the manufacturer. I sought out legal 
representation, not because I wanted financial compensation, 
but because I took great pain to care for Rooney.
    The final 18 months of her life were agonizing to watch. If 
I could help prevent another family from going through what my 
family went through, I wanted to act.
    I'm here today in furtherance of that effort. I appreciate 
the committee taking the time to investigate this matter. And 
thank you for your time.
    Mr. Krishnamoorthi. Thank you, Mr. Maiorino, for your 
testimony. We are deeply sorry for your loss as well.
    Mr. Maiorino. Thank you.
    Mr. Krishnamoorthi. To all witnesses, thank you for your 
testimony. Panel one is now concluded, and you are released.
    I now invite the witnesses appearing in person for the 
second panel to approach the witness table and ask the clerks 
to prepare the zoom for the witnesses appearing remotely as 
well.
    Great. I would now like to introduce our second panel of 
witnesses. These witnesses will accept questions following 
their testimoneys.
    First, Mr. Jeffrey Simmons is the President and CEO of 
Elanco Animal Health, Inc., the current manufacturer of the 
Seresto flea and tick collar.
    Second, Dr. Nathan Donley is the Environmental Health 
Science Director at the Center for Biological Diversity.
    Third, Ms. Karen McCormack is retired from the EPA where 
she served for over 40 years in various positions, including as 
Scientist,Ppolicy Analyst, and Communications Officer, 
including in the Office of Pesticide Programs.
    Finally, our last witness is Ms. Carrie Sheffield, a 
columnist and Senior Policy Analyst at Independent Women's 
Voice.
    Thank you all for being here today.
    The witnesses appearing remotely will be unmuted so that we 
can swear everyone in.
    I will now swear in the witnesses.
    Please raise your right hands.
    Do you swear or affirm that the testimony you are about to 
give is the truth, the whole truth, and nothing but the truth, 
so help you God?
    Let the record show that all the witnesses answered in the 
affirmative.
    Thank you.
    Without objection, your written statements will be made 
part of the record.
    With that, Mr. Simmons, you are now recognized to provide 
your testimony.

  STATEMENT OF JEFFREY SIMMONS, PRESIDENT AND CHIEF EXECUTIVE 
           OFFICER, ELANCO ANIMAL HEALTH INCORPORATED

    Mr. Simmons. Thank you, Chairman.
    Chairman Krishnamoorthi, Ranking Member Cloud, and members 
of the subcommittee, my name is Jeff Simmons. I'm the president 
and CEO of Elanco Animal Health.
    I joined Elanco 33 years ago directly out of college 
because of the company's culture and its commitment to make a 
difference in the lives of animals. Our company and our people 
are dedicated to protecting and enhancing the health of 
animals, which is why I appreciate the opportunity today to 
provide more details on our Seresto collar.
    There are a few points I would like to emphasize up front.
    First, the EPA approved Seresto following more than 80 
safety and toxicity studies, all of which showed that Seresto 
and its ingredients have a strong safety profile.
    Second, more than 80 regulatory bodies around the world 
have approved Seresto. Seresto is widely used in more than 80 
million collars worn over the past decade to protect dogs and 
cats from fleas and ticks around the world.
    Third, adverse event reports are not intended to be and, in 
fact, are absolutely not proof of causation. Reports require 
further investigation and analysis to determine cause. And 
after years of review, our pharmacovigilance team, made up of 
veterinarians and other experts who study adverse event 
reports, has not identified a single death caused by the active 
ingredients in the collar.
    Finally, the benefits Seresto brings to pets and their 
owners are very significant and must be weighed against any 
risks. Seresto provides working families with 8 continuous 
months of protection against fleas and ticks in an affordable, 
easy to use collar available over the counter.
    Fleas and ticks aren't just annoying. They can carry 
serious and potentially fatal diseases to pets and people, like 
Lyme disease and Rocky Mountain Spotted Fever.
    At Elanco, we understand the unique and loving bond pet 
owners have with their pets. And as someone who's always had 
dogs as part of our family, I share that bond.
    This understanding drives our rigorous, science-backed 
approach to safety. We're committed to transparency and take 
adverse event reports, which we share with the EPA, very 
seriously.
    At the same time, our decisions are guided by the best 
available scientific evidence, and that evidence provides 
robust support for the strong safety profile of Seresto.
    Seresto was first approved by the EPA in 2012 following 
numerous toxicity studies, pharmacokinetic studies, safety 
studies, and laboratory and field efficacy studies.
    Seresto's safety was studied in dogs and cats actually 
wearing the collars. Some pets wore up to five Seresto collars 
at a time. Yet the only treatment-related adverse effects seen 
in any of these studies were some local reactions caused by the 
physical nature of the collar.
    The incident report data similarly supports Seresto's 
safety. We recognize the impression that can be left with 
viewing the total number of incident reports without any 
context or analysis. But with 33 million collars sold in the 
United States alone, incident reports, most of which are minor 
or moderate, represent an extremely small proportion of the 
Seresto collars in use.
    Moreover, incident reports are submitted to the EPA without 
regard to causation. The best scientific evidence available 
shows the overwhelming majority of reported major events not 
even possibly caused by Seresto's active ingredients.
    No product is without risk. What matters is whether those 
risks are reasonable and in light of the benefits, and numerous 
studies and the incident report data for Seresto demonstrate, 
the product does not pose an unreasonable risk and has a strong 
safety profile, which is why the American Veterinary Medical 
Association opposed canceling Seresto's EPA registration.
    The incidence of flea-and tick-borne diseases is on the 
rise. CDC estimates approximately 500,000 cases of Lyme disease 
and Rocky Mountain Spotted Fever annually. Climate change may 
accelerate this trend.
    Seresto offers pet owners a much-needed cost-effective 
option for protecting their pets and people as well. Given the 
robust scientific evidence for Seresto's strong safety profile, 
we are proud to stand behind the product.
    Thank you very much for your time, and I look forward to 
your questions.
    Mr. Krishnamoorthi. Thank you, Mr. Simmons.
    Dr. Donley, you are now recognized to provide your 
testimony.

   STATEMENT OF NATHAN DONLEY, PH.D., CENTER FOR BIOLOGICAL 
                           DIVERSITY

    Mr. Donley. Thank you.
    Good morning--well, morning where I am, afternoon where you 
are--Chairman Krishnamoorthi, Ranking Member Cloud, and 
distinguished subcommittee members.
    My name is Dr. Nathan Donley. I'm the Science Director for 
the Environmental Health Program at the Center for Biological 
Diversity. I have a Ph.D. in cell and developmental biology 
from Oregon Health and Sciences University.
    The last seven years of my professional life have been 
spent researching how pesticides impact people and the 
environment and the regulatory failures that can actually 
facilitate harm rather than prevent it.
    I've published three peer-reviewed scientific articles and 
five technical reports on this subject. I've authored over a 
hundred technical scientific comments to the EPA on pesticide 
documents, including for flumethrin and imidacloprid, the two 
active ingredients in the Seresto collar.
    I've read through thousands of pages of FOIA documents I 
requested on matters related to the approval and continued use 
of Seresto.
    And it's really important for this committee to understand 
that Seresto is the symptom of a much larger problem at EPA. 
It's simply one of the most egregious examples of what happens 
when the agency that is supposed to be making sure products 
that we encounter in our daily lives are safe is not up to the 
task.
    Other than from the laboratory studies conducted by the 
pesticide companies themselves, the EPA actually knows very 
little about how pesticides will behave in the real world 
before they are approved, and this is why incident reporting by 
the public is essential to track pesticide impacts, and this is 
where EPA fails.
    While other agencies, like the FDA, have robust systems in 
place to surveil harms from products under their purview, EPA 
only requires minimal information be submitted four times a 
year, and they delegate this responsibility to the pesticide 
industry itself.
    The limited information that is collected includes only the 
pesticide product name, where the incident occurred, and the 
severity of the incident. That's it. Oftentimes the agency 
doesn't even know if the incident involves a dog or a cat.
    Even though the EPA determines what incident information it 
collects, it then turns around and laments that the incident 
data are insufficient to take regulatory action to protect 
public health, the environment, and our pets. It's a system 
designed to achieve nothing other than maintaining the status 
quo.
    Worse yet, reported incidents significantly underestimate 
the true scope of harm. The EPA recently estimated that only 
one in 25 pesticide incidents involving another pesticide 
called dicamba was actually reported to the authorities. That's 
only a four percent reporting rate.
    Given that 100,000 people have reported their concerns 
about Seresto, this is very alarming because the true number of 
harmful incidents to pets could be potentially far higher.
    The EPA's counterpart in Canada was so concerned about 
Seresto incidents and the harm to pets and humans that it 
denied Seresto approval in 2016. Canada analyzed U.S. incident 
data and determined that Seresto collars had an incident rate 
50 times greater than the average flea collar and 36 times 
greater than Canada's trigger for review.
    EPA has no trigger for review of any pesticide product, no 
matter how much harm is being reported. And because the agency 
has no mandated trigger for reviewing pesticides like Seresto, 
rather than choosing to use incident reporting data to inform a 
robust regulatory process and take dangerous products off the 
market, EPA routinely chooses to do nothing at all. That's 
especially troubling when you consider that Seresto is just one 
of 18,000 pesticide products currently approved by the EPA.
    People are telling the authorities about the terrible 
things that happened to their pet or child. They deserve more 
than to have their reports ignored. Until the system changes, 
it's impossible to have any confidence that the EPA is actually 
protecting us, our children, and our pets from harmful 
pesticides.
    Thank you so much for the opportunity to be here today and 
to speak on behalf of this important issue.
    Mr. Krishnamoorthi. Thank you, Dr. Donley.
    Ms. McCormack, you are now recognized to provide your 
testimony.

STATEMENT OF KAREN MCCORMACK, FORMER SCIENTIST, POLICY ANALYST, 
    AND COMMUNICATIONS OFFICER (RET.), OFFICE OF PESTICIDE 
                    PROGRAMS, ENVIRONMENTAL 
                       PROTECTION AGENCY

    Ms. McCormack. Good afternoon, Chairman Krishnamoorthi, 
Ranking Member Cloud, and distinguished subcommittee members.
    My name is Karen McCormack. At the present time, I am a 
retired government employee after working over 40 years at the 
Environmental Protection Agency.
    During my career at EPA, I first worked in an EPA 
laboratory as a research coordinator, and in that capacity, I 
conducted research on numerous pesticides.
    Later, I transferred to EPA's headquarters in Washington, 
DC, and worked in various positions in the pesticide program, 
as a Scientist, Policy Analyst, and a Communications Officer.
    I also worked in a number of offices at EPA, including the 
Office of the Assistant Administrator for Pesticides and 
Toxics.
    Although I'm retired from EPA, I'm still closely following 
a number of environmental topics, and one of those topics of 
interest to me has been the impact of flea and tick pet 
products on cats and dogs.
    The U.S. Environmental Protection Agency is charged with 
regulating products that contain pesticides and in ensuring 
that all pesticide products are safe to use. Before 1996, EPA 
did not consistently require manufacturers to conduct animal 
safety studies for pet products containing pesticides.
    Because pet products with pesticides were available readily 
in commercial stores, consumers thought they must be safe.
    This is not necessarily the case. Flea and tick products 
are designed to kill insects, and they often contain poisonous 
chemicals.
    When combined with pesticides that are used outside the 
home and in the water and food that people drink and eat, the 
aggregate risks from all these sources of pesticides can be 
high, especially for children who are vulnerable to toxic 
chemicals, much more vulnerable than adults.
    And it wasn't until the passage of the 1996 Food Quality 
Protection Act that EPA began to examine the risks from sources 
other than food, including risks from pet products containing 
pesticides.
    After the passage of FQPA, pesticide manufacturers were 
required to submit to EPA animal safety studies and incident 
reports showing harm to animals and humans exposed to 
pesticides and pet products.
    Between 2012 and the present time, the EPA received an 
increasing number of incident reports related to the use of 
flea and tick pet collars for dogs and cats. The toxic effects 
that were described in these many incident reports from the use 
of certain pet collars range from mild effects, such as skin 
irritation, to more severe effects, such as intense tremors, 
seizures, paralysis, organ failure, and death.
    The largest number of incident reports that EPA received 
during this period were from the use of a pet collar called 
Seresto. Between January 2012 and the present time, EPA has 
received over 100,000 incident reports, and these incident 
reports include human incidents as well as pet incidents. These 
reports also include at least 2,300 reports of pet deaths.
    The number is most likely a very low estimate of the actual 
number of incidents that are occurring since many pet owners do 
not know that they can report incidents to EPA, and they may 
not know how to correlate the adverse effects in their pets 
with a particular pet product.
    Determining the safety of pet products such as Seresto is 
very difficult for consumers and pet owners. There are no 
independent organizations that rank the safety of pet products, 
and the sales data which is needed to rank the safety of pet 
products is considered confidential business information by the 
manufacturers.
    EPA's risk assessments also do not tell the full story of 
what pet products are safe as they rely heavily on industry-
generated studies that were conducted on mice and rats rather 
than dogs and cats, and EPA's risk assessments also are based 
mainly on studies that were conducted with only one pesticide 
in Seresto rather than the combined pesticides in this pet 
product.
    Although the original manufacturer of Seresto, Bayer, did 
conduct a number of efficacy and safety studies on dogs and 
cats treated with Seresto, the company did not conduct two very 
critical studies that are important for determining the safety 
of a pet product.
    These tests include a pet transferrable residue study--a 
petting study--to determine the exposure of humans to Seresto, 
and they did not conduct a study that measures the amount of 
pesticide that gets in the blood of treated dogs and cats.
    Both Bayer and Elanco have claimed that Seresto is safe for 
pets, and Bayer has claimed that the pesticides in Seresto 
remain on the outer surface of the animal's skin and hair coat.
    An independent study conducted at Murray State University, 
though, found that one of the pesticides in Seresto, 
imidacloprid, can cross the skin barrier and enter the blood of 
treated pets.
    Mr. Krishnamoorthi. Ms. McCormack, I'm sorry. We're out of 
time on your testimony. You can answer questions further about 
that.
    I'd like to now recognize Ms. Sheffield for her five 
minutes of testimony.

STATEMENT OF CARRIE SHEFFIELD (MINORITY WITNESS), SENIOR POLICY 
               ANALYST, INDEPENDENT WOMEN'S VOICE

    Ms. Sheffield. Mr. Chairman, Mr. Ranking Member, and other 
subcommittee members, thank you for inviting me to appear 
today.
    My name is Carrie Sheffield, and I'm a Senior Policy 
Analyst at the Center for Economic Opportunity at Independent 
Women's Forum. We are a nonprofit organization committed to 
increasing the number of women who value free markets and 
personal liberty. We advance policies that advance people's 
freedom, opportunities, and well-being.
    Before I begin my remarks, I would like to acknowledge the 
witnesses on the earlier panel. Their stories of losing beloved 
pets, who are family members in nearly every sense of the word, 
break our hearts.
    As someone who grew up with beloved pets and cats in our 
family, I know how the unconditional love from our family pets 
is wonderful and life giving. If only we could all be half the 
human beings that are pets believe us to be.
    My understanding is that this subcommittee launched its 
investigation into the collars in March 2021, following the 
publication of an investigative report about possible injuries 
and deaths related to this dog collar.
    What is heartbreaking about this case is that we are almost 
a year and a half since the initial discovery, yet we don't 
have this issue resolved.
    We are hearing from both sides about this issue today, and 
no matter what is decided here, this is clearly a case of 
government regulatory failure to provide clarity to the 
American people and our vulnerable furry friends.
    This lack of clarity on pet collars is part of a widespread 
pattern of limited clarity throughout government. We're seeing 
it at the FDA in protecting our baby formula national supply 
chain, which is so critical for millions of families, and on 
top of that women nationwide are also reporting a shortage of 
tampons.
    Sadly, what's happening right now is what some commentators 
are calling ``The Great Distrust.'' We see in many instances 
Americans have lost their confidence in our political leaders 
and our institutions, from the EPA to the FBI and Congress, to 
public education, the CDC, and much more.
    We see this lack of confidence in last week's overwhelming 
recall of San Francisco District Attorney Chesa Boudin, who 
refused to protect citizens and favored criminality over 
justice. What's telling is that reports indicate people of 
color rejected Boudin at higher rates than White voters. They 
know that defunding the police widens economic inequality by 
destroying the safety of businesses in minority communities.
    These Black and Brown voters stood up and they pushed back. 
Their businesses and physical safety suffer most under a 
``defund the police'' ethos, which is endorsed by some members 
of this subcommittee.
    According to your website, this subcommittee has 
jurisdiction in part over the following areas: income 
inequality and policies that affect the growth and prosperity 
of the middle class, including education, housing, labor, 
trade, small business, agriculture, securities regulation, and 
consumer protection. Your last subcommittee hearing was held 
June 23, 2021, on youth e-cigarette use.
    As mentioned previously, while my heart goes out to any pet 
owners that have lost a pet, besides dog collars and vaping 
there are a host of widespread problems plaguing the country 
that fall under the jurisdiction of this subcommittee. These 
vital issues have not been discussed to date.
    If this committee was paying attention to the widespread 
issues affecting the American people that we are deeply 
struggling with, it would have multiple hearings on how the 40-
year inflation high is making it hard for Americans to buy 
basic needs and small business owners to make ends meet.
    According to the BLS data for May 2022, prices for the 
purchase of pets, pet supplies, and accessories rose 7.1 
percent year over year, with pet food costs rising 9.1 percent.
    Part of ensuring pet security is ensuring pet food 
security. Tragically, we have seen in the news that rising 
inflation costs for pets is forcing some people to surrender 
their animals to shelters.
    In addition to caring for pets, this committee should also 
have held a hearing, not just sent a letter, regarding the baby 
formula shortage. An estimated 43 percent of baby formula 
inventory last month was out of stock nationally. That is up 
from 18 percent at the start of 2022 and three percent from the 
same time last year.
    In addition to baby formula, this subcommittee should 
examine the gas prices that are pummeling American families 
with record prices daily.
    This subcommittee should also move to stop the Securities 
and Exchange Commission from creating red tape that inhibits 
new market entrants. This red tape will further constrain our 
supply chain.
    So, while the subcommittee today is meeting to discuss an 
important topic of pet collar safety, the American people want 
your legislative body to understand that American households 
across the board are hurting in multiple other areas and are 
not receiving the attention that they deserve.
    Thank you for allowing me to testify today.
    Mr. Krishnamoorthi. Thank you, Ms. Sheffield.
    Votes have been called, and so we are going to adjourn 
until votes have been held, and then we'll come--or, I'm sorry, 
we'll recess. I better use the right word here. We'll recess--
--
    Mr. Cloud. I second that motion.
    Mr. Krishnamoorthi. We're going to recess until after the 
votes and then come back.
    Very good. Thank you.
    This committee stands in recess.
    [Recess.]
    Mr. Krishnamoorthi. Thank you, everybody, for bearing with 
us as we cast our votes. We are going to resume this hearing. 
And I now recognize myself for five minutes of questioning.
    Mr. Simmons, according to Elanco's 8K filing from May 2021, 
1,852 pet deaths were, quote, ``recorded where the Seresto 
collar was mentioned alongside the death of a pet,'' correct?
    Mr. Krishnamoorthi. I think you're on mute, Mr. Simmons. We 
can't hear you.
    Mr. Simmons. Can you hear me now?
    Mr. Krishnamoorthi. Yes, we can hear you now. Can you 
restore the time, please?
    Mr. Simmons. I'm sorry.
    Mr. Simmons. Could you repeat the question, Chairman?
    Mr. Krishnamoorthi. Yes, sir.
    According to Elanco's 8K filing from May 2021--I'm quoting 
it--1,852 pet deaths were, quote, ``recorded where the Seresto 
collar was mentioned alongside the death of a pet,'' correct?
    Mr. Simmons. That is correct.
    Mr. Krishnamoorthi. But you and Elanco maintain that there 
is, quote, ``no scientific evidence of a causal link in 
Seresto's active ingredients in pet deaths,'' correct?
    Mr. Simmons. That is correct, Chairman. The data from our 
pharmacovigilance team, and the review of the data over 10 
years, the 33 million dogs that have worn the collar, there's 
no linkage to the active ingredients to a pet death.
    Mr. Krishnamoorthi. And, in fact, in your comment that you 
submitted to the EPA in September 2021, you determined that 
only 0.51 percent of deaths were quote, ``probably or possibly 
caused by the collar,'' didn't you?
    Mr. Simmons. That is correct. And my understanding from 
that data is the majority of those were linked to entrapment of 
physical, like, getting caught on a fence as an example.
    Mr. Krishnamoorthi. Correct.
    So let me just show you some analysis that was conducted by 
Elanco, which we just referred to, as well as the EPA, as well 
as the Canadian equivalent of the EPA, which is called the 
PMRA.
    Essentially, we look at this chart here, and we see that at 
the top, Elanco computed that 0.51 percent of pet deaths were 
possibly or probably caused by the Seresto collar.
    The PMRA in Canada, looking at a sample of pet deaths, 
concluded that 33 percent of those pet deaths were possibly or 
probably caused by Seresto collars, and the EPA here concluded 
that 45 percent were possibly or probably caused by the Seresto 
collar.
    Now, sir, I think originally you said that there's no 
scientific evidence, no evidence of a causal link. This is 
clearly evidence. It was so compelling that the Canadian 
equivalent of the EPA never allowed for Seresto collars to be 
sold in Canada, correct?
    Mr. Simmons. Yes, I'm aware of that decision. I would also 
add that 80 other countries have approved this product. We've 
had over 80 million collars actually used. I'm not familiar 
with these two, this data comparison and this data.
    What I can say is, following the EPA regulatory process 
around the oversight that we call pharmacovigilance, hosted 200 
veterinarians and staff on our team, looking at the data 
through the way the EPA wants us to, we have not seen a linkage 
from the active ingredients in the collar to----
    Mr. Krishnamoorthi. Well, I understand that, sir. I 
understand you haven't seen the linkage, although other 
authorities have, and their scientists, who are not paid by 
you, have done so.
    Now, Dr. Donley, let me just briefly ask you a question.
    How could it be that Elanco's percentage that it calculated 
is so low compared to the percentages that the EPA or the PMRA 
calculated?
    Mr. Donley. Thank you for your question.
    This is what we commonly see, quite frankly, when the 
regulated industry is doing their own research. It commonly 
finds that their products are safer than when government 
agencies or academic scientists take on a similar analysis. 
This is just----
    Mr. Krishnamoorthi. Well, I appreciate that. I appreciate 
that, sir.
    Now let me go to Ms. McCormack.
    First of all, thank you for your service to the EPA, and I 
know you're retired after 40 years of service.
    We have FOIA documents from the EPA and emails, internal to 
the EPA, talking about the Seresto collar. Here is just one of 
them. This is from an employee who basically voiced their 
opinion about recent coverage of the Seresto controversy.
    He said, ``Looks like the shit has hit the fan. Will be 
interesting seeing where this goes. I hope there's a FOIA for 
all communications on this so that our emails are made public. 
We have been screaming about Seresto for many years.''
    I presume that you've heard some of these screams and 
concerns, correct, Ms. McCormack?
    Ms. McCormack. That's correct. A number of EPA employees 
have contacted me and given me detailed descriptions about 
what's happening with Seresto, and they were very upset that 
EPA refused to do anything about it. Instead they----
    Mr. Krishnamoorthi. Let me talk about one other email 
before I'm out of time.
    There was a May 30, 2019, email that we received in the 
FOIA which said the following: ``It is my strong opinion the 
agency needs to take action regarding Seresto to protect family 
pets.'' This is from May 2019, before USA Today or we 
scrutinized the situation.
    I presume you've heard similar concerns and tell us why 
those concerns were voiced.
    Ms. McCormack. Those concerns were voiced because a number 
of the scientists--and this is not unusual--feel that the 
decisionmakers are not considering the science and they are 
making decisions based on political reasons.
    I did--I don't know if I have time to talk about this--but 
I did look at the science that the Canadian Government did, the 
causality analysis. They looked at the consistency and toxicity 
of effects from exposure of pets to Seresto.
    And what they found was very disturbing. It was so 
disturbing that they decided the risks were too high to approve 
Seresto, and they could not be mitigated by putting a label 
statement on the product or by issuing warning labels. So, they 
refused to approve Seresto.
    Mr. Krishnamoorthi. Thank you, Ms. McCormack.
    I'd like to now recognize Mr. Cloud for his five minutes of 
questions.
    Mr. Cloud. Thank you, Chairman. Hello? Is the audio 
working?
    OK. Thank you, Chairman and thank you, Ms. McCormack, for 
acknowledging that the EPA sometimes makes political decisions. 
That's something we'll definitely be coming back to next term.
    Ms. Sheffield, the latest Consumer Price Index report 
revealed that inflation hit 8.6 in May compared to a year 
prior. This is the highest percentage in the last 40 years. And 
we've already discussed, of course, families now unfortunately 
have to make the decision between food and fuel, a lot of them.
    Of course, this affects animals and pets as well. You 
mentioned animals that are being taken to shelters. Some are 
being abandoned as families have to decide to feed their kids 
or their pet.
    Could you talk about how inflation affects families? And 
doesn't inflation impact everyone in the same way?
    Ms. Sheffield. Yes. Thank you for the question.
    Inflation hurts poor and minority households the most. And 
so that's what is the perverse outcome of what's happened by 
all of the trillions of dollars in spending that's been pushed 
through by progressive leaders, including the $1.9 trillion 
``stimulus'' plan--I use the word in quotes, ``stimulus''--last 
spring, in addition to the $1.2 trillion in infrastructure 
spending last fall.
    All of these, combined with what happened and was rushed 
through during the COVID pandemic, has combined to create this 
inflationary pressure.
    And we just had word today that now the Federal Reserve 
will raise interest rates by 0.75 percent. That's a rate not 
seen of a hike since 1994.
    And what's that going to do? It's going to increase the 
price of housing, to buy a home, a first-time home buyer. It 
will shatter the American Dream for so many people. And that is 
a direct result of the inflation because the Fed is trying to 
tamp down the inflation by raising interest rates.
    And, again, who is hurt the most by this? It is people of 
color, it is women, it is single mothers. And this is the 
result of failed liberal policy.
    Mr. Cloud. One of the issues I think that seems to be 
contributing to the inflation at some level is the supply chain 
crisis. Most notably, right now baby formula is a shortage.
    Could you speak to some of the reasons why we're seeing 
baby formula shortage?
    Ms. Sheffield. Certainly.
    Well, as I touched on in my opening remarks, it was a 
failure by the Biden administration, particularly the FDA, to 
raise a red flag very rapidly and quickly as to the problems of 
this baby formula crisis.
    And, in particular, as The Wall Street Journal has noted, 
and other sources, that the baby formula plant in question in 
Michigan that was sort of the source of the supposed taint, 
there was no actual evidence that the babies in question who 
fell ill actually had the same type of strain of the illness, 
of the disease, which you can test. It was not actually found 
in the plant itself.
    And so, you had this overreaction by the Federal Government 
to shut down a plant that was crucial to the supply chain 
without evidence that this indeed was driving the illness in 
these children.
    And then, again, months of dragging this process along, as 
we've seen here with the Seresto collar, months of this process 
being dragged out.
    This is why the American people have lost trust in 
government. This is why our institutions are failing us.
    Mr. Cloud. And this is the Economic and Consumer Policy 
Subcommittee. You mentioned in your testimony that there's a 
number of things really that the American people are dealing 
with right now that could fall under the jurisdictional scope 
of the subcommittee. Could you highlight some of those for us?
    Ms. Sheffield. Certainly.
    Gas prices are certainly one of those issues that is really 
hitting home. We produce a monthly inflation tracker that we've 
put out since we've been following this inflation problem. In 
May, this May, 2022, compared to last year, gas prices are up 
48.7 percent, and the gas bill for your home is 30.2 percent 
higher.
    I mean, again, this hurts people of color, poor families, 
single mothers the most, and this is a direct result of the 
policies including tamping down on the oil production, gas 
production.
    And I know that sometimes on the left people say, well, 
we've got lots of leases and existing ability to develop. But 
the reality is that these oil and gas and natural gas 
companies, they make decisions and political--or business 
calculations. Sadly, they have to factor in the political 
calculation.
    And Biden administration officials have explicitly said 
that they want to destroy the oil and gas market. And that is 
what is driving this, the harm and the pain that poor and 
minority and women households are feeling.
    Mr. Cloud. And I would come back to the previous comment 
about the EPA making political decisions. Certainly, that's 
been true when it comes to a number of the energy policies and 
leases and fuels and such that touch on those types of things.
    Thank you very much. Thank you for being here today.
    Ms. Sheffield. Thank you.
    Mr. Krishnamoorthi. Thank you, Mr. Cloud.
    Now I'd like to recognize Congresswoman Porter for her five 
minutes of questions.
    Ms. Porter. Thank you very much, Mr. Chair.
    Mr. Simmons, does Elanco sell Seresto collars in other 
countries?You're on mute sir.
    Mr. Simmons. I'm sorry, I apologize. Yes, we do, 
Congresswoman. We sell in over 80 countries.
    Ms. Porter. Are the active ingredients for Seresto in the 
United States different from the active ingredients for Seresto 
collars in other countries?
    Mr. Simmons. No. I do not believe they're any different 
than the other 80 countries.
    Ms. Porter. In other countries, like in Colombia and 
Australia, the warning labels for Seresto collars classify the 
collar as highly toxic and as poison.
    Does the label for Seresto in the United States include 
that language?
    Mr. Simmons. Labels differ in animal health products around 
the world for different reasons. And, no, we do not have that. 
We have 80 complete studies that were submitted to the EPA that 
cover all aspects of----
    Ms. Porter. Reclaiming my time, sir. I'm just trying to ask 
a factual question.
    Does the label in the United States have language like 
``highly toxic'' or ``poison,'' yes or no?
    Mr. Simmons. It does not.
    Ms. Porter. OK. So, the warning label here in the United 
States, though, does say that mild reactions may occur. It 
mentions hair loss, scratching, and redness. The most severe 
symptoms listed are eczema and lesions.
    Does this label mention--this is the warning label--does it 
mention the potential for death?
    Mr. Simmons. It does not. And, again, the label is----
    Ms. Porter. It does not. So, a pet owner, looking at this 
label that we're looking at, would have absolutely no reason, 
no way to know that Seresto may have caused roughly 100 pet 
deaths. That's what both the Canadian pest management agency, 
the PMRA, and the EPA found.
    Will you change this label so that it includes death as a 
possible side effect?
    Mr. Simmons. Congresswoman, we do not believe the 
scientific data warrants a label change. And, again, that is 
not just the 80 studies that were submitted. There's been 20 
additional added studies since and all of the oversight data 
that's been done on the 33 million pets over the 10 years.
    So, again, following an EPA-regulated process, we're always 
open. If a data warranted some need for a change, we would do 
that. But this is a public health business, just like human 
health, and data science and facts is absolutely critical to 
warrant any kind of a change to a label.
    Ms. Porter. Reclaiming my time, Mr. Simmons. Let's talk 
about--we can turn the screen-sharing off--let's talk about the 
EPA.
    The EPA encouraged both your predecessor, Bayer, and your 
company, Elanco, to update the warning label. Yet you just said 
that you never have.
    So, the Federal Government did, in fact, advise you to 
update the label and you failed to do so. Is that correct?
    Mr. Simmons. I do not believe that is correct. We are in a 
regular engagement with the EPA. We've not received any 
formal--there's no data that warrants that, and there's been no 
formal engagement on that to our----
    Ms. Porter. Reclaiming my time. Mr. Simmons. I don't want 
to argue the data because I'm not the data scientist here. I 
just want to--I trust the people at the EPA. So, let's go back 
to the EPA for a minute.
    The EPA asked Bayer, the predecessor here, in 2019 to help 
the Agency collect data on adverse incidents for cats and dogs, 
using the Seresto collar. EPA asked Bayer to split the 
registration for cats and dogs so the Agency could better 
understand and evaluate the risks for each type of pet.
    Bayer refused, saying that that change might have, quote, 
``an adverse impact on sales,'' and they also said, quote, ``It 
would be a substantial increase in work.''
    Mr. Simmons, are you willing to make that change and split 
the registration for cats and dogs as the EPA requested, or do 
you believe it's too much work?
    Mr. Simmons. I am willing to engage with the EPA on 
anything that the scientific data and an engagement under the 
regulatory body of the EPA merits is the right thing to do.
    We believe the 80 studies and all of the pharmacovigilance 
data that we've submitted to them stands, that this is a safe 
product, as well as all the value that this brings to the pets 
and to the human health with a tick-borne illness on over 
500,000 people a year that the CDC highlights.
    So, the value is significant. The risk is reasonable. 
Always we're willing to engage with the EPA.
    Ms. Porter. But with all respect, Mr. Simmons, it's not 
your job to decide if the risk is reasonable. That's the job of 
the regulatory body.
    My concern here is that Seresto is standing in the way of 
allowing the EPA to gather those necessary data and make that 
decision.
    I encourage Elanco to work with the EPA to get this data, 
and if they won't, then Seresto will have to come off the 
market because too many families have suffered already.
    I yield back.
    Mr. Krishnamoorthi. Thank you, Congresswoman.
    I'd like to now recognize Mr. Clyde for his five minutes of 
questions.
    Mr. Clyde. Thank you, Chairman Krishnamoorthi and Ranking 
Member Cloud.
    I feel obligated to begin by stating the obvious this 
afternoon: Today's hearing is a colossal waste of time and 
resources.
    Out of all the economic concerns keeping the American 
people up at night--namely, 40-year high inflation, inflation, 
and more inflation--I'm afraid flea and tick collars just don't 
quite make the cut.
    Yet here we are at the very first Economic and Consumer 
Policy Subcommittee hearing of 2022, to examine Seresto flea 
and tick collars. I mean, seriously?
    What comfort or assistance does this hearing render to 
families of Georgia's Ninth District struggling to make ends 
meet?
    What information does this hearing provide to small 
businesses in my district that are battling rising costs, 
supply chain disruptions, and labor shortages?
    What assistance does this hearing offer to northeast 
Georgians living paycheck to paycheck just to put people food 
on the table or dog food in the dog bowl?
    Have you seen the price of dog food lately? Rising 
inflation is driving it higher and higher.
    My Doberman Pinscher is on the Hill today, and I was going 
to have her join us if the topic was about the price of dog 
food, because, you know, she works for food. But it's not. It's 
about flea and tick collars.
    So, I thought I would share a few pictures of her instead. 
So, if you would roll the first picture.
    The first one, this picture was taken a few years ago--here 
we go--when the price of dog food was reasonable.
    And if you'd roll the second picture.
    This picture was taken a few months ago when the price of 
dog food began to greatly increase.
    And then the third picture was taken today--if you'll 
change that, thank you--the third picture was taken today after 
we realized that the focus of this hearing was not going to be 
about inflationary pressures on dog food, but it was going to 
be on flea and tick collars.
    As you can see, she is not happy with the ever-increasing 
price of dog food, dog bones, and dog treats.
    Thank you.
    But Democrats have managed to bury their heads in the sand 
for over a year as President Biden's disastrous agenda, failed 
economic policies destroy the lives of middle-class Americans.
    The American people just don't have the luxury of living in 
the left's utopian fantasy because consumers are burdened with 
the inescapable reality of skyrocketing inflation and record 
high gas prices every solitary day.
    After more than a year of excuses, lies, and deception, 
Americans recognize the truth: That President Biden--with the 
help of congressional Democrats--ignited inflation by injecting 
trillions of dollars into the economy.
    Despite month after month of sticker shock and price pains, 
Democrats have continued to carelessly balloon our national 
debt, which is now over $31 trillion, and have naively ignored 
the Jimmy Carter era levels of inflation.
    Instead of holding ridiculous, nonsensical hearings that 
provide absolutely no help to American workers and families 
struggling to put food on the table, fill their gas tanks, and 
purchase common goods, this subcommittee must do its job and 
hold legitimate hearings on the real economic issues at hand so 
we can discuss effective solutions to get our country back on 
track.
    Now, I'm not going to be holding my breath, because my 
Democrat colleagues conveniently take cover every time 
President Biden's self-inflicted crises damage our country.
    Yes, today's hearing is a massive waste of time, but it is 
also evidence of a desperate distraction to fill the empty void 
of leadership, allowing Democrats to avoid their legitimate 
responsibility of conducting proper oversight over the Biden 
administration.
    Make no mistake, the American people deserve better, they 
deserve real issue hearings, and they deserve it now.
    I have a question, Ms. Sheffield. Thank you for being here 
in person today.
    In your testimony, I believe that you mentioned pet food 
prices are increasing at a rate greater than the reported 40-
year high rate of inflation. I think you mentioned over nine 
percent, where the inflation rate is just over eight percent.
    So, what does your experience and research show is 
happening to American families due to the increasing prices of 
pet food?
    Ms. Sheffield. Well, certainly we are seeing reports that 
animals, some animals, sadly, are being abandoned, and some 
animals are being taken to shelters because families have to 
choose between feeding their children and feeding their dogs or 
their cats or other pets.
    And I think that in this developed country, a First World 
country, this should never be an issue. We should never have 
gotten to this point.
    And this hearing, I find very puzzling why there is no one 
from the actual agency in question, the EPA, present.
    Mr. Clyde. Thank you. Thank you for that. And I agree with 
your assessment.
    With that, I yield back.
    Mr. Krishnamoorthi. Thank you, Mr. Clyde. Thanks for 
sharing the pictures of your dog too. I notice she was not 
wearing a Seresto collar.
    Let me call on Mr. Johnson.
    You are now on for five minutes, Mr. Johnson.
    Mr. Johnson?
    OK. Let's go to Mr.--oh, Shontel Brown.
    Congresswoman Brown, you are recognized for five minutes.
    Ms. Brown. Thank you, Chairman Krishnamoorthi, for holding 
this hearing.
    As a former dog owner, I take the safety of pet products 
very seriously. It is deeply troubling to find that Seresto 
flea and tick collars are killing our pets instead of keeping 
them healthy.
    Mr. Simmons, Elanco and Bayer signed an agreement for 
Elanco to purchase Bayer's Animal Health Division in August 
2019. Yes, or no?
    Mr. Simmons. That is correct.
    Ms. Brown. Did the purchase relieve Elanco from any 
reporting duties owed to EPA concerning products it had 
acquired in connection with the purchase of Bayer Animal 
Health? Yes, or no?
    Mr. Simmons. I do not believe that it did at all, no.
    Ms. Brown. Well, nevertheless, between April 2020 and March 
2021, Elanco did not provide EPA any incident reports 
concerning Seresto. Yes, or no?
    Mr. Simmons. I would like to explain. We did continue to 
report them physically. We sent them in the mail. They changed 
during the pandemic to electronically. So, they continued to be 
sent but not received. As soon as senior management found this 
out, it was changed within days.
    Complete reports were sent to them. There was no change in 
the data, in all the data that's been submitted.
    But I will take accountability. That's unacceptable for our 
organization. And the quality changes have made since then.
    But that happened during the pandemic, that is correct.
    Ms. Brown. OK. So, Mr. Simmons, it is your testimony here 
today that between April 2020 and March 12, 2021, nearly one 
full year, Elanco received zero adverse incident reports 
concerning the Seresto collars from consumers?
    Mr. Simmons. The reports were sent in. They were completed 
and received by the EPA, but not on a monthly or quarterly 
timely basis because of the mix-up in the pandemic. There was 
not any slowing down of sending them. It was just a process 
change.
    But all of that data, every incident report that's ever 
happened for the 10 years, has been submitted to the EPA and 
received under normal process.
    But during that change from hard copy to digital, yes, 
there was a period where they were sent back to us.
    Ms. Brown. OK. So, in fact, it cannot be your testimony, 
because as USA Today reported, and other sources have now 
publicly reported, Elanco failed to turn over as many as 11,000 
adverse incident reports concerning the Seresto collar between 
mid-2020 and early 2021.
    Mr. Simmons. The EPA received all of those reports, not in 
the timely fashion as requested because of the change from 
physical copy to digital copy. The intent was that they were to 
be sent, and it was a process change and was not fully executed 
against.
    Ms. Brown. I have no further questions.
    Mr. Simmons. But all reports, all data have been----
    Ms. Brown. I'm reclaiming my time. I have no further 
questions, and I yield back.
    Thank you.
    Mr. Simmons. Thank you.
    Mr. Krishnamoorthi. Let me take some of that time that 
you're yielding back, Congresswoman Brown.
    Now, let me go to Dr. Donley for a second.
    Can you put up the chart? Actually, show me the chart with 
regard to the--yes, thank you, that one.
    So, Dr. Donley, I'm holding up the chart with regard to the 
estimates of reported pet deaths probably or possibly caused by 
the Seresto collar. This 0.51 number, that represents 12 deaths 
out of 2,340 pet deaths that Seresto says was probably or 
possibly caused by the Seresto collar, but not because of the 
active ingredients, but because of entrapment and other types 
of injuries, whereas the PMRA and EPA say something very, very 
different.
    Are you familiar with the way that Elanco has hired 
consultants, independent review bodies, such as SCI and KNW 
consultancies, to come up with these numbers?
    Mr. Donley. Yes, I'm familiar with it.
    Mr. Krishnamoorthi. And tell me your thoughts about those 
consulting firms and what they do for Elanco and how you could 
come up with a number that low compared to what other agencies 
have come up with.
    Mr. Donley. So, it's very common for pesticide companies to 
hire consultants and to pay those companies money to do 
analysis for them. This is very common.
    Mr. Krishnamoorthi. So, if they're paid money, are they 
going to be more biased than scientists at the PMRA and EPA?
    Mr. Donley. There's a rich amount of literature showing 
that if you have a financial conflict of interest, if you are 
profiting off of something, you're going to find that that 
product is generally much safer than an independent scientist 
would, for instance.
    Mr. Krishnamoorthi. I understand. Thank you.
    I'm going to now recognize Mr. Johnson.
    Congressman Johnson, you are now on the clock.
    Mr. Johnson. Thank you, Mr. Chairman. And thanks for 
conducting this investigation into how man's best friend has 
been treated by Republicans.
    Under Republican leadership, Congress has defunded 
persistently the EPA and has installed, under Donald Trump, 
administrators who undermine its purpose. And so, what we have 
as a result is pets needlessly suffering grim fates and their 
owners being left saddened by what they're trying to do in 
order to make their pets' lives just a little better.
    And these Seresto collars caused more harm than fleas and 
ticks ever could. Eighty-six thousand consumers filed 
complaints with the EPA. But when it came to protecting man's 
best friend, we couldn't depend on the EPA. And it refuses--or 
it refused to act on the concerns of the public.
    Mr. Donley, the EPA knew about these reports for five 
years, and the first reports were from 2015, when 50 to 100 
consumers began reporting the deaths of their pets linked to 
the Seresto flea and tick collar.
    And when you have 50 to 100 reported incidents, how many 
more can we estimate actually occurred? How many more pet 
deaths and injuries occurred? Do you have any way of telling, 
of knowing, estimating?
    Mr. Donley. Well, it's probably going to differ between 
pesticides. But what we do know is that pesticide incident 
reporting is much far lower than the actual incidents 
themselves.
    For some pesticides, the reporting rate is as low as four 
percent. So only 1 in 25 harms from that pesticide will 
actually get reported to the proper authorities.
    So, you're looking at numbers that are actually drastically 
underestimating the true scope of harm here.
    Mr. Johnson. And the only reason that the public knew about 
the harm caused by this pesticide is because the Center for 
Biological Diversity publicly petitioned the EPA to cancel 
registrations for Seresto flea collars.
    If they had not brought this to light, do you think we 
would even know of the dangers presented by these collars?
    Mr. Donley. No, we wouldn't. The investigation that came 
out in USA Today in 2021 really brought this to the public 
attention. And if there wasn't that amount of pressure from the 
public, this would just still be completely unknown.
    EPA, for the last 10 years, has not done anything to alert 
consumers to the harms associated with this product or any 
other pesticide products where there are a very high number of 
incidents.
    Mr. Johnson. Thank you.
    Ms. McCormack, in 2016 Canadian officials contacted the EPA 
about Seresto and ultimately decided to not allow the Seresto 
collar to be sold to the Canadian public. It would seem that 
this decision was made due to evidence that the collars would 
be dangerous to pets in Canada.
    Why did the EPA fail to take proper action based on what it 
knew about these collars six years ago?
    You should unmute.
    Ms. McCormack. Yes, I'm doing that. I think some of the 
people at EPA are programmed to go along with whatever industry 
says. It makes life easier for you, you can go home earlier, 
and you can also get promoted easier if you go along with what 
industry says.
    It's unfortunately a problem there, and I've seen it over 
the years, and it's very hard to do something about it.
    But I think Canada's analysis was very scientific. It was 
not only based on incident data and sales data. It was based on 
the toxicity of the two pesticides in Seresto. And they looked 
at the consistency and what happened eventually with the pets 
that were exposed to Seresto.
    But unfortunately, EPA decided they would keep monitoring 
the situation, and they didn't give a deadline as to when they 
would stop monitoring and do something about the pesticide.
    Mr. Johnson. Well, thank you.
    I'm out of time. But, Mr. Chairman, this is not an example 
of American exceptionalism. And with that, I yield back.
    Mr. Krishnamoorthi. Thank you, Congressman Johnson.
    I will take a couple minutes here for closing remarks, and 
then we'll adjourn.
    I just want to thank all the witnesses for coming, and 
thank you to Ms. Sheffield for appearing in person, and thank 
you to all of our witnesses for appearing by Zoom.
    This is a very serious topic. American families consider 
pets as one of their family, and when, as Mr. Simmons has said 
in the past and in various statements, when a pet is healthy, 
their owners are healthier too.
    And the flip side is unfortunately true as well, which is 
when a pet is unhealthy, their owners and the family are left 
distraught.
    And so, in this particular instance, there are a hundred 
thousand incident reports of pets who suffered in a lot of 
cases very grievous harm and thousands of pet deaths.
    Two regulatory bodies, the EPA and the PMRA, dug deep into 
why there were these pet deaths and came up with rather 
startling conclusions.
    On the one hand, Canada acted. They decided not to have 
Seresto being sold in the marketplace. If I might cite what Ms. 
Sheffield said, they acted promptly.
    The EPA did not. The EPA dragged its heels for years and 
years and years, and here we are.
    And so, I am very disappointed with Seresto--I'm sorry, 
Elanco--for not having truly independent bodies review the 
science and provide it with detailed analysis, instead 
preferring to have SCI and KNW and other outfits whom they pay 
handsomely to provide rather alarming analyses such as what 
we've had.
    Point-fifty-one (0.51) percent of these incidents being 
possibly or probably caused by Seresto does not pass the smell 
test. It just does not pass the smell test. Out of more than 30 
million collars sold in the United States, for Elanco to say 
that 12 pets may have possibly or probably died because of the 
collar but not because of any of its active ingredients does 
not seem plausible in the least.
    And so here we are, and we have to make some decisions. And 
so because of the tremendous number of pet incidents, the 
tremendous number of deaths, even when factoring in sales, I 
sadly have no choice but to recommend that the EPA commence a 
Notice of Intent to Cancel proceedings and to fully investigate 
what's going on with the Seresto collar.
    And I respectfully request Elanco to voluntarily recall 
these collars at this time, pending this further investigation.
    Finally, a word for EPA. What they have done is completely 
unacceptable. They have been asleep at the switch with regard 
to Seresto collars. Millions of pet owners out there are 
waiting for the EPA to act, and we are calling upon the EPA to 
act now.
    With that, in closing, I just want to say--I'd like to 
recognize Mr. Cloud.
    Do you have any closing remarks?
    Mr. Cloud. Yes. Thank you, Mr. Chairman.
    And thank you, again, Ms. Sheffield, for showing up in 
person and to the other witnesses who joined us online and to 
the committee members who participated.
    I appreciate this committee and the mandate upon this 
committee and the work that we have, and certainly the 
potential we have to work on some important things. And I would 
just continue to point to the fact that people--people--humans 
are suffering throughout this Nation each and every day, making 
tough decisions about food, about fuel, about their families.
    And this being the Economic Policy Committee, I would 
recommend that we be looking at things like our energy policy 
that has helped create this issue, supply chain breakdown, food 
supply shortage, including the baby formula shortage.
    We should be talking about inflation and interest rates. We 
also could be talking about the businesses who can't operate 
their business because of the smash-and-grab rioting that's 
happening in cities and the policies from leftist DAs who make 
it hard for businesses to work and to thrive, and the families 
that are affected by that and the communities that are 
certainly affected by that.
    So, there's certainly a lot of things that are on the mind 
of the American people when it comes to the economic policies 
that are causing real troubling times for us right now.
    We were headed back to economic recovery. Right now, no one 
can find people who will work. Every industry I talk to right 
now is having trouble finding people.
    That's the same answer I would get when I would ask the 
industries three years ago, but it was for very different 
reasons. Three years ago, we had every demographic throughout 
America wages were going up and people were thriving, and we 
had as close as we've ever been to full employment.
    Now we see a very different picture and the American people 
are hurting. And so, we need to get back to that and making 
sure that American families are able to thrive here in the 
United States.
    Thank you, and I yield back.
    Mr. Krishnamoorthi. Thank you so much, Mr. Cloud.
    Without objection, all members will have five legislative 
days within which to submit additional written questions to the 
chair for Mr. Simmons, Dr. Donley, Ms. McCormack, and Ms. 
Sheffield.
    These questions will be forwarded to the respective 
individual for his or her response. I ask our witnesses to 
please respond as promptly as you are able.
    Now this hearing is adjourned.
    [Whereupon, at 4:59 p.m., the subcommittee was adjourned.]