[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.]