[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

                              ----------                              
                                                                   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

                              ----------                              


                     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:]

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    [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
    
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    [GRAPHIC] [TIFF OMITTED] T8134A.008
    
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    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:]

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    [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:]

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    [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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