[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]




            CONTAMINATED FOOD: PRIVATE SECTOR ACCOUNTABILITY

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 26, 2008

                               __________

                           Serial No. 110-92


      Printed for the use of the Committee on Energy and Commerce
                        energycommerce.house.gov







            CONTAMINATED FOOD: PRIVATE SECTOR ACCOUNTABILITY

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 26, 2008

                               __________

                           Serial No. 110-92


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov



                  U.S. GOVERNMENT PRINTING OFFICE
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                    COMMITTEE ON ENERGY AND COMMERCE

JOHN D. DINGELL, Michigan,Chairman        JOE BARTON, Texas
HENRY A. WAXMAN, California                   Ranking Member
EDWARD J. MARKEY, Massachusetts           RALPH M. HALL, Texas
RICK BOUCHER, Virginia                    FRED UPTON, Michigan
EDOLPHUS TOWNS, New York                  CLIFF STEARNS, Florida
FRANK PALLONE, Jr., New Jersey            NATHAN DEAL, Georgia
BART GORDON, Tennessee                    ED WHITFIELD, Kentucky
BOBBY L. RUSH, Illinois                   BARBARA CUBIN, Wyoming
ANNA G. ESHOO, California                 JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                     HEATHER WILSON, New Mexico
ELIOT L. ENGEL, New York                  JOHN B. SHADEGG, Arizona
ALBERT R. WYNN, Maryland                  CHARLES W. ``CHIP'' PICKERING,
GENE GREEN, Texas                             Mississippi
DIANA DeGETTE, Colorado                   VITO FOSSELLA, New York
    Vice Chairman                         STEVE BUYER, Indiana
LOIS CAPPS, California                    GEORGE RADANOVICH, California
MICHAEL F. DOYLE, Pennsylvania            JOSEPH R. PITTS, Pennsylvania
JANE HARMAN, California                   MARY BONO, California
TOM ALLEN, Maine                          GREG WALDEN, Oregon
JAN SCHAKOWSKY, Illinois                  LEE TERRY, Nebraska
HILDA L. SOLIS, California                MIKE FERGUSON, New Jersey
CHARLES A. GONZALEZ, Texas                MIKE ROGERS, Michigan
JAY INSLEE, Washington                    SUE WILKINS MYRICK, North Carolina
TAMMY BALDWIN, Wisconsin                  JOHN SULLIVAN, Oklahoma
MIKE ROSS, Arkansas                       TIM MURPHY, Pennsylvania
DARLENE HOOLEY, Oregon                    MICHAEL C. BURGESS, Texas
ANTHONY D. WEINER, New York               MARSHA BLACKBURN, Tennessee
JIM MATHESON, Utah                          
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana               
                                     

                           Professional Staff

                   Dennis B. Fitzgibbons,Chief of Staff
                    Gregg A. Rothschild,Chief Counsel
                       Sharon E. Davis,Chief Clerk
                  David L. Cavicke,Minority Staff Director
                 
              Subcommittee on Oversight and Investigations

                     BART STUPAK, Michigan,Chairman
DIANA DeGETTE, Colorado              ED WHITFIELD, Kentucky
CHARLIE MELANCON, Louisiana              Ranking Member
    Vice Chairman                    GREG WALDEN, Oregon
HENRY A. WAXMAN, California          MIKE FERGUSON, New Jersey
GENE GREEN, Texas                    TIM MURPHY, Pennsylvania
MIKE DOYLE, Pennsylvania             MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois             MARSHA BLACKBURN, Tennessee
JAY INSLEE, Washington               JOE BARTON, Texas(ex officio)
JOHN D. DINGELL, Michigan(ex 
    officio)

                                  (ii)








                             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. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     8
    Prepared statement...........................................     9
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................    10
    Prepared statement...........................................    12
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................    12
    Prepared statement...........................................    13
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................    15
    Prepared statement...........................................
Hon. Tim Murphy, a Representative in Congress from the State of 
  Pennsylvania, opening statement................................    16
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................    17
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................    18
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, prepared statement......................................   179
Hon. Jan Schakowsky, a Representative in Congress from the State 
  of Illinois, prepared statement................................   180

                               Witnesses

Michael Greger, M.D., Director of Public Health and Animal 
  Agriculture, The Humane Society of the United States...........    19
    Prepared statement...........................................    22
John A. Williams, Executor Director, Southern Shrimp Alliance....    61
    Prepared statement...........................................    63
William D. Marler, Esquire, Marler Clark LLP PS..................    74
    Prepared statement...........................................    78
Gary M. Rodkin, Chief Executive Officer, Conagra Foods, Inc......   104
    Prepared statement...........................................   105
B. Keith Shoemaker, President and CEO, Butterbal, LLC............   108
    Prepared statement...........................................   110
Christopher D. Lischewski, President and CEO, Bumble Bee Foods, 
  LLC............................................................   112
    Prepared statement...........................................   113
Rick Ray, President and CEO, New Era Canning Company.............   115
    Prepared statement...........................................   118
David A. DeLorenzo, President and Chief Executive Officer, Dole 
  Food Company, Inc..............................................   122
    Prepared statement...........................................   124
    Answers to submitted questions...............................
David A. Eisenberg, Chairman, ANRESCO Laboratories...............   129
    Prepared statement...........................................   132
Robert E. Brackett, Ph.D., Senior Vice President and Chief 
  Science and Regulatory Affairs Officer, Grocery Manufacturers 
  Association....................................................   141
    Prepared statement...........................................   142

                           Submitted Material

Chart entitled ``Seafood Recall List''...........................   183
Chart entitled ``School Districts Given Recalled Meat''..........   188
Subcommittee exhibit binder......................................   194

 
            CONTAMINATED FOOD: PRIVATE SECTOR ACCOUNTABILITY

                              ----------                              


                       TUESDAY, FEBRUARY 26, 2008

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:00 a.m., in 
room 2322 of the Rayburn House Office Building, Hon. Bart 
Stupak (chairman) presiding.
    Members present: Representatives Stupak, DeGette, Doyle, 
Schakowsky, Inslee, Dingell (ex officio), Shimkus, Walden, 
Murphy, Burgess, Blackburn and Barton (ex officio).
    Staff present: Scott Scholegel, David Nelson, Kevin 
Barstow, Richard Wilfong, John Sopko, Kyle Chapman, Alan 
Slobodin, Krista Carpenter, Whitney Drew.

  OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr.Stupak. This meeting will come to order.
    Today we have a hearing entitled ``Contaminated Food: 
Private Sector Accountability.'' Each member will be recognized 
for a five minute opening statement. I will begin.
    Today we hold the fifth subcommittee hearing on the safety 
of our Nation's food supply. Although it was purely 
coincidental that this hearing was set before the largest beef 
recall in American history. It is not a coincidence that 
recalls of this magnitude are escalating. Since starting our 
investigations Americans have witnessed one food safety 
disaster after another. In the last 18 months alone we have 
seen in August and September of 2006, E. coli in bagged spinach 
sickened 204 people and killed three. In September of 2006 
salmonella found in tomatoes sickened 183 people. In December 
2006 lettuce contaminated with E. coli at Taco Bell and Taco 
John restaurants sickened 152 people. In February 2007 Peter 
Pan peanut butter contaminated with salmonella sickened 425 
people. In February and March 2007, 100 brands of tainted pet 
food were recalled after sickening and killing thousands of 
pets. In June 2007 Veggie Booties snacks contaminated with 
salmonella caused 65 illnesses. In July 2007, 90 canned food 
products with botulism contamination were recalled after 
sickening eight people. In August 2007, almost a year and a 
half after the last spinach E. coli outbreak, another 
nationwide recall of fresh spinach occurred following discovery 
of salmonella in test batches. In October of 2007 frozen pot 
pies carrying salmonella were recalled after illnesses were 
reported in 31 states. In September of 2007 nearly 22 million 
pounds of beef were recalled after E. coli contamination was 
found. And finally, just over a week ago, nearly 144 million 
pounds of beef were recalled by Westland/Hallmark Meat Packing 
Company after being determined to be unfit for human 
consumption. Our food safety system is broken. So called 
voluntary compliance, relying on the food industry to place 
safety before profits, does not appear to be working. The 
budgets and regulatory policies of this Administration have 
crippled both the Food and Drug Administration and the Food 
Safety and Inspection Service of the United States Department 
of Agriculture. In fact, some 76 million Americans, almost one 
out of every four Americans, are affected each year by 
illnesses from contaminated food. Since sickness from 
contaminated food is largely preventable this committee has 
actively pushed the public and private sectors to focus on 
preventing this epidemic.
    What have we learned so far? We found a fragmented food 
safety program suffering from willfully inadequate resources, 
inconsistent oversights, and ineffective coordination. In 
December the FDA's own science board report noted that FDA's 
Food Safety Program has put American lives at risk, and the FDA 
``does not have the capacity to ensure the safety of food for 
our Nation.'' We have also learned that the problems are not 
just limited to the FDA. The once vaulted USDA seal of 
wholesomeness can no longer be relied upon to protect 
consumers. USDA, despite having about four times the food 
safety budget of FDA and a network of inspectors in many, if 
not all meat processing facilities, is also failing to protect 
Americans. Last week's extraordinary recall of over 143 million 
pounds of beef by Westland/Hallmark Meat Packing Company 
follows more than 20 other beef recalls in the preceding 20 
months. Nearly two meat recalls per month. My colleagues and I 
are fully aware that the product recalls by the USDA does not 
indicate success, rather each recall means that the system has 
failed. Recalls tell us that contaminated beef made it into the 
marketplace, restaurants, schools and our kitchen tables. Last 
fall our hearing drew attention to 22 million pounds of beef 
that was recalled that was packaged in carbon monoxide, 
deceiving consumers into thinking the meat was fresh, wholesome 
and free of contaminants. I am troubled to tell my colleagues 
that despite our investigation, and despite one major 
retailer's request to label their meat as having been packed 
with carbon monoxide, the USDA is still refusing to allow 
retailers to label their meat as such.
    Today's hearing focuses on the role of private industry and 
protecting our Nation's food supply. Responsibility for 
supplying safe and wholesome foods does not rest solely with 
the government. It is always the food processor that has the 
first opportunity to ensure the safety of their product and 
prevent these tragic food illnesses. We intend to ask food 
processors what they have learned from the food recalls, 
illnesses and deaths of last year, what they are doing to 
protect the American consumer and ensure their food is safe. 
Some of the food processors whose products were recalled last 
year will testify today. Eating vegetables, such as spinach, 
was once every parent's refrain. But as we learned last year, 
eating vegetables and spinach nearly led to the serious injury 
and death of defenseless children. Unfortunately, the problems 
associated with Salinas Valley, known as America's salad bowl, 
continue to plague us. Is America any safer today? Hopefully 
the CEO of Dole, the Nation's largest distributor of E. coli 
spinach that sickened and killed people last year, will tell us 
what he is doing to stop these problems. ConAgra, a firm that 
blamed the problems relating to Peter Pan peanut butter on a 
leaky roof in testimony before us last April, is also back to 
explain why the same strain of salmonella got in their peanut 
butter jars six months after the leak was fixed. ConAgra still 
has to explain to the American people how salmonella infected 
its Banquet brand turkey pot pies. We also need to understand 
from ConAgra and their supplier Butterball how fully cooked 
turkey could sicken people who ate their pot pies. We also 
planned to have asked Steve Mendell, the CEO of Hallmark and 
Westland Company, to explain how he could produce and ship over 
143 million pounds of raw and frozen beef products that the 
USDA determined was unfit for human consumption. Hallmark/
Westland's February 17 recall is the largest meat recall in the 
Nation's history. Fifty-five million pounds of this meat was 
shipped to feed children in federally sponsored school lunch 
programs. How could children and seniors be fed beef from 
cattle that could not legally be slaughtered. USDA inspectors 
were at the plant. Where were they? Why didn't Federal 
inspectors catch the illegal slaughter of downer cows before 
millions of children were put at risk of mad cow disease and 
other health problems from eating meat from cows that were too 
sick to even stand up?
    We will also hear from the CEO of Bumblebee and New Era 
about the deadly botulism bacteria that were found in their 
food. We need to know how botulism, a very deadly but rarely 
found bacteria, survived the sterilization process required for 
low acid canned foods in the Bumblebee plant in Georgia and the 
New Era facility in Michigan. I believe this is the first time 
in over 30 years that botulism has been discovered in our food. 
If we can no longer trust our food companies to provide us with 
food that is supposed to be pasteurized, then America's food 
safety has sunk to a new low. How many other foods that are 
supposed to be sterilized before they are being sent to the 
grocery stores, but are not being pasteurized before being sold 
to American consumers.
    Today we will also have more testimony of banned 
antibiotics found in imported seafood that the FDA is unable to 
keep off our tables.
    We will also have with us today a witness from a private 
laboratory that tests imported food for safety. We expect to 
learn how easily companies can manipulate the current 
inspection system to allow contaminated imported food into our 
supply. Fifteen years ago America's trust in the food supply 
was shattered when four children died and more than 700 people 
became sick after eating Jack-In-The-Box hamburgers. USDA 
responded to this tragedy in 1995 with creation of an industry-
supported Hazard Analysis Critical Control Point, or HACCP. The 
HACCP system was promoted as a science-based strategy for 
protecting public health. Although the scientific principals of 
HACCP remain sound, many experts contend that it actually 
decreased Federal oversight, because of industry's self 
reliance on self inspection under HACCP.
    Today our food safety system is broken. The overarching 
question for the corporate CEOs testifying today is simply how 
do we fix our critical food safety net? Chairman Dingell, 
myself, and a number of our colleagues are determined to 
restore confidence in our food safety system. We need your 
support. I hope today is a start to correct the problems that 
created the litany of recalls and illnesses of food recalls 
last year. Members of this committee look forward to working 
with you in this effort.
    My opening statement is complete. Next we turn to Mr. 
Shimkus, from Illinois, for his opening statement, please, sir.
    [The prepared statement of Hon. Bart Stupak follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
  OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Mr.Shimkus. Thank you, Mr. Chairman. As you stated today 
this hearing is fifth in a series of food safety hearings 
conducted over the past year. And the hearing brings together a 
number of recent food safety cases representing four or five 
distinct issues. Import surveillance, adherence to good 
manufacturing practices, the role of Federal guidance and 
mandates and enforcement of and company adherence to existing 
rules and regulations. As the hearing title suggests the 
essential theme today is private sector accountability. Our job 
today is to shine the light on these cases before us to 
identify whether there were any deficiencies in private sector 
actions, and to determine what changes, if any, by the 
regulators or the regulated could have prevented the outbreaks 
from occurring. We will be hearing some alarming stories about 
food safety practices. We should keep some perspective on this. 
According to the Centers for Disease Control and Prevention 
there are approximately 76 million food borne illnesses a year, 
which result in an estimated 5,000 deaths and 325,000 
hospitalizations. These numbers indicate that food safety 
regulation standards and guidelines should be reviewed and 
updated frequently and enforced to ensure that all Americans 
are eating wholesome and safe food. While any death or 
hospitalization is one too many, it is not so clear whether we 
are experiencing a significant across the board spike in food 
borne illness outbreaks compared with a decade ago. Date of 
last April from CDC surveillance showed that illnesses from 
consuming raw seafood, mostly oysters, have spiked well above 
the late 1990s. But the relatively low rate of salmonella and 
viral E. coli outbreaks, although rising in recent years, were 
still below the 1996 to 1998 baseline. We should nevertheless 
be constantly vigilant for ways to improve our food safety 
regulatory system. The goal is to reduce the risks of food 
borne illnesses while maintaining the wonderful variety, 
abundance, and value of our Nation's food supply.
    Imports are our special regulatory challenge. But 
technology advances are providing tools that can help address 
the risks domestically. Due to advances in information 
technology such as pulsenet and foodnet the CDC and the State 
Health Departments now have access to and can input 
surveillance data into national databases that monitor and 
track food borne illnesses. These technologies instituted in 
the late 1990's serve as powerful investigative tools to help 
uncover the source of food borne illnesses and outbreaks in our 
country. Prior to these systems tracking food borne illnesses 
and tracing the illnesses back to the root sources was more 
cumbersome and incomplete. Now that we are doing a better job 
of tracking food borne illnesses we should work to make sure 
this information is put to maximum use to improve safety 
systems.
    This hearing focuses mainly on several companies that have 
produced food products that have been contaminated by harmful 
pathogens including E. coli, salmonella and botulism. These 
contaminants can lead to human illnesses, especially in those 
who are immune, such as children and the elderly. Our witnesses 
today are divided into two panels, but are here for one reason. 
We all want to discern what both the public and private sector 
can do to reduce the risks of food borne illnesses. I 
understand that the American public wants someone to be held 
accountable, corporate or otherwise. However, before we can 
determine what should be done, we need to answer some 
fundamental questions. What is the source of contamination in 
each one of these cases? Can it ever be identified? Can we 
identify deficiencies in the company practices that would have 
prevented or would prevent this harm in the future? Would 
increased federal regulations address these deficiencies, or it 
is merely a matter of closely adhering to existing rules and 
practices? Are some of the cases representative of bad actors 
that violated existing regulations and need penalties enforces 
against them? I have a hunch, Mr. Chairman, that we will find 
today a range of answers depending upon the case before us. For 
that reason I think one of difficult, but useful goals of this 
morning is to sort out clearly for the Director the separate 
lessons we can draw from each of these cases.
    I look forward to the witnesses this morning, and the 
variety of perspectives and expertise. This promises to be an 
informative hearing. I yield back.
    [The prepared statement of Hon. John Shimkus follows:]

                     Statement of Hon. John Shimkus

    Thank you Mr. Chairman. As you stated, today's hearing is 
the fifth in a series of food safety hearings conducted over 
the past year. And the hearing brings together a number of 
recent food safety cases, representing four or five distinct 
issues: import surveillance, adherence to good manufacturing 
practices, the role of federal guidance and mandates, and 
enforcement of--and company adherence to--existing rules and 
regulations.
    As the hearing title suggests a central theme today is 
private sector accountability. Our job is to shine a light on 
these cases before us to identify whether there were any 
deficiencies in private sector actions and to determine what 
changes, if any, by the regulators or the regulated could have 
prevented the outbreaks from occurring.
    We will be hearing some alarming stories today about food 
safety practices. We should keep some perspective on this. 
According to the Centers for Disease Control and Prevention 
(CDC) there are approximately 76 million food-borne illnesses a 
year, which result in an estimated 5,000 deaths and 325,000 
hospitalizations. These numbers indicate that food safety 
regulations, standards, and guidelines should be reviewed and 
updated frequently and enforced to ensure that all Americans 
are eating wholesome and safe food.
    While any death or hospitalization is one too many, it is 
not so clear whether we are experiencing a significant across-
the-board spike in food-borne illness outbreaks compared with a 
decade ago. Data last April from CDC surveillance showed that 
illnesses from consuming raw seafood (mostly oysters) have 
spiked well above the late 1990s, but that the relative rate of 
salmonella and virulent E. coli outbreaks--although rising in 
recent years--were still below the 1996-1998 baseline.
    We should nevertheless be constantly vigilant for ways to 
improve our food-safety regulatory system. The goal is to 
reduce the risk of food borne illness, while maintaining the 
wonderful variety, abundance, and value of our nation's food 
supply.
    Imports are a special regulatory challenge, but technology 
advances are providing tools that can help address the risks 
domestically. Due to advances in information technologies, 
including PulseNet and FoodNet, the CDC and the state health 
departments now have access to and can input surveillance data 
into national databases that monitor and track food borne 
illnesses. These technologies, instituted in the late 1990s, 
serve as powerful investigative tools to help uncover the 
sources of food borne illness outbreaks in our country.
    Prior to these systems, tracking food borne illnesses and 
tracing the illnesses back to root sources was more cumbersome 
and incomplete. Now that we are doing a better job of tracking 
food borne illnesses, we should work to make sure this 
information is put to maximum use to improve safety systems.
    This hearing focuses mainly on several companies that have 
produced food products that have been contaminated by harmful 
pathogens including E-coli, salmonella, and botulism. These 
contaminants can lead to human illness especially in children 
and the elderly.
    Our witnesses today are divided into two panels, but are 
here for one reason: we all want to discern what both the 
public and private sector can do to reduce the risk of food 
borne illness. I understand that the American public wants 
someone to be held accountable: corporate or otherwise.
    However, before we can determine what should be done, we 
need to answer some fundamental questions: What is the source 
of contamination in each one of these cases? Can it ever be 
identified? Can we identify deficiencies in the company 
practices that would have prevented and would prevent this harm 
in the future? Would increased federal regulations address 
these deficiencies or is it merely a matter of closely adhering 
to existing rules and practices? Are some of the cases 
representative of bad actors that violated existing regulations 
and need penalties enforced against them?
    I have a hunch, Mr. Chairman, that we will find today a 
range of answers, depending on the case before us. For that 
reason, I think one of the difficult but useful goals for us 
this morning is to sort out clearly for the record the separate 
lessons we can draw from each of these cases.
    I look forward to the witnesses this morning, and their 
variety of perspectives and expertise. This promises to be an 
informative hearing.
    ###
                              ----------                              

    Mr.Stupak. Thank you, Mr. Shimkus.
    Mr. Dingell, for an opening statement, please.

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr.Dingell. Good morning to the Chairman. Thank you for 
holding this hearing.
    I commend you for the vigor of your oversight of food and 
drug and other important matters of concern to this Committee. 
Oversight of food safety is one of the most important 
undertakings of this Committee, and it appears that this is a 
subject that needs the most vigorous attention of the 
Committee.
    Today we are going to hear from leading companies in the 
food processing industry about what does or does not work in 
safeguarding our food supply. Unfortunately we are forced to 
return to issues and to hear from witnesses from our prior 
hearing of last April. At that time ConAgra testified regarding 
the discovery of salmonella in their Peter Pan peanut butter. 
What we did not know then, due to FDA obfuscation and delay, 
was that this problem was more serious than we had been told. 
After the hearing we learned that many more jars containing the 
deadly bacteria had been found, and that some had been 
processed fully six months after ConAgra claimed that the 
problem had been fixed. Since last April's hearings we have 
learned of another problem with ConAgra. Apparently their 
Banquet brand of pot pies have made hundreds of Americans sick. 
While the source of this contamination is still in doubt, 
ConAgra blames Butterball, who claims that the turkeys for the 
pies was the source of the problem. Butterball disagrees and 
claims that their turkey is fully cooked before it is shipped. 
Ironically, the FDA has no opinion on the matter. Today we hope 
that these companies can clarify this issue and assure the 
consumer that their products are safe. We also hope that we 
will hear something from the FDA, which will enable us to have 
some confidence that they know what they are doing.
    Last April we also heard testimony about contaminated 
lettuce and spinach. We were assured then that the problem was 
under control due to the issuance of new voluntary compliance 
standards. Since then, however, we have had two more recalls of 
leafy greens. We will hear from Dole Foods as well as from Mr. 
Brackett of the Grocery Manufacturers Association who recently 
retired as the head of food safety at FDA, and helped develop 
these voluntary standards. Suffice to say that we have 
questions about some of these proposals. And we also want to 
hear how voluntary standards can be made to work to protect the 
consumers. Apparently there is some evidence to the contrary 
here before us this morning.
    We also will hear from two firms where botulism has been 
found in their low acid canned foods. This is very unusual. It 
is the first time in more than 30 years that such products have 
been infected with botulism in this country. One of these 
plants even had a USDA inspector on the premises for full-time. 
We also wanted to hear from the head of the California Meat 
Packing Company who recently recalled 143 million pounds of 
beef, including 55 million pounds destined for our school 
children. It appears that the head of this company has refused 
our offer to testify voluntarily. We will now have to consider 
whether we need to compel his appearance to probe how on-site 
USDA inspectors could have missed these safety problems and the 
inhumane treatment of animals who were slaughtered there.
    Finally, Mr. Chairman, I would like to address the broader 
issue of industry responsibility. Under this Administration we 
have experimented with voluntary health and safety regulations 
to protect our food. Yet it appears that our food supply 
becomes more dangerous all the time both from imported products 
and from domestically produced products, sometimes contaminated 
by unwise imports from China and other places. It is clear that 
our regulatory system is broken. It is plain that Food and Drug 
does not have the personnel. It does not have the money. It 
does not have the resources to carry out its important 
responsibilities. It is also appearing to me that they do not 
have the leadership that is necessary to do the things that are 
required for the protection of the American consumer.
    I am going to urge industry to provide serious 
recommendations today, and more importantly, to strongly 
support legislation that will ensure food safety. The time has 
passed for halfway measures or asking regulators to do more 
with less. I began listening to the rather plaintive remarks of 
the head of Food and Drug when Mr. Young was the head of that 
agency. And he used to call me up and tell me, Dingell, we are 
going to do a good job. We have a new system, which will make 
it possible for us to do the job better with less money. It 
turned out it was hooey, and he is no longer with the agency. 
This is a situation, then, which is serious. The health of the 
American people is at stake. I urge our witnesses and others in 
the industry to join with us in changing the current system. I 
can assure you that this will not be the last time that you 
will be before us testifying about another recall and another 
failure in protecting our Nation's food supply. I look forward 
to an explanation of what you have done, why this has happened 
and what you are going to do to assure us that this will not 
occur again. Thank you, Mr. Chairman.
    [The prepared statement of Hon. John Dingell follows:]

                   Statement of Hon. John D. Dingell

    Mr. Chairman, thank you for holding this hearing. Oversight 
of food safety is one of the most important undertakings of 
this Committee.
    Today we will hear from leading companies in the food 
processing industry about what does or does not work in 
safeguarding our food supply. Unfortunately, we are forced to 
return to issues and hear from witnesses from our prior hearing 
last April.
    At that time, ConAgra testified regarding the discovery of 
Salmonella in their Peter Pan peanut butter. What we did not 
know then, due to FDA obfuscation and delay, was that this 
problem was more serious than what we had been told. After the 
hearing, we learned that many more jars contained the deadly 
bacteria and some had been processed fully 6 months after 
ConAgra claimed they had fixed the problem.
    Since last April's hearing, we have learned of another 
problem with ConAgra. Apparently, their Banquet brand pot pies 
have made hundreds of Americans sick, while the source of the 
contamination is still in doubt. ConAgra blames Butterball, 
which supplies the turkey for the pies. Butterball disagrees 
and claims their turkey is fully cooked before shipped. 
Ironically, the FDA has no opinion on the matter. Today, we 
hope those companies can clarify this issue and assure the 
consumer that their products are safe.
    Last April, we also heard testimony about contaminated 
lettuce and spinach. We were assured then that the problem was 
under control due to the issuance of new voluntary compliance 
standards. Since then, however, we have had two more recalls of 
leafy greens.
    We will hear from Dole Foods as well as from Mr. Brackett 
of the Grocery Manufacturers Association who recently retired 
as head of food safety at FDA and helped develop those 
voluntary standards. Suffice it to say, we have some questions 
about those proposals.
    We also will hear from two firms where botulism has been 
found in their low acid canned foods. This is very unusual. It 
is the first time in more than 30 years that such products have 
been infected with botulism in this country. One of those 
plants even had a USDA inspector on premises full time.
    We also wanted to hear from the head of the California meat 
packing company who recently recalled 143 million pounds of 
beef, including 55 million pounds destined for our school 
children. It appears he has refused our offer to testify 
voluntarily. We now will have to consider whether we need to 
compel his appearance to probe how on-site USDA inspectors 
could have missed these safety problems and the inhumane 
treatment of the animals that were slaughtered there.
    Finally, Mr. Chairman, I would also like to address the 
broader issue of industry responsibility. Under this 
Administration, we have experimented with voluntary health and 
safety regulations to protect our food. Yet, our food supply 
becomes more dangerous all the time.
    It is clear our regulatory system is broken. I urge 
industry to provide serious recommendations and, more 
importantly, strongly support legislation that will ensure food 
safety. The time has passed for half measures or asking 
regulators to do more with less. Our health is at stake. If you 
don't join us in changing the current system, I can assure you 
that this will not be the last time you join us in testifying 
about another recall and another failure in protecting our 
Nation's food supply.
                              ----------                              

    Mr.Stupak. Thank you, Mr. Dingell.
    Mr. Barton, for an opening statement, please.

   OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr.Barton. Thank you, Mr. Chairman, for holding this 
hearing on the contaminated food and private sector 
accountability.
    I want to say at the outset, and while there are partisan 
differences in the Congress on various issues, on this issue, 
the issue of food safety for the American people, there is no 
daylight between Mr. Stupak, Mr. Dingell, Mr. Shimkus, myself 
and the Republicans and Democrats on this oversight, 
subcommittee and the full Committee.
    If you go back not too many years ago most families, mine 
included, grew most of what they consumed. My grandparents and 
great-grandparents both grew up and lived on farms in central 
Texas. They grew their own--they raised their own cattle, 
chickens, pigs. Both of my great-grandmothers and grandmothers 
had huge truck gardens. I can remember in the early 50s if I 
wanted, when it was in season, if I wanted green beans or corn 
I went out and picked them and brought them in. And my 
grandmother shucked the corn and boiled it and split the green 
beans and we had--that is what we had. I doubt they are many 
families in America today that do that. We depend on a vast 
network of producers and distributors and processors so that 
when, like my 2\1/2\-year-old several days ago wanted a banana, 
I did not go out in the backyard since banana trees would not 
grow in Texas anyway. I went to the grocery store and bought 
some bananas. I think I paid 20 cents a pound for them or 
something.
    It is absolutely imperative that the food safety, the food 
products on the shelves of our grocery stores, is beyond 
question. Now, I don't believe anybody in this room would say 
that you do not support that. Yet, when we look at the record, 
it is stunning how much impaired food is reaching our shelves 
and the dinner tables of American families. If statistics are 
to be believed in the last year 5,000 Americans died because 
they consumed contaminated food products. Most of those 
products were beef or seafood. A large number of the products 
apparently were imported from overseas, and a fair amount of 
that from the--from China.
    I am working on a bipartisan basis to introduce legislation 
in the very near future that would give the Food and Drug 
Administration the authority to have jurisdiction outside the 
United States when necessary to protect our food supply and do 
food inspections. We have got a letter of support from the 
Administration. The Clinton Administration supported this type 
of legislation. There have been some court decisions that said 
it was ambiguous, so I am hopeful that between myself and Mr. 
Dingell, Mr. Stupak and Mr. Shimkus and others, we can 
introduce that bill very soon. But in the meantime we will 
continue to do, you know, aggressive investigative oversight. I 
want to commend Mr. Stupak and Mr. Dingell and Mr. Shimkus for 
their role in this effort, and I look forward to this hearing.
    We have the National Governors downstairs in the big 
committee room on the SCHIP program, so several of us are going 
to be shuttling back and forth between food safety and SCHIP. 
They are both important hearings and they both deserve the 
committee's attention. I thank you, Mr. Chairman, for holding 
this hearing.
    [The prepared statement of Hon. Joe Barton follows:]

                      Statement of Hon. Joe Barton

    Thank you, Chairman Stupak. Let me note at the outset that 
I support the Committee's continued oversight of food safety 
and its efforts to gather new information on this issue. Nobody 
should have to worry whether dinner will make them sick, and my 
feeling is that most people will resent it if we let politics 
get between us and good policy. So I look forward to working 
with you and writing bipartisan legislation to ensure that 
eating isn't going to become dangerous.
    The various food-borne illness outbreaks, recalls, and 
import alerts over the past year raise questions on how to 
improve food safety even in the changing the realities of the 
modern marketplace. As we do so, we should not forget that it 
isn't the government, but the marketplace, that puts dinner on 
the table. Cutting-edge technologies and global connections 
have brought tremendous gains in variety and cost-savings to 
the American consumer. Like ancient Athens, our country draws 
the produce of the world into our markets, so that to the 
American, the fruits of other countries are as familiar a 
luxury as those of his own. We must preserve these benefits as 
we detect and eradicate any deficiencies in safety.
    The cases we are looking at today raise legitimate concerns 
about failings in food safety oversight. Some of the health 
hazards are known, but surely not all, and many of the exact 
causes are not established.
    Where we believe the facts and science support a safety 
problem, we should ask what changes, including legislative 
changes, could have prevented harm or at least reduced its 
probability. For example, if a company's microbiological 
testing misses traces of dangerous pathogens, but FDA's tests 
on the same products detects them, it seems plain that 
something at the company needs to change. But should the change 
include mandating particular testing methods for all companies? 
I don't know the answer yet, and I am not sure if one case 
study can answer that question.
    The truth remains that in some of the cases we are 
examining today, the source of contamination simply isn't known 
yet, at least not by us. I hope that we get more answers from 
these companies today. And, I hope that these companies will 
explain what they plan to do to reduce the likelihood of future 
contamination in their products.
    Our job is to find the right balance between federal 
regulation and industry responsibility. As overseers of safety, 
we want to protect the American public's health, but without 
strangling industry's productivity, creativity, and ability to 
supply Americans with the products they want to buy. I hope we 
begin to understand today where that balance lies and that our 
witnesses can offer their ideas on how to increase food safety.
    No one here is going to tolerate lying, cheating, or 
wantonly violating any federal statute or good manufacturing 
practice, much less one that delivers food to be consumed on 
dinner tables or school lunchrooms. If laws or regulations were 
violated, the violators should be held accountable, and I can 
assure everybody here today that both Democrats and Republicans 
are of one mind about this. If laws or regulations are not 
being adequately enforced, those agencies should also be held 
accountable by us, and on a bipartisan basis.
    Thank you, Mr. Chairman, and I look forward to listening to 
our witnesses' testimony.
                              ----------                              

    Mr.Stupak. Thank you, Mr. Barton.
    And it is good to remind the members we will be moving back 
and forth. This week alone I think we have seven hearings for 
this committee, so it is going to be a busy week.
    Mr. Doyle, for an opening statement, please.
    Mr.Doyle. Mr. Chairman, I am not going to make an opening 
statement, but I do just want to reiterate what our 
distinguished Chairman and ranking member both said.
    We count on you folks to make sure this food supply is 
safe. In the Pittsburgh City School District we were recipients 
of some of this meat that had to be thrown away. It is a scary 
thought, that any parent or child, when we go and buy things in 
our stores should have to worry about whether or not this meat 
is going make us sick or kill us. Something obviously has to be 
done, and the industry needs to take this very, very seriously 
because I can assure you we take it very seriously.
    Thank you, Mr. Chairman.
    Mr.Stupak. Thank you, Mr. Doyle. Mr. Burgess, for an 
opening statement, please.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr.Burgess. Thank you, Mr. Chairman.
    And to the interest of time I will keep my remarks brief. I 
think we have 10 witnesses that will testify before us today, 
and it is an important topic, and I am anxious to get to the 
matter at hand. This committee has aggressively pursued the 
issue of safety of the Nation's food supply. And I think we 
have made some progress in identifying some of the areas of the 
law where perhaps we have some inadequacies. Since our 
committee has jurisdiction over the Food and Drug 
Administration we have jurisdiction over roughly 80 percent of 
the food supply. In my opinion, especially for food imports, we 
should try to get the Food and Drug Administration standards, 
especially the equivalency standard up to a par with the United 
States Department of Agriculture, which has jurisdiction over 
the other 20 percent, specifically meat and poultry.
    We have had a lot of hearings on this, and I think through 
those hearings, at least my opinion, that is where the danger 
primarily is. And I have actually introduced legislation that 
will address some of the safety problems with imported foods, 
specifically H.R. 3967. And we have rules in this country, but 
clearly the rules are not always followed, and they are not 
always enforced, but we have strict rules to keep our food 
safe. Other countries don't have the same rules, and I do not 
believe that we should accept food from other countries that do 
not certify that they abide by our standards.
    While today we are discussing a specific incident at a 
specific plant history has proven that our meat is safe in this 
country because of the rules the United States Department of 
Agriculture has and the regulations that they have in place. 
Unfortunately, those rules this time were not enforced in 
California, but the rules were still there.
    Mr. Chairman, as you know I am from Texas, and we like our 
beef. However, we also realize the dangers to consumers if beef 
products are not handled correctly. Our Nation has long 
recognized that our meat and poultry industry needed specific 
inspections and specific rules and regulations. Those 
inspections and rules and regulations must be enforced. There 
is simply no margin for error. There are no justifications to 
not enforce the rules. I am grateful the Humane Society brought 
this issue before us today, but I do have to wonder why they 
waited so long. The video was taped during the fall in the 
month of October, and they knew that the meat was going to 
school children. So why wait until February to release the 
video? Now, the Humane Society has friends on the hill. I count 
myself as one of those. I worked with the Humane Society on the 
issue of horse slaughter back in my home state of Texas, and 
working to affect the horse slaughter ban. So they have friends 
on the hill. Why wait until now to bring this to our attention? 
Their delay in no way absolves the companies involved or the 
United States Department of Agriculture for their part in this. 
But I certainly would like the Humane Society to address this 
issue.
    Mr. Chairman, we must be thorough. We must be methodical as 
we continue to approach the issue of food safety. I look 
forward to continuing this important conversation today and 
working with the leadership of this committee, and drafting 
legislation regarding the safety of the food supply, 
specifically the 80 percent that is under the jurisdiction of 
the Food and Drug Administration and as a consequence under the 
control of this committee.
    I thank you for holding the hearing, and I will yield back 
the balance of my time.
    Mr.Stupak. Thank you, Mr. Burgess.
    As to the video that you mentioned, we will have it right 
after the opening statements here. The video was given to law 
enforcement first. It took law enforcement some time to react. 
That is why the Humane Society did not put it out publicly. It 
was given to law enforcement so they could do their law 
enforcement work. I agree. Yes. And I don't think anything 
would have been done unless there had been the threat to 
release it publicly, because I think law enforcement may have 
fallen short here on this notification. We will have another 
hearing. I guarantee you. The Humane Society is here though.
    Let us see. Opening statement, next to go to Mr. Murphy, 
please.

   OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr.Murphy. Thank you, Mr. Chairman.
    And one of the things I realize in my time in Congress is 
how--what a mess it is, the Federal Food Safety Program. I 
believe there is over two, perhaps three, dozen laws and areas 
that make up the Federal Food Safety Program and no single 
agency oversees them all. This continues to be a nonsense gone 
fragmented system. And I believe we saw the situation where the 
Department of Agriculture and specs, open-faced meat sandwiches 
and frozen pepperoni pizzas, and the FDA inspects closed-faced 
sandwiches and cheese pizzas. We have had intensive hearings on 
that. One of the most challenging scientific things of our 
time. I say that tongue-in-cheek because sometimes it is 
ridiculous of how this system here in Washington works. And one 
of the things that I hope comes out of these hearings today is 
hearing from the witnesses of the how we can help make it 
better. That is critically important. Yes, we do have problems, 
and they are significant with 5,000 deaths and 325,000 
hospitalizations a year of people who have food poisoning. I 
might add that also disturbing to me is we have two million 
hospitalizations a year and 90,000 deaths a year from people 
who pick up an illness in a hospital. Something that is 
certainly far more severe in terms of the number of fatalities 
we have, and also should demand the attention of this and other 
committees and the Engineering Commerce committee. But, 
nonetheless, in Pennsylvania where agriculture is our number 
one industry, where we have high quality companies in 
Pittsburgh, such as Heinz and Del Monte, we know the challenges 
are ongoing in preventing outbreaks in food borne illnesses. It 
has to be something that we all have to work at together. And I 
know there is a great deal of motivation for us all to point 
the fingers of blame. I want those fingers to point towards 
solutions, and not just be a time of roderick for us to be 
coming up with a tax. Every single statement made should be 
pointed in some direction of how we can make this system work 
better. The public demands it. The public deserves it, and this 
committee needs to work on it. And I yield back.
    Mr.Stupak. Ms. DeGette, for an opening statement, please.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms.DeGette. Thank you, Mr. Chairman.
    I am sure our witnesses have heard that we are all running 
from hearing to hearing. I think there are seven subcommittee 
hearings. And the Health Committee subcommittee hearing is also 
an issue I have been working on a lot. The SCHIP bill, so 
between food safety and SCHIP I want apologize to the witnesses 
for running back and forth today.
    Over the last year this subcommittee has had five hearings 
examining the safety of our Nation's food supply. I am glad we 
are continuing this investigation, which has brought to light 
some serious inadequacies in our system, both in the public and 
private sectors. But sadly the hearings have turned out more 
questions than answers, and even more sadly, like just last 
week, there have been more outbreaks every time we have a 
hearing. What is absolutely maddening is that these incidents 
are preventable. In almost every case we can trace the serious 
threats to public health back to an agency that has been 
starved for funding or to a corporation with substantial 
agricultural or industrial practices.
    I want to welcome the CEOs who are here with us today, and 
I am looking forward to hearing your testimony. I want to focus 
just a minute on ConAgra, because that is a major food producer 
nationwide, which has operations in my state of Colorado. Six 
years ago it was ConAgra which appeared before us to talk about 
one of the biggest recalls in history, after E. coli was found 
in its beef and so many people got sick. Last year they were 
before this committee talking about the peanut butter that was 
tainted with salmonella. Then it revealed that its popcorn 
contained chemicals that could make workers and consumers sick. 
And then this past fall citizens around the country were 
poisoned by ConAgra made pot pies containing salmonella. You 
can see how frustrating this is for us as representatives of 
the consumers, because the companies come before us, apologize 
profusely, and then they tell us about the new facilities they 
are installing or the money they are spending to make sure 
nothing like this happens again. So for example today, ConAgra 
is going to talk about its fantastic progress in ensuring the 
safety of Peter Pan peanut butter. Well, that is great news, 
but what about the pot pies? What about the next thing? I am 
sure the company has taken great pains at great expense to 
ensure the safety of the product, but what the next outbreak? 
And that is what we are worried about. With an organization 
this large that touches so many segments of the marketplace 
what can we do better to ensure these outbreaks do not happen 
in the future, rather than just coming in and apologizing but 
for the past? Now many of the companies before us today have 
been involved in massive recalls of tainted products. The 
members of this committee know that I have been introducing 
legislation for many years, H.R. 3484, that would grant the 
USDA and FDA mandatory recall authority. My constituents are 
frankly shocked when they learn that right now these agencies 
do not have mandatory recall authority. They think they do, 
because they hear about the recalls. And they don't realize 
that the recalls are as a result of voluntary recalls by these 
companies. All of the recalls today, when they finally 
occurred, were issued voluntarily. And it is my contention that 
waiting on the company to make the decision is truly the fox 
guarding the hen house. ConAgra, for example, did not order a 
recall immediately upon learning of illnesses related to the 
pot pies. They issued a consumer advisory instead. It was only 
after days had passed, and even more people got sick, that the 
company decided it was in its financial best interest, in 
addition to the public interest, to recall the products. So 
this legislation, H.R. 3484, would correct the conflict of 
interest by allowing the USDA or FDA to order recalls as soon 
as it became clear that an outbreak has occurred, and it 
provides for the immediate notification of consumers and public 
health officials.
    I want to thank you, Mr. Chairman, for continuing to work 
on these issues and I will pledge to be your partner, as 
always, as we move along. I yield back.
    Mr.Stupak. Thank you, Ms. DeGette.
    Ms. Blackburn, for opening statement, please.

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF TENNESSEE

    Ms.Blackburn. Thank you, Mr. Chairman, and I thank you for 
the hearing today and to all of our witnesses as everyone is 
saying.
    We do have the SCHIP hearing that is going on downstairs, 
and we are back and forth. But we appreciate the hearing and 
the attention that is being put on this issue, because it is a 
high priority issue. It is not only one of public health and an 
issue that we are addressing on the public health front, but 
also the National security front.
    I had a really interesting episode occur recently or a 
little occurrence. I was in my hometown in the grocery store 
strolling my buggy down the aisle, and someone was passing me 
and they said how do you know what to buy? How do you know what 
is safe anymore? And they kind of chuckled and rolled on. They 
had been watching the hearings. They were aware of what we were 
doing, but to me it points out something very, very important. 
There is a certain level of trust that the American public has 
of the products that you all produce. And they want to know 
with a certain degree of assurance that when they go to that 
grocery store and they take something off the shelf and put it 
into that buggy that it is safe. When they pull it out of the 
freezer compartment that it is safe. And when they cook it and 
serve it to their family, after having followed the directions, 
that everybody is going to be OK.
    And my hope is that we can get through this. This is our 
fifth hearing as you have heard. It is something that we are 
tremendously concerned about, and we want to be certain that 
not only the FDA, but you all go from defense to offense. And 
how do we best accomplish that? I have been just amazed that 
only one percent of the 8.9 million shipments of imported food 
are inspected. One percent. And we know from the USDA that we 
are expected to import a record 70 billion in agriculture 
products this year, which is double the nearly 36 billion 
purchased in '97, and that we have seen total food imports. The 
total imports have increased by 50 percent in the last five 
years, and it is frustrating to us that the FDA does not have a 
timeline for how they are going to change their practices to 
address this issue. So that something we are focused on and we 
are going to continue to work on.
    I am not going to go through my full statement. You all 
have been very patient with us. We are going to be up and down. 
But I will tell you when we hear about recalls of pet foods and 
toothpaste and pizza products and baby formula, this is 
something that does get our attention. And we are going to seek 
accountability, greater accountability, through reform of the 
FDA system. We are looking for ways that we can make certain 
that the food coming into our product streams is something that 
is reliable and safe. They trust, the American consumers, 
trusts that we will do that. I am looking forward to making 
certain that everyone agrees to work together to make certain 
we reach this goal. Mr. Chairman, I thank you for the time, and 
I yield back.
    Mr.Stupak. Thank you. That concludes the opening statements 
of members of the subcommittee.
    I'd like to call our first panel of witnesses to come 
forward.
    [Witnesses sworn.]
    Mr.Stupak. Before we hear the witness's testimony I would 
like to show a brief video that was produced by the Humane 
Society as part of their undercover investigation of the 
Hallmark/Westland Corporation's slaughter house operation.
    We invited Mr. Steve Mendell, the CEO of Hallmark/Westland 
to appear to day, but he refused the Committee's invitation. I 
do, however, plan to discuss this matter with the Chairman and 
with ranking members Barton and Shimkus as to our next step in 
compelling Mr. Mendell to appear before this committee to 
explain his company's behavior. Before we run the video I must 
caution viewers some parts of it is quite graphic. Kyle, run 
the video. You may want to dim those lights. I don't know if 
anyone can see it with these lights on. Then after the video we 
will start with opening statements.
    [Video shown.]
    Mr.Stupak. That concludes the video. We will start with our 
5-minute opening statement for our witnesses. You may submit a 
longer statement if you wish, for inclusion in the hearing 
record.
    Mr. Greger, we will start with you, please. Dr. Greger.

 STATEMENT OF MICHAEL GREGER, M.D., DIRECTOR OF PUBLIC HEALTH 
AND ANIMAL AGRICULTURE, THE HUMANE SOCIETY OF THE UNITED STATES

    Dr.Greger. Mr. Chairman, members of the subcommittee, thank 
you for this opportunity to testify about the----
    Mr.Stupak. Try pulling your mic up a little bit. Even up 
here it sounds like we are having a little bit--had a little 
bit of trouble here getting to project our voices. Go ahead.
    Dr.Greger. Thank you for allowing me to testify about the 
horrendous animal cruelty and food safety issues that we 
uncovered in our extensive hidden camera investigation of this 
dairy cow slaughter plant in California.
    My name is Michael Greger. I am a medical doctor and serve 
as director of Public Health and Animal Agriculture at The 
Humane Society of the United States. That video you saw was 
narrated from the perspective of our undercover investigator, 
who worked at the Hallmark packing plant for 6 weeks at the end 
of 2007 in both October and November. And personally witnessed 
and documented the egregious mistreatment of animals, 
particularly these downed cows to sick or injured to even stand 
or walk. And I trust you can appreciate the identity of this 
investigator must be kept confidential for his own safety and 
to not compromise the efficacy of his current investigative 
efforts and future efforts. It is critical to first point out 
that the agency did not cherry pick this plant. This plant was 
selected at random, and only during the course of the 
investigation did we learn that Westland was the number two 
beef supplier for the National School Lunch Program, that 
Westland was a USDA supplier of the year, and that this 
facility had been previously cited for mishandling animals, 
with allegations going back over a decade.
    The blatant cruelties highlighted in the video are not 
isolated cases. They were daily happenings at this plant every 
day the worker was there. The horrific treatment of animals we 
documented is being downplayed as an aberration. 
Unconscionable, yet the work of just a handful of rogue 
employees. We don't think this is an accurate characterization. 
It has since come to light that this plant, Hallmark/Westland, 
has a long and well documented history of abusing downed cows. 
In fact, FSIS cited Westland in 2005 for mishandling animals 
and the local Pomona Valley Humane Society and SPCA had 
notified USDA multiple times about possible violations dating 
back to 1996. And this is not the only plant that has been 
documented to have downer cows going into the food supply. The 
USDA's own Office of the Inspector General chastised the agency 
in 2006 for violating its own downer policy. The OIG sampled 12 
slaughter plants over a 10 month period, and found 29 downed 
cows going into the food supply. Again, violating the USDA's 
own interim final rule passed in 2004 after the first case of 
BSE was discovered in the United States.
    Downed cattle are not only more likely to be infected with 
BSE, bovine spongiform encephalopathy or mad cow disease, but 
studies suggest they may also be more likely to harbor food 
borne pathogens, such as E. coli 0157H7, and salmonella. No 
surprise, perhaps, given the fact that many of these animals 
may be wallowing in their own waste. Despite the potential 
health risks, despite the legitimate animal welfare concerns, 
and despite their own Inspector General finding violations, the 
USDA in 2006, instead of strengthening the final downer ban 
rule they critically weakened it. Codifying a loophole into it 
that allowed some downed animals to continue to be slaughtered 
for human food. Currently inspection personnel are allowed to 
determine on a case-by-case basis the disposition of cattle 
that go down after passing antemortem inspection. And this 
loophole provides the incentive, the financial incentive, for 
what you just witnessed on that video. Workers trying every 
cruel tactic imaginable to get--to force downers up for the 
inspection, knowing full well that should the animal then 
collapse down for good the loophole allows the inspector to 
pass downed animals. To pass that downed animal as USDA 
approved beef. If, on the other hand, downers could not go into 
the human food supply then there is no reason to prolong her 
misery. Even if a cow is down even for just what appears to an 
acute injury, like she breaks her leg, there may be an 
underlying disease that caused her to fall and break it. 
Indeed, at least three of the documented BSE cases in North 
America, were injured cattle. These infected cattle were 
identified as downed not due to illness, but due to injury. 
One, indeed, just broke a leg. Another slipped on ice. All 
right. And so the meat is safe, right? Because it is ``just an 
injury,'' but it turned out it was more than just an injury. 
They had mad cow disease. A truly comprehensive ban on the use 
of any meat from downed animals in the human food supply is 
needed to protect food safety and animal welfare, and with 
vigorous enforcement, of course, to ensure compliance. USDA 
must rewrite its rules to close the current loophole and 
redirect resources to provide adequate oversight.
    Finally, we urge Congress to enact swiftly two pieces of 
legislation that will help prevent such abuses from 
reoccurring. H.R. 661, the Downed Animal and Food Safety 
Protection Act by Representatives Ackerman and LaTourette, 
would implement a comprehensive ban on processing downed 
animals, which the USDA has so far failed to do. And H.R. 1726, 
the Farm Animal Stewardship Purchasing Act, by Representatives 
DeFazio and Shays should set basic animal welfare standards for 
producers who sell to the National School Lunch Program and 
other federal programs, including no downed animals.
    Thank you, again, for this opportunity to testify about 
this important animal welfare and food safety issue.
    [The prepared statement of Dr. Greger follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Mr.Stupak. Thank you.
    Mr. Williams, opening statement, please.

  STATEMENT OF JOHN A. WILLIAMS, EXECUTOR DIRECTOR, SOUTHERN 
                        SHRIMP ALLIANCE

    Mr.Williams. Good morning. My name is John A. Williams, and 
I am here today both as someone with 30 years of experience in 
the shrimp industry and as Executive Director of the Southern 
Shrimp Alliance.
    I operate a small business in Tarpon Springs, Florida, and 
I am proud to have the privilege of representing the other 
small business men and women in the shrimp industry. Thousands 
of other small businesses of men and women in the shrimp 
industry throughout the Gulf of Mexico and the south Atlantic.
    Mr.Stupak. Would you pull that mic up a little bit closer, 
please, sir?
    Mr.Williams. Thanks. I appreciate the opportunity to 
testify on the FDA's failure to protect Americans from harmful 
seafood imports. I ask the committee to refer to my written 
comments for more detail on the urgent need for meaningful FDA 
reform.
    There can be no denying that the FDA is broken. The essence 
of FDA's approach to imported food safety is to accept 
unverified representations of importers who have repeatedly 
disregarded the safety of American consumers. We know and the 
FDA knows that aquaculture in much of the developing world has 
led to the introduction of harmful contaminants into our 
imported seafood. Imported foreign raised shrimp are often 
produced with minimal quality control in crowded ponds filled 
with feces, banned antibiotics and toxic chemicals. And yet, 
the FDA's only check on self-serving representations is the 
inspection of one percent of seafood imports.
    The FDA's failure to prevent importation of massive amounts 
of contaminated shrimp has a number of negative effects on our 
market. In addition to putting consumers at risk, contaminated 
shrimp imports depress demand for all shrimp when consumers 
fail to distinguish between safe and unsafe sources of shrimp. 
Shrimp buyers know that shrimp sources from farms in countries 
with lax controls are likely to be contaminated and, therefore, 
offer lower prices.
    In addition, the simple fact that large amounts of shrimp 
enter the U.S. market that should not have been allowed to 
enter further depresses prices for all shrimp. The combination 
of stringent imported food safety regimes and other major 
importing markets and lax enforcement of U.S. law encourages 
the diversion of contaminated seafood to the United States. 
Canada, Japan and the European Union all do significantly more 
to protect consumers than the FDA to safeguard the American 
public. As a result our Nation has become a dumping ground for 
rejected and inferior seafood products that could not be 
exported to other countries.
    For example, when the EU imposed a complete ban of shrimp 
from China in 2002 because of illegal antibiotic use, Chinese 
shrimp imports to the United States shot up 30 percent in one 
year, adding millions of additional pounds of shrimp to this 
market. And the same thing happened when the EU decertified 
Pakistani seafood products in April of 2007. In just 2 months, 
Pakistani shrimp to the U.S. jumped from 0 to 165,000 pounds. 
Now we are facing the same problem with Vietnam. While the EU, 
Japan and Canada all have recently taken action against 
Vietnamese shrimp for illegal antibiotic use the FDA has done 
nothing. The FDA has sufficient evidence of the hazards of farm 
raised seafood from Vietnam, both from its own investigation 
and as we have been told by reliable sources from direct 
admission by Vietnamese authorities, of the widespread use of 
banned substances in the production of farm raised seafood. And 
for some of those substances the FDA apparently has no testing 
protocol to detect them. Concerns about the FDA's inability to 
assure the safety of the imported seafood has risen to the 
point that states have been doing their own testing of seafood 
imports. And these states have repeatedly found harmful banned 
substances in the imported seafood they test--seafood allowed 
by the FDA to enter this country. While we are pleased that 
state governments have attempted to step into the breech, the 
burden of ensuring that imported seafood is safe to consume 
should not be forced upon them. There is no substitute for a 
strong federal food safety system. Unfortunately, the FDA 
appears to take action only when facing a crisis or public 
outrage.
    We respectfully suggest that this committee should be 
outraged. We have prepared a series of proposals for 
legislative changes to improve the safety of imported seafood. 
These proposals are discussed in detail in my written 
testimony, but I will provide a couple of examples here.
    The FDA should require, as a condition of importation, that 
the country of origin of an imported seafood product administer 
a system of food safety that is equivalent to that of the 
United States. Also, the FDA should take note of the detection 
by other major importing countries of contaminants in food so 
that the FDA can focus its enforcement effort. For the health 
of our consumers, for the integrity of our Nation's food supply 
I ask you, members of this committee, to enact meaningful FDA 
reform. The FDA has promised before that it can change on its 
own, but the evidence demonstrates just how dangerous the FDA's 
broken promises have become. Thank you.
    [The prepared statement of Mr. Williams follows:]
    
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    Mr.Stupak. Thank you, Mr. Williams.
    Mr. Marler, opening statement, please, sir.

  STATEMENT OF WILLIAM D. MARLER, ESQUIRE, MARLER CLARK LLP PS

    Mr.Marler. Thank you.
    Chairman and members of the committee, my name is Bill 
Marler. I am a trial lawyer. My law firm Marler Clark located 
in Seattle, Washington specialized in representing victims of 
food borne illness. Unfortunately for my clients and many of 
the corporations that are going to come after me, I have been 
in business too long. I thank you for the honor of being 
allowed to testify before this committee. I am proud of the 
work this committee has done to try to improve food safety 
throughout the United States.
    Although I have never had the honor to testify before 
Congress, I have had the honor to be here before in 1994 for 
Senate hearings about the lack of safety in our food supply. At 
that time I was with Brianne Kiner, then 9 years old, who spent 
6 months hospitalized, suffered acute kidney failure and 
multiple strokes, had her large intestine removed, was in a 
coma for over a month, and spent 100 days on dialysis, all from 
eating a hamburger. Thirteen years later I was here again in 
April of this year. This time with Ashley and Isabella 
Armstrong, who I think the committee would all agree were the 
cutest kids you have ever seen before any committee. Victims of 
the more recent spinach outbreak that sickened 205, killing 
five. I was with Sean Pruden, the victim of the E. coli 
outbreak at Taco Bell, that sickened over 100, and with Terry 
Marshall, whose mother-in-law has remained in a nursing home to 
this day after eating a few spoonfuls of salmonella tainted 
peanut butter. Since 1993 I have had the privilege to represent 
thousands of Americans, some your constituents. In 2002, during 
the middle of yet another E. coli outbreak, during the middle 
of another visit to an ICU to watch a new client struggle for 
life, attached to more tubes than you can imagine, I penned--
for the Denver Post. Here's part of it.
    This summer scores of Americans, most of them small 
children and senior citizens, have already or will become 
deathly ill after eating ground beef boldly labeled USDA 
approved. The now infamous outbreak started with a few sick 
kids in Colorado and quickly spread coast to coast, eventually 
triggering the recall of 19 million pounds of ground beef 
tainted with E. coli 0157H7. Because their parents trusted our 
government's food inspections several kids suffered kidney 
failure and dialysis, or weeks hooked up to all sorts of 
machines. For some the long-term prognosis is grim with the 
risk of further kidney failure, dialysis, transplants or worse. 
Most of these kids' parents' have hired me to help them get 
compensation for hundreds of thousands of dollars in medical 
costs, and the risk of future kidney failure. That may prompt 
some readers to consider me a blood sucking ambulance chaser 
who exploits other people's personal tragedies. If that is the 
case, here is my plea. Put me out of business. For this trial 
lawyer, E. coli has been a far too successful practice and a 
heartbreaking one. I am tired of visiting with horribly sick 
kids who did not have to be sick in the first place. I am 
outraged with the food industry that allows E. coli and other 
poisons to reach consumers and a President, Congress and 
federal regulatory system that does nothing about it. Stop 
making kids sick and I will happily move on. That, ladies and 
gentlemen, was in 2002. The time has finally come to put me out 
of business. The CDC estimates that there are still 76 million 
Americans getting sick every year, each and every year, from 
eating food. That means one in four Americans will contract a 
food borne illness every year. Hundreds of thousands will be 
hospitalized and thousands will die. That is the human 
suffering part. There is also a business part. Billions of 
dollars will be spent on medical treatment and many more 
billions will be in lost wages, in recall costs, in the sale of 
food and yes, in legal fees to defend and prosecute these 
companies. Civil litigation in America is a blunt instrument 
for change. It is better for the government and business to 
work together to eliminate the need for lawsuits and lawyers. 
When American business poisons its customers and when our 
regulatory agencies do not have the manpower, willingness, or 
ability to help businesses perform, people die and market share 
is lost nationally and internationally. It is time to help 
business and consumers to simply make me unnecessary. If you 
fix the food safety system trial lawyers like me will become a 
small irrelevant footnote in history, but you will be 
remembered and honored for helping to fix a broken system.
    The issue of food safety is not new, of course. A century 
ago Upton Sinclair's book The Jungle exposed both contamination 
of meat processing and corruption that led inspectors to look 
the other way. What has changed since Upton Sinclair's time? 
Are we better off than we were 100 years ago? A year ago I was 
asked by the spinach and lettuce growers of California to 
address them in Salinas. Considering that by then the leafy 
green industry was on its knees financially and I had lawsuits 
pending in several states, it was a bit of a tense lunch. Why 
was I invited? I am frankly still not sure, but why I was suing 
them was all too clear. In the prior 10 years there had been 21 
outbreaks related to fresh leafy products with hundreds 
sickened. In 2006 hundreds became sick and five died from 
eating E. coli contaminated spinach, followed quickly by 
lettuce outbreaks at Taco Bell and Taco John. The common 
denominator, California lettuce and spinach and more lawsuits. 
Mexico banned the importation of California spinach and 
lettuce. I told the quiet audience of growers and producers a 
story that I believe at the time to be true. I told them I had 
seen, since the 1993 Jack-In-The-Box case, I told them what 
seemed to have happened after the Jack-In-The-Box crisis was 
the incidence of E. coli seemed to decline. In fact, the CDC 
indicated by the year 2006 that E. coli cases tied to ground 
beef had gone down by 42 percent. I told them that they should 
immulate what the beef industry did. That the beef industry had 
worked hard to put me out of business. And the reason I can say 
that is because during that 2003 to early 2007 I had no 
ambulances to chase because I simply had no E. coli victims 
tied to E. coli--not tied to hamburger. And in the spring of 
2007 started with an ominous uptick in E. coli recalls and 
illnesses, and ended with hundreds sickened, 33 million pounds 
of meat recalled. And guess what? More sick and dead children. 
And guess what? More lawsuits. China banned the import of U.S. 
beef. And if you ask the USDA and industry to explain this 
uptick, they have none. It is unacceptable.
    Although things are certainly different from Upton 
Sinclair's time there are some big similarities, and certainly 
some things that are new and different challenges. First, there 
is a terrorist threat to our food system. Just as too many 
could not imagine the horror in 9/11, too many cannot envision 
the kind of food disaster today. When a terrorist attacks our 
food system it will look eerily similar to any other outbreaks 
of food borne illness. Second is the growth of imports. 
Sinclair could not have imagined a world where the meat that 
may be in one hamburger could originate in Argentina, Canada 
and Colorado, or that we would have vegetables year round from 
South America, Asia and Africa. It is with these two enormous 
issues in mind I offer five suggestions of how to finally put 
me out of business.
    First, create a local, state and national public health 
system that catches outbreaks before they balloon into personal 
and business catastrophe. CDC pulsejet and food net, as one of 
the members mentioned, were launched after the Jack-In-The-Box 
outbreak and are rightly credited for helping reduce the size 
of outbreaks by helping more quickly conclude the suspect 
product was causing harm. But surveillance of human bacterial 
and viral disease is lacking. For many food borne illnesses, 
for every culture-positive case 20 to 50 other cases are missed 
because of lack of surveillance. Most people who become ill 
with a bacterial viral disease are either seldom seen or never 
cultured. The more people are tested, the greater the 
likelihood that a source, accidental or not, will be found 
sooner.
    Second, actually inspect and sample food before it is 
consumed. At present local and state authorities, along with 
the USDA and FDA, employ thousands of inspectors across the 
nation and world to inspect tens of thousands of plants that 
produce billions of pounds of food. The GEO has warned that our 
food sampling and inspection system is so scattered and 
infrequent there is little chance of detecting microscopic E. 
coli, or other pathogens for that matter.
    Third, consider mandatory recall authority on all food 
products. Recalls must be completed transparent. If a recall is 
ordered consumers need to know what in fact is being recalled. 
Full disclosure must be the rule. Under the present system of 
voluntary recalls, last September we saw the disastrous Tops 
recall, where the company knowingly left E. coli contaminated 
product on store shelves weeks after being confronted with an 
ill customer, and his product both testing positive for E. 
coli.
    Fourth, merge and then adequately fund the three federal 
agencies responsible for food safety. Right now USDA and FDA 
share this mission with the CDC. The system is, in a sense, 
trifurcated, which leads to turf wars and split 
responsibilities. We need one independent agency that deals 
with food borne pathogens. You have a moral responsibility to 
consumers in your home town or anywhere U.S. goods are sold. It 
is time to adequately fund our health and safety authorities to 
help businesses protect the consumers.
    Finally, we cannot completely regulate ourselves out of 
this. Standards need to be set with the entire food chain at 
the table, from farmer to manufacturer to retailer and 
customer. Standards must also be based upon good science. We 
must invest in solid research at our land grant institutions to 
help producers manufacture food that is safe, nutritious, and 
the envy of the world.
    Thank you very much.
    [The prepared statement of Mr. Marler follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Mr.Stupak. Thank you.
    We will begin with questions. Members will have 5 minutes 
for questions.
    Dr. Greger, if I may start with you. In your investigation 
at the Westland/Hallmark, did you investigator ever observe the 
company alerting USDA inspections or inspectors of the cattle 
that went down after the 6:30, and I think you said, 12:30 
inspection?
    Dr.Greger. Never. The investigator did not witness it or 
hear anyone talking about getting the inspector back to look at 
these animals that had subsequently gone down after antemortem 
inspection.
    Mr.Stupak. And I take it from the video the person who did 
the video here was fairly close to what was going on in order 
to make those--that video.
    Dr.Greger. The investigator is what was called a pen 
worker, essentially doing exactly that. Unloading these 
animals, getting them through the pens, and finally into the 
kill chute.
    Mr.Stupak. OK. Let me ask this, because it came up in the 
opening statements. If your investigator was at the plant in, I 
believe you said the Fall of 2007, why didn't the Humane 
Society notify USDA, the School Lunch Program, about what was 
happening at the plant before the end of January?
    Dr.Greger. This investigation took over 2 months to 
complete. It was shot--he worked at the plant in October, 
November. We gave this evidence over to the local district 
attorney's office the San Bernardino County district attorney, 
and they asked us not to publicly release this information. To 
hold off so they could carry out their own criminal 
investigation into the animal cruelty that was witnessed. We 
complied with that request, but by January, after a month had 
occurred, we felt we had to go ahead, and so we indeed 
contacted USDA and then made it public. But the fact that 
downers were being slaughtered for human consumption, this is 
something that is allowed under the 2007 USDA loophole, and 
something that the USDA's own inspector general found was 
happening across the country.
    Mr.Stupak. I was going to ask you to explain that a little 
bit more, the rule of antemortem inspections of downer cattle. 
As long as the--when the inspector looks at it and/or sees the 
animal, and if the animal is standing it can be used for 
slaughter. If the inspector leaves, it falls over, it can still 
be used for slaughter?
    Dr.Greger. Let me----
    Mr.Stupak. Or human consumption?
    Dr.Greger. Let me kind of explain the chronology of this 
loophole. In 2000 USDA declared that they would not be using 
beef from downed animals. Evidently agreeing that this meat was 
too risky to be fed to kids at school, but evidently not too 
risky to feed the kids once they get home from school, or to 
adults for that matter. We have for years been pushing for a 
complete downer ban, but it took a case of mad cow disease in 
the United States, December 23, 2003, before finally, then 
Secretary Veneman, within a week, said we will have no downer 
animals, downer cattle being allowed into the American food 
supply, no exceptions. And a week after that they published 
their interim final rule in the federal register, January 12, 
2004, again no downers, no exceptions. And then even after, in 
2006, when the Inspector General published their critique 
saying that downed animals were, indeed, going to the food 
supply. In July 2007 when this rule was finalized, instead of 
strengthening the rule, realizing that there wasn't proper 
enforcement, they critically weakened the rule codifying in a 
loophole, which allowed for animals that went down after 
antemortem inspection to on a case by case basis with the 
inspector's approval be allowed into the American food supply. 
So, you know, live cows can be fed to people, dead cows can 
only go to pet food or animal feed: pigs, pets and poultry. But 
you get more per pound if the animal can, indeed, enter the 
National School Lunch Program, then can be just going to canned 
pet food. And so if downed animals were indeed lumped in as 
they should be with dead animals and only fed to pets, for 
example, then if a downed animal arrives on a truck, just like 
when a dead animal arrives on a truck they would be thrown--
they would be euthanized and thrown on the dead pile. There's 
no incentive for the workers to kind of prolong their misery. 
But if some downed animals may--if there is a loophole that is 
saying some downed animals may indeed be passed for inspection 
into the food supply, then you see the financial incentive for 
the workers to, basically by any means necessary, force these 
animals up to walk back and forth in front of the inspector. 
And that knowing full well if the animal goes down after 
inspection then the inspector can pass that downed animal into 
the food supply. Even if the animal is down and completely non-
ambulatory, and even if it appears that this cow was just down 
because they broke a leg, an animal shouldn't just break a leg 
at slaughter plant. Either this animal is mishandled or maybe 
the animal was sick, you know, confused, unsteady gait, and 
that is why they fell down. That is why Linda Detwiler, the 
head of the BSE Surveillance, the previous head of the USDA BSE 
Surveillance Program, has explicitly written to the USDA saying 
that injury and illness are interrelated. If a cow is down, if 
a cow cannot walk to the kill box it should not be slaughtered 
for human consumption. OK.
    Mr.Stupak. My time is up and I still had questions for Mr. 
Williams and Mr. Marler, but we are going to move right on. We 
will go for a second round, and I am going to try to keep 
members to five minutes, because I know you are bouncing back 
and forth between the different hearings.
    Mr. Shimkus, for questions.
    Mr.Shimkus. Thank you, Mr. Chairman. This is, again, a very 
important day and very frustrating, very sad. So some 
interesting points have been raised and what we want to follow 
up on is--Mr. Marler, first of all, I appreciate that work you 
have done, and your testimony is pretty interesting because--
and I have dealt with the trial bar quite a bit. And, you know, 
I have a lot of friends. I am from southwestern Illinois, 
Madison County, St. Clair County. Friends, but not always 
allies in the debate. I mean they always remind me of, you 
know, what the vast majority are trying to do is, you know, is 
take up the cause for those who can't fight for themselves. And 
I think your record has been one of doing that. But you also, 
in your testimony, you also make some interesting statements 
about how instead of the punitive adversarial relationship, 
that if we really want to get to a place where, I think, we all 
want to be regardless of what side of the dais we sit on. That 
is a credible food safety environment where when, you know, it 
is easier for our female members to talk about going to the 
grocery store, talk about feeding their children. Men are less 
compassionate, you know, neanderthal sometimes.
    Ms.DeGette. Excuse me. But you don't go to the grocery 
store?
    Mr.Shimkus. I do. I'm a Jif guy though, OK, and a Banquet 
Pot Pie guy, so I am limited in my purchases. The--but talk 
about this relationship about government regulation and 
corporate responsibility and how in working together. One of 
your comments talks about how--the two things I want to focus 
upon is that, and also the scientific research dollars that you 
identify is kind of outside this whole purview. Because it 
talks about the formation of pathogens, how they migrate and 
how, you know, that is something that we may or may not be 
doing that good of a job then. Can you address those two?
    Mr.Marler. You know, in 15 years of taking the depositions 
of, you know, many corporate leaders and workers very few of 
them have I ever come away with a sense that they did it on 
purpose. Mistakes happen, failure in their system happen. These 
bugs are different. You know, in 1982 0157H7 didn't even exist 
as a known pathogen. Many of the rules and regulations that 
USDA goes by, you know, go back into the '50s and '40s and 
'30s. They haven't caught up to somehow some of these pathogens 
change. I think putting more money in research dollars in our 
land grant institutions to figure out--and you'll hear this 
from the corporations that follow me. Some of the outbreaks, 
they don't even know how they happen. And, you know, to be 
honest with you I don't even know how they happened. And a lot 
of times in the litigation we explore the edges or sort of the 
dirty edges of that. But the reality is that U.S. corporations, 
it is bad for business to poison consumers. And to the extent 
where, I think, government can be most helpful is not to try to 
look for punitive action against corporations, but is really to 
be sort of a--to work with them both in the research area. And 
then to set aside good science based regulations that help 
these corporations do the thing that they really want to do, 
which is ultimately the right thing.
    And I, you know, granted if you did those things you 
wouldn't have a kind of trial bar, because we would have to go 
with something else.
    Mr.Shimkus. Thank you. And Dr. Greger, I want to follow up 
with my remaining time and appreciate what you have done. That 
is very frustrating. From southern Illinois, a rural area, 
beef, pork producing area, corn, soy beans, livestock of all 
sorts, it is, I mean it is the same business types. And you 
look at the time, effort and energy that is going on with these 
individuals who try to move these downer cows, and you think 
about real time processing you think they are losing time. I 
mean the time and effort to move these instead of just 
segregating them, getting them through the process.
    So I want to follow up on just one of the reports that you 
cite, which is the audit report from January 2006. Dr. Greger, 
you claim that the slaughter of downed cattle is a widespread 
problem. That 29 were put to slaughter, however, in this report 
that you rely for this information, and it indicates that only 
2 of the 12 plants inspected allowed downer cattle to be 
slaughtered. To me that would, you know--here is a little chart 
right here. We want to go after bad actors. I mean we really 
want to make sure that people who are abusing the system, the 
available laws, the rules and regulations for whatever reasons, 
that they are held accountable to the fullest extent of the 
law. Especially in the report--the film, you keep highlighting 
California law, you know, this is going on. The law is being 
broken. And this report highlights two processors, but then it 
also highlights the other 12--10 that are in compliance. So I 
guess our question will be focus in on the bad actors and 
making sure that those who we think are good actors remain 
good. But is it a systematic world problem of this country, or 
is it a problem of a few bad actors that we need to be 
concerned about?
    Dr.Greger. It is a problem with these dairy cow slaughter 
plants. And that is what the IG report found, and that is what 
we found at this plant. This was essentially, what we found out 
later, a magnet plant for what are called ``spent'' dairy cows. 
Dairy cows under current production only last about 4 years 
before being kind of ground to hamburger. So this plant brought 
downer cows from states surrounding California to this plant. 
In fact, between 90 and 95 percent of the cows at this plant 
were dairy cattle, not beef cattle. And it is these--and USDA 
estimates, perhaps, 295,000 downed cattle every year. It is 
probably more, maybe half a million is the latest estimate. But 
these are predominately dairy cattle at the end of production 
who are spent, who may have metabolic problems, who may have 
mastitis, infections of the utters, who may be lame for other 
reasons who are transported long distances to get to these 
plants. If we had a complete downer ban, if these cows--if it 
wasn't worth transporting these animals, then presumably they 
would be euthanized on the farm. And even better there would be 
an incentive for producers to prevent these animals going down 
in the first place by providing adequate bedding. Up to 90 
percent--for example, according to Dr. Grandin, a livestock 
consultant, up to 90 percent of downers are preventable. And so 
if you can't get money from a downer cow then there won't be 
this incentive to continue to send them and process them.
    Mr.Shimkus. OK. Thank you, Mr. Chairman.
    Mr.Stupak. Mr. Doyle, for questions, please.
    Mr.Doyle. Thank you, Mr. Chairman. I just have a couple 
questions.
    I am really intrigued by this financial incentive. It makes 
a lot of sense to me to ban downer cows. I am trying to 
understand. When you saw that video and these workers spending 
all that time and effort to get these cows to stand up--I don't 
know much about the slaughter business. What is that--I mean is 
there a financial incentive to those workers? Are they somehow 
paid on how many--to go through that extra effort to shock and 
forklift and roll and do all that stuff we saw on the film. And 
where does that financial incentive sit? At the supervisor's 
level? I mean do these workers have some financial interest in 
getting those cows to stand up?
    Dr.Greger. Well, finally the criminal testimony has been 
published from the San Bernardino district attorney's office. 
The Chino police did the investigation, and we actually have 
the kind of written transcript. And these workers claim that 
this was a company policy. That they were under pressure from 
supervisors to get these cows into the slaughter plant. Again, 
if they are irreparably down then they may have to just be 
thrown on the dead pile, and not get those kind of extra 
pennies per pound that they would be if they were allowed into 
human consumption. And so they claim that they were just kind 
of being pressured from above. But if you see more extended--I 
mean there are hours of videotape. You can see some of the 
online workers coming out, you know, because the line is 
stopped because there is a cow actually downed in the kill 
shoot. And so we have footage where they are shocking animals, 
actually getting cows to trample over downed cows to get into 
the kill box. And so when you have an animal that is actually 
down in these very narrow pens it may actually stop the line 
completely. And so they are coming out saying, what's the 
holdup? And so tremendous amount of human resources is used. 
And the only thing I can imagine is, this industry has kind of 
a razor thin profit margin and that losing literally hundreds 
of pounds of beef, even though some of these dairy cattle were 
quite skinny. I mean potentially losing all that weight and you 
would hear comments from supervisors saying this cow is too big 
to be down, because there is weight there that could be sold.
    Mr.Doyle. Well, what is troubling is the pressure seems to 
be coming from the top. So it is more a culture in that 
particular corporation at least, which says, you know, we are 
going to get as many cows into that kill box as we can 
regardless what condition they are in. It seems rather 
troubling that that philosophy is going up higher than just at 
some lower lever. What is the percentage? I am just trying to 
understand to downer cattle to the total that go into the kill 
box. What are we talking about in terms of lost, you know, 
production?
    Dr.Greger. Because of the kind of unique cattle population 
that was going to this plant, and similar plants like it across 
the country, our investigator witnessed literally downed cattle 
every day coming off trucks.
    Mr.Doyle. Ten percent, 20?
    Dr.Greger. He said that typically on a truck there would be 
at least one downed cattle per truck.
    Mr.Doyle. And how many cows on a truck?
    Dr.Greger. And so 30, 35 animals coming down. And so now 
this plant slaughtered 500 cows a day. Had the capacity to hold 
about 1,000, so there was this constant, you know, trying to 
move these animals through the system, and as you can see, just 
extraordinary methods used to try to kind of squeeze every last 
penny out of these decrepit animals.
    Mr.Doyle. Well, it seems to me if you change the financial 
incentive to keeping cows being able to stand by treating them 
better. You know, if that is the incentive that seems a much 
better way to save money to increase production and certainly 
is a much more humane way to deal with the situation. And maybe 
that is one of the things we should be looking at. How do we 
create an incentive to do it the right way instead of to do it 
the wrong way?
    Mr. Marler, I just have less than a minute. I just have two 
questions. You said in your testimony between 2003 and 2006 
that E. coli outbreaks linked to tainted meat had declined 
dramatically. But since last year there has been this uptick in 
E. coli illnesses and recalls again. Why do you think this is 
the case and what can companies or the government do to reverse 
the trend? I mean why do we get--it looked like we got it right 
for three years and all of the sudden it seems we are headed in 
the wrong direction?
    Mr.Marler. I think probably unfortunately, my answer might 
require a full committee hearing on that. And I think there 
really is a need for a committee hearing on that particular 
issue. I think if you reach out to the industry and to USDA 
they won't really have a great answer, but I think I can give 
you at least--I have reached out to industry. I have reached 
out to academics, and I think there are a couple of things that 
are going on. One is that back in 2006 INS rated a lot of 
slaughter plants throughout the United States, and a lot of 
really highly qualified, but illegal workers, were forced out 
of their jobs. And a lot of unqualified, but legal workers, got 
into their jobs. So that was happening in late 2006. At the 
same time with the increased gas prices, oil prices, there is 
more ethanol being used in the system. There is a lot of 
collocation of ethanol plants with feed lots. There are some 
studies that have come out of Kansas State University that show 
that cattle fed the by-product of ethanol production, 
distillers grain, have a higher quantity of E. coli 0157H7 in 
their guts than normal cows. So I think you have a number of 
things happening simultaneously. You have less qualified 
workers, more E. coli coming into the system, and then I think 
there is an aspect of just, you know, frankly that some of 
these companies I think became complacent. It had gone so well 
for so long. But I can tell you that I have never had more 
severely injured children in my office in 2007 than I have had 
since 2002. So something is really wrong. Somebody needs to get 
to the heart of it. I am not a scientist, but those are some of 
the things that I have seen that I think you have to look at.
    Mr.Doyle. Thank you. Thank you, Mr. Chairman. I see my time 
is up.
    Mr.Stupak. Thank you, Mr. Doyle. Mr. Walden, questions.
    Mr.Walden. Thank you, Mr. Chairman, and thank you for 
holding this hearing. I think all of us are concerned about our 
food safety in America, especially as we see the rise of 
imports coming in, and so I appreciate the testimony of all the 
witnesses.
    I am troubled, though, as a parent of somebody who is in 
public school in Oregon in the northwest. I don't know if the 
beef from this plant made it into the food chain there, but I 
assume some of it probably did. And I remember when we had the 
hearings on Ketek here, which is a drug, there was a lot of 
concern about the fact that the FDA sort of put criminal 
investigations ahead of patient safety. And I feel a similarity 
here that, perhaps, the Humane Society didn't do that, perhaps 
did, but maybe in coordination with San Bernardino. Did you say 
the sheriff's office don't tell----
    Dr.Greger. The district attorney's office.
    Mr.Walden. So the district attorney of San Bernardino 
County told you don't tell USDA there is a food problem here?
    Dr.Greger. They told us to wait on any kind of public 
release of this information.
    Mr.Walden. Is that different than notifying USDA?
    Dr.Greger. Frankly, the reason we did not go to USDA first 
is because USDA has a history of not responding to----
    Mr.Walden. But I want to get to the point here. So the 
district attorney didn't tell you not to go to USDA. They just 
said don't make the video public or--is that right?
    Dr.Greger. They asked us----
    Mr.Walden. Because I would like to know for the DA, Mr. 
Chairman, if--well, I guess Mr. Chairman's magically 
disappeared. But is that what happened?
    Dr.Greger. They asked us to hold onto the information while 
they completed their investigation and----
    Mr.Walden. Did they notify USDA?
    Dr.Greger. I am not aware.
    Mr.Walden. Well, it just strikes me. Here we have got the 
largest beef recall in American history. I think that is 
correct, 143 million pounds. Secretary Schafer felt that it was 
a big enough issue to recall it all, even though most of it now 
has been consumed. So while kids are eating this meat that may 
or may not be bad, certainly slaughter conditions were 
unacceptable, and mostly illegal I think under USDA rules. 
Nobody--so you didn't tell USDA, the district attorney didn't 
tell USDA. So even if in the past USDA's been bad about doing 
recalls on a timely basis, they didn't even know in this case?
    Dr.Greger. Well, in fact this plant's behavior had been 
brought----
    Mr.Walden. Right.
    Dr.Greger [continuing]. To USDA multiple times.
    Mr.Walden. A couple of times. I have read that.
    Dr.Greger. And evidently they--nothing was done.
    Mr.Walden. But you had evidence something was wrong on 
tape, right?
    Dr.Greger. Well, evidence from the Pomona Valley Humane 
Society--and SPCA, they also had evidence, which they provided 
to the USDA. This was back in 1996, 1997.
    Mr.Walden. No. But I mean in this case?
    Dr.Greger. Yes.
    Mr.Walden. You had your Humane Society here or locally had 
the video----
    Dr.Greger. Yes.
    Mr.Walden [continuing]. Evidence. But that never got to 
USDA until after the district attorney--or in January. You 
waited a couple of months.
    Dr.Greger. Until January, and we contacted the USDA before 
releasing it.
    Mr.Walden. Let me ask you this. And I wish--I know our 
jurisdiction doesn't go out to USDA, so I guess that is why we 
don't have a witness here. But it seems to me that part of the 
fault clearly is the faults with the company. I mean at least 
from--allegedly with the companies who are all not getting sued 
by trial attorneys for, you know, whatever. But clearly USDA, 
it seems to me, didn't do their job in the plant. Are they not 
supposed to have inspectors there throughout this entire 
process observing? And, Mr. Marler, you have got to be an 
expert on this, and you have done great work for injured kids 
and families, and I applaud you for that. But isn't USDA 
supposed to have an inspector watching as the cattle are 
unloaded?
    Mr.Marler. The short answer is yes, but you have also seen 
in the last--just last week about the lack of inspectors, the 
numbers of inspectors, I think.
    Mr.Walden. Right.
    Mr.Marler. There is a shortage and----
    Mr.Walden. What we get at is, because some of what has 
occurred and Dr. Greger you may insight it as a good service to 
the public by exposing this problem. But part of what has 
occurred in each of these has already violated existing rules 
and regulations. I think----
    Dr.Greger. Right.
    Mr.Walden [continuing]. Mr. Marler, you said we can't 
regulate our way out of this. How do we get it so we can trust 
our food supply? I mean I am just about----
    Mr.Marler. I think the answer is the economic incentive. 
You have got to figure out the economic disincentive to shove 
these cows through the system. And whether that is a complete 
ban on downer cows, a way of, you know, figuring out some sort 
of tax credit to get rid of the cows humanely. There are 
certain things to do. With respect to inspectors one of the 
things I think that needs to be discussed is whether or not 
more inspectors are necessary.
    Mr.Walden. Right.
    Mr.Marler. Whether or not some of the new technologies that 
are available, both in testing and video cameras and all of 
that, would be available and useful as we all face, you know, 
difficulties with tax dollars.
    Mr.Walden. And one other question just for my own sake. Was 
the meat--do you feel that the meat that was recalled posed a 
health risk to those who consumed it? Have you had a chance to 
look at that?
    Mr.Marler. Let me say that I think that this recall, 
although the video is shocking----
    Mr.Walden. Yes.
    Mr.Marler [continuing]. There are no ill people.
    Mr.Walden. Right.
    Mr.Marler. And the risk of BSE is so exceedingly low in 
this instance that I sort of feel that we could use these 
resources that we are spending on this recall and the amount of 
meat that is being recalled. And now it is being expanded into 
products that might have some trace element of this meat. I 
think we could probably spend those resources wisely in other 
areas.
    Mr.Walden. All right. My time has expired. I really 
appreciate your work in these areas. Thank you, Mr. Chairman.
    Mr.Stupak. Thank you. Ms. DeGette for questions.
    Ms.DeGette. Thank you, Mr. Chairman. You know, part of the 
reason we have to do these recalls on such a broad level like 
this one is because we don't really have traceability with our 
meat supply. Is that correct, Dr. Greger?
    Dr.Greger. We----
    Ms.DeGette. I mean we can't trace back which lots of meat 
may have contained the meat from those downed cows that we saw 
on the video, right?
    Dr.Greger. My colleague, Mr. Marler, is probably best able 
to answer that question in terms of the traceability and in 
terms of the kind of proprietary----
    Ms.DeGette. Yes.
    Dr.Greger [continuing]. Of this data. I mean----
    Ms.DeGette. But I am correct, right, Mr. Marler?
    Mr.Marler. Correct.
    Ms.DeGette. And so if you can't trace which exact lots 
these downed cows were in you have to have these broad recalls. 
That is another piece of legislation I have got, the Trace Act, 
that I am doing with Congresswoman DeLauro. Because we feel 
like when Mr. Shimkus goes to the grocery store because his 
wife sent him and he buys a package of hamburger he can't 
tell--and this is part of the problem we have with these 
recalls. He can't tell if he goes to you because his kid gets 
sick and you, his lawyer, look at the package that the meat 
came from we can't trace that back to what lots that came from. 
So we don't know if those lots contained those downed cows, 
correct?
    Mr.Marler. For the most part that is true.
    Ms.DeGette. Now you have done a lot of litigation around 
food safety, and you know that there are some manufacturers 
actually do have traceability, correct?
    Mr.Marler. Correct.
    Ms.DeGette. So we could actually technologically do it with 
meat, right?
    Mr.Marler. My friends at Dole now have instituted some of 
the most far reaching traceability on their lettuce.
    Ms.DeGette. And we have heard from them in some of these--
--
    Mr.Marler. Right.
    Ms.DeGette [continuing]. Hearings. They do have great 
traceability and that would help. That would both help 
consumers have more confidence, but it would also help industry 
not have to do these massive recalls. And yet unbelievably, Mr. 
Marler, every time I bring industry in to talk with me about 
traceability they oppose it. You don't even have to respond to 
that. You were talking earlier about economic incentives, and I 
completely agree with that, which is why I think mandatory 
recall is also a good idea. Let me talk for a minute about 
the--one of the things you talked about in your testimony was 
the Tops beef recall from last year, and how E. coli 
contaminated products were on the shelves for three weeks. Why 
do you think it took Tops so long to recall that beef?
    Mr.Marler. Well, it was a combination really of Tops and 
the USDA working or not working in concert. There was an ill 
child in Florida that tested positive in her stool for E. coli 
0157H7. Meat in her freezer tested positive for E. coli 0157H7. 
It was a genetic match, but the USDA had a rule at the time. 
They no longer have that rule. The rule at the time was that 
if, if the meat came from an opened box of--and this was 
preformed patties----
    Ms.DeGette. Right.
    Mr.Marler [continuing]. With plastic covers. If it came 
from an open box they would not institute a recall.
    Ms.DeGette. OK.
    Mr.Marler. But what happened was they waited. They waited 
weeks until more victims piled up, and that is when the recall 
happened.
    Ms.DeGette. Yeah. Well, OK. So in the ConAgra peanut butter 
recall this is what happened. There was a couple of years, I 
think 2004, there was a whistle blower complaint about the 
peanut butter contamination at the ConAgra plant in Georgia. 
And so the FDA investigators went in to check it out, and they 
asked ConAgra to give them some documentation, and ConAgra said 
no. Because not only do we not mandatory recall, we don't have 
apparently mandatory document production unless they have got 
you to subpoena them or us----
    Mr.Marler. But they have given those documents.
    Ms.DeGette. Well, yes, they have. Because you know why? We 
had a congressional hearing then in this subcommittee and low, 
right before the subcommittee hearing ConAgra changed its 
policy and they did give over the document. Well, then what 
happened was they actually had complaints and they had a 
shutdown in 2006, I believe, of the plant from the contaminated 
peanut butter. But so all of this time you have the complaint, 
then you have this kind of gray area where people are going 
back and forth, then finally you actually get people sickened. 
Then you finally shut--you had the CDC shut the plant down. 
That was several years later. My view all along has been that 
if you had the USDA and the FDA with authority to do mandatory 
recall with hope you wouldn't have to use that very much. That 
just the threat of a mandatory recall, economically, would make 
the producers act much more quickly on a voluntary basis. What 
is your view on that?
    Mr.Marler. I think mandatory recall is in a sense what 
everybody believes happens. Everybody in the--if you go out to 
some of the----
    Ms.DeGette. Just what I said in my opening statement.
    Mr.Marler. Exactly. Everybody believes it, but it is not 
really the case. In 15 years of representing victims I can tell 
you unequivocally that there have only been a handful of cases 
where companies did not quickly do the recall when confronted 
with the facts. It is--so most companies, in fact----
    Ms.DeGette. OK.
    Mr.Marler [continuing]. Ninety-five percent of all 
companies will act responsibly. Whether or not the government 
wants to take on that responsibility of mandatory recall is 
something, I think, frankly the government has to think about 
pretty hard.
    Ms.DeGette. Thanks.
    Mr.Stupak. Mr. Burgess, for questions.
    Mr.Burgess. Thank you. Mr. Marler, can we just continue on 
that thought for a second, because this comes up too with the 
Consumer Product Safety Commission. Another subcommittee where 
this statement or the philosophical approach that the voluntary 
recall is, perhaps, the more nimble or agile way to go about 
getting an unsafe product off the shelf. Because as you just 
pointed out the companies are themselves anxious if there is 
what--I got to believe if I am faced with the possibility of a 
mandatory recall, are you swearing out of rit, that I will be 
more frightened of the rit that you swear out than I would be 
of the USDA or the FDA issuing a mandatory recall. So if I am a 
company and I am told that there is going to be--the likelihood 
of voluntary recall I go to take that very, very seriously, I 
think, because of the blunt instrument that you wield out 
there. Is that--in the food safety arena is there any parallel 
with the consumer product area where they say we can be more 
nimble and more quick with a voluntary recall, rather than 
going to mandatory route where now we have got to--someone has 
got to hire counsel. We have got to go in front of an 
administrative law judge to get this thing proved up. Where it 
is going to take weeks to get that done, and where as a 
voluntary recall can be done within days. Is that a fair 
statement?
    Mr.Marler. I think there is a place for where government 
investigators and government regulators and companies can find 
sort of a happy medium on having the stick of mandatory recall, 
but the opportunity for a voluntary recall. And in an essence, 
that is what I think for the most part in the food industry 
that is what happens. There is sort of a----
    Mr.Burgess. I think so too.
    Mr.Marler. And so I think it is one of those sort of things 
that, I think, that there are some issues, especially with 
respect to bioterrorism. I think those are some things that I 
think we have to have a fallback position. The government can 
ultimately have that responsibility to pull product off the 
shelf.
    Mr.Burgess. And I can't help myself. I have got to ask you 
this question. When you had that lunch with the spinach growers 
what did they serve you?
    Mr.Marler. We had spinach salad and spinach and chicken. I 
actually--there were about 50 more photographers here in front 
of me watching to see whether or not I ate the spinach. And I 
have to tell you I did and it was delicious.
    Mr.Burgess. All right. Well, good. Again, I couldn't help 
myself. I just had to know. Now, on this issue that is before 
us this morning with the issue of the Humane Society brought to 
the floor is--if this had been E. coli in this meat in October 
would the justification of waiting until the DA had his ducks 
in a row, would that be something that you would have seen as a 
positive response to a crisis this order of magnitude?
    Mr.Marler. Well, I think the fact of the matter is that E. 
coli 0157 is an--and under the USDA food code. And so any time 
a product has 0157H7, as long as it is hamburger, there are 
some quirks in the law that allow E. coli 0157H7 to be on other 
meat products. And that is another thing the hearing probably 
should be about. But the fact of the matter is that if, in 
fact, there was a 0157H7 positive it would have been recalled, 
and so there wouldn't have been a lag. And so I----
    Mr.Burgess. Well, I guess what I am getting at is the issue 
of scaling. I mean an E. coli contaminate, people on dialysis, 
people in the ICU. BSE, nobody gets sick----
    Mr.Marler. Right.
    Mr.Burgess [continuing]. Except for three people and there 
is an issue of scale there. And I guess what concerns me, Dr. 
Greger, is, you know, you didn't want to go public with it 
because the DA wasn't ready. But you don't have to go public to 
go to the USDA. I mean you could do that confidentially, can 
you not?
    Dr.Greger. We have had experience with the USDA not 
following up on animal cruelty charges, even when they have 
potential public health implications. It wasn't illegal to 
process downed animals. It is illegal to not tell the inspector 
about it after antemortem. It is illegal to treat the animals 
like we saw. These were criminal charges, so we went to the 
state and local authorities, which did the criminal 
investigation.
    Mr.Burgess. But at the same time there was a public health 
issue where, in your opinion, some of these were downer cows 
that should never have made their way into the stream of 
commerce for school lunches. And, I guess, what is really 
bothering me is that gap of time where all these lunches are 
served in November, December and January, and the product is 
consumed. If you are concerned about the public health aspect, 
even though the incidents of BSE is far less than if you truly 
had an outbreak of something as devastating as E. coli, but 
still if you are concerned about that why not do something? I 
mean it seems like the USDA could handle that confidentially 
where it wouldn't mess up the DA's case down the road.
    Dr.Greger. The USDA has procurement policies that disallow 
downed animals into the National School Lunch Program. But when 
we were at this plant we didn't know----
    Mr.Burgess. With all due respect that sounds like a 
bureaucratic answer. I mean I think what the American public 
wants to know is how can they in the future feel safe knowing 
that here the Humane Society had some data that is pretty darn 
important. Important enough for you to come to this 
subcommittee this morning and show us an emotional film, and 
not important enough that we don't stop it going into the 
stream of commerce. That is what the American people don't 
understand. I mean I realize there can be bureaucratic reasons, 
but to be quite frank with you I just say those are not 
acceptable.
    I appreciate it, Mr. Chairman. I know I have gone a little 
bit over. I will yield back.
    Mr.Stupak. Do you want the gentleman to answer?
    Mr.Burgess. If he has----
    Mr.Stupak. Do you want to answer his last----
    Dr.Greger. We were not aware that this was a supplier to 
the National School Lunch Program while we were doing the 
investigation. The USDA does not disallow downer meat, but we 
know that the National School Lunch Program does. So had we 
known that, perhaps, we would have been able to get that 
information. But downed animals continue to this day. It is 
unfathomable to the American public that we continue to allow 
any downed animals as USDA inspected meat. And so we are hoping 
that this investigation will not only shore up food safety 
across the board, but that we will finally have a downer ban. 
We knew downed animals were going to the food supply, but that 
is legal. It is legal for downed animals to go into the food 
supply thanks to the July 2007 USDA loophole.
    Mr.Stupak. OK. Thank you. We are going to go another round 
of questions here as members. Mr. Inslee, you have not asked 
questions yet. I'm sorry. And we will after, Mr. Inslee, we 
will go the second round.
    Mr.Inslee. Thank you. I want to welcome my constituent 
neighbor, Bill Marler. And, Bill, I want to thank you for your 
work. You have done as much, perhaps, as Congress in trying to 
assure food safety over the last decades, and I want to thank 
you for it. And that work is just beginning, and we thank you 
for your efforts.
    We are talking about the difference between voluntary 
standards and regulatory legal enforcement standards. My staff 
handed me a quote from 1906 from Sinclair Lewis and he says, 
``it is difficult to get a man to understand something when his 
salary depends on his not understanding it.'' And it seems to 
me that that 1906 observation might apply. You and I have 
talked about the need for standards regarding vegetables and 
leafy products, and we have talked about the success we have 
had in the meat industry. Even though we have got a problem 
here today there were improvements in part because of your 
litigation, and in part because some of the things Congress 
did. Can you talk about what you think we ought to be doing as 
far as leafy vegetables, non-meat products, to try to learn 
from the experiences in meat to improve our food safety?
    Mr.Marler. I think the first thing that you have to do is, 
really in many respects, really partner with consumer groups 
and industry, and your governmental agencies, as well as 
academia. There is a lot of research that still needs to be 
done as to how these pathogens get on these products, and why 
they are able to be transported for a long period of time and, 
you know, exactly how they operate. And the thing about these 
bugs too is that they morphin change over time. So whatever 
regulatory scheme, whatever standards you set, will always be 
things that will have to be in somewhat fluid motion. But I 
think the most important thing is to work with industry, to 
work with consumers, to build safety nets and to create a 
culture of food safety. There is a real big lack of both solid 
research, a lack of funding at research institutions, there is 
a lack of enforcement simply because you don't have enough FDA 
inspectors. I mean we talked about the ConAgra plant. That 
inspector was in there in 2005. Most FDA inspectors very 
seldom, maybe once a year, once every other year, will get to 
major manufacturing facilities. Those are the sorts of things 
that really need to change. But, again, it has to do I think 
first with good solid working relationships with these partners 
in this room, but also good research.
    Mr.Inslee. You have suggested consolidation of these 
agencies into one single purpose agency. And I assume because 
in regard to USDA you think that there is a conflict between 
the promotional responsibilities of this agency and the 
regulatory food safety. I am assuming that. Maybe you can 
comment on that.
    Mr.Marler. As Tommy Thompson said, certainly before he 
left, it is just really a matter of not whether, it is a matter 
of when we have a bioterrorism act against our food supply. A 
bioterrorism act against our food supply will look absolutely 
exactly like these things on your charts, but it will be 
somebody that did it on purpose. And my view is that that 
really should be where Congress needs to focus its energy and 
attention. And I think that is why, in my experience, 
especially in cases where FDA, USDA and the CDC are all in a 
sense in the same pot, there are so many conflicts between 
those agencies about information sharing, information gathering 
that sometimes they stumble over each other for trying to do 
the right thing. But they just simply stumble over each other, 
and it slows the process down of being able to figure out what 
the cause of an outbreak is sooner, rather than later.
    Mr.Inslee. Let me ask you something that may not be a 
headline grabber, but grabbed my family a few months ago when I 
had a family member get, you know, sort of violently ill 
suddenly, which we thought may have been food related. No long-
term lasting damage. I didn't have to give you a call. Just 
some days of great distress. And I suspect that is going on in 
thousands of occurrences across the country with no sort of 
reporting system, because there is no real medical 
intervention. Is this a problem? And number one, what can we do 
about that sort of lesser severity issues?
    Mr.Merle. I think that--and that is probably something that 
this committee and Congress is, you know, acutely aware of. 
That our public health system has some real challenges. And the 
fact is that even with our concern about bioterrorism we 
haven't put the money in on the ground for investigators to do 
testing of victims of potential food borne illnesses. Because, 
again, that is where you are going to catch it. You are going 
to catch it in the ER's. You are going to catch it in doctors' 
offices. And that is where you are going to catch these 
outbreaks before they balloon into something that is worse. So 
I think looking at how our public health system operates or 
doesn't operate, and giving physicians the tools, specifically 
with respect to stool cultures for vital and bacterial 
illnesses, would get us a long way there to stopping some of 
these outbreaks before they get bigger.
    Mr.Inslee. We hope the wisdom from Bainbridge Island 
becomes the national policy. Thanks, Bill, for being here.
    Mr.Marler. Thanks.
    Mr.Stupak. Going to a second round of questions here.
    Mr. Marley, let me ask you this. It is my understanding, 
you know, we talked about the other recalls. Jack-In-The-Box, 
we got Tops, and now we got this Westland/Hallmark hamburger 
area. When you do hamburger, when they go through these 
slaughter houses, they trim from different animals that are 
going down and load up the burger, and it is put in a box, and 
the box can weigh up to 2,000 pounds. And the way we inspect 
it, you reach in, you take a little bit out, you inspect it. If 
it passes that whole 2,000 pounds go, correct?
    Mr.Marler. Yes.
    Mr.Stupak. So how do you then really do an inspection of 
the quality of the meat or the hamburger that is being 
produced? And as you said earlier it is the dairy cows that 
sort of is the basis for our hamburger in this country, right?
    Mr.Marler. Seventeen percent of----
    Mr.Stupak. Seventeen percent.
    Mr.Marler [continuing]. Hamburger in the country is from--
--
    Mr.Stupak. OK.
    Mr.Marler [continuing]. Dairy cows.
    Mr.Stupak. So how do you really get at it if--how do you 
get at these microorganisms, E. coli, whatever may be there?
    Mr.Marler. When the inspecting system was created in the 
United States most of the people didn't understand how 
bacterial or viral illnesses sickened people anyway. You were 
looking for things. You were looking to see if the cow had 
tumors or if it was tubercular. You were looking for those 
sorts of things. It is a new day now, and these pathogens are 
out there. Some of them, you know, morph. We have seen new 
forms of E. coli. Pathogenic E. coli show up in our food system 
just in the last few years. We have the technology to do 
scientifically based testing. In fact, one would argue that 
many of the retail outlets, the Jack-In-The-Boxes, McDonald's, 
the big retails outlets forced random testing onto suppliers. 
Which was what I think one of the reasons why E. coli 0157H7 
cases went down so dramatically after 2002, because we were 
testing. It is not a perfect system, but random scientifically 
based 0157H7 testing can get us a long way to making our food 
supply safer.
    Mr.Inslee. But after Jack-In-The-Box we came up with the 
HACCP Program for hazardous detection. But then, as you said 
here, here is the meat recall that is just in the last 12 
months there have been 91 recalls, 63 of them are meat alone.
    Mr.Marler. Right.
    Mr.Inslee. So has government then said well, we have this 
HACCP system, therefore, industry is self regulating itself. We 
won't have to do it.
    Mr.Marler. I think that is why that is the problem. You 
have got to not only--it is not only a partnership with 
industry to help set the standards so they are actually 
workable standards that make sense, but I do think that there 
has to be ultimately your people on the ground in the plants 
making sure that the kinds of abuses that we saw at Westland/
Hallmark don't occur. The sort of follow-up that didn't occur 
by FDA officials at the ConAgra plant--to make sure that those, 
in fact, do occur. It is a resource issue. It is a manpower 
issue.
    Mr.Inslee. Any reason why we should not label meat products 
that is treated with carbon monoxide or seafood with carbon 
monoxide to let the consumer know?
    Mr.Marler. No, I see no reason why.
    Mr.Inslee. Mr. Williams, let me ask you this. In your 
testimony you are talking about shrimp and you are talking 
about when Pakistan went from 0 to 165,000 pounds. China 
dumping it here.
    Mr.Williams. Yes.
    Mr.Inslee. What is the danger here? You are saying the FDA 
isn't inspecting it. Explain this, especially when we are 
talking a little bit about pathogens and all that in shrimp and 
other--and you said Vietnam's next on our list we got to watch 
for?
    Mr.Williams. Right. Well, when another importing nation, 
such as European, Japan or the European Union, Canada, 
increases their inspection rates when they find problems, which 
they do. They inspect up to 25 percent. We inspect less than 
one percent. When they increase their inspection rate the 
imports suddenly stop going to those countries and they----
    Mr.Inslee. So in other countries increase their inspections 
the imports stop, and they get shifted to the United States. So 
we become the dumping ground.
    Mr.Williams. Exactly, exactly.
    Mr.Inslee. We have had other hearings where it indicates, 
let us say, like seafood especially, they will bypass our 
inspections in San Francisco where we have a very good lab and 
go, let us say, to Las Vegas and bring it in the back door. Is 
that a continuing problem?
    Mr.Williams. That is the term they use. They call it port 
shopping. They will send this product to a port that will be 
the less likely to inspect their product, and if they do 
inspect it they don't--they have the option of taking it back 
out of the country or it will be destroyed. Of course they will 
take it back out of the country and send it to another port 
with what may not get inspected. You ought to have a 99 percent 
chance of getting it in without being inspected.
    Mr.Inslee. What are the fungi and antibiotics that may be 
found in shrimp and other seafood? We had one report that 
summed the seafood being treated with carbon monoxide. About 20 
percent of it was already rotted before it was ever sent to the 
United States, but the carbon monoxide, of course, masked the 
problems with the seafood.
    Mr.Williams. Right.
    Mr.Inslee. So what are the fungi and antibiotics we look 
for?
    Mr.Williams. In seafood there is malachite green. There is 
a host of nitrofurans, chloramphenicol, which is--causes 
several irreversible blood diseases such as aplastic anemia. 
And what is particularly troubling with some of these diseases 
is you will not see this for probably 10 years down the road. 
We don't know what amount causes these diseases. That is why we 
have a zero tolerance on it, and it is banned worldwide for use 
in food consumption.
    Mr.Inslee. OK. Thank you. Dr. Greger, my time is up at 
this--what did your undercover--if you know, what did your 
undercover investigator tell you USDA inspectors were doing? 
You said 6:30 and 12:30 was their inspections. What were they 
doing in between?
    Dr.Greger. There are on-line and off-line inspectors. So by 
law a plant cannot operate without on-line inspectors looking 
at the carcasses. However, the plant can continue to work if 
there aren't these off-line inspectors. They are the ones that 
are looking at the pens and supposedly doing random checks. Not 
in this case. Not looking at the unloading of animals. Not 
looking at them antemortem, before the slaughter of these 
animals. And so the plant can continue to operate. So in a 
situation of understaffing the inspectors are in the plant on 
the line and others, you know, may get out or maybe between 
multiple plants. I mean in some areas of the country there are 
more severe understaffing issues than others.
    Mr.Stupak. OK. Thank you. Mr. Shimkus, questions.
    Mr.Shimkus. Thank you. Let me just follow up Dr. Greger one 
more time on the whole terminology of downer. These are dairy--
spent dairy cattle?
    Dr.Greger. Yes.
    Mr.Shimkus. Spent dairy. And they are shipped from multi-
state regions, so they arrive--downer means they are down, 
right? That is kind of the definition. They could be down for a 
lot of different reasons?
    Dr.Greger. Correct.
    Mr.Shimkus. We--obviously mad cow. People--we know that. 
But downer doesn't mean that all these are mad cow. They could 
be just fatigue and major fatigue. They could have been going 
without food and water for multi-hours over the road haul. So, 
and you mentioned one per tractor trailer load. What should 
have this processor done? Should they have--and think if he was 
processed. Just segregate the downed cattle? Could they have 
allowed that downed cattle then time to recover if it was just 
fatigue and water to then, without assistance, get up on its 
own and then process through the veterinarian check and then--
or by definition once down, always down regardless of the 
reason it was down?
    Dr.Greger. Well, what should have happened--I mean downer 
animals are veterinary emergencies and should be treated as 
such, and they should receive individual veterinary treatment 
or they should be humanely euthanized. But there is a system in 
which one can segregate so-called ``suspect'' animals, and see 
if indeed they can perk up and are able to walk on their own. 
And then by definition they are no longer downer cattle. At 
this plant there was no suspect pen. There were no suspect 
stickers.
    Mr.Shimkus. If they would have just moved all these downed 
cattle to a pen, a suspect pen, and then monitored those and 
those that were able to revive processed back through, and 
those who can't then deal with them as per law.
    Dr.Greger. The problem is, is it is very difficult to 
humanely transport these downed animals. Hundreds of pounds and 
so how are you going to do it? As you can see----
    Mr.Shimkus. Right.
    Dr.Greger [continuing]. Forklifts and chains. I mean there 
are humane ways to do it via these sleds and--but it is 
something that is, you know, much more intensive and----
    Mr.Shimkus. Right.
    Dr.Greger [continuing]. It may just make more sense to 
euthanize them on the spot certainly.
    Mr.Shimkus. Thank you. The--and, Mr. Williams, thank you 
for your patience. I am glad the Chairman directed some 
questions. On this whole imported shrimp, who makes the 
wholesale purchases of this imported shrimp?
    Mr.Williams. I am sorry?
    Mr.Shimkus. Who makes the wholesale purchases of the 
imported shrimp?
    Mr.Williams. That would be mostly the importers and 
distributors.
    Mr.Shimkus. And what obligations do the firms who are 
purchasing through the wholesalers have in testing the shrimp?
    Mr.Williams. I am sorry. Say that again.
    Mr.Shimkus. Well, here is my frustration in the food 
processing perspective. It is not a cost benefit to business, 
especially with the ability of litigation, food recalls, you 
know, to--I actually have a hard time believing that companies 
willfully, for a profit margin, allow unsafe foods to the 
market. I believe, I think, that there are mistakes and errors. 
There is evolution to these pathogens. We need to do more 
science to figure out how to stop this stuff. In the 
manufacturing process if you are building a car and you are 
going to a--you got a wholesaler who is creating the widget and 
has to be one millimeter of inch, it is tested before it is 
exported to the assembly line. And when the person receives it 
they are testing to make sure it is within the specifications. 
So isn't there testing on both? Shouldn't there be testing on 
both ends?
    Mr.Williams. There is testing on both ends. We are under 
strict Federal, State and local guidelines, or health 
guidelines, to test our product whether they are imported or 
not. But once they reach these shores and the FDA allows them 
in because of their lack of testing we don't test for 
chemicals. Our shrimp are not tested for illegal antibiotics or 
chemical contamination. We are tested on the safety and the 
quality of it going out to the consumer.
    Mr.Shimkus. Should we?
    Mr.Williams. I don't know. They shouldn't be allowed in 
because there are no chemicals in domestic shrimp.
    Mr.Shimkus. Right.
    Mr.Williams. Those shrimp should be tested before they 
leave the foreign nations.
    Mr.Shimkus. Right.
    Mr.Williams. And here also before they come into our 
market.
    Mr.Shimkus. And I think there is credible debate on the--we 
definitely don't want to be the dumping ground when other 
countries have established some standards, you know. Not always 
when you set standards--hopefully they are scientifically 
based. That makes sense. And then we don't want to be the 
overflow and the dumping ground for that. But I also think it 
is just not good business if you know that there are additives 
in foods that affect the people that you are trying to sell 
your product to. To not test--establish those standards and not 
purchase it if it doesn't meet those standards.
    Mr.Williams. Well, I agree. And therein lies the problem 
that, you know, these shrimp should be tested. We should have 
at least equivalence with the foreign countries as we do here. 
Have it at least the same amount of testing over there as they 
do here. In 2006, for example, the FDA tested 2,480 inspections 
of domestic fish and fishery products here in the United 
States. Only 200 in the foreign nations, and we imported over a 
billion pounds of shrimp that year. And we produced 200 
million.
    Mr.Shimkus. And so your basic premise is our domestic 
standards are much higher than our imported standards.
    Mr.Williams. Well, yeah. We think the--yeah, the health 
standards are. Yes, but like I said we don't test for 
chemicals.
    Mr.Shimkus. Right, OK. Thank you, Mr. Chairman.
    Mr.Stupak. Mr. Walden, questions.
    Mr.Walden. Thank you, Mr. Chairman. I want to make a point 
that getting back to this issue of the malachite green, which 
was the carcinogen in eels. Which, I guess, South Korea banned 
in July of '05, and then Canada in January of '06. And it took 
our FDA another 8 months after, or 7 to figure it out. But what 
do we need to do here?
    Mr.Williams. Well, I think we have put together what we 
think is a very comprehensive food safety program that the FDA 
should adopt and put in place. And, you know, I have heard that 
we can't inspect our way out of this mess. That may be true, 
but we can certainly do a better job than what we are doing. 
But I think if they look at our--in our written comments if you 
will look at our safety program that we think is very 
comprehensive and would take us out of this mess.
    Mr.Walden. OK. I guess as a consumer, you know, and I have 
supported country of origin labeling and all, and then been 
shocked as I go down the seafood display at my local grocery 
store just where stuff comes from. I wanted assurance that what 
I am buying for my family is safe.
    Mr.Williams. Yeah.
    Mr.Walden. And I will tell you, Mr. Chairman, every time I 
come to one of these hearings you are holding I walk away 
thinking what can I eat, you know, or what vitamins should I 
take, or what prescription should I avoid. And it is just very 
troubling, and yet we know overall our food supply is pretty 
darn safe and secure. But so I think we are trying to find out 
where the hole is. Where are the breaches? What do we need to 
fix here? When you think of how much food is produced and 
consumed without any problem. I mean these are kind of along 
the edges, but it is not along the edge when it is your son or 
daughter that is hooked up to feeding tubes or dies. And that 
is--we want to get to zero tolerance. And it sounds like most 
importantly we need a better inspection regime and more 
inspectors. It sounds like, at least with FDA and probably 
USDA, we need more real time intelligence capabilities. It 
shouldn't take eight months after Canada figures it out and 
probably a year after South Korea figures it out. Far after 
data reaches similar conclusion on a known carcinogen. I mean 
we are not the legislative committee. We are just the oversight 
committee, but we all serve on the committee that has 
legislative authority. What else can you offer us that you 
haven't already in terms of what we need to do?
    Mr.Williams. Well, I think just about everything in our 11 
point program would--we feel it would be very--would take care 
of this.
    Mr.Walden. All right.
    Mr.Williams. As far as seafood, imported seafood. And I 
think another example would be Cambodia. When the European 
Union went over there and found they had no, absolutely no, 
safety standards at all and would not allow their shrimp into 
the European Union, we continued to accept them.
    Mr.Walden. We did what?
    Mr.Williams. The FDA allowed them into this country. Our 
imports went up most like the Pakistani issue.
    Mr.Walden. See, that is encouraging. That is encouraging. 
We haven't touched on the issue of radiation in beef. Does 
somebody want to tackle that one? Because I hear a lot that, 
you know, that could actually eliminate a lot of the disease. 
Mr. Marler, would that help?
    Mr.Marler. Yes.
    Mr.Walden. Should we be doing that?
    Mr.Marler. Yes.
    Mr.Walden. Is there any consumer issue with that?
    Mr.Marler. I think the consumer issue with it, I think the 
science isn't there to support the fear, but there is a fear. 
But we----
    Mr.Walden. Right.
    Mr.Marler [continuing]. Radiate a lot of products.
    Mr.Walden. And the practical effect of that is what?
    Mr.Marler. None.
    Mr.Walden. Other than that?
    Mr.Marler. I mean other than eliminating or certainly 
reducing pathogens. The gentleman who talked about, you know, 
getting corn out of his field and eating the way we ate in the 
'50s and '60s, those days are long gone.
    Mr.Walden. Right.
    Mr.Marler. And I think when our food chain is longer and 
more complex we have to look at interventions to protect us 
from pathogens that change on a daily basis.
    Mr.Walden. You know those days are long gone, but perhaps 
our inspection regime is still stuck there.
    Mr.Marler. I would agree with you on that.
    Mr.Walden. It is sort of like a car in Cuba, you know, they 
have got the best mechanics in the world because they keep 
those 50-year-old cars running, and or more. Thank you, Mr. 
Chairman. I am going to yield back to get onto the next panel.
    Mr.Stupak. On your radiation this committee has a joint 
request in right with GEO just waiting for the report back. It 
is something that we have looked at as part of the total food 
safety issue.
    Mr.Walden. Perfect. Thank you, Mr. Chairman.
    Mr.Stupak. Ms. DeGette, for questions.
    Ms.DeGette. Thank you very much, Mr. Chairman. Mr. 
Williams, your testimony got me to thinking about something I 
say quite often in these hearings. And that is it seems--and I 
think the shrimp industry's probably one of the best examples 
of how our entire food--or actually all of our consumer goods 
including food. Thirty years ago most of that food was 
domestically produced, and now a huge percentage is coming from 
overseas. And I frankly think that is one of the main reasons 
why our oversight agencies, like the FDA and the USDA, have 
broken down, because they are being asked to inspect things 
that they weren't asked. Would you agree with that statement?
    Mr.Williams. Somewhat, yes.
    Ms.DeGette. In your industry, over the last say 30, 40 
years, what is the percentage--how have you seen the percentage 
of imports change?
    Mr.Williams. It is since--actually since the late '90s we 
have been losing----
    Ms.DeGette. If you can move that microphone a little.
    Mr.Williams. Since the late '90s we have been losing more 
market share, especially since 2000, because of we feel like 
the lack of inspection for the imports. These products--this 
product is allowed to come in and capture our market. We are 
down to about 10 percent of our entire market now. We feel like 
if those shrimp were inspected they would not be allowed to 
come into the Nation, because they are contaminated. They are 
contaminated with illegal antibiotics, and they shouldn't be in 
this market.
    Ms.DeGette. And one reason why people are buying them is 
they are cheaper than domestically produced shrimp.
    Mr.Williams. That is right.
    Ms.DeGette. Correct? And I would assume your industry's 
position is they're cheaper because they are not raised under 
the same strict standards your industry sets forward, correct?
    Mr.Williams. That is right. We are wild caught domestic 
industry. We can produce and compete with anyone in the world. 
We always have until they started breaking the rules. And that 
is what they have done is break the rules and put our industry 
in jeopardy. We have----
    Ms.DeGette. And do you think that there is more consumer 
risks to these imported shrimp as well.
    Mr.Williams. Oh, yes, definitely. I had a--and this may be 
extreme, but I had a gentleman--when we started this early on 
we filed these trade petitions against these countries, and one 
of them was because of the chemicals. I had a rep from a 
chemical company. He was a salesman for years and years. And he 
told me that some of these chemicals such as chloramphenicol 
you really don't want to touch this product without rubber 
gloves on.
    Ms.DeGette. Great. Now, Dr. Greger, one thing. I hope no 
one asked this, and I apologize, in my absence. You--one thing 
that struck me about that really horrifying video is that the 
USDA inspectors were actually at that plant twice a day. I 
think they said what, 6:30 a.m. and 12:30 p.m. Were those 
inspectors on site?
    Dr.Greger. There have to be inspectors on site----
    Ms.DeGette. OK.
    Dr.Greger [continuing]. One-hundred percent of the time 
inside on the line, but not necessarily off-line inspectors or 
in the holding pens or in that area. And that is why something 
like closed circuit television----
    Ms.DeGette. Right.
    Dr.Greger [continuing]. Camera or random checks.
    Ms.DeGette. But let me stop you right there.
    Dr.Greger. Yes.
    Ms.DeGette. What were those inspectors doing the rest of 
the time between when they went out there?
    Dr.Greger. And so inspectors were either inspecting other 
plants or were inside.
    Ms.DeGette. So those two inspectors--or however many 
inspectors there were, they weren't on that particular site all 
day long?
    Dr.Greger. That--there was one inspector came the same 
time, same two times every day, but I am not sure where that 
inspector was at other times. Whether they were at that plant 
or looking at other plants.
    Ms.DeGette. I see. OK. We had been under the impression 
there were inspectors on site during the whole work day. That 
is not correct.
    Dr.Greger. There are USDA inspectors inside the plant 
watching the carcasses.
    Ms.DeGette. But they are different inspectors?
    Dr.Greger. There are on-site inspectors and on-line 
inspectors.
    Ms.DeGette. OK.
    Dr.Greger. Excuse me. And off-line inspectors. For a plant 
to operate there has to be someone--there has to be a federal 
inspector looking at the carcasses, but there does not 
necessarily have to be an inspector watching the unloading and 
treatment of the animals before slaughter.
    Ms.DeGette. OK.
    Dr.Greger. They have a mandate to do that, but evidently 
they don't have the----
    Ms.DeGette. The resources.
    Dr.Greger [continuing]. Personnel.
    Ms.DeGette. But both you, and also Mr. Marler, said that 
you could solve some of these problems with technology. And I 
would suspect too, Mr. Williams, in the shrimp industry we are 
going to have to get--this is true. We have been doing all 
these consumer product hearings and food hearings, and I mean 
frankly our food inspection and consumer products inspection 
systems are completely broken. But there is also no way we 
could ever have enough of a budget for every single lot of meat 
or every single lot of shrimp to be inspected. So I think one 
of the challenges that we have to face, we are in the 21st 
century, is to find innovative testing that is like these video 
surveillance cameras and other types of testing. Wouldn't you 
agree with that, any of you?
    Mr.Williams. I would agree, but also agree that it should 
begin in the exporting nations. That is where it should begin.
    Ms.DeGette. Yeah. Well, the last I heard the U.S. Congress 
doesn't have very much jurisdiction over the Chinese food 
business. But if we can figure that out I think we will be a 
big step ahead.
    Thank you so much, Mr. Chairman.
    Mr.Stupak. Well, thank you. That concludes all the 
questions for this panel. We want to thank this panel. Before 
we leave, you know, we learned a lot about--this is our fifth 
food safety hearing, and a lot about imports. And Richard 
Wilfong, who is a detainee from another department agency, ICE, 
the Immigration and Customs Enforcement, will be leaving us. 
And, Richard, I just want to thank you for all your work in 
helping us understand the import business as you do. It makes 
all of us members who ask questions--the brains behind the 
operation are really sitting behind us and helping us out. And 
that goes on both sides. We have got a great staff. So I want 
to compliment the staff before we dismiss this panel and before 
we call up our next panel. And thank you to this panel for all 
of your insight. Thank you.
    Mr.Wilfong. Thank you. Thank you very much.
    Mr.Stupak. I will now call up our second panel of 
witnesses. On our second panel we have Mr. Gary M. Rodkin, 
Chief Executive Officer of ConAgra Foods. Mr. B. Keith 
Shoemaker, President and CEO of Butterball. Mr. Christopher D. 
Lischewski, President and CEO of Bumblebee Foods. Mr. Rick Ray, 
President and CEO of New Era Canning Company. Mr. David 
DeLorenzo, President and Chief Executive Officer of Dole Food 
Company. Mr. David A. Eisenberg, Chairman of ANRESCO 
Laboratories, and Dr. Robert E. Brackett, PhD., Senior Vice 
President and Chief Science Regulatory Affairs Officer at the 
Grocery Manufacturers Association.
    I think we are just waiting for one more. OK.
    [Witnesses sworn.]
    Mr.Stupak. You are now under oath, and we will begin 
opening statements. Please, limit it to 5 minutes. If you have 
a longer statement we will include it in the record.
    Mr. Rodkin, we will start on my left, if you would like to 
start. I am going to ask you to pull that mic up. Pull it 
towards you. If we get it closer we can hear it a little 
better. It is not the best system in this room. Thanks.

 STATEMENT OF GARY M. RODKIN, CHIEF EXECUTIVE OFFICER, CONAGRA 
                          FOODS, INC.

    Mr.Rodkin. Good morning, Mr. Chairman and members of the 
committee.
    My name is Gary Rodkin, and I am the chief executive 
officer for ConAgra Foods. Thank you for the invitation to 
testify today about the safety of our Nation's food supply. I 
became ConAgra Foods' CEO in October of 2005, and during my 
tenure we have made food safety a top priority throughout our 
company. We fully agree with the committee's objective of 
ensuring that our Nation's food supply is among the safest in 
the world.
    I am pleased to report back to the committee on progress 
made with our Peter Pan peanut butter since our vice president 
for operations testified before you in April of last year, and 
how we have responded to new challenges with other products. I 
want to assure you how seriously we take our food safety 
responsibilities, and that this is a top priority throughout 
our company. As the CEO of the company whose core mission is to 
provide the consumers with safe, nutritious and wholesome food, 
the very possibility that one of our products could cause 
anyone harm is the very last thing that I would want to happen. 
I want to reiterate how truly sorry we are for any harm that 
our recalled peanut butter or pot pie products may have caused 
any consumer.
    Today I want to convey three main messages to the 
committee. One, ConAgra Foods has followed through on our 
commitments made here last spring regarding steps needed to 
resume production of our Peter Pan peanut butter by creating a 
state-of-the-art manufacturing facility in Sylvester, Georgia. 
In fact, that plant successfully resumed operations in August 
2007. Two, ConAgra Foods addressed a completely different type 
of food safety concern with our Banquet and store brand pot 
pies in October 2007. We have since resumed operations after 
making enhancements to that product line. And three, ConAgra 
Foods has undertaken a complete revamping and modernization of 
our food safety practices companywide with the benefit of 
outside experts and the full commitment from all our food 
safety program managers. Our foremost goal is to prevent food 
safety problems from occurring, but should they ever occur we 
will continue to act quickly and responsibly to protect 
consumers and make any needed safety improvements.
    Throughout this process we have cooperated with the 
committee's investigation and will continue to do so. We have 
provided the subcommittee with written testimony that contains 
additional detail on the first two product specific messages so 
I will not repeat those here. Rather, I would like to focus my 
time speaking to you directly on our final message regarding 
our companywide food safety modernization efforts. Namely, that 
ConAgra Foods is conducting a companywide upgrade of our food 
safety programs and will make continuous improvements to ensure 
that we provide safe food to consumers. As we reported to the 
committee last spring ConAgra Foods is committed to a 
companywide process to continuously improve our food safety 
programs starting with our hiring of a new chief global quality 
officer and the establishment of a food safety advisory 
committee. We have since taken the process much further and 
have undertaken the following steps. First, we are making a 
major investment in facility upgrades and in hiring additional 
quality personnel throughout the company. Specifically we have 
earmarked millions of dollars in capital for our facilities for 
projects that will further enhance the safe manufacture of our 
products. We are also in the process of hiring an additional 
250 quality personnel companywide primarily to support our 
enhanced food safety standards at our facilities. Second, we 
have made a major commitment to enhanced training in our food 
safety requirements for all of our plant personnel and 
suppliers. Specifically, in September of last year we convened 
a meeting of every plant manager and every quality manager at 
our headquarters facility in Omaha, which I attended, to launch 
an enterprise-wide set of food safety improvements. We are 
conducting continuous food safety and quality training for all 
plant employees companywide. We have also reached out to our 
co-packers and plan to hold a food and safety quality 
intervention event with all key supervisors and contract 
packers in the very near future. Finally, we are conducting 
continuous safety audits across all plants with a particular 
focus on one, incoming ingredient quality programs; two, 
allergen and sanitation programs; three, foreign material 
control programs; and four, overall infrastructure. By the end 
of the year we will have reassessed every HACCP plan across all 
of our platforms. We have also created within ConAgra Foods a 
new microwave center of excellence--center of expertise, and 
have begun a review of cooking instructions across all of our 
products.
    In conclusion, we appreciate the committee's interest in 
food safety, and we fully support the committee's goals. At 
ConAgra Foods we have met the commitments we made to the 
committee last spring regarding the process to be followed 
before resuming operations of peanut butter manufacturing at 
our Georgia facility. We responded quickly to an unexpected 
outbreak related to our pot pies, and we are well into a 
companywide process to review and upgrade our food safety 
programs for our entire business.
    I want to emphasize that these improvements are ongoing and 
will continue. I personally will ensure that we will 
continuously challenge and improve our food safety programs and 
make certain that food safety is the centerpiece of our 
corporate culture. Thank you.
    [The prepared statement of Mr. Rodkin follows:]

                      Statement of Gary M. Rodkin

    Good Morning Mr. Chairman and Members of the Committee. My 
name is Gary M. Rodkin, and I am the Chief Executive Officer 
(CEO) for ConAgra Foods, Inc. (ConAgra Foods). Thank you for 
the invitation to testify today about the safety of our 
nation's food supply. I became ConAgra Foods' CEO in October of 
2005 and, during my tenure, we have made food safety a top 
priority throughout our company. We fully agree with the 
Committee's objective of ensuring that our nation's food supply 
is among the safest in the world.
    ConAgra Foods is one of North America's leading packaged 
food companies, serving grocery retailers, as well as 
restaurants and other foodservice establishments. Popular 
ConAgra Foods consumer brands include: Chef Boyardee, Egg 
Beaters, Healthy Choice, Hebrew National, Hunt's, Marie 
Callender's, Orville Redenbacher's, PAM and many others, 
including Peter Pan and Banquet. We operate more than 100 
manufacturing facilities in 30 states, as well as facilities in 
several international locations.
    I am pleased to be able to report back to the Committee on 
progress made with our Peter Pan peanut butter since our Senior 
Vice President for Operations testified before you in April of 
last year, and how we have responded to new challenges with 
other products. I want to assure you how seriously we take our 
food safety responsibilities and that this is a top priority 
throughout our company. As the CEO of a company whose core 
mission is to provide consumers with safe, nutritious and 
wholesome food, the very possibility that one of our products 
could cause anyone harm is the very last thing that I would 
want to happen. I want to reiterate how truly sorry we are for 
any harm that our recalled peanut butter or pot pie products 
may have caused any consumer.
    Today, I want to convey three main messages to the 
Committee. One, ConAgra Foods has followed through on our 
commitments made here last spring regarding steps needed to 
resume production of our Peter Pan peanut butter by creating a 
state-of-the-art manufacturing facility in Sylvester, Georgia. 
In fact, that plant successfully resumed operations in August 
2007. Two, ConAgra Foods addressed a completely different type 
of food safety concern with our Banquet and store brand pot 
pies in October 2007. We have since resumed operations after 
making enhancements to that product line. And three, ConAgra 
Foods has undertaken a complete revamping and modernization of 
our food safety practices company wide, with the benefit of 
outside experts and the full commitment from all our food 
safety program managers. Our foremost goal is to prevent food 
safety problems from occurring, but should they ever occur, we 
will continue to act quickly and responsibly to protect 
consumers and make any needed safety improvements. Throughout 
this process, we have cooperated with the Committee's 
investigation and will continue to do so. Let me now describe 
these three points in greater detail.
    1. ConAgra Foods has followed through on its commitments to 
this Committee by making its peanut butter manufacturing plant 
in Sylvester, Georgia a state-of-the-art facility before 
resuming operations in August 2007.
    When ConAgra Foods testified before this Committee in April 
2007, we committed to addressing the suspected causes of the 
contamination at our Sylvester, Georgia facility that 
manufactures Peter Pan peanut butter, and to implement 
significant changes in the plant, including new, state-of-the-
art machinery, technology, and designs throughout the facility. 
We further committed, prior to resuming operations, to obtain 
an independent review by an expert third-party and seek the 
concurrence of the Food and Drug Administration (FDA) as to the 
adequacy of the measures implemented. We have met each of these 
commitments, and our Sylvester plant resumed operations in 
August 2007 as a state-of-the-art facility.
    Specifically, with the assistance of our outside experts, 
we took the following steps:
    a. We made a significant capital investment (approximately 
$40 million) to substantially upgrade the Sylvester facility. 
This included: (1) installation of a new roaster; (2) 
installation of a new roof; (3) physical separation and 
segregation of raw material and finished product areas and 
activities (each with dedicated employees and equipment) to 
minimize possible cross-contamination; (4) dedicated equipment 
wash rooms for raw and finished areas; (5) upgraded air flow 
systems; and (6) enhanced quality control systems supported by 
additional quality personnel.
    b. We enhanced both the frequency and sensitivity of our 
environmental and finished product testing programs for this 
facility, and assigned responsibility for sample testing to an 
independent, accredited laboratory.
    As we made these changes, we kept FDA informed of our 
progress. Once the plant was fully operational, FDA conducted a 
multi-day, on-site inspection of the Sylvester facility and was 
satisfied with the overall condition of the facility. We 
believe that we have created an industry-leading, state-of-the-
art facility for manufacturing peanut butter. We have also used 
this process as a springboard to assess and improve our food 
safety operations throughout the company.
    2. ConAgra Foods responded quickly to a government finding 
in October 2007 that its Banquet and store brand pot pies had 
been implicated in a salmonella outbreak and has implemented 
necessary steps to improve the safe consumption of this 
``ready-to-cook'' product.
    In October 2007, we faced a very different kind of food 
safety challenge with our Banquet and store brand pot pies 
produced at our Marshall, Missouri plant which manufactures, 
among other products, pot pies in the turkey, chicken and beef 
varieties. Unlike peanut butter which is sold to consumers as a 
``ready-to-eat'' product, pot pies are sold to consumers as a 
``ready-to-cook'' product, meaning the product needs to be 
fully cooked prior to consumption. This cooking process, 
whether in a conventional or microwave oven, further assures 
the safety of the product by effectively killing any bacteria 
that may possibly be present. We were therefore surprised to 
learn from the United States Department of Agriculture (USDA) 
that this product line had been implicated in a salmonella 
outbreak.
    Nevertheless, we responded quickly. We suspended our pot 
pie manufacturing and distribution operations immediately upon 
learning of the outbreak on October 8, 2007. We promptly 
commenced environmental sampling and testing within the plant, 
followed by our issuance of a consumer advisory and, 
ultimately, a voluntary recall of all of our Banquet and store 
brand turkey, chicken and beef pot pie products. All of these 
actions were taken in close cooperation with USDA's Food Safety 
and Inspection Service (FSIS), which has primary jurisdiction 
because these pot pies are meat and poultry-based.
    Our investigation into the root cause started with 
extensive laboratory testing of both environmental and finished 
product samples. Each of our 577 environmental samples tested 
negative for salmonella. We also conducted 219 laboratory tests 
of our ingredients, which were also all negative. We undertook 
testing of 2968 samples of finished product, which yielded 17 
positives for the outbreak strain. All of those positives 
related only to Banquet turkey pot pies from the production 
dates July 13, 2007 and July 31, 2007.
    As noted, because pot pies are a ``ready-to-cook'' product, 
salmonella had never been deemed a ``hazard'' in the context of 
our Hazard Analysis Critical Control Points (HACCP) plans, and 
we believe this to be so throughout the industry. Following 
this incident, however, we revised our HACCP plans to recognize 
salmonella as a potential hazard and to require Certificates of 
Analysis from our suppliers demonstrating that all ingredients 
are free of salmonella. We also instituted finished product 
testing for salmonella by an independent laboratory. Finally, 
we have instituted a multitude of process and equipment changes 
at the plant.
    Our investigation also led us to learn a great deal more 
about microwave ovens and to determine that consumers needed 
much clearer directions for use on the product labels. In 
particular, we learned there is both a greater variability in 
the performance of microwave ovens than we were previously 
aware, as well as a lack of full understanding with respect to 
microwave cooking efficacy. Consequently, we made major changes 
to our on-pack cooking instructions to address these learnings 
with considerable specificity. These changes include a more 
prominent statement on the front and side panels that the 
product ``Must Be Cooked Thoroughly. See Back for Directions.'' 
In addition, we have devoted most of the back panel to step-by-
step microwave cooking instructions that include: (a) minimum 
wattage for microwave ovens (1100 watts); (b) proper cooking 
time (4-6 minutes); and (c) consumer-friendly ways to know when 
the product is cooked thoroughly, such as the visual cue 
``Crust is golden brown and steam rises from filling.'' To 
reinforce these messages, we added safe microwave cooking 
guidance on our website, conducted a satellite media tour that 
encouraged news stations to carry a news feature that further 
educated consumers about safe cooking in microwaves, and 
provided further training on the subject to our consumer 
affairs representatives who field calls from consumers.
    Moving forward, we have engaged the National Center for 
Food Safety Technology at the Illinois Institute of Technology 
(often referred to as the Moffett Center) to undertake cooking 
tests and research on the use of microwaves to cook frozen 
foods. We have also engaged the American Frozen Food Institute 
in the process and have urged the food industry as well as 
microwave manufacturers to address the cooking issues 
associated with microwave ovens through improved cooking 
instructions and clear information regarding microwave oven 
wattages.
    Throughout the investigation, we were in constant 
communication with the USDA and the Centers for Disease Control 
and Prevention (CDC). We shared with them on a real time basis 
all of our test data and the results of our investigative 
efforts. We worked closely with USDA on improvements that 
needed to be made. With the concurrence of USDA, we resumed 
production of our Banquet brand pot pies in November, 2007.
    Having now been involved in two very different food safety 
outbreaks, we are more determined than ever to follow through 
on our commitment to improve our systems company wide to ensure 
we are producing safe, wholesome, quality products, whether 
they are ``ready-to-eat'' or need to be further cooked by 
consumers.
    3. ConAgra Foods is conducting a companywide upgrade of our 
food safety programs and will make continuous improvements to 
ensure we provide safe food to consumers.
    As we reported to the Committee last spring, ConAgra Foods 
is committed to a company wide process to continuously improve 
our food safety programs, starting with our hiring of a new 
Chief Global Quality Officer and the establishment of a Food 
Safety Advisory Committee. We have since taken the process much 
further and have undertaken the following steps.
    First, we are making a major investment in facility 
upgrades and in hiring additional quality personnel throughout 
the company. Specifically, we have earmarked millions of 
dollars in capital for our facilities for projects that will 
further enhance the safe manufacture of our products. We also 
are in the process of hiring an additional 250 quality 
personnel company wide, primarily to support our enhanced food 
safety standards at our facilities.
    Second, we have made a major commitment to enhanced 
training in food safety requirements for all of our plant 
personnel and suppliers. Specifically, in September of last 
year, we convened a meeting of every plant manager and every 
quality manager at our headquarters facility in Omaha to launch 
an enterprise-wide set of food safety improvements. We are 
conducting continuous food safety and quality training for all 
plant employees, company wide. We have also reached out to our 
co-packers and plan to hold a food safety and quality 
intervention event with all key supervisors and co-packers in 
the very near future.
    Finally, we are conducting continuous food safety audits 
across all plants, with a particular focus on: (1) incoming 
ingredient quality programs; (2) allergen and sanitation 
programs; (3) foreign material controls programs; and (4) 
overall infrastructure. By the end of this year, we will have 
reassessed every HACCP plan across all of our platforms. We 
have also created within ConAgra Foods a new Microwave Center 
of Expertise and have begun a review of cooking instructions 
across all products.
    In conclusion, we appreciate the Committee's interest in 
food safety, and we fully support the Committee's goals. At 
ConAgra Foods, we have met the commitments we made to the 
Committee last spring regarding the process to be followed 
before resuming operations of peanut butter manufacturing at 
our Sylvester, Georgia facility. We responded quickly to an 
unexpected outbreak related to our pot pies. And we are well 
into a company wide process to review and upgrade our food 
safety programs for our entire business. I want to emphasize 
that these improvements are ongoing and will continue. I 
personally will ensure that we continuously challenge and 
improve our food safety programs, and make certain that food 
safety is a centerpiece of our corporate culture.
                              ----------                              

    Mr.Stupak. Thank you. Mr. Shoemaker, your testimony please.

STATEMENT OF B. KEITH SHOEMAKER, PRESIDENT AND CEO, BUTTERBALL, 
                              LLC

    Mr.Shoemaker. Thank you, Mr. Chairman. I am Keith 
Shoemaker, Chief Executive Officer of the Butterball, LLC. 
Butterball was formed in 2006 when Carolina Turkey purchased 
the Butterball brand from ConAgra Refrigerated Food. Butterball 
is the best known brand in the turkey industry. Food safety is 
to be job one. Let me make it clear that the food safety 
investigation regarding salmonella in ConAgra turkey pot pies 
suggested that Butterball turkey was not the source of 
production contamination. I would like to clarify information 
reported in the media. No Butterball, LLC product has been 
recalled. Butterball complies with all USDA requirements. USDA 
food safety officers are present in Butterball facilities on a 
daily basis. However, my company does not rely on federal 
inspection to ensure the safety of our products. At Butterball 
we go beyond federal regulations by using the latest food 
safety technologies, comprehensive food safety practices and 
stringent microbiological surveillance.
    Permit me to explain how our food safety practices apply to 
ingredients, cooking, packaging and handling. Our requirements 
include stringent food safety practices for the handling of raw 
materials. It is generally recognized that raw meat, especially 
poultry meat, may contain salmonella. Science states salmonella 
does not grow below 44 degrees Fahrenheit, and will not 
typically grow below 50 degrees. That is why Butterball 
monitors and controls the temperature of our meat to less than 
40 degree Fahrenheit and the room temperature to less than 44 
degrees. This is a common industry practice to slow or stop the 
growth of bacteria in raw turkey. The fact that Butterball raw 
materials are received from one of our own slaughter and debone 
facilities allows us to assure temperature control throughout 
the supply chain. Serving to keep the level of bacterial growth 
at a minimum prior to meat being cooked. Data generated by USDA 
from Butterball facilities indicates a very low presence of 
salmonella. In fact, facilities supplying the raw product have 
been identified by FSIS as demonstrating the best control for 
salmonella. The turkey products supplied to ConAgra is fully 
cooked, ready to eat, cooked in a bag turkey logs. Cooked in a 
bag products are generally considered one of the lowest risk 
meat products. Possible contamination of the product after 
cooking is prevented by the fact that the product is protected 
from environmental exposure subsequent to cooking.
    That should help explain why the investigations regarding 
the ConAgra recall found no data to support that Butterball 
turkey meat is the likely source of salmonella identified in 
the outbreak. The turkey log we provided to ConAgra was made 
from our own raw materials, stuffed into packaging material, 
thorough cooked to kill bacteria that may be present. By 
packaging prior to cooking we prevent possible contamination 
after cooking. The food safety investigation regarding the 
recall confirms the effectiveness of these systems. No 
salmonella of the type that contained within the pot pies has 
ever been found in a Butterball facility. With cooked in the 
bag product the cook step is critical to the safety of the 
product. To ensure maximum food safety USDA requires a minimum 
of 160 degrees Fahrenheit instantaneously. At Butterball we do 
more. Specifically, these turkey logs are exposed to 162 
degrees Fahrenheit for between 15 to 20 minutes. Our ovens 
include four computerized temperature probes that provide 
continuous readout. A calibrated hand held thermometer serves 
to verify product temperature as well. After cooking the cooked 
in the bag log is then shielded in temperature controlled as 
long as we have it.
    From the time the disease was first identified Butterball 
cooperated with ConAgra Foods and USDA in investigating the 
possible source of the salmonella. Between August and October 
of '07, USDA conducted three major reviews of the Jonesboro 
facility and ConAgra conducted two more. There were no 
significant food safety findings in any of these reviews.
    In our own inquiry, Butterball conducted intense 
microbiological testing. Again, all results were negative. In 
short, at the conclusion of the investigations, logs were fully 
cooked and the product in the package was likely not the source 
of outbreak.
    Mr. Chairman, we at Butterball are eager to take every 
practical step to assure food safety for our customers. We have 
worked cooperatively with this committee and all other 
investigators and highly respect the experts. We remain eager 
to continue such efforts in the interest of future food safety.
    Finally, Mr. Chairman, I would like to thank the committee 
for its efforts to advance food safety and interest in learning 
about food science principals that guide our practices. We at 
Butterball would be pleased for you to tour one of our 
facilities to learn more about our operations. Thank you.
    [The prepared statement of Mr. Shoemaker follows:]

                      Statement of Keith Shoemaker

                                Summary

    1. BUTTERBALL TURKEY NOT IMPLICATED. The food safety 
investigations regarding Salmonella in ConAgra turkey pot pies 
suggest that the Butterball turkey ingredient in those pot pies 
was NOT the source of product contamination.
    2. INGREDIENT CONTROL. The turkey log Butterball provided 
to ConAgra was made from our own raw turkey, controlled to keep 
the level of bacterial growth at a minimum prior to the meat 
being cooked. Butterball facilities supplying the raw product 
have been identified by FSIS (USDA) as category one--
``demonstrating the best control for Salmonella.''
    3. SPECIAL PACKAGING. Cooked in bag products are considered 
one of the lowest risk meat products because cooking destroys 
pathogens and the product is not subject to environmental 
exposure subsequent to cooking.
    4. FULLY COOKED. Butterball cooks its turkey log to a 
higher temperature and holds that temperature longer than food 
safety requirements. Elaborate monitoring systems assure 
adherence to Butterball procedures to destroy pathogens.
    5. INVESTIGATIONS. The food safety investigations regarding 
the pot pie recall confirmed the effectiveness of these 
systems. Further, no Salmonella of the serotype that 
contaminated the pot pies has ever been found in a Butterball 
facility. Indeed, only once has that Salmonella serotype been 
found in turkey.
    6. BUTTERBALL COOPERATION. Butterball thanks the committee 
for its attention to food safety and invites Members and staff 
to tour a Butterball facility.

                               Testimony

    Thank you Mr. Chairman. My name is Keith Shoemaker, and I 
am Chief Executive Officer for Butterball, LLC (Butterball). 
Butterball was formed in 2006 when Carolina Turkey of Mt. 
Olive, North Carolina, purchased the Butterball Brand from 
ConAgra Refrigerated Foods. Butterball produces over 1.4 
billion pounds of turkey meat annually.
    At the outset, permit me to make clear that the food safety 
investigation regarding Salmonella in ConAgra turkey pot pies 
suggests that the Butterball turkey ingredient in those pot 
pies was NOT the source of product contamination.
    All Butterball products bear the mark of Federal 
Inspection, noting compliance with all United States Department 
of Agriculture (USDA) regulatory requirements. USDA Food Safety 
Officers are present in all Butterball facilities on a daily 
basis. However, my company does not rely on Federal Inspection 
to ensure the safety of our products. At Butterball, we go 
beyond federal requirements by using the latest food safety 
technologies, comprehensive food safety practices, and 
stringent microbiological surveillance.
    Food safety is top priority at Butterball, and I would like 
to focus my remarks today on our food safety practices. With 
specific reference to the turkey product used in the ConAgra 
turkey pot pies, permit me to explain how our food safety 
practices apply to ingredients, cooking, packaging, and 
handling. That should help explain why the investigations 
regarding the ConAgra recall have found no data to support the 
Butterball turkey meat is a likely source of the Salmonella 
identified in the pot pie illness outbreak. In short, the 
turkey log we provided to ConAgra was made from our own 
carefully controlled raw turkey, thoroughly cooked to kill 
Salmonella and other bacteria that may be present and packaged 
prior to cooking to prevent possible contamination after 
cooking has made the product safe. The food safety 
investigations regarding the pot pie recall confirmed the 
effectiveness of these systems. Further, no Salmonella of the 
serotype that contaminated the pot pies has ever been found in 
a Butterball facility. Indeed, only once has that Salmonella 
serotype been found in turkey.
    INGREDIENT CONTROL
    Our requirements include stringent food safety practices 
for the handling of the raw materials. It is generally 
recognized that raw meat, especially poultry, may contain 
Salmonella. Scientific literature states Salmonella does not 
show growth below 44 F and will not typically grow below 50 
F. That is why our company monitors and controls the 
temperature of the meat (<40F) and the room (<44F). This is a 
common industry practice and has been recognized to slow or 
stop growth of bacteria in raw turkey. The fact that Butterball 
raw materials are received from our own slaughter and debone 
operations allows us to assure temperature control throughout 
the supply chain, serving to keep the level of bacterial growth 
at a minimum prior to the meat being cooked.
    USDA data confirms the effectiveness of Butterball 
Salmonella control procedures. Raw materials coming from our 
own slaughter facilities undergo USDA Salmonella testing. Data 
generated from Butterball facility indicate a very low presence 
of Salmonella. In fact, facilities supplying the raw product 
have been identified by FSIS as category one--``demonstrating 
the best control for Salmonella.''
    SPECIAL PACKAGING
    The turkey product supplied to ConAgra is fully cooked, 
ready to eat, cooked in bag turkey log. To make this product, 
raw turkey meat is stuffed into the log packaging material and 
fully cooked in steam ovens. Packaging material for the turkey 
log is of a special design to allow the product to be fully 
cooked in the packaging without disrupting package integrity. 
Thus, it is called cooked in bag product.
    Cooked in bag products are generally considered one of the 
lowest risk meat products because pathogens (bacteria that 
cause illness) that may commonly be found on raw product are 
destroyed by cooking. Possible contamination of the product 
after cooking is prevented by the fact that the product is 
protected from environmental exposure subsequent to cooking. 
Listeria monocytogenes is generally considered the leading risk 
for environmental bacteria contamination from exposure after 
cooking.
    FULLY COOKED
    With the cooked in bag product, the cook step is critical 
to the safety of the product. The leading pathogen risk for raw 
poultry is Salmonella. All cook temperatures of products are 
targeted at reducing Salmonella 7 logs (a ``log'' is 10 
organisms per centimeter squared; 7 logs is 10,000,000 
organisms per centimeter squared). Studies conducted by 
industry, USDA, FDA, and other scientific bodies, both 
internationally and domestically, recognize this as the 
necessary safety level to destroy the maximum amount of 
organisms. To achieve a 7 log reduction in products like turkey 
logs, USDA requires a minimum of 160 F <1 min. At Butterball, 
we do more. We cook our turkey logs to a higher internal 
temperature for a longer period of time. Specifically, our 
turkey logs are exposed to 162 F for between 15-20 minutes. 
This extra time and temperature is actually destroying far more 
than 7 logs of Salmonella required.
    To be sure we actually meet our cooking specifications, our 
ovens include four computerized temperature probes that provide 
continuous read-out. Alarms sound on the oven when all probes 
reach 162 F. A calibrated hand-held thermometer serves to 
verify product temperature, as well.
    PRODUCT HANDLING
    Immediately after cooking, the cooked in bag turkey log is 
then taken into coolers and chilled to the appropriate 
temperature and maintained at that temperature as long as we 
have it.
    FOOD SAFETY INVESTIGATIONS
    From the time the foodborne disease outbreak was first 
identified, Butterball cooperated with ConAgra Foods and USDA 
to investigate the possible source of the Salmonella. Several 
audits of records, facility, cooking, and food safety practices 
were conducted.
    A review of the inspectional record was reassuring.
     August 2007--The Jonesboro facility had only recently 
undergone the USDA Food Safety Assessment, completed, with no 
major finding.
     October 6, 2007--USDA came back into the facility for 
another review, again with no findings reported.
     October 25, 2007--USDA took fifteen microbiological swabs 
of the processing environment, all reported negative for the 
presence of the Salmonella.
    In our own inquiry, Butterball conducted intensified 
microbiological testing including turkey logs ready for 
shipment, combo bins used for shipping the log and the trailers 
used for shipping again, all results were negative.
    A ConAgra review team came to the facility October 14 and 
15 to review records and production practices. No adverse 
findings were identified. On October 31 another team of ConAgra 
representatives, including outside experts, came to the 
facility to further investigate production practices associated 
with the oven operation. Butterball routinely calibrates the 
ovens and shared this information and the finding with the 
ConAgra review team. Again, there were no adverse findings 
noted.
    Additionally, at the request of ConAgra, a third party went 
into Jonesboro and validated each oven in the facility. The 
results of the third-party testing indicated that the ovens 
were functioning as they should, and the cooking cycles were 
far exceeding the lethality targets outlined in the food safety 
plan.
    Finally, a review of Salmonella testing data serotypes from 
USDA illustrates that no Salmonella of the serotype that 
contaminated the ConAgra turkey pot pies (Salmonella I 
4,[5],12:i:-) has ever been identified in a Butterball 
facility. Scientific literature available on this particular 
serotype notes it is commonly associated with chickens. USDA 
data shows only one incident of this serotype in turkey over 
several years of testing. That was not a Butterball turkey.
    In short, the conclusion of the investigation: the logs 
were fully cooked, and the product in the package was likely 
not the source of the outbreak.
    ****
    Mr. Chairman, we at Butterball are eager to take every 
practical step to assure food safety for our consumers. We have 
worked cooperatively with this committee and all other 
investigators and highly respected experts. We remain eager to 
continue such efforts in the interest of further improving food 
safety.
    Finally, Mr. Chairman, I would like to thank the committee 
for its efforts to advance food safety and interest in learning 
about the food science principles that guide our practices. We 
at Butterball would be pleased for you to tour one of our 
facilities to learn more about our operations.
    Thank you.
                              ----------                              

    Mr.Stupak. Thank you. Mr. Lischewski.

  STATEMENT OF CHRISTOPHER D. LISCHEWSKI, PRESIDENT AND CEO, 
                     BUMBLE BEE FOODS, LLC

    Mr.Lischewski. Mr. Chairman and members of the committee, 
my name is Chris Lischewski, President and CEO of Bumblebee 
Foods and Castleberry's Food Company.
    I appreciate the opportunity to be here today to provide my 
testimony and to respond to the committee's questions related 
to the recall of canned products of Castleberry's Food Company 
due to the risk of botulism contamination.
    First, I would like to say that we are in the business of 
providing wholesome food products to the public and making sure 
that our food is safe is always our first priority. Previously 
food that had to be recalled was the worst thing we could have 
faced, and we deeply regret that it occurred. We have tried to 
deal with the situation in a manner that reflects our sense of 
responsibility, our understanding of the gravity of the 
situation, our desire to make whole all the purchases of our 
recalled products and our continuing commitment to ensuring 
that all of our products are safe for consumers.
    Upon learning of possible botulism contamination from FDA 
and the CDC Castleberry's immediately instituted a voluntary 
recall of 10 products. To further minimize the risk to public 
health we quickly expanded the recall to extend beyond the 
specific products and production dates linked to apparent cases 
of illness. And ultimately our product recall included over 90 
products produced over a two year period. We also voluntary 
ceased production at our operating facility in Augusta. We 
informed the public about the recall through extensive public 
awareness programs in both English and Spanish. Frequent press 
releases and advisories were issued and multiple press 
conferences were held. The consumer hotline was established and 
staffed around the clock with call center professionals. Our 
website was updated. Advertisements ran in regional and 
national newspapers, direct mailing were sent to consumers and 
warnings were even printed on cash register receipt printouts. 
And including and in addition to that we engaged in numerous 
interviews with the media. As of October of last year there had 
been nearly 5,000 broadcast stories on the recall, in large 
part generated by the company to drive public awareness. And we 
also made it very easy for consumers to obtain refunds. No 
proof of purchase or return of product was required, and we 
just trusted the people to be honest with us.
    Retrieving recalled products in the marketplace was a large 
task, and we mobilized vast resources. I believe both FDA and 
USDA will confirm that we did everything they asked of us and 
more in order to notify retailers and consumers of the recall, 
and to quickly and safely remove product from the shelves. Upon 
announcement of the recall we immediately began by telephoning 
and e-mailing the contacts of all of our direct retail 
customers who had purchased any of the recalled products at any 
time during the previous two years. In addition to these 
ongoing telephone calls we sent nine company bulletins to these 
customers between July 18 and August 15 to update them on the 
recall. In addition to our direct contact to retail customers 
we engaged a company called RMX to physically visit 18,619 
stores during the 10 day period following the recall to confirm 
removal of the product from the store shelves. And we followed 
that up with another company called RMX to over the next 60 
days to cover 22,000 stores again. In less than one percent of 
the stores visited were recalled products on the shelf. We 
worked with customers that had loyalty card programs to send 
letters directly to consumers who had purchased recalled 
products. And, again, also engaged Catalina Marketing to run a 
program where by consumers who had previously purchased any 
recall product would receive on their register tape with the 
next purchase a warning notifying them of the recall.
    Throughout the recall we were in constant communication 
with the regulatory agencies establishing a daily conference 
call during the first few weeks of the recall to keep the 
agencies apprised of our efforts, to seek their input, and to 
provide answers to their questions. We also engaged an 
experienced consultant to advise us in any additional measures 
we might take. We worked openly and diligently to cooperate 
with FDA, USDA and this committee to facilitate all 
investigations including granting interviews and providing all 
documents requested. Together with processing authorities and 
regulatory experts we conducted an extensive, intensive 
investigation and identified the cause of the contamination. We 
have taken effective steps to prevent an occurrence and have 
also taken the opportunity to elevate our safety practices and 
procedures to an even higher level. In addition, we completed 
independent third party audits at all of our other facilities 
to ensure that appropriate procedures are in place.
    I truly appreciate the opportunity to come before you to 
discuss the recall, and hope that this can be a learning 
experience for all those involved in the industry where we work 
together to ensure that these types of incidents never happen 
again. Thank you.
    [The prepared statement of Mr. Lischewski follows:]

                     Statement of Chris Lischewski

    I'm Chris Lischewski, President and CEO of Bumble Bee Foods 
and Castleberry's Food Company. I appreciate the opportunity to 
be here today to provide my testimony and to respond to the 
Committee's questions related to the recall of canned products 
by Castleberry's Food Company due to the risk of botulism 
contamination.
    First, I would like to say that we are in the business of 
providing wholesome food to the public. Making sure that our 
food is safe is always our first priority. Producing food that 
had to be recalled was the worst thing we could have faced, and 
we deeply regret that it occurred. We have tried to deal with 
the situation in a manner that reflects our sense of 
responsibility, our understanding of the gravity of the 
situation, our desire to make whole all of the purchasers of 
our recalled products, and our continuing commitment to 
ensuring that all of our products are safe for consumers.
    Upon learning of possible botulism contamination from FDA 
and CDC, Castleberry's immediately instituted a voluntary 
recall of ten products. To further minimize the risk to the 
public health, we quickly expanded the recall to extend beyond 
the specific products and production dates linked to apparent 
cases of illness. Ultimately, over ninety products produced 
during a two-year period were recalled. The factory voluntarily 
ceased all production and distribution.
    We informed the public about the recall through an 
extensive public awareness program in both English and Spanish. 
Frequent press releases and advisories were issued, multiple 
press conferences were held, a consumer hotline was established 
and staffed around the clock with call center professionals, 
the Castleberry's website was regularly updated (in both 
English and Spanish), advertisements ran in regional and 
national newspapers, direct mailings were sent to consumers, 
warnings were printed on cash register receipt print outs, and 
we engaged in numerous interviews with the news media. As of 
October of last year, there had been nearly 5,000 broadcast 
stories on this recall in large part generated by the company 
to drive public awareness. Also, we made it very easy for 
consumers to obtain refunds-no proof of purchase or return of 
product was required. We trusted people to be honest with us.
    Retrieving the recalled product from the marketplace was a 
large task, and we mobilized vast resources. I believe FDA and 
USDA will confirm that we did everything they asked of us, and 
more, in order to notify retailers and consumers of this 
recall, and to quickly and safely remove products from store 
shelves. Upon announcement of the recall, we immediately began, 
by telephone and e-mail, to contact all of our direct retail 
customers who had purchased any of the recalled products at any 
time during the previous two years. In addition to these 
ongoing personal telephone calls and emails, we sent nine 
company bulletins to these customers between last July 18 and 
August 15, to update them on the recall and to provide 
additional information on things such as procedures for product 
retrieval and destruction. We engaged a contractor to retrieve 
and dispose of recalled product to avoid it being returned to 
the factory or to any of our distribution centers.
    In addition to our direct contact with our retail 
customers, we engaged a company called RMX to physically visit 
18,619 stores during the ten-day period following commencement 
of the recall, to confirm removal of recalled product from 
store shelves. Then, as a follow-up to the RMX visits, we 
engaged the CORE retail team division of Advantage Sales & 
Marketing to further assess the effectiveness of the recall by 
visiting more than 22,000 stores during the next 60 days. In 
the less than 1% of the stores visited where recalled product 
was found on a shelf, the CORE team worked with the stores to 
dispose of the product. We worked with customers that had 
loyalty card programs to send letters directly to consumers who 
had purchased recalled products. We also engaged Catalina 
Marketing to run a program at approximately 22,000 stores 
whereby consumers who had previously purchased any recalled 
product would receive on their register tape, at their next 
purchase, a warning notifying them of the recall and directing 
them to our website and hotline. Throughout the recall, we were 
in constant communication with the regulatory agencies, 
establishing a daily conference call during the first few weeks 
of the recall to keep the agencies apprised of our efforts, to 
seek their input and to provide answers to their questions. We 
also engaged an experienced consultant to advise us on any 
additional measures we might take. We did everything we 
reasonably could to get the recalled products off of store 
shelves and out of consumers' kitchens.
    We worked openly and diligently to cooperate with FDA, 
USDA, and this Committee to facilitate all investigations, 
including granting interviews and providing all documents 
requested. Together with processing authorities and regulatory 
experts, we conducted an intensive investigation and identified 
the cause of the contamination. We have taken effective steps 
to prevent a recurrence, and have also taken the opportunity to 
elevate our safety practices and procedures to an even higher 
level. We also completed independent third-party audits at all 
of our other facilities, to ensure that appropriate safety 
procedures are in place.
    Following the completion of our investigation and 
implementation of improved preventative safety procedures, we 
prepared submissions to USDA and FDA documenting the findings 
of our investigation and seeking their approval of our plan to 
re-open the facility. Our SVP of Technical Services and other 
management from Augusta met with FDA officials in Washington on 
September 5, 2007, to discuss our submission and to address any 
questions or concerns. At FDA's request, we set up a conference 
call the next day with our process authority to address FDA's 
questions. We received approval to re-open from FDA on 
September 12th and from USDA on September 14th. On September 
17th, the plant re-opened. The line on which the recalled 
product was manufactured is not and will not be run until a 
further in-depth review has been completed and additional 
operational control systems have been reviewed for possible 
installation to provide more robust operating and monitoring 
systems for these complex retorts.
    I want to reiterate our deepest regret that this incident 
occurred. Consumer safety is of the utmost importance to our 
company and to its employees, including me. We have taken, and 
continue to take, this matter extremely seriously and 
personally. As we try to move forward from this experience, we 
do not forget those who were most affected. We are working with 
those individuals who contracted botulism to resolve their 
claims in a fair and amicable manner.
    I truly appreciate this opportunity to come before you to 
discuss the recall, and I hope that this can be a learning 
experience for all those involved in the industry as we work 
together to ensure that these types of incidents never happen 
again.
    Thank you.
    Major Points:
     Upon learning of possible botulism contamination from 
FDA, Castleberry's immediately instituted a voluntary recall, 
which was quickly expanded to extend beyond the specific 
products and production dates linked to apparent cases of 
illness, in order to minimize any potential risk to the public. 
The factory was voluntarily shut down.
     With the assistance of a team of process authorities and 
regulatory experts, Castleberry's conducted an intensive 
investigation and has identified the cause of the 
contamination, has taken effective steps to prevent a 
recurrence, and has taken the opportunity to elevate its safety 
practices and procedures to an even higher level. Bumble Bee 
initiated independent third party-audits of all of its other 
facilities. Those audits were all successfully completed last 
year, with no issues of significance.
     Following the completion of our investigation, we worked 
together with FDA and USDA to obtain their approval to re-open 
the plant (other than the line on which recalled product was 
produced.
     Castleberry's worked diligently to cooperate with FDA, 
USDA and this Committee to facilitate all investigations, 
including granting interviews and providing documents.
     Castleberry's has gone beyond what was required by FDA, 
USDA and state agencies to ensure an effective recall. Efforts 
included website communications (both Spanish and English), 
media coverage (press releases, advertisements, press 
conferences and media interviews), customer calls, direct 
mailing to consumers, RMX/ASM-CORE retail coverage, Catalina 
program, third-party product retrieval/destruction service.
     Refunds were made easily available for consumers via our 
website without requiring return of product.
     Castleberry's is working with consumers who claim they 
contracted botulism from recalled products to resolve the 
claims.
                              ----------                              

    Mr.Stupak. Thank you.
    Now, Mr. Ray, your testimony, please.

   STATEMENT OF RICK RAY, PRESIDENT AND CEO, NEW ERA CANNING 
                            COMPANY

    Mr.Ray. Good afternoon, Mr. Chairman and members of the 
committee. My name is Rick Ray and I serve as president of the 
New Era Canning Company. Thank you for your invitation to 
testify today.
    New Era Canning Company is a small fourth generation family 
owned fruit and vegetable canning operation located in New Era, 
Michigan. For the past 98 years New Era Canning has been 
serving customers in the retail and food service industry with 
high quality canned fruits and vegetables. The New Era name is 
not widely known because we serve primarily the private label 
or store brand market. We operate a single facility and employ 
50 full-time people as well as 100 to 200 seasonal employees 
during our processing seasons. We process asparagus, green 
beans, wax beans, applesauce, sliced apples, pumpkin and a 
variety of dry bean items.
    We have a long tradition of providing safe food products to 
our customers. We fully realize that we are accountable for 
every case of canned food that we produce. We take that 
responsibility seriously. Today New Era's in the midst of a 
recall of our low acid canned vegetable products. The reason is 
that FDA discovered C. botulinum spores in New Era's canned 
vegetables.
    In New Era's 98 year history we have never previously 
experienced anything such as this. Permit me to explain what my 
scientific experts have told me about the classic concern 
regarding the C. botulinum contamination of canned foods, 
especially low acid canned foods. C. botulinum spores are 
ubiquitous. They originate in soil and, therefore, they are all 
around us. The spores are not harmful, but in the proper 
environment they can produce C. botulinum toxin which is highly 
toxic. In simple terms we are prudently assuming that C. 
botulinum spores will be naturally present in canned vegetable 
products. Thus, the most important step in canning is to bring 
the canned product to a sufficiently high temperature to kill 
the C. botulinum spores. Then to prevent overcooking the canned 
vegetables the cans are promptly cooked using water. The 
classic C. botulinum problem in canned vegetables occurs when 
some part of the product does not reach a killing temperature. 
In that situation the spores have been shocked, but not killed 
by the cooking. The shock to the spores prompts them to start 
growing and producing toxins. Unfortunately, low acid canned 
foods are a suitable environment for the growth of C. botulinum 
spores and the production of toxin.
    While our investigation is still under way and we have not 
yet received key information from the FDA about their findings, 
our scientific experts tell me that it appears that the classic 
C. botulinum situation is not what occurred at New Era. In the 
extensive sampling of New Era production, most of which we had 
on hold due to production irregularities, the C. botulinum 
spores, but not toxin was found. At least to date the C. 
botulinum found appears not to be a result of insufficient 
canning temperature to kill C. botulinum spores. Instead, it 
appears the presence of C. botulinum spores, but not toxin, in 
New Era canned vegetables is due to the entry of spores into 
cans during the cooling of the product after the can has been 
sealed and the product cooked. If the can seam is not to 
specification or becomes damaged microscopic--of cooling water 
can enter the can. This is why the industry has long used only 
safe drinking water in the can cooling.
    There are several reasons why this is the leading theory 
for the presence of C. botulinum in New Era canned vegetables. 
First, FDA tests of drinking water wells used by New Era for 
cooling water found that C. botulinum spores were present in 
the water. Second, the New Era processes that produced the 
contaminated product appear to have been achieving appropriate 
canning temperatures. Third, the presence of C. botulinum 
spores, but not toxins, suggests that the spores were not 
shocked by cooking temperatures, which corresponds with the 
theory that the introduction of the spores was in the cooling 
water.
    In the scant scientific literature on the subject C. 
botulinum spores are regarded as so unlikely to be found in 
water that testing is not a standard procedure.
    Mr. Chairman, the investigations, however, are still under 
way, so this conclusion must be regarded as preliminary. The 
FDA investigation of our company began 11 weeks ago. Working 
with technical experts we are addressing all issues raised by 
the FDA, as well as investigating additional opportunities to 
improve our overall operation. While it appears that the spores 
that entered New Era products in this manner have not been 
shocked and did not produce toxin, that fact is not 
satisfactory to New Era, and for that matter the FDA. No C. 
botulinum spores that have the capacity to produce toxins 
should ever be present in our products.
    This has been a resource intensive and difficult process 
for New Era to experience. But it is our intent to determine 
the cause of the current problem and to take whatever measures 
are necessary to ensure a safe product. We are very thankful 
that, to the best of our knowledge, there have been no reported 
illnesses from any of our canned vegetables. Again, we are and 
always have been committed to our responsibility to produce 
safe and wholesome products. Thank you.
    [The prepared statement of Mr. Ray follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Mr.Stupak. Thank you. Mr. DeLorenzo.

STATEMENT OF DAVID A. DELORENZO, PRESIDENT AND CHIEF EXECUTIVE 
                OFFICER, DOLE FOOD COMPANY, INC.

    Mr.DeLorenzo. Thank you, Mr. Chairman. Is that on?
    Mr.Stupak. Yes, it is. It sounded good.
    Mr.DeLorenzo. OK. Thank you again, Mr. Chairman and members 
of the subcommittee.
    My name is David DeLorenzo and I am the CEO of the Dole 
Food Company residing in Westlake Village, California.
    Our mission at Dole is to provide healthy, nutritious 
products to consumers. Food safety and consumer confidence in 
the safety of the food chain is not only vital to the mere 
existence of our firm, but we believe to the health of the 
Nation. We are pleased to participate in this hearing, and any 
other forums that might work toward ensuring food safety and 
with it the dietary habits of America.
    I would like to address the two vegetable recall events 
that touched our vegetable division during the past two years, 
and the steps that we and industry have taken to respond to 
those food safety incidents. First was the industry-wide halt 
of all spinach sales that occurred in September of 2006, after 
Natural Selection Foods recalled all packaged fresh spinach 
that it has produced and packaged. These packages were sold 
under 28 different brand names, one of which was ours. Our name 
was on the product, but it was produced and packaged by Natural 
Selection Foods, a highly regarded company that I believe has 
already testified before this subcommittee. Dole did perform 
regular audits of their operations and accepted the product 
into the Dole label and responsibility for their good 
practices. Dole has no ownership or other economic interest in 
Natural Selection Foods. Federal and state regulators reported 
that the source of the problem came from a specific spinach 
farm that was being farmed organically. At that time Dole did 
not internally farm or package spinach. We did not have the 
necessary specialized machinery to produce spinach and, 
therefore, had contracted with Natural Selections Foods to 
produce and package these products for us. Since that time we 
have invested in the machinery to package spinach and other 
tender leaf products ourselves, and are in the process of 
moving all of this activity under our own farming and into our 
own plants.
    The other incident I wish to address involved the recall of 
some of our salad product in Canada in September of 2007. On 
September 14 the Canadian Health Ministry told us that they had 
randomly pulled a number of bags of our salad from a store 
shelf in Canada, and that one had tested positive for E. coli. 
We immediately announced a recall. None of the other Canadian 
bags, nor any other bags of the same production batch that we 
had retained, nor any of the bags turned in by consumers tested 
positive for E. coli or any other pathogen. Our processing 
plant and the farms in which the produce was grown were 
carefully inspected by Canadian, U.S. federal and state 
regulators, and there is nothing negative to report there 
either. More significantly, there were no illnesses reported 
that were associated with this product in Canada or the United 
States. The source of this incident, unfortunately, remains a 
mystery, which is disconcerting and I believe unacceptable.
     And I will second what was said earlier in testimony, and 
I would recommend later in my testimony the urgent need for 
more research about bacteria, E. coli 157. I'm sorry, 155. 
Despite the need for more research I do believe that the 
reaction to this spinach problem by the industry and Dole was 
swift and did show an unprecedented commitment to food safety. 
The leafy greens industry in California studied, prepared and 
adopted the Leafy Greens Marketing Agreement within four months 
of inception. The backbone of the program is mandatory testing 
and audits by California state inspectors using such food 
safety metrics as irrigation water tests, employee hygiene, 
harvesting equipment sanitation, buffer zones, soil amendments, 
wildlife intrusion and previous land use. We have taken a 
leading role in this statewide initiative and remain part of 
its ongoing board. We are now working with the Arizona industry 
to establish a similar agreement. Dole supports national 
regulatory food safety standards for all fresh produce items, 
and the California and Arizona programs could be the starting 
point toward designing and implementing these standards for 
both domestic and imported items. As a company Dole fresh 
vegetables has undertaken some key initiatives aimed at 
providing a higher level of food safety. First is our 
implementation of a trace back system that is RFID driven. RFID 
stands for radio frequency identification. This process 
involves placing a unique tag on every bin of lettuce harvested 
in the field. The tag is scanned using the global positioning 
system so that there is a tracking record of where in the field 
the product originated, how far and how long it traveled after 
that and how soon each bin was cooled and processed. RFID 
tracking is not a firewall for food safety. It does, however, 
provide real time field locations to within approximately 100 
feet of where the product was harvested in the even trace back 
is needed. The inability to quickly trace back to a specific 
field location hampers the ability to determine the root cause 
of a problem, and has been a major impediment to regulatory 
investigators, not because our industry is unwilling, but 
because the technology available until now was not adequate as 
we mentioned earlier.
    In addition Dole and its growers have implemented testing 
for pathogens in the field prior to harvest, as well as testing 
at our produce centers, our processing plants and as it leaves 
a spinach product. Since the spinach incidences we have 
completed approximately 4,000 of these tests for pathogens. 
Thus far we have not had any positive tests for pathogens.
    Other Dole fresh vegetable risk reduction activities 
include a full-time staff of quality assurance and food safety 
specialists. All of our fields in California are irrigated by 
water from deep wells or city water. We test the wells once a 
month during the growing seasons when the water is used. We 
will not grow, harvest or purchase crops from fields that get 
flooded with run off from other fields, let alone from cattle 
pastures, nor from fields that are too close to a place where 
cattle have been. We also contract with third party food safety 
companies to supplement our auditing processes in addition to 
the state inspectors that are part of the California Leafy 
Greens Agreement. All of our salad processing plants have full-
time quality assurance staffs on site, and all operate under a 
defined HACCP plan, and our fields operate under defined GAP or 
Good Agriculture Practices plan, as well as the leafy greens 
audit.
    The produce industry needs to continue to move forward with 
refining agricultural practices as science and technology 
advance. We need government support for more research 
activities in understanding how pathogens survive and migrate 
in the natural environment, especially E. coli. We also need 
research in developing microbial kill steps that will work on a 
perishable product. The amount of research needed is 
significant in both time and dollars. Dole supports 
standardized regulations in the food industry to ensure food 
safety. Food safety begins at the farm and continues through 
the supply chain to manufacturing plants, transportation, 
handlers, retail outlets and the hands and homes of the 
consumer. We encourage and support efforts to establish 
industry-wide protocols and procedures, as well as consumer 
education. Due to the perishability of fresh produce and the 
exactitude necessary for proper laboratory testing we would 
encourage all funding necessary for the state-of-the-art 
laboratories that can provide quick turn around of tests with 
exactitude of findings.
    Private companies such as Dole will continue to accelerate 
and champion new practices and technologies aimed at 
eliminating food safety risks. Produce is a living, breathing 
organism grown for the most part in the open air that requires 
specialized care. It will continue to take a concentrative and 
significant effort in time, funding and regulation from both 
the government and the private sector to make our food system, 
already the safest in the world, even safer. We commit 
ourselves to work with your subcommittee and help in any way 
possible with improving future food safety regulation. Thank 
you.
    [The prepared statement of Mr. DeLorenzo follows:]

                    Statement of David A. DeLorenzo

    Two E. coli recall events touched our Vegetables Division 
during the last two years:
    1. September 2006 industry-wide halt of all spinach sales, 
after Natural Selection Foods LLC recalled packaged fresh 
spinach it had produced and packaged. These packages were sold 
under 28 different brand names, one of which belonged to Dole. 
Dole has no ownership or other economic interest in Natural 
Selection Foods. The source of the problem appeared to be in a 
spinach farm field, owned by a reputable grower, that was being 
farmed organically.
    2. September 2007 recall of some of our salad product in 
Canada. Canadian Health Ministry told us that a bag of our 
salad randomly picked from a store shelf in Canada had tested 
positive for E. coli. None of the other Canadian bags, nor any 
other bags of the same production batch, nor any of the bags 
turned in by consumers, tested positive for E. coli. Our 
processing plant and the relevant farms were inspected by 
Canadian, US Federal and State regulators--no problems were 
found. More significantly, no illnesses were reported that were 
associated with this product in Canada or the United States.
    Responses to the 2006 spinach issue: The California Leafy 
Greens Marketing Agreement, covering 99% of California leafy 
greens handlers, was implemented. The backbone of this 
Agreement is mandatory testing and audits by California state 
inspectors using such food safety metrics as: irrigation water 
tests, employee hygiene, harvesting equipment sanitation, 
buffer zones, soil amendments, wildlife intrusion, and previous 
land use. Our Vegetables' division President sits on the 
governing boards of both the California and the proposed 
Arizona programs.
    We view these industry programs as only a starting point. 
Dole supports national regulatory food safety standards for all 
fresh produce items.
    Dole has made significant investments in developing and 
applying RFiD technology to leafy greens; we have made this 
program available to the all companies in the industry, without 
any payment whatsoever to Dole. RFiD tracking allows trace-back 
to within approximately 100 feet of where the produce was 
harvested. The inability to quickly trace back to a specific 
field location has been a major impediment to regulatory 
investigators, until now.
    We have implemented testing for pathogens in the field 
prior to harvest; we also test produce as it enters our 
processing plants and as it leaves as finished product. We have 
completed approximately 4,000 of these tests for pathogens. 
Thus far we have not had any positive test results for 
pathogens.
    We need government support for more research activities in 
understanding how these pathogens survive and migrate in the 
natural environment, as well as in developing microbial kill 
steps that will work on perishable produce. The amount of 
research needed is significant in both time and dollars. We 
believe that the federal agency best suited to oversee this 
research effort is the USDA. We also encourage more funding for 
state-of-the-art laboratories that can provide quick turn 
around of tests with exactitude of findings.

                               Statement

                              Introduction

    Mr. Chairman and Members of the Subcommittee, my name is 
David DeLorenzo and I became the CEO of Dole Food Company, Inc. 
last June, having worked for Dole for the last 37 years. Thank 
you for allowing Dole the opportunity to be a part of the 
ongoing discussions on food safety.
    Our mission at Dole is to provide healthy, nutritious 
products to consumers. Food safety, and consumer confidence in 
the safety of the food chain, is not only vital to the mere 
existence of our firm, but, we believe, to the health of the 
Nation. We are pleased to participate in this hearing and in 
any other forums that might work toward ensuring the safety of 
the food chain and with it the improved dietary habits of our 
constituents.
    We take great pride in our people, the quality of our 
products and our commitment to Corporate Social Responsibility, 
including food safety, the environment, and the welfare of our 
workers. We also believe in transparency, and welcome any 
audits and scrutiny of our own operations and that of the 
industries in which we operate, to ensure that we and others in 
the industry are doing everything possible to deliver healthy, 
safe products to the consuming public. Toward that end, we 
would certainly welcome and encourage any Member of this 
Subcommittee and its staff to please come and visit any of our 
operations, to see our farms, refrigerated supply chain and 
manufacturing plants. Our salad manufacturing plants are in 
California, Arizona, Ohio and North Carolina, but we source 
from most of the fruit and vegetable growing areas in the 
United States, including California, Arizona, Oregon, 
Washington, Michigan, Texas, Colorado and Florida, to mention a 
few. Being this diverse requires us to establish strict and 
important relationships with farmers across a wide spectrum of 
crops who join us in adhering to good agricultural practices 
and strict protocols.
    We have been around as a company for more than 150 years, 
and we always are willing to exchange views and share our 
experience. The work this Subcommittee is doing is vital to our 
Nation, and to our industry, and we want to help in any way we 
can.
    Dole Fresh Vegetables is one of our divisions in North 
America; it is headquartered in Monterey, California. This is 
our division that has been affected by two E. coli recalls in 
the last two years. As I will discuss in a minute, in the first 
of these recalls, our name was on the product but it was 
produced and packaged for us by an unrelated, but highly-
regarded company that has an excellent name in the production 
of spinach and tender leaf salads and in organic salads. In the 
more recent and much smaller recall, originating in Canada, one 
bag of our salad, pulled at random from a store shelf in 
Canada, tested positive, but no other bags tested positive in 
Canada or the U.S., our farms and processing plant were found 
to be totally clear and no one was reported sick or injured. 
Because these two recalls involved leafy greens, I will focus 
on our Vegetables business. Our Vegetables business is a 
provider of leafy greens, as well as other commodity vegetables 
to retailers and wholesalers in North America. The main 
products on a tonnage basis that make up the leafy greens 
category are spring mix, spinach, romaine lettuce, iceberg 
lettuce and cabbage. Our Vegetables business supplies these 
items both in a commodity form and in a prepackaged form.
    Our Vegetables business on average ships over 5,000,000 
servings each and every day of nutritious products in a 
prepackaged form. This number of servings almost doubles when 
you add in our commodity produce.
    When it comes to food safety, one illness is one too many. 
All of us at our company and in this industry have families 
that consume these products, and we understand first hand our 
responsibility to deliver products that are as safe and 
nutritious as possible.

                              Two Recalls

    The Subcommittee staff requested that I address the two 
vegetable E. coli recall events that touched our Company during 
the last two years. First was the industrywide halt of all 
spinach sales that occurred in September of 2006. On September 
15, 2006, Natural Selection Foods LLC recalled all packaged 
fresh spinach that Natural Selection Foods produced and 
packaged with Best-If-Used-By dates from August 17 through 
October 1, 2006, because of reports of illness due to E. coli 
O157:H7 following consumption of packaged fresh spinach 
produced by Natural Selection Foods. These packages were sold 
under 28 different brand names, only one of which was owned by 
Dole. At that time, Natural Selection Foods was our sole 
supplier of spinach items, under a contract we had with them. 
On September 15, 2006, Dole announced that it supported the 
voluntary recall issued by Natural Selection Foods. Dole has no 
ownership or other economic interest in Natural Selection 
Foods. The U.S. Food and Drug Administration announced on 
September 29, 2006 that all spinach implicated in the outbreak 
had been traced back to Natural Selection Foods. The FDA stated 
that this determination was based on epidemiological and 
laboratory evidence obtained by multiple states and coordinated 
by the Centers for Disease Control and Prevention.
    From what the federal and California state regulators 
reported after the incident, it appears that there was no 
problem at Natural Selection Foods' processing plant; instead 
the source of the problem was in one spinach farm field, owned 
by a reputable grower, that was being farmed organically. I 
understand that the Subcommittee received the testimony given 
last April by Charles Sweat, who is the President of Natural 
Selection Foods, so I will assume the Subcommittee needs no 
further detail on the Natural Selection recall from September 
2006. At that time, we did not internally farm or package 
spinach. We did not have the necessary specialized machinery to 
produce spinach salad products and therefore had contracted 
with Natural Selection Foods to produce and package these 
products for us. Since that time, we have invested in the 
machinery to package spinach and other tender leaf products 
ourselves.
    The spinach recall galvanized an industry that already 
approached food safety as a top priority into becoming an 
industry with a heightened sense of urgency of the need to 
understand what steps we need to take to reduce this risk even 
further in the future. Some of this effort has involved 
strengthened good agricultural practices and some has involved 
more testing of produce in the field, at the processing plant 
door and of finished product. We recognize that we are an 
industry that still needs to do more, and we strongly believe 
that government has an important role to play, particularly in 
supporting needed scientific research on the causes of 
outbreaks and in developing nationwide food safety regulation, 
which I will discuss further in a moment.
    The other incident I wanted to talk about involved a recall 
of some of our salad product in Canada in September of 2007. On 
September 14, 2007, the Canadian Health Ministry told us that 
they had randomly pulled a number of bags of our salad from a 
store shelf in Canada, and that one had tested positive for E. 
coli. We immediately announced a recall of the affected lot 
code. We expanded the Canadian recall to parts of the United 
States since some of the same raw materials were used in 
product sold in those parts of the U.S. and Canada. None of the 
other Canadian bags, nor any other bags of the same production 
batch that we still had, nor any of the bags turned in by 
consumers, tested positive for E. coli or any other pathogen. 
Our processing plant and the farms on which the produce was 
grown were carefully inspected by regulators--and there was 
nothing there, either. More significantly, there were no 
illnesses reported that were associated with the product in 
Canada or the United States.

 Moving Forward--Efforts Undertaken and Needed Research and Regulation

    The fact our industry has had recalls should not be viewed 
as an indication of complacency. Research is the key to 
understanding the following scientific questions that need to 
be answered: where does this E.coli O157:H7 microorganism 
survive in the natural environment, other than inside cattle, 
which is the primary host organism; how does E.coli O157:H7 
survive in the natural environment; how is E.coli O157:H7 
transferred from one location to another; and how do we kill or 
otherwise eradicate it, without destroying a highly perishable 
product? From a government support viewpoint, we believe there 
is severe under-funding in the area of applied research and 
science-based mitigation strategies. At times we are forced as 
an industry to react to anecdotal, or bench-top tests which 
cannot be replicated in real world field conditions.
    You may ask: why is this so difficult a scientific problem 
to solve? The answer lies in how extremely rare it is to find 
the virulent E.coli O157:H7 on crops. For example, since the 
September 2006 spinach event, we instituted raw crop testing in 
the fields before harvesting, as well as testing of raw crops 
as they enter our processing plants and testing of finished 
product. Since September 2006, we have run approximately 4,000 
of these tests to date, using state-of-the-art tests, and we 
have not yet had a single positive test for E.coli O157:H7.
    We strongly feel that research is where the lion's share of 
any extra resources allocated by Congress should go. Please 
note that we don't have any objection to spending more federal 
dollars on inspections and audits. Adding more inspectors to 
regulatory agencies or giving them mandatory recall authority 
is a good thing. However, having more inspectors will not get 
to the root cause of how pathogens like E.coli O157:H7 survive 
and transfer from one location to another, and it will not 
address the science needed to develop a true kill step or other 
prevention. It's the old question of where you can get the most 
bang for the buck. We'd recommend that Congress put most of 
that extra money into well thought-out research. This 
Subcommittee can play an invaluable role in taking testimony 
from public/private panels of the best scientific minds to 
figure out what specific research should be funded, and in what 
priority order. We at Dole would be happy to share our best 
thoughts on this topic, too.
    I want to highlight for the Subcommittee some of the 
additional steps that have been taken since September of 2006, 
in both our company, and in the industry as a whole. The leafy 
greens industry in California has adopted the Leafy Greens 
Marketing Agreement (for purposes of this hearing this is 
referred to as the CA-LGMA). The CA-LGMA is an unprecedented 
commitment to food safety. Although it is in theory voluntary, 
the backbone of the program is California state inspectors in 
the fields of CA-LGMA signatories, auditing against a set of 
food safety metrics established by some of the sharpest 
scientific minds from industry, academia, and the public 
sector. For example, some of the specific areas the California 
state inspectors audit against include irrigation water tests, 
employee hygiene, harvesting equipment sanitation, buffer 
zones, soil amendments, wildlife intrusion, and previous land 
use. We take pride that, not only was our Vegetables business 
one of the companies instrumental in driving this state-wide 
initiative, but our Division President is currently the Vice-
Chairman of the CA-LGMA Board. Arizona has a similar LGMA 
program under development which is almost identical to the 
California program. Our Vegetables' division President also 
sits on the Arizona governing board, which is tasked with 
developing and implementing a complete audit program.
    Some would criticize this program as voluntary, but please 
understand that the only thing voluntary about it is whether to 
join or not. Once you're in, compliance and government 
inspection are mandatory. Ninety nine percent (99%) of the 
leafy greens handlers in California have signed onto the 
program--and some got encouraged into ``volunteering'' by big 
customers who would not buy their products unless they 
``volunteered.'' So compliance and inspection are, for all 
intents and purposes, mandatory for the whole industry in 
California. The CA-LGMA program, including state inspectors, is 
funded by assessments paid by signatory members.
    Some would argue that federal or state regulations would 
have been the proper avenue, instead of the CA-LGMA program. If 
time had not been of the essence, that route might well have 
made sense. The industry felt, however, that it couldn't wait 
for government to act. As a testament to our industry 
commitment to food safety, private industry developed this 
field audit program, from absolutely nothing to having 
California state inspectors in our fields performing audits, in 
less than four months.
    The fact that our industry did not have the luxury of 
waiting for government to act does not mean that we think the 
job is finished or that there is no role for government now. On 
the contrary, Dole supports national food safety standards for 
leafy greens, and the California and Arizona programs should be 
the starting point toward designing and implementing these 
standards. In the past, leafy greens food safety was considered 
a West Coast problem. However, as fuel costs continue to 
escalate, more Midwest and East Coast states, and Canada, are 
learning how to grow leafy greens in climates outside of 
California and Arizona.
    I also would like to bring to your attention another 
important industry initiative--the Center for Produce Safety, 
headquartered at the University of California, Davis. Trade 
groups, private companies, the University of California, and 
the California Department of Food and Agriculture, have funded 
the launch of this Center through grants. This Center is 
intended to be the clearing house for available produce food 
safety research, and to fund new scientific studies focused on 
strategies to mitigate risks. As discussed above, we very 
strongly believe that the federal government should play a key 
role in the research efforts.
    As a company, Dole Fresh Vegetables has under taken some 
key initiatives aimed at providing a higher level of food 
safety. First is our implementation of a trace back system that 
is RFid driven. RFiD stands for Radio-Frequency-Identification. 
The process involves placing a unique tag on every bin of 
lettuce harvested in the field. Once a bin is filled, the tag 
is scanned using the global positioning system and attached so 
that there is a tracking record of where in the field a product 
originated and where it traveled after harvest. RFiD tracking 
is not a fire wall for food safety. It does, however, provide 
real time field locations to within approximately 100 feet of 
where the product was harvested in the event trace back is 
needed. The inability to quickly trace back to a specific field 
location hampers the ability to determine the root cause of a 
problem and has been a major impediment to regulatory 
investigators, not because our industry is unwilling, but 
because the technology available until now was not adequate.
    Although Dole has made significant investments in 
developing and applying the RFiD technology to leafy greens, we 
have made this program available to anyone in the industry who 
wishes to use it, without any payment whatsoever to Dole. We 
believe that the members of our industry should compete with 
each other on quality and service, not on food safety.
    As I mentioned a few moments ago, a second initiative we 
implemented is testing for pathogens in the field prior to 
harvest. Similar to the HACCP (Hazard Analysis of Critical 
Control Points) principles developed for NASA, we believe that 
testing needs to be a part of an overall risk reduction 
strategy and that prevention before the product leaves the 
field is a critical and proactive step. We are also testing 
produce as it enters our processing plants and as it leaves as 
finished product. To date we have completed approximately 4,000 
of these tests for pathogens. As noted, thus far we have not 
had any positive test results for pathogens--at times it seems 
like we are looking for the proverbial ``needle in a 
haystack.'' With research help from government, a lot more 
testing should be done, by many more companies, and when the 
pathogens are found in this broader effort, science will have 
the data on the basis of which we can eradicate this problem.
    Other Dole Fresh Vegetables risk reduction activities 
include a full time staff of quality assurance and food safety 
specialists. Their primary function as it relates to food 
safety is to develop and implement science-based risk reduction 
strategies, as well as seek out and evaluate best practices 
within our industry as well as other food industries.
    All of Dole's fields in California are irrigated by water 
from deep wells or city water. We test the wells once a month 
during the growing season, when the water is used. We will not 
grow, harvest or purchase crops from fields that gets flooded 
with runoff from other fields, let alone from cattle pastures, 
nor from fields that are too close to a place where cattle have 
been.
    In addition, we contract with third-party food safety 
companies to supplement our auditing process, in addition to 
the state inspectors that are part of the California leafy 
greens agreement. One third-party company provides us with 
independent oversight to our field operations, and another is 
used to provide independent oversight to our salad processing 
plants. All of our salad processing plants have full time 
quality assurance staffs on site anytime the plant is 
operating. All of our plants operate under a defined HACCP 
plan, and our fields operate under a defined, formal GAP (Good 
Agricultural Practices) plan, as well as the CA-LGMA audit 
program.
    We are also working with outside vendors in developing even 
more reliable pathogen testing kits. Because of the amount of 
naturally occurring beneficial bacteria that is found on all 
produce, rapid test kits to detect pathogens that were 
developed in other industries, such as the meat or poultry 
industries, tend to give a high rate of false positives on 
lettuce.

                               Conclusion

    The produce industry needs to continue to move forward with 
refining agricultural practices as science and technology 
advance. We need government support for more research 
activities in understanding how pathogens survive and migrate 
in the natural environment. We also need research in developing 
microbial kill steps that will work on a perishable product. 
The amount of research needed is significant in both time and 
dollars. The first agenda item for any research program is to 
determine the right questions to ask. We believe that the 
federal agency best suited to address the important issues 
related to leafy greens is the USDA. The USDA already has a 
research station set up in Salinas, California, which is in the 
heart of the industry, and has extensive experience with 
various leafy greens products. USDA also has conducted some 
limited applied research on pathogens, but they have been 
limited in scope by funding.
    A group of over seventy technical experts from academia, 
government regulatory and research, and the private sector, met 
in Washington, D.C., at a research symposium co-sponsored by 
Dole, this past September, focusing on understanding how 
pathogens survive and migrate in the natural environment. 
Everyone present agreed that there is a daunting task ahead of 
us, and we just do not yet have enough science-based answers to 
some very practical questions. But we have to start somewhere, 
and we have to remain committed to the research.
    We respectfully ask this Subcommittee, and, more generally, 
the Energy and Commerce Committee, to do whatever it can within 
its power to influence significant funding of pathogen research 
for produce. Private companies such as Dole will continue to 
accelerate and champion, as fast as possible, new practices and 
technologies aimed at eliminating food safety risks. Produce is 
a living, breathing tissue that does not hold up to most 
conventional food safety practices that work in other 
industries. We cannot inspect our way out of food safety 
problems any more than we can test our way out of it. It will 
continue to take a concerted and significant effort in time and 
funding and regulation from both the government and private 
sector, to make our food system--already the safest in the 
world--even safer. We heartily agree with this Subcommittee 
that we--all of us--can, in good conscience, do no less.
                              ----------                              

    Mr.Stupak. Thank you. Mr. Eisenberg, please.

STATEMENT OF DAVID A. EISENBERG, CHAIRMAN, ANRESCO LABORATORIES

    Mr.Eisenberg. Thank you for inviting my testimony.
     My name is David Eisenberg. I am chairman of ANRESCO 
Laboratories, founded in 1943. I have been with the company 34 
years.
    While ANRESCO was a USDA accredited meat laboratory for 30 
years, from 1976 to 2006, we surrendered our accreditations 
this past year because we were rarely analyzing regulatory 
samples, and most of all because the USDA dramatically 
increased the cost for accreditation.
    The regulatory work we perform today relates to FDA 
regulated imports, and it is to this role I speak today. 
ANRESCO has performed sampling and analytical work for 
importers to meet FDA requirements since 1981. Such work 
represents 40 percent of our business. We run almost every 
analysis the FDA runs routinely. Private laboratories in total 
employ possibly 50 people nationwide to service this very small 
specialized market. ANRESCO's sampling and analytical work is 
equivalent to that performed by the FDA's own laboratories. The 
FDA regulates the food in regulated imports by reviewing import 
entries, releasing imports it considers low risk, and sampling 
and analyzing at its own laboratories, imports it believes may 
be unsafe or otherwise violate U.S. food standards. This work 
is performed under its Surveillance Program.
    When the FDA finds an imported product violates its 
standards it may place the product on Detention Without 
Physical Examination, DWPE, where the FDA considers the 
products violative until the importer proves it meets FDA 
standards. The importer does so by retaining a private 
laboratory such as ANRESCO to sample and analyze the product 
and to submit such results to the FDA. Only a very small 
proportion of FDA regulated imports are subject to DWPE.
    With this as background I am pleased to offer suggestions 
to improve the FDA's regulation of imports. Relating to its 
Surveillance Program the FDA should provide an organized forum 
where industry can provide advice into what imports the FDA 
selects for sampling. The import industry could have possibly 
advised the FDA that melamine was being added to wheat gluten 
meal in China. The FDA should reallocate its import staff so 
enforcement of its regulations is uniform among its 15 
districts. For years the FDA has been understaffed in New York 
and in Los Angeles and overstaffed at smaller ports. This leads 
to port shopping. The FDA should allow importers to use private 
laboratories that it accredits to sample and analyze samples 
under its surveillance program. This could significantly 
increase the number of shipments analyzed. The FDA should 
eliminate its current line by line review of private laboratory 
submissions that waste extensive FDA staff time. The FDA must 
have the legal authority to audit the accredited laboratories 
whenever it wants to and for whatever reason it believes 
necessary. The incentive for importers to use private 
laboratories for surveillance sampling and analysis is that 
such laboratories will perform the work more quickly than the 
FDA does itself. Shipments can then be released into commerce 
more quickly, critical to importers. Private laboratories would 
be willing to pay a fee to FDA for FDA accreditation as this 
will provide them additional work. ISO 17025 accreditation is 
not an adequate basis for assuring private laboratories are 
competent to perform work to FDA standards. The FDA must itself 
accredit private laboratories and only then will it have 
confidence in their work and then rely on it.
    Relating to the DWPE Program, while this program is 
excellent in concept and works well in practice for most 
imports, it is greatly weakened by inadequate FDA 
implementation. The FDA's Southwest Import District in Dallas 
has procedures that assure the honesty of the DWPE Program. 
These procedures should be adopted nationwide immediately. They 
include a requirement that DWPE shipments are sampled by the 
private laboratory. The New York district still allows 
importers to take their own samples. This is akin to the wolf 
guarding the sheep. The importer must advise the FDA in advance 
what private laboratory they intend to use for a given import. 
In the other districts when ANRESCO finds a violative import 
the importer usually advises us not to submit the result to the 
FDA. The importer may then find another private laboratory to 
take new samples to reanalyze the product to get the shipment 
released.
    In June of 2006 Dr. Robert Brackett, then director of FDA's 
CFSAN, at the Institute of Food Technologists meeting at 
Orlando, Florida advised the FDA did not consider pesticide 
residues in foods a serious matter and it would no longer 
monitor them. This sent a message to the produce industry that 
it was not important to comply with EPA, FDA regulations. If 
the FDA considers its regulations governing pesticide residues 
in foods unnecessary it should request Congress to change the 
law, not ignore its responsibility to enforce it.
    Twice during 2005 I met with senior FDA staff to complain 
the FDA was not enforcing its pesticide residue requirements on 
snow peas imported from Guatemala. I presented data for 25 
samples ANRESCO had taken at retail and had analyzed finding 13 
violative. I pleaded for FDA to take more surveillance samples. 
Instead the FDA reduced the number of surveillance samples it 
took. I was flabbergasted when I saw President George Bush on 
television talking from a Guatemalan farm last year praising 
that industry for developing an export business for produce 
when his appointees knew a high percentage of the product 
violated FDA standards, and they had facilitated its 
importation.
    Other suggestions, the FDA should allow the electronic 
submission of all private laboratory reports relating to food 
imports, especially perishables. It is critical that the import 
process be as quick as possible to assure compliance with it. 
The FDA should not allow importers to place their products in 
commerce before having a release, as has been the case in south 
Florida. Thank you.
    [The prepared statement of Mr. Eisenberg follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Mr.Stupak. Thank you, Mr. Eisenberg.
    Dr. Brackett, your testimony, please.

STATEMENT OF ROBERT E. BRACKETT, PHD, SENIOR VICE PRESIDENT AND 
     CHIEF SCIENCE AND REGULATORY AFFAIRS OFFICER, GROCERY 
                   MANUFACTURERS ASSOCIATION

    Dr.Brackett. Thank you, Mr. Chairman.
    Good afternoon to the rest of the committee.
    I am Robert Brackett, Senior Vice President and Chief 
Science and Regulatory Affairs Officer at Grocery Manufacturers 
Association.
    Food companies recognize our responsibility to ensure that 
the food we provide to consumers is safe. To address the 
challenges posed by rising imports and changing consumer 
preferences we constantly identify under duress potential 
sources of contamination throughout each product's life cycle. 
We have made significant new investments in food safety, 
identifying and adapting a range of practices in programs to 
reduce the risk of contamination. Food safety is our top 
priority.
    Ultimately, the burden of providing safe food falls on our 
industry, but this responsibility is shared by federal, state 
and local agencies. By setting and enforcing tough food safety 
standards agencies like FDA and USDA's food safety inspection 
service help the food industry to ensure that the safety of our 
food supply is as safe as it can be.
    Providing these agencies with adequate resources is 
critical to their ability to help the food industry ensure the 
safety of our food. As director of FDA's Center for Food Safety 
and Applied Nutrition between 2004 and 2007 I routinely stated 
to the agency the critical need for more resources. In my view, 
FDA's food safety and food related programs were willfully 
inadequate and I shared that view with the agency. But despite 
my best efforts funding for FDA food related programs barely 
kept pace with inflation. As a result more than 800 scientists, 
inspectors, and other critical staff have been lost in the last 
four years, including some of FDA's most experienced experts. 
Recent nationwide recalls remind us how devastating food borne 
illness can be and how critical it is for FDA to respond 
quickly to safety problems. It is important to maintain this 
level of response, but there is a need--but there needs to be 
an increased focus on prevention and intervention to stop these 
outbreaks from happening in the first place. The adoption of 
preventative controls to prevent contamination, the use of 
modern testing strategies to detect pathogens before the 
product is released and application of innovative new 
processing technologies to destroy pathogens all have a role in 
improving the safety of our foods.
    While at CFSAN we recommended a variety of options to 
address the safety of foods, including the proposal to improve 
produce safety that could include a requirement for tough, but 
enforceable produce safety standards. A position that is not 
only shared by, but has actually been requested by, the food 
industry and many farm organizations. The overall goals of the 
plan were to prevent contamination, minimize public health 
impact in the event that contaminated product did get into the 
marketplace, to enhance the capability to provide safe 
products, and also to improve communications to both domestic 
as well as foreign suppliers. And also facilitating and 
supporting the science that should always be the underpinning 
of any food safety effort.
    Interestingly, these recommendations contained elements 
that specifically addressed actions that were recommended later 
in the same year in GMA's four pillars document, as well as 
FDA's Food Protection Plan. Unfortunately, the Administration 
did not seek funds for the plan and Congress failed to provide 
adequate funding as well. Consequently, the industry decided to 
act on its own through promoting their and statewide 
regulations and marketing orders.
    In addition to requiring tough, but enforceable produce 
standards, Congress should also require FDA to complete their 
proposed modernization of good manufacturing practice 
standards, or GMPs, and require food importers to document the 
food safety efforts of their foreign suppliers. In the highly 
unlikely situation that a company refused to voluntarily recall 
a product that poses a severe health consequence, FDA should be 
given the power to order a recall. FDA could also do much more 
to rebuild FDA's scientific and information technology 
capacity, and could do more to build capacity of foreign 
governments to ensure the safety of our imported foods.
    The food industry supports giving FDA new responsibilities 
that would help ensure the safety of our food, but new 
responsibilities without new resources will not improve the 
safety of our food supplies. In fact, new responsibilities 
without requisite resources to carry out those responsibilities 
has just the opposite affect. It dilutes out existing efforts 
in safety and makes FDA less able to address the real food 
safety issues. Likewise, new restrictions on ports of entry, 
new penalties or any new labeling requirements will also not 
result in a safer food supply for the American people. By 
focusing our efforts on prevention, by increasing FDA resources 
and by leveraging the expertise in resources of the food 
industry itself Congress can help us meet the challenges posed 
by rising imports and changing consumer preferences.

    Thank you. I will be happy to answer any questions.
    [The prepared statement of Mr. Brackett follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr.Stupak. Thank you, and thank you to everyone on this 
panel.
    We are expecting votes. We are going to get going and see 
how many we can through here before we have to run off for our 
votes.
    We are going to go five minutes and we will probably go a 
second or third round if necessary.
    Mr. Shoemaker, we got Mr. Rodkin there. I am a little 
confused on what happens, especially on the pot pies, because 
tests performed by ConAgra or Banquet showed that all the meat 
pies were prepared with the same equipment. Since the turkey 
pot pies contained salmonella where else could the bacteria 
have come from but the turkey? I'm sorry. Yeah, go ahead.
    Mr.Shoemaker. I can only address what has happened within 
the Butterball facilities, the four walls there. I have no 
knowledge of ConAgra's facilities. But within our four walls we 
met the kill step, we met the low bacterial level and then also 
all tests within that facility have proven that it was negative 
for salmonella.
    Mr.Stupak. OK.
    Mr.Shoemaker. Also the salmonella strain that was found was 
a strain that has been found in chickens in all but one 
incident----
    Mr.Stupak. But not in the pot pies?
    Mr.Shoemaker. And in turkey only once, and that was not 
within our system.
    Mr.Stupak. Right. But there was the vote. Son of a gun. OK. 
Let me ask you this. You said you monitor and control 
temperature. Why don't you test for salmonella and other 
bacteria right after the product is cooked instead of waiting 
until it is chilled?
    Mr.Shoemaker. Whenever you look at a cook in the bag 
product, a low risk product, we have specifications from all of 
our customers how you want to check it. What are the 
specifications, whether it is a size, whether it is the regime 
on checking the product, there was not a test to check because 
it being a low risk and had gone through the kill step and----
    Mr.Stupak. So if your customer would ask you to----
    Mr.Shoemaker. In other words----
    Mr.Stupak [continuing]. Check right after the cooking, you 
would do it then before you chilled it?
    Mr.Shoemaker. Yes, we would. We would do whatever our 
customer asked.
    Mr.Stupak. OK. Does that make sense, Mr. Rodkin, then? Let 
us say on turkeys to test for salmonella after it is cooked, 
before it is cooled?
    Mr.Rodkin. I am not an expert----
    Mr.Stupak. OK.
    Mr.Rodkin [continuing]. On that, but I believe that is one 
of the steps that we have implemented subsequently. I also will 
agree with Mr. Shoemaker that they cooperated fully and we 
never were able to say exactly, precisely that it was an issue 
with the Butterball turkey. So I want to agree with that, but I 
can also--yes?
    Mr.Stupak. Where does it come from then?
    Mr.Rodkin. Yes.
    Mr.Stupak. I mean I guess that is----
    Mr.Rodkin. Yes.
    Mr.Stupak. And being a consumer and not a scientist I guess 
I am asking the same question.
    Mr.Rodkin. Sure.
    Mr.Stupak. You are telling me it is not you. You are 
telling me it is not you. Where does it come from?
    Mr.Rodkin. Well, on the first day that we became aware of 
the issue we knew very little about the source, but we did know 
as Mr. Shoemaker has said that any possible salmonella would be 
killed through proper cooking, because salmonella can't survive 
past--beyond 165 degrees.
    Mr.Stupak. Right.
    Mr.Rodkin. So consumers are not at fault. They should 
expect safe product. This generated an intensive analysis of 
our cooking directions and microwave performance. But also 
because it was our absolute responsibility to find the root 
cause in the product we took over 3,000 samples of product we 
had from finished pot pies and were able to isolate salmonella 
in just 17. Those all happened to be Banquet turkey pot pies 
from two dates in July of 2007. But despite very intensive 
investigations and analysis and cooperation we were not able to 
determine the exact, precise source of the contamination. It 
was not absolutely proven and, therefore, we had our people 
take the broadest possible approach and assume that all 
possible sources were or could be the source. And as a result 
we have made some extremely----
    Mr.Stupak. Well, let me ask you this. If it is not the 
packaging, if it is not the turkey, if it is not the machine, 
could it come from the gravy? Is the gravy made from a separate 
firm that comes into your pot pies?
    Mr.Rodkin. We have checked every last ingredient and have 
found no source of salmonella. And, therefore, because we care 
very deeply about making the safest food possible. We took a 
number of steps across the board in that facility to make sure 
that all raw materials now have tighter specifications----
    Mr.Stupak. Sure. Let me put my consumer hat back on.
    Mr.Rodkin. Yes.
    Mr.Stupak. So if you have tested everything and Butterball 
says not our fault, but yet we have salmonella, then how can 
Americans be sure that the next pot pie they buy won't have 
salmonella in it? If it is not the gravy, it is not the 
packaging, it is not the turkey, it is not the cooking, it is 
not the microwave, it is not nothing. How do we know then?
    Mr.Rodkin. Again, having made all of these changes----
    Mr.Stupak. Right.
    Mr.Rodkin [continuing]. That I was describing and in 
working in conjunction with the USDA I did mention that in the 
slightest possible chance that any salmonella could come 
through the process it would be killed with proper cooking. 
And, therefore, we took a very intensive look at our 
instructions and at microwaves.
    Mr.Stupak. Right.
    Mr.Rodkin. And found much greater variability than we had 
historically in microwaves and, therefore--this was our old 
package. Sorry it is so small. I hope you can see that. But 
importantly on the back are where the instructions are. We have 
made changes before we reintroduced the product into the 
marketplace. Took off where it says ready in four minutes in a 
microwave.
    Mr.Stupak. Right.
    Mr.Rodkin. Said microwaveable, but must be cooked 
thoroughly. See back for directions. And now the directions 
have been changed----
    Mr.Stupak. So the answer is to cook it longer for the 
consumer then, in other words?
    Mr.Rodkin. That is what----
    Mr.Stupak. I guess I am trying to--my time is up and they 
are calling us for votes. Let me ask you one more. On the Peter 
Pan peanut butter for salmonella, again, ConAgra didn't find 
it, but the FDA did. What changes were made in Peter Pan then? 
I mean I think Peter Pan you have the salmonella and said it 
was a leaky roof. That was repaired and we still found it after 
that, after a new batch, so----
    Mr.Rodkin. That is a question I need clarification on, 
because we have not found any salmonella subsequently.
    Ms.DeGette. If the gentlemen will yield. It was the FDA 
that found the salmonella.
    Mr.Rodkin. Right.
    Ms.DeGette. Not you.
    Mr.Stupak. After----
    Mr.Rodkin. And I need some clarification on that, because 
with this we are unaware of that.
    Mr.Stupak. OK.
    Mr.Rodkin. We are unaware of that because we closed the 
facility down immediately and only reopened last August. And it 
is an extremely different facility, totally redone, totally 
remade. And, again, it is because we are extremely concerned 
about, as Mr. Marler said, food safety risk is a bad business 
decision.
    Mr.Stupak. OK. Our votes are up. We got three votes on. I 
think now is probably appropriate time, Mr. Dingell, unless you 
want to go. All right. Let us--yeah. Well, we are going to 
adjourn for--until 12:50, one o'clock?
    Mr.Dingell. Yeah.
    Mr.Stupak. One o'clock, two o'clock? How about 1:50? 1:50. 
That will give us 40 minutes and we are going to have votes. 
And the first one is just up that usually extends more than 15 
minutes, so I think with three votes we better give it 40 
minutes. We will recess until then. We will be back at 1:50. 
Thank you.
    [Recess.]
    Mr.Stupak. The Committee will come back to order. Oh, mics 
are much better. Thanks.
    Mr. Shimkus, for questions, please.
    Mr.Shimkus. Thank you, Mr. Chairman.
    I want to thank the panelists for being here. I had to make 
sure I got my own processed food while I am going back and 
forth to vote. It is a glamorous lifestyle we have here, and 
this is our lunch.
    So a couple things. First of all, especially with the CEO's 
who are present. Can you maximize shareholder wealth by 
producing unsafe foods and having recalls? Yeah?
    Mr.Rodkin. First, if I might. I would just like to clarify 
when before we left for lunch there was a question on peanut 
butter. And I wanted to clarify to let you know that the 
product that was discussed that FDA found salmonella was 
recalled product. That was product that they found in our plant 
that we had already recalled. The plant had been shut down for 
six months, so this was not product out in the marketplace. It 
is the reason that we did the recall, and it is the reason that 
we had such a major renovation, total remake of our facility. 
We did not just fix the roof. It was a total facility. All the 
equipment, all the testing procedures, additional personnel. I 
can tell you it is many, many millions of dollars and it is now 
the state-of-the-art facility from a peanut butter 
manufacturing standpoint. So I wanted to just make sure I 
clarified that.
    Onto your question. Taking any kind of food safety risk is 
a really bad business decision as Mr. Marler talked about. 
There is nothing worse than thinking that one of your products 
could cause someone harm. It does damage to your brands, 
consumer perception, and that is our most valuable asset on our 
books. It harms relations with your customers. By that I mean 
our retailers, because you have to remove product from their 
shelves. And it is a big, big financial burden I can tell you 
from a peanut butter standpoint, and the corrections that I 
just talked about and all the costs of that recall are many 
multiple years of the brand's profit.
    Mr.Shimkus. And I am sure that will really kind of be a 
similar answer as far as, you know, name ID, a product line, 
safety of food, and your reliable customers. I mean it really 
does take a dive when things like this happen. I mean so 
everyone agrees with that. I mean it is not a marketing ploy to 
want to do this. In fact, it is damaging across the board. And 
I think it is also important that we understand raising a 
capital formation for the risks involved, the return on the 
investment and all those challenges that operate. Of all, we 
were talking about some on the walk over to the votes. I mean 
we do have lapses, and that is kind of what we are trying to--
the folks who are on now, because we do have a safe food 
supply. We are consuming a multitude of pounds of food in this 
country by the second, and but we do have lapses.
    When we talk about a recall, a voluntary recall, from the 
amount of the lot and the batch, whatever you all decide to 
finally--it is voluntary so you are going to recall a product 
that has been produced from one of your factories. That occurs 
after the fact that the product has been on the shelf. Someone 
has purchased it, and there has been in essence an adverse 
reaction. So if you take the lot, the 100 percent of the 
product line, from whatever window you decide the recall needs 
to occur, how much--what percentage actually returns? How much? 
What percentage actually consumed and gone? So when--if you 
were to receive everything back. Say you say, OK, let us do a 
voluntary recall of peanut butter, and it is going to be this 
lot of whatever. What percentage actually would come back? And 
in this case you were given the answer to the question of the 
Chairman of the reinspected of the lots that had returned. But 
how much? What is it, 10 percent of a product line that once 
you recall after it has been out in the consumer sector and 
some of it had been consumed, some of them purchased and 
probably in some--on some shelf somewhere? What is the 
percentage? Why don't we just go to the top four food 
processors here.
    Mr.Rodkin. I can't give you an exact percentage. I can tell 
you it is significant. And, I guess, the most----
    Mr.Shimkus. What is that, 50--what is it? I mean----
    Mr.Rodkin. Well, I think the most important thing is in the 
case of our two recalls, we recalled total production, 
everything, 100 percent. And that meant destroying all of our 
own inventory, taking all the product, 100 percent of the 
product, off the retailer's shelves.
    Mr.Shimkus. But a lot of that had been consumed and 
purchased in the food chain, correct?
    Mr.Rodkin. It is possible that some of it could have. I 
mean----
    Mr.Shimkus. I am a big peanut butter eater.
    Mr.Rodkin. Yes.
    Mr.Shimkus. All right. So we go through peanut butter 
pretty quick in our household. So a lot of that, if it is--my 
question is--and I don't want to be simplistic. But, yeah, how 
much product, if you are just doing a basic percentage of any 
type of product, how much is actually returned to you all in a 
recall?
    Mr.Rodkin. Yeah. In the case of peanut butter it was very 
significant. I don't know exactly what the numbers were. I 
can----
    Mr.Shimkus. As significant at 30 percent?
    Mr.Rodkin. Yes.
    Mr.Shimkus. Twenty-five percent?
    Mr.Rodkin. Yes, at least that.
    Mr.Shimkus. At least. Is that normal? Why don't we--Mr. 
Shoemaker?
    Mr.Shoemaker. I think that when you are talking about this 
I think there is different types of premises you have got to go 
by. We have never had a recall at Butterball, but we do mock 
recalls. And within our mock recall it goes back to do you know 
where your product's coming from? We have the ability by daily 
lots on some products to break where the lots are. And on some 
of the products, depending on their risk level, might be test 
and hold. So 100 percent of that product might be in our own 
facility, but it just depends on your category of risk as to 
what our percentage of products would be that we would capture 
back.
    Mr.Shimkus. Mr. Lischewski?
    Mr.Lischewski. We have a--our example is a bit more 
specific. When we did the Castleberry's recall we recalled over 
two years worth of product until we isolated the problem. When 
we isolated it down to two product codes, to this date we have 
been able to pull back approximately 74 percent of the product 
under our control. Now, on top of that we allowed retailers, 
rather than return it to us, to destroy product at their 
location. And consumers were allowed to destroy product at home 
and just send in for a refund regardless of whether it was one 
of the actual product codes involved, or any of our other 
products. So 74 percent of ours are able to track absolutely. 
The other 26 percent, again, we are not sure how much of that 
would have been destroyed by retailers, consumers, or it would 
have been consumed.
    Mr.Shimkus. Mr. Ray?
    Mr.Ray. Congressmen, our situation, our recalls required 
our--recommended that consumers destroy the product and not 
return it. And so we had a very low percentage of product 
returned.
    Mr.Shimkus. How do we know that the consumers comply? I 
mean the reality is you have--the postal service clerks can--
canned foods for food shelters and stuff. How--we just don't 
know do we?
    Mr.Ray. No.
    Mr.Shimkus. I mean we all hope that they do. We are hoping 
that they, first of all, know about it. Even though our best 
efforts, we don't--our best effort is to educate the consumers 
that they have trouble. But then we don't, we really don't know 
where, especially when you are asking the consumer to destroy 
it.
    Mr.Ray. In our particular situation most of our products 
that have been affected have been food service products, so we 
have been able to go to the distributor. The distributor then 
can go to their consumer. And I think it can get good 
withdrawal in that scenario.
    Mr.Shimkus. Let me finish. And Mr. DeLorenzo, I'm sorry. I 
didn't want to leave you out there. Yeah, the camera is 
blocking mine.
    Mr.DeLorenzo. Yes. On the--we have perishable products for 
the most part that we are talking about here, and so we even 
have a--percent actually returned, but----
    Mr.Shimkus. Can you check and see if there should a button 
or two?
    Mr.DeLorenzo. There is a green light. I thought it was on. 
So the bags that were actually returned are few. How much is 
destroyed as we say? I will say though, Congressmen, that from 
what I could see from this last recall there was very, very 
good coverage in the media. The radio--I think it must be by 
law that every radio station, every television station. So I 
think at least from that perspective there was very, very good 
coverage. But in terms of what is actually returned it is a 
small amount.
    Mr.Shimkus. The--and finally, all these cases are 
different. They have, you know, different criteria. It is great 
for the panel to understand the enormity of the problem, but it 
is very difficult to, you know, get into each little--I am not 
going to get into each little manufacturing problem or stuff, 
so I would like to end this. Obviously there we have had 
problems, and we would like to get to zero defects. We know we 
don't live in a perfect world, but everybody wants this, and it 
is good for you, it is good for your shareholders, it is good 
for the safety of our constituents. How many of these--and I 
also, from a military background having watched the Army IG and 
inspector general come down and say I am from, you know, the 
IG. I am here to help you. Usually that is not always a good 
sign. And though I think they are intended to be helpful, 
sometimes we feel them as not being as helpful as they can be. 
So what, in your estimation, is the aspect of some of these 
problems either in good manufacturing practices or the lack 
thereof? Lack of federal regulations or legislation, or 
nominally that we are talking about with these changes in 
pathogens that is unidentifiable? I mean a lot of these things 
there is a valve that didn't close or didn't open. We have 
other issues. What do we need to do to be--we would like to be 
from the Federal Government. We would like to be helpful. We 
would like not to be harmful. So give us your things on how we 
can be helpful, and go with Mr. Rodkin.
    Mr.Rodkin. One thing I would say is that while I don't 
really want to speak for the regulatory bodies, FDA, USDA or 
CDC, I would tell you that if we could have, we as the 
manufacturers, could have access to the information earlier in 
the process, rather than right at the very end it would help us 
to protect consumer health. It would allow us to take any kind 
of necessary actions sooner, rather than having it dumped all 
at once and then have to spring into action. So we would like 
to be brought into the process much sooner.
    Mr.Shimkus. I think that is a great response. Thank you. 
Mr. Shoemaker, anything?
    Mr.Shoemaker. I think it goes back to your HACCP Program 
and your processes and procedures, and how strict you have your 
HACCP Program. The industry writes their HACCP Program. I have 
had a lot of people come into our facilities and say, you do 
not manufacture product for productivity the way you 
manufacture product and overcooked product and do things for 
lethality of bacteria. That is what you work for, and that is 
what we do focus on. It is for food safety. And it depends on 
the degrees within your HACCP Program as to how tight you want 
to do it. You can overdo and you can do at a marginal level. 
Our philosophy is to overdo.
    Mr.Shimkus. Mr. Lischewski?
    Mr.Lischewski. I think one of the areas where we see an 
opportunity is really more consistency. You know, if you look 
at our Augusta factory, we run both USDA and FDA products and 
so in some cases we are under two different types of criteria 
in terms of the product that we are producing.
    Mr.Shimkus. Mr. Ray?
    Mr.Ray. I would say a very important issue for us is 
research, continued research in food safety. In our particular 
situation as we are dealing with an issue that we have not 
gotten to the conclusion at this point in time, some of the 
research that we are looking at goes back into the early 
1980's. And to be able, as an industry, to fund research to 
learn more about food safety of canned and canned low acid 
vegetables would be very important to us.
    Mr.Shimkus. And, Mr. DeLorenzo?
    Mr.DeLorenzo. I think that there has to be a clear 
regulation and very definitive regulation as to procedures of 
processes and testing that entire industries have to follow. 
And there has to be complete transparency, and it should work 
on both sides on part of the FDA, USDA and the industry so that 
any and all records are immediately available. There is no such 
thing as Mr. Eisenberg testified earlier that someone could 
take a test and then hide it somehow. So this transparency is 
very important and I think clear and definitive guidelines are 
important. I think on the one big issue that concerns me the 
most is this E. coli problem, and their research is definitely 
necessary.
    Mr.Shimkus. Thank you. And I am going to end with that, but 
I was just going to follow up with a statement. That I found 
interesting about both panels is the fact that this really goes 
back to real time information. If we are talking about the 
health and safety of the public food source then I don't care 
who has information. That information needs to go to folks that 
can take action on that. There shouldn't be a delay, you know, 
whether it is law enforcement or whether it is proprietary 
information based upon the people that you are contracted to do 
testing for. We have got to have a way to have the information. 
The sooner the information, the better.
    So thank you, Mr. Chairman, you have been very generous 
with the time. I yield back.
    Mr.Stupak. Thank you, Mr. Shimkus.
    Mr. Dingell, for questions, please.
    Mr.Dingell. Mr. Chairman, thank you.
    Mr. Eisenberg, when a food importer employs your lab to 
take samples and analyze that for submission to FDA, to satisfy 
the agencies requirements under import rules, who owns the 
rights to the results?
    Mr.Eisenberg. The importer.
    Mr.Dingell. The importer?
    Mr.Eisenberg. We are working for the importer.
    Mr.Dingell. What are the rights of FDA with regard to that 
information?
    Mr.Stupak. Mr. Eisenberg, put your mic on, would you 
please, sir?
    Mr.Dingell. Does FDA have the right to that information or 
not?
    Mr.Eisenberg. The FDA, in its procedures, requires that we 
sign a laboratory director's statement that we are submitting 
all work that we have done on a sample. And if an FDA district 
requires that statement we research our records and provide all 
the work that we did.
    Mr.Dingell. But automatically get that information or not? 
Is there a great toe dance that goes on before they get it or 
do they get it right away as a matter of rights?
    Mr.Eisenberg. Well, in that situation they would get all of 
it right away, however, if the importer tells us not to submit 
the information to the FDA, the FDA never sees it.
    Mr.Dingell. Under what circumstances do they keep this from 
FDA? When, how and why?
    Mr.Eisenberg. Well, sometimes they may want to keep a clean 
record on their item, on their food item, with the FDA.
    Mr.Dingell. So they don't send it to Food and Drug?
    Mr.Eisenberg. That is right. They don't submit--they advise 
us, tell us, not to submit the work.
    Mr.Dingell. Food and Drug doesn't know what the situation 
is?
    Mr.Eisenberg. That is right. The importer may re-export the 
product. We don't know.
    Mr.Dingell. And that could be something coming in with 
salmonella or mercury or----
    Mr.Eisenberg. Sure.
    Mr.Dingell [continuing]. PCBs or some kind of bacterial or 
viral contamination, right?
    Mr.Eisenberg. Yes.
    Mr.Dingell. OK. Now, if somebody imports, for example, 
shrimp from China, which is currently under import alert and 
you test for antibiotics or fungicides and find excessive 
levels what happens to your report?
    Mr.Eisenberg. If the importer tells us not to submit it to 
the FDA we don't submit it to the FDA. If we see something that 
we view as being an imminent hazard to public health, which is 
very, very rare, we advise the importer of this and then we 
check with the importer to make sure that they have reported 
the problem to the FDA. And if they had not reported the 
problem, then we would. We had two situations where importers 
took our laboratory reports and whited out information on our 
reports that was harmful to the entry of the import. In those 
cases we had no choice. We went to the FDA and immediately 
advised them of what had happened.
    Mr.Dingell. So it is perfectly legal for you, then, to 
discard the analysis without informing the FDA?
    Mr.Eisenberg. Yes.
    Mr.Dingell. And you can do that at the instigation or 
request of the importer. Is that right?
    Mr.Eisenberg. Yes.
    Mr.Dingell. All right. Now, the FDA has made a big point to 
say that it is the private lab, and not the importer, that 
decides from the place in a shipment, that is which bag, box 
location in the container, or where in the warehouse the 
samples are taken. Is it your experience that the importers 
make such a decision for you and/or for your competitors? They 
decide which parts of the, you know, the lot from the import 
that is going to be scrutinized?
    Mr.Eisenberg. An analysis is only as good as the sample 
taken.
    Mr.Dingell. That is correct, because it is not----
    Mr.Eisenberg. And if we take a sample we will sign a 
collection report that we sampled the shipment without bias. We 
are not saying that we sampled it in a random way. And if we 
sign that report that we took it without bias then we were 
responsible for the sampling, and no one directed us as to what 
the sample, and we did our best----
    Mr.Dingell. But you are never----
    Mr.Eisenberg [continuing]. To make sure the sample is 
representative.
    Mr.Dingell. But you are not required to make a random 
sampling are you?
    Mr.Eisenberg. No. And if you have 40 pallets of product it 
is unrealistic to ask the importer to bring down all 40 pallets 
to look at.
    Mr.Dingell. All right. Now, in your statement you say that 
you lost your Miami business, because you could not--rather you 
would not give the importers the results they wanted. Would you 
supply, then, for the records of the committee either publicly 
or privately the names of the importers that chose to move to 
less reputable competitors and have you not delivered that kind 
of information to Food and Drug and the public? To--either 
publicly or privately? I leave the choice to you.
    Mr.Eisenberg. I could try to provide it.
    Mr.Dingell. All right. Don't try to provide it, do provide 
it. And we will expect to have it.
    Mr. Chairman, I am not going to ask that that be inserted 
in the record, but I do want to have it. I do want to receive 
that.
    Mr.Eisenberg. Our Florida laboratory was a branch 
operation. I was advised by our manager of the laboratory on 
various occasions when this occurred, but I was not directly 
involved. And our manager is now elsewhere, because we closed 
the Florida laboratory due to lack of business and due to the 
corrupt situation in south Florida.
    Mr.Dingell. All right. Now, in the same vein, will you 
please supply us with the names and the circumstances 
surrounding each instance where you were asked to discard 
violative findings by a client? You can do that either for the 
record or privately to the committee.
    Mr.Eisenberg. That we should be able to do.
    Mr.Dingell. OK.
    Mr.Eisenberg. And we can simply see all the violations that 
were never reported.
    Mr.Dingell. We would like to receive that, and we will put 
it in the record or use it in other fashion.
    Now, Mr. Rodkin, you did test the lots of Peter Pan peanut 
butter that were found to contain salmonella that sickened over 
600 people. Is that correct?
    Mr.Rodkin. That is correct.
    Mr.Dingell. And your microbiologic testing found two jars 
contained this toxin, but you failed to inform Food and Drug of 
the finding. Is that right?
    Mr.Rodkin. I am not aware of that specific instance. Can 
you give me the details on that? The timing?
    Mr.Dingell. It was October.
    Mr.Rodkin. Of?
    Mr.Dingell. October 2004.
    Mr.Rodkin. I am somewhat aware of that situation, but that 
was prior--I arrived a year later.
    Mr.Dingell. OK.
    Mr.Rodkin. So I don't really know the details of that.
    Mr.Dingell. Now, from October 2004 forward your in-house 
product testing found no salmonella. Is that correct?
    Mr.Rodkin. That is correct.
    Mr.Dingell. Now, but CDC identified Peter Pan peanut butter 
as the source of the 2007 outbreak. Is that correct?
    Mr.Rodkin. That is correct.
    Mr.Dingell. Now, in the staff briefings, in the ConAgra 
testimony of last year, your company blamed the salmonella 
incident on a roof that leaked for a week over late July and 
early August in 2006. Is that correct?
    Mr.Rodkin. Everything that we know points to water being 
the source of the salmonella issue. The roof leak was cited as 
one possibility and the other was a malfunction in a sprinkler 
system.
    Mr.Dingell. Now, after the hearing was over, however, the 
committee learned that FDA took jars of Peter Pan peanut butter 
from ConAgra warehouses in February of last year, that's 2007, 
and found 14 out of the 130 jars sampled contained salmonella 
Tennessee. Can you explain why such a large percentage of jars 
tested by Food and Drug discovered the toxin, but ConAgra's 
tests did not?
    Mr.Rodkin. I am not a scientific expert, but I can tell you 
that salmonella requires water to germinate, to grow, and it 
takes time for that to develop. And our product testing had 
been done on the line when the product was produced. So it is 
possible to take a significant amount of time for that 
salmonella to show up.
    Ms.DeGette. Will the Chairman yield?
    Mr.Dingell. Certainly. I would be glad to yield.
    Ms.DeGette. That testing that the FDA did though last year 
was after you fixed the roof and the sprinkler system, correct?
    Mr.Rodkin. That testing was on product that had been 
recalled, not on new product that had been produced.
    Mr.Dingell. So you say this is with regard to product that 
was recalled and not new product for distribution?
    Mr.Rodkin. That is correct. And, in fact, the plant was 
shut down for over six months and totally redone. We did not 
just repair the roof. We totally remade the plant at a cost of 
many, many millions of dollars, changed all the processes. That 
is a totally different plant today.
    Mr.Dingell. Now, we seem to have a difference of opinion 
here. FDA said that this was out of the warehouse and was not 
from samples of the product that was recalled. How do we 
explain that?
    Mr.Rodkin. Our product--my understanding of that timing 
that you are talking about our plant had been closed, and all 
product had been recalled, and the FDA came in and tested 
product that we had recalled. Potentially that came out of a 
warehouse and was returned to us.
    Mr.Dingell. Now, I am told that the production dates on 
this particular lot were as late as January 2007, which is some 
six months after the leak in the roof was fixed. How do we 
explain that?
    Mr.Rodkin. I need to make sure I have my dates right. But 
all of--yes. All of the product prior to shutting the plant 
down was recalled, so that fell into that timeframe.
    Mr.Dingell. I don't quarrel with that statement, sir, but I 
note that some of the jars that FDA labs found positive for 
salmonella Tennessee had production dates as late as January 
2007. Some six months after the leak in the roof was fixed. 
Now, did ConAgra know of the FDA lab results on April 24, 2007, 
when your vice president for manufacturing testified before 
this subcommittee?
    Mr.Rodkin. I am not aware of that.
    Mr.Dingell. All right. Does FDA share the results of these 
kinds of tests with ConAgra?
    Mr.Rodkin. That is the normal procedure.
    Mr.Dingell. And when did they do that here? Do you know?
    Mr.Rodkin. I do not know that specifically.
    Mr.Dingell. Now, if you got results prior to 4/24/07, then 
can you explain to us how you can blame a leaky roof for 
samples which were marked with a production date after the date 
that the roof was fixed?
    Mr.Rodkin. I'm sorry, sir. I am--I do not know the answer 
to that.
    Mr.Dingell. Now, what other questions.
    Gentlemen, thank you. Mr. Chairman, I thank you for your 
courtesy.
    I yield back the balance of my time.
    Mr.Stupak. Thank you, Mr. Chairman.
    Ms. DeGette, for questions, please.
    Ms.DeGette. Thank you, Mr. Chairman.
    Now, Mr. Rodkin, I want to thank you for coming personally 
today. I know it can't be a happy experience for you, and I am 
not happy myself, because since the beef recall in 2002 we have 
had ConAgra in front of this committee talking about E. coli, 
salmonella in peanut butter. In your opening statement you 
didn't talk about the popcorn line, but one of those people 
actually lives in Colorado, my home state. And now here we are 
with salmonella in the pot pies. And the thing that is 
frustrating to us, as members of the Oversight and 
Investigations Committee, most of us have been on this 
committee for some years now, is every 6 months or a year you 
folks are in with some new problem. And our constituents are 
stopping us and saying, what can you do to make our food safer? 
So it seems to us that many of the industries represented here 
really are making a good faith effort, including ConAgra, to 
improve the situation, but it is all done in a reactive way. 
The peanut butter's contaminated, so you fix the roof. So the 
popcorn line is making people sick, so you take that additive 
out of the popcorn, and on and on. What I am interested in, and 
I think what Mr. Stupak and the Chairman are interested in and 
the folks on the other side of the aisle, is how can we stop 
food from being contaminated. And one thing that you talked 
about and that we have talked about is these recalls, and so 
let me ask you first about the recalls in the pot pie outbreak 
and the subsequent recall. Now, ConAgra heard about people 
getting sick on October 8. Is that correct?
    Mr.Rodkin. We first learned of that on Monday, I believe 
October 11. It was whatever Columbus Day was.
    Mr.DeGette. OK. So you learned on October 11. And then you 
said that you immediately issued--that is not right? OK. Staff 
says that is not right. They are saying it is October, Friday, 
October 8. But be that as it may, what happened next was there 
was a consumer advisory issued, correct?
    Mr.Rodkin. A consumer advisory was, which means telling 
consumers not to eat the product, and telling----
    Ms.DeGette. And how was that disseminated?
    Mr.Rodkin. I am not aware of the exact details.
    Ms.DeGette. OK.
    Mr.Rodkin. But I can tell you it was done in conjunction 
with the USDA.
    Ms.DeGette. Now, why wasn't a recall issued instead of a 
consumer advisory, which is the next step up?
    Mr.Rodkin. We were working with the USDA and they asked us 
to do a consumer advisory. The next day----
    Ms.DeGette. So it was because the USDA asked you to do it?
    Mr.Rodkin. We were working collaboratively with the USDA.
    Ms.DeGette. Well, you know, that is kind of a lawyerly 
answer. Did ConAgra say to the USDA, well, we think we will 
issue a consumer advisory, and they said OK, or did the USDA 
say we want you to issue a consumer advisory?
    Mr.Rodkin. The----
    Ms.DeGette. That makes a difference to me.
    Mr.Rodkin. We worked together with the USDA.
    Ms.DeGette. And you decided jointly to issue a consumer 
advisory and not a recall?
    Mr.Rodkin. The USDA asked us to do that, and we agreed.
    Ms.DeGette. OK, thank you. Now, at some point then was 
the--the pot pies were recalled, correct?
    Mr.Rodkin. The next day after the advisory we at ConAgra 
decided there might possibly be some consumer confusion, so we 
decided to make it a total recall of all of our pot pies.
    Ms.DeGette. So why did you decide there would be consumer 
confusion?
    Mr.Rodkin. Because we were doing our own analysis and 
investigation with our customers and consumers, and decided 
that----
    Ms.DeGette. What did you think they would be confused 
about?
    Mr.Rodkin. That they might not get the full impact of the 
advisory, and we wanted to go all the way to a total recall.
    Ms.DeGette. OK. And so then you recalled all the pot pies?
    Mr.Rodkin. Correct.
    Ms.DeGette. Now, I have introduced legislation the past 
couple years giving the USDA mandatory recall authority. What 
is ConAgra's position on that legislation?
    Mr.Rodkin. We believe that mandatory recall for any company 
that is not cooperating is fine. We would agree with that.
    Ms.DeGette. But you think that the company should have the 
ability to do voluntary recall first?
    Mr.Rodkin. We believe that a company should do what is 
right.
    Ms.DeGette. Right, OK. But your answer, again, was kind of 
a hedge answer, because you said we believe in mandatory recall 
authority if they don't do the right thing.
    Mr.Rodkin. If we are presented with the----
    Ms.DeGette. But my question is let us say the USDA is 
presented with a situation where they have a serious problem 
with some food. And let us say they have a manufacturer who 
says, well, we are going to do some more testing, we are going 
to do some different things, and then we will decide what to 
do. Do you think that the USDA should have the ability to come 
in and say, this is such a public health risk, we are going to 
mandatorily recall this product?
    Mr.Rodkin. I can't speak for other companies, but----
    Ms.DeGette. No, I am asking you as the chairman of ConAgra.
    Mr.Rodkin. If it was ConAgra and they presented us with 
that information----
    Ms.DeGette. No, no. I am asking you should they have the 
ability to do that? Yes or no?
    Mr.Rodkin. For any company that is not cooperating we 
believe mandatory--we would support mandatory.
    Ms.DeGette. But if--now, who defines are they cooperating? 
You, the company?
    Mr.Rodkin. In the instance that you just talked about I 
would consider that not cooperating.
    Ms.DeGette. OK. Well, who decides that? The company or the 
USDA?
    Mr.Rodkin. The USDA.
    Ms.DeGette. Thank you. Now, one last thing. I think a lot 
about this mandatory recall issue, and the problem with 
mandatory recall is once you--or a consumer advisory, once you 
are doing it that horse is out of the barn. That product is out 
there on the shelves, and the mothers are buying the jars of 
peanut butter and putting them on the sandwiches for their 
kids. They may not--you know, I tell you they may not see the 
consumer advisory, which we don't even know to disseminate it. 
They may not even know about the recall, so this is my 
question, and I just want you to think about this. And if 
anybody else wants to try me, and I would be happy to hear your 
view. What can we do to beef up the FDA's and the USDA's power 
in cooperation with industry to make sure that that product is 
safe when it goes out, so we don't have to rely on recalls, 
which are a faulty way of getting products back?
    Mr.Rodkin. I think it is incumbent upon the industry to act 
responsibly, and I believe that we have. We have taken very 
prompt actions as soon as we learned of any issues, spent 
significant resources proactively. That is time and money to 
raise our standards, made very proactive precautionary change 
across the entire company. And, in fact, in our approximate 
$450 million capital budget, the number one priority on a go 
forward basis is safety.
    Ms.DeGette. So you don't really think anything in addition 
can be done, except for the industry making a commitment?
    Mr.Rodkin. I think the primary responsibility is on the 
industry, and also to cooperate 100 percent are priorities.
    Ms.DeGette. Because they have done such a swell job so far. 
Thank you very much, sir.
    Mr.Stupak. I hate to say this to this panel, but we have 
got votes again. They told us it would be awhile, but obviously 
they were wrong in their guesstimation. We have got about three 
minutes left--the votes. And we got a Motion to Recommit, so it 
is probably going to be 3:15 by the time we get back, so we are 
going to stay in the recess until 3:15. Other members have 
expressed interest about asking the panel's questions of this 
panel. So we are going to ask the panel to hold.
    3:15, see you back here at this time. We will stand in 
recess.
    [Recess.]
    Mr.Stupak. OK. The Committee will be back in order.
    Let me remind all witnesses we are still under oath. Sorry 
about the delays. We thought we were just going to have a few 
votes, and it ended up being more than what we thought. But the 
good news is we are done with votes, so hopefully we can get 
this panel done, and we can finish up today. The bad news is 
the SCHIP hearing is done so members may be coming in for more 
questions.
    Let me go with the questions. Again, everyone is under 
oath.
    Mr. Rodkin, if I may, I hate to continue to bring up this 
about the salmonella, but we were just getting conflicts in 
answers up here from facts of what we know. And then as you 
know this came up at a previous hearing, so we are getting 
conflicting information.
    In response to the peanut butter contamination outbreak has 
ConAgra gone back and tested products for salmonella on peanut 
butter?
    Mr.Rodkin. Yes.
    Mr.Stupak. OK.
    Mr.Rodkin. We certainly have on an ongoing basis with much 
more rigorous testing in a totally renovated and revamped new 
plant.
    Mr.Stupak. OK. And in that testing ConAgra found, have they 
not, they found salmonella in peanut butter produced in 2004, 
2005, 2006, 2007?
    Mr.Rodkin. The only peanut butter that I am aware of that 
was tested for salmonella was in 2006. I am not aware of the 
other dates.
    Mr.Stupak. So you don't know in 2004, 2005 or 2007? You are 
not aware of it?
    Mr.Rodkin. I am not aware of those dates, just 2006.
    Mr.Stupak. OK. For the record would you go back and check 
with your folks----
    Mr.Rodkin. Yes.
    Mr.Stupak [continuing]. And get this thing cleared up once 
and for all?
    Mr. Eisenberg, if I may. In your testimony, page 2, it says 
the purpose of the PICSC, Pacific Import Community Steering 
Committee, right, was to provide a conduit for information from 
the FDA to the regulated import community, and from that 
community back to the FDA in the public interest to assure and 
improve FDA's regulation of imports. The three sections would 
meet three times a year by televideo conference. It says the 
FDA ended its involvement or sponsorship of the PISCA in early 
2006. Is that correct?
    Mr.Eisenberg. Yes, that is correct.
    Mr.Stupak. Why did they end this relationship where private 
industry is trying to work with you and others to detect import 
problems and imports with food?
    Mr.Eisenberg. Well, they advised me that they were meeting 
with different groups, and that they were creating different 
groups that they wanted to meet with. And they were no longer 
interested in meeting with the PISCA group.
    Mr.Stupak. Did they give you any indication of what these 
other groups--who these other groups were?
    Mr.Eisenberg. No.
    Mr.Stupak. OK. Who terminated this? Who did you learn this 
from at the FDA?
    Mr.Eisenberg. Mark Rowe, the acting regional director.
    Mr.Stupak. OK. In a question--in your answer to a question 
that Chairman Dingell, that because of the corrupt situation in 
south Florida you closed your office. Explain that.
    Mr.Eisenberg. Well, first of all, the FDA had deregulated 
or was not enforcing their regulations with regard to 
pesticides residues, especially in snow peas. So a significant 
part of the market, of the business down in south Florida, had 
evaporated. It no longer existed. But also we were the first 
people to open a laboratory in south Florida, and we worked, we 
spent a lot of money, we tried--we did excellent work. But 
along the way a gentleman who had actually worked for us for 
six months left and set up his own laboratory with two leased 
gas chromatographs. A Dunn and Bradstreet report indicating $68 
is the maximum amount of his assets or whatever, and the FDA 
accepted his reports on an equal basis. And I, you know, his--I 
cannot prove it, but I do not have confidence that all the work 
that he did was honest.
    Mr.Stupak. OK. Is your lab certified by the FDA?
    Mr.Eisenberg. The FDA does not certify any laboratories. It 
doesn't accredit. What it has done is it will disqualify labs 
that it finds due to deficient work.
    Mr.Stupak. OK.
    Mr.Eisenberg. And we are not disqualified. We do work 
nationwide and we are not disqualified.
    Mr.Stupak. Well, when there is an alert and you are asked 
to test a product, a company comes to you and says I got to get 
this import alert lifted, I have to test this product. It has 
to be tested, what three times, before it is allowed to 
continue on?
    Mr.Eisenberg. At least five times, then the importer must 
file various paperwork that I am not----
    Mr.Stupak. OK.
    Mr.Eisenberg [continuing]. Knowledgeable about. Sometimes, 
though, the FDA may say, well, we are not satisfied with five 
clean shipments. We want 10 before we even go and review the 
paperwork.
    Mr.Stupak. Well, whatever the number is.
    Mr.Eisenberg. Normally a minimum of five shipments.
    Mr.Stupak. And when you do tests, the test results go to 
who? The FDA or their client who asked you to do their tests?
    Mr.Eisenberg. We generate the results and then we request 
in writing from the importer confirmation that we should submit 
the results to the FDA.
    Mr.Stupak. OK. If you do not get a confirmation from the 
importer what do--are you allowed to ship those results into 
the FDA or not?
    Mr.Eisenberg. We are afraid of--we have a fiduciary 
relationship to our client, so if they tell us not to submit 
the results we don't submit them.
    Mr.Stupak. Do you know of any reason why any tests your or 
any other lab does should not simultaneously, whether it is a 
positive or a negative, go to the FDA and to the client 
shipper?
    Mr.Eisenberg. I think it absolutely should go to the FDA 
concurrently with when it goes to the shipper, but this is not 
the--this is not in the FDA rules at this point in time.
    Mr.Stupak. Right, correct. OK.
    Mr. Lischewski, if I may, a couple questions. You indicated 
in testimony that Castleberry products were recalled due to 
risk of possible botulism contamination, correct?
    Mr.Lischewski. Correct.
    Mr.Stupak. Aren't there about 90 products that were looked 
at possibly that might have been contaminated?
    Mr.Lischewski. Correct.
    Mr.Stupak. And, I think, you said in your previous 
testimony that two products were found to have problems?
    Mr.Lischewski. That is correct.
    Mr.Stupak. And these two products you had the lot codes and 
you were able to recall what they were. Is that correct?
    Mr.Lischewski. Yes.
    Mr.Stupak. OK. Botulism typically occurs in low acid canned 
foods when those cans are not heated long enough and to high 
enough temperatures that kill the spores that could cause 
botulism, correct?
    Mr.Lischewski. Correct.
    Mr.Stupak. OK. And did you tell our committee staff that 
botulism contamination on your products occurred when certain 
products were not heated to a high enough temperature to kill 
the spores which cause botulism?
    Mr.Lischewski. Yes, that is correct.
    Mr.Stupak. OK. And is it true that under the heating 
process was caused by a malfunction of a valve at the bottom of 
your retort system? A system that heats the canned foods?
    Mr.Lischewski. Yes.
    Mr.Stupak. And because of the type of food that you produce 
both FDA and USDA would be in your Augusta, Georgia plant where 
this botulism problem may have occurred, correct?
    Mr.Lischewski. USDA was at the factory every day.
    Mr.Stupak. USDA.
    Mr.Lischewski. But FDA was also there. We produce products 
and they are both jurisdictions, but FDA only comes on an 
inspection basis.
    Mr.Stupak. OK. This malfunctioning valve, explain that to 
us. If FDA's there and if that is one of the areas or USDA--if 
that is one of the areas you check, I'm curious, why didn't 
anyone catch it?
    Mr.Lischewski. The valve basically, the type of equipment 
that we used for sterilization, is produced by a company called 
Malo. And what happens is these tanks are full of water, 
product--canned product goes in, water is pumped out----
    Mr.Stupak. Correct.
    Mr.Lischewski [continuing]. Through this valve and steam is 
applied to sterilize.
    Mr.Stupak.
    Mr.Lischewski. The malfunction of the valve allowed some 
water to stream back into the bottom of the container such that 
some of the cans were submerged in water. The design of these 
particular retorts did not allow for any reporting of 
temperatures at the bottom of----
    Mr.Stupak. How about visually? I mean visually wouldn't you 
see the water in the cans?
    Mr.Lischewski. No, these are stainless steel containers.
    Mr.Stupak. Right, these retorts.
    Mr.Lischewski. You can't see inside of them.
    Mr.Stupak. OK.
    Mr.Lischewski. So, again, normally we look at pressure 
gauges and we look at temperature gauges to monitor the 
performance of the retort. The small amount of water in the 
retort didn't allow us to see any deviations in the pressure. 
And the fact that there weren't temperature gauges throughout 
at the bottom of the container we couldn't see the difference 
in temperatures.
    Mr.Stupak. So in your situation it was both the water plus 
temperature?
    Mr.Lischewski. Correct. The fact that cans were in the 
water----
    Mr.Stupak. Right.
    Mr.Lischewski [continuing]. And the steam was going onto 
the regular cans, but that particular water caused a partial 
sterilization. So that when we went through our normal quality 
protocol post processing where we normally would have picked up 
an under processed product the fact that some heat had been 
applied meant it went through our normal process, and didn't 
basically grow the botulism bacteria until after it has been 
released.
    Mr.Stupak. So when your finished product was done----
    Mr.Lischewski. Yes.
    Mr.Stupak [continuing]. Before you shipped is there testing 
then that you do?
    Mr.Lischewski. Yeah, we basically----
    Mr.Stupak. Or does it----
    Mr.Lischewski. Once the product is finished, the day after 
processing, we do an organ analeptic evaluation of the product. 
And we also put the product on a three day incubation, so if a 
product had not been sterilized then that product would swell 
and we would pick it up before it ever went into our 
distribution channel. Given that it was partially sterilized 
and there were no control mechanisms within the Malo retort 
that allowed us to see that or see variations that product 
actually made it through our process.
    Mr.Stupak. And you said swell. You mean the can itself 
would swell?
    Mr.Lischewski. The can itself. If it wasn't sterilized the 
protein inside would swell and you would be able to notice it 
in the product.
    Mr.Stupak. And that would occur within three days?
    Mr.Lischewski. Yes.
    Mr.Stupak. OK.
    Mr. Ray, let me ask you then, because in the FDA reports I 
saw you actually had swelling in the cans from what the FDA 
said. Right in front of you is a book there, sir. You may want 
to go to Tab No. 41. This is--and the reason why I want you to 
go there is it is form No. 483 of the FDA. Because in your 
testimony you stated our investigation is still underway and we 
have not yet determined--have not yet--excuse me. Have not yet 
received key information from the FDA about their findings. But 
when I look at this reform here, this form 483----
    Mr.Ray. Um-hum.
    Mr.Stupak. It looks pretty clear to me. You received form 
483, right? You are familiar with that form?
    Mr.Ray. Yes, we did on February 15.
    Mr.Stupak. OK. And the FDA confirms that botulism spores 
were found in four cans, correct?
    Mr.Ray. That is correct.
    Mr.Stupak. OK. And is it not true that the botulism spores 
were found in four water wells that the company uses?
    Mr.Ray. That is correct.
    Mr.Stupak. OK. And before you use these water wells didn't 
you use to use water that was treated with chlorine?
    Mr.Ray. That is correct. Well, we used----
    Mr.Stupak. Chlorine would kill the botulism spores, right?
    Mr.Ray. No, that is not correct.
    Mr.Stupak. OK. But, OK, so they found it in cans and they 
found it in the wells. Then the company used the water from 
these wells to cool the cans after they have been cooked, 
right?
    Mr.Ray. That is correct.
    Mr.Stupak. OK. Then is it not true that the FDA believes 
that botulism spores entered the cans through loose seams after 
being cooked while the cans were being cooled?
    Mr.Ray. That is correct. You had asked about the 
chlorination. The chlorination for the drinking water levels 
would only be probably one to two parts per million.
    Mr.Stupak. Sure.
    Mr.Ray. To actually destroy the C.bot spore----
    Mr.Stupak. Sure.
    Mr.Ray [continuing]. It would have to be probably 10 to 20 
times that.
    Mr.Stupak. But to use these wells you had to check to see 
if they contained any spores or any bacteria that might be 
harmful in your food process did you not?
    Mr.Ray. No, we did not. That is not normal process. We 
would do potability testing. We would test the water every four 
months and return the information to the district health 
department.
    Mr.Stupak. Then how did the botulism spores then get in 
these four wells then?
    Mr.Ray. We did not anticipate or did not test for--in 
history prior to FDA drawing samples we had never tested, nor 
is it industry practice, to test--to have botulism in water 
wells, or botulism spores, I should say.
    Mr.Stupak. The FDA stated that the post process botulism 
contamination in low acid canned food products has only 
occurred about four times since 1940. It is very rare for this 
to happen.
    Mr.Ray. Right.
    Mr.Stupak. But the FDA determined that you manufactured 
multiple lots of low acid canned foods with lose seams, and 
that was--and the company was aware of the lose seams before 
the FDA investigation was it not?
    Mr.Ray. No, we were not, sir.
    Mr.Stupak. Well, in that form right there at observation 
#6.
    Mr.Ray. OK.
    Mr.Stupak. Does it not indicate that the company was aware 
of the lose seam problem?
    Mr.Ray. Observation #6. The observation I see in front of 
me was that the FDA came in and made an observation that they 
felt that some of our technicians were not properly evaluating 
the double seams.
    Mr.Stupak. Right. And that, therefore, you didn't have any 
many as you should have in these cans which would cause 
problems with it?
    Mr.Ray. As many--I don't understand the question.
    Mr.Stupak. You were supposed to have somebody crimping the 
cans are you not?
    Mr.Ray. Well, the condition of the seam itself is evaluated 
by a technician.
    Mr.Stupak. And you didn't have a qualified individual who 
could detect that. Is that not what they found?
    Mr.Ray. We felt--they--we felt we had qualified 
technicians.
    Mr.Stupak. You felt that, but the FDA did not?
    Mr.Ray. That is correct.
    Mr.Stupak. OK. In your testimony you stated that botulism 
spores are regarded as so unlikely to be found in water that 
testing was not a standard procedure. But isn't there a 
regulation that states that low acid canned food manufacturers 
must chlorate their water or sanitize the cooling water used in 
the process?
    Mr.Ray. I believe it does depending on the use of the 
water, sir.
    Mr.Stupak. And it is also on that finding that you didn't 
consistently do this. Either use the chloride water or sanitize 
cooling water used in your process, correct?
    Mr.Ray. There was a point in time that our former quality 
service manager had through some corrosion studies ceased using 
chlorine. That was a mistake.
    Mr.Stupak. Right, it is observation no. 7 there. So the 
bottom line on this whole thing was number one, you didn't have 
a qualified person to check on the cans and the crimping that 
which led to lose seams, which is susceptible to botulism 
contamination. And you didn't treat or test the water that 
might enter the cans through these lose seams, which could have 
lead to botulism, correct? Those are the two findings of the 
FDA.
    Mr.Ray. Well, I think the one thing to make clear about is 
that chlorination, that the chlorination of drinking water, it 
was not sufficient enough to destroy the C. botulism spores.
    Mr.Stupak. Well, again, looking at Exhibit 41 there, here 
is what the FDA observed. That you failed to properly evaluate 
defective lots in a timely manner to assure that there are no 
potential public health hazards associated with your finished 
products. Your firm's employees did not conduct a complete 
spoilage diagnosis to determine whether spoilage was due to 
under processing or post process leakage. Corrective action was 
not taken in a timely manner to remove and destroy defective 
spoiled cans, to fix the problem causing the spoilage, whole or 
portions of effective lots were observed with swells, buckled 
or defective seams in the warehouse. Isn't that correct?
    Mr.Ray. That is what the work order says, sir.
    Mr.Stupak. You don't feel your company was responsible for 
that? Well, I think I would like to ask--maybe you don't want 
to admit it.
    But Mr. Lischewski was telling us about the can would swell 
within the three days. Your company actually had employees take 
the swelled cans and put them in a process where they pressed 
the can back to basically hide the swollen cans, right?
    Mr.Ray. We had debuckled--back several years ago there was 
some debuckling of cans by some employees. I think in 2005.
    Mr.Stupak. Well, according to the FDA your firm, and again 
I am reading from the report now, reshaped cans of LACF 
products that exhibited evidence of buckling by using a hand 
press to push the can ends back into place. These debuckled 
cans were then released from the hold status and made available 
for sale to your customers. Isn't that true?
    Mr.Ray. That is correct.
    Mr.Stupak. So I mean if you didn't know about the water, 
you didn't know about crimps or the seams, you certainly knew 
about the buckling. You certainly knew you had a problem, but 
you continued to sell them to your customers.
    Mr.Ray. The circumstances of what you are talking about 
were two very different points in time. The buckling of the 
cans occurred based on recommendation of our can supplier back, 
I believe, in 2005. The situations in which we are talking 
about in these observations are defective lots that were--
observation 1C, for example, that we had defective lots that we 
did not handle on a timely basis. Those defective lots were 
lots that we had identified as processed deviations.
    Mr.Stupak. Right. But this is from November 26, 2007 to 
February 15, 2008, top right-hand corner. I mean that is when 
this report is, and that is when they found these cans and your 
debuckling.
    Mr.Ray. We would to--I'm sorry, sir. Could you repeat the 
question?
    Mr.Stupak. Sure. You said that they were from some time, 
but this report, this 483, Exhibit----
    Mr.Ray. Um-hum.
    Mr.Stupak [continuing]. Report 483. Actually date of report 
is 11/26/2007 it looks like 2/16/2008, right?
    Mr.Ray. That is correct.
    Mr.Stupak. So these findings were during that period of 
time, so they weren't from 2005.
    Mr.Ray. The debuckling was from a prior time.
    Mr.Stupak. So you still had the cans on the premises?
    Mr.Ray. No, we did not, sir. We had them at a prior time.
    Mr.Stupak. Mr. Lischewski, the buckling of cans and them 
pressing them back is that a standard procedure within the 
industry?
    Mr.Lischewski. No.
    Mr.Stupak. OK. Mr. DeLorenzo, let me ask you this. We had 
testimony here--and I think last we were talking about E. coli 
spinach and lettuce and all this. That we have had about 20 
outbreaks in the Salinas Valley within the last 10 years, 
correct?
    Mr.DeLorenzo. I am not sure how many.
    Mr.Stupak. Somewhere around there. About every 6 months we 
seem to have one of these. I'm sorry. You got to turn on your 
mic. Has Dole--you are the largest producer in that area, or 
processor. Have you done anything to try to figure out what is 
going on here? It seems like if you have one of these salad 
problems, E. coli, problem, every 6 months you want to do 
something. I mean I have asked the FDA the same question, and 
they just look at me like, you know, what to do. I mean an 
epidemiology study I have suggested to them. Have you suggested 
anything like that?
    Mr.DeLorenzo. Yes. I think the industry is desperate to 
make sure there are no more incidents or recalls. As I 
described, the industry got together and has put a very, I 
think, significant food safety processing and protocol in place 
for the farming and processing. I personally co-funded just a 
few months ago a seminar here in Washington, because I wasn't 
satisfied either with the answers that we are getting. That 
this E. coli is prevalent and nobody has a kill step, and 
nobody is exactly sure where it is coming from. So we had a 
seminar----
    Mr.Stupak. And what did you learn from that seminar?
    Mr.DeLorenzo. I learned that we----
    Mr.Stupak. No answer?
    Mr.DeLorenzo. No answer. We had 70--we had approximately 70 
scientists from Academia. We had the USDA, FDA scientists. And 
my, perhaps naively, agenda was to come away from that after 
two days of being here with all these people who had studied 
this for many, many years, mostly out of the meat industry--
that is where most of the E. coli studies have come from. 
Basically what they--the conclusion was A, that they are not 
sure where it comes from. Obviously cattle is the primary--
cattle droppings is the primary cause. They are not sure how it 
migrates. They are not sure how it lives, is able to live in 
the environment that we have. They are not sure how it avoids 
the kill step in the chlorine wash that we have.
    Mr.Stupak. Well, then we would--irradiation that we talked 
a little bit about today. Would that help solve this problem in 
the Salinas Valley?
    Mr.DeLorenzo. We have an irradiation--we had an irradiation 
expert from, I think, he was from Texas, and we are still 
working with him. Unfortunately, with irradiation of fresh 
produce it tends to cook the product so we haven't gotten over 
that one yet. But we are actually going to be funding some work 
that he is going to be doing. And I will admit it is very, very 
disconcerting when it comes to E. coli.
    Mr.Stupak. Well, let me ask you this. The produce industry 
had called on the FDA to enter tough new regulations regarding 
the handling of fresh produce; however, the FDA has not done 
this. It has been reported that earlier this year the FDA came 
up with new regulations on handling of fresh produce. These 
regulations were intended to replace existing voluntary 
guidelines. That is what is in place now, right? And according 
to the Wall Street Journal, May 16, 2007, the FDA proposal, and 
I am quoting now, went nowhere after it got a cold reception 
from the Department of Health and Human Services. The article 
states the FDA plan, which would have cost $76 million over 
three years was rejected after it was presented in February at 
HHS headquarters. Would you want to see mandatory regulations?
    Mr.DeLorenzo. Yes, I would.
    Mr.Stupak. OK. Were you involved in helping to put together 
any of these mandatory, or Dole or anyone, putting together 
these mandatory regulations that were presented to the 
secretary in 2007?
    Mr.DeLorenzo. Let me--do you mind if I just ask a question, 
because I wasn't----
    Mr.Stupak. Sure.
    Mr.DeLorenzo [continuing]. At the company at that time? I 
guess we were involved indirectly through the trade groups, and 
then directly in California with the Leafy Greens Agreement 
that the industry put in place.
    Mr.Stupak. OK.
    Mr.Shimkus. Can I----
    Mr.Stupak. Sure, go ahead. Jump in. Mr. Shimkus wants to 
jump in, and we might go back and forth here for a bit. Go 
ahead.
    Mr.Shimkus. I was just going to give you a chance to get 
your breath.
    Mr.Stupak. I am just getting warmed up. Go ahead.
    Mr.Shimkus. That is what I am afraid of. The--just going 
back, Mr. DeLorenzo, just on the timeline. The spinach that we 
are talking about, you were a purchaser of that, correct, and 
then have you now changed the processes where you are the 
producers now? It is more in-house where you are attempting to 
try to get control?
    Mr.DeLorenzo. Yes, we agree.
    Mr.Shimkus. That is kind of the timeline then I heard.
    Mr.DeLorenzo. Right. We are taking everything in-house now.
    Mr.Shimkus. And that--why are you doing that?
    Mr.DeLorenzo. Well, I am doing it more just to make sure 
that we have complete control over the processes. And I am not 
trying to blame the other company, because I think it was a 
reputable company. But there is enough--in the fresh business 
there is enough variables that I just felt it was important to 
have everything in-house.
    Mr.Shimkus. I mean I heard that in the opening and the 
questions, and I think that when you--I mean you have better 
control of the operation when it is yours. And obviously there 
are risks in----
    Mr.DeLorenzo. Can I jump in?
    Mr.Shimkus. Yes.
    Mr.DeLorenzo. Are you talking about the Natural Selection 
one? The hearing we had last time, Natural Selection?
    Mr.Shimkus. Yes.
    Mr.DeLorenzo. Natural Selection have seen then testified 
that they have gone through and testified the leaf as they 
process it now.
    Mr.Shimkus. Yes. Did you do that or do you still rely upon 
Natural Selection or----
    Mr.DeLorenzo. We are doing our own testing. As I said since 
that incident we have done over 4,000 tests on our products 
both field and in processing, and so far they have all come up 
negative.
    Mr.Shimkus. OK. What you and Natural Selection are doing, 
is that the exception to the rule or do most producers now do 
that?
    Mr.DeLorenzo. No, I think most producers. The Salinas 
Valley is very, very motivated to eliminate this problem, 
because every farmer's livelihood is based on this. And so I 
think that there has been a very good industry movement. More 
than I----
    Mr.Shimkus. OK. Natural Selection said they were the only 
one, you would be second. So this would all be since September 
of 2007, I think, was the last recall.
    Mr.DeLorenzo. I am not sure how much testing every company 
is doing, but I am pretty sure all the large companies are 
testing.
    Mr.Shimkus. Thank you.
    The--Dr. Brackett you have been on the end there, quiet, 
and just a couple questions to you. Mr. Eisenberg testified 
that when you were assistant and director you advised, in June 
2006, that FDA would no longer monitor pesticide residues in 
foods because the agency did not consider the residues a 
serious matter. Can you comment on this?
    Mr.Eisenberg. Yes, Mr. Shimkus. I am glad I have the 
opportunity to respond to that. In fact, I never did say that 
we didn't consider it a serious matter. Any violation of the 
law was a serious matter. And it wasn't just IFT, but in other 
locations I said with the limited amount of resources we were 
going to focus on those things that had the biggest public 
health impact at that time. So if it was a matter of testing 
for something that was killing children, like E. coli 157H7 or 
a violative pesticide, we were going to go on saving children.
    Mr.Shimkus. Mr. Eisenberg, you state you lost business 
because of this. Can you restate that for us, please?
    Mr.Eisenberg. I'm sorry. Can you repeat the question?
    Mr.Shimkus. You--I am just restating that you, because of 
the decision, you closed down operations, lost business. I mean 
I am just----
    Mr.Eisenberg. That is correct. The FDA had substantially 
reduced the number of shipments that it stopped for detention 
without physical examination, analysis and sampling. And then 
what little work was left was being taken by a laboratory that 
we could not compete with.
    Mr.Shimkus. Mr. Brackett, based upon the testimony you have 
heard today, do you believe that the case studies and, you 
know--that is what we have in a multitude of different aspects. 
Do you believe that the case studies are representative of 
general problems found in the food processing arena?
    Dr.Brackett. Well, I think it is a good selection of the 
type of problems that could be found. You have got a variety of 
different commodities oriented here, and they all have 
similar--well, they all have differences because of the science 
involved, but they all have some similarities too, and they all 
point to five different things that we can think of. One of 
which is that we have got to resource the regulatory agencies 
so they can oversee the industry the way that would help them. 
Secondly, we think that it would help if the industry as a 
whole was mandated to have a plan where they actually looked 
down the line what was going to happen and then had remediation 
steps to deal with those. Thirdly, also to be able to, as Mr. 
DeLorenzo said, we do believe that they should have some sort 
of mandatory baseline safety rule for produce industry, again, 
to make sure that that is taken care of. And secondly, also, 
which was in our pillar one at the Grocery Manufacturers 
Association, to make sure that importers require of the 
companies that are importing to them documentation of the 
safety practices that they are engaged in so that we can 
facilitate commercial. And then of course part of this that we 
have talked about too is supporting mandatory recall when the 
manufacturer delays or refuses to do it.
    Mr.Shimkus. And finally, just going back, Mr. Brackett, and 
you kind of mentioned it on the import end, because on the 
first panel we had the--Mr. Williams talked about some of those 
challenges that they are facing. Anything in that first panel 
that you could respond to, to help clarify some of the 
testimony there?
    Dr.Brackett. With respect to which part are you asking?
    Mr.Shimkus. Well, I mean obviously formerly with the FDA 
there was a lot of--while you served, you know, there. And I 
was just giving you the opportunity to respond to anything that 
you thought that you may need to respond to out of the first 
panel.
    Dr.Brackett. Well, I think out of the first panel probably 
what Mr. Marler said was probably the most significant is there 
is a lot of calls for regulations, and while I was there were 
called for regulation standards, and in some cases they are 
needed. But a regulation based on no or bad science is going to 
be more problematic for the industry than putting something out 
there. We do have to have more science. We need to have that as 
a foundation of our regulations, but there are things that we 
can do now, and some of the things I just mentioned a moment 
ago are some of them.
    Mr.Shimkus. Thank you, Mr. Chairman.
    Mr.Stupak. Thanks.
    Mr. DeLorenzo, if I may, 2005 Dole had a recall. What was 
that on? Spinach? Do you know? E. coli? It was something. I 
forget what it was.
    Mr.DeLorenzo. We did have a recall on E. coli in 2005 also.
    Mr.Stupak. Was that on spinach or lettuce or----
    Mr.DeLorenzo. No. I think it was other leafy greens.
    Mr.Stupak. OK, OK. In your testimony you gave me the 
impression that Canadians had a recall on your product there in 
2007, possible E. coli, on packaged salad. And you didn't 
believe the Canadians or----
    Mr.DeLorenzo. No, we----
    Mr.Stupak. I got the impression. I mean----
    Mr.DeLorenzo. No, no, no. We immediately had a recall. What 
happened is that when you have a--when we had the recall we 
pulled in product and we tested everything that--all product 
that came in from consumers.
    Mr.Stupak. Right.
    Mr.DeLorenzo. From the Canadians that they had, and from 
whatever products we retained in the plant. Whenever we run the 
plants we retain products off the line----
    Mr.Stupak. Right.
    Mr.DeLorenzo [continuing]. So that we have the bags that we 
can go back to. So all of those came up negative. There was no 
sight of the E. coli. There was also no sign of E. coli when 
the different federal and state agencies came through and the 
Canadian government came through. Our plants and our farms. So 
the only thing I said is it remains a mystery of where this 
came from and how it happened and how we could prevent it 
again. And so there is a possibility it could be a laboratory 
error. That is always a possibility, but we are not taking it 
as a laboratory error. We are saying that science says that 
this is possible. There could be one cell out there----
    Mr.Stupak. Right.
    Mr.DeLorenzo [continuing]. In one bag at any time.
    Mr.Stupak. Well, the----
    Mr.DeLorenzo. That is what we really need to do the 
research.
    Mr.Stupak. And I think that is a good point based upon your 
earlier testimony. This Canadian example, because all this 
costs, all the follow-up with bags that were out there could 
have been a laboratory error, right?
    Mr.DeLorenzo. It is always possible, yes.
    Mr.Stupak. I mean so there--that was a huge response.
    Mr.DeLorenzo. Yeah. I think that one thing that we would 
like to do in any regulation is that I think that there should 
be transparency on both the regulating side and the company's 
side. I think the company's records should be an open book on 
any kind of--we did ask the Canadian government if we could go 
look at the tests just to double check them.
    Mr.Stupak. Right.
    Mr.DeLorenzo. And we weren't allowed access to it. But that 
is--we are not saying it wasn't.
    Mr.Stupak. Well, have you ever done a recall and then found 
out later the tests were all wrong? I mean before there is a 
recall, let us face it, there are tons of tests, right?
    Mr.DeLorenzo. Well, in this case there was just one bag 
of--they had----
    Mr.Stupak. OK.
    Mr.DeLorenzo. As I understand it there is a number of bags 
of lettuce that they did, and in one bag they found E. coli. 
And when we went back to double--we did go back and asked can 
you do more testing on that bag, but there was nothing left. 
They said it had been destroyed.
    Mr.Stupak. Well, let me ask you this. Because you said in 
your testimony, you talked about Dole's testing for pathogens. 
You said you test for pathogens in the field prior to harvest. 
You test pathogens that enter your processing plant, and you 
test produce as it leaves as a finished product. How many 
companies do that? I mean you got three testing processes going 
on here, right?
    Mr.DeLorenzo. And we test water also in the field.
    Mr.Stupak. OK.
    Mr.DeLorenzo. So it is four.
    Mr.Stupak. All right.
    Mr.DeLorenzo. Let me--may I just ask our----
    Mr.Stupak. Sure.
    Mr.DeLorenzo. He is saying that all of the major--he 
believes that all of the major vegetable companies in the 
Salinas Valley are doing it.
    Mr.Stupak. That is all since about 2007 then, right?
    Mr.DeLorenzo. Yes.
    Mr.Stupak. OK.
    Mr.DeLorenzo. Since the spinach.
    Mr.Stupak. When you test the water do you test the water 
you use in other countries? I mean some of your products come--
--
    Mr.DeLorenzo. Yes.
    Mr.Stupak [continuing]. From Mexico and other areas.
    Mr.DeLorenzo. Yes.
    Mr.Stupak. OK. Mr. Brackett, just a couple of questions if 
I may. You were at the FDA and the agency essentially, from our 
point of view, set back in a passive position and relied on 
companies to follow voluntary guidelines to ensure the safety 
of food. Do you believe in relying on voluntary guidelines is 
still a sufficient means to protect our Nation's food supply?
    Dr.Brackett. Well, Mr. Chairman I think it depends on what 
you are talking about the voluntary guidelines do. I think 
there is a role for a baseline set of mandatory standards that 
can be done if you have got the scientific information done. 
But then there are----
    Mr.Stupak. But what do we have right now? We have voluntary 
standards, right?
    Dr.Brackett. Well, there are still some----
    Mr.Stupak. As a general rule it is a voluntary standard.
    Dr.Brackett. Food, Drug and Cosmetic Act. So----
    Mr.Stupak. Right.
    Dr.Brackett [continuing]. For adulterated food that is 
mandatory. The specifics is where really guidance fits in 
better and where you are going to have a change in some of the 
knowledge. That is where guidance needs to be used.
    Mr.Stupak. So is--you are now with the Grocery 
Manufacturers. Are you for voluntary or do you want to see 
mandatory guidance in this area?
    Dr.Brackett. Both. I think that there is a place for 
mandatory standards on which you place voluntary guidelines.
    Mr.Stupak. OK. So Grocery Manufacturers, like Dole is doing 
right now.
    Dr.Brackett. Um-hum.
    Mr.Stupak. They are testing the field, testing the plant, 
testing the finished product and they test all water sources. 
Do you think that should be mandatory or voluntary?
    Dr.Brackett. No, I don't think that part should be 
mandatory. I think that----
    Mr.Stupak. Why not?
    Dr.Brackett [continuing]. Testing is sort of a mistaken way 
of protecting the product if you have no other preventative 
controls to rely on.
    Mr.Stupak. What point should it be tested then?
    Dr.Brackett. Well, I think----
    Mr.Stupak. If it is not in the field, if it is not in the 
processing plant, if it is not in the water, if it is not in 
the finished product, where should we test it?
    Dr.Brackett. Well, the place for testing that is not the 
issue here. The issue is it shouldn't become contaminated in 
the first place. The work has to be done to prevent 
contamination. If you have no kill step, if you have no other 
way then you should be testing the water and----
    Mr.Stupak. But we don't live in a perfect world.
    Dr.Brackett. No.
    Mr.Stupak. OK.
    Dr.Brackett. But until we get to a point where we can use 
irradiation or something else there is a role for testing, but 
being----
    Mr.Stupak. Well, what testing would your organization, 
Grocery Manufacturers Association, what testing would you 
support? I mean the only testing we really have right now are 
people getting sick.
    Dr.Brackett. Well, that is right, and we can't have people 
getting sick. But the point is, is that testing is such a 
prescriptive action that if you mandate that, any particular 
type of test, that prevents better tests from being developed. 
We want whatever is used to be the very best that science 
provides, and that is a moving target.
    Mr.Stupak. It is a moving target?
    Dr.Brackett. Right.
    Mr.Stupak. So these 91 recalls we have had in the last 14 
months since it is a moving target we can continue to expect 
it?
    Dr.Brackett. No. I think we need to drop that. I want to 
Mr. Marler out of business. The way you use testing is in 
conjunction with the regulations that you talked about together 
with the best processing practices that you talk about. There 
is a role for testing, but putting that into a rule is not the 
most appropriate use for it.
    Mr.Stupak. And you can't articulate what testing should be?
    Dr.Brackett. Well, you should--well, there is different. 
There are five different ways that you can test. You can test 
for quality standards. That is not going to help you. You can 
test for a specific pathogen. You are going to miss some and it 
is going to get out there, and then consumer confidence is 
going to be eroded again.
    Mr.Stupak. Sure.
    Dr.Brackett. So you want to have a series of barriers. You 
want to have prevention. You want to have preventative controls 
to eliminate them. You want to have the testing to make sure 
that those are working.
    Mr.Stupak. And whose responsibility should that be? The 
government or the manufacturers of this?
    Dr.Brackett. That should be the manufacturers. We are 
responsible for the product.
    Mr.Stupak. Would you agree with the Science Board when they 
recently testified before the committee that the FDA does not 
have the capacity to ensure the safety of the food for our 
Nation?
    Dr.Brackett. Well, let me just state for the record also 
that being an employee of GMA now I can't really respond from 
the FDA's side. What I can say is that the FDA's comprised of 
some of the most talented people I have ever worked with, and 
they have every bit of ability to do something. If you have 
more than one something at a time, and that is where the races 
are done, they spend probably more time than they need to 
responding to things, rather than being able to plan ahead and 
build a system that they would like to build.
    Mr.Stupak. Right. So Science Board says they don't have the 
capacity to protect our Nation's food supply. Do you agree with 
that or not?
    Dr.Brackett. Again, they have the ability to protect one 
event, or maybe two, but when you build--or protecting is not 
the same.
    Mr.Stupak. Do they have the ability to be pro-active?
    Dr.Brackett. They have the knowledge and the ability. They 
don't have the resources to do that.
    Mr.Stupak. I asked Mr. DeLorenzo about the Wall Street 
Journal article and FDA's proposal went nowhere. Did you 
present that to the secretary of Health and Human Services at 
the time in your role as FDA?
    Dr.Brackett. Yes, I did, and in fact that was a proposal. 
That was at a time when we noticed the number of outbreaks of 
produce related illnesses going up. And it was an informational 
meeting. We went and presented this to the Department of Health 
and Human Services and provided several different options that 
could be done, one of which was mandatory standards. We also 
made sure that we----
    Mr.Stupak. So what happened to mandatory--why did mandatory 
standards get turned down?
    Dr.Brackett. Well, it wasn't turned down. That was not a 
decision making meeting. It was really to lay out before HHS 
what the problem is, what some of the solutions might be, and 
then that is the point at which----
    Mr.Stupak. Well, did you expect HHS to get back with you 
then with the options that were laid out at that meeting?
    Dr.Brackett. At some point, yes,
    Mr.Stupak. Have they ever responded? HHS ever respond back?
    Dr.Brackett. Well, there was never a response back for 
that. What happened in the intervening time is we had other 
outbreaks that occurred. In the meantime we had melamene, we 
had all of the other things----
    Mr.Stupak. Well, wouldn't all these other outbreaks then 
reinforce your request to the secretary of HHS that you have 
some mandatory standards if you are having more and more 
outbreaks? As the problem was growing wouldn't you go with your 
strongest recommendation as opposed to not?
    Dr.Brackett. Well, I think at that point that was something 
that we needed to enter in the discussion. We had no idea 
exactly what that meant to our regulation, other than the fact 
that there had to be some baseline level of mandatory 
protection for our produce.
    Mr.Stupak. Was the implementation of $76 million to 
implement this program over three years? Was that one of the 
reasons why it was rejected?
    Dr.Brackett. Well, it wasn't rejected. We presented it 
before them. And I asked our staff when we prepared that plan 
to put a budget and a timeframe together so that decision 
makers would know what it would take to do it right and what 
resources would be required in a timely way.
    Mr.Stupak. Let me ask you this. We are talking about 
regulations here. The Food Safety Inspection Service has 
announced plans to change its policy in identifying co-signees 
in a food recall, but the rule seems to have become bogged down 
in the bureaucracy at the United States Department of 
Agriculture and the OMB. Is the industry, Grocery 
Manufacturers, fighting the rule and what are the merits and 
problems with telling customers that they may have potentially 
dangerous food on their shelves?
    Dr.Brackett. Well, I have to be honest I am not familiar 
with that whole issue. A lot of that happened before I came to 
GMA, so I am going to have to defer on that.
    Mr.Stupak. OK. Is there someone in your organization who 
could comment on that?
    Dr.Brackett. There would be, but I am not sure who the best 
person is. I can get that information to you, Mr. Chairman.
    Mr.Stupak. OK. Well, let me ask you one more. A statement 
by Mr. Eisenberg bothered some of us on the committee. He told 
us in his testimony that twice during 2005 he met with the 
senior FDA staff. The second time with Margaret Glavin, 
Associate Commissioner for Regulatory Affairs, to complain the 
FDA was not adequately enforcing its pesticide residue 
requirements on snow peas imported from Guatemala. You are 
familiar with that?
    Dr.Brackett. I--yes.
    Mr.Stupak. OK. The testimony goes on to say I presented the 
data for 25 samples that they had taken at a retailer in the 
greater Miami area during 2004 and analyzed with 13 being 
violative of FDA standards. I pleaded with the FDA to take more 
surveillance swabs and then to place violative shippers on the 
import alert status as they had done in prior years. Even 
though the FDA had found a high percentage of violations itself 
the result of my pleading was FDA reduced by 50 percent the 
number of surveillance samples analyzed. Does this represent 
the FDA sort of surrendering in the war against unsafe food 
imports from other countries?
    Dr.Brackett. No, I don't think it represents surrendering. 
I think it really represents a prioritization under limited 
resources. Again, having the right amount of resources to both 
food safety as well as pesticide analysis. And again, what I 
said, making sure that we put some plans in place to make sure 
that we can document what is being done in other countries to 
make sure that those pesticides are not applied. But again, it 
ultimately comes down--and I am not sure why Ms. Glavin made 
that decision. But it probably had to do with fact, what are 
you going to do with your resources? Are you going to spend it 
on something that is immediately public health significance or 
something that is a violation, a technical violation, of the 
regulation?
    Mr.Stupak. Should the FDA--and I am asking you because you 
were there for quite awhile. Should the FDA be encouraged to 
apply strict liability standards to food processing operations? 
Specially should executives be criminally prosecuted for 
repeated failures to supply food free of contamination to their 
customers?
    Dr.Brackett. No, I don't think that that is going to make 
the food supply any safer at all. As was stated earlier by some 
of the others it is really bad business for companies to be 
involved in outbreaks. If, unless of course, the person has 
knowingly and wantonly allowed a product to go out in----
    Mr.Stupak. Well, what about those cattle today? Downer 
cows? So far two people who were at that plant have been 
charged. The people working in the yards, but no one higher up 
is taking any responsibility for this.
    Dr.Brackett. Well, not being familiar with the USDA side, 
but I really can't comment other than that they violated the 
law and legal action was taken.
    Mr.Stupak. OK. I can go a little longer if you want me too. 
OK.
    I think that should probably conclude this panel for now. I 
don't see any other members present. But I should also note for 
the record that during our hearing today FDA sent out yet 
another recall notice on imported fish products that may be 
contaminated with botulism spores. So we have yet another 
recall to add to our charts.
    And with that I will dismiss this panel. Thank you very 
much all of you for being here. Some of you even promised us 
some information. We look forward to seeing it as we will 
continue our hearings on food and drug safety. With that I will 
dismiss this panel. Thank you all for being here.
    I want to thank all of our witnesses for coming today and 
for their testimony. I asked unanimous consent that the hearing 
record will remain open for 30 days for additional questions 
for the record. Without objection the record will remain open. 
I ask unanimous consent that the contents of our document 
binder on the desk there be entered in the record. Without 
objection the documents will be entered in the record.
    That concludes our hearing. Without objection this meeting 
of the subcommittee is adjourned.
    [Whereupon, at 4:30 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                      Statement of Hon. Gene Green

    Mr. Chairman, thank you for holding this hearing today on 
food contamination in the private sector. I think it is 
important that we continue to have these hearings to address 
the issue food contamination in the US.
    Each year in the US there are approximately 76 million 
cases of foodborne illness and in the past year there have been 
numerous high profile food product recalls involving meat, 
fish, and vegetables.
    This committee has held numerous hearings on the issue of 
contaminated food and the safety of our food. These hearings 
have continuously highlighted the fact that the FDA and 
industry need to do more to make sure our food is safe to eat.
    While the hearing today focuses on incidents in private 
sector and industry responsibility, I want to point out that 
the FDA needs to improve their food inspection system. I 
believe that many of the outbreaks that have recently occurred 
can be directly linked to a poor inspection system.
    During these hearings on food safety, I have spoken many 
times of the need for more FDA inspectors at our ports. I 
represent the Port of Houston and I actually spent one day on 
the docks as they unloaded cargo and saw how the products are 
inspected.
    It is clear to me that the FDA does not have enough 
inspectors to inspect the food and products that are entering 
our country.
    If the FDA needs to hire third party inspectors or partner 
with another agency like the Department of Agriculture, then 
the FDA should do so to ensure product safety.
    It is our responsibility to make sure that the FDA has the 
resources it needs to protect us from contaminated food 
products. We can't point out the problem without offering some 
solution as well.
    If we need to provide more funding to allow the FDA to do 
its job then we should do just that. Consumers should be able 
to purchase food without having to worry about botulism, E. 
coli, salmonella, or pesticides in their food.
    I want to thank our witnesses for appearing before the 
committee today and thank you Mr. Chairman for holding this 
hearing. I yield back my time.
    
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