[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
THE OUTBREAK OF SALMONELLA IN EGGS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 22, 2010
__________
Serial No. 111-157
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
BRUCE L. BRALEY, Iowa GREG WALDEN, Oregon
Vice Chairman Ranking Member
EDWARD J. MARKEY, Massachusetts ED WHITFIELD, Kentucky
DIANA DeGETTE, Colorado MIKE FERGUSON, New Jersey
MIKE DOYLE, Pennsylvania TIM MURPHY, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas
DONNA M. CHRISTENSEN, Virgin
Islands
PETER WELCH, Vermont
GENE GREEN, Texas
BETTY SUTTON, Ohio
JOHN D. DINGELL, Michigan (ex
officio)
C O N T E N T S
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Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Prepared statement........................................... 5
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 8
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 10
Prepared statement........................................... 13
Hon. Robert E. Latta, a Representative in Congress from the State
of Ohio, opening statement..................................... 15
Prepared statement........................................... 16
Hon. Bruce L. Braley, a Representative in Congress from the State
of Iowa, opening statement..................................... 20
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 21
Hon. Michael F. Doyle, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 22
Hon. Donna M. Christensen, a Representative in Congress from the
Virgin Islands, opening statement.............................. 23
Hon. Edward J. Markey, a Representative in Congress from the
Commonwealth of Massachusetts, prepared statement.............. 24
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 112
Witnesses
Sarah Lewis, Victim of Salmonella outbreak....................... 25
Prepared statement........................................... 28
Carol Lobato, Victim of Salmonella outbreak...................... 30
Prepared statement........................................... 32
Austin DeCoster, Owner, Wright County Egg........................ 46
Prepared statement........................................... 48
Peter DeCoster, Chief Operating Officer, Wright County Egg....... 61
Orland Bethel, President, Hillandale Farms of Iowa............... 62
Duane Mangskau, Production Manager, Hillandale Farms of Iowa..... 62
Prepared statement........................................... 65
Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, U.S.
Food and Drug Administration................................... 85
Prepared statement........................................... 88
Answers to submitted questions............................... 137
Submitted Material
Document binder.................................................. 115
Letter of October 15, 2010, from Mr. Burgess to Mr. Waxman....... 133
Letter of October 18, 2010, from Mr. Waxman to Mr. Burgess....... 135
Statement of United States Senator Tom Coburn.................... 136
THE OUTBREAK OF SALMONELLA IN EGGS
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WEDNESDAY, SEPTEMBER 22, 2010
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 12:06 p.m., in
Room 2123, Rayburn House Office Building, Hon. Bart Stupak
[chairman of the subcommittee] presiding.
Present: Representatives Stupak, Braley, Markey, DeGette,
Doyle, Christensen, Dingell, Waxman (ex officio), Burgess, and
Latta.
Staff Present: Phil Barnett, Staff Director; Bruce Wolpe,
Senior Advisor; Rachel Sher, Counsel; Eric Flamm, FDA Detailee;
Dave Leviss, Chief Oversight Counsel; Meredith Fuchs, Chief
Investigative Counsel; Stacia Cardille, Counsel; Erika Smith,
Professional Staff Member; Scott Schloegel, Investigator; Ali
Neubauer, Special Assistant; Karen Lightfoot, Communications
Director, Senior Policy Advisor; Elizabeth Letter, Special
Assistant; Lindsay Vidal, Special Assistant; Mitchell Smiley,
Special Assistant; Krista Rosenthall, Minority Counsel,
Oversight; and Alan Slobodin, Minority Chief Counsel,
Oversight.
Mr. Stupak. This meeting will come to order.
Today we have a hearing entitled, ``The Outbreak of
Salmonella in Eggs.''
The chairman, ranking member, and chairman emeritus will be
recognized for a 5-minute opening statement. Other members of
the subcommittee will be recognized for a 3-minute opening
statement. I will begin.
Before we begin, I am going to ask unanimous consent that
the contents of our document binder be entered into the record,
provided that the committee staff may redact any information
that is business proprietary, relates to privacy concerns, or
is law enforcement-sensitive. Without objection, the documents
will be entered into the record.
[The information appears at the conclusion of the hearing.]
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. Today's hearing, entitled ``The Outbreak of
Salmonella in Eggs,'' will mark the thirteenth hearing of the
Oversight and Investigations Subcommittee since January 2007
regarding food-safety issues. We have examined Salmonella
outbreak associated with peanut butter products manufactured by
the Peanut Corporation of America, which resulted in criminal
investigation. Additionally, we have investigated an E. coli
outbreak traced to tainted spinach, the melamine-contaminated
pet food, and other food-safety inquiries.
Today we will continue our examination into the food-safety
problems that continue to plague farms, producers, and American
consumers. This time around, we are dealing with two companies
producing eggs in the State of Iowa and sold nationwide. One
thousand six hundred eight people were infected with Salmonella
Enteritidis from the eggs between May 1st and September 14th.
What we learned about the two egg operations in Iowa that
produced the tainted eggs paints a very disturbing picture of
egg production in America. When FDA inspectors entered the
plants in August, they found facilities riddled with unsanitary
and unsafe conditions.
According to the inspectors' preliminary reports, employees
working within the hen laying houses did not wear or change
protective clothing when moving from house to house. Live
rodents were located in the laying houses, as the picture up
here shows. And you can see the eggs just to the left of the
circle there. We have liquid manure oozing out of buildings.
And there is another photograph there that shows it actually
coming out of a doorway. We have dead and decaying chickens
found at the sites; live and dead flies too numerous to count.
Most importantly, positive test results for Salmonella were
found in both farms, including in the feed mill and in the
water used to wash the eggs. Even more alarming, during the
course of its investigation, the committee has obtained records
that showed that Wright County Egg tested positive for
Salmonella contamination in its Iowa facilities prior to the
widespread outbreak of the illness. Environmental sample
reports taken in and around the chicken cages between 2008 and
2010 indicate that Wright County Egg received 426 positive
results for Salmonella, including 73 that were potentially
positive for Salmonella Enteritidis, the same strain that
sickened 1,600 people.
Perhaps these findings should not be a surprise given the
record of the DeCoster Farm operation that owns the Wright
County Egg facilitates. In fact, DeCoster Farm had so many
environmental and safety violations that the State of Iowa
declared them habitual violators and assessed a total of
$219,000 in civil fines. DeCoster Farm is the only entity to
receive the habitual-violator status from the State of Iowa.
The work of this subcommittee, coupled with the work of the
Health Subcommittee and the full committee, on food safety
culminated in the bipartisan introduction of H.R. 2749, the
Food Safety Enhancement Act. This legislation passed the
committee by unanimous consent in the U.S. House of
Representatives on July 30, 2009. The food-safety legislation
has been stalled in the Senate for more than a year.
The provisions contained in our food-safety legislation
would address several concerns raised by this outbreak. For
example, the bill would require new trace-back regulations that
enable the Secretary to identify the history of the food as
quickly as possible but no later than 2 business days.
The food-safety legislation would give the FDA the needed
authority to issue mandatory recalls and subpoena records of
tainted food products. While in this case the two Iowa farms
did issue voluntary recalls, the FDA should not have to rely on
the company's goodwill when the public health is at risk.
The legislation will also give the FDA a guaranteed
consistent source of funding through the registration fees.
These fees will allow the FDA to conduct more inspections, to
be proactive, to prevent outbreaks from occurring.
We will hear testimony from witnesses with different
perspectives on the recall: victims of this outbreak, the
manufacturers of the recalled eggs, and a representative from
the FDA.
On our first panel, we have two victims that were affected
by the Salmonella Enteritidis: Sarah Lewis and Carol Lobato.
Sarah is a 30-year-old mother of two, who contracted
Salmonella from eating a tart at her sister's college
graduation banquet. Sarah has been admitted twice to the
hospital to be treated for Salmonella and is just now beginning
to feel better. Sarah works at her parents' butcher shop, which
they have owned since the 1970s. Sarah is very familiar with
local and State regulations, as they are subject to constant
inspections.
Carol is a 77-year-old mother of four and grandmother of
four. When Carol and her husband took her grandson out to
dinner in Colorado, she contracted Salmonella. Carol is very
familiar with egg farms, as she was raised in Iowa on a chicken
farm. Carol spent 5 days in the hospital, suffering from toxic
shock, severe diarrhea, and vomiting.
Our second panel will include Austin DeCoster, owner of
Wright County Egg; his son, Peter DeCoster, chief operating
officer; Orland Bethel, president of Hillandale Farms of Iowa;
and Duane Mangskau, production manager, Hillandale Farms of
Iowa.
It is my sincere hope that these gentlemen will be
forthcoming regarding the events of the outbreak and what they
are doing to ensure eggs produced on their farms are safe for
the American people.
On our third and final panel, we will have Dr. Josh
Sharfstein, deputy commissioner from the Food and Drug
Administration.
I look forward to hearing from our witnesses today about
the progress that has been made since the outbreak occurred and
how we can strengthen our food-safety system.
Our committee began pushing for reform of the food-safety
system more than 3 years ago. Our hearings have demonstrated
the weaknesses in our food-safety systems that will remain
until we enact an effective food-safety bill into law. Make no
mistake about it: Without legislative action, it is not a
matter of if, but when, more lives will be put at risk by
another outbreak, as evidenced by today's hearing. This
outbreak affected more than 1,600 individuals, 2 of which are
here to tell their story today. Fortunately, no one has died.
In each of our 13 food-safety hearings, we are reminded
that each year approximately 76 million Americans become sick
from food-borne disease such as Salmonella, 325,000 are
hospitalized, and 5,000 deaths will occur in the United States.
It is time to give our regulators the tools they need to be
proactive in the fight against food-borne illnesses and
diseases.
[The prepared statement of Mr. Stupak follows:]
[GRAPHIC] [TIFF OMITTED] T8134A.001
[GRAPHIC] [TIFF OMITTED] T8134A.002
[GRAPHIC] [TIFF OMITTED] T8134A.003
Mr. Stupak. I yield back the balance of my time. I next
turn to the ranking member of the subcommittee, Mr. Burgess of
Texas, for an opening statement.
Mr. Burgess?
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman.
I want to thank you and our witnesses who are here with us
today for participating in this very important hearing.
Because, once again, as you have already articulated, we find
ourselves in the middle of a food-borne illness outbreak, this
time involving the safety of a food item that we frequently
buy, eat, and serve to our families.
Just this morning, I viewed pictures taken by the Food and
Drug Administration at both companies' egg production
facilities during the FDA inspections. These photos document
some extremely unsanitary and unsightly conditions, including
piles of chicken manure that was pushed up against an open
doorway and leaking outside a laying house, dead flies by the
thousands, rodent holes, structural damage to buildings, and
chicken carcasses.
Now, these companies must be able to account for and
respond to these photos. And I am also anxious to ask the Food
and Drug Administration if the public can take comfort in the
fact that these observations are not normal. I wonder if the
FDA will be able to answer this question, considering that they
have not inspected any other egg production facilities besides
these two in quite some time.
To date, the Centers for Disease Control has reported that
over 1,500 illnesses are likely to be associated with
Salmonella in eggs. I want to thank our first panel of witness,
both victims of this outbreak, for appearing today to share
your stories.
The outbreak of Salmonella in eggs is unique in that the
Salmonella contamination is not from the shell but from the
interior of the egg. Test results indicate that the laying hens
themselves were infected with Salmonella and the hens passed
the contamination through the inside of the eggs.
One very important fact about the investigation, perhaps an
indication that this hearing is held before we have all the
facts, is that the ultimate source of the Salmonella
contamination is not yet certain. Concerns about the feed given
to the young chickens and the unsanitary conditions of the
suspect farms have been raised. I hope that the testimony
provided today will move us closer to understanding the
original source of the contamination and how to prevent it from
ever happening again.
By early August, the trace-back investigations completed by
the CDC, the FDA, and the State partners indicated a common
source of contamination from a single farm owned by the
DeCoster family. On August 13, Wright County Egg issued a
voluntary recall of approximately 380 million. And on August
19, Hillandale, owned by Mr. Orlando Bethel, issued a voluntary
recall of eggs after being suspected as a potential source of
contamination.
Responsible corporate actors are crucial in maintaining a
safe and reliable food industry. Companies must observe good
manufacturing agricultural practices. The documents and
subsequent photographs obtained by this committee raise serious
questions about whether both of these companies were
consistently maintaining such good practices.
Of particular interest are the documents that show the test
results done on behalf of DeCoster Farms in 2008 through 2010.
The occurrence of Salmonella positive environmental samples is
frequent: 72 of environmental sponges were tested for
Salmonella, and only 8 were negative.
Experts who have spoken to staff have indicated that
environmental samples that turn up positive for Salmonella may
be expected on a farm and do not necessarily indicate that the
food and product is contaminated, but I want to know if these
findings warrant cause for alarm and become troublesome if
positive results become a pattern and are not rectified.
I want to ask the DeCosters about these tests and what the
company gleaned from this information, and I am also interested
in what the FDA has to say about this, as well.
Other documents obtained by the committee include numerous
sanitation reports completed by the Department of Agriculture
and marketing services, some of the hazard plans,
unsatisfactory conditions--unsatisfactory sanitary conditions,
and an array of observations of Wright County Egg over a 4-year
period of time. I would like Mr. DeCoster to comment and
explain these records.
Although the Food and Drug Administration has told my staff
that eggs have historically been considered a high-risk food
product, the FDA did not inspect these egg facilities prior to
the outbreak. During the inspections discussed in the FDA Form
483, the investigators noted that each company failed to fully
implement and follow procedures in their Salmonella-prevention
plans, and now we have the pictures to document that failing.
Tests conducted in August by FDA investigators at Wright
County Egg were positive for the same and other strains of
Salmonella. These samples were taken from manure pits,
walkways, chicken feeds, and other surfaces. I want an up-to-
date report from the companies and the FDA explaining where the
exact matches of Salmonella to the outbreak strain that caused
human illnesses were found and how the companies and the Food
and Drug Administration interpret these results.
It is important for the FDA, as well as the industry, to
work cooperatively internally with other Federal agencies and
with health and agricultural departments to reduce the number
of and help prevent food-borne illness. A new egg rule became
effective this July that addresses several of these concerns
associated with eggs involved in this outbreak. However, it
took the Food and Drug Administration over 10 years to act on
this issue, illustrating the continued systemic, problematic,
and bureaucratic weaknesses that plague the Food and Drug
Administration. The future FDA should not be a reactive body;
it should be proactive.
Mr. Chairman, I support conducting this investigation and
holding a hearing. I am concerned that we are not always done
in a most bipartisan and useful manner. September 9, I sent a
letter to you stating that I thought the CEO of the FDA, the
commissioner of the FDA, Dr. Margaret Hamburg, should be here
to offer the agency's official testimony. She and the Obama
administration have repeatedly stated publicly that food safety
and the resources of the FDA is a top priority and must be
taken seriously, quickly addressed. In the 110th Congress,
Commissioner Andrew von Eschenbach was here four times and
testified on food safety.
The majority declined to invite a representative from the
United States Department of Agriculture to testify, even though
the committee sent a document request to the agency, held a
briefing, and received thousands of pages of relevant
information concerning their role in the regulation of these
farms and this outbreak.
Staff has obtained and reviewed relevant revealing USDA
documents, including USDA shell egg plant system audit reports,
preoperative sanitation reports. And the USDA inspector notes
an observation from Wright County Egg. This hearing would be
more productive if a USDA official were here to answer
questions related to these documents and perhaps answer the
number-one question: Why didn't you say anything to the Food
and Drug Administration?
The ultimate goals of this hearing are good, and I support
the food-safety legislation this House has passed in 2009. I am
eager for the Senate to move on this important issue.
Mr. Chairman, I thank you for your forbearance, and I will
yield back the balance of my time.
Mr. Stupak. The gentleman's time has expired.
Mr. Waxman, chairman of the full committee, for an opening
statement, please.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Chairman Stupak, for
calling this hearing.
And before I address the concerns of this hearing
specifically, I want to thank you for a record of 4 years of
diligence in pursuing issues of food safety. Your work stands
out as a model of congressional oversight and investigation,
and you have illustrated very clearly the need for stronger
food-safety laws. You have had 13 hearings in the last 4 years.
You educated the members of this committee and the American
people about glaring deficiencies at all levels of our food-
safety network.
Today we are going to examine two of the Nation's largest
egg producers, Wright County Egg and Hillandale Farms of Iowa.
They have been asked to appear today because of evidence that
they produced eggs in filthy conditions that caused food
poisoning in thousands of consumers across the country.
The DeCoster family, which owns Wright County Egg and
raised eggs for Hillandale Farms in Iowa, has known about
safety problems at these facilitates for decades, yet they
continue to persist. Over 30 years ago, eggs from a farm
operated by the DeCoster family killed 9 people and sickened
500 in New York. Twenty years ago, Maryland ordered the
DeCosters to stop selling eggs in the State because of the
contamination problem.
As the committee revealed last week, environmental testing
at DeCoster facilities over the last 3 years tested positive
dozens of times for potential contamination by a dangerous form
of Salmonella. Yet, despite these warnings, the DeCoster
facilities were operated with a shocking level of disregard for
basic food-safety controls.
Food-safety inspectors from FDA finally went inside the
facilities in August. And as a photograph I would like to have
displayed shows, they saw decaying corpses of rodents. They
also saw unsealed rodent holes along the walls of a henhouse.
Conditions were so bad in one facility that the wall of the
barn was bursting open because of the excessive manure.
DeCoster farms have had warning after warning, yet they
continue to raise chickens in slovenly conditions and to make
millions of dollars by selling contaminated eggs. The risks are
real.
Our first two witnesses today are Ms. Sarah Lewis and Ms.
Carol Lobato. Ms. Lewis ate contaminated eggs while celebrating
her sister's college graduation. Ms. Lobato was sickened when
she went out to dinner with her grandson. They were both
hospitalized and gravely ill. And I commend both of them for
their courage in speaking out today and being with us at this
hearing.
Unfortunately, their horrific experiences were shared by
many others. The eggs that are the subject of today's hearing
sickened over 1,600 people in 11 States.
This hearing will make abundantly clear that our food-
safety laws need a thorough overhaul. Under the leadership of
our chairman emeritus, John Dingell, the committee and the
House passed a bipartisan bill last year that would protect
consumers from these abuses. The House bill would require farms
to report to FDA when they find their unsafe food has entered
the food supply. It would give the FDA the clear authority to
access records on egg farms during investigations. It would
empower the FDA to mandate recalls when firms do not comply
voluntarily. These are the kinds of tools that will ensure the
safety of the food we consume.
Yet, as we hold this hearing today, one Senator, a lone
Senator, Tom Coburn, is holding this vital safety legislation
hostage in the Senate. His actions are preventing the FDA from
strengthening its oversight and enforcement programs. In fact,
they are preventing the Senate of the United States from
debating the issue, offering amendments, and making decisions
about the legislation.
And I have a plea for Senator Coburn: For the sake of Ms.
Lewis, Ms. Lobato, and hundreds of thousands of Americans who
are poisoned by Salmonella every year, please lift your hold
and allow this vital safety legislation to move forward.
We are going to have some tough questions today for Jack
DeCoster, the CEO of Wright County Egg, and Orland Bethel, the
CEO of Hillandale Farms. But I do want to thank them for
appearing here voluntarily and for cooperating with our
committee's investigation.
I also want to thank FDA Deputy Commissioner Dr. Joshua
Sharfstein for testifying before us today.
Our goal is to make American families safer. That is why
this hearing is so important and why we must reform our food-
safety system so that we can eradicate or at least reduce food-
borne illnesses.
Imagine: The FDA cannot get information from these farms.
They don't have the ability to subpoena. They have to be given
to them voluntarily. They can't issue a warrant. They have to
try to issue a warrant to get information. There is no
obligation by these farms to report to the FDA, even when they
know there is a food-safety problem.
This is unthinkable. That is why the House unanimously--
this committee unanimously approved the bill and the House
overwhelmingly adopted it. And now we want the Senate to act.
Let's don't go home from Congress without passing food-safety
legislation.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Waxman follows:]
[GRAPHIC] [TIFF OMITTED] T8134A.004
[GRAPHIC] [TIFF OMITTED] T8134A.005
Mr. Stupak. Thank you, Mr. Waxman.
Mr. Latta for an opening statement, please, 3 minutes.
OPENING STATEMENT OF HON. ROBERT E. LATTA, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO
Mr. Latta. Thank you, Mr. Chairman, Ranking Member Burgess.
Thank you for holding this subcommittee hearing on the outbreak
of the Salmonella in eggs, as the incidence of contaminated
food products are a serious concern for our public health.
I am very glad that the two witnesses on our first panel
who were affected by these eggs are here today and are on the
road to recovery and able to be with us.
This hearing is also of grave concern to me because egg
production is critical to my State, Ohio, which is the second-
largest egg-producing State in the Nation. I know many of you
have heard me in the past say that I represent the largest
manufacturing district in Ohio, but at same time I also
represent the largest agricultural district in the State of
Ohio. And in those numbers, I also am home to one of two of the
top egg-producing counties in the Nation. When you look at
465.5 million eggs being produced in my district, that has an
economic impact of $102.4 million. Ohio is also 1 of the 10
States with an egg quality assurance program, with the aim to
minimize Salmonella in eggs.
First of all, I think it is important that we remember that
the purpose of this hearing is to get the facts. While we have
the FDA Form 483 with its general observations about the
conditions at the Wright County Egg and the Hillandale Farms
operations in Iowa that are being investigated, we do not have
the establishment inspection report, which will provide more
clear answers.
Furthermore, I am disappointed that the FDA commissioner is
not here to testify, nor is a representative from the USDA. We
need to get these answers and hear what went wrong from these
producers so that the industry can learn from this recall. We
do not want the public to lose confidence in our egg producers.
Several of the egg producers in my district are fourth-
generation farmers and have been committed to producing a safe,
healthy product for years. If we have overburdening regulations
that are placed out there, many of these farmers may be forced
out of business, unfortunately preventing a fifth generation
from being able to farm.
The safety and security of our Nation's food supply is of
the utmost importance to me. Mr. Chairman, I want to thank you
very much for the opportunity. And I look forward to hearing
the testimony from our witnesses on the panel today.
And, Mr. Chairman, if I may, I would also like to submit
for the record from the Ohio Poultry Association a document on
egg facts in Ohio.
Mr. Stupak. Without objection, that will be made part of
your opening statement and we will receive the document.
Mr. Latta. Thank you. And I yield back.
[The prepared statement of Mr. Latta follows:]
[GRAPHIC] [TIFF OMITTED] T8134A.006
[GRAPHIC] [TIFF OMITTED] T8134A.007
[GRAPHIC] [TIFF OMITTED] T8134A.008
[GRAPHIC] [TIFF OMITTED] T8134A.009
Mr. Stupak. Thank you.
Mr. Braley from Iowa for an opening statement, please.
OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF IOWA
Mr. Braley. Thank you, Mr. Chairman.
Some of my earliest memories are walking into my
grandparents' henhouses in Iowa to gather eggs. There was
something almost spiritual about this daily routine act.
Growing up in Iowa, you couldn't avoid commercials promoting
``the incredible, edible egg.'' Eggs were a staple in our diet.
We ate them fried, poached, hardboiled, softboiled, overeasy,
overhard, sunny side up, scrambled, in omelets. And that was
just for breakfast. We truly believed that eggs were nature's
most nearly perfect food.
Growing up in Iowa, I don't remember my mother buying eggs
in a supermarket. We drove out to the country and we bought
them right off the farm from the mothers of the kids we went to
school with. We dyed them at Easter, and we threw them on
Halloween, and we never, ever imagined that they could cause
life-threatening illness and kill us.
That is why the recent revelations of an incomprehensible
half-billion egg recall originating in my home State was so
disturbing.
So why are we here? First and foremost, we need to examine
how and why this happened to ensure the safety of American
families and prevent this type of tragedy from happening in the
future.
Second, we need to identify and eliminate weaknesses in our
State and Federal food-safety enforcement system and take
strong measures to hold wrongdoers accountable and protect the
good reputations of producers who consistently play by the
rules and supply safe food that is at a high quality and a
reasonable price.
The economic impact of egg producers in Iowa is
indisputable. Iowa is America's number-one egg producer by a
country mile. Yet, economic impact is no trump card when lives
are at stake. Like many Americans, I am disturbed by the
increasing number of food-borne illnesses in the United States.
These incidents all raise important questions about the safety
and security of our Nation's food supply.
As an Iowan, I am offended that some in the egg industry
are suggesting that consumers are somehow responsible for
getting sick because they didn't properly cook their eggs. Now
is the time for accountability, not blame shifting.
As an Iowan, I was disgusted to read reports about Federal
investigators finding live mice, infestations of flies,
mountains of manure, and other unsanitary conditions in Iowa
henhouses linked to the largest Salmonella outbreak of its kind
in the United States.
It is clear that changes need to be made to our food system
to provide assurances to parents that the food they feed to
their families is safe. The House passed food-safety
legislation last year. You have heard about it. It would give
the FDA authority to order mandatory food recalls, impose fines
for food-safety violations, and require more frequent food
facility inspections. It would also give the FDA access to
company records in the case of an emergency. These are
important first steps to make sure our food supply is safe.
We need to be doing a much better job of protecting
American families from unsafe food. Every 4 years, Mr.
Chairman, people come to my State for the presidential caucuses
and see our magnificent gold-domed capitol. Yet few people take
the time to go inside and look up at the rotunda, where our
ancestors put the wisdom of the ages. My favorite saying in
that rotunda is from the Greek lawmaker Solon, who said, ``The
ideal state: that in which an injury done to the least of its
citizens is an injury done to all.''
Until we get serious about uniform Federal food-safety
practices in this country, we are far from becoming that ideal
state. And until consumers feel as safe and secure buying eggs
in their neighborhood supermarket as I felt in my grandparents'
henhouse, egg producers in Iowa and across the country have
their work cut out for them.
I yield back.
Mr. Stupak. Thank you for your opening statement. But do
you want on the record you threw eggs at Halloween?
Ms. DeGette, opening statement, please.
OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you very much, Mr. Chairman.
I want to add to the chairman's thanks to you for all of
these hearings over the last number of years, the 13 hearings.
I think I have been sitting with you, Mr. Chairman, for every
single one of those hearings, everything from spinach to peanut
butter, to jalapeno peppers, to meat, to nuts. Pretty much the
American diet has been under scrutiny in the last few years.
And I just have one question. And the question that I have
is, when is the Senate going to pass the very fine food-safety
bill that this House passed over a year ago? I don't think it
is any excuse that one Senator can hold up the bill. But if
that is the excuse, then I would add to Chairman Waxman's
demand that Senator Coburn release his hold on this bill.
But, beyond that, I think the Senate should stay in session
until they pass this bill. The reason is, if we don't, we are
going to be sitting here every 6 months, just like we have been
for the last 4 years. And the problem with that, it is not just
about us passing the legislation; it is about people like the
witnesses who are sitting here today, Ms. Lewis and Ms. Lobato.
And, you know, I want to welcome all of you and say how
glad I am that you are putting a human face on this again. I
particularly have to welcome the Lobatos because they have been
family friends of my family, Mr. Chairman, for many, many
years. We won't say how long, because then we will have to
reveal our ages. But thank you for coming to talk to us about
what is going on here.
You know, we can fix this problem. This egg outbreak, which
is outrageous, could have been minimized. I mean, aside from
the conditions at the henhouses and everything else, if this
bill had been law, several things in this legislation could
have mitigated this problem.
It took 3 months before this voluntary recall, and there
were thousands of Americans that fell ill before we determined
what the source of contamination was. There are three
components to the legislation that this committee and the House
passed that are now in the Senate bill that would have
prevented this.
Number one, under our legislation, the FDA would be able to
get the records to show where the contamination came from.
Number two, traceability. This was a provision that I
worked to get into the legislation which would allow
contaminated products to be quickly traced from the field, or,
in this case, the henhouse, to the fork. And that would greatly
decrease the amount of time it would have taken for us to
identify the source of the contamination.
And the third thing is, the FDA would have now mandatory
recall authority. So if the producers themselves didn't recall
the product, then the FDA could have.
All of these things together would have applied in this
situation if this bill had become law. And so, frankly, Mr.
Chairman, we can't wait until after the election. We can't wait
until the next Congress starts. We need to make this bill law
now. And I would urge every single person who is here or who is
watching this to call their Senators and urge them to enact
this law before we leave.
Mr. Stupak. The gentlelady yields back.
Mr. Doyle for an opening statement, please.
OPENING STATEMENT OF HON. MICHAEL F. DOYLE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Doyle. Thank you, Mr. Chairman. I will be brief. I want
to thank you for holding this hearing, and also to say what a
pleasure it has been to serve with you on this panel over the
years. We are going to miss your presence next year.
My thanks also go out to all the witnesses for agreeing to
be here to testify, especially our first panel, Ms. Lewis and
Ms. Lobato.
You know, I remember growing up and learning from my mom
how to properly cook eggs because you never knew if the
heartbreak of Salmonella was just around the corner. And it
took me years before I found out that ``Sam and Ella'' weren't
actually people in the eggs.
But even though Salmonella has always been a risk when
dealing with eggs and poultry and even though consumers know
they have to cook them the right way, people have a reasonable
expectation that egg producers are doing all they can to
identify and fix issues in production that could cause their
hens to get Salmonella and pass it on to the eggs.
And it looks like it didn't happen here, so I look forward
to learning why. Why did companies with a record of prior
violations not ensure their facilities were clean and free of
rodents? Why did positive tests for Salmonella not cause the
producers to go into overdrive to clean up their premises? Why
did those eggs go to market, into restaurants, into consumers'
homes, where they could make so many people sick?
You know, it is a blessing that there are no reported
deaths from these cases. So I hope we can learn enough today to
make sure there isn't a next time, because next time we might
not be so lucky. So I look forward to hearing from our
witnesses today.
And, with that, Mr. Chairman, I will yield back.
Mr. Stupak. Thank you, Mr. Doyle.
Mrs. Christensen for an opening statement, please.
OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS
Mrs. Christensen. Thank you, Mr. Chairman.
Here we go again, unfortunately, at another hearing of food
contamination. But thank you, Chairman Stupak and Ranking
Member Burgess, for your quick response in holding today's
hearing on the recent outbreak of Salmonella in eggs, which
highlights yet another crack in our country's food-safety
system.
In late August, the Food and Drug Administration officials
reported that they found positive samples of Salmonella that
linked two farms into a massive egg recall. Investigators
reportedly found Salmonella in chicken feed sent to both Wright
County Egg and Hillandale Farms. More than 550 million eggs
from the 2 farms were recalled in August after they were linked
to as many as 1,300 cases of Salmonella poisoning.
And I want to also join my colleagues in thanking some of
those who were harmed by this outbreak for being here today to
testify.
FDA indicated that contaminated feed was the source of the
outbreak but possibly not the only source. Subsequent on-site
inspections revealed grossly unsanitary conditions.
A common thread in the numerous hearings we have held on
food safety, or the lack thereof, is the inadequate and
fragmented regulation of food in this country. As in this case,
there is often a long history of noncompliance with safety and
sanitation measures, resulting in problems. Wright County
Farms, the company involved in this outbreak, has been
associated with outbreaks since the early 1980s.
In the case of eggs, the Ag Department oversees chickens
and grades eggs for their quality. The FDA is responsible for
the safety of eggs on their shelves. FDA inspects farms after
an outbreak of egg-borne disease has been detected, not before.
This is just another example of the bureaucratic gaps in
regulating food safety that continue to put consumers at risk.
As you have heard, last year the House passed H.R. 2749,
the Food Safety Enactment Act, in response to our Nation's
food-safety--what we consider a crisis. But it remains stalled
in the Senate. Among other regulatory changes, this bill would
give the FDA the power of mandatory recall of diseased food, as
well as oversight and access to the safety plans that food
service facilities establish, as well as the tests that are
conducted to measure safety and inspection records. Until these
new regulations are in place, we will not be able to strengthen
the food-safety oversight.
And I do realize that FDA did put some new regulations in
place too late--a little too late to really stop this outbreak.
But I hope today's hearing will further emphasize the need for
the Senate to pass this bill.
Thank you, Mr. Chairman. I yield back the balance of my
time.
Mr. Stupak. Thank you.
Mr. Markey for an opening statement, please.
OPENING STATEMENT OF HON. EDWARD J. MARKEY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF MASSACHUSETTS
Mr. Markey. Thank you, Mr. Chairman, for holding this
hearing.
Thanks to Chairman Waxman for his leadership in bringing
this issue out into the open.
And, to our witnesses, we wish you all a full and speedy
recovery from this debilitating and life-threatening
experience.
We can all easily agree that Americans should be able to
have their eggs over-easy without having to worry that the eggs
will make them queasy. But more than a thousand people have
been severely sickened by eggs laced with Salmonella since the
eggs first entered the food chain in May. More than half a
billion eggs have been voluntarily recalled since August. As we
have learned, the conditions found in the facilities connected
to these eggs were horrific, like something out of Upton
Sinclair's ``The Jungle.''
It is my fear that this recall may not be the end of the
story. There are many egg-producing facilities in other States
with strong corporate ties to the companies responsible for the
Iowa recall that have not yet been inspected by the FDA.
And with Senator Tom Coburn's recent announcement of
opposition to the Senate food-safety bill, the FDA may well
continue to be denied the strong enforcement tools it needs to
crack down on unsafe practices that the House passed last year,
leaving the corporate fox in charge of the henhouse
indefinitely.
I know that Senator Coburn is a Republican. I know the
Republicans in the Senate are trying to stop any legislation
from passing. This is a public health imperative. There must be
some exception for Republicans in the Senate when it goes to
the health of millions of Americans. They must release this
bill so we can protect millions of families.
This past July, the FDA's new egg rule went into effect,
imposing additional safety requirements on large egg producers
and ensuring that there will be more FDA inspections at the
facilities. So the jury is still out as to whether the Iowa
facilities implicated in this infestation represent just a few
rotten eggs or whether the safety of this country's egg supply
is more like Humpty Dumpty: shattered and in need of full-scale
reconstruction.
According to reports, companies owned or operated by one of
our witnesses today have a decades-long record of public
health, labor, and environmental offenses. DeCoster Egg and
Feed facilities in Maine and other States have a long history
of being found to be responsible for Salmonella infection,
dumping piles of dead chickens aboveground, animal cruelty,
worker-safety violations, and other problems. Instead of
walking on eggshells to comply with State and Federal
regulations, the hardboiled corporate executives in Iowa kept
facilities from inspections that showed that ultimately they
were overflowing with manure and infested by rodents and flies.
My home state of Massachusetts gets many of its eggs from
the Maine facilities owned, operated, or otherwise tied to Mr.
DeCoster. It is going to be important for us in Massachusetts,
in New England, to know whether or not we are at threat, as
well.
Thank you, Mr. Chairman, for having this hearing.
Mr. Stupak. Thank you, Mr. Markey.
That concludes----
Mr. Burgess. Mr. Chairman, may I ask for a moment for a
unanimous consent request?
Mr. Stupak. You can ask. I am not sure it is going to be
given, but----
Mr. Burgess. I would like unanimous consent to insert a
statement into the record from Dr. Tom Coburn, in that he is
not blocking this bill. It is Senator Reid who has failed to
bring this bill to the floor. Senator Reid's comments that
Senator Coburn is blocking the bill are false, and Mr. Reid
knows they are false. And that needs to be entered into the
record.
Mr. Stupak. All right.
Mr. Waxman. I object. I don't believe that that is an
accurate statement, so I would object it going into the record.
Mr. Stupak. OK. The objection will not be made part of the
record. If you want to submit something later, Mr. Burgess, to
supplement your testimony, I am sure we can work with it. But
right now nothing is going to be entered in the record, OK?
All right. That concludes the opening statements by the
members of the subcommittee. I want to call our first panel of
witnesses.
Our first panel, we have--first is Ms. Sarah Lewis from
Freedom, California, and Ms. Carol Lobato from Littleton,
Colorado.
I would ask you to please come forward, take a seat at the
witness table.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that you have a right under the
rules of the House to be advised by counsel during the
testimony. Do either of you wish to be represented by counsel?
Ms. Lewis. No.
Ms. Lobato. No.
Mr. Stupak. No? OK. Then I am going to ask--you both
answered, no, you do not wish to be represented by counsel.
Therefore, I will ask you to rise and raise your right hand to
take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect that the witnesses
replied in the affirmative. They are now under oath.
We will look forward to your opening statement.
Ms. Lewis, if you don't mind, I will start with you. If you
would like to pull that mike forward and press the button, a
green light should go on. There we go. We are ready to go.
Thank you. Thank you for being here.
TESTIMONY OF SARAH LEWIS, VICTIM OF SALMONELLA OUTBREAK; AND
CAROL LOBATO, VICTIM OF SALMONELLA OUTBREAK
TESTIMONY OF SARAH LEWIS
Ms. Lewis. Good afternoon. Thank you, Chairman Stupak,
Ranking Member Burgess, and Chairwoman Waxman, and committee
members. I am honored to be here today and speak to you about
my experience with Salmonella poisoning that I got from the
recent Wright County and Hillandale Farms egg recall.
My name is Sarah Lewis. I am 30 years old. I am a mom, a
wife, and a proud daughter of a small-business owner that
abides by all of our local and State regulations. I have two
beautiful daughters: Hailey, 7; Kyndall, 4. I have a wonderful
husband who has served our country proudly as a Marine, Chris
Lewis.
Not only did this experience affect me, it affected my
whole family. My sister Stacey also got Salmonella poisoning
from the eggs. The night we ate the custard tart was at my
sister's graduation banquet. My whole family was there: my mom,
my kids, my husband, my mom and dad, my grandma, my sister, and
her boyfriend. We were all there celebrating this amazing
achievement for my sister, not even suspecting that that night
would change our lives for a very long time.
My sister and I look back at that night and say, ``What if
our grandma or one of my daughters would have eaten that tart
that we would have received? They probably would have died.''
Knowing how sick we were scares the heck out of us now.
The night after the college banquet, I started having
severe abdominal cramping and overall not feeling well. My
husband said, ``Sarah, go lay down. You are not feeling and
looking so hot.'' During the night, I woke up vomiting and had
severe diarrhea so bad I was so beyond embarrassed to have to
even ask my husband for help. My mom, who lives next-door, came
over and took one look at me and knew something was terribly
wrong. And if you know me, all I wanted to do was stay home and
try and feel better.
The next day, my mom took me to urgent care, where I was
told they would give me a shot to help me stop throwing up. And
if I was able to keep water down in 20 minutes, I could go
home. Well, 21 minutes later, I was being admitted into the
hospital for what would turn out to be the first of two long
stays.
When I was admitted for the first time, I spent 12 hours in
the ER, so sick they were scared to move me. They thought they
were going to have to do emergency bowel surgery. Because the
CT scan showed bowels that were so inflamed and so sick, I was
put in ICU. I was so sick and so dehydrated and in so much pain
I could not even see straight.
While in ICU, I started to develop severe tachycardia and
was moved to the critical care heart unit for 3 days. During
that time, I had to go through things I never even want to talk
about again. I was so mortified.
When I was discharged, I was so excited. This meant I would
be able to go to my daughter's preschool graduation that night.
This may seem like a very small thing to many of you, but it
meant the world to me. And I thought, great, I can start the
healing process and get back to being a mom, a wife, and a
daughter.
Boy, was I wrong. Approximately 2\1/2\ weeks later, still
sick as a dog, I called my doctor. And when I got to the
office, he took one look at me and told me I was going back
into the hospital. And if, for one moment, you can imagine two
little girls' faces when I had to tell them, ``Mommy is going
back into the hospital.'' It was the hardest thing I ever had
to do. It was devastating for any 7- or 4-year-old kid.
When I was readmitted, I was so dehydrated they had to
insert a PICC line into my arterial vein in my right bicep.
Talk about traumatic. I was so scared. I was about to have a
line inserted into my heart.
I proceeded to spend 5 more days in the hospital, with my
girls crying and screaming every time they had to leave me. I
truly do not know what I would have done without my family and
friends during this time.
When I was released for the second time, I was sure I was
on the mend. Wrong again. I developed a severe infection called
``C. difficile colitis'' from all the antibiotics and from
being in the hospital. C. diff causes severe diarrhea and
cramping, as though I didn't have this already. I had to be on
antibiotics every 6 hours for the next 14 daysagain. And all
during this, I found out that the Salmonella was still present
and raging in my body. This was just devastating news to my
family and myself.
I still have severe cramping, diarrhea, fevers, and the
stress and fear that the Salmonella is present in my body.
Every day, when I leave to go to work or even just to the
grocery store, my youngest daughter looks at me and starts
crying. It just breaks my heart.
This whole time, I am trying to figure out what has caused
my Salmonella poisoning. Then one morning, my dad is reading
the newspaper, and there was an article about my sister Stacey
and I, that we were part of the egg recall.
As I start reading about the egg companies, it causes my
stomach to turn. My family owns a retail butcher shop, Freedom
Meat Lockers. And as we go through weekly State inspections and
quarterly county inspections, we have to maintain and uphold a
standard that we are very proud of. We are rated the number-one
butcher shop in all of California for cleanliness and
sanitation. To think that my sister and I got sick from a
company that does not care about their regulations and quality
is beyond appalling to me and my family.
I do not come to you today just for me and my sister. I
come for every man, woman, and child who has gotten sickened by
Wright County Eggs and other producers who did not consider the
repercussions of their actions. I wish I could say this would
never happen again. Please consider changing your FDA policies
to more closely monitor the egg industry.
Thank you for your time in listening to my story.
Sarah Lewis.
[The prepared statement of Ms. Lewis follows:]
[GRAPHIC] [TIFF OMITTED] T8134A.010
[GRAPHIC] [TIFF OMITTED] T8134A.011
Mr. Stupak. Thank you, Ms. Lewis.
Ms. Lobato, your testimony, please. I am going to ask you
to turn on that mike and pull it a little closer to your person
there.
TESTIMONY OF CAROL LOBATO
Ms. Lobato. Good morning, Chairman Waxman, Chairman Stupak,
and the members of the committee. Thank you for inviting me to
Washington to share my story. I hope that, by doing so,
together we can make our dinner tables and our entire food
system safer for all of us.
My name is Carol Lobato. I live in Littleton, Colorado. I
am 77 years old and, today, have been married to my husband for
54 years. We are retired and blessed with four children and
grandchildren. Ed is a World War II veteran and was awarded the
Bronze Star and Purple Heart for his services in Okinawa.
My story began the evening of July 10th of this year, the
night that Ed and I took our grandson, Drew, to The Fort
Restaurant in Morrison, Colorado. The Fort is an upscale
restaurant that serves wild game and other exotic dishes. The
Fort was the restaurant that hosted President Clinton and the
other world leaders for the Summit of the Eight dinner in 1997.
One of the items that we ordered that night was an
appetizer of rattlesnake cakes. All of us tasted the dish, and
none of us particularly liked it.
The next afternoon, I felt very sick. At the beginning, I
started to shake and experience chills. Then came waves of
vomiting and explosive diarrhea. My fever rose to 102. Later,
the doctors called this septic shock.
Ed rushed me to the emergency room. There, doctors
administered several tests, including chest X-rays; CT scan;
blood, stool, and urine samples. They gave me IV hydration and
sent me home after several hours and told me to return if the
symptoms did not improve.
The next day, I went to see our family doctor, as I was
experiencing diarrhea, stomach cramps, dizziness, and weakness.
He examined me and sent me to Swedish Hospital in Englewood.
The ride to the hospital was very unpleasant. I was quite
sick. My electrodes were depleted. My potassium level was
dangerously low. And the doctors at the hospital immediately
put me on IVs of antibiotics, potassium, and I also was on
oxygen.
A few days later, the cultures come back as positive for
Salmonella bacteria that was both in my bloodstream and my
intestines. Since I take medication for rheumatoid arthritis,
which compromises my immune system, I was particularly at risk
for an infectious bacteria like Salmonella.
The infection wiped me out, to the point where I was unable
to function. I could not even get out of bed without help. I
remained at the hospital for an agonizing 4 nights, 5 days
before I was finally discharged to come home.
The Salmonella infection is not over for me. I have lost my
stamina. I often experience indigestion, and it is difficult
for me to enjoy certain foods. I feel very tired and require
rest during the day. I lost 8 pounds in the hospital, which was
the only plus of this ordeal. My doctors told me that I almost
certainly would have died without aggressive intervention.
Ed and Drew, our grandson, were also ill, but their
condition was not as serious as mine. The CDC and the Jefferson
County Department of Health later determined that the
rattlesnake cakes that we consumed at The Fort was the source
of our illness. Through a trace-back procedure, investigators
found that the eggs used in the rattlesnake cakes had not been
properly cooked. They were from the Wright County Egg farm in
Iowa. The Salmonella found in my cultures was the exact DNA
match to the Salmonella found in the egg farm.
The CDC has recently published reports of at least 1,500
others in the country who have also suffered from the identical
strain of Salmonella found in the contaminated eggs from Wright
County Eggs and Hillandale Farms.
The FDA has now inspected the farms and found several
violations. The published inspection report shows the
following: chicken manure piles 4 to 8 feet high in the
henhouses; live wild birds, not chickens, flying around in the
henhouses; rodent burrows along the baseboard of the henhouses;
liquid manure seeping through the concrete foundation; standing
water in the chicken manure pit; loose chickens walking through
the manure piles and laying their eggs inside; 31 live mice
observed in the henhouse; live and dead flies too numerous to
count inside the henhouses; 65 unsealed rodent holes in the
walls of the henhouse.
These findings are shocking to me, not only as a consumer,
but because I have personal experience with chickens and eggs.
You see, I grew up on an Iowa farm. I was one of five girls,
and I shared the responsibility for doing the work and the
chores that went with the family farm. That included raising
chickens from little chicks to the time they were ready for
market, and for the eggs that we gathered and sold.
Our farm never looked the way these two farms looked and
have been described. We never had any problems because we kept
our farm clean, took proper care of our chickens, and did
things the correct way.
Three years ago, this country suffered a horrible
Salmonella outbreak linked to contaminated peanut butter that
sickened over 700 nationwide. Last year, this country was
struck by another peanut butter Salmonella outbreak that
sickened 700, killing 9, tragically. Both times, survivors like
me come before this committee asking for help.
But this time, I am the one asking for you, on behalf of
myself and my family and 1,500 others who were sickened, to
please make our food supply safer. Pass legislation that
provides funding and more inspectors so that these companies
keep us safe. Pass legislation that requires testing of
products before they leave the factories. Pass legislation that
rewards companies who do the right thing and punish those who
refuse to do so. Because, if we don't, we will all be here
again.
Thank you. Respectfully, Carol Lobato.
[The prepared statement of Ms. Lobato follows:]
[GRAPHIC] [TIFF OMITTED] T8134A.012
[GRAPHIC] [TIFF OMITTED] T8134A.013
[GRAPHIC] [TIFF OMITTED] T8134A.014
Mr. Stupak. Thank you.
And thank you both for your testimony. Thank you for coming
here to Washington, D.C., traveling here with your families.
And I deeply regret that you have suffered as part of this
massive outbreak of Salmonella, but your testimony has really
helped us, telling Members of Congress your story, but also the
American people. And it will help us, and hopefully we can move
the legislation that you heard so much about this morning--I
should say, this afternoon.
Let me ask you a couple questions, if I may. In the binder
in front of you there, there is Tab No. 16. Mr. Waxman and I
showed photographs that were taken by Federal public health
officials in the course of their inspections of the egg
facilities. And, Ms. Lobato, you sort of mentioned them in your
testimony, as you have had some experience with farms and that.
When you look at these photos, what goes through your mind
about the conditions of these farms, Ms. Lobato?
Ms. Lobato. It is just a deplorable situation here. Filth.
Mr. Stupak. You know, Ms. Lobato, you said in your
testimony--you said, maybe we should consider rewarding
companies for doing things right so we don't have these food
outbreaks. Isn't the fact that a consumer would put confidence
in, let's say, a Wright Farm or Hillandale Farm, isn't that
enough reward? We shouldn't have to reward people to produce,
in this case, eggs in a proper, sanitary, safe condition,
should we?
Ms. Lobato. They should be safe. They should all be safe--
--
Mr. Stupak. And without reward. OK.
Ms. Lobato [continuing]. Coming from the farm.
Mr. Stupak. OK.
Ms. Lewis, anything you want to add on the photographs or
anything?
Ms. Lewis. It is appalling to me. My family owns a retail
shop, and when I show pictures to people of our facility, they
are amazed at how clean it is and how we give tours of the
whole place. And we are not afraid to show people around. We
don't have anything that is appalling as this. And----
Mr. Stupak. In your butcher shop, do you have a plan to
take care of pests and rodents and flies?
Ms. Lewis. Absolutely. We have strict regulations and
guidelines that we have to abide by, and we have weekly
maintenance services that come out and tend to that. So it has
never been a problem. We have never had an infestation of any
kind in our facility. And my father Howard has owned it since
1970, and he took it over from his dad, and my dad and my mom
have always upheld the standards that we are proud of. And like
I said, we give customers tours. We will show them our
facility. We are not afraid to show what we do to everybody who
wants to see it.
Mr. Stupak. Do you find the inspections at your level in
your butcher shop overburdensome?
Ms. Lewis. No.
Mr. Stupak. Too much regulation?
Ms. Lewis. We are State and we are quarterly county
inspected, and we don't worry about it. They come in, and the
last thing was because somebody didn't have a hat on. So our
plant is so clean that when they come in, they say it is
honestly a pleasure to come into our facility, and they
actually want people to come to our plant and view our plant
and how my dad has everything tiled, stainless steel, and he
has everything to a certain standard.
Mr. Stupak. So in areas like food safety, government
regulation in your estimation as owning a butcher shop is good?
Ms. Lewis. Repeat the question. Sorry?
Mr. Stupak. Sure. Government regulation. We hear so much
government shouldn't be in our lives, get them out of there. We
don't need government regulations. In your own personal
experience, has it been helpful to you in your business?
Ms. Lewis. Absolutely. I feel as though if we did not have
regulations on our facility, there's other butcher shops, and
if they didn't uphold to a certain standard, then the product
that is out there is not going to be of a certain level. And if
it is not, then this is what's going to happen, and this is not
acceptable.
Mr. Stupak. In all of our hearings we've had, we always
hear it is young people, older citizens, or people with a
compromised immune system who are susceptible to food, whether
it is E. coli or Salmonella or Listeria. You don't seem to fit
any one of those categories.
Ms. Lewis. I actually do have a compromised immune system.
I have asthma, and I have been on steroids on and off for a
long period of time due to my asthma and my lungs. And so they
figured that, due to my compromised immune system, that is why
it hit me so hard. And I actually had heart surgery when I was
18, so I have a long history of health trouble. And so when
this came into my system, it just overpowered my whole system,
and it took over. And I am still not feeling well. And to think
that anybody has to go through this is sickening.
Mr. Stupak. Are you off your medication now?
Ms. Lewis. No. I laugh. No offense. I have a little old
lady box of medicine that I take every day. And I--you know, I
don't have a choice. I am on 5 to 10 different medications. And
I have lost 30 pounds. And my sick joke is, OK, you can cure my
Salmonella in 30 more pounds. You know what I mean? But it's
not funny, and I don't want to be on all these medications to
keep my immune system up. It is not acceptable for supposedly
someone who is young and 30 and healthy. It is not OK.
Mr. Stupak. Ms. Lobato, you have completely recovered now
from your experience?
Ms. Lobato. I can't say that, no. There are a lot of things
I can't eat that just are really hard to digest and give you a
lot of heartburn and upset stomach and so forth.
Mr. Stupak. Well, we are glad you are still here, glad you
had your 54th wedding anniversary, and you are celebrating it
with us.
And, Ed, thank you for your service to our country.
With that, let me yield to Mr. Burgess for questions.
Mr. Burgess. Thank you, Mr. Chairman.
And thanks to both of you for sharing what are very
compelling stories with us.
I don't know if you heard, in my opening statement I
referenced some of the surveillance cultures that were done at
the egg farm, that 72 swabs, and only 8 were negative for
Salmonella. Now, obviously, to me at least, I, too, spent time
on a farm as a youngster, and my family was involved with--in
the meat business on my mother's side. I would think that is an
outlier. We will get a chance to ask the egg manufacturers
directly.
But when you look at the oversight, Ms. Lewis, you've
suggested that there are several places that regulate you. But
you said those are State and county? So no USDA, no FDA coming
into your shop.
Ms. Lewis. We are not a federally regulated plant. We are a
State-regulated plant, And so the meat that does come in to us
is USDA inspected. Absolutely.
Mr. Burgess. But just the notion that you would have that
many positive tests and no surveillance by the Federal agency
responsible for ascertaining egg safety, I mean, that seems a
little bit large; does it not?
Ms. Lewis. Absolutely. If there is supposed to be a Federal
agent on premises at all times, that is his job as well as the
owners' to make sure and to uphold those standards. And he is
supposed to be walking around and checking everything, and that
is why he's there. That's why they are a Federal regulated
plant. There's reasons why you have a Federal agent in your
building mandating it. There is reasons, and obviously those
reasons were not met.
Mr. Burgess. Ms. Lobato, your experience with the egg
business, when you had opportunities to observe it up close and
personal, you never saw anything like these astonishing
photographs that were shared with us this morning?
Ms. Lobato. Not at all.
Mr. Burgess. And that is sort of my recollection as well,
although I will confess to you I've never spent time on a
commercial farm, so I don't know the context in which to place
these photographs.
Ms. Lobato. Our chickens would be what would be called free
range now. They walked everywhere. They were all over.
Mr. Burgess. And I promise you, I am only buying cage-free,
free-range eggs from this point on after seeing those
photographs. They are fairly dramatic.
Now, Ms. Lewis, you said you became sick the early part of
July. The recall started August 13th. Do I have the time frame
correct there?
Ms. Lewis. The banquet was Saturday, May 29th, to my
knowledge.
Mr. Burgess. You were ill in May.
Ms. Lewis. Yes.
Mr. Burgess. And then, Ms. Lobato, your exposure was later?
Ms. Lobato. July 10th.
Mr. Burgess. Unfortunately, when you look at some of these
things in the recalls, we did tomatoes a couple years ago also
with Salmonella, it does take time. To either of you, does that
seem unreasonable; that time span from May 27th to August 13th
or July 2nd to August 13th, when the recall was effected, does
that seem like an unreasonable period of time? A tough question
to ask because you both suffered with the consequences.
Ms. Lewis. Well, from my point of view, when you are eating
a dinner at a banquet, you have 10 different things on your
plate from butter to chicken to different things. And then on
your salad, you as well have several different things. So you
have to try and figure out if it came from what's on your
dinner plate, your salad plate, your appetizer. So, yes, I do
think that it would take time to try and pinpoint where it came
from.
Mr. Burgess. When were you questioned in the sequence of
this about the source of your illness? Or did it just come up
from the DNA testing?
Ms. Lewis. It came up from the DNA testing, and I read a
newspaper article, and then I called----
Mr. Burgess. So you sought them out rather than them?
Ms. Lewis. Yes, I did. I had to call the county nurse and
be like: Is this me in the newspaper article and my sister? Is
this? You know, am I that person? And she is like, umm. And I
said, am I? And she said, yes. And that is how I found out. I
had to seek out the information.
Mr. Burgess. Well, I want to thank both of you for being
with us. And, Ms. Lewis, I will just tell you from the
perspective of a former practicing physician, the clostridium
gastrocele complication which you suffered, one of the most
fearsome things that you can undergo as a consequence of
antibiotic therapy, I certainly had patients with that during
my professional lifetime, and it is in and of itself an ordeal
and a memorable one.
Mr. Chairman, just before I yield back--and, again, thanks
to our witnesses. Before I yield back the balance of my time, I
do want to read Dr. Coburn's statement.
If Majority Leader Reid believes----
Mr. Stupak. Mr. Burgess, we have had objections.
Mr. Burgess. I still control the time, Mr. Chairman.
Mr. Stupak. Mr. Burgess, you have been directed that the
statement would not----
Mr. Burgess. If Majority Leader Reid believes that this
legislation is a matter of life and death, he should bring it
to the floor immediately for a full and open debate. As
majority leader, he sets the schedule. I do not--Mr. Chairman,
I just have to say, I do not recall--this is a bipartisan
issue. I voted with you on the dang bill. I worked with you on
the dang bill. Now, it is just preposterous that you have
conducted or that the majority has conducted the hearing in
this fashion. We have to sit here and listen to a Member of the
Senate be excoriated by Members of your side when he is not the
problem. Yes, he may become a problem if Senator Reid brings it
to the floor, but if Senator Reid won't bring it to the floor,
he is not the problem. So, again, I just do not understand why
you would turn what is a bipartisan effort into such a
partisan, excoriated affair.
Mr. Stupak. Mr. Burgess, legislation came out of this
committee because of the work of many people on this committee,
the full committee, Democrats and Republicans, as bipartisan.
And we passed that bill July of 2009, after 3 years of work by
this committee. And, yes, we are a little frustrated that the
Senate, one person, can put a hold on a bill.
Mr. Burgess. That is Senator Reid. Senator Reid, the
majority.
Mr. Stupak. One person can put a hold on a bill, and the
legislation does not move. So if you have a beef, take it up
with Senator Coburn, and maybe we can move our legislation.
With that let me turn it to Mr. Braley for questions,
please.
Mr. Braley. Thank you, Mr. Chairman.
And, Ms. Lobato, I am very pleased to hear that you had a
lovely childhood growing up in Iowa. Did any of the comments I
made in my opening statement ring true with you?
Ms. Lobato. Absolutely.
Mr. Braley. Now, one of the things that struck me about
both of your testimony was that neither one of you prepared the
food that made you sick, and that illustrates one of the
challenges we have been trying to face on this committee, which
is we have a hodgepodge of State and Federal food safety
regulations that impose different requirements on different egg
producers depending upon where their facilities are located. We
are making some strides based upon the recent regulation that
the FDA passed regulating egg-production facilities. But both
of you are the living examples of how consumers are at risk,
through no fault of their own, because of cooking techniques
that they have no control over.
Now, one of the things I want to talk to you about is the
mandatory recall authority, because, as you heard, our
committee began pushing for reform of the food safety system
for years and, as you heard, this is the 13th hearing this
subcommittee has conducted on food safety in the last 4 years.
Our committee authored and successfully passed H.R. 2749, the
Food Safety Enhancement Act, and included in that legislation
is a provision that would give the FDA much-needed increased
authority to issue mandatory recalls of tainted food products.
And I am going to ask both of you, would it surprise you to
learn that the FDA currently lacks the authority to issue a
mandatory recall?
Ms. Lobato. That is surprising.
Mr. Braley. And while the two Iowa farms in question did
issue voluntary recalls, do you two believe that FDA should
have to rely upon the company's goodwill to do that when the
public's health is at risk?
Ms. Lewis. No.
Ms. Lobato. No.
Mr. Braley. Now, one of the things that we know is that the
legislation, like the House bill that we have been talking
about, would give the Food and Drug Administration the power to
require the recall of a contaminated food that is needed. Do
you think that would be a good idea for food safety for the
consumers in this country?
Ms. Lobato. It is a start.
Mr. Braley. Now, Ms. Lewis, you spent a lot of time talking
about the incredible impact that your illness from the
Salmonella contamination had on your quality of life.
Ms. Lewis. Absolutely.
Mr. Braley. And I think there is this great misperception
in the public that these symptoms that people deal with from
Salmonella contamination are like a minor case of intestinal
flu.
Ms. Lewis. No. It was so severe, I didn't even want to
leave my house. I didn't even want to go to work, and I work
right across the street. I didn't want to take my kids to
school. To be blunt, you don't even want to sneeze or cough. It
is miserable. Life as you know it completely changes.
Mr. Braley. And you don't even want to move.
Ms. Lewis. Oh, you can't move because you are in such
physical pain from the stomach cramps, and you have like--your
whole body head to toe was in agony. I was in fetal position
for I don't even know how long. I couldn't even move.
Mr. Braley. You also talked about the need to insert
something called a PICC line into your bicep. Can you just tell
us a little bit more about what that was and what it was
designed to do?
Ms. Lewis. Yes, absolutely. I was so dehydrated that they
could not find a vein to insert an IV in, and they needed to
get antibiotics, steroids, and fluids into me as quickly as
they could. And my doctor suggested a PICC line, and it goes
right here in your arm. And once it goes in, they do an X-ray
to make sure that the line is properly inserted into your
heart. And, to my knowledge, once it goes in, it's a pretty
permanent port, and I have scars from it, and I will always
have those scars. But it was something that I had to do;
otherwise, I would not be able to have the medication I needed.
Mr. Braley. And, Ms. Lobato, I am giving you the chance to
make the same type of comment. What was this like for you on a
daily basis to deal with the symptoms from your Salmonella
contamination?
Ms. Lobato. Well, you are just so severely sick. And, as
Sarah said, you really can't go very far from the bathroom. And
you are just sick. You are so tired, you are so fatigued, worn
out. You just--you see the bed, and you just want to flop in
it. And another end result is that you really--you have a hard
time trusting food.
Mr. Braley. Let's talk about that briefly. Do you remember
ever having a duck egg, Ms. Lobato?
Ms. Lobato. No. I don't think so.
Mr. Braley. That is what is amazing is that in the 1920s
and '30s, duck eggs were more popular for consumers than
chicken eggs, and it was a result of a Salmonella problem with
those eggs that they basically disappeared from the American
table. And, as a result of those problems, there were many food
safety bills that were passed to address the problem and try to
protect consumers.
We need to bring that same level of focus in 2010 and
protect consumers from these food-borne illnesses. And thank
you both for your testimony.
Ms. Lewis. Thank you.
Mr. Stupak. Mr. Latta for your questions, please.
Mr. Latta. Thank you, Mr. Chairman.
And, again, ladies, thank you very much for being with us
today. And having been one that has had food poisoning twice,
you know, a lot of us go to a lot of events, and you eat what
they put out in front of you. And I can commiserate with you on
what happened to you, because I know for 2 to 3 days, my case,
I know I was down. And you are absolutely right, you don't want
to get too far from home. So I can really empathize with you on
that.
Ms. Lobato, your background sounds like my mother's. She
grew up on a 100-acre farm in Ohio, and they had cows and some
pigs and chickens, and my mom to this day still likes brown
eggs the best. But it is one of those things that our
agriculture has kind of changed through the years.
But I have got to ask this question of both of you, because
in reading your testimony and hearing you talk about and as has
been brought up about that you didn't prepare the food, I have
got to ask you this: What is rattlesnake cake, and how is that
prepared? Is it raw? Is it baked? Fried? How is that prepared?
Ms. Lobato. Well, this is kind of a bit of an exotic
restaurant, but it is built like a fort, and they specialize in
meats of, well, supposedly the 1800s, early 1900s. And they
have elk and buffalo and bison and all kinds of things. But one
of the appetizers is rattlesnake cake, and it comes like a
little crab cake, small, and they apparently boil the
rattlesnake for 6 hours or something, then they grind it up,
and it's with bread crumbs and eggs and spices to hold it all
together, and it comes in a little plate as an appetizer and
had some green sauce on the top of it, relish, garnish. And I
understand that that's where the raw egg was or the uncooked
egg was in the relish that was on the top.
Mr. Latta. So it wasn't in the breading that was holding
the whole thing together?
Ms. Lobato. I don't believe so. I am not sure that that's
been determined at this point.
But I just wanted to say, our farm was not a chicken farm
per se. We had all kinds of animals, pigs and chickens and----
Mr. Latta. It does sound like where my mom grew up.
And, Ms. Lewis, with a custard tart, is that--my wife is
not here to help me out with these things. Is that something
that is baked, or is that raw? Is there something raw in there?
How is that prepared? Do you know?
Ms. Lewis. From what I was told, it's like a cheesecake
base. And the bakery that made it, they always use a pasturized
egg solution, and that day they happened to run out of that and
started using whole eggs. And so that's where the Salmonella
came from was the whole eggs. So but, to my knowledge, it is
like a baked kind of dessert, and then--to a certain point, so
it still stays like a custard.
Mr. Latta. Well, thank you very much.
And, Mr. Chairman, I yield back.
Mr. Stupak. Thank you, Mr. Latta.
Ms. DeGette for questions, please.
Ms. DeGette. Thanks, Mr. Chairman.
Mr. Latta, this restaurant, The Fort, is actually a fort
that's been around for many, many years. And as Ms. Lobato
pointed out, this was a restaurant where they even had a big
event when the G-8 came to Denver some years ago. And so what I
think Ms. Lobato is trying to say is this kind of contamination
can happen anywhere, even at the very nicest restaurants or
just little places, and that's what concerns all of us.
I want to ask both of you. Ms. Lobato, the food you ate was
in, I think, July 11th, around the first part of July, correct?
Ms. Lobato. July 10th.
Ms. DeGette. And, Ms. Lewis, the food that you ate was at
the end of May; is that correct?
Ms. Lewis. That is correct.
Ms. DeGette. So that was maybe 6 weeks apart between the
two of you when you had those. Do you think that that's--and of
course, the recall didn't happen until late August. So do you
think that's an unreasonable amount of time to identify the
source of the contamination and to get these products off the
shelves?
Ms. Lewis. Well, you know, it's funny, my sister Stacey and
I were the number one and number two case in Salmonella in all
of California. And so for her and I to be the first and second,
you know, to me it seems like a long time. But to the person
who is number 500, it happened maybe a couple weeks later when
they found out, you know. So being the first and second person,
of course it is going to seem like a longer period of time than
it would to somebody who got sick later.
Ms. DeGette. But what I am saying is what you described was
the bakery that made those tarts had used a different kind of
egg solution that day. So, theoretically, someone would--it
wouldn't have been that hard to figure out that that was
different, and then to look where those eggs came back--came
from and trace it back to the farm in Iowa, right?
Ms. Lewis. True. But like I said before, there is also 10
things in my plate for dinner.
Ms. DeGette. Sure.
Ms. Lewis. There's 10 things on my plate for salad. There's
an appetizer. So, in fact, did it come from X, Y, or Z? It's
hard to tell at that time until you start actually pulling out
everything and researching it. So as they start researching it,
then I do feel, you know what I mean, it was done
appropriately. But you can't tell if it is this or this because
there's so many different components to what you receive at a
banquet.
Ms. DeGette. Well, would you be surprised to know we
actually can tell if it is this or this? And if you have a
traceability system, you actually can trace it? I mean, part of
the problem we have now is that the Food and Drug
Administration, as you told Mr. Braley, they don't have
mandatory recall authority, and we don't have traceability, so
it is harder to figure out where the components come from. But
technologically we have the ability throughout our food
industry to be able to trace where things came from. So if they
had taken all of the components on your plate and they had been
able to trace them back, it would have moved much more quickly.
Does that make sense to you?
Ms. Lewis. That seems appropriate, yes.
Ms. DeGette. And did anybody else from that graduation
party get sick besides you and your sister?
Ms. Lewis. There was, to my knowledge, another gentleman
that got sick as well. We were at the graduation banquet, and
then the next night was a prom, and people from that prom----
Ms. DeGette. Also?
Ms. Lewis. Yes. I believe so.
Ms. DeGette. Also got sick.
So, you know, you had a group of people that got sick. We
saw this with some of the other outbreaks as well, the peanut
butter and other ones, where lots of people were getting sick.
And when you see a big group like that getting sick, it's
something that the State health officials really pay attention
to.
And, Ms. Lobato, did you want to add to that?
Ms. Lobato. Well, I just wanted to say that the Department
of Health for Jefferson County and for Denver were on my case
while I was in the hospital. They called 3 days in and wanted
to know what I had eaten at the restaurant, what I had eaten
for the week before. So I was very impressed at how fast they
were on the situation.
Ms. DeGette. Right. You know what we've been finding the
last few years with these food-borne illness outbreaks,
oftentimes it's the public health officials who identify it.
They are the first ones. But because we don't have a modern
food safety and tracing system, it takes many weeks to then
track down where that came from. So if you had the components
of our legislation that we passed in it by--sometimes you hear
us sniping up here, but we actually passed this bill in a
bipartisan way through the House. And if you had that in place,
once those State officials identified what it was, it would be
a lot easier then to trace it back to a source, and it would
eliminate many new cases of illness because you could get the
recall going much more quickly.
Thank you. Thank you both for coming again.
Mr. Stupak. Mr. Doyle for questions, please.
Mr. Doyle. Thank you, Mr. Chairman.
Ms. Lewis, thank you for your testimony.
And, Ms. Lobato, happy anniversary, and thank you.
You know, I appreciate the fact that you come here today
because it is important we put a face on these problems. The
chairman said earlier, people talk all the time about all this
government regulation and let's get the government off our
backs and no more regulation. Like we sit here every day
thinking of ways to harass businesses and make them lose money
and go out of business. But the reality is the fact that most
Americans can take for granted that when they turn their water
spigot on, the water they drink isn't going to poison them, or
the food they eat is going to be safe, or the air they breathe
in their neighborhood isn't going to cause them grave harm, a
lot of it is due to the fact that things like this happen. And
one of the ways we address that is to come up with regulations
to make sure that when food is being produced, it is done in a
certain way. There's standards in place. The same with how our
water is treated and what you can put in the water and what you
can put into the air.
And sometimes you can have the best regulations in the
world; and if you don't have it enforced, if there is not
proper oversight, even good regulations fall short. We saw that
in the Gulf of Mexico not too long ago with the terrible oil
spill.
So I hope Americans see this today, they see two people,
and they look at both of you and hear your stories and say,
that could be my grandmother, that could be my mom, that could
be my sister, and people realize there is a reason for this;
and that, yes, we do need good regulations, and we need good
oversight. And when everybody does things the way they are
supposed to do it, people can make money, and businesses can
thrive, and we can all feel good about the fact that what's put
on our tables or when we go to a restaurant, that something
terrible isn't going to happen to us after we leave that
restaurant.
And that is really the purpose of the hearing today is to
get to the bottom of these things. And I think more than
anything we will hear today, it will be your personal stories,
I think, that will touch many of the people in the U.S. Senate
and whoever has got that hold over there.
You know, on the Senate side, it's a strange institution.
One of these guys can hold up legislation no matter what it is.
I had a bill that passed here this year that a Senator had a
hold on, so I went over and talked to him, and he lifted his
hold; and then another Senator put a hold on the bill, so I
went over and talked to that Senator, and he lifted his hold.
Then I was told there was a secret hold on the bill, and now we
don't know which Senator has a hold on it. So it is a strange
institution over there, and sometimes it takes stories like
this to move them to action.
So thank you for coming today and helping us out and
helping your fellow citizens in America have safe food to eat.
Thank you.
Mr. Chairman, I'll yield back.
Mr. Stupak. Thank you, Mr. Doyle.
Seeing no further Members ask question, I want to thank you
again for coming and for helping us out. And I know you came
here on your own free will and with your own experience, and so
we appreciate it. And so on behalf of Congress and the American
people, thank you for being here.
Mr. Burgess. Mr. Chairman.
Mr. Stupak. Mr. Burgess.
Mr. Burgess. I wonder if I might be recognized for the
purpose of entering into a colloquy with the chairman.
Mr. Stupak. Sure. Go ahead.
Mr. Burgess. Mr. Chairman, is it not true that under
committee rule 3, subsection D, under Questioning, the right to
interrogate a witness before the committee or any of its
subcommittees alternates between the majority and minority,
Members. Each member shall be entitled to 5 minutes in
interrogation of the witnesses.
Is that your understanding of the rule?
Mr. Stupak. To question witnesses, that is correct.
Mr. Burgess. Five minutes of time was to be controlled by
the ranking member of the committee, and 30 seconds of that
time were taken from me. Could I ask the chairman's indulgence
to restore that time on the next panel of witnesses?
Mr. Stupak. No, Mr. Burgess. You were instructed that there
was--your unanimous consent was denied, and you tried to
violate the wishes of this subcommittee by going backdoor. You
said you were done with your questions. It is not unusual for
Members to end less than 5 minutes, we yield back our time and
move on. I asked you not to go on and read it. You insisted
upon reading it. I let you read until your 5 minutes expired,
and then I muted your mike. So you had your 5 minutes. You
chose to use your last 30 seconds or whatever to read a
statement. So I am not going to give you more time with the
next witnesses.
Mr. Burgess. Mr. Chairman, with all due respect, you muted
my mike immediately upon my beginning to read the statement.
And, further, in regards to that controlling of 5 minutes, as
you know, it is a well-established pattern, especially in this
committee, that Members may use their time to talk about
whatever they wish. Sometimes they offer soliloquies that I
think are entirely far afield from where we are, but I don't
object to them doing that. And certainly I don't recall anyone
ever being treated in the way of having their microphone
silenced. I looked upon that as a period of censorship that you
exercised, and I have got to tell you I feel very strongly
about this, that I think that was wrong, and I think this
committee needs to rectify it.
Mr. Stupak. The record is clear what happened. If we have
to read it back later, we can. You had your 5 minutes. Even
after the objections of this committee, you decided to go ahead
and read a statement which you asked unanimous consent be
submitted into the record. The Members on our side objected.
You should not the--if you want to follow the rules of the
House, you would not have tried to backdoor it by reading it
in. I let you go--excuse me. Don't interrupt me. I let you go
until your 5 minutes was up. You had your full 5 minutes. And
this has happened before. I have been here 18 years. In fact,
even up here, though I could mute your mike because it says
``private,'' and it says ``mute off.'' This is not the first
time it happened. It has happened many times.
You have to go by the rules of this committee and by the
ruling of the Chair. You cannot take and make your own rules as
we go along. You are violating the wishes of the committee, you
are violating the rules of this subcommittee, you are violating
the proper decorum as the way we conduct hearings. My job, my
responsibility is to move this hearing forward, conduct it in
an fair and impartial manner. I did that.
Mr. Burgess. Mr. Chairman, I would submit that rule 3,
subparagraph B was violated by the chair and not by the ranking
member.
Mr. Stupak. We are not going to agree, so let's move on.
Mr. Stupak. Let me call our next panel of witnesses.
On our second panel we have Austin ``Jack'' DeCoster, owner
of Wright Country Farm; Peter DeCoster, chief operating
officer, Wright County Egg; Orland Bethel, president,
Hillandale Farms of Iowa; Mr. Duane Mangskau, production
manager, Hillandale Farms of Iowa.
Just waiting for people to settle down here a little bit.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that you have the right under the
rules of the House to be advised by counsel during your
testimony. Do any of you gentlemen wish to be represented by
counsel?
Mr. DeCoster, you want to press that button? And I would
ask you to give us the name of your counsel.
Mr. Austin DeCoster. Jan Kramer.
Mr. Stupak. And during your testimony, before you answer a
question, if you would like to consult with your counsel, you
have a right to do so.
Mr. Austin DeCoster. Thank you.
Mr. Stupak. Anyone else?
Mr. Peter DeCoster. Yes. Mr. John Bodey.
Mr. Stupak. Mr. Bethel.
Mr. Bethel. Yes. Yes, I have counsel here.
Mr. Stupak. Would you state counsel's name?
Mr. Bethel. Tom Green.
Mr. Stupak. And, again, if you wish to consult with them
during questions, you may, but questions have to come from
you--or, the answers have to come from you. I'm sorry.
And Mr. Mangskau?
Mr. Mangskau. No.
Mr. Stupak. No counsel with you. OK. So we have that on the
record.
And, again, anytime during the questioning you wish to
consult with your counsel, you may.
So I am going to ask you to please rise, raise your right
hand and take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect each witness answered in
the affirmative. They are now under oath.
We will now hear a 5-minute opening statement from our
witnesses. You may submit a longer statement for inclusion in
the hearing record. So Mr. DeCoster on my far left, Jack, if
you want to start your opening statement, please do. Press the
green light there on that microphone and pull it forward, and
we can hear you.
STATEMENTS OF AUSTIN DeCOSTER, OWNER, WRIGHT COUNTY EGG; PETER
DeCOSTER, CHIEF OPERATING OFFICER, WRIGHT COUNTY EGG; ORLAND
BETHEL, PRESIDENT, HILLANDALE FARMS OF IOWA; AND DUANE
MANGSKAU, PRODUCTION MANAGER, HILLANDALE FARMS OF IOWA
TESTIMONY OF AUSTIN DeCOSTER
Mr. Austin DeCoster. Commissioner, Mr. Chairman, and
members of the committee, thank you for the opportunity to
testify. My name is Austin DeCoster. I go by ``Jack.'' My son
Peter and I are here to answer your questions.
[Disturbance in hearing room.]
Mr. Stupak. All right. We ask the room be cleared.
I would ask that you suspend for a few minutes. I would ask
that you would cease and desist, please, sir. The hearing must
continue. We will resume these hearings. It is not unusual for
us to have an few outbursts whether it's on this side of the
dais or the other side.
Mr. DeCoster, go ahead, please.
Mr. Austin DeCoster. We were horrified to learn that our
eggs may have made people sick. We apologize to everyone who
may have been sickened by eating our eggs. I have prayed
several times each day for all of these people for improved
health.
For generations our family has been producing eggs, and I
have spent my life as a chicken farmer. I have been blessed to
be able to work with my sons on our farms as well. Over the
years we have grown to be pretty big in producing eggs;
unfortunately, we got big quite a while before we stopped
acting like we were small. What I mean by that is we were big
before we started adopting sophisticated procedures to be sure
we met all of the government requirements.
While we were big but still acting like we were small, we
got into trouble with government requirements several times. I
am sorry for those failings. I accept the responsibility for
those mistakes in our operations. Eventually I realized that to
put those problems behind us, we would have to become very good
at meeting all the government requirements, so for about 10
years now we have been focused on doing just that.
We are moving forward. We have put in place effective
employee training systems, additional monitoring and control
procedures to assure compliance with government requirements.
When necessary, we hire top experts to be sure the procedures
are right. Also, in critical areas, including reduction of
Salmonella Enteritidis, we have been going beyond government
requirements in an effort to improve our operations with all
these systems. We have made important strides, and I am proud
of our work. Still, these challenges never stop.
Mr. Stupak. Does that complete your testimony?
Mr. Austin DeCoster. Yes. That completes it.
[The statement of Mr. Austin DeCoster follows:]
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Mr. Stupak. OK.
TESTIMONY OF PETER DeCOSTER
Mr. Peter DeCoster. Mr. Chairman, my name is Peter
DeCoster. I am the chief operating officer for Wright County
Egg of Galt, Iowa. In other words, I run the Wright County Egg
Farms. Permit me to begin with a short overview of Wright
County Egg farming operation in Iowa.
Three hundred fifty people are employed at our Iowa farms.
We have 5 farms with 73 hen-laying barns, each about 33,000
square feet in size. Almost all of the barns are a two-story
structure with the hens located in the upper part of the barn.
In all, Wright County has 5.8 million laying hens. Our farms
produce approximately 2.3 million dozen eggs per week, or about
1.4 billion eggs per year.
In addition, Wright County Egg operates the barns at the
Hillandale Farm near Alden, Iowa, with 10 barns and
approximately 1 million laying hens, producing more than
435,000 dozen eggs per week.
Each of the six farms we operate is at a different
location. No two farms are less than 1 mile from another. In
addition to our farms, at a separate location Wright County Egg
operates a feed mill which produces our poultry feeds. It was
inspected by Iowa with no major deficiencies found. The
inspection report was transmitted to us by the FDA in May.
Some background on the Salmonella Enteritidis and how our
egg farms are monitored for the bacteria may also be useful.
Regrettably, SE is a fact of life in the egg industry. That is
why all egg cartons bear the ``safe food handling''
instructions and the FDA model code requirements that eggs be
thoroughly cooked.
Like everyone else who has been producing eggs for decades,
we have fought SE for a long time, and we have not always been
successful. Today we have extensive SE reduction practices that
were unknown in previous years. To protect against SE
contamination, our farm follows stringent standards for egg
production, processing, and transportation to ensure both the
quality and safety of our eggs when they reach our customers.
In addition to the following food safety guidelines and the
new FDA egg safety rules, our farm also established in July of
2009 a voluntary overall Salmonella intervention and risk
reduction program which sets specific protocols in the areas of
chicks and breeder flocks, biosecurity, cleaning and
disinfecting between flocks, test management, vaccination, and
refrigeration. Further, Wright County Eggs has been working
with two top scientists to enhance our biosecurity and bird
health needs. They provide outside counsel to decide effective
programs, monitor their performance, and make operational
requirements as necessary.
Of particular potential assistance to your investigation,
Dr. Charles Hofacre has advised us on bird health matters. Dr.
Hofacre is recognized as one of the world's leading authorities
in SE control, and I appreciate his presence in the hearing
room today.
As a tool in our SE reduction program, Wright County Egg
began SE vaccinations of our flocks. That vaccination program
and the voluntary environmental testing program that guided it
and other operational decisions is outlined in our written
testimony.
So we have had extensive SE reduction programs designed to
meet all regulatory requirements and go substantially beyond
the requirement with additional measures, notably our SE
vaccination program. So we were stunned to learn that our eggs
appeared to be responsible for an SE disease outbreak.
In mid-August, FDA requested that Wright County Egg
undertake a voluntary recall of our eggs. We promptly did so in
cooperation with FDA. Our first recall was announced on August
13, 2010, which involved three of our farms. Then our second
recall was announced on August 18, 2010, and addressed eggs
from the other two farms. An extensive food safety
investigation followed.
At this time we cannot be absolutely certain of the root
cause of the contamination of the eggs we produced; however, we
view that the most likely root cause of contamination to be the
meat and bone meal that was an ingredient in our feed.
At this point I would appreciate a projection of the first
slide we provided to the committee.
Meat and bone meal was produced at a rendering facility.
Part of the production process in rendering includes cooking
carcasses to a temperature that would eliminate SE. However, as
always in food safety matters, there is the potential for
recontamination either at the rendering facility and the
transportation from the rendering facility, or subsequently
after the meat and bone meal is delivered to Wright County Egg.
In particular, contaminated meat and bone meal that entered our
bin with the ingredient could have contaminated the bin and
additional meat and bone meal that was subsequently added to
the bin.
Next slide.
Not only is this suspicion consistent with the FDA test
results, but it also is consistent with the fact that the only
Hillandale Farms operation to produce eggs that tested positive
for the SE contamination was the Alden farm, which received its
feed from the Wright County Egg's feed mill. So all of the
flocks that have been proven to be the source of this SE
outbreak received feed from the Wright County Egg's feed mill.
My written testimony outlines the exhaustive operational
changes that Wright County has undertaken to take every
precaution against this ever happening again. By focusing on
our flocks, our feed, and our worker biosecurity protocols, we
intend to demonstrate our commitment to the production of eggs
that are of high quality and safe.
We look forward to answering your questions so an accurate
understanding of what caused this food-borne disease outbreak
might be achieved. Thank you.
Mr. Stupak. Thank you.
Mr. Bethel, your opening statement, please, sir.
Mr. Bethel. Mr. Chairman, I do not have an opening
statement.
Mr. Stupak. OK. Thank you.
Mr. Mangskau.
TESTIMONY OF DUANE MANGSKAU
Mr. Mangskau. Mr. Chairman, Dr. Burgess, and other
subcommittee members, my name is Duane Mangskau, and I am
Hillandale Farms of Iowa, Incorporated's, production
representative.
I grew up in Minnesota, and upon graduation from high
school spent nearly 13 years working on a family farm with my
father and brother in Ellendale, Minnesota. In the late 1980s,
I entered college to study business administration. While
completing my studies in 1991, I learned about feed and poultry
production while working for an independent-owned grain and
feed company.
After graduation, I continued working with feed and poultry
flocks with the farmers' cooperative located in Oakland,
Minnesota. Based upon my knowledge of poultry flocks, I was
invited to manage production for the Interstate Value Added,
IVA, Farmers Cooperative when it began construction in 1998. I
served as the production manager and later the general manager
of operations at the IVA facility in West Union, Iowa, until it
was purchased in December of 2007.
I left the West Union facility in March of 2008 and
returned at the request of Hillandale Farms of Iowa in March of
2010. I now serve as Hillandale's production representative at
the West Union facility.
It will probably help our discussion today if I define a
few industry terms. When I talk about egg production, I mean
the first of three steps in getting eggs to our customers. Egg
production encompasses every aspect of farming and raising the
hens up until the eggs are ready for processing. The next step,
egg processing, involves cleaning, grading, and packaging the
eggs. The final phase, which involves marketing and
distribution, has traditionally been Hillandale's area of
expertise.
In order to get fresh quality eggs to market, Hillandale
must be able to rely on good production and good processing.
From 2008 until recently, Hillandale relied on Wright County
for production in Iowa.
In its 50 years of existence, I believe that Hillandale
Farms, while not perfect, historically has had a record and
reputation for supplying the Nation with safe quality eggs. In
fact, to the best of my knowledge, Hillandale Farms had never
been involved in a recall until 3 weeks ago, when the FDA told
us that seven people had become ill from Salmonella at a
Mexican restaurant that received Hillandale Iowa eggs. There
are many other potential sources of Salmonella contaminations
in restaurants, and we were, to be honest, shocked by the
allegation.
During the prior 4 months, we had shipped about 170 million
eggs from Iowa, and it was difficult to understand why FDA was
saying that our eggs were responsible for seven people sick at
one restaurant.
The recall has, however, forced Hillandale to take a hard
look at our operations and will, in the long run, make our
operations better.
On August 20, we voluntarily recalled the relevant eggs,
diverted all other eggs from those facilities to breaking
facilities, and have been cooperating with the FDA, State
officials, our customers, and this subcommittee ever since. And
even if the source of the Salmonella illness is never
confirmed, where we have fallen short in Iowa, we are committed
to improving our operations. At Alden, where Hillandale Farms
has no ownership interest, we have terminated our marketing
relationship with its owner, Wright County, because we were
disappointed in the test results there. At the West Union
facility, we have redoubled our safety efforts and fully
addressed all of the issues identified on the FDA's 483 report.
We would like to emphasize, however, that no egg from West
Union has tested positive for SE.
Nonetheless, Hillandale has retained the former Associate
Commissioner of Foods at FDA and the former head of food safety
at several Fortune 200 companies, including H.J. Heinz,
Campbell Soups, and Tricon Restaurants, to conduct an intensive
assessment of food safety at our West Union facility and offer
recommendations. You have our commitment that we will implement
any and all of these recommendations.
Moreover, Hillandale Farms will continue to cooperate with
all government officials, including this subcommittee. And I
look forward to answering any questions that you may have.
Thank you.
Mr. Stupak. Thank you.
[The statement of Mr. Mangskau follows:]
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Mr. Stupak. That concludes testimony. We will open for
questions. I will begin.
Mr. Bethel, I will start with you, if I may. Following the
outbreak of the Salmonella, Federal public health officials
inspected your egg facilities in Iowa over the course of 7
days. During the course of the FDA's investigation, your
employee Mr. Mangskau, who is providing testimony to the
committee today, accompanied the agents as they conducted the
inspection.
I would like to ask you about an e-mail you received on
August 21, 2010. In this e-mail you received, Mr. Mangskau
summarized his notes from the inspection. He wrote:
Barn 7. Put lids on the dead chicken barrels to reduce
vector access.
Barn 8. Wet manure due to water leaks. Didn't say it needed
to be removed, but they didn't like it.
Barn 9. Saw old dead birds in a few cages and old chicken
heads on egg belts.
So here is my question. And, again, you are under oath,
sir. Mr. Bethel, prior to receiving Mr. Mangskau's e-mail, were
you aware of the conditions he noted at the Hillandale egg
facilities in Iowa?
Mr. Bethel. I respectfully decline to answer the question
based on the protection afforded me under the Fifth Amendment
of the Constitution.
Mr. Stupak. Mr. Bethel, I understand that you are invoking
your right against self-incrimination, which is your
prerogative under the Fifth Amendment to the Constitution of
the United States. Is it your intention to invoke the right to
refuse any questions during this hearing?
Mr. Bethel. Yes.
Mr. Stupak. Then I will refrain from asking you additional
questions about this subject matter and request that other
Members also refrain from asking you further questions.
Mr. DeCoster--I'm sorry, Mr. Burgess?
Mr. Burgess. Just simply, will I allowed to question Mr.
Bethel?
Mr. Stupak. You can. But, I mean, I think he has made it
pretty clear he is going to take the Fifth Amendment to any
questions, though.
Mr. Burgess. I reserve the right to question the witness.
Mr. Stupak. You reserve the right during your time.
Mr. Jack DeCoster, if you will. In your testimony, you
admit that your facilities had problems in the past. That is
indisputable. There have been several outbreaks associated with
your eggs in two States. Specifically Maryland and New York
have been mentioned today in which your eggs were actually
banned.
Your response in your written testimony, you indicated that
when you were small, and that you have had--put those problems
behind us, was what you said. My question to you is this. If
you have cleaned up your operations as you say, why did this
outbreak happen?
Mr. Peter DeCoster. Mr. Congressman, if I could answer
that?
Mr. Stupak. Well, that is directed at your father. So let
him answer if he can. Can he answer that question?
Mr. Austin DeCoster. Well, I will try to answer it, but I
am having trouble hearing. Could you speak up a little bit
more, please?
Mr. Stupak. Sure. In your testimony, you admitted your
facilities have had problems. That is indisputable. There have
been several outbreaks associated with your eggs in two States
we have heard about today, both Maryland and New York, where
your eggs were actually banned. Your response, and in your
written testimony, you said: This all occurred when DeCoster
Farms were small, and that you have put those problems behind
you.
So my question is if you have cleaned up your operations as
you say, why did this outbreak occur?
Mr. Austin DeCoster. Well, this is a--Mr. Chairman, this is
a complicated subject. I have to take it piece by piece kind
of. Will that be OK?
Mr. Stupak. Sure. Let's go piece by piece, and take the
document binder right there. Go to binder--to tab number 16.
And we will go through it piece by piece.
Mr. Austin DeCoster. Sixteen?
Mr. Stupak. Right here. Look under tab 16.
In August, the FDA inspectors went into your facilities.
The conditions they found were appalling. Let me show you some
photographs from the inspection. It is a photograph that I put
up during my opening statement of decaying chickens in your
egg-laying facility. You said you were following sophisticated
procedures to keep your facilities clean. How do you explain
dead chickens in your laying--hen-laying houses?
Mr. Peter DeCoster. Mr. Congressman, this particular----
Mr. Stupak. I'm sorry. I am talking to Mr. DeCoster, Jack
DeCoster.
Mr. Peter DeCoster. But he doesn't run the operation. I do.
Mr. Stupak. Right, I know, but he testified that he cleaned
up; that when you were small, you didn't have these problems.
OK. Do you want to answer?
Mr. Peter DeCoster. Yes, sir.
Mr. Stupak. OK. How do you account for dead chickens then?
Mr. Peter DeCoster. Well, there's eight dead hens here that
are in the back of building. And, you know, kind of like a
large city, there's 80,000 birds in the building.
Mr. Stupak. Sure.
Mr. Peter DeCoster. Occasionally we will have some
mortality. And these are taken to the back of the barn now. Our
policy is to have these in a barrel.
Mr. Stupak. But they weren't at the time, Were they?
Mr. Peter DeCoster. No. No, sir, they're not.
Mr. Stupak. OK. Go through the other photos, the mice along
the conveyor belt for the eggs.
Mr. Peter DeCoster. But this here would not be acceptable.
Mr. Stupak. Right. Either are mice by this.
And go through there. Look at the manure coming out of the
building from the foundations, the door. This isn't something
that just happened overnight. That manure pile is about 7 to 8
feet tall. It is seeping out through cracks. So, number one,
you have got too much manure. It is flowing out of your
buildings. You've got cracks, you've got dead mice, you've got
dead chickens, you've got maggots. That stuff just didn't
happen. I agree, you have a--you're a big operation, but with
big operations come big responsibilities.
So how did you clean up your act if you started small and
now you've cleaned up your act?
Mr. Peter DeCoster. In the case--if I could just, kind of,
go one at a time here on the photos.
The one that shows the door being gapped open with the
manure, these houses--as you can see, it is a house that is
basically 18 foot at the ease there. It is a two-story
structure.
Mr. Stupak. Sure.
Mr. Peter DeCoster. The hen population is in the top story.
The building is designed to have these manure pits. And I know
this has got a lot of press, but this is a standard practice in
the industry to have manure underneath the birds and then be
taken out.
Mr. Stupak. Sure.
Mr. Peter DeCoster. The problem we had here--the manure
accumulation in the pit, I agree with you, is not overnight.
The doors coming open like this is basically an overnight
problem. The weather through this past winter and this past
spring in Iowa has been unbelievable, the likes that we have
never seen before. And the local co-op who takes our manure out
for us was just behind. They had got behind. I take full
responsibility----
Mr. Stupak. Or maybe you have too many birds in the house?
Mr. Peter DeCoster. What?
Mr. Stupak. Maybe you have too many laying hens in the
house, that the house can't handle all the manure coming down?
You have too many birds?
Mr. Peter DeCoster. No, sir. The house has got 80,000
birds. It is actually designed for 101,000.
Mr. Stupak. OK.
Mr. Peter DeCoster. The reason we have 80,000 is we follow
the UEP Animal Welfare Guidelines.
But this problem was cleaned up that very day that this
picture was taken. And what the picture doesn't show you is
that there was a manure crew on-site taking this manure out.
Mr. Stupak. OK. Did DeCoster Farms, you as operating
officer--you knew about the FDA putting out a final rule in
July. Did you comment while that rule was being developed? Did
you comment, submit comments to the FDA on how you thought the
rule should be?
Mr. Peter DeCoster. I don't believe I commented on the rule
that came out in 2009.
Mr. Stupak. OK. So you didn't need the rule to understand
that this was unacceptable.
Mr. Peter DeCoster. Yes, this doesn't have really much to
do with the rule.
Mr. Stupak. Right. I realize that.
Mr. Peter DeCoster. And then what--the problem I have with
this is not the manure in the pit, sir, but the fact that the
door is gapped open and it can allow mice inside our
facilities.
Mr. Stupak. Sure. There is also another photo of manure
coming out of the side of some holes. There's holes in your
building, and the mice would have been going in those holes,
but they probably couldn't get in because the manure was coming
out.
So, with that, my time has expired. Mr. Burgess for
questions?
Mr. Burgess. Thank you, Mr. Chairman.
Mr. Bethel, I understand you asserted your privilege under
the Fifth Amendment, but, nevertheless, I do want to ask you
one question. Please feel free to answer it if you wish.
An e-mail dated August 31, 2010 from you to John Glessner
states, quote, ``Hillandale needs to totally disassociate
itself from Jack, and it has to be real. Hillandale has a good
business base, but it will be all gone if I don't move quickly.
And I will not try to deceive the public,'' closed quote.
First, do you recall sending this e-mail? Is the reference
to ``Jack'' Jack DeCoster? And further, why did you state that
Hillandale needs to disassociate itself from Jack DeCoster?
And why did you feel a need to state that you will not try
to deceive the public? Had someone previously asked you to
deceive the public? And, if so, would you please share with the
committee who that would be?
Mr. Bethel. I respectfully decline to answer the question
based on the----
Mr. Stupak. Sorry, Mr. Bethel, would you please turn on the
mike and pull it forward and then read your statement again?
Mr. Bethel. I respectfully decline to answer the question
based on the protection afforded me under the Fifth Amendment
of the Constitution.
Mr. Burgess. I appreciate that. As the chairman did not
excuse you as a witness, I felt obligated to ask you that
question, because it was a significantly important part of our
investigation.
So, Mr. DeCoster--and either Mr. DeCoster--let me ask you
this: You have seen the photographs. We have talked about the
photographs taken by the Food and Drug Administration
inspectors at your farms to document the observations made in
Form 483 and show what appear to be astonishingly unsanitary
conditions.
How would you characterize these photographs? And do they
warrant the alarm and concern being voiced here today? And, if
not, share with us why not.
Mr. Peter DeCoster. Yes, sir. Thank you.
The photo--and I haven't looked at all of them in detail,
Mr. Congressman. But the rodents that were brought up in the
483, if we could take that one first. There was 31 rodents that
was counted by FDA, and those 41 rodents were found in going
through over 107 barns that we own. These barns cover
approximately 66 acres of ground, just on the upper level, not
counting the manure pits. So----
Mr. Burgess. Now, you know, rather than going through and
dissecting out the data, do you think the alarm that has been
evidenced here today, is that warranted?
Mr. Peter DeCoster. I would like to invite each and every
member of this board to come and view----
Mr. Burgess. I wish we had had that opportunity also, Mr.
DeCoster, but it wasn't afforded to us by the majority.
Let's go on. I may submit some questions to you in writing,
but, as you see, the chairman has a pretty quick gavel with me.
Prior to the FDA egg rule, there were no Federal
requirements, testing requirements, for Salmonella at egg
production facilities, but some States and some industry groups
voluntarily set guidelines.
So if the Salmonella testing is not required by law, when
and why did you start testing for Salmonella?
Mr. Peter DeCoster. Our reason for testing for Salmonella,
we first originally started testing to see if we may have it.
We didn't have any trace-backs, we didn't have any reported
illnesses. There was no government agency that says that we
should test. We tested voluntarily because we was trying to
learn if we had the problem, and then if we did have the
problem, what would be the best practices that we could set
forward----
Mr. Burgess. Yes. Now, I'm going to interrupt you again.
I'm not trying to be rude. But let me just suggest that if you
took 72 swabs in 1 day and all but 8 tested positive, you've
got a problem.
Mr. Peter DeCoster. Well, yes, sir, and we----
Mr. Burgess. Can I suggest that to you?
Mr. Peter DeCoster. Well, you can suggest it, sir. But I
would like to talk to Dr. Chuck Hofacre. He is the leading
expert on this. And he has been guiding us through this whole--
--
Mr. Burgess. And I will tell you what, let me submit that
to you in writing, because I do want to get an additional
question in.
Prior to the egg rule, when your company received a
positive environmental result for Salmonella, what corrective
action did you take? And did you automatically test the eggs as
a precautionary measure?
Mr. Peter DeCoster. The results--we have been taking this
kind of as--over a period of time, we have been learning more
and working with Dr. Hofacre. But we have implemented things
such as vaccinating, and then vaccinating the flocks twice as
we learn more. We have eliminated molting in our system. And we
have also eliminated the use of meat and bonemeal.
Mr. Burgess. I'm going to stop you because I'm about to run
out of time.
When did the FDA come to you and suggest that you needed to
recall your eggs? Do you remember the calendar date?
Mr. Peter DeCoster. I'm going to say the first, initial
contact was a phone call, and that would have been August 12th.
Mr. Burgess. And what date did you institute the recall?
Mr. Peter DeCoster. The very following day. We received
that call that late afternoon, and the very next day we issued
the recall.
Mr. Burgess. Were you required to do so?
Mr. Peter DeCoster. No, sir. This was a voluntary measure
that we----
Mr. Burgess. Thank you, Mr. Chairman. I appreciate your
indulgence.
Mr. Stupak. Thank you.
Does any other Member wish to ask Mr. Bethel a question?
Because I'm about to excuse him since he has invoked his Fifth
Amendment. I had asked Members to refrain from asking him a
question. The reason why I did not dismiss you after is because
Mr. Burgess was insisting on asking you a question. It is not--
because if I wouldn't have given him the opportunity, he would
have accused me of censorship. So I thought I would give him
that opportunity.
So does any other Member--seeing no other response, Mr.
Bethel, you certainly invoked your rights, and that is your
right and privilege here. And thank you for being here, but you
will be dismissed from this panel.
Mr. Bethel. Thank you.
Mr. Stupak. Mr. Waxman for questions.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Jack DeCoster, how long have you been in the business
of chickens and eggs?
Mr. Austin DeCoster. Since 1949, September 5th, when my dad
died.
Mr. Waxman. Uh-huh. So you inherited the business from your
father, as your son is doing the business with you?
Mr. Austin DeCoster. Yes. He had 125 hens. I took them
over.
Mr. Waxman. Now, you have had a history of over 30 years of
problems with Salmonella-infected eggs, and you had a pretty
sordid record. You said it was because you were a small
operation and you got bigger and you still operated as if you
were a small operation. You had problems in the 1990s, and you
had problems in Maine and Maryland. Now you're in Iowa, and you
don't want to have any problems anymore. So you said you really
tried to change your operation. You modernized and cleaned up
the facility.
But that's not what the record indicates. FDA conducted an
inspection. They did this last August. I want to read you some
passages and ask you to respond.
They found, quote, you ``failed to achieve satisfactory
rodent and pest control, as evidenced by the following: live
and dead flies too numerous to count. The live flies were on
and around egg belts, feed, and shell eggs. In addition, live
and dead maggots too numerous to count were observed.''
Does this sound like a clean facility to you?
Mr. Peter DeCoster. Mr. Congressman, if you don't mind, I
would like to answer the 483 questions for Iowa.
Mr. Waxman. Well, I'm happy to hear from you because you're
very much involved in running the operation now. But your
father has been in this business for longer than you have, and
he wanted to make sure he is living up to a higher standard. I
want to know if he feels this is a higher standard.
Mr. Austin DeCoster. OK. Well, higher standards in the
State of Maine, where I live----
Mr. Waxman. Well, I'm not asking about Maine. I'm asking
about the report of the inspection from the FDA. You were
determined to run a clean operation, and then they found all
these dead flies and maggots and other problems. Does that
bother you?
Mr. Austin DeCoster. It bothers me a lot. But I feel like
Peter--we have a certain way we handle flies, a certain way we
handle mice. We have hired Maxcy Nolan, who is considered an
expert.
Mr. Waxman. When did you hire him?
Mr. Peter DeCoster. Maxcy has been coming out to our
facility since last summer. And he set up our fly and rodent
program.
Mr. Waxman. Well, I want to read to you another finding
from the FDA, and you may want to consider firing this guy.
The FDA said you ``failed to take steps to ensure that
there is not introduction or transfer of SE''--Salmonella
Enteritidis--``into or among the poultry houses. This was
evidenced by the following observations: uncaged birds.
Chickens having escaped were observed in the egg-laying
operation in contact with the egg-laying birds. The uncaged
birds were using the manure, which was approximately 8 feet
high, to access the egg-laying area.''
What this means is that the chickens had escaped the
henhouse, they were walking in the manure pit, and then mixing
in with the caged birds. Do you agree with the FDA that this is
a violation of appropriate safety standards or procedures?
Mr. Peter DeCoster. We are, kind of, jumping around a
little bit. We are going from rodents to flies to loose
chickens. But if we want to stick with the loose chickens for a
minute, there was--they observed two or three loose chickens
that had got out of their cages in a couple different houses.
And in the course of our barn men doing their work, they will
access a cage, whether it be a sick hen, a water nipple that
may be leaking or need repair, and a chicken can escape when
they open the door. Or if they forget to close the door
completely, a chicken can escape.
Now, these chickens----
Mr. Waxman. Mr. DeCoster, let me interrupt you to say this.
You have had problems in the past, right? Over 30 years of
problems in different States. You had a call from the FDA to
recall your eggs, and you voluntarily did that, and then the
inspection took place.
Mr. Peter DeCoster. Yes.
Mr. Waxman. That's when the FDA found all these problems.
You've claimed that you were going to modernize and clean up
your facility, but it doesn't appear that you have modernized
and cleaned up your facilities. It sounds like, to me, that
both of you are refusing to take responsibility for a very poor
facility.
According to the FDA inspections, they found all these
rodents. You would think, after you were called on to recall
the eggs, you would have made sure your facility was cleaned
up. Maybe you did. Maybe this is as clean as you got it, but it
still looked pretty dirty.
How do you respond to that?
Mr. Peter DeCoster. Well, hopefully I will be allowed to
finish this time. But, I mean, we are jumping all over the
place. You're not giving me fair time to answer the question.
And then----
Mr. Waxman. Well, then I'm going to--I'm going to have your
father respond, because he talked about how he wanted to clean
up the facility. And I want to ask him to tell us whether he
approves of the conditions and how his son operates the
facility.
Mr. Peter DeCoster. Mr. Congressman----
Mr. Waxman. After this FDA inspection, all of these
problems they just found, after the recall already started, do
you think this is a satisfactory way for the facility to be
run?
Mr. Peter DeCoster. Mr. Congressman----
Mr. Waxman. I have asked your father. I have asked your
father. I'm asking the questions.
Mr. Jack DeCoster?
Mr. Austin DeCoster. Yes, I follow what you are saying. OK?
However, this is a very big operation. We have a certain way we
go about running it. Regardless----
Mr. Waxman. You had problems when you ran it that way, and
you were going to clean it up. So, where you are now is, you
feel, cleaned up and adequate?
Mr. Austin DeCoster. Sir, please, let me talk, OK?
We have a certain way that--our barn man goes into the
chicken house. He has a certain way he does this work. OK? He
starts in the morning, he pulls out the dead chickens. He
spends a certain amount of time checking the egg belts, taking
the dead chickens out, checking the water, checking the lights.
Then what he does, he goes and he sweeps all of the barns. He
goes into the pits. He checks the leaking water that is coming
down from upstairs into the pit. He checks loose birds in the
pit. He puts light bulbs in if there's any missing light bulbs.
He was supposed to be checking this door that was pushed out.
That door would not stay like that very long.
Mr. Waxman. Mr. DeCoster, we only have a certain amount of
time, and my time is pretty much over. But I do want to tell
you this.
Mr. Austin DeCoster. I'm sorry.
Mr. Waxman. It is hard for me to reconcile your words, that
you wanted to clean up and you did clean up the facility, with
the record before the committee. The conditions in your
facility were not clean, they were not sanitary. They were
filthy. And given the 30-year record of violations, it appears
that you are a habitual violator of basic safety standards. And
I must say, for you to come before us and say, ``It is the
feed; we had nothing to do with it,'' it is hard for me to
believe and accept at face value.
My time has expired, but I just want you to know my
thoughts about it.
Mr. Stupak. The gentleman's time has expired.
Mr. Latta for questions, please.
Mr. Latta. Thank you very much, Mr. Chairman.
Mr. DeCoster, Peter, looking at this report, this 483, the
date of issue is August the 30th. How often has the FDA been
inspecting?
Mr. Peter DeCoster. That's the first time the FDA has been
to our facilities.
Mr. Latta. For any of your facilities? OK.
Mr. Peter DeCoster. Well, for the barns, the chicken barns.
Mr. Latta. OK. Let me ask, is the USDA on your premises at
all times or at the different houses?
Mr. Peter DeCoster. The USDA EMS does grading of our
processing plants, all of our processing facilities. We have
the voluntary program of USDA, which, you know, we incur the
cost.
Mr. Latta. OK. But, again--I know I have been in different
houses and facilities, and there is usually someone from the
USDA. Is there a USDA person on the premises part of the time,
all the time?
Mr. Peter DeCoster. USDA would be in the processing plant
during the hours of operation, generally from 6:00 in the
morning until whenever we finish in the afternoon.
Mr. Latta. OK. Do you have the Department of Agriculture in
Iowa inspecting out there? Does the Department of Agriculture
in Iowa inspect facilities?
Mr. Peter DeCoster. No, sir. The DNR would inspect any
environmental-type issue, but Department of Ag has never been
out to inspect.
Mr. Latta. OK. What does your DNR do?
Mr. Peter DeCoster. It stands for the Department of Natural
Resources.
Mr. Latta. Right, right, but, I mean, what is their role on
the farm, then?
Mr. Peter DeCoster. Their role is basically on any
environmental issue. If manure threatens the water of the
States would be one of the major ones.
Mr. Latta. OK. When they do their--now, they do, like, an
inspection of the houses around the facility? Do they do water-
quality tests like in--you know, I come from the largest county
in the State of Ohio that has ditches. I've got 3,000 miles of
ditches in my home county. And so, you know, are they doing
water-quality tests in ditches? Is that what they are doing?
Are they away from the facility, or are they on the facility's
site?
Mr. Peter DeCoster. The only thing they would inspect on
the facility is a complaint or if there is an annual inspection
on the lagoons.
Mr. Latta. OK. Now, and talking about, like, with the
lagoon--and I heard what you said about it was a wet spring out
there, and I know it was a wet spring in Ohio, trying to get
crops out. What is your manure management plan? Do you have to
file that with someone?
Mr. Peter DeCoster. Yes, there's manure management plans on
every CAFO in Iowa. Our manure management plan, because we do
the sale of our manure with the local co-op, who uses it for
fertilizer, they have the manure management plan.
Mr. Latta. OK. And who do you file that CAFO plan with?
Mr. Peter DeCoster. The DNR.
Mr. Latta. The DNR. OK, do they--OK. Now, because I know we
were just talking about looking at water quality and things
like that, does the DNR then do an inspection around the
buildings, then, on that for the CAFO?
Mr. Peter DeCoster. Not on a regular basis. But the DNR,
after, I guess, reading some of the articles in the newspaper,
came up and did an inspection around our layer barns and said
everything looked OK. I haven't heard anything more.
Mr. Latta. OK. Now, let me ask you, then, when you say they
come not that often, how often would they come around from DNR
on that end?
Mr. Peter DeCoster. Normally, under those type of
circumstances, if they are called out to do it.
Mr. Latta. So they wouldn't do it on, like, a 6-month or
12-month basis?
Mr. Peter DeCoster. No.
Mr. Latta. OK. Now, who hauls your--you know, how often do
you have to clean your barns? Are your barns deep pit, or do
you have conveyer----
Mr. Peter DeCoster. The majority of our barns are deep pit,
like the pictures show here, but we do have one facility that
is a belt battery, where the manure is removed on a daily basis
and put in another barn.
Mr. Latta. And then, with the deep pit, how do you get that
out? Are you using, like, skid steers, Bobcats?
Mr. Peter DeCoster. Yes, skid steers. Bobcat would be a
brand that would be used. But they go through these doors that
are shown in the picture.
Mr. Latta. And then, how often would they do that?
Mr. Peter DeCoster. Our program was to clean every barn
every other year. We did that for a measure of fly control.
Fresh manure, you tend to have a better environment for the
flies. So we was going with every other year, which we have
changed that policy last year to remove the manure every year.
Mr. Latta. Thank you.
Mr. Chairman, I think my time has expired, and I yield
back.
Mr. Stupak. Thank you, Mr. Latta.
Mr. Braley for questions, please.
Mr. Braley. Thank you.
Gentlemen, you weren't here earlier when I delivered the
ode to the Iowa egg. And I can tell you, I have personally been
supporting the Iowa egg industry for 53 years, and there is no
bigger fan of the products you produce.
But I also was sitting down to breakfast in a restaurant
when I first heard about this story. And I can tell you, it
literally made me sick to my stomach and caused me to order
something different on the menu.
And then I was down at the Iowa State Fair earlier this
year, in the Varied Industries Building, looking at a lot of
very nervous egg producers with the Iowa Egg Council.
So I'm going to ask each one of you, do you feel any
personal responsibility to the impact that this recall, this
massive recall, is having on Iowa egg producers?
Mr. Mangskau?
Mr. Mangskau. It is too bad that this occurred, and we do
feel sorry for any inconvenience and cost that it has caused
the industry.
Mr. Braley. I apologize to the two Misters DeCoster, but
it's easier if I just refer to you by your first names, if
that's all right.
Mr. Peter DeCoster. That's fine.
Mr. Braley. Peter?
Mr. Peter DeCoster. Yes, absolutely. I mean, this--this is
an issue I feel terrible has occurred, and it is affecting our
industry.
Mr. Braley. Jack?
Mr. Austin DeCoster. I feel very bad about it, very bad. It
is a horrible thing.
Mr. Braley. Well, the problem that egg producers in Iowa
and all over the country are facing is a series of headlines
like the one in today's New York Times, ``An Iowa Egg Farmer
and a History of Salmonella''; the Los Angeles Times, ``Filthy
Conditions Found at Egg Producers''; ``Egg Farms Violated
Safety Rules''; ``FDA Details Numerous Violations At Egg
Farms''; ``Egg Recall: Mouse, Fly Infestations Date Back 10
Years, Workers Say''; Tainted Eggs Reveal Lapse in State
Protocol.''
And the problem that a lot of us have here on this
committee is a sense that there is a disconnect between the
problems identified in these stories and identified in the
FDA's investigation and the sense of responsibility.
And we had two witnesses who testified at the earlier panel
who talked about the personal impact that this Salmonella
contamination had on them.
Here is the story in today's New York Times: ``On a July
night in 1987, scores of elderly and chronically ill patients
at Bird S. Coler Memorial Hospital in New York City began to
fall violently ill with food poisoning from eggs tainted with
Salmonella. `It was like a war zone,' said Dr. Philippe Tassy,
the doctor on call as sickness started to rage through the
hospital. By the time the outbreak ended more than 2 weeks
later, 9 people had died and about 500 people had become sick.
It remains the deadliest outbreak in this country attributed to
eggs infected with the bacteria known as Salmonella
Enteritidis. This year, the same bacteria sickened thousands of
people nationwide and led to a recall of a half a billion eggs.
Despite the gap of decades, there is a crucial link between the
two outbreaks. In both cases, the eggs came from farms owned by
Austin J. DeCoster, one of the country's biggest egg
producers.''
And, Jack, I think one of the things that people around the
country are asking is, if your company's commitment to food
safety is as strong as you have indicated in your opening
statement to this committee, how is it possible that, after all
this time, we have another DeCoster egg producer involved in a
half-billion-dollar recall?
Mr. Austin DeCoster. Well, the question is complicated,
sir.
Mr. Braley. I would like the record to reflect that the
counsel for the witness has handed him a document.
Mr. Austin DeCoster. Congressman, this SE happened 23 years
ago in one of our farms in Maryland. We destroyed the flocks.
After we destroyed the flocks, we cleaned it all out, washed it
all up, and then put the new pullets in it. And then, it wasn't
very long after that that we--after we put the new pullets in--
which we bought these pullets from a company in Indiana. It
wasn't ones that we raised, or at least not all of the ones we
put in the complex.
And after we get it all filled up again with new birds, all
clean, we thought--and we had, also, a person from
Pennsylvania, a doctor, coming down to our flocks and testing
all of them, reporting that they was OK. And then we had a
reason to take a bird or a few birds down to the Salisbury
Laboratory in Maryland. And we took them down, and they found
SE in a bird or--I don't remember too clearly right now, but
they at least found Salmonella in the birds.
So then FDA came over to our place. And way back then FDA
came over, and they tested every one of our flocks and our
chicken houses. And if I remember this correctly--this was a
long time ago--but we had to take out at least half of all the
flocks again, maybe--it was a seven-house complex. We had to
take at least three to four flocks out. We had to wash it all
again, and then we filled it back up again.
And then, as I remember it, the next time it was OK.
Mr. Braley. Mr. Chairman, my time has expired. But I would
ask unanimous consent to submit for the record the editorials
that I referred to earlier in my questioning.
Mr. Stupak. Without objection--before they are entered, a
request to see them. So if you would provide them, we will look
at them. Then, without objection, we will put them in.
[The information was unavailable at the time of printing.]
Mr. Stupak. Mr. Dingell for questions, please.
Mr. Dingell. Thank you, Mr. Chairman. And I commend you for
this hearing and for the extraordinary leadership that you have
given in our efforts to reform and to enhance the powers of
FDA.
My questions are going to remind me of a day in 1990 when
this subcommittee went into the questions of food safety and,
indeed, in Salmonella in eggs.
I would like to welcome you both, Messrs. DeCoster. And I'd
begin my question by saying this: The Food and Drug
Administration's staff reports on this matter, which I ask
unanimous consent be inserted in the record----
Mr. Stupak. Without objection.
Mr. Dingell [continuing]. Refer to inquiries about your
facilities.
[The information was unavailable at the time of printing.]
Mr. Dingell. And they say, ``Barns were infested with
flies, maggots, and scurrying rodents. Manure piled 4 to 8 feet
high in certain areas. Leaking manure pits. Employees working
without protective clothing. And uncaged hens tracking manure
from manure pit to other areas of the operation.''
Is that true?
Mr. Peter DeCoster. We've--if we could take one of these at
a time. The comment about the employees----
Mr. Dingell. Well, it is either true or not. Is it true, or
is it not true? Yes or no?
Mr. Peter DeCoster. I would say that it's partially true.
Mr. Dingell. Partially true. Well, that's like being
partially pregnant. It's pretty hard to do.
Now, having said this, you were having trouble in the
1990s, and it resulted in a calamitous situation at the Bird S.
Coler Memorial Hospital in New York, just referred to by one of
my colleagues.
I'm curious here, do you dispute any of the allegations
made in the reports by Food and Drug, yes or no?
Mr. Peter DeCoster. On the 483?
Mr. Dingell. The reports of the Food and Drug staff to Food
and Drug, do you dispute any of the statements in those with
regard to the conditions at your farms?
Mr. Peter DeCoster. Yes, sir. When we did our----
Mr. Dingell. Specifically which ones do you dispute?
Mr. Peter DeCoster. OK, the one that you brought up about
the people going from one barn to another. That was not
specified in the FDA's rule, that it says even in their
guidance document----
Mr. Dingell. OK. Is that your only dispute?
Mr. Peter DeCoster. No, sir.
Mr. Dingell. What others do you dispute?
Mr. Peter DeCoster. Well, the dispute we had also--they
named some manure doors that they said was pushed open from
manure, and they were not. There was only 4 doors that were
like that out of the 292. The----
Mr. Dingell. Now, do you dispute the finding that there
were live mice and dead flies too numerous to count in your
facilities?
Mr. Peter DeCoster. I would say there was live and dead
flies. This is a farm; they are chicken barns. We have a very
stringent fly program that Dr. Maxcy Nolan has laid out that is
even tougher than the FDA rules.
Mr. Dingell. Do you dispute the statement of Food and Drug
that these conditions do not promote safety and quality?
Mr. Peter DeCoster. I guess I'm not familiar with that
statement.
Mr. Dingell. OK. What plans do you have in place to prevent
Salmonella contamination?
Mr. Peter DeCoster. We have outlined a very extensive plan
that we submitted to the FDA.
Mr. Dingell. Would you submit those plans for the record,
if you please?
Mr. Peter DeCoster. Yes, I'd be more than happy to.
Mr. Dingell. All right. Now, I understand that two positive
SE samples were collected from your feed mill. Is this true?
Mr. Peter DeCoster. Yes. There was two swabs that were
positive.
Mr. Dingell. The source is thought to be a raw ingredient
acquired from a third party. Is this true?
Mr. Peter DeCoster. That's what we believe, sir. We have
not----
Mr. Dingell. Now, what levels of responsibility do you have
for the ingredients you receive from third parties and
subsequently use in your operations?
Mr. Peter DeCoster. We've put in a full array of testing.
We're taking samples from every incoming load. We've talked to
all of our vendors, for them also to do testing. We are going
to do a composite on these loads weekly and send them in for
testing. We are going to do a monthly swabbing of our feed
mill. We are currently in the process of completely cleaning
and disinfecting the entire mill from top to bottom. And we
have done extensive employee training to make sure that the
mill is kept tightened up, so that there is no open hatches as
noted in the----
Mr. Dingell. What steps do you take to ensure that those
planned or announced safeguards are implemented?
Mr. Peter DeCoster. We have a daily inspection by the mill
manager. Then we have an outside supervisor who is going to
inspect the facilities once a week and give me a full report.
Mr. Dingell. Do you still have--do you still have your hog
operations?
Mr. Peter DeCoster. We own some hog facilities, but we
don't own any hog----
Mr. Dingell. I'm sorry?
Mr. Peter DeCoster. We don't operate hog facilities. We
just lease them.
Mr. Dingell. I see.
Mr. Chairman, I note with some distress that my time is up,
and I thank you for your courtesy.
Mr. Stupak. Thank you, Mr. Dingell.
Ms. DeGette for questions, please.
Ms. DeGette. Thank you, Mr. Chairman.
Mr. DeCoster, your company hires a private auditing company
to audit Wright County Farms annually, correct?
Mr. Peter DeCoster. Yes, ma'am.
Ms. DeGette. And this company is AIB, which is a private,
for-profit food-safety auditing firm, correct?
Mr. Peter DeCoster. Right. They are----
Ms. DeGette. Thank you. OK.
And if you will turn to Tab 5 of the notebook in front of
you, on June 7th and 8th, 2010, your farm was actually
inspected by AIB, correct?
Mr. Peter DeCoster. Yes, ma'am.
Ms. DeGette. And AIB actually issued a superior certificate
to the farm, correct?
Mr. Peter DeCoster. Yes, they did.
Ms. DeGette. And this has been happening--you get inspected
annually. And if you'll take a look at Tab 7 of your notebook,
on August 20th, 2008, the farm was also--oh, I'm sorry, that's
a different one. Let's just stick with Tab 5 for a minute. I'll
talk about Tab 7 in a second.
So AIB audited your company in 2008 two times, four times
in 2009, and at least one time in 2010. And every time, you
were found to be superior. Is that correct?
Mr. Peter DeCoster. Yes. This is an inspection of the
processing facility----
Ms. DeGette. Uh-huh.
Mr. Peter DeCoster [continuing]. And not of the chicken
barns.
Ms. DeGette. OK.
And what I wanted to talk about with Tab 7, if you'll look
at that, unbelievably to this committee, in 2009 AIB was the
same auditor that audited the Peanut Corporation of America and
also gave them a superior recommendation.
Do you see that in your notebook, as well?
Mr. Peter DeCoster. Yes, ma'am.
Ms. DeGette. So here's the thing, is both the Peanut
Corporation of America and Wright County Egg paid AIB to audit
their companies and receive superior ratings right before both
companies sold products that sickened thousands of people with
Salmonella.
And, Mr. Chairman, I bring this up to say that just relying
on third-party auditors is not going to guarantee consumer
safety, which is why, getting back to all of our point, we need
to pass this bill.
I wanted to ask you a couple of questions, Mr. Mangskau. In
your opening statement, you said, ``In order to get fresh,
quality eggs to market, Hillandale must be able to rely on good
production and good processing,'' correct?
Mr. Mangskau. That is correct.
Ms. DeGette. You can't have good production and good pro-
cessing without a clean and up-to-standard facility, correct?
Mr. Mangskau. Yes.
Ms. DeGette. And you also said in your opening statement
that you were surprised it was difficult--quote, ``difficult to
understand'' why FDA was saying your eggs were responsible for
seven people sick at one restaurant, correct? Because you
thought that your processes were good; is that right?
Mr. Mangskau. That's correct.
Ms. DeGette. OK.
Now, the FDA inspected your facilities August 19th through
August 26th, 2010, and they found numerous, quote, ``unsealed
rodent holes, liquid manure streaming from a crack in the
manure pit, and uncaged hens tracking manure through the laying
facilities.''
Do you think that that's up to a standard of care, sir?
Mr. Mangskau. Those--the rodent holes were open because we
were baiting them.
Ms. DeGette. OK. Do you think those findings are consistent
with the high standard of care at the facility, yes or no?
Mr. Mangskau. No.
Ms. DeGette. Thank you.
Now, you said a minute ago, when someone asked you about--
Mr. Braley actually asked you about the effect on the egg
industry, and you said you apologized for any inconvenience.
Do you have any idea how much the egg industry's profits
have gone down because of these recalls?
Mr. Mangskau. I would not know.
Ms. DeGette. Do you know that, Mr. DeCoster?
Mr. Peter DeCoster. No, ma'am. I don't have knowledge of
that.
Ms. DeGette. All right.
Well, Mr. Chairman, I think we'll find that out, because I
am sure it's millions and millions of dollars.
Mr. DeCoster, I wanted to ask you one last question, and
that is: Chairman Waxman was talking to you about the condition
of the facilities, which you apologized for. But you also seem
to think that perhaps the Salmonella came in in the feed,
correct?
Mr. Peter DeCoster. That's what we are believing at the
moment.
Ms. DeGette. OK. So here is my question. You're running
large egg facilities. Do you have a regular system where you
test the feed that comes in, to make sure that it is not
contaminating the chickens that eat it?
Mr. Peter DeCoster. We don't test--we did not test for----
Ms. DeGette. Are you going to establish such a system now,
sir?
Mr. Peter DeCoster. Yes, ma'am. That is what I was talking
about earlier with the testing every load and doing a weekly
composite and sending that into the lab.
Ms. DeGette. Right.
Mr. Peter DeCoster. We're currently doing that.
Ms. DeGette. Probably you should have been doing that all
along, huh?
Mr. Peter DeCoster. Yes. In hindsight, yes, ma'am.
Ms. DeGette. Thank you.
Thank you, Mr. Chairman.
Mr. Stupak. Thank you, Ms. DeGette.
Mr. Doyle for questions, please.
Mr. Doyle. Thanks.
Mr. Mangskau, I want to ask you about the role you played
in Hillandale's egg operations in Iowa. When did you start
working for Hillandale Farms?
Mr. Mangskau. I was hired in March of 2010.
Mr. Doyle. And, at the time of the recall, what were your
responsibilities at the two facilities?
Mr. Mangskau. I was overseeing the plant at West Union and
working--trying to work into the opportunity to have more
control of the day-to-day productions at the Alden facility.
Mr. Doyle. Now, I understand that one Hillandale facility
is located in Alden, Iowa. And in a letter to committee staff,
dated September 17th, 2010, the lawyers for the company wrote
that, in this facility, Hillandale, quote, ``has virtually no
authority over the production and processing aspects.''
And in regards to the second facility in West Union, your
company lawyer stated that Hillandale has limited
responsibility for the production and processing phases of that
facility.
Mr. Mangskau, can you clarify what role Hillandale played
at these two facilities?
Mr. Mangskau. When I was hired in March by Hillandale
Farms, they wanted me to come back and work with the West Union
facility initially, start to take a role in the day-to-day
operations there, and, as time went on, hopefully to work into
some day-to-day control at the Alden facility.
Mr. Doyle. Uh-huh. Who owned the buildings on these farms?
Mr. Mangskau. To the best of my knowledge, Wright County
Farms owns the Alden facility and has a shared interest in the
West Union facility.
Mr. Doyle. How about the chickens? Who owns the chickens?
Mr. Mangskau. I don't have any direct knowledge on who owns
those.
Mr. Doyle. How many Hillandale employees do you have at
each of these facilities?
Mr. Mangskau. The people at West Union are Hillandale
employees. It varies up and down, and there's probably in the
forties in payroll there.
Mr. Doyle. In your testimony, you stated that Hillandale
has terminated its marketing relationship with Wright County
Egg at the Alden facility. To your knowledge, does Hillandale
have any other business relationships in other States with Mr.
DeCoster or any of his associates?
Mr. Mangskau. That's outside of the scope of my job duties.
Mr. Doyle. So I guess I get Hillandale didn't make the
eggs; Wright County did. But you're a major egg producer too,
and you're in a position to know whether you're running a clean
and safe operation.
Let me ask you, in light of this recall, how has this
changed the culture at Hillandale on how you produce eggs and
do business?
Mr. Mangskau. Well, it's definitely going to make us take a
closer look at what we do. We have hired two consultants to
come in. The gal that was at the FDA and the person with food
safety at several Fortune 200 food companies, we brought them
in. They are going to be doing recommendations to improve our
food-safety programs.
We have discontinued our agreement with the Wright County
Farms at Alden. We will no longer be receiving pullets that
Wright County has raised for the West Union facility. We are
bringing on another staff position at West Union to increase
and do a better job of documentation on quality control.
Mr. Doyle. OK. Well, you know, Hillandale Farms is a brand
I see in my store all the time in Pittsburgh, and I venture to
say that I've eaten hundreds of your eggs. I want to continue
to feel good about picking those boxes up when I go to the
supermarket.
You know, the important thing that comes out of this
hearing and subsequently if we can finally get a bill out of
the Senate, we just want to make sure that every consumer, when
they go into that store, has a good feeling about a brand when
they see it. And your company has a pretty good reputation in
my neck of the woods, so I was surprised to see your name
mentioned when this broke out.
But I hope it is a wake-up call to everybody in the
industry, that Americans expect--have a right to expect that,
when they buy your food, your products, that you're not going
to make them sick or, worse yet, cause them to die.
Mr. Chairman, I see my time has expired.
Mr. Stupak. Thank you, Mr. Doyle.
That concludes the questions from the panel. I'm going to
excuse this panel. And thank you for coming today, but you will
be excused.
We'll go to our third panel in a moment here.
On our third panel today we have Dr. Josh Sharfstein,
deputy commissioner, Food and Drug Administration.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that you have the right under the
rules of the House to be advised by counsel during your
testimony. Do you wish to be represented by counsel?
Dr. Sharfstein. No.
Mr. Stupak. OK. Then I'm going to ask you please rise,
raise your right hand, and take the oath.
[Witness sworn.]
Mr. Stupak. Let the record reflect the witness has stated
that he will--he testified in the affirmative that he
understands he is now under oath.
Dr. Sharfstein, welcome. And you may begin your opening
statement, please.
TESTIMONY OF JOSHUA M. SHARFSTEIN, M.D., PRINCIPAL DEPUTY
COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION
Dr. Sharfstein. Thank you. Good afternoon, Chairman Stupak,
Congressman Burgess, and members of the subcommittee. I am
Joshua Sharfstein, the principal deputy commissioner of the
U.S. Food and Drug Administration. Thank you for the
opportunity to appear before you today to discuss the recent
food-borne illness outbreak caused by Salmonella Enteritidis.
I would like to provide some general background on egg
safety, discuss the outbreak and response, and then talk about
what FDA and Congress can do to further protect the food
supply.
Salmonella Enteritidis, or SE as it is known, is a pathogen
know to contaminate eggs. Contamination can occur when bacteria
is passed from the chicken to the inside of the egg or when
bacteria passes through fractures in the shell. If not fully
cooked, eggs with Salmonella Enteritidis can cause human
disease.
If an egg farm is out of control for Salmonella
Enteritidis, then many thousands of illnesses can result. It is
estimated that contaminated eggs cause as many as 140,000
illnesses a year in the United States.
In 1999, FDA announced an Egg Safety Action Plan to reduce
this enormous burden of illness. FDA staff pushed for a decade
to put into place specific safety standards at egg production
facilities. The agency finalized its rule in July 2009, with
provisions to take effect starting in July 2010.
FDA's egg rule requires producers to have a clear plan for
preventing SE contamination and to implement recognized control
measures that reduce the risk of contamination, including
buying chicks and young hens only from suppliers who meet
standards for producing SE-free birds; establishing rodent,
pest control, and other bio-security measures to prevent the
spread of bacteria throughout the farm; conducting testing of
the poultry house environment for Salmonella Enteritidis, and
if an environmental sample is found positive, testing eggs and
disinfecting the house before adding new laying hens; diverting
eggs that have been found to be positive to processed uses; and
refrigerating eggs at 45 degrees Fahrenheit during storage and
transportation.
Before implementation of this important rule took effect,
the number of SE cases nationwide began to grow in late spring.
By July, CDC had noticed a significant increase, and several
States had begun conducting epidemiological investigations to
identify the source of the problem.
FDA set up an emergency response team to help sort through
the various theories of what was causing the outbreak and
identify its source. The agency relied upon its field staff in
multiple States. And, working with CDC and our State and local
partners, we traced the problem to eggs produced at several
Iowa farms. As soon as this trace-back was completed, FDA
recommended, and Wright County Egg agreed, to a major recall of
eggs from the linked farms.
FDA also sent inspectors in to look at the conditions of
the nearby farms also under Wright Egg and Hillandale as
additional epidemiological evidence accumulated. Because of
concerns about the conditions of these farms, FDA recommended
and Wright County Egg and Hillandale Farms agreed to additional
recalls.
Significantly, these recalls, totaling 500 million eggs,
came about 2 weeks before any positive lab findings. FDA acted
before confirmatory evidence became available, using our best
judgment to protect the public health.
What caused the SE outbreak? FDA inspectors found numerous
problems at both farms. These included significant deficiencies
in pest control, significant problems with the handling of
manure, and significant gaps in bio-security measures to
prevent cross-contamination. We also identified SE matching the
outbreak strain in the feed mill supply on the farms which are
associated with Wright County Egg, in environmental samples at
multiple locations on the farms, and in the water used to clean
the eggs at the Hillandale Farm.
We believe that there are multiple potential sources of
introduction for SE on these farms. Once introduced, these
farms did not have the systems in place to control the spread.
In fact, some of the deficiencies likely contributed to the
spread of SE, leading to widespread contamination.
Prevention of food-borne illness is what consumers expect
and deserve from our food-safety system. With our State and
Federal counterparts, we are reviewing this outbreak to
understand what the agency can do to improve its work on behalf
of the public.
Now that the egg rule is in place, FDA is moving to quickly
inspect other egg facilities. To assure that strong preventive
efforts are in place, we intend to inspect all 600 or so large
egg facilities that are now subject to the rule by the end of
calendar year 2011.
In order for these inspections to be as successful as
possible, there is something Congress can do to help us.
Proposed legislation will give FDA more tools as we are doing
these inspections to assure compliance, including enhanced
administrative detention authority, civil money penalties,
stronger criminal penalties, and mandatory recall.
This critical legislation will also do a lot more than help
make eggs safer. It would give FDA the tools to establish
appropriate prevention standards much more efficiently across
the food supply, and it would strengthen FDA's ability to hold
companies accountable for meeting these standards with a new
inspection mandate, new resources, and stronger enforcement
tools.
The legislation would also strengthen our ability to
respond to problems through new traceability standards,
mandatory recall authority, and closer collaboration with our
State partners to build upon and leverage their frontline
capacities.
We hope this Congress will take the historic step of
enacting comprehensive food-safety legislation to give FDA the
resources and tools we need for a modern and effective food-
safety system.
Thank you very much. I'm happy to take questions.
[The prepared statement of Dr. Sharfstein follows:]
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Mr. Stupak. Thank you, Doctor.
I will begin with the questions.
Salmonella Enteritidis is a major cause of food-borne
illness in the United States. In fact, in your testimony you
said 140,000 people become--Americans become sickened each year
from it. And it is my understanding approximately 30 deaths per
year are directly related to the consumption of eggs
contaminated with Salmonella.
My question--and, as we have heard today, Mr. Dingell
started about 1990, where he had a Salmonella-in-eggs hearing
with this committee. Mr. Braley mentioned the New York Times.
You mentioned 1999, the FDA began to develop a rule. It is my
understanding that the Clinton administration in 2000 put forth
a proposed rule. And it is my understanding nothing happened
until 2004; then President Bush put forth a proposed rule.
Then what happened between 2004 and July of 2010? Why did
it take, if you will, 11 years to get a rule out on this? Did
different administrations just abandon this effort? I mean, the
Obama administration has been here since January of 2009, and
you put out a proposed rule out in July of 2009, if I am--am I
correct?
Dr. Sharfstein. That is correct.
Mr. Stupak. And then there is a year of comments and back-
and-forth, correct? Public comment?
Dr. Sharfstein. It was a year for implementation. I mean,
we actually--I started at the very end of March as the acting
commissioner, and by July we had issued the proposed rule. This
was a very high priority for the administration.
Mr. Stupak. Do you know what happened, as you put forth the
proposed rule in July of 2009, what happened between 2004--I
understand President Bush put it forward--what happened between
2004 and 2009? Five years we lost.
Dr. Sharfstein. You know, I wasn't at the agency at that
time. You know, there----
Mr. Stupak. Could you have the agency put up a timeline and
see what happened, starting back in 1999 when it was first
proposed? Because, for a lot of people, it seems pretty
preposterous that it takes us 11 years to put forth a rule.
Dr. Sharfstein. Well, you know, I can tell you that some
people who are career employees at FDA have been interviewed
about that question.
Mr. Stupak. OK.
Dr. Sharfstein. And I will quote one, Bill Hubbard, who you
may know----
Mr. Stupak. Yes.
Dr. Sharfstein [continuing]. Who has testified before the
committee. And this is a direct quote from him, that ``The FDA
simply couldn't get through to the White House. They were very
hostile to regulation. I was told that each time FDA tried to
get the rule cleared through OMB, the response was that there
were, quote, `not enough bodies in the street,' that the number
of cases, hospitalizations, and deaths did not rise to the
level that justified greater regulation of egg producers.
Obviously, public health officials felt strongly that there was
a strong justification, but the prevailing attitude at the time
within the administration was that regulation was an evil that
should be avoided unless there was a compelling argument for
government action.''
That was what Bill Hubbard stated.
Mr. Stupak. OK. I guess after today we have enough
compelling arguments on why we need this final rule for eggs.
But the final rule was put out July 9th, 2010, and it aims
at reducing the amount of eggs contaminated with harmful
Salmonella. The rule applies to egg producers with 3,000 or
more egg-laying hens. This means both Hillandale Farm and
Wright County Egg must comply with the new rules.
In questions, both the gentlemen from Hillandale and
DeCoster Farms knew about the new rule, but what do we need to
implement this rule?
I have a copy of the summary from the FDA on these two
farms--or on these farms here that we have had the egg recall.
Starting in September 4th, 2008, to June 12th, 2009, there were
approximately 178 violations. After the rule was out, starting
on July 31st, 2009, through July 26th, 2010, there's 207
violations.
So it looks like during this period of time when you had
the proposed rule, it doesn't look like these farms are trying
to do anything to comply with the rule. We have actually
increased Salmonella outbreaks after the rule has been
proposed.
Dr. Sharfstein. You're referring to their testing of
Salmonella at the facility, I believe.
Mr. Stupak. Correct.
Dr. Sharfstein. Those results were not disclosed to FDA.
And, under our rule, if you get a contaminated finding in the
facility, you have to go ahead and test the eggs. So there
would be a different response to those findings under the rule.
Mr. Stupak. All right. So, underneath the proposed rule, or
the final rule, I should say, if I have a positive test, I have
to report it to the FDA.
Dr. Sharfstein. If you have a positive test as part of the
testing procedure, it is, in fact, available to the FDA.
Mr. Stupak. But they would have to notify you, correct?
Dr. Sharfstein. I don't--I'll have to get back on whether
they affirmatively notify us. I think----
Mr. Stupak. All right. OK. Well, let me ask you this.
Dr. Sharfstein [continuing]. It's not reported to us, but
it's available to us.
Mr. Stupak. OK. Let me ask you this: How would the newly
implemented egg rule--what does that really mean for the
American consumer? What can we expect?
Dr. Sharfstein. It means a lot. Because it means that we
can go now to all the major egg facilities and we can make sure
that they have very important preventative safeguards in place,
including an approach to rodents that keeps the rodents out of
the eggs, an approach to general contamination, an approach to
refrigeration, and an approach to testing, so that they can
have confidence that the farms in the United States, as, you
know, overseen by FDA with an independent look, are following
things to prevent illness in the first place.
Mr. Stupak. OK. This final rule that's now in place and has
the effect, applies to those farms, egg-producing farms, with
3,000 or more egg-laying hens. How many farms is that in the
United States? We have heard from two today, but how many are
there?
Dr. Sharfstein. I know that there are about 600 that are
50,000 or more. I think there are several thousand that are
between 3,000 and 50,000. We'd have to get the exact number to
you.
Mr. Stupak. OK.
My time has expired. Mr. Burgess for questions.
Mr. Burgess. Thank you, Dr. Sharfstein, for being here.
So now you have the ability to inspect egg-producing
facilities? Is that correct?
Dr. Sharfstein. That's correct.
Mr. Burgess. And now, this----
Dr. Sharfstein. Well----
Mr. Burgess [continuing]. Just came under your jurisdiction
in July?
Dr. Sharfstein. No. What started in July----
Mr. Burgess. Well, let me ask you a question. Did you have
the ability to do these egg inspections in 1999, 2004, 1990,
all of these other dates that have been mentioned?
Dr. Sharfstein. FDA had jurisdiction over egg production
farms, but we didn't have these standards against which we
could inspect.
Mr. Burgess. Were you prohibited from inspecting?
Dr. Sharfstein. No.
Mr. Burgess. Let me ask you this. And I guess you've
already answered the question about how many egg production
facilities are under your jurisdiction: 600 large-scale
productions with greater than 50,000 hens. Now, over the last 5
years, could you give us a total number of inspections that
have been done?
Dr. Sharfstein. We have been in some of these facilities
because of outbreaks. And we could give you the number of
inspections, but we have not done general inspections. And I
think that there are two reasons for that.
Mr. Burgess. OK. The number of general inspections, then,
would be zero.
Dr. Sharfstein. I don't believe we did any inspections
proactively.
Mr. Burgess. OK. I am just trying to ascertain.
Dr. Sharfstein. Sure.
Mr. Burgess. You know, it's come up to us in newspaper
articles, the DeCosters, they've kind of attracted some
attention in the past.
Dr. Sharfstein. Uh-huh.
Mr. Burgess. Why wouldn't you look? Well, actually--and Bob
Latta brought it up a moment ago--you had a companion agency on
the street, in the henhouse, if you will.
Dr. Sharfstein. Right.
Mr. Burgess. Did they not see an 8-foot-tall pile of
manure? Did they not see a door that was broken down with a
manure pile pushing outside? What do they look at while they're
there, just the size of the egg and whether it's grade A?
Dr. Sharfstein. Well, I can't speak for USDA. But, you
know, there are--so it may be better----
Mr. Burgess. On an issue that's so important and sickened
so many people--by your estimation, 100,000 cases a year--and
it's a high-risk food, why wouldn't there be a tendency for
cross-communication between a Federal agency under the USDA and
the Food and Drug Administration?
Dr. Sharfstein. FDA has been very concerned about this
potential risk. That's why FDA fought to put this rule----
Mr. Burgess. Obviously not enough. If the USDA is not--I
mean, an 8-foot pile of--I mean, we showed the pictures. That's
got to get your attention. I mean, I know you're just there to
measure with a little micrometer the diameter of the egg. But,
holy cow, how do you just not notice that? And if you know this
is a high-risk food and a high-risk practice and the DeCosters
kind of have a history, why wouldn't someone say something?
Dr. Sharfstein. Well, I----
Mr. Burgess. OK. We've got a food-safety bill--we have got
a food-safety bill that's over in the Senate. And we've heard
all kinds of stuff today about the problems. I supported the
food-safety bill. I worked on it. I tried to amend it, I tried
to make it a better product. Ultimately, it wasn't perfect, but
I voted for it, both in committee and on the floor of the
House.
But, really, what did you have in that bill that you didn't
already have? I mean, the recall--we heard the DeCosters
testify. The minute the recall was suggested to them, boom,
they flipped the switch, they recalled the eggs. So it wasn't
like you had to go to court to get a court order to do it. They
voluntarily did that.
So, all right, we're going to have a mandatory recall with
the new bill. That's great. But it didn't affect the outcome
here. What would have affected the outcome here is if one
Federal agency had used common sense and talked to another
Federal agency. How do we legislate that between the FDA and
the USDA?
Dr. Sharfstein. FDA and USDA are working on improving
communication. But I think the--from my perspective, this rule
is what gives FDA the ability to be at these facilities,
inspecting for prevention. And the law allows us to make those
inspections--would allow us to make those inspections as
effective as possible.
Mr. Burgess. My time is very short. Let me ask you a
question about the law. You brought it up yourself; you talked
about civil and criminal culpability.
Dr. Sharfstein. Right.
Mr. Burgess. Is there criminal--is there the ability to
bring criminal charges against one of these producers now, if
the conditions are found to be so egregious that they should
have been stopped?
Dr. Sharfstein. Yes. There would be enhanced criminal
penalties under the bill.
Mr. Burgess. But criminal penalties exist today.
Dr. Sharfstein. Right.
Mr. Burgess. Nothing is stopping you or nothing is
preventing the Department of Justice from pursuing this if they
decide to do so.
It's unusual to have Salmonella inside the egg, isn't it?
Dr. Sharfstein. Not at this facility, I don't think.
Mr. Burgess. But just in general. Now, would there be any
way the consumer would know? I mean, if you've got a rotten
egg, we all know, you crack a rotten egg and it would be
trouble. But this wouldn't create that kind of trouble, would
it?
Dr. Sharfstein. Correct. Correct.
Mr. Burgess. Have there been any other cases where
Salmonella has occurred inside--in any other of the food
recalls, the egg recalls that the FDA has overseen, have there
been issues with Salmonella internal to the egg?
Dr. Sharfstein. Absolutely.
Mr. Burgess. So do you have--you have other studies that
you have done where you can compare and contrast what you're
doing now with what has happened in the past? And I'd
appreciate if you would provide that to us. And I will provide
that question in writing.
Dr. Sharfstein. I think this is a known risk, and that's
why FDA has fought so hard to----
Mr. Burgess. But, generally, it's on the outside of the
egg, not internal to the egg. So I'd just like an accounting of
where the FDA has been in the past with this.
Finally, let me just ask you--you said you started in March
of 2009. I appreciated the kindness you showed me when I went
out for a tour of your facility. That's 18 months. So when can
we expect, under your tenure--and I'm sorry we don't have the
CEO of the FDA here today--but under your tenure, when can we
expect this to be better? You've had 18 months. You've known
it's a problem. When is it going to improve?
Dr. Sharfstein. I believe that we're in a position, through
these inspections, to inspect the facilities that produce 80
percent of the eggs by the end of fiscal year 2011. And I
believe, as we do that and we assure under the rule that we put
into place very quickly in the Obama administration, we will be
able to feel a lot more confident about the conditions under
which the vast majority of eggs are produced.
Mr. Burgess. So we won't be back here next----
Mr. Stupak. The gentleman's time has expired.
Mr. Waxman for questions, please.
Mr. Waxman. Thank you, Mr. Chairman.
Dr. Sharfstein, it seems to me you have had a number of
problems. You didn't have this egg rule in place. It's now in
place. Can you tell us succinctly what it will do to help FDA
prevent this problem in the future?
Dr. Sharfstein. Sure.
The egg rule requires certain types of preventive measures
that keep Salmonella from getting in the eggs. And these
include standards around rodent control, it includes standards
around refrigeration, and it includes testing protocols,
because Salmonella does, even in the best-managed facilities,
get in, but you've got to identify it quickly and control it.
So those are three examples.
And the firms must have their own plan, and they must keep
to the plan. And by being able to inspect against the plan, we
can have a high level of assurance that we will not see these
situations again.
Mr. Waxman. Then why do we need the law to be changed as
per the House-passed bill on food safety? How will that help
you?
Dr. Sharfstein. It will help--we are looking at 600
inspections by the end of fiscal year 2011. Right now, we have
very limited authority to do administrative detention, we have
no ability to do civil penalties, we have limited criminal
penalties. There are a number of things that will directly help
us in this task of inspecting the other 600 facilities that we
would like to inspect by the end of fiscal year 2011.
And then, of course, the bill goes far beyond just eggs.
And there are other products out there where there are not
standards, and we don't want to spend a decade putting those
standards into place. We want preventive standards in place
much faster for other products so we are not back here every 6
months, as the committee has noted, talking about another major
food recall.
Mr. Waxman. Mr. Burgess seemed to--in the way he asked the
question, I got the sense he was saying you don't really need
this law because you have a lot of authority now.
Can you demand a recall, or do you have to rely on the
company to voluntarily recall a product?
Dr. Sharfstein. Well, I appreciate that Congressman Burgess
supports the bill.
Mr. Waxman. Yes, he does.
Dr. Sharfstein. And I think that, right now, we cannot
demand a recall. It has to be voluntary. And I do think, you
know, in this case we are very pleased that, as soon as we
recommended a recall, you know, even before we had confirmatory
lab testing, the company did it.
But we have 600 to go. And if we wind up in prolonged court
battles with some of those companies, we don't know what could
happen. It is much better, if we need to protect the public,
for us to be able to order a recall.
Mr. Waxman. How about penalties? If you find that some
companies have been acting inappropriately--and, obviously,
penalties deter for the future--what can you do now?
Dr. Sharfstein. Now? There are certain types of criminal
penalties, but it requires, you know, very--and, actually, I
could get you the exact penalties. But it obviously requires a
big investigation to get there. We do not have the authority to
assess civil money penalties, which the bill would give us.
So it would be a much more flexible type of tool, much
more--give us stronger teeth for what we want to do to protect
the public via prevention-oriented inspections.
Mr. Waxman. Well, that's civil penalties. How about
criminal penalties? If you have a company that, over a 30-year
period, constantly gets into trouble because they have
Salmonella in, let's say, eggs, and they have been assessed
civil money penalties, they've been told by the States they
can't sell their eggs in the States--certain States any longer,
what more can you say if they continue to act in a way that
causes this problem to reoccur?
Dr. Sharfstein. Well, criminal penalties are, you know, an
option available to the agency, and they would be strengthened
under the bill.
Mr. Waxman. Under the bill. But right now, do you have to
go to the Justice Department?
Dr. Sharfstein. Correct.
Mr. Waxman. And has the Justice Department ever sought
criminal penalties, to your knowledge, against a food processor
or food producer?
Dr. Sharfstein. I'd have to get back to you.
Mr. Waxman. OK. It seems to me, to my recollection, it's
very, very unlikely. And because it's so difficult to go to
court and prove these cases, they usually settle with some slap
on the wrist.
I guess my time has expired.
Do you feel that the FDA is now in a position to do more
because of the rule that's finally in place, but with the food-
safety legislation that passed the House, overwhelmingly, on a
bipartisan basis, that will give you the additional tools,
resources, and additional legal tools to make sure this whole
thing will work and we're not going to have hearing after
hearing on Salmonella in peanut butter, eggs, spinach, or
whatever?
Dr. Sharfstein. Here's my bottom line: We need this bill.
We need this bill to protect the safety of the food supply. We
need this bill to help us prevent another egg outbreak just
like the one that we've experienced and the one that we heard
from the earlier witnesses that devastated their lives.
Mr. Waxman. Thank you.
Thank you, Mr. Chairman.
Mr. Stupak. Ms. DeGette for questions, please.
Ms. DeGette. Thank you, Mr. Chairman.
Dr. Sharfstein, I want to talk to you about both preventing
food-borne illnesses and then also quickly identifying them and
removing them. Obviously, it's in all of our interest to
prevent these illnesses from occurring in the first place, and
I think that would be your top priority, as well. Is that the
main focus of the new egg rule, as well?
Dr. Sharfstein. Correct.
Ms. DeGette. Preventing the salmonella from getting in the
eggs.
And, by the way, I just wanted to clarify, it is not
uncommon for Salmonella to be inside the eggs, correct? It's
not just on the shell of the eggs.
Dr. Sharfstein. Yes, I think it's well-understood that one
of the major routes of transmission is through the chicken into
the egg.
Ms. DeGette. OK.
And so, one thing that struck me with the previous panel
testifying is they said they think it's--despite all of the
other issues, the large piles of manure, et cetera, they think
it is in part because of contaminated feed. Do these new egg
rules address the feed issue?
Dr. Sharfstein. The new egg rules do help with the feed
issue. But let me say that FDA has not reached this conclusion
that you heard earlier from----
Ms. DeGette. Right. I understand that. But it would seem to
me, no matter what the source of the Salmonella inside the egg
was, be it the manure or the rodents or anything like that,
whatever source it would be, if you're testing the eggs, you
should be able to identify that they are contaminated, and then
you wouldn't send them out, right?
Dr. Sharfstein. That's correct.
Ms. DeGette. So the testing is a big part of it.
Dr. Sharfstein. That's correct. And it's the responsibility
of the company to identify if there is a risk----
Ms. DeGette. Right.
Dr. Sharfstein [continuing]. From whatever source. And
then, when they find the contamination, take action to control
it.
Ms. DeGette. And then go back and figure out what caused it
and remove that, correct?
Dr. Sharfstein. Exactly. Exactly.
Ms. DeGette. Now, the second thing I wanted to ask you is,
does the FDA currently, if the Senate does not pass the food-
safety bill, have the resources to do all the inspections that
are going to be needed under these new egg rules?
Dr. Sharfstein. You know, as you know, FDA has been
significantly strapped for resources. And, you know, you should
know there are 150,000 or so domestic food facilities, and FDA
does about 18,000 food inspections every year. We are
prioritizing under the rule these egg facilities, so we will do
them. But the legislation, which gives us additional resources
as well as additional tools, will make a tremendous difference
in FDA's ability to prevent future outbreaks.
Ms. DeGette. And to inspect these facilities, correct?
Dr. Sharfstein. And to do all the inspections we are
expected to do.
Ms. DeGette. OK.
Let me talk to you for a minute about, then, after there is
contamination, after the contaminated food leaves.
Dr. Sharfstein. Sure.
Ms. DeGette. Chairman Waxman talked to you about mandatory
recall authority. And, as you pointed out, in this case, the
company did, when told, voluntarily recall the eggs. But that
is not always the case, is it?
For example, the peanut butter outbreak, where the company
resisted recalling the contaminated peanut butter for quite
some time and the government didn't really have the authority
to do anything, correct?
Dr. Sharfstein. I can tell you there have been, definitely,
instances where there's been some tension between FDA and firms
over doing a recall.
Ms. DeGette. And just the threat of a mandatory recall
might make a firm hop to and recall tainted food even on their
own before the FDA had to exercise that mandatory recall
authority.
Dr. Sharfstein. And FDA would intend to be extremely
reasonable about using this because we understand, you know,
that companies could be worried. We would be reasonable. But,
yes, we would very much like to have that ability.
Ms. DeGette. Let me talk to you about another issue that I
care a lot about, because I worked hard to include it in the
food-safety bill, and that is the traceability provisions.
On our first panel, one of the witnesses said, part of the
problem is there's a lot of food on the plate and we have to
identify which of the foods is contaminated and where it came
from.
But having traceability for all of those food systems,
that's interoperable--not necessarily the same traceability
system, but systems that are interoperable, that would help the
FDA more quickly identify the source of the contamination,
wouldn't it?
Dr. Sharfstein. Yes.
Ms. DeGette. And that's something that the FDA doesn't have
the ability to order right now under current law, correct?
Dr. Sharfstein. That's correct.
Ms. DeGette. So the food-safety bill would really help
once--if there was food that was contaminated, it would help
identify the source much more quickly and enable that recall to
happen so further people aren't sickened.
Dr. Sharfstein. That's an extremely good point. I've spoken
about the enforcement provisions of the bill, I've spoken about
the prevention provisions of the bill----
Ms. DeGette. Correct.
Dr. Sharfstein [continuing]. But the trace-back provisions
are very important also.
Ms. DeGette. Thank you.
Thank you very much, Mr. Chairman. I yield back.
Mr. Stupak. Thank you, Ms. DeGette.
Mr. Braley for questions, please.
Mr. Braley. Dr. Sharfstein, welcome.
I have a very significant constituent who lives and farms
in New Hartford, Iowa, and he has made an important statement
about these egg recalls I want to read to you.
``The recent egg recalls have troubled consumers and
weakened confidence in our Nation's food supply. When Americans
visit their local grocery store, they should be able to trust
that the food they are purchasing to feed their family is safe
to consume.''
That was a statement that Senator Grassley made in a letter
to USDA Secretary Tom Vilsack, our former Governor.
Do you agree with that statement?
Dr. Sharfstein. Yes.
Mr. Braley. Now, one of the concerns that we have is that,
right now, among the 50 States and the Federal Government,
there is this hodgepodge of State requirements that relate to
the production of eggs that may vary from State to State, and
yet those individual State enforcement activities are part of
this complementary network of food-safety enforcement that we
have in this country.
And I would like you to share with us your opinion as to
whether we can continue to rely on a system where one State's
requirements may have lower thresholds of food safety, which
then goes into a stream of commerce and goes around the country
to other States, and whether we can continue to afford that
type of enforcement system, given the problems identified with
this egg recall.
Dr. Sharfstein. I would say that our goal is an integrated
Federal food-safety system where we are working with our
partners at the State and local level off the same playbook.
And there has been a tremendous amount of work at FDA to move
this forward. There was recently 50 State meetings where we
discussed what this system would look like. And the legislation
would propel that forward in a number of ways.
So our goal is for there to be a clear standard across the
country and for the States and localities and the Federal
Government to be in much greater sync than they are today.
Mr. Braley. What were some of the breakdowns that led to
this half-billion-dollar egg recall between the FDA and the
State officials in Iowa?
Dr. Sharfstein. I'm not sure that I would describe it as
breakdown between the State officials and the FDA. I think that
what FDA recognized is the importance of having clear,
prevention-oriented standards that then could be inspected
against.
And, you know, that's why very shortly after, you know, I
started at FDA and the administration's Food Safety Working
Group came together, the administration prioritized getting
this egg safety rule out, having a period implementation, and
getting it going as quickly as possible.
So our focus is on getting that in place. And that gives us
a basis, the foundation to really work closely with States and
localities around clear standards. What the bill would give us
is the ability to do that in other areas to reasonable
standards, integrated with States and localities, to prevent
illness.
Mr. Braley. And I want to talk about why this is so
important. We know that, every year, there are about 5,000
deaths related to food-borne illness in this country. Isn't
that correct?
Dr. Sharfstein. That's correct.
Mr. Braley. And, every year, there are approximately
325,000 hospitalizations in this country related to food-borne
illnesses. And we heard from witnesses here today about how
devastating that can be to their quality of life.
Dr. Sharfstein. That's right. And, as a physician, I have
taken care of patients who have died from food-borne illness.
Mr. Braley. So the other thing that we know about the bill
that we passed in the House is that there is a cost-sharing
that goes along with this responsibility and that most of the
cost associated with the enforcement, under the food-safety
bill we passed, would be the result of fees in the food
industry. Is that correct?
Dr. Sharfstein. That's correct.
Mr. Braley. And so, haven't these hearings that we've been
holding in this committee, haven't they demonstrated why it's
so important to save these lives and keep people out of the
hospital by making food safety a higher priority in this
country?
Dr. Sharfstein. Yes, I think that the work that the
committee has done in this area is extremely important. And we
really do appreciate the bipartisan support that this bill has
gotten.
Mr. Braley. Thank you. That's all.
Mr. Stupak. Thank you, Mr. Braley.
Mr. Markey for questions.
Mr. Markey. Thank you, Mr. Chairman, very much.
As you know, Mr. DeCoster, whose Iowa facility has been
implicated in this outbreak, is also tied to a number of egg-
processing businesses in Maine. Some of these businesses may
merely rent land from Mr. DeCoster, while others may have
closer ties, like purchasing chicken feed from other facilities
that Mr. DeCoster runs.
As I am sure you know, facilities owned and operated by Mr.
DeCoster in Maine have a long history of public health,
environment, worker abuses and animal cruelty violations.
So, just to be clear, have there been any recent Salmonella
infections that were later linked to eggs or facilities from
New England?
Dr. Sharfstein. Not that I am aware of, but we'll get back
to you.
Mr. Markey. OK. Thank you. I think that's important for us
to know. To the best of my knowledge, the answer is no, but I
think we should nail that down so that residents of
Massachusetts or other New England States are not concerned.
Dr. Sharfstein. Well, let me say this. I think, in the
past, we have measured success or failure just by an outbreak.
But the way we're looking at it now is, we would like to have
the assurance that there is good preventive----
Mr. Markey. Great.
Dr. Sharfstein [continuing]. Controls in place. And one of
our priorities in doing these inspections is really getting
that assurance. So not just that there isn't a massive
outbreak, but that there's actually prevention-oriented
standards.
And in picking which firms and which places to go, where to
look first, we are going to be prioritizing companies that have
had problems in the past. We will be reaching out to other
agencies, and we've been working with OSHA, for example, to
identify if there are findings that other agencies have had. We
have had an agreement with USDA that we will be learning from
their inspectors. So we intend to use all the information at
our disposal to prioritize which companies need an FDA visit
quickly.
Mr. Markey. So, just to go from the general to the
specific, because I appreciate the direction in which the FDA
is heading, so you plan to prioritize your inspections so that
you start with the riskiest facilities, like those in Maine or
other States that have a history of violations or those that
buy feed or chicks from companies like Mr. DeCoster or other
repeat violators who own or operate. Is that correct?
Dr. Sharfstein. Right. We will be using a wide variety of
data, including information from other agencies like USDA and
OSHA, to help us prioritize the highest-risk facilities.
Mr. Markey. So, just to take it one step further, the
Nuclear Regulatory Commission gears its inspection regime
towards those who have had the longest history of violations.
Dr. Sharfstein. Right.
Mr. Markey. You intend on doing the same thing?
Dr. Sharfstein. Absolutely.
Mr. Markey. And this Maine facility falls into that
category?
Dr. Sharfstein. You know, I couldn't specifically talk
about a specific facility, but I can tell you we will look at
not only the history of facilities but corporate issues. If we
have concerns about a particular owner, for example, that makes
us think that other farms could have a problem, that will
influence our prioritization.
Mr. Markey. But if it is amongst the greatest violators,
then that's where you're most likely to be going first?
Dr. Sharfstein. That's correct, yes.
Mr. Markey. OK. Good. So that's an important--and you can
hear a sigh of relief going on all over New England right now
because of the record there. And, again, right now there is no
evidence, but we want to make sure that we go in to get the
answers as quickly as possible.
The gentleman who testified here today, or did not testify
here today, Mr. DeCoster, clearly has no regard for regulations
until the point at which he actually gets caught. You know,
that's a constant refrain that we hear from people who get
sworn in to testify at that table. You know, we went from BP to
Salmonella, and it's a long history of witnesses at that table,
and they're always then quite concerned that their actions have
been misunderstood.
Do you think that you can, under your current regulations,
guarantee that habitual violators like Mr. DeCoster can be
quickly caught and held accountable?
Dr. Sharfstein. Well, what I testified to is that we are
going to go out to these 600 facilities, but our tools, what we
can do when we get there, are limited; and that the legislation
that is pending would be extremely helpful for us to do the job
well, because it would give us a whole other series of tools to
enforce the law.
Mr. Markey. Thank you. Thank you for your service. Welcome
back to our committee.
Dr. Sharfstein. Thank you.
Mr. Markey. And thank you, Mr. Chairman. I appreciate it.
Mr. Stupak. Thank you, Mr. Markey.
That concludes all questioning.
And thank you, Dr. Sharfstein, for being here.
And I want to thank all witnesses for coming today and for
their testimony.
The committee rules provide that Members have 10 days to
submit additional questions for the record to witnesses. I ask
unanimous consent that the contents of our document binder be
entered into the record, provided that committee staff may
redact any information that is business proprietary, relates to
privacy concerns, or is law enforcement-sensitive. Without
objection, documents will be entered.
That concludes our hearing. This meeting of the
subcommittee is adjourned.
[Whereupon, at 3:30 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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