[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



 
  THE SALMONELLA OUTBREAK: THE CONTINUED FAILURE TO PROTECT THE FOOD 
                                 SUPPLY
=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE

                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                           FEBRUARY 11, 2009

                               __________

                            Serial No. 111-2


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov



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                    COMMITTEE ON ENERGY AND COMMERCE

   HENRY A. WAXMAN, California, 
             Chairman
JOHN D. DINGELL, Michigan
  Chairman Emeritus
EDWARD J. MARKEY, Massachusetts
RICK BOUCHER, Virginia
FRANK PALLONE, Jr., New Jersey
BART GORDON, Tennessee
BOBBY L. RUSH, Illinois
ANNA G. ESHOO, California
BART STUPAK, Michigan
ELIOT L. ENGEL, New York
GENE GREEN, Texas
DIANA DeGETTE, Colorado
  Vice Chairman
LOIS CAPPS, California
MIKE DOYLE, Pennsylvania
JANE HARMAN, California
TOM ALLEN, Maine
JAN SCHAKOWSKY, Illinois
HILDA L. SOLIS, California
CHARLES A. GONZALEZ, Texas
JAY INSLEE, Washington
TAMMY BALDWIN, Wisconsin
MIKE ROSS, Arkansas
ANTHONY D. WEINER, New York
JIM MATHESON, Utah
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA CHRISTENSEN, Virgin Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont                 JOE BARTON, Texas
                                       Ranking Member
                                     RALPH M. HALL, Texas
                                     FRED UPTON, Michigan
                                     CLIFF STEARNS, Florida
                                     NATHAN DEAL, Georgia
                                     ED WHITFIELD, Kentucky
                                     JOHN SHIMKUS, Illinois
                                     JOHN B. SHADEGG, Arizona
                                     ROY BLUNT, Missouri
                                     STEVE BUYER, Indiana
                                     GEORGE RADANOVICH, California
                                     JOSEPH R. PITTS, Pennsylvania
                                     MARY BONO MACK, California
                                     GREG WALDEN, Oregon
                                     LEE TERRY, Nebraska
                                     MIKE ROGERS, Michigan
                                     SUE WILKINS MYRICK, North Carolina
                                     JOHN SULLIVAN, Oklahoma
                                     TIM MURPHY, Pennsylvania
                                     MICHAEL C. BURGESS, Texas
                                     MARSHA BLACKBURN, Tennessee
                                     PHIL GINGREY, Georgia
                                     STEVE SCALISE, Louisiana
                                     PARKER GRIFFITH, Alabama
                                     ROBERT E. LATTA, Ohio


                                  (ii)
              Subcommittee on Oversight and Investigations

                    BART STUPAK, Michigan, Chairman
BRUCE L. BRALEY, Iowa                GREG WALDEN, Oregon
  Vice Chairman                        Ranking Member
EDWARD J. MARKEY, Massachusetts      ED WHITFIELD, Kentucky
DIANA DeGETTE, Colorado              MIKE FERGUSON, New Jersey
MIKE DOYLE, Pennsylvania             TIM MURPHY, Pennsylvania
JAN SCHAKOWSKY, Illinois             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas
DONNA M. CHRISTENSEN, Virgin 
    Islands
PETER WELCH, Vermont
GENE GREEN, Texas
BETTY SUTTON, Ohio
JOHN D. DINGELL, Michigan (ex 
    officio)

                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Bart Stupak, a Representative in Congress from the State of 
  Michigan, opening statement....................................     1
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     4
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     6
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................     7
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     8
Hon. Nathan Deal, a Representative in Congress from the State of 
  Georgia, opening statement.....................................     9
Hon. Bruce L. Braley, a Representative in Congress from the State 
  of Iowa, opening statement.....................................    10
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................    11
Hon. Donna M. Christensen, a Representative in Congress from the 
  Virgin Islands, opening statement..............................    13
Hon. George Radanovich, a Representative in Congress from the 
  State of California, opening statement.........................    14
Hon. Betty Sutton, a Representative in Congress from the State of 
  Ohio, opening statement........................................    14
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................    15
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................    16
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, opening statement.....................................    17
Hon. Peter Welch, a Representative in Congress from the State of 
  Vermont, opening statement.....................................    18
Hon. John Sullivan, a Representative in Congress from the State 
  of Oklahoma, opening statement.................................    19
Hon. Edward J. Markey, a Representative in Congress from the 
  Commonwealth of Massachusetts, opening statement...............    19
Hon. Janice D. Schakowsky, a Representative in Congress from the 
  State of Illinois, opening statement...........................    20
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, prepared statement................................    95

                               Witnesses

Jeffrey Almer, Savage, Minnesota.................................    22
    Prepared statement...........................................    25
Lou Tousignant, Minneapolis, Minnesota...........................    28
    Prepared statement...........................................    30
Peter K. Hurley, Wilsonville, Oregon.............................    32
    Prepared statement...........................................    34
Stewart Parnell, President, Peanut Corporation of America........    51
    Prepared statement \1\.......................................    51
Sammy Lightsey, Plant Manager, Peanut Corporation of America.....    51
    Prepared statement \2\.......................................    51
Stephen Sundlof, D.V.M., Ph.D., Director of the Center for Food 
  Safety and Applied Nutrition, Food and Drug Administration, 
  Accompanied by Michael Chappell, Acting Associate Commissioner 
  for Regulatory Affairs, Food and Drug Administration...........    54
    Prepared statement...........................................    57
Oscar Garrison, Assistant Commissioner, Consumer Protection 
  Division, Georgia Department Oof Agriculture...................    70
    Prepared statement...........................................    72
Darlene Cowart, President, J. Leek Associates, Inc...............    78
    Prepared statement...........................................    80
Charles T. Deibel, President, Deibel Laboratories................    88
    Prepared statement...........................................    90

----------
\1\ Mr. Parnell did not present an opening statement.
\2\ Mr. Lightsey did not present an opening statement.


  THE SALMONELLA OUTBREAK: THE CONTINUED FAILURE TO PROTECT THE FOOD 
                                 SUPPLY

                              ----------                              


                      WEDNESDAY, FEBRUARY 11, 2009

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:05 a.m., in 
Room 2123 of the Rayburn House Office Building, Hon. Bart 
Stupak (chairman) presiding.
    Members present: Representatives Stupak, Braley, Markey, 
DeGette, Schakowsky, Christensen, Welch, Green, Sutton, Barrow, 
Inslee, Pallone, Dingell, Waxman (ex officio), Walden, Deal, 
Radanovich, Sullivan, Burgess, Blackburn, Gingrey and Barton 
(ex officio).
    Also present: Representative Bishop.

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

    Mr. Stupak. This meeting will come to order.
    First I want to take the opportunity to welcome all of our 
new and returning members to the subcommittee. I am honored to 
be able to serve as chairman for another term. I want to 
welcome our new ranking member, Mr. Walden of Oregon, and also 
Mr. Braley, the vice chair of this subcommittee. You have been 
on the subcommittee for some time, Mr. Walden. I look forward 
to working with you in a good, bipartisan working relationship 
in the 111th Congress like we had in the 110th Congress.
    I welcome Chairman Waxman in his new role as chairman of 
the full committee. Mr. Chairman, I know you will serve us well 
and will continue the tradition of aggressive and fair 
oversight that this committee has become known for. I also look 
forward to working with your staff along with Mr. Kevin 
Barstow, who in this case here traveled once again to Georgia 
to look at the peanut plants in Georgia as he did in 2007. I 
think Kevin is going to be in every peanut plant in Georgia if 
this keeps up, so I want to thank Kevin and Scott Schloegel and 
the whole staff for all their hard work in preparation for 
today's hearing.
    I want to thank Chairman emeritus, John Dingell, the 
gentleman from my home State of Michigan, for his long and 
distinguished career in the House and here in the Energy and 
Commerce Committee. I must note today in fact the first 
resolution on the floor today, so members will be moving back 
and forth in and out of this committee to pay tribute to Mr. 
Dingell as being the longest-serving Member in the history of 
the U.S. House of representatives. He served more than 53 years 
and 2 months. As was noted in the ceremony honoring Chairman 
Dingell last night, we will honor him for the time he has 
served and we honor him more for what he has done while 
serving. It is truly a pleasure and a privilege to serve with 
Mr. Dingell and have him on this committee.
    Now the business before us today. This hearing today that 
we have is ``The Salmonella Outbreak: the Continued Failure to 
Protect the Food Supply.'' We will begin with opening 
statements. The chairman, the ranking member, the chairman 
emeritus will be recognized for 5 minutes for an opening 
statement, and other members will be recognized for 3 minutes 
for their opening statements. I should note, there is a lot of 
interest in this hearing. We already have a statement submitted 
by the record with unanimous consent. Representative Sanford 
Bishop is here. He is from Georgia. He has an interest in this. 
And also Mr. Barrow is here, again not part of the subcommittee 
but he is a member of the full committee. Mr. Green is here, so 
a lot of interest in this hearing. So I will begin with the 
opening statement.
    Since late 2008, the United States has been in the grips of 
a nationwide outbreak of salmonella infections that to this 
date is believed to have caused 550 illnesses and eight deaths 
in 43 States. In January, public health officials in Minnesota 
and Connecticut connected the outbreak to peanut butter 
produced by the Peanut Corporation of America, PCA, at its 
plant in Blakely, Georgia. This finding triggered a series of 
recalls that have included all peanut butter and other peanut 
products produced at the facility for the past 2 years and 
recalls by over 54 companies of more than 1,900 products 
containing the ingredients from the Blakely, Georgia, and 
Plainview, Texas, facilities of PCA. The recalls have cost 
business and government millions of dollars. The psychological 
cost has been widespread concern among parents of the millions 
of children nationwide who daily enjoy peanut butter 
sandwiches, cookies, crackers and other snacks. The President 
of the United States has expressed the view of parents across 
America when he said that his 7-year-old daughter eats peanut 
butter probably three times a week and that, ``I don't want to 
have to worry about whether she is going to get sick as a 
consequence to having her lunch.''
    Today's hearing will examine how this contamination was 
allowed to grow unchecked and the collective failure of 
multiple players--the peanut butter manufacturer, the Food and 
Drug Administration, State regulators and private industry--to 
take steps that might have prevented the outbreak. This 
subcommittee is well versed on the issues we address today. In 
the last Congress we held eight hearings to examine the safety 
and security of the Nation's food supply including one in April 
of 2007 in which we specifically examined a similar outbreak 
arising from salmonella contamination of peanut butter 
manufactured by ConAgra.
    Although we continue to learn new facts about the outbreak 
in the Georgia facility at which it all started, the facts we 
already know paint a very disturbing picture. When the FDA 
inspectors entered the plant in Georgia, they found a facility 
riddled with unsanitary and unsafe conditions according to the 
inspector's preliminary report. Mold was observed growing on 
the ceiling and walls in the cooler used to store peanut butter 
products. A live roach and several dead roaches were observed 
in the washroom adjacent to the production/packaging area. Most 
importantly, salmonella was found in two separate locations in 
the plant including the one that was only 3 feet from finished 
peanut butter products. Even more disturbing is the fact that 
Peanut Corporation of America knew about salmonella 
contamination for over a year and a half but did nothing to 
address it. Internal company records reveal that since June 
2007, PCA's products tested positive for salmonella on 12 
different occasions but that the company continued to produce 
and distribute its peanut butter products without consequence.
    And we know that the multiple players had opportunities to 
report or detect the contamination but failed to do so. The FDA 
had the authority to conduct inspections at the PCA facility 
and to test for salmonella, but when the FDA sent state 
inspectors to the plant on its behalf in 2007 and 2008, it did 
not test for salmonella, even though both visits occurred after 
the 2007 salmonella outbreak traced to the ConAgra plant just 
70 miles down the road from the PCA plant. One of these 
inspectors occurred just one day after PCA-manufactured product 
had tested positive for the presence of salmonella. The Georgia 
Department of Agriculture conducted two inspections of the 
Blakely plant in 2008 but did not conduct tests for salmonella 
on either occasion despite an internal goal to conduct such 
tests once a year. Private laboratories that conducted the 
tests when PCA had firsthand knowledge of the positive findings 
of salmonella failed to report those results to anyone but the 
company. Neither the FDA nor the State of Georgia requested 
access to those records until after the salmonella outbreak. 
PCA's largest customers such as Kellogg's engaged contractors 
to conduct audit of the Blakely plant but they did not conduct 
their own salmonella test and did not require PCA to show them 
their internal test results, which would have revealed a 
consistent pattern of salmonella contamination.
    So we appear to have a total systemic breakdown with severe 
consequences for hundreds of victims for which we need 
explanation. That is why we have asked representatives from 
each of these players, the manufacturer, the FDA, the State 
regulator, the private laboratories as well as victims of this 
outbreak to testify today. At this hearing we will seek answers 
to the following questions. What has been the human impact of 
this outbreak? How could the company, regulators, laboratories 
and industry let the salmonella contamination remain hidden for 
over a year before the outbreak? What legislative or regulatory 
changes can be implemented to prevent such catastrophic 
failures in the future? On this last question, it bears noting 
that we already have a vehicle for change in this area, H.R. 
759, the FDA Globalization Act of 2009, which I am sponsoring 
along with Congressmen Dingell and Pallone.
    I look forward to today's testimony as an opportunity to 
gather additional information with which to shape this 
legislation to address the public health impact of this and 
similar outbreaks. If there any good that can come from this 
tragic outbreak, it could come from long-overdue legislative 
change to protect the American people from dangers in the 
Nation's food supply.
    Next I would turn to my ranking member, Mr. Walden, for his 
opening statement, please.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you very much, Mr. Stupak, and Mr. 
Chairman, I look forward to working with you in my new role as 
the ranking Republican on the Oversight and Investigation 
Subcommittee. We have worked together on issues before for many 
years to protect the safety of Americans in many different ways 
and to improve security and other things in agencies. So I look 
forward to our work together.
    Ladies and gentlemen, I remember our previous food safety 
investigations into E. coli in spinach, E. coli in meat, 
salmonella in peanut butter, salmonella in jalapenos, now 
salmonella in a variety of peanut-containing products. This 
container is full of products that less than a month ago people 
were consuming thinking it was fine to eat, and one of the 
things I am going to do today is ask Mr. Parnell from Peanut 
Corporation of America if he would like to open this and sample 
some of the products that he didn't think were a problem in 
sending out to the rest of us to eat. Now, there are some 
recalled products in here and there are some that are probably 
oK now. Lives were lost and people were sickened because they 
took a chance and I believe knowingly shipping product that was 
contaminated.
    Yesterday we learned there is another plant in Texas that 
the FDA didn't even know existed that apparently has never been 
inspected and now we learn there was salmonella in that plant 
as well. This is simply outrageous.
    The latest outbreak of salmonella has sickened 11 people in 
my home State of Oregon. It has touched the lives of teenagers 
in Baker County and toddlers all the way the other side of the 
State in Medford and in Wilsonville. Pets have now been added 
to the list of those falling ill from salmonella-tainted 
products. A dog in Oakland, Oregon, apparently is the first 
animal illness in the Nation linked to recalled products.
    Today we will hear from a witness from one of these 
affected families, Peter Hurley. Mr. Hurley, I welcome you and 
your wife and your three children today. Jacob is here. Three-
year-old Jacob, do you want to stand up and give a wave there? 
You are going to hear about Jacob's story. Jacob became sick in 
January. For about 2 weeks Peter and his wife watched as poor 
Jacob got sicker and sicker and they consulted their 
pediatrician and sought counsel and advice and poor Jacob 
apparently couldn't keep anything down. The pediatrician said 
well, what does Jacob like to eat because at least maybe we can 
get him to eat what he likes to eat and help him along. Austin 
peanut butter crackers is his favorite. So he continued to 
peanut butter crackers, and eventually as the news came forward 
that those crackers and other products like those in this 
container may well be containing salmonella, a State 
epidemiologist showed up at their house on a Saturday night, 
took the crackers, and from what I understand, every other 
package was contaminated with salmonella. Can you imagine the 
tragedy as a parent of knowing that in effect you have been 
poisoning your 3-year-old child with the help of your 
pediatrician, none of whom knew this was the problem until the 
damage was done?
    Salmonella is a naturally occurring microorganism. It is 
usually transmitted to humans by eating contaminated foods. To 
reduce the risk of contamination, we require food-processing 
firms to follow the Food and Drug Administration's current Good 
Manufacturing Practices that serve as the minimum sanitary 
processing requirements for producing safe food. Failure to 
comply with the Good Manufacturing Practices is a violation of 
law, and if noncompliance leads to the distribution of 
adulterated or contaminated foods, more severe penalties may be 
applicable. Good Manufacturing Practices also serve as the 
basis for food-firm inspections conducted by the FDA and by 
State government inspectors.
    Now, the Peanut Corporation of America, whose president and 
plant manager are invited witnesses today, has been identified 
as the sole source of this salmonella outbreak. Several of the 
company's products were tainted with salmonella at the PCA 
plant in Blakely, Georgia, and shipped to more than 100 
consignee firms that serve as suppliers to food producers large 
and small for use as an ingredient in hundreds of different 
products such as cookies, crackers, ice cream, cereal and 
candy. At least two Oregon companies I am aware of have had to 
recall their products because they included ingredients that 
were sourced back to PCA. The health implications are all too 
clear, as our witnesses will testify today. Additionally, there 
are economic consequences for the food producers that use those 
ingredients and had to conduct those recalls.
    As FDA has reported and as indicated in documents obtained 
by this committee, the Peanut Corporation of America routinely 
violated numerous Good Manufacturing Practices and knowingly 
shipped adulterated products to its customers. In an internal 
e-mail chain between the plant manager, Sam Lightsey, and the 
president, Steward Parnell, the two men discussed microbial 
testing completed on finished product. The e-mails state the 
company was notified of a confirmed positive salmonella test on 
a sample conducted by an outside lab. That sample was tested 
again and a negative reading occurred. Then Peanut Corporation 
of America shipped contaminated product to another outside lab 
and received a negative result. In response to getting a 
negative result, the company president gave instructions to his 
plant manager to ship the salmonella-positive products, 
specifically telling them ``turn them loose.'' Another e-mail 
from Mr. Parnell, the president wants to discuss another 
positive test of salmonella and the time lapse in the shipment 
of product as a result. Mr. Parnell expresses his concern of 
losing huge amounts of dollar sign, dollar sign, dollar sign, 
dollar sign, dollar sign due to delays in shipment and costs of 
testing. It appears Mr. Parnell was more concerned about his 
company's bottom line than the food safety of Americans.
    Expert witnesses will explain that a subsequent negative 
test result for salmonella on a sample never, never negates the 
initial finding of a confirmed positive. In response to a 
confirm positive, PCA should have immediately destroyed the 
entire lot of contaminated product, ceased production and 
attempted to uncover the root cause of the contamination. All 
these steps are part of the FDA's manufacturing requirements 
that firms are forced to follow, required to follow.
    FDA must enhance the GMPs for food and get stronger 
authority. Food firms should be required to give FDA access to 
records that show compliance, prove that kill step for 
pathogens actually works and confirm sanitation and protection 
against cross-contamination. To help prevent outbreaks in the 
future, FDA inspectors must have access to internal documents. 
We must assure the public the food on our grocery shelves is 
safe and what we put into our mouths and those of our children, 
elderly parents and even our pets is safe. While Congress moves 
on legislation, our food safety agencies and food manufacturing 
firms can take immediate action to improve the production of 
safe food, and I suggest that we demand those actions now, Mr. 
Chairman. Thank you.
    Mr. Stupak. Thank you, Mr. Walden. I suggest you keep your 
contaminated products on your side of the aisle. That would be 
a new way to get back into the majority but we will pass on 
that.
    Mr. Waxman, opening statement, please, sir.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you very much, Mr. Chairman. I am pleased 
to see you continuing your aggressive oversight on the issues 
of food safety and I am pleased also to see that you are 
working with our counterparts on the Republican side, 
especially Ranking Member Walden, to do this in a bipartisan 
basis. There is no partisanship when it comes to questions of 
food safety. We are shocked at what has been going on in this 
country on food issues, and what this committee needs to do is 
to find out the truth, hold people accountable and make sure it 
doesn't happen again.
    For too long, people have been worried about this and they 
want to know what is happening, who is responsible. Well, we 
are going to hear in this first panel that those who most often 
pay the price are the young, the elderly and the infirmed 
because these tainted products distributed by the Peanut 
Corporation of America were sent to elementary schools, nursing 
homes, hospitals and even FEMA meal kits handed out in the wake 
of the Kentucky ice storms. We are going to hear today the 
results of our subcommittee's investigation and we have 
obtained documents that I would ask unanimous consent be made 
part of the record.
    Mr. Stupak. Without objection.
    [The information was unavailable at the time of printing.]
    Mr. Waxman. These documents obtained by our subcommittee 
are very disturbing because what they show is that this company 
cared more about its financial bottom line than it did about 
the safety of its customers. Last September, for example, PCA 
was notified by a private lab that its products had testified 
positive for salmonella. This wasn't the first positive test 
the company received and it may not be the last. In response, 
the president of the company sent an e-mail. Stewart Parnell 
was complaining that the positive salmonella tests were costing 
them huge amounts of money, and I see on the screen that we are 
flashing up this e-mail. ``There is going to be a huge lapse in 
time from the time we pick up peanuts until the time we can 
invoice.'' Well, even after the FDA began investigating in 
January and forced the company to recall some products, PCA's 
first concerns were financial. On January 19, Mr. Parnell sent 
an e-mail pleading with the FDA officials to allow the company 
to keep doing business. He wrote that they ``desperately at 
least need to turn the raw peanuts on our floor into money.'' 
He assured the FDA that these peanuts would be cooked and 
further processed by their Texas facility. This Texas facility 
is the same one that was shut down yesterday after salmonella 
was found there too.
    The subcommittee also obtained documents that appear to 
show that Mr. Parnell was not forthcoming about his company's 
past. Despite multiple records showing positive salmonella 
tests over 3 years, he wrote an e-mail to his company's 
employees on January 12 asserting flatly that, ``We have never 
found any salmonella at all,'' and he blamed the news agencies. 
They are looking for news stories that are going to scare 
people about the cause of this food sickness outbreak. The 
subcommittee obtained a statement from an official at one of 
the private labs used by PCA to test for salmonella. The lab 
official reported that PCA's plant manager in Georgia, Sam 
Lightsey, admitted to shipping products before receiving lab 
results. The official stated, ``When I called Mr. Lightsey in 
early October 2008 to give him the serology reports that JLA 
obtained from the lab for the confirmed salmonella, he paused 
and said uh-oh or something to that effect and then told me he 
had released the product for shipping. When I asked him if he 
could get it back, he said it was on a truck heading to Utah.'' 
This lab official also informed us that PCA stopped using its 
services because it received too many positive tests. The 
official stated, ``I called Mr. Lightsey to follow up on the 
recent discussion regarding the confirmed positive and he 
confirmed that because of the high coliform results, they are 
going to send samples to a different lab.''
    Mr. Chairman, I want all these documents in the record. I 
want them to be made public. I hope that in this hearing, we 
are going to be able to find out more about the actions of 
these PCA officials. I look forward to hearing from the labs 
that conducted these tests as well as the State and federal 
officials in charge of overseeing this company, and I also want 
to extend my condolences to the victims and family member, the 
victims who are here today. We have got to find out the truth. 
We have got to hold people accountable and we have got to make 
sure that this doesn't continue in the future.
    Thanks for your hard work and the aggressive oversight that 
I know you are committed to. I yield back the time.
    Mr. Stupak. Thank you, Mr. Chairman.
    I next turn to Mr. Barton of Texas for an opening 
statement.

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

    Mr. Barton. Thank you, Mr. Chairman.
    Today you are going to see Congress at its best and at its 
worst. This subcommittee hearing is Congress at its best. We 
have an issue that affects the public health and safety of 
American people. We have a chairman and a subcommittee chairman 
who have quickly acted to bring it to the country's attention, 
to bring witnesses forward both from the victims' side and from 
the regulatory side and also give an opportunity for the 
affected party, the company in this case, to present their side 
of the story. That has been done on a bipartisan basis with 
full cooperation including yesterday a full committee meeting, 
business meeting, where we unanimously voted to subpoena to 
compel some of the witnesses that didn't want to voluntarily 
testify to come before the Congress so that people would know. 
That is Congress at its best. Mr. Waxman and Mr. Stupak are to 
be commended for their leadership.
    I also want to commend Mr. Walden, the new ranking member 
on the Minority side, for the best opening statement I have 
heard in 22 years in an oversight hearing, and that goes back 
to John Dingell, Billy Tozan, Tom Bliley, Mr. Waxman and others 
who have always specialized in aggressive oversight. He put the 
case succinctly. He put the case in personal terms. He did it 
in a way that we can understand. So that is Congress at its 
best.
    Unfortunately, today we are also going to see Congress at 
its worst. We have the stimulus package that is in limbo 
somewhere in conference between the Senate and the House of 
Representatives, and the House conferees were appointed 
yesterday. This committee, who has got jurisdiction for 
approximately $100 billion of that stimulus, including all the 
healthcare issues, all the telecommunications issues, all the 
energy issues, all the environmental issue has one conferee, 
the chairman of the committee. Nobody on the Minority side. It 
is a very small conference but the Speaker has seen fit that 
the Minority doesn't count. Our voice doesn't count. Well, I 
have a prediction to make. By the end of the day or the end of 
the week, they are going to hear the voice of the Minority on 
this issue. We need to do something to help the economy for 
this country, we need to do it cooperatively on a bipartisan 
basis, but when you shut one side out, it makes it very 
difficult to work in a positive fashion.
    So on a positive note, this is an important hearing. We are 
totally supportive. Whatever the results of the hearing are, I 
am sure we will work together to implement those, but on the 
other issue, it is not democracy when only one side has a 
voice.
    With that, Mr. Chairman, I yield back.
    Mr. Stupak. Thank you, Mr. Barton.
    By order of appearance, members will be recognized for 3 
minutes for an opening statement. Next would be Mr. Green from 
Texas.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman. I want to thank you for 
holding the hearing today. Last year we had many hearings on 
food safety, but unfortunately, the committee was never able to 
pass a food safety bill. The recent salmonella outbreak is yet 
another example of how the FDA and State agencies are unable to 
protect the American food supply. The committee's investigation 
has shown that Peanut Corporation of America was operating with 
blatant disregard for safety standards, which ultimately led to 
at least eight deaths and sickened 600 individuals. 
Investigations by this committee found the Peanut Corporation 
of America shopped for labs that gave them negative salmonella 
results after originally testing positive, that they would not 
wait for the results and would ship the products out for 
consumption without ensuring they were safe for consumption. 
Peanut Corporation of America's plants are also in deplorable 
condition, especially the plant in Georgia with cockroaches 
near the peanuts, water leakage, mold and unsanitary production 
line.
    On the 3rd we learned that the Peanut Corporation of 
America was operating an unlicensed and uninspected plant in 
Plainview, Texas. This plant was never inspected until the FDA 
began investigating the salmonella outbreak, at least never 
inspected by the FDA. Unfortunately, my home State of Texas is 
one of the states where the FDA relies on our State inspectors 
to oversee food safety. On Monday the Texas Department of State 
Health Services shut down the Plainview plant after it tested 
positive for possible salmonella. It is unbelievable that a 
food-processing plant can deliver possibly tainted products 
into our food supply without a license and without ever being 
inspected. One thing is clear: No plant should be able to 
operate in the manner in which the Peanut Corporation of 
America has operated.
    Congress, myself included, said for years that the FDA is 
underfunded, and that is still true, but throwing money at them 
will not solve the problem. We need to overhaul the way the FDA 
reviews and inspects our food-processing plants and food 
supply. This committee, Congress and the new Administration 
must do all we can to shut down those unlawful operators and 
find a new way to protect the American food supply.
    Again, I want to welcome our witnesses here, particularly 
the children. I have a 4-year-old granddaughter who loves 
peanut butter and crackers. In fact, as I sit here today, my 
son, they are having a new baby this morning in south Texas, a 
little boy, and all of them, all my grandchildren eat peanut 
butter and I have a jar here, and I didn't bring it to check it 
for salmonella, but anyway, it is so important for the American 
people literally from our smallest citizens to our oldest.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you, Mr. Green.
    Mr. Deal for an opening statement, please, 3 minutes.

  OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Deal. Thank you, Mr. Chairman.
    First of all, I would like to welcome the deputy 
commissioner of agriculture from the State of Georgia, Mr. 
Terry Coleman, who by the way is a former speaker of the 
Georgia House of Representatives as a Democrat, Mr. Chairman, 
and also Mr. Oscar Garrison, who is the assistant commissioner 
of agriculture of the Georgia Department of Agriculture, who is 
going to testify on one of our panels.
    Mr. Chairman, our Nation has always prided itself on having 
the safest food supply in the world. This confidence is founded 
on the hard work of those who grow, process, package and 
deliver our food coupled with the oversight and inspections 
provided by the federal agencies such as FDA and USDA working 
with their comparable State regulatory authorities. Let no one 
misunderstand, however, we are all outraged by the alleged 
violations of law and common standards of safety which are the 
focus of this hearing, and our sympathy goes out to those who 
were injured and to those who have suffered losses. Although I 
am a resident of the State of Georgia where the production of 
peanuts is a vital part of our State's economy, there will be 
no statements of provincial protectionism from me for it is 
those who are closest to the problem that are the most 
infuriated by it for we know that the vast majority of those 
who produce peanuts and the resulting products are decent, law-
abiding people. Right now peanut farmers are poised to plant 
this year's crop. The uncertainty created by the actions of 
Peanut Corporation of America will cost them millions of 
dollars. They and many more in the chain of production have 
done nothing wrong but they are suffering the consequences of 
the questionable actions of one company. These innocent 
individuals and companies are more concerned than almost anyone 
that the cloud of suspicion be removed from the peanut 
industry.
    As legislators, we should be asking how we can make the 
system work better. I am sure we can learn from this 
unfortunate experience how to reform our inspections system at 
both the federal and state levels. In fact, the Georgia General 
Assembly is in session right now and is considering legislation 
to strengthen the role of our State inspections and oversight. 
We have the responsibility to shake the scales of justice as it 
relates to food safety but the architect whose eyes are focused 
only on the actions of the most egregious will design scales of 
justice that will not work for it fails to account for the 
overwhelming weight of the majority who are honest and law 
abiding. That is our challenge as we go forward to ensure the 
safety of all without destroying the underlying industry.
    I am confident that the peanut industry of my State and the 
Nation will work cooperatively with this committee, with this 
Congress and the legislatures of the various States to craft 
reforms that will restore the confidence of the American people 
in the safety of peanut products. Toward that end, I pledge my 
best efforts, for after all, the good health of the American 
public and in fact the fate of the peanut butter and jelly 
sandwich lie in the balance.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you, Mr. Deal.
    Next we will hear from Mr. Braley, the vice chair of the 
subcommittee, a new member of the committee. Welcome.

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF IOWA

    Mr. Braley. Thank you, Mr. Chairman. I just want to tell 
you how honored I am to be serving as your vice chairman. I 
look forward to working with you and Ranking Member Walden on 
the important work of the committee.
    As I was preparing for the hearing today, I thought of 
Upton Sinclair and what he must be thinking as we sit hear 
nearly 100 years after the publication of The Jungle facing the 
very same food questions that dominated the discussion of this 
Capitol over 100 years ago, and that was highlighted by this 
advertisement that appeared in USA Today where we have the 
unbelievable aspect of corporations paying thousands of dollars 
to say ``it ain't me'', and as we focus on the important topics 
we are here to talk about today, we need to keep in mind the 
enormous economic consequences to people who are not involved 
in this contamination as well.
    This recent outbreak of salmonella in peanut products has 
resulted in the recall of over 1,700 products, one of the 
largest recalls ever under the jurisdiction of the FDA, but 
this outbreak is not just disturbing because of its size. It is 
particularly troubling because of its impact on Americans most 
vulnerable to tainted food. As noted in the Monday issue of USA 
Today, salmonella affects people who are most vulnerable 
depending upon the strength of their immune system and how old 
or young they are, and we all know that salmonella is most 
dangerous to very young children. Given that, I think it is 
outrageous that the contaminated King Nut peanut butter, which 
was the product in which the source of this salmonella outbreak 
was first located, was distributed to nursing homes, hospitals 
and schools.
    Yet the serious concerns I have about the severity of the 
effects of salmonella on children are only compounded by the 
sheer popularity of peanut butter and peanut butter snacks 
among children. As President Obama noted recently, peanut 
butter is very prevalent in the diets of young children like 
his daughter Sasha. As a parent, I know this firsthand. I am 
also concerned as a parent that three States have had to remove 
tainted Peanut Corporation of America products from their 
school lunch programs. These States receive peanut butter or 
roasted peanuts from the Federal Government, which bought them 
from the Peanut Corporation of America. It is completely 
unacceptable that our Nation's schools could be serving 
children products that could make them severely ill or kill 
them and that the Federal Government would be purchasing and 
distributing these potentially dangerous products to our 
schools.
    There are many questions that need to be answered today 
about the practices of Peanut Corporation of America, about the 
FDA and State inspections of their plants, and about the 
general safety of our food supply. One thing that is clear is 
that we need to be doing a much better job of protecting 
Americans, particularly children and other vulnerable 
populations, from unsafe food products. I look forward to 
hearing the testimony of the witnesses and hope that this 
hearing will help to determine what Congress needs to do to 
prevent these outbreaks in the future and ensure the safety of 
our Nation's food supply.
    Mr. Stupak. Thank you, Mr. Braley.
    Mr. Gingrey for an opening statement, please. I guess he is 
not there.
    How about Mr. Burgess for an opening statement? Order of 
appearance we have been going by. Mr. Burgess.

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

    Mr. Burgess. Thank you, Mr. Chairman.
    Mr. Chairman, it seems like we have been here before. We 
have previously established that there are serious problems 
within the FDA. In the last Congress we had 16 FDA-related 
hearings. Now we begin a new session of Congress with a hearing 
on the Food and Drug Administration and their role in 
inspecting the Peanut Corporation of America, the source of 
over 553 salmonella-related illnesses and at least eight 
deaths. Mr. Chairman, this is like a bad movie and we all have 
read the script before. In 2007, we investigated the Food and 
Drug Administration's role with ConAgra and the salmonella 
illness in their peanut-based products, and just like today, in 
2007 it was the State of Georgia which was the source of the 
salmonella and peanut-based products, so it is not just a bad 
movie script, it is a deadly one, and it has got the same 
theme, salmonella, the same actors, the Food and Drug 
Administration and the State of Georgia, but with one crucial 
difference: this time there is the possibility of criminal 
activity by the Peanut Corporation of America. And we know that 
the Peanut Corporation of America engaged in deliberate 
misconduct in this case. We know that the Peanut Corporation of 
America not only retested salmonella-positive batches of peanut 
products, they intentionally shipped the products to their 
unsuspecting clients. At least 75 companies, 16 different food 
categories make over 1,000 types of consumer foods with peanut 
products made by the Peanut Corporation of America and then 
they put them in front of the whole world for our consumption. 
It is no wonder in the past month, it seems like almost on 
every newscast at the top of every hour we are notified of yet 
another recall of yet another product creating yet another 
crisis, a crisis in an already troubled economy.
    Mr. Chairman, this is a deliberate act that is almost 
astonishing in its cruelty. It is a violation not only of the 
trust of the American consumer but also of their business 
partners. The president of the Peanut Corporation of America 
could give us answers, should give us answers, but we won't get 
them today because it is my understanding, that individual is 
going to plead his Fifth Amendment rights. Boy, I would love to 
ask, how did you think this was going to work out for you.
    I also continue to be troubled by how much the Food and 
Drug Administration needs our attention and modernization. They 
need more powers like the mandatory recall power, which I had 
previously advocated, as well as the power to retrieve all 
records for any food company being investigated. But no matter 
how much demand greater action and accountability from the Food 
and Drug Administration, we can only hold the Food and Drug 
Administration accountable for the laws that are there and then 
businesses like the Peanut Corporation of America, they violate 
not just the law but the fundamental tenets of their business 
practices. It is not any longer about following the rules of 
the FDA. It is just about being a good citizen of the world. So 
for me, yes, it is time again to focus on the Food and Drug 
Administration and how we need to work on the Food and Drug 
Administration and help it in its mission but we also should 
focus on punishing the bad actors in this case.
    Mr. Chairman, now it is a criminal matter, and although we 
need to work to continue to modernize the FDA by giving them 
the money and the power they need to continue to protect our 
citizens, you know, there is not a night that goes by it seems 
that Lou Dobbs doesn't end his newscast by saying, ``Doesn't 
anyone deserve a government that works?'' and that is not just 
a rhetorical question, Mr. Chairman.
    Mr. Chairman, let me ask that this committee answer Mr. 
Dobbs in the affirmative. Let us make it unambiguous. Let us 
make it a bipartisan affirmative and let us also commit that 
from this hearing forward we will make our actions match our 
rhetoric, and I will yield back.
    Mr. Stupak. Thank you, Mr. Burgess.
    Ms. Christensen for an opening statement. Welcome to the 
committee.

       OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 
       REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

    Ms. Christensen. Thank you, Mr. Chairman, and good morning, 
Chairman Waxman, Chairman Stupak, Ranking Members Barton and 
Walden. This is my first hearing with the Subcommittee on 
Oversight and Investigations and I am glad to be here but I am 
really sickened by the reasons that we are meeting this 
morning.
    The recent salmonella outbreak demonstrated clear and 
serious deficiencies in our country's food safety system, some 
based on centuries-old legislation, and so this hearing is very 
important to fixing the problems that cause so much preventable 
illness and the eight deaths that should not have happened, so 
thank you for holding it, and thank you also to those who are 
here to testify, especially the families of those who suffered 
because of the unscrupulous, likely criminal business practices 
and the fact that our government failed you. I extend 
condolences to the Almer and Tousignant families, and to Mr. 
and Mr. Hurley, we are glad to see that Jacob is well enough to 
be here with us today.
    For the past several months we have heard countless reports 
about the salmonella outbreaks, and with each story and each 
investigation we learn a bit more about how many gaps there are 
in our Nation's processes to ensure food safety. We have also 
learned how key agencies such as FDA lack the authority, 
resources and oversight that they clearly should have to ensure 
the safety of our food and the health of our families and our 
loved ones. Finally, we have learned about the tragic 
consequences that these gaps in food safety have on innocent 
lives, consequences that could have been avoided, should have 
been avoided and consequences that I look forward to working 
with you, my colleagues on this committee, to avoid in the 
future.
    Thanks to Mr. Dingell, Mr. Pallone and Mr. Stupak, who have 
already launched an effort that is heading us in the right 
direction with the introduction of H.R. 759, the Food and Drug 
Administration Globalization Act of 2009, which I am proud to 
cosponsor. Through provisions which empower the FDA with 
additional resources and mandatory recall authority as well as 
oversight over and access to the safety plans of food service 
facility established as well as access to those tests that are 
conducted to measure safety and inspection records, we are 
finally on a better path to prevention. We know those measures 
are too late for the precious lives that have been lost and the 
others that were put in jeopardy, lives of some of more 
vulnerable people, those in nursing homes, hospitals and 
schools, all because we had to wait for a company to initiate 
the recall of a product that they knew was tainted, that they 
knew would make people sick just to protect their profit 
margins.
    There is plenty of blame to go around because many balls 
were dropped. The only blameless ones in all of this are the 
individuals who died, those who got sick and their families and 
loved ones. If for no one else, let this hearing be about them 
and let the lessons we learn and the next steps we take to 
ensure that their suffering is not forgotten.
    Thank you, Mr. Chairman. I yield back the balance of my 
time.
    Mr. Stupak. Thank you.
    Mr. Radanovich for an opening statement, please.

 OPENING STATEMENT OF HON. GEORGE RADANOVICH, A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Radanovich. Thank you, Chairman Stupak and Ranking 
Member Walden. Also I want to thank Mr. Waxman and Mr. Barton 
for holding this important hearing on the outbreak of 
salmonella in peanut products.
    As a representative of one of the largest agriculture 
producing districts in the Nation, I am keenly aware of the 
importance of food safety as a public health hazard and also as 
an issue of national security. However, what truly makes me 
more concerned about food safety, it is not so much my role as 
a Member of Congress but as a father of a 10-year-old boy who 
happens to love peanut butter and jelly sandwiches. Parents 
these days have so many things to worry about. It is 
unfortunate that peanut products, which are often a staple in 
the diet of a 10-year-old boy, have been added to this list. 
Even with the best parenting in the world, there are some 
things that are out of our control as parents. My wife and I 
can choose to avoid packing my son peanut products in his lunch 
but that doesn't stop him from trading his granola bar for 
trail mix that has salmonella-tainted peanuts in it.
    My condolences go out to those who have lost your loved 
ones and to those who have been tragically affected by the 
salmonella outbreak, it was an avoidable situation, and I am 
looking forward to hearing the testimony from the witnesses and 
learning how Congress can help prevent situations like this 
from reoccurring.
    So I look forward to the hearing and what we might learn 
from it, and Mr. Chairman, I yield back.
    Mr. Stupak. Thank you.
    Ms. Sutton for an opening statement, 3 minutes. Welcome to 
the committee.

  OPENING STATEMENT OF HON. BETTY SUTTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF OHIO

    Ms. Sutton. Thank you, Mr. Chairman.
    On Christmas Day, my local newspaper had a story about a 
resident in a Summit County nursing home, that she was very 
ill, and on top of many other medical conditions she suffered 
from fever, abdominal cramps and diarrhea. Doctors diagnosed 
this woman with a case of salmonella, and a few weeks later she 
died. The woman I speak is one of the eight people who died of 
salmonella and is among the 550 people nationwide who became 
sick as a result of this bacteria. According to the Ohio 
Department of Health, there have been 89 cases of salmonella 
reported in Ohio in the past 4 months. This figure is much 
higher compared to occurrences in other States.
    Mr. Chairman, this outbreak demonstrates yet again that our 
food inspection system is broken. The source of the salmonella 
was traced to a factory in Georgia, we have heard, called the 
Peanut Corporation of America, or PCA, and on multiple 
occasions PCA's peanut products have tested positive for 
salmonella. PCA still shipped their products to schools, 
nursing homes and stores, despite that. Now there is a document 
on the FDA Web site with 288 pages worth of recalled products 
that include peanuts. The negligent practices in this food 
manufacturing plant are unacceptable and the government must do 
more to protect Americans. Regulatory agencies like the FDA, 
they need more power and they must execute more power and 
oversight to prevent another catastrophe like this. This is why 
I reintroduced the Protect Consumers Act. This bill is very 
simple. It would give the FDA mandatory recall authority over 
food products. Mandatory recall authority is only one of the 
critical steps, and there are other bills out there that are 
equally important and more comprehensive but just taking this 
simple step is a step that we should pursue with haste. 
Currently, the FDA is forced to rely on the company at issue to 
do the right thing, and we know that that isn't a good way to 
operate.
    I look forward to hearing from PCA to learn why they 
continued to sell their contaminated products. I am also eager 
to hear from government officials to learn about their role in 
the recall and I look forward to working with my colleagues 
here on the committee to fix our broken system so that 
America's families can trust that the food they are eating is 
safe. That is not too much to ask.
    Thank you.
    Mr. Stupak. Thank you.
    Ms. Blackburn for an opening statement, please.

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

    Ms. Blackburn. Thank you, Mr. Chairman. Thank you for the 
hearing, and I want to thank our witnesses for taking their 
time to come before us today.
    As you have heard, FDA review and oversight is not new to 
this committee. This is something that we have gone over and 
over and over during my 4 years on this committee, and Mr. 
Chairman, I sit here and I am listening to the opening 
statements and looking at our witnesses and I think, how many 
more Americans are going to have to be affected by some type of 
illness or worse before we get down to the basics on review, 
reform and accountability that is lacking in the system that is 
before us. I think it is unacceptable for the American public's 
health, and indeed, their life in many cases to be put at risk.
    Now, peanuts, as you have heard, this is why we are here. 
This is the latest of our contamination issues in our food 
supply, and it is so unfortunate that contaminated product was 
knowingly shipped to various locations, some in my State of 
Tennessee, and indeed, we express our sympathies to the 
families who have been injured, harmed or experienced loss of 
life because of this. We have 11 cases that are in Tennessee 
alone. Indeed, this is something that could have been 
prevented. We all know the source. We have discussed that with 
Peanut Corporation of America. We are going to look more into 
that today. And one thing that I am really going to want to 
know a bit more about is how there could have been 12 known 
cases of salmonella between June of 2007 and September of 2008, 
how there could have been 12 times that this was known and 
appropriate action was not taken. And what the American people 
are wanting to see is not more rhetoric, they want to see 
action, and Mr. Chairman, I think that is where reforming this 
system comes forward as what our next step should be to make 
certain that the American people can trust us to do our job, to 
reform the system so that they have trust in the food supply 
and the product that is placed on their shelves, and I yield 
back the balance of my time.
    Mr. Stupak. Thank you.
    Ms. DeGette for an opening statement. Ms. DeGette is vice 
chair of the full committee.

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

    Ms. DeGette. Thank you so much, Mr. Chairman. We spend a 
lot of time together in these food safety hearings, and I want 
to welcome our new members of the committee. I have been on 
this subcommittee for 12 years now, and since I have been on 
this subcommittee this is our 10th food safety hearing at which 
the members of the Oversight and Investigation Subcommittee 
spend quite a bit of time in a bipartisan way wringing our 
hands.
    Now, in the meantime, with the latest problem, over 500 
people have been sickened, 15 of them are in my home State of 
Colorado, half of the sickened people are children, and eight 
people have died. This is the deadliest outbreak of foodborne 
illness in decades but we have seen in the last few years 
jalapenos, peanut butter again, meat, dog food and on and on 
and on. I guess my question is to Congress in general, how many 
sick kids does it really take for us to finally act? How many 
workers need to get laid off before private industry and 
Congress put resources into protecting the integrity of our 
food distribution system? And I cannot think of a case that 
better demonstrates the need for the FDA and USDA to have 
mandatory recall authority than this case. The Peanut 
Corporation of America sells in bulk to companies and then 
those companies manufacture and distribute processed foods. So 
even though people started getting sick last summer, current 
federal law does not empower public health officials to issue a 
recall in response to an emergency like this. My constituents 
are shocked when they hear this, and instead companies are left 
to voluntarily decide for themselves if and when to recall 
their products. And so Mr. Chairman I know this isn't a 
legislative hearing but I am sure that the parents who are 
sitting here today would like to know that there are actually 
legislators working on these issues. I have introduced 
legislation again this year, which I have introduced many times 
in the past, to finally give the government mandatory recall 
authority, and the good news is, finally this is supported not 
just by the regulators but also by the industry, and so I think 
when we pass comprehensive food safety legislation, finally the 
FDA and USDA will have mandatory recall authority.
    The second bill I have reintroduced this year, which I have 
introduced many times in the past, is the TRACE Act, and what 
this bill does is creates a comprehensive traceability system 
so that we can trace from where the peanuts came from to when 
they are in those little peanut butter crackers that the 
children are eating, where that came from so that we can recall 
that right away. That problem was a particular problem last 
year with the jalapenos in the salsa. I am happy to report that 
Mr. Dingell and Mr. Stupak have included both my mandatory 
recall language and some traceability language in their 
comprehensive bill and I am also happy to report that the 
regulators support traceability and now again the manufacturers 
are beginning to understand that situation.
    Mr. Chairman, I am eager for this hearing today. We need to 
shed light on this situation, but once we do that, Mr. 
Chairman, I look forward to working with you and Mr. Waxman so 
that we can move legislation and begin to solve these problems.
    Mr. Stupak. Thank you.
    Mr. Gingrey for an opening statement, please, 3 minutes.

  OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Gingrey. Mr. Chairman, thank you for recognizing me on 
this, my first hearing as a member of this subcommittee, and I 
look forward to serving under your leadership and that of 
Ranking Member Walden in the crucial oversight role of the 
subcommittee. Let me welcome our former Georgia Speaker of the 
House and now deputy commission of agriculture, Terry Coleman, 
as well as Mr. Oscar Garrison, the assistant commissioner, who 
I certainly look forward to hearing his testimony on the third 
panel
    Now, I first want to express my sincere condolences to the 
families that are here today and those families across the 
Nation who have either lost a loved one or have suffered 
illness as a result of this salmonella outbreak. For those 
testifying today, I appreciate your willingness to come before 
this subcommittee and share your stories, as difficult as it 
may be, with us. All of us have a responsibility to learn from 
this tragedy and to take the necessary steps to ensure that no 
other family has to ensure what you have experienced.
    Mr. Chairman, it is regrettable to see that the facility 
under investigation today is located in my home State of 
Georgia and it is also unfortunate that Mr. Parnell and Mr. 
Lightsey from PCA, the Peanut Corporation of America, will 
likely refrain from testifying in accordance with their Fifth 
Amendment rights. And while they are within their 
Constitutional rights, I would offer this admonition to them 
and to anyone else who makes the products that our citizens and 
their families consume: If you circumvent the law or merely 
take advantage of lax oversight, don't think you have gamed the 
system forever because justice will catch up to you and you 
will pay. Further, if the circumstances as presented and 
reported to this point bear out to be true, then it seems the 
decision to achieve shortsighted profits has trumped common 
sense and morality. For this, there will be an accounting.
    Mr. Chairman, as we in Congress move forward, we must also 
recognize that no matter how high a regulatory wall we erect, 
there will always be someone who is brazen enough or stupid 
enough or greedy enough to try and climb over that safety 
barrier, and though our gut reaction might be to build an even 
higher wall, we have an obligation to thoroughly evaluate and 
ensure that current law was properly enforced first. The wall's 
integrity, after all, comes not from the height, Mr. Chairman, 
but from its foundation.
    So as we proceed with this hearing, I will listen carefully 
to the witnesses and their statements and their responses to 
the questions in the hope that we will get to the bottom of 
this tragedy.
    Mr. Chairman, with that I yield back.
    Mr. Stupak. Thank you, Mr. Gingrey.
    Again, by order of appearance at the subcommittee, Mr. 
Welch from Vermont. Welcome to the committee, and you are 
always welcome to come sit up here on the top row too.

  OPENING STATEMENT OF HON. PETER WELCH, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF VERMONT

    Mr. Welch. I hear the air is pretty good up there.
    Thank you very much. I want to echo what Mr. Gingrey said 
and express my condolences, and believe me, it is very kind of 
you to come here and it makes a real difference that you are 
willing to share your story, painful as it is, and I apologize 
that we have added to your burden by making you sit through so 
many opening statements. But, you know, I have been listening 
to them too and there is something that I find quite heartening 
in this. We all agree that what Peanut Corporation of America 
did was despicable and outrageous and they should be held to 
account. But what you as parents, as sons have a right to 
expect from your government is that we have systems in place 
that give you the assurance that when you buy food, it is safe. 
It is as simple as that. And obviously there is nothing worse 
as a parent to see a child who is sick and we don't know what 
the outcome is going to be or to lose a parent before his or 
her time. And I am heartened by what I have heard today from 
the members of this committee and also I was earlier at the 
meeting of the whole committee when I heard our chairman, Mr. 
Towns, and our ranking member, Mr. Issa, both expressed the 
commitment to having vigorous oversight, and that doesn't 
change just because we have had a new change in Administration 
because there are unscrupulous folks out there who for a quick 
buck will put in peril people that you love, and it is our 
mutual responsibility to do every single thing we can to have 
systems in place that give you the assurance that the food you 
buy is safe, and what you are doing, and we so appreciate, is 
your coming forward with your personal story that makes it 
real, that makes it vivid, and that is at some personal 
inconvenience and pain to you, so I join my fellow committee 
members in thank you for your service.
    Mr. Stupak. Thank you, Mr. Welch.
    Mr. Sullivan for an opening statement, 3 minutes, and 
welcome to the subcommittee.

 OPENING STATEMENT OF HON. JOHN SULLIVAN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF OKLAHOMA

    Mr. Sullivan. Thank you, Chairman. I appreciate it.
    As a new member of the Oversight and Investigation 
Subcommittee, I would like to thank Chairman Stupak and Ranking 
Member Walden for holding this hearing this morning. It is an 
honor to be named to this prestigious subcommittee. I am 
pleased to be part of this important discussion on food safety 
and look forward to working with each of you as we move forward 
in the 111th Congress. Unfortunately, the salmonella outbreak 
has hit my state of Oklahoma. According to the Oklahoma 
Department of Health, three adolescents contracted salmonella 
due to the tainted peanut butter. One of those adolescents was 
from Rogers County which borders my district. Fortunately, they 
are all recovered but this serves as a reminder that we must 
take every precaution necessary to keep our food safe.
    In late 2008, the Centers for Disease Control identified an 
outbreak of salmonella affecting 600 people in 43 States with 
the recent outbreak perhaps contributing to eight deaths. This 
is an issue that affects each and every one of us, our friends 
and our families. It is clear that the food companies and the 
FDA have a shared responsibility in keeping our food supply 
safe and secure, and I look forward to their recommendations on 
how to do that in light of the recent salmonella outbreak.
    Thank you in advance to our panels before us today, and my 
condolences to those who have lost loved ones in this 
unfortunate incident. I look forward to the hearing and 
testimony of our witnesses to get to the bottom of this 
incident, and I yield back the balance of my time.
    Mr. Stupak. Thank you, Mr. Sullivan.
    Mr. Markey, a member of the subcommittee, for a statement, 
please.

OPENING STATEMENT OF HON. EDWARD J. MARKEY, A REPRESENTATIVE IN 
        CONGRESS FROM THE COMMONWEALTH OF MASSACHUSETTS

    Mr. Markey. Thank you, Mr. Chairman, very much, and thank 
you so much for having this hearing.
    Peanut butter is a classic American food enjoyed by young 
and old alike, and when it is contaminated by a dangerous 
pathogen, it is something that sends chills through every 
family in America because there are few things more American 
than peanut butter, perhaps baseball of course, but this week 
we learned that there too was a positive test for steroids, and 
salmonella poses a serious health risk as well. So this 
requires an ongoing effort by this Congress to ensure that in 
all of these cases that there is no contamination of these 
things that Americans take for granted as being American. 
Peanut butter goes well with jelly but not with salmonella. 
Peanut butter was probably half of my diet as a child. It is 
one of those foods that is really good for you and tastes great 
too, but now mothers and fathers across America are worried 
about salmonella and don't know what to put in their kids' 
lunches. This is not good for our country. More than 1,800 food 
products have been recalled including crackers, snack bars, 
cookies and all sorts of other items made with peanut butter 
that may contain the disease-causing bacteria. Salmonella 
already has had an impact on hundreds of families.
    The FDA under the Bush Administration failed to take steps 
necessary to ensure the safety of our food supply. We learned 
once again with this recall that mandatory authority is 
required. When it comes to food safety recalls, we need 
mandates and not maybes. We cannot run the risk that we will 
see families across this country once again afflicted with this 
kind of a problem. The families who testify here today, and we 
thank you for that, represent millions of other frightened 
families across this country, and your story is their story. 
Your story represents this fear that a parent can be lost, that 
a child can be sickened by a product which they assume is safe 
because the Federal Government is ensuring that it is safe by 
putting the fear of the government into the hearts of those 
that produce products like peanut butter and peanut butter-
related products. That did not exist and that is why you are 
here today. We thank you for your courage in testifying today. 
I can promise you that your testimony today will result in the 
changes that will protect millions of families in our country.
    I yield back the balance of my time.
    Mr. Stupak. Thank you, Mr. Markey.
    Ms. Schakowsky for an opening statement, please.

       OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 
     REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS

    Ms. Schakowsky. Peanut butter. Peanut butter. Is there a 
kitchen that doesn't have peanut butter, is there a lunchbox 
that doesn't have peanut butter sandwiches at some point? It is 
actually more American than apple pie. But what I really find 
amazing is that it was known by the Peanut Corporation of 
America that their product was tainted with potentially life-
threatening salmonella and yet released into the food stream 
anyway. How could that possibly happen? The only explanation is 
they thought based on some reality, given the lax regulation of 
the last Administration, that they would get away with it.
    I am so sorry to the testifiers and the families that are 
here today that were burdened by this, afflicted by this, 
tortured by this, that your government failed you, and I am 
grateful to the chairman for holding this hearing today so that 
we can set in motion those safeguards that will never let that 
happen again and to hold accountable the people that made the 
decisions that allowed it to happen. In one of the most 
developed nations in the world with access to unparalleled 
technologies and resources, there is simply no excuse that we 
can offer to you that contaminated or otherwise unsafe food 
made it all the way to consumers and to your tables.
    I have been a food safety advocate since 1969 when I a 
young group of housewives got together to get freshness dates 
on food. We led a little housewives' campaign that has resulted 
in dates, expiration dates, sell-by dates being on food 
throughout our marketplace, and yet today we find that this 
could happen. So I thank the panel before us right now for 
being here to testify.
    I want to just mention that one of the laboratories, 
Deibel, is in my district. I have been told by the committee 
that they were very cooperative with the committee. I 
appreciate that and look forward to their testimony as well and 
want to join with my other colleagues in assuring you that we 
will act to make your families safe from this kind of potential 
killer. Thank you.
    Mr. Stupak. Well, thank you. That concludes the opening 
statements of members of the subcommittee. I noted once for the 
record Mr. Barrow is here. He is a member of the full 
committee. Do you have an opening statement you would like to 
submit?
    Mr. Barrow. Well, first off, thank you, Mr. Chairman, for 
holding this hearing and for allowing me to audit these 
proceedings as though a member. I have very little to add to 
what has been said before but I will add very little.
    Mr. Stupak. Very quickly, because you are not allowed 
opening----
    Mr. Barrow. It seems to me that in addition to the 
provisions that have been talked about before that are part of 
a comprehensive reform, things like mandatory recall authority, 
one thing we very badly need is a testing regime in the 
industry in which folks are required to test and know what they 
need to know and a mandatory contemporaneous reporting 
requirement so that the regulators will know what the 
processors know when they know it. I think that would add great 
teeth and great effectiveness to any mandatory recall 
authority, and that is what I look forward to exploring with 
other members on the panels later on.
    Mr. Stupak. Well, thank you. We discussed that 
certification of labs and testing before and it is part of our 
global bill, and we would love to have you on the bill. You 
will be allowed to ask questions later as we move on.
    Mr. Bishop, we already have your opening statement. A 
valuable Member of the House, while not part of the committee, 
we appreciate you being here and monitoring the proceedings. 
Without objection, Mr. Bishop's statement will be made part of 
the record.
    [The information was unavailable at the time of printing.]
    Mr. Stupak. As I said, that concludes our opening 
statements by members. I would now like to have our first panel 
of witnesses to testify. First we have Mr. Jeffrey Almer of 
Savage, Minnesota, whose 72-year-old mother, Shirley, died 
after eating salmonella-contaminated peanut butter at a nursing 
home--I should also note he has a photograph of his mother that 
I am sure he will explain to us as we move on; Mr. Lou 
Tousignant of Minneapolis, Minnesota, whose 78-year-old father, 
Clifford, died after eating salmonella-contaminated peanut 
butter at a nursing home, and Mr. Peter K. Hurley, a police 
officer from Wilsonville, Oregon, whose 3-year-old son, Jacob, 
was severely sickened by salmonella after eating Austin 
crackers.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised that you have the right under the 
rules of the House to be advised by counsel during your 
testimony. Do you wish to be represented by counsel, gentlemen? 
OK. Everyone indicates no. I am going to ask you to rise and 
raise your right hand to take the oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect that the witnesses 
replied in the affirmative. You are now under oath. We will 
begin with your opening statement. If you don't mind, Mr. 
Almer, would you begin, please, 5-minute opening statement, and 
we appreciate you all being here and coming here.

TESTIMONY OF JEFFREY ALMER, SAVAGE, MINNESOTA; LOU TOUSIGNANT, 
   MINNEAPOLIS, MINNESOTA; AND PETER K. HURLEY, WILSONVILLE, 
                             OREGON

                   TESTIMONY OF JEFFREY ALMER

    Mr. Almer. Thank you, Mr. Chairman and committee members 
for inviting me to testify today. My name is Jeff Almer and I 
am here today on behalf of the family of Shirley Almer, my 
mother, and as a member of S.T.O.P., Safe Tables Our Priority, 
a nonprofit organization that represents foodborne illness 
victims nationwide. My sisters, Vickie and Ginger, are also 
with me today.
    Shirley Almer had a lot of Sisu, which in her Finnish 
heritage describes a person with spunk, fortitude and 
determination. That is why her death on December 21 from all 
things salmonella-contaminated peanut butter came as such a 
shock to our family.
    In May of 2007, Mom had a couple of dime-sized spots of 
cancer diagnosed on her right lung. She decided to have it 
removed at the University of Minnesota and was subsequently 
diagnosed cancer-free. She took a family trip to Florida a year 
later to celebrate with her children and grandchildren, and it 
was such a joy to see her enjoying life after that terrible 
scare.
    Then in July 2008, she suffered a seizure and was diagnosed 
with a brain tumor. The prognosis was hopeful and she was 
determined to do whatever it took to beat cancer for a second 
time. A second seizure robbed her of movement and speech 
capabilities. She underwent brain radiation and a gamma knife 
procedure. She was required to stay at the University Hospital 
but fought back through rehab and regained the use of her limbs 
and her speech despite the diagnosis of some doctors. It was 
sheer determination and a can-do attitude she overcome all of 
that, never complaining. One of her wonderful rehab nurses told 
me she was a shining light and said she was absolutely amazed 
at the recovery. Mom was released in early October to 
recuperate with her family and was once again declared cancer 
free. She made plans. She bought Christmas presents. She wanted 
to get another puppy. She wanted to visit her sister Mary in 
Arizona and she was looking forward to being around to watch 
her grandchildren grow up.
    Unfortunately, she suffered a urinary tract infection 
around Thanksgiving and needed to check in short term to a 
rehab care facility for treatment. Her short stay was supposed 
to end the Monday prior to Christmas when she would then join 
the family for the holidays. She began to complain of stomach 
cramping and had diarrhea. There was a downward spiral from 
that point on. Our family was absolutely stunned to learn on 
the day before her scheduled release that doctors were giving 
her hours to live. It was very unexpected and equally hard to 
fathom how she could have gotten to this point. We were 
devastated as we ended up saying our tearful goodbyes and 
watching her last breaths on that Sunday.
    It was just after the New Year that my sister Ginger was 
informed by the Minnesota Department of Health about the 
positive test for salmonella. A week before her death she had 
unknowingly consumed salmonella-laced peanut butter while in 
her immune-compromised state of health. Cancer couldn't claim 
her but peanut butter did. Now that we understood the cause of 
her death, our grief was replaced by anger as we struggled to 
accept this preventable tragedy. Our family feels cheated. My 
mom should be here today.
    Her death and the deaths of seven others could have been so 
easily prevented if it were not for the greed and avarice of 
the Peanut Corporation of America. PCA appears to be more 
concerned with squeezing every dollar possible at the expense 
of sanitary conditions and sound food manufacturing processes. 
Every company needs to have a moral and ethical compass when 
producing the Nation's food supply. In this absence, we need a 
cohesive regulatory system to serve as our safety net; too 
often it is reactive, if at all.
    While they were not expecting to kill anyone, PCA now has 
the blood of eight victims on their hands along with the 
shattered health of a known 600 others, and they have 
devastating their own community with the unemployment. Their 
legacy is now that of a company that did what it could get away 
with until their shoddy practices has led to the Nation's 
largest recall. Their behavior is criminal, in my opinion. I 
want to see jail time and I want to see them served nothing but 
the putrid sludge they have been trotting out. I don't believe 
anyone in this country buys all the protests of innocence they 
have been saying.
    Shirley Almer loved this country but was terribly let down 
by a broken and ineffective food system with abysmal oversight. 
She was let down in the worst possible way by the very 
government whose responsibility it is to protect its citizens' 
health and safety. We cannot continue to ignore the public 
health threat caused by poorly regulated and contaminated 
foods. We cannot allow food safety to be continually 
underfunded and expose unsuspecting Americans to deadly 
pathogens.
    This brings up many important questions. How much time and 
money will end up being spent on the act of recalling over 
1,000 food products? What about the lost productivity and 
medical expenses for the sickened? When we will have a 
proactive instead of a reactive system? And my last question 
would be, when will all these painful deaths and sickness stop 
being collateral damage?
    The government and the industry need to work together to 
correct a multitude of problems. I am proud to be asking for 
change on behalf of my mother, Shirley, and on behalf of 
S.T.O.P. Although this country has many important issues right 
now, I am urging President Obama and distinguished Members of 
Congress to make the safety of our Nation's food supply a 
priority. It is imperative that Americans trust that their 
health is not compromised by the food on their plate.
    We love you, Mom, and we miss you every day. Thank you very 
much.
    [The prepared statement of Mr. Almer follows:]
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    Mr. Stupak. Thank you, Mr. Almer.
    Mr. Tousignant, your opening statement, please. If you want 
to submit a longer statement for the record, it will be 
included. If you would, please, Mr. Tousignant.
    Mr. Tousignant. Before I begin, Mr. Chairman, would you 
start the video, please?[Video]

                  TESTIMONY OF LOU TOUSIGNANT

    Mr. Tousignant. Mr. Chairman, members of the committee, my 
father was a highly decorated Korean War veteran. He fought in 
many difficult battles in his years in Korea and was awarded 
three Purple Hearts for his valor. He faithfully served his 
country for over 22 years and he loved every minute of it. The 
only thing that he loved more was his family.
    He was the proud father of six: Paul, with me here today, 
Marshall, Susan, Calvin, Jane and myself. As you can see by 
those photos, he loved spending time with his grandchildren and 
his great-grandchildren. He had 15 grandchildren and 14 great-
grandchildren.
    But he was a man that physically and psychologically 
scarred from Korea, and early on it was difficult for our 
family, but like most battles in his life, he overcame it, so 
much so that he became one of the most generous men that many 
had known. The night of his funeral, I was having a 
conversation with my brother-in-law, Dan Herrick, almost with 
me today, and he shared a story with me of when he and my 
sister were first married. Like most young married couples, 
times were tight back then and my father knew that, and he 
would invite them over, make up a story saying my car starter 
won't work right, something is wrong with the brake, something 
is wrong with the door, come on over and take a look at it. And 
he would always give Dan and my sister Jane a little something 
for the trouble of coming over. He helped a lot of through the 
years including his own parents when he joined the Army as a 
teenager. He sent money back home because times were tight then 
as well. As long as he had a few dollars in his pocket, he was 
more than willing to help anyone.
    His final battle occurred in December of 2008 when he ate 
some contaminated peanut butter from PCA. He suffered for weeks 
until he finally died on January 12, 2009. He had just entered 
a full-time healthcare facility in Brainerd, Minnesota, a month 
earlier. He had few goals left in life except for one: he 
wanted to live to be older than his father. He wanted to live 
to be 80 years old. He was 78 when he died, a year and a half 
too early.
    We can't be certain of how many years Dad was robbed of, 
and because of the way he died, because of all the media 
attention, our grieving process has been different than most. 
We should not be sitting here in front of you today, any of us. 
We can no longer pick up the phone and ask him what game he is 
watching today. My nieces and nephews can no longer crawl over 
to Grandpa and have their photos taken with him. My brother 
Marshall and my sister-in-law Ann, who were fortunate enough to 
spend the last 3 1/2 years with him, can no longer go to his 
house daily and just check in and see how he is doing. My 
brother Paul, who spoke with him frequently, can no longer call 
him just when he feels like. He has trouble sleeping at night 
now, not just because we lost our father but the senseless way 
that this happened.
    What happened to our father, the seven other families like 
the Almers, the over 600 others sickened like the Hurleys is 
not new. Over the years there have been hundreds of similar 
outbreaks and other heartbreaking stories. Why has this been 
allowed to happen? Two years ago the Peter Pan outbreak 
affected more than 600 people in 47 States. Two years later, 
here we are again asking for change.
    I submit to you, ladies and gentlemen, how can we truly be 
leaders of the free world if we can't keep our own citizens 
safe from the food that we eat every single day? We have a 
blind faith that when we go to a grocery store, the food there 
is also safe. Clearly it is not.
    Do not let the death of my father, the seven others and 
hundreds sickened by in vain. Please do your job. Do not let us 
be back here next year or the year after experiencing the same 
thing. Companies like PCA and Mr. Parnell who make our food 
should have rules that they live by. Companies should be 
inspected more than once every 5 years. Companies should not be 
allowed to shop around for lab results. Companies like King Nut 
should not be allowed to slap a label on their product they 
received from a factory that they know nothing about, never 
visited nor even ever inspected once. The FDA should also have 
the right to recall contaminated food themselves and not wait 
for companies to do so on their own. We can't allow the number 
of FDA inspectors and inspections to continue to decline.
    My father was a good man. He faithfully served his country. 
The system that was set up to protect all of us here today has 
failed. My father died because he ate peanut butter.
    [The prepared statement of Mr. Tousignant follows:]
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    Mr. Stupak. Thank you, Mr. Tousignant.
    Mr. Hurley, your testimony, please.

                  TESTIMONY OF PETER K. HURLEY

    Mr. Hurley. Good morning, Congressmen, Congresswomen and 
committee members. My name is Peter Hurley. My wife Brandy and 
I are parents of three children: Lauren, 5, Jacob, 3, and 
Alyssa, 8 months. I am a police officer in Portland, Oregon, 
and my wife is a marketing manager.
    Our whole family, baby and all, have traveled from Oregon 
to Washington, D.C., to testify before you regarding the 
salmonella outbreak that has affected us as well as hundreds, 
if not more likely, thousands, of fellow Americans.
    I want to take a moment to acknowledge the eight families 
who have lost loved ones. Eight people have died due to PCA's 
willful negligence. We were just lucky. It could have been very 
different for us.
    We made this journey to appear before you because we felt 
it important enough for you to hear our story of how the Peanut 
Corporation of America poisoned our son. We want you to hear 
how Jacob and a PCA-supplied product are genetically linked in 
the hopes that you will take action to protect our food supply.
    Jacob's story began with him becoming ill with diarrhea and 
vomiting in early January. He was sallow, lethargic and 
probably had a fever that we missed. In a few days he began to 
have blood in his diarrhea. We took him to the pediatrician. A 
few days later the pediatrician called to let us know that the 
lab results had come back and that Jacob had salmonella 
poisoning. At this point we did not know how Jacob got the 
poisoning, and because of that, we did not know how to protect 
the rest of the family. All we knew was that five or six people 
had already died in a new salmonella outbreak. At that time 
only King Nut peanut butter, a PCA product, was listed as a 
source, which we did not have. What had we unknowingly given 
him that had given him salmonella poisoning?
    As Jacob's diarrhea continued, my wife was given the oK 
from our pediatrician's office for Jacob to eat his favorite 
comfort food, Austin toasty crackers with peanut butter, the 
very food that we later found was the cause of his poisoning, 
so here we have a boy who is trying to get over food poisoning 
and one of the foods that was seen safe even to the people in 
the pediatric medical community is the exact product that is 
continuing to poison him.
    A week later, Dr. Bill Keene from Oregon's Office of 
Disease Prevention and Epidemiology came to our house at 5:00 
on a Saturday night. As a friend said, this is like having the 
head of the FBI coming out to take fingerprints. On that 
Saturday night, Dr. Keene took custody of our supply of Austin 
toasty crackers with peanut butter manufactured by Kellogg's 
with a PCA product. One week later, Dr. Keene called us to say 
that Jacob and the crackers he had taken from our house had an 
exact DNA subtype match for salmonella. Three out of the six 
packages of crackers he tested were positive, and that was all 
that we had left. The issue was no longer what had we done 
unknowingly but what had PCA done knowingly.
    Jacob continued to have diarrhea for 11 days. We had to be 
extremely vigilant to ensure that there was never any cross-
contamination between Jacob and Alyssa, our 7-month-old. If 
Alyssa had come down with salmonella poisoning, there is a good 
chance that we would be one of the families who had lost a 
loved one due to PCA's willful negligence.
    I have read the FDA's most recent report. This was not an 
accident. It sickens me to know that a company and its 
employees could knowingly allow tainted product to go out the 
door and into the Nation's food supply. Does no one have a 
conscience anymore? People would be in utter outrage if they 
heard of a police officer putting a loaded gun to someone's 
head, pulling the trigger, and then in the horrific aftermath 
say it was just that the bullet in the chamber wouldn't fire. 
We, the United States, are the first world. Have we fallen to 
second world food status for our food safety? As the woman 
taking care of our dog while we are here in D.C. said, ``Even 
my dog is not safe. What is this, China?''
    Where do we go from here? We need to have a faster 911-
oriented medical response for food contamination in order to 
prevent further innocent victims. We need FDA inspectors out 
there with the authority to stop production immediately when 
there is a problem. We need the FDA to have the ability to 
criminally prosecute quickly and effectively. Oregon has the 
dubious distinction of suffering the first-ever domestic 
terrorism in the United States. It was carried out by the 
Rajneeshees in the 1980s. They sprayed a salad bar in The 
Dalles, Oregon, with salmonella. If a small group of religious 
fanatics in Oregon could pull it off, who else could?
    None of us should be so naive as to think that Al-Quaeda 
could not easily taint our food supply. If the very well-funded 
Al-Quaeda could put it mind to it, I shudder to think of what 
could happen to this country when people do not know where to 
turn to find safe, uncontaminated food. The panic, pandemonium 
and lawlessness would be horrific.
    I will leave you with my favorite quote by the 19th century 
author, poet and philosopher, Johann Wolfgang Goethe: ``Few men 
have imagination enough for reality.'' On behalf of all 
Americans, my whole family, Jake and I ask you to please have 
imagination enough to think of the worst-case scenario and to 
work to protect against it. Thank you.
    [The prepared statement of Mr. Hurley follows:]
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    Mr. Stupak. Thank you, and thank you to this panel for not 
only being here but also sharing your story and your video to 
put a human face on this latest recall we have. I would like to 
express my condolences to you, Mr. Almer, and to you, Mr. 
Tousignant, and Mr. Hurley, we are glad that Jacob is doing 
better and it is good to have your whole family here. Thank you 
for being here.
    As family members and victims of this outbreak, I am sure 
that you have asked yourself the same questions I have asked 
myself: What was this company thinking releasing tainted 
product to the public. During our investigation, the committee 
requested and received internal e-mail from PCA relating to the 
outbreak and past testing for salmonella. I would like to ask 
you about some of these documents. Mr. Hurley, right in front 
of you is there book, the document book. Let me ask you this. 
On October 6, it is tab #43, if you want to open it up there. 
Tab #43, on October 6, 2008, Stewart Parnell, president of the 
Peanut Corporation of America, responded to news from Sam 
Lightsey, the manager of PCA's plant in Blakely, Georgia, as 
tab #43 says, Mr. Lightsey had informed Mr. Parnell, ``We 
received final lab results from Deibel this morning and we have 
a positive for salmonella.'' Mr. Parnell's response was as 
follows, and again, it is found there in tab #43: ``We need to 
discuss this, the time lapse. Besides the cost, it is costing 
us huge...'' and there are dollar signs ``and causing obviously 
a huge lapse in time from the time we pick up peanuts until the 
time we can invoice.'' And in there you see there are five 
dollar signs. Let me ask each of you, what is your reaction to 
this company responding to positive salmonella testing with 
concern about its own financial well-being? Mr. Hurley, do you 
want to start?
    Mr. Hurley. Not to sound trite or overly confident, but as 
a police officer, I can unequivocally say that it is criminal.
    Mr. Stupak. Mr. Tousignant?
    Mr. Tousignant. An act that is this egregious, I completely 
agree with Mr. Hurley. I mean, this is a completely criminal 
act that in essence he was really playing Russian roulette with 
children and the elderly when he sent this peanut butter out.
    Mr. Stupak. Mr. Almer, do you care to comment?
    Mr. Almer. When I came here today, I didn't think I could 
possibly get more outraged than I already am about how this 
happened, but I have to tell you, it has reached another level 
after seeing e-mails and comments from Mr. Parnell. No excuses.
    Mr. Stupak. On tab 46, there is another tab in there, 
another e-mail, and let me just--there are other faxes and e-
mails the committee has uncovered but you indicated that it was 
criminal, Mr. Hurley. Being a former police officer myself, I 
am identifying with you. The Justice Department is doing their 
investigation. There are certain things that our committee 
could and could not bring out at this time, so I want to assure 
all of you that there still is a criminal investigation going 
on.
    You also mentioned about your dog and the sitter taking 
care of it saying, ``What are we, China?'' Well, in 2006 some 
of those peanuts that were positive came from China, so it is a 
global problem.
    But let me ask you this, #46, tab 46, even after several 
weeks into this outbreak, Mr. Parnell was asking the FDA 
whether it could use peanuts from its plants. Here is what they 
wrote to the FDA, ``Obviously we are not shipping any peanut 
butter products affected by the recall but desperately at least 
need to turn the raw peanuts on our floor into money.'' So we 
have at least two e-mails here in which Mr. Parnell reacts to 
the outbreak by worrying about how money it is costing him. Any 
comments on that? Mr. Hurley.
    Mr. Hurley. Narcissistic, I would say, maybe.
    Mr. Stupak. OK. Mr. Tousignant?
    Mr. Tousignant. I am at a loss, personally. I mean, I just 
can't see how anyone could run a business and be a member of a 
community and maybe even belong to a church in that community 
and be making decisions not only like this but also putting 
jobs in that community as well in a very, very tight 
environment like this too.
    Mr. Stupak. Mr. Almer?
    Mr. Almer. I would expect that if you are making food, you 
would want to eat that food that you are producing, and I don't 
believe that Mr. Parnell would actually want to eat this 
product if he is producing food in that manner.
    Mr. Stupak. Well, thank you, and again, let me thank you 
for coming here and sharing your stories. I know it is 
difficult, but we need to have the human face because people 
have to see. They just think we have these hearings but there 
is a reason for these hearings and that is so people see what 
happens when frankly a number of people let us down but 
including our own government. That concludes my 5 minutes for 
questioning. Mr. Walden for questions, 5 minutes, please.
    Mr. Walden. Thank you very much, Mr. Chairman. As we have 
sat here, I have been updated that now in Oregon we have 12 
lab-confirmed reports of salmonella, and also as I referenced 
in my comments, they now have confirmed the dog and the dog 
biscuits from the household were positive as well, so Mr. 
Hurley, I believe it was you who said somebody is watching your 
dog. We now know that it is there as well.
    I wonder of Mr. Parnell is in the audience. Is Mr. Parnell 
in the audience? You know, I would think that the least he 
could have done was be here to hear your comments and to hear 
about your loved ones, like a victim impact panel, because that 
is really what this is today.
    Mr. Almer, I will be asking Mr. Parnell, as I mentioned in 
my opening statements, and I appreciated the comment about 
Russian roulette because that is really what this is about is, 
which of these would he eat and his company because they sure 
put it out there for your mother and your father and, Mr. 
Hurley, your son, and all the rest of us to consume, and I 
wonder if he will take the top off. We are going to give him 
that opportunity.
    Mr. Hurley, from your written testimony it seems like you 
were pleased with the State of Oregon's response to your son's 
illness. Can you tell me what Oregon did that was helpful to 
you and may serve as a model for other States? What out of that 
experience can you share with us?
    Mr. Hurley. At the time when Dr. Keene came to our house, I 
was unfamiliar with his rank and status and----
    Mr. Walden. As the state epidemiologist.
    Mr. Hurley. As the state epidemiologist. Exactly. And since 
then I have learned, as my friend said, it is kind of in terms 
of rank like having, you know, the director of the FBI come by 
to take latent fingerprints. What he did though is unique for 
the whole country, and that is that Jake is the only person in 
the whole country where you have a DNA link between the 
product, the Austin peanut butter crackers, and his lab 
samples. Sorry for the crassness, but it was lab fecal samples. 
And it is an exact DNA match so that they know that the peanut 
butter crackers that he ate that went through his system is 
what made him sick, and Jake is the only one in the whole 
country and that is because Dr. Keene came to our house at 5 
p.m. on a Saturday night on his own time while running errands 
because he was concerned enough about where this was going and 
what was happening that he then took those samples, sent them 
off to the lab and he said that the lab spent lots of time and 
lots of hours and money on it to find that link, and with that 
kind of a link, then they had a batch number and a processing 
number that they were able to contact Keebler with directly.
    Mr. Walden. And as far as you know, that wasn't done 
anywhere else in the country?
    Mr. Hurley. To this date when I--I spoke to him last on 
Friday, I believe it was, and at that time nobody else had any 
direct links, and as he said, most States don't have the 
manpower or money to do that, and also it seems as if most 
State epidemiologists, they know that people have gotten sick 
because they get that from the county health records and then 
they work on the other side looking at the lab results of 
product out there or voluntary lab results but they don't put 
the two and two together by looking for product at its 
location.
    Mr. Walden. I would say too as my staff was collecting this 
assortment of products that are on the recall list, we ran into 
even in some of their homes items that are on that list that 
frankly they thought had already been thrown out, destroyed, 
whatever, and sort of beyond this hearing but in real time, 
people may still have products at home that should be 
destroyed, and as we were chatting here, just the breadth, the 
scope of the items that are out there, what would you--Jacob 
suffered through this. Certainly as apparent, and I, like you, 
am a parent, but what should we be telling people across the 
country today about this?
    Mr. Hurley. I don't know what we should be telling them but 
I do know that one of the tough things in this has been getting 
all the products off the shelves. I know that locally in Oregon 
there was a story done where they went to some small local 
markets where people weren't getting their product directly 
from a supplier, they were going out and purchasing themselves, 
a small mini market kind of situation, with lots and lots and 
lots of products on the shelf, and, you know, how do you get 
that word out when it is voluntary. There is no system in place 
to get the word out to all these retailers of all these 
different products.
    Mr. Walden. Did you do searches online looking for products 
once you started down this process? I mean----
    Mr. Hurley. No. You know, we gave up our supply of peanut 
butter crackers to the doctor and after that, as he said, you 
know, just don't eat anything with peanuts in it or any peanut 
products until we know more down the road, and so, you know, we 
have got stuff still in our pantry but it is sitting there 
waiting to kind of see how this develops because I know it will 
be a little bit longer.
    Mr. Walden. I guess that is the concern is everything in 
the pantry, and it is amazing to me how much of what we consume 
has some peanut or peanut paste or something in it that may 
well be on this list.
    Thank you, Mr. Chairman. Thank you, Mr. Hurley.
    Mr. Stupak. Thank you. I just want to let you know, as of 
last night, the Republican cloakroom still had the Keebler 
peanut butter crackers in there. Mr. Shimkus brought it to our 
attention, and I think we got it out of your cloakroom.
    Mr. Walden. Yes, they are supplied by the Democrats in a 
conspiracy.
    Mr. Stupak. Just trying to help.
    Ms. Christensen for questions, please.
    Ms. Christensen. Thank you, Mr. Chairman, and again, thank 
you and your families for being here this morning and for 
sharing these painful stories with us.
    Do you have any concerns about the speed with which they 
outbreak was linked to peanut butter by public health 
officials? We have focused a lot on the company itself but I 
want to just turn the focus to our response as a government.
    Mr. Almer. I would like to add that my mom at the peanut 
butter some time in mid-December and the salmonella outbreak 
was known about in early September, so the time it took to find 
out the cause could have prevented a lot more of the problems 
that happened.
    Ms. Christensen. I just have another question that either 
of you could answer or all of you. I will preface it by saying 
that as a physician I used to do drug testing on ships coming 
into port and so forth, the people that worked there, and I had 
to ascertain by temperature that this person gave me the sample 
and I had to be responsible for the chain as it went from the 
ship to the lab. So I have a lot of concerns about the second 
lab test, whether the second samples were from the same batch, 
especially with positive tests going back to 2007. Do you think 
it is good enough for the company themselves to be the ones 
collecting, contracting for the testing and reporting the 
results? Shouldn't that be fixed?
    Mr. Tousignant. Well, I think clearly in this case that is 
definitely the key. I mean, clearly the company could not be 
trusted to do it on their own. Now, I know that there are 
probably a lot of companies that are running an ethical 
business, but unfortunately, we have to worry about the ones 
that are not, and we have to have a process in place that 
allows us to be in charge of that.
    Ms. Christensen. Thank you. I don't have any other 
questions for this panel, Mr. Chair.
    Mr. Stupak. Thank you, Ms. Christensen.
    Mr. Deal for questions, please, 5 minutes.
    Mr. Deal. Well, I too express my sympathy to all of you for 
the loss of your family members and certainly the trouble that 
your young son has undergone. We have heard Mr. Hurley talk 
about his interaction with his State epidemiologist. Would the 
other two of you elaborate on any contact you may have had with 
health authorities? For example, did any of you get contacted 
by the CDC, et cetera?
    Mr. Tousignant. My brother, actually Marshall, was 
contacted by the State of Minnesota and we found out, I wan to 
say about a week after the fact after my father died or maybe a 
few days after he died that indeed he did have salmonella and 
they actually found it in his blood.
    Mr. Almer. It was about 2 weeks after my mother died that 
my sister Ginger received a call from the Minnesota Department 
of Health if we had brought in any kind of food from the 
outside, had she eaten chicken, had she eaten peanut butter, 
and it was my sister who remembered she had served my mother 
peanut butter toast two times. That really became a huge key to 
finding out--actually I have heard the Minnesota Department of 
Health was very instrumental in finding the very source of this 
outbreak, and we were told by them that my mother's death was 
key to the whole thing.
    Mr. Deal. Well, I think the reason for this oversight and 
investigation hearing is to find out how we can best plug the 
loopholes and close the gap so that hopefully we will not see a 
repeat of this kind of situation in the future, and we thank 
you all for taking the time and going to the expense of being 
here today, and with our assurances that I am sure our chairman 
and other members of this committee will follow through to try 
to make sure we can do the best we can from our end to make 
sure it doesn't repeat itself.
    Thank you all for being here. I yield back.
    Mr. Stupak. Ms. Sutton for questions, please.
    Ms. Sutton. Thank you, Mr. Chairman, and thank you all so 
much for your testimony, for coming here to dispel any notion 
that your loved ones are acceptable collateral damage or some 
sort of statistic as opposed to real people with real families 
who are suffering because of actions that have been taking 
place.
    If I may, I would like to show you some new information 
that the subcommittee received and get your response to it. I 
have a statement from Michelle Pronto, and I believe it is at 
tab 10. Ms. Pronto works for J. Leek Associates, which is one 
of the private labs PCA used to test salmonella. She manages 
the microbiology lab there. The subcommittee spoke with Ms. 
Pronto and she agreed to provide a written statement, which I 
ask to be placed into the record.
    Mr. Stupak. Without objection.
    [The information was unavailable at the time of printing.]
    Ms. Sutton. Ms. Pronto explains in her statement that in 
October of last year her lab found salmonella in PCA's peanut 
products. She reported this positive finding to Sam Lightsey, 
who is the plant manager, as we know, in Georgia, and this is 
how she described their conversation. She stated, ``When I 
called Mr. Lightsey in early October 2008 to give the serology 
reports that JLA had obtained from Deibel Lab for the confirmed 
salmonella, he paused and said uh-oh or something to that 
effect and then told me he had released the product for 
shipping. When I asked if he could get it back, he said it was 
on a truck heading to Utah.'' Now, you guys saw that earlier, 
and let me ask you, any of you, is there anything you would 
like to say in response when you hear this statement from the 
plant manager and that he shipped the product without even 
waiting to get the results of the salmonella test?
    Mr. Almer. I would like to add, I know that trucks can be 
stopped, doors can be opened, product can be taken out, or the 
truck can be just turned right around. It costs more money, 
sure, but it is easy to do.
    Ms. Sutton. Anybody else?
    Mr. Hurley. I would concur. That is absolutely ludicrous.
    Ms. Sutton. And let me share something else that Ms. Pronto 
had to say. She said, ``During a phone conversation in August 
2008, Sammy Lightsey of PCA informed me that the Albany, 
Georgia, JLA lab was reporting higher aerobic plate counts--
those are APC results--and higher coliform results than another 
lab he apparently used.'' Then she said this: ``I received an 
e-mail on 9/10/08``--September 10 of 2008--``from JLA employee 
Stephanie Fletcher stating that she was told by QC manager''--
quality control manager--``of PCA that PCA was no longer going 
to send us samples.'' Finally, she said this: ``I called Mr. 
Lightsey to follow up on the recent discussion regarding the 
confirmed positive and he confirmed that because of the high 
coliform results, they were going to send samples to a 
different lab.'' So this lab official certainly seems to be 
saying that when PCA didn't like the positive test results, it 
just took its business elsewhere.
    So what is your opinion, and I could guess but I don't 
think anyone could say it better than you. What is your opinion 
of a business that engages in activity like this?
    Mr. Tousignant. I think unfortunately that is an example of 
why we can't trust self-checking or self-regulation, and I 
think this is an example of why our food supply is not safe.
    Mr. Hurley. You can't have lab shopping. You can't have lab 
shopping going on to find your best results.
    Mr. Almer. It is just a complete conflict of interest. They 
are the ones who do not benefit by the negative results or 
positive results, whatever they may be. They can't shop around.
    Ms. Sutton. Again, I thank you very much for your testimony 
and I am so very sorry for your loss.
    Mr. Stupak. Following up that last question, if I may, with 
your 30 seconds, do you think any lab results from any food 
producer should automatically be sent not only to the producer 
of that food but also to the FDA simultaneously? Any objection 
to that?
    Mr. Hurley. No objection, and I actually would have just 
been under the assumption that that is how the process already 
was.
    Mr. Stupak. That is not the way it goes. It is part of our 
legislation. Thank you.
    Mr. Gingrey for questions, please, 5 minutes.
    Mr. Gingrey. Mr. Chairman, thank you, and I have already 
expressed my condolences to the families and I will repeat that 
now. I know this is a painful experience for all the family 
members as we can see in your faces as you give your testimony.
    I guess the main question that I want to ask you because we 
will have the two subsequent panels, hopefully the second panel 
will respond to our questions but it is likely, as I said in my 
opening statement, that they will not, but of course, the third 
panel is a very important panel, so I guess my question to each 
of you is, what would you want us to ask them? And when I say 
``them'' I am talking about the FDA, I am talking about the 
CDC, I am talking about USDA, United States Department of 
Agriculture, and I am talking about the department of 
agriculture in the respective States, all 50 have one, and the 
health departments. And so if you could maybe tell me ahead of 
time what to ask, I will be glad to do that when we have that 
opportunity.
    Mr. Almer. I would like to respond and ask them why anyone 
would not want to have mandatory recalls. Why do we leave it up 
to the companies to decide when they are going to recall their 
product? That is an important part. I guess that would be my 
main question.
    Mr. Tousignant. I am not sure that you are asking the 
question maybe down this line but the question that I have is, 
why does the FDA not already have this authority? Why do they 
not have the ability to recall these items themselves? And 
secondly is a budgetary issue. Why are there inspectors and 
number of inspections continuing to decline? Who is in charge 
of the budget? Because if you think about people's main 
concern, it is safety of food foremost. We have to be able to 
eat. This is just as important as the economy is right now.
    Mr. Hurley. No comment.
    Mr. Gingrey. Well, I thank you gentlemen, and again, I 
think that we on the committee are very appreciative of you 
coming and testifying as painful as it is. I don't know if you 
are aware but on this committee, on both sides of the aisle, we 
probably have three M.D.'s, we have a registered nurse, we have 
a clinical psychologist, and we have some experts that have 
been on the committee for a long time, the chairman and ranking 
member, in regard to these healthcare issues. So it is 
something that certainly has got our attention and obviously we 
plan to do everything we can to try to close that weak link in 
the chain because, as I said, it is only as strong as the 
weakest link and obviously there is a problem, and we thank you 
so much for being here.
    Mr. Walden. Would the gentleman yield?
    Mr. Gingrey. I will be glad to the yield to the ranking 
member.
    Mr. Walden. I think it is important to point out that it is 
already against the Food, Drug and Cosmetic Act law to 
knowingly ship product that tests positive. That is the amazing 
thing here. Out of everything we have, it would appear they 
knew it was positive. If you get a positive hit on a salmonella 
test, you are supposed to destroy the product. They may test 
again to figure out in their process where they are having this 
contamination. That is a different deal. But you are not 
supposed to ship it out for consumption, and that is what is 
outrageous here. So that piece is already in the law. Obviously 
the inspection piece and some of these other things need to be 
dealt with, but it is just stunning.
    I yield back.
    Mr. Gingrey. Mr. Chairman, if I have any remaining time, I 
yield back.
    Mr. Stupak. The chair will use 45 seconds of your remaining 
time. Even subpoena power, I have been trying to get the FDA to 
have subpoena power for 12 years. They keep denying us saying 
they don't need it, a great example where you need subpoena 
power.
    Ms. DeGette.
    Ms. DeGette. [Presiding] Thank you. Well, oK, let us talk 
about subpoena power. Let us talk about the criminal laws. But 
these companies don't even have to produce their records to the 
FDA if they have these tests for salmonella, and in the 
previous peanut contamination hearing we had with ConAgra, what 
happened was, they had--it wasn't as blatantly criminal as this 
case, but what happened in that case was, they had water 
dripping down and they had all kinds of records that showed 
this, and they had the FDA inspectors come to the factory but 
the company made this decision not to produce the records 
because the records showed that there was a problem, and so 
while it is true that it is criminal activity and while it is 
also true that the FDA could use subpoena authority, it would 
be pretty simple for Congress to pass a law, and in fact, I 
think it is in Mr. Dingell's bill, to say that it is also a 
requirement that they produce this information when they have a 
test that shows negative, that they produce it to the FDA and 
put some criminal penalties in place, and I am sure all of you 
gentlemen would agree with that too.
    I don't really have any questions. I just sit here and I 
feel sick at heart when I hear you talk about your families, 
and Mr. Hurley, when I see your little kids, you know, I have 
two girls myself, so I feel sickened hearing about your 
parents, and what makes me so sick, as I said in my opening 
statement is, I have been sitting here for 12 years listening 
to this. So I guess what I will say is, I want to echo what all 
of you said. It shouldn't be that hard for the most 
sophisticated country in the world to put a system in place 
that requires them to provide the documents when they see a 
problem, that gives the FDA mandatory recall authority, which 
by the way would act, I think, to light a fire under these 
companies if they knew that there was mandatory recall 
authority and they couldn't mess around. And then as I 
mentioned in my opening statement, traceability so that what 
happened in Oregon could happen in all the States where if you 
had mechanisms in place that were interoperable, then if you 
found salmonella in a little kid in Oregon, you could rapidly 
work throughout the United States to figure out the source of 
that salmonella and to recall all those food products. And if 
that happened, I don't think we would have lost Mr. Almer's and 
Mr. Tousignant's parents because we knew about that salmonella 
several months in advance.
    So I will make a commitment to you as someone who has 
worked on this for years along with Mr. Stupak, Mr. Dingell, 
Mr. Waxman, our friends on the other side of the aisle. We are 
going to do this, and I hope we will do it this year because I 
don't want to be back here in 6 months. Neither do you, Mr. 
Walden or Mr. Gingrey, any of you guys. We have just sat here 
too long listening to this and we can fix it. I have got some 
legislation. We have comprehensive legislation. We need to 
figure out, should we move this one bill at a time. We could do 
my mandatory-recall bill on the suspension calendar next week. 
Mr. Walden would agree. I will bet you Mr. Barton would agree. 
And we could do comprehensive food safety. We have been working 
on it for a long time. So I will just make the commitment to 
you. We are going to do this and we are going to do this in one 
your loved ones' memories. I will yield back.
    I recognize Mr. Burgess for 5 minutes.
    Mr. Burgess. I thank you. And it does seem like deja vu all 
over again to quote a great American. Mr. Walden is exactly 
correct in the way we have dealt with a lot of these things 
repetitively and all the issues with notification, all the 
issues with recall, all of the issues with the failure of the 
kill step to take the bacteria off the exterior of the peanut. 
Those are all very important. If you have a criminal mind at 
the back of it running the operation, it is just hard to know 
how you deal with that asymmetric threat. We know that through 
multiple hearings, as I referenced in my opening statement, we 
beat on the FDA until it is a wonder there is anything left of 
them. They need better systems in place. We need to fund them 
better. We recognized that through hearing after hearing after 
hearing last Congress. We haven't even done our appropriations 
from last year yet. Those are due to come up in an omnibus bill 
in March so they need more money and we know that. We have been 
slow to respond. But still, the baseline, if you have got that 
asymmetric threat of a criminal mind, all of these things are 
very, very difficult to prevent if you have got someone who is 
willfully ignoring the rules and not just ignoring the rules, 
purposely working against you.
    Dr. Gingrey is correct. You do have three physicians on 
this subcommittee. You have got a clinical psychologist and a 
nurse. After today's hearing, we may need the clinical 
psychologist as well as the nurse. I am not sure if the doctors 
are going to do you any good.
    But let me just ask you, being a physician myself, I would 
like to ask each of you the same question generally, and Mr. 
Deal got to it a little bit, but this can be a difficult 
diagnosis, even though the clinical symptoms present 
themselves, and we are talking about salmonella and it seems 
very obvious to link the clinical symptoms with the ultimate 
diagnosis, but Mr. Almer, in your situation, was the correct 
diagnosis, did the doctors have that in order to timely offer 
treatment or was this something that was established after the 
fact?
    Mr. Almer. We actually though she had died from pneumonia, 
and we found out 2 weeks later that that wasn't even on the 
death certificate, and we were given notice by the department 
of health of the salmonella positive test. That was our first 
notice of it.
    Mr. Burgess. And there is some time lag in normal clinical 
circumstances between submitting a sample and getting a test 
result back, whether it is positive or negative. So is that in 
fact what occurred during that time interval or was this 
something in fact that was discovered completely after the 
fact?
    Mr. Almer. From what I am told, somebody was doing their 
due diligence at the facility and they noticed they had some 
patients with diarrhea and sent the stool samples for testing 
and my mother's was one of those.
    Mr. Burgess. So there were actually more people in the 
facility who were affected?
    Mr. Almer. There were actually--my sister lives up in the 
Brainerd community where three of the people have died. There 
actually are two others that may also die of salmonella at this 
time.
    Mr. Burgess. Just for my curiosity, were any diagnoses made 
in time to offer treatment? Salmonella is treatable. Oftentimes 
the other underlying conditions can make it impossible but the 
organism itself is one that we can generally get if we have got 
the knowledge.
    Mr. Almer. There was some treatment, possible sepsis, blood 
infection, which is common, I guess, with salmonella, but I 
don't think any of us knew or the facility knew that my mother 
had salmonella at that time, so she was already gone before 
anyone knew.
    Mr. Burgess. So to the best of your knowledge, no one 
received lab results in a timely fashion that would have 
allowed treatment to stop the disease?
    Mr. Almer. No, to my knowledge, no.
    Mr. Burgess. Yes, sir, and in your case with your dad?
    Mr. Tousignant. I am sorry?
    Mr. Burgess. I am going to mess up your name anyway but I 
can't see your name plate. Tousignant?
    Mr. Tousignant. Mr. Tousignant, yes.
    Mr. Burgess. Yes, sir. OK. I am sorry. In your situation, 
was the diagnosis established before your dad died?
    Mr. Tousignant. To the best of my knowledge, no. I believe 
it was, like I mentioned earlier, a few days to a week later.
    Mr. Burgess. And again, very, very difficult for the 
caregivers involved because they are doing their best, and in 
your dad's situation, a bloodborne infection which obviously 
would be a good deal more aggressive.
    And then Mr. Hurley in your situation, the epidemiologist 
came to the house, but prior to that level of involvement, did 
your son's caregivers have an idea, did your son's physicians 
have an idea, that his symptoms clinically might tip off the 
diagnosis of salmonella?
    Mr. Hurley. Nothing was mentioned to us in the beginning, 
and actually the samples were given on a Wednesday. On Friday 
the pediatric nurse called and said so far things look good, 
and then it was the next day on Saturday or Sunday that the 
doctor called from home to let us know.
    Mr. Burgess. And then it was that result that led the 
epidemiologist to come to your home to collect samples?
    Mr. Hurley. Correct. First it went to the county. A couple 
days later I got a call from the county health, and then a 
couple days later got a call from the state epidemiology 
office, answered some questions over the phone because then 
things were really starting to move along nationally in terms 
of PCA, and so then when he found out that even while he was 
sick that he was eating the peanut butter crackers, he said can 
I come over in a couple of hours.
    Mr. Burgess. But of course, your son was under active care 
from a pediatrician or infectious disease specialist during the 
course of his illness?
    Mr. Hurley. No. I mean, they told us what the illness was. 
Basically we just treated for--I mean, just made sure he had 
plenty of fluids and----
    Mr. Burgess. So it was symptomatic treatment?
    Mr. Hurley. Right, symptomatic treatment, but no, he was 
not in a hospital.
    Mr. Burgess. Well, again, this underscores it. It is a 
difficult diagnosis in a clinical setting and then obviously 
made more much difficult by the criminal minds behind this 
enterprise. So again, just like every other member of the 
committee, our condolences on your loss and thank you for 
spending so much time with us this morning.
    I yield back, Mr. Chairman.
    Mr. Stupak. Ms. Schakowsky for questions, please.
    Ms. Schakowsky. It is not so much a question, unless you 
want to respond to it, but I do want to be sure and get on the 
record, and I am wondering, is Mr. Parnell here yet? He is to 
be on the next panel, I guess. There is on tab 4 a couple of e-
mails that I just can't get over. On June 6, 2008, a PCA 
employee sent an e-mail to Steward Parnell alerting him that 
their product may have salmonella. If you look at that, you see 
it says ``lot number put on hold,'' exclamation points, ``I 
just spoke with Stephanie, with JLA,'' the private laboratory. 
``This lot is presumptive salmonella,'' in caps, and a total of 
15 exclamation points in these two sentences alone. Now, to any 
normal person, this would be a red flag and the alarms would go 
off and you would realize this is serious. I am sure everyone 
would agree with that.
    So here is the e-mail that Mr. Parnell sent in response. 
Later in the day he wrote, ``I go through this about once a 
week. I will hold my breath again.'' So how is anyone to react 
to the incredible disregard of this urgent e-mail? It is just 
absolutely beyond me. I don't know if any of you can put this 
into words, and certainly we would welcome your words on the 
record. Mr. Tousignant, did you want to----
    Mr. Tousignant. When this first happened, I think for a 
couple of my brothers and sisters and I, we wanted to believe 
that this somehow was really just an accident, that something 
happened with one of the companies, that somehow this got into 
the food. And as we have gone along in this process of 
discovery and learning more information as each day goes on, it 
just baffles me and I know it probably baffles every single one 
of us up here today and our families and the others in the 
country, that this is affected, that any one person can make a 
decision like this so consistently and so blatant.
    Ms. Schakowsky. I also want to say that I understand if you 
feel angry at us as well because as Congresswoman DeGette said, 
we have been here before, and again, as others have, I just 
want to make a commitment that we are definitely going to 
create the systems, act quickly so that hopefully we put in 
place the assurances that you are the last panel of people 
suffering from this that have to come before us. Thank you.
    Mr. Stupak. Thank you, Ms. Schakowsky.
    Let me thank this panel again. I think that concludes 
everybody's questions. So Mr. Hurley, your family asked when we 
were going to let you go. You are free to go if you want or 
stay for the rest of this hearing, you can, Mr. Tousignant and 
Mr. Almer, if you would like to, you can, but thank you for 
being here and thank you for putting a face on the tragedy that 
families are feeling across this country. Thank you very much 
for your testimony.
    Once the clerk clears that table, we will start with our 
second panel of witnesses. Our second panel of witnesses will 
come forward. On our second panel, we have Mr. Stewart Parnell, 
who is president of Peanut Corporation of America, and Mr. 
Sammy Lightsey, plant manager of that Peanut Corporation of 
America's Blakely, Georgia, facility.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised, gentlemen, that witnesses have 
the right under the rules of the House to be advised by counsel 
during their testimony. Do you wish to be represented or 
advised by counsel, Mr. Lightsey?
    Mr. Lightsey. No.
    Mr. Stupak. Mr. Parnell?
    Mr. Parnell. Yes, sir.
    Mr. Stupak. I would ask you to state the name of your 
counsel who will be advising you. Counsel cannot testify but 
can advise you, and before you answer a question if you want to 
consult with them before you answer it, you are allowed to 
under the rules of the House. So who would your counsel be, 
sir?
    Mr. Parnell. Bill O'Reilly.
    Mr. Stupak. OK, and Mr. O'Reilly, you are right here then, 
right? OK. Mr. Lightsey?
    Mr. Lightsey. I am sorry. I misunderstood the question.
    Mr. Stupak. Hit your mic, right there, a little button 
there. Is Mr. O'Reilly going to be your counsel too?
    Mr. Lightsey. No, Jim Parkman.
    Mr. Stupak. Jim?
    Mr. Lightsey. Parkman.
    Mr. Stupak. Parkman. OK. Mr. Parkman, raise your hand just 
so we know who you are. OK. Very good. The sample applies to 
you. If you want before you any questions you want to consult 
with your counsel, you have a right to do so. So I am going to 
ask you both to rise and raise your right hand to take the 
oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect that the witnesses 
replied in the affirmative. You are now under oath. You will 5 
minutes for an opening statement or you may submit a longer 
statement for inclusion in the hearing record.

TESTIMONY OF STEWART PARNELL, PRESIDENT, PEANUT CORPORATION OF 
AMERICA; AND SAMMY LIGHTSEY, PLANT MANAGER, PEANUT CORPORATION 
                           OF AMERICA

    Mr. Stupak. Mr. Lightsey, do you have an opening statement?
    Mr. Lightsey. No, I do not.
    Mr. Stupak. Mr. Parnell?
    Mr. Parnell. No, sir.
    Mr. Stupak. Then we are going to go right to questions, and 
members have 5 minutes for questions, and I will begin.
    Mr. Parnell, I want to ask you about an e-mail you sent to 
your employees at the Peanut Corporation on January 12, 2009, 
after public health officials found salmonella in peanut butter 
from your plant in Georgia. Right in front of you right there 
is our binder tab. It is tab #44, if you care to look at it. In 
particular, I want to ask you about the following statement you 
made in that e-mail. You said, ``We do not believe the 
salmonella came from our facility. As you probably know, we 
send hourly PB samples to an independent lab to test for 
salmonella during production of peanut butter and we have never 
found any salmonella at all.'' Mr. Parnell, during its 
investigation FDA found on 12 separate occasions between June 
2007 and September 2008 peanut products produced by PCA and 
tested by private labs were found to be contaminated with 
salmonella. On six of these occasions the FDA found that you 
had already shipped the product and that you conducted no 
subsequent testing. So your statement that you ``never found 
any salmonella at all'' does not appear to be true. So here is 
my question then, and I remind you, you are under oath: Mr. 
Parnell, did you or any officials at the Peanut Corporation of 
America ever place food products into the interstate commerce 
that you knew to be contaminated with salmonella?
    Mr. Parnell. Mr. Chairman and members of the committee, on 
the advice of my counsel, I respectfully decline to answer 
questions based on the protection afforded me under the United 
States Constitution.
    Mr. Stupak. Mr. Parnell, let me ask you this. In the last 
panel, and you heard the last panel testify, did you not?
    Mr. Parnell. Mr. Chairman and members of the committee, on 
the advice of my counsel, I respectfully decline to answer your 
question based on the protection afforded me under the United 
States Constitution.
    Mr. Stupak. I just asked you if you heard the other panel.
    Mr. Parnell. Mr. Chairman and members of the committee, on 
the advice of my counsel, I respectfully decline to answer your 
question based on the protection afforded me under the United 
States Constitution.
    Mr. Stupak. OK. Well, let me ask you this question, Mr. 
Parnell. The earlier panel, we talked a little bit about money 
and some of the e-mails and statements attributed to you about 
cost of business, how not moving product was hurting you, 
hurting your business, and that actually you deal with 
salmonella, again from the e-mails, once a week. So the food 
poisoning of people, is that just a cost of doing business for 
your company?
    Mr. Parnell. Mr. Chairman and members of the committee, on 
the advice of my counsel, I respectfully decline to answer your 
question based on the protection afforded me under the United 
States Constitution.
    Mr. Stupak. Mr. Walden, I believe you had a question you 
had alluded to earlier. Would you like to ask that question?
    Mr. Walden. I would, Mr. Chairman.
    Mr. Parnell, Mr. Lightsey, let me just cut to the chase 
then. In this container are products that have your ingredients 
in them, some of which were on the recall list, some of which 
are probably contaminated. It seems like from what we read you 
are willing to send out that peanut base with these 
ingredients, and I just wonder, would either of you be willing 
to take the lid off and eat any of these products now like the 
people on the panel ahead of you, their relatives, their loved 
ones did?
    Mr. Parnell. Mr. Chairman and members of the committee, on 
the advice of my counsel, I respectfully decline to answer your 
question based on the protection afforded me under the United 
States Constitution.
    Mr. Walden. Mr. Lightsey?
    Mr. Lightsey. At this time on advice of counsel, I exercise 
my rights under the Fifth Amendment of the Constitution.
    Mr. Stupak. Mr. Parnell, is it your intent to refuse to 
answer all of our questions today based on your right against 
self-incrimination afforded to you under the Fifth Amendment of 
the Constitution?
    Mr. Parnell. Yes.
    Mr. Stupak. Mr. Lightsey, is it your intention to refuse to 
answer all our questions today based on the right against self-
incrimination afforded to you under the Fifth Amendment of the 
Constitution?
    Mr. Lightsey. Yes.
    Mr. Stupak. All right. Then I have no choice but that both 
of you are dismissed at this time. You are subject to the right 
of the subcommittee to recall you at a later time and date if 
necessary.
    I would now like to call our third panel of witnesses to 
come forward. On our third panel we have Dr. Stephen Sundlof, 
who is the director of the Center for Food Safety and Applied 
Nutrition at the Food and Drug Administration; Mr. Oscar 
Garrison, who is the assistant commissioner of the Consumer 
Protection Division at the Georgia Department of Agriculture; 
Ms. Darlene Cowart, who is the president of J. Leek Associates 
Incorporated, JLA, and Mr. Charles Deibel, who is president of 
Deibel Laboratories.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised that you have the right under the 
rules of the House to be advised by counsel during your 
testimony. Do any of you wish to be advised by counsel during 
your testimony? Ms. Cowart?
    Ms. Cowart. Yes, Mr. Chairman, I have counsel present 
today, and I do wish to be represented.
    Mr. Stupak. Counsel's name is?
    Ms. Cowart. Mr. Evans Plowden and his associates.
    Mr. Stupak. OK. If you want to consult with them before you 
answer a question, please do.
    Ms. Cowart. Thank you.
    Mr. Stupak. Mr. Deibel?
    Mr. Deibel. Yes, sir, I have counsel present but they are 
sitting in back of me.
    Mr. Stupak. Just identify their name for the record.
    Mr. Deibel. Charles Deibel.
    Mr. Stupak. Mr. Deibel, your lawyer's name. You stated your 
name.
    Mr. Deibel. Richard Chapman.
    Mr. Stupak. Mr. Garrison, do you wish to have counsel 
present?
    Mr. Garrison. Yes, sir, I am being represented by Mr. Ted 
Hester of King and Spaulding at the request of our Georgia 
Attorney General, Thurbert Baker.
    Mr. Stupak. Very good. Mr. Chappell?
    Mr. Chappell. Mr. Chairman, no, sir.
    Mr. Stupak. Dr. Sundlof?
    Dr. Sundlof. No, sir, Mr. Chairman.
    Mr. Stupak. OK. As I said, it is the policy to take all 
testimony under oath. I am going to ask you now to rise and 
raise your right hand to take the oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect that the witnesses 
replied in the affirmative. You are now under oath. We will 
begin with opening statements for 5 minutes. If you wish to 
submit a longer statement for inclusion in the record, that 
will be allowed. Dr. Sundlof, let us start with you, please, 
sir.

 TESTIMONY OF STEPHEN SUNDLOF, D.V.M., PH.D., DIRECTOR OF THE 
  CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG 
    ADMINISTRATION, ACCOMPANIED BY MICHAEL CHAPPELL, ACTING 
 ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS, FOOD AND DRUG 
    ADMINISTRATION; OSCAR GARRISON, ASSISTANT COMMISSIONER, 
      CONSUMER PROTECTION DIVISION, GEORGIA DEPARTMENT OF 
  AGRICULTURE; DARLENE COWART, PRESIDENT, J. LEEK ASSOCIATES, 
    INC.; AND CHARLES DEIBEL, PRESIDENT, DEIBEL LABORATORIES

                  TESTIMONY OF STEPHEN SUNDLOF

    Dr. Sundlof. Thank you, Mr. Chairman and members of the 
committee. I am Dr. Stephen Sundlof, director of the Center for 
Food Safety and Applied Nutrition at the U.S. Food and Drug 
Administration, which is part of the Department of Health and 
Human Services. I am accompanied today by Mr. Michael Chappell, 
FDA's acting associate commissioner for regulatory affairs. FDA 
appreciates the opportunity to discuss our ongoing 
investigation of the foodborne illness outbreak associated with 
salmonella typhimurium, which has been found in peanut products 
produced by the Peanut Corporation of America, or PCA.
    Let me begin by expressing my personal and the agency's 
concern for people harmed in this outbreak of foodborne 
illness. FDA can and will learn from this outbreak what we can 
do to better assure the safety of our food supply moving 
forward. And it is important to note that the manufacturers 
play a critical role in ensuring the safety of the foods that 
they introduce into commerce. Strong food safety programs begin 
with a commitment and the strong oversight of the managers and 
the promotion of strong food safety culture throughout the 
company.
    In the typical traceback process employed by FDA and our 
partners at the Centers for Disease Control and Prevention, CDC 
notifies FDA when it identifies the possible foods associated 
with foodborne illness through its epidemiological 
investigation. At that point the FDA starts its investigation 
to identify the source of contamination. In the current case, 
FDA started its tracing process before CDC notified us of a 
strong epidemiological link to both help inform the 
epidemiological study and to shorten the time required to 
remove potentially contaminated foods from the market. Since 
early December of 2008, FDA has collaborated with the CDC, U.S. 
Department of Agriculture and state public health departments 
to investigate the multi-State outbreak of human infections due 
to salmonella typhimurium.
    Peanut butter was first identified as a possible source in 
mid-December, and on January 7 and 8, based on preliminary 
epidemiological data, the FDA decided to investigate 
institutional food sources of peanut butter rather than wait 
for more-conclusive data. On January 7, FDA made its initial 
contact with the King Nut Company, which distributes peanut 
butter manufactured by PCA to institutional facilities, food 
service industries and private label companies. Two days later 
on January 9, FDA initiated our inspection of the PCA 
manufacturing plant in Blakely, Georgia. As part of its 
epidemiological investigation, the Minnesota Department of 
Health tested an open 5-pound container of King Nut peanut 
butter obtained at a nursing home where three patients were 
sickened by the outbreak strain of salmonella typhimurium. By 
January 10, Minnesota health officials had found that peanut 
butter contained the same strain of salmonella typhimurium. 
However, because it was an open container which could have been 
contaminated by someone or something else in the environment, 
these results did not confirm the Blakely plant as the source.
    So FDA expanded the testing of unopened containers of the 
same brain of peanut butter, and on January 19, the Connecticut 
Department of Health tested an unopened container of King Nut 
peanut butter and found that it contained the same strain of 
salmonella typhimurium associated with the illness linked to 
the outbreak. The fact that salmonella typhimurium was 
confirmed in an unopened container of peanut butter indicated 
that the peanut butter was contaminated when it left the 
Blakely processing plant.
    As I noted earlier, FDA had already initiated the 
inspection of PCA's Blakely plant on January 9. We completed 
our inspection on January 27. FDA's environmental sampling at 
the plant found two salmonella strains, neither of which was 
associated with the outbreak. We are confident, however, that 
based on the investigations by the States, CDC and FDA that the 
Blakely plant is the source of contamination related to the 
salmonella typhimurium outbreak. Further, FDA's review of the 
testing records revealed that there were instances in 2007 and 
2008 where the firm distributed product in commerce which had 
tested positive for salmonella.
    The first recalls began on January 10 by the King Nut 
Company, and on January 13 by PCA. Expanded recalls followed on 
January 28 and on January 28 the firm voluntarily recalled all 
peanut products processed in its Blakely facility since January 
1, 2007, and these included dry and oil-roasted peanuts, 
granulated peanuts, peanut meal, peanut butter and peanut 
paste. Many companies that received the peanuts and peanut 
products manufactured by PCA's Blakely facility have in turn 
conducted their own voluntary recalls. FDA is continuing to 
work with the purchasers of PCA's peanuts and peanut products 
to identify affected products and facilitate their removal from 
the market. FDA initiated inspections at the direct consignees 
of PCA and King Nut and continues to follow the distribution 
points of the products. FDA has established a web page to 
provide constantly updated information on the contamination and 
recall. It includes a searchable databases to assist consumers 
in quickly identifying recalled products, and we encourage 
consumers to check this Web site frequently.
    FDA is reviewing with Health and Human Services our prior 
legislative requests to strengthen the agency's ability to 
protect Americans from foodborne illness to determine whether 
those requests should be updated in light of our experience 
with this outbreak. At this time we want to highlight the need 
for enhanced authorities in several areas. Number one, 
authority for FDA to issue preventive controls for high-risk 
foods; two, authority for enhanced access to food records 
during routine inspections; three, the authority for FDA to 
require food facilities to renew their registrations every 2 
years and for FDA to modify the registration categories. In 
addition, we note that mandatory recall authority would be a 
useful tool that in some circumstances could result in faster 
removal of implicated products from commerce.
    In closing, Mr. Chairman, let me assure you that the FDA is 
working hard to ensure the safety of the food supply in 
collaboration with our federal, State, local and international 
food safety partners. Although the salmonella typhimurium 
foodborne illness outbreak underscores the challenges that we 
face, the American food supply continues to be among the safest 
in the world and food safety is a priority of the new 
Administration. Please be aware that FDA is actively conducting 
both criminal and regulatory investigations related to this 
matter. To protect the integrity of these ongoing 
investigations and any related actions that might be pursued in 
the future, FDA must necessarily keep certain information 
confidential. It is also premature for FDA to draw conclusions 
about our preliminary observations or how the FDA's legal 
authorities might apply to those observations, but that said, 
we will do our best to respond to any questions that you may 
have.
    Thank you again for the opportunity to discuss these 
important public health matters.
    [The prepared statement of Dr. Sundlof follows:]
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    Mr. Stupak. Thank you.
    Mr. Chappell?
    Mr. Chappell. I don't have an opening statement.
    Mr. Stupak. OK. Mr. Garrison, opening statement, please, 
sir, 5 minutes. If you have a longer statement, we will submit 
it to the record.

                  TESTIMONY OF OSCAR GARRISON

    Mr. Garrison. Chairmen Waxman, Stupak, Ranking Members 
Barton and Walden, and distinguished members of the 
subcommittee, I would like to thank you for the opportunity to 
offer this testimony today. I am here on behalf of Georgia's 
Commissioner of Agriculture, Tommy Irvin. I am Oscar Garrison, 
the assistant commissioner responsible for Georgia Department 
of Agriculture's Consumer Protection Division. I have been 
directly involved with food safety at various levels for more 
than 15 years. I want to express my sympathy to the victims of 
the salmonella outbreak that were here today and also to the 
victims of foodborne illness in this country.
    The Georgia Department of Agriculture takes its commitment 
to food safety very seriously. We are more concerned about food 
safety and food being sold and processed in Georgia than 
anyone. To more effectively carry out our mission, the 
Department is working with our State legislature on an 
amendment to the Georgia Food Act that would require regular 
testing by the food manufacturers in Georgia. This legislation 
would require processing plants to promptly report to the 
Department the presence of any suspected contamination that 
would render food injurious to health or otherwise unfit for 
consumption. We encourage this committee to consider federal 
legislation that would require similar testing and reporting 
nationwide.
    We would like to have additional resources that would 
permit us to perform more inspections more frequently and 
comprehensively along with product testing, but with tightening 
budgets, FDA, Georgia and other States are stretching their 
resources about as effectively as we are able to. The 
Department has requested and our governor has recommended $24 
million to help fund a new laboratory to be located in south 
Georgia that would increase the product testing that our 
Department is currently capable of performing. Currently, we 
can test about 4,500 food samples per year in our State 
laboratories. The Georgia Department of Agriculture is required 
through the Georgia Food Act to license and inspect food sales 
establishments and processing plants. We inspect approximately 
16,000 facilities ranging from processing plants to food 
storage warehouses to retail grocery stores. These inspections 
are conducted by a field force of approximately 60 inspectors.
    For many years the Department of Agriculture, like agencies 
in other States, has had a contractual relationship with the 
Food and Drug Administration that requires us to conduct 
inspections at various food-processing plants in Georgia that 
ship products into interstate commerce. Including the two 
inspections we conducted for FDA, our Department conducted a 
total of nine inspections at the plant between 2006 and 2008. 
During these inspections, our inspectors did not see any 
conditions that would raise a red flag indicating an imminent 
health hazard.
    An inspection is simply a snapshot in time. An inspector 
can only see what is there at that particular time that they 
are conducting the inspection. The Department utilizes all the 
resources available to us to verify that food processors are 
operating responsibly. However, it is important to recognize 
that if processors do not act responsibly and most certainly if 
they engage in criminal activity designed to avoid detection, 
the most rigorous and regular inspections would not readily 
detect a problem. We do not have all the facts, but once the 
Peanut Corporation of America had test results disclosing the 
presence of salmonella, it was unconscionable for that company 
to ship the product, fail to recall the product or fail to 
notify us or FDA.
    In closing, let me thank you for joining with us in an 
effort to improve the safety of this country's food supply. 
This tragic situation must serve as a wakeup call leading to 
reforms in the United States food safety network and through 
additional funding that will permit food safety agencies at the 
federal, State and local levels to more effectively perform 
their jobs. Thank you.
    [The prepared statement of Mr. Garrison follows:]
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    Mr. Stupak. Thank you, Mr. Garrison.
    Ms. Cowart, your opening statement, please, for 5 minutes. 
If you have a longer statement, we will insert it in the 
record.
    Ms. Cowart. Thank you.
    Mr. Stupak. Thank you.

                  TESTIMONY OF DARLENE COWART

    Ms. Cowart. Mr. Chairman, my name is Darlene Cowart, and 
you have my biographical information, I believe, in the record. 
My education has been in biology and food science, and I have 
worked in the agricultural commodity and food-related quality 
control area since completing my education. I am currently 
president of JLA USA. Our company is one of several under the 
umbrella of JLA Global, which has facilities in the United 
States and abroad. JLA USA has testing facilities in seven 
locations in the United States. While the majority of our work 
is related to the peanut industry, we also provide services and 
testing to the almond industry and to some degree other food 
businesses. JLA USA maintains microbiology laboratories in 
Albany, Georgia, and Edenton, North Carolina. We provide a 
broad range of testing services to the agricultural commodity 
and food business. I understand the committee's concerns today 
relate to the recent salmonella outbreak and therefore involve 
our microbiology testing.
    Mr. Chairman, when we test for salmonella, we receive from 
the customer samples of the product to be tested together with 
the notification of the test that the customer wants us to 
perform. Specifically, we receive a request for analysis which 
details the battery of tests desired by the customer and 
includes the customer's description of the product to be 
tested, and I believe you have copies of these also in the 
record. I have also furnished the committee staff a detailed 
description of the method we use to test for salmonella, and I 
will simply summarize that here.
    First we pull a representative sample from the customer's 
containers to get a composite sample of 375 grams. That 
composite sample is then put into a sterile bag with other 
substances and incubated. We remove some of the mixture into 
the test tubes and for other procedures and eventually we put 
the resulting substance into what is called a VIDAS instrument. 
This machine's computer will automatically give us the result 
either positive or negative for salmonella. If the result is 
not negative from the instrument, the negative certificate of 
analysis is sent to the customer. If the result is positive, it 
is what we call in our laboratory a presumptive positive, which 
must be confirmed, because at this point several organisms can 
look like salmonella but are not. However, since the test 
necessary to confirm the presumptive positive can take up to 5 
days, we notify the customer of the presumptive positive by e-
mail and a telephone call. The confirmation process is quite 
technical and is also described in the paper that we furnished 
the committee staff. If after the confirmation we find that 
salmonella is ruled out, we prepare a negative certificate of 
analysis for immediate release to the customer. If we do 
confirm that the presumptive positive is salmonella, then we 
prepare and issue a positive certificate of analysis and again 
we notify the customer via a telephone call and an e-mail 
alert. Mr. Chairman, all these procedures confirm to the 
appropriate FDA and accepted laboratory standards.
    From January 1, 2007, through September of 2008, we tested 
approximately 1,000 samples of product from Peanut Corporation 
of America. Of these in 2007, six samples were confirmed 
positive for salmonella, and all the rest were negative. In 
2008 we issued a total of four confirmed salmonella positive 
certificate of analysis. I wish to emphasize, Mr. Chairman, 
that we at JLA do not take the samples from the product nor do 
we have knowledge of the sampling procedure used by PCA for the 
samples we receive. With respect to the PCA samples on each 
occasion that JLA received samples, the product samples would 
have been sent by mail to a JLA laboratory together with this 
request for analysis. The information provided on the request 
for analysis is the only information about the sample that JLA 
receives. Following a confirmed salmonella positive issued to 
PCA in August of 2008, PCA discontinued sending product samples 
to JLA with one exception. We did receive a few test samples 
under the name PP Sales, and it is my understanding that this 
name is an internal designation within PCA and possibly refers 
to a different product line. JLA did test and obtain a 
confirmed salmonella positive on a PP Sales sample sent to JLA 
in late September 2008. A positive COA was issued to PCA in 
early October 2008. In every instance when we found presumptive 
positives or confirmed positives, we reported the results to 
PCA by e-mail and telephone as I described earlier.
    Salmonella can occur in raw agricultural commodities and 
the accepted procedure for killing salmonella in raw 
agricultural products is to heat the product to a necessary 
temperature for the appropriate period of time, and that 
procedure is commonly referred to as the kill step. It is 
possible for salmonella to be reintroduced into a product after 
the kill step. This can occur if the product comes in contact 
with contaminated raw ingredients, equipment or personnel. 
Therefore, it is extremely important that all food 
manufacturing facilities maintain proper procedures and 
processes to ensure that recontamination does not occur. 
Salmonella in processed foods is preventable and the 
application of an appropriate kill step combined with good 
manufacturing processes that eliminate the possibility of 
recontamination should result in a salmonella-free product. 
Microbiological testing for salmonella and other pathogens is 
an important evaluative tool that manufacturers can and should 
employ to ensure that their manufacturing processes are safe.
    Mr. Chairman, we are cooperating fully with the committee 
and your staff and JLA pledges to continue working with the 
committee to make certain the food supply is safe for all 
consumers. Thank you, Mr. Chairman.
    [The prepared statement of Ms. Cowart follows:]
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    Mr. Stupak. Thank you.
    Mr. Deibel, your opening statement, please.

                  TESTIMONY OF CHARLES DEIBEL

    Mr. Deibel. Good morning, Chairman Stupak and members of 
the subcommittee. I would like to thank you for giving me this 
opportunity to speak with you today. My name is Charles Deibel 
and I am the president of Deibel Laboratories, a firm that 
specializes in microtesting food and personal care products and 
food safety consulting. We have 10 labs in North America with 
our headquarters in Illinois. For more than 40 years Deibel 
Labs has provided scientific consulting services to food 
manufacturers around the country. My father, who remains active 
in the company today, started Deibel Labs when he was the dean 
of the University of Wisconsin's bacteriology program in the 
late 1960s. He is widely recognized as one of the most 
knowledgeable scientists in the food industry, pioneering test 
methods still in use today and helping to shape food safety 
systems in America. In addition to microtesting food products 
and their ingredients, we work with many manufacturers to help 
evaluate their existing food safety programs, conduct risk 
assessments, perform plant audits and offer training in food 
safety procedures.
    I would like to give you a brief summary of Deibel Lab's 
dealings with Peanut Corporation of America, or PCA. My company 
did not provide day-to-day testing services for PCA as we did 
for many of our clients. Instead, during 2007 and 2008, PCA's 
Plainview, Texas, and Blakely, Georgia, facilities sporadically 
submitted samples containing peanuts to Deibel Labs to test. We 
have voluntarily cooperated with the Centers for Disease 
Control, the Food and Drug Administration and this subcommittee 
to provide detailed records of the tests we performed for PCA's 
facilities including samples from PCA's Blakely facility that 
tested positive for salmonella in late September 2008 and our 
records of the immediate communications of those results to 
PCA's Blakely facility personnel. We also provided records 
detailing the requests that personnel at the Blakely facility 
made to us to retest existing samples and the negative results 
of those tests.
    Mr. Chairman, may I briefly supplement the written 
statement that is in the record?
    Mr. Stupak. Without objection, yes.
    Mr. Deibel. As you know, the story about PCA's actions 
becomes clearer almost by the hour. I have learned more in 
reading the FDA's Web site publications, the results of the 
investigation recorded, readings in newspapers and in sitting 
today. I am horrified in seeing the projections of the very 
damning e-mails in the screens to our left and right.
    In late January the FDA and CDC requested that our labs 
provide them with cultures of ingredients we tested, and based 
on provisions of the 2002 Bioterrorism Act we voluntarily 
submitted this work. In late January counsel for this committee 
came to us as part of the subcommittee's investigation. We 
voluntarily and promptly provided staff counsel with all 
relevant documents and access to witnesses and myself within 
minutes of any request. On February 5, 2009, we first saw and 
learned of the willful and gross negligence in sanitary 
manufacturing and Good Manufacturing Practices contained in 
FDA's amended investigation report. At about that same time we 
received samples from the PCA Texas facility and found them to 
be positive for salmonella. We promptly provided that 
information to your committee and FDA.
    It is not unusual for Deibel Labs or for other food testing 
laboratories to find that samples clients submit do test 
positive for salmonella and other pathogens. What is virtually 
unheard of is for an entity to disregard those results and 
place potentially contaminated products into the stream of 
commerce. I commend the subcommittee for examining what can be 
done to prevent an incident like this from happening again.
    As discussions progress on how best to reform our national 
food safety program, I urge you to look at the entire model 
used today. Our current food safety system relies heavily on 
inspections conducted by the FDA and the State agencies with 
which it contracts. This is a reactive response rather than the 
comprehensive, systemic process needed to safeguard our food. 
The FDA should focus on quality control systems that minimize 
the potential for contamination to occur in the first place and 
develop mitigating strategies for correcting a potential issue 
before it impacts food safety.
    The FDA has a great deal of knowledge and understanding of 
how manufacturers can improve our food safety practices. Our 
Nation's small and medium-sized companies in particular could 
greatly benefit from guidance documents from FDA yet their job 
is to inspect, not to provide guidance and so they don't. Yet 
the USDA routinely issues guidance documents to the food 
processors under its jurisdiction. FDA staff are reluctant to 
point manufacturers to the information and resources they need 
or provide direct guidance on how an observation can be 
corrected. As a result, opportunities to improve food 
production practices are missed. Testing, much like inspection, 
is only one piece of an overall food safety policy. It is the 
last chance to catch a problem.
    The larger piece, however, is on the front end, quality 
control systems that minimize the potential for the 
contamination to occur in the first place. Every year millions 
of pounds of food products end up in landfills because of 
positive test results for harmful organisms. The problem here 
is not in finding a positive test result. The issue we are 
discussing here is a firm that found a positive, tried to 
contest the compliancy and released the product anyway. The 
attention to this issue of food safety is important. It is an 
opportunity to build stronger bridges between FDA and the food 
manufacturers. By taking a preventative, systemic approach, we 
can implement reforms that will go a long way towards ensuring 
that consumers have access to safe and wholesome foods. Thank 
you.
    [The prepared statement of Mr. Deibel follows:]
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    Mr. Stupak. Thank you. That concludes the opening 
statements. I ask unanimous consent that Chairman Dingell, his 
full statement be made part of the record. Without objection.
    [The prepared statement of Mr. Dingell follows:]
    [GRAPHIC] [TIFF OMITTED] 63824.043
    
    [GRAPHIC] [TIFF OMITTED] 63824.044
    
    Mr. Stupak. I will also note for the record that Mr. Inslee 
was here. I guess he is going to be back, and as a member of 
the full committee would be allowed to ask questions of this 
panel.
    And we have three different parts of this panel, if you 
will. We will probably go more than one round of questions so 
we will try to go 5 minutes and we will come back if we have 
to.
    Ms. Cowart, let me ask you a couple questions if I may. On 
tab 38 is the first tab I sort of see in here in the binder. It 
is a November 2, 2006, letter to Mr. Parnell of PCA, Peanut 
Corporation of America. In 2006 were you consulting with them 
as to their plant and salmonella? In looking at this, it looks 
like you were acting more as a consultant as opposed to lab 
testing, right?
    Ms. Cowart. At this point I received a phone call, our JLA 
received a phone call, and they had a problem or they reported 
a problem with some salmonella in some peanut granules and they 
needed someone to do a walk-through of the facility, and so by 
proximity, based in Albany, Georgia, and I have that 
background, I did go through and do a walk-through and tried to 
help them understand where the salmonella was coming from on 
that particular issue.
    Mr. Stupak. So in 2006 JLA was not testing, you sort of did 
a walk-through to try to figure out where the salmonella was 
coming from?
    Ms. Cowart. Right. I didn't pull any samples at that point. 
Our company has a microbiology department that does testing, 
and then there is another piece that will help, as you just----
    Mr. Stupak. Sure. And in this tab 38, in this letter, you 
sort of indicated three sources, right? It could have come from 
the organic Chinese peanuts?
    Ms. Cowart. That was what they told me when I arrived 
there, that that was the source of the granules.
    Mr. Stupak. OK. Or I think you identified it come have come 
from production because there was some question about not 
cooking it long enough, high enough temperatures to kill the 
salmonella, right?
    Ms. Cowart. What I asked for was the documents for the time 
and temperature of the roaster, and that could not be provided 
at the time.
    Mr. Stupak. And then of course there was also in the 
packaging because they were using water in the packaging area 
and we all know water is a great source of salmonella, 
especially in peanut butter, as we know from the 2007 ConAgra 
outbreak.
    Ms. Cowart. Yes, sir, and also if you will note in the 
letter, it also takes about packaging roasted product in a raw 
zone.
    Mr. Stupak. Correct. OK. So we had three possibilities 
there identified in your letter there. Let me go next to 
Exhibit 40, just two back. That is dated February 4, 2008. Now, 
at this point in time, because you are talking about a kill 
study and you are making suggestions as to a kill study, is 
that correct?
    Ms. Cowart. Yes, sir, I believe they contacted our Edenton, 
North Carolina, facility to help them understand a kill step 
study for their roaster, and we were trying to understand how 
to go about doing that. That is not something that we had ever 
done before as a laboratory and so this was a new process for 
us and so we were trying to understand how to do that.
    Mr. Stupak. OK. So between 2006 and 2008, is it fair you 
consulted, JLA was a consultant then to the Peanut Corporation 
of America?
    Ms. Cowart. No, sir, we were not. These were--this was a 
moment in time in 2006, and I didn't have any follow-up with 
them after that.
    Mr. Stupak. OK. So 2006, and you didn't have any follow-up 
with them until 2008, until this possible kill study, right?
    Ms. Cowart. Correct. They contacted us, and that is how it 
usually worked with PCA from JLA's perspective. We are an 
independent testing laboratory and we do microbiology testing. 
If they have a question, we will try to answer their question.
    Mr. Stupak. So between 2006 and then again in 2008, in 2006 
you had salmonella. Did you have any indication in 2008 at the 
time this memo was written, which is February 4, that they had 
other occurrences of salmonella at the Blakely plant?
    Ms. Cowart. No, sir, I was not aware of them, no, sir.
    Mr. Stupak. OK. You indicate in here that, again the same 
document, February 4, on Monday you are using oven at three 
different temperatures, you are going to use these spore 
strips, which was something different. What is the cost of 
those spore strips?
    Ms. Cowart. I am sorry. Could you repeat that question?
    Mr. Stupak. Sure. The third paragraph from the bottom, it 
says, ``Monday I am starting a lab study using oven at three 
temperatures, 295, 300, 310 with duplicate BI spore strips 
exposed to the heat for varying times,'' and you listed times. 
To do that, these spore strips, which is to help kill the 
salmonella spores, correct, if there is any in there, if you 
heat it up?
    Ms. Cowart. Yes, sir, this is a lab study and so these 
spore strips, what they were trying to do is not to introduce a 
pathogen but a surrogate, yes, sir.
    Mr. Stupak. What would it cost to put these spore strips in 
with your production?
    Ms. Cowart. I am not sure I know. I don't know that answer.
    Mr. Stupak. Let me ask you this. You support then, it has 
been suggested throughout today, that labs, food processors 
should be registered, should be certified, the people doing the 
testing, and that the results should be filed with the FDA on 
every test?
    Ms. Cowart. Yes, sir, I think we agree with that. I mean, 
having heard what we have heard this week and in the papers, I 
think it is the right thing to do. I think we would want to be 
a part of the solution, absolutely, yes, sir.
    Mr. Stupak. Mr. Deibel, how about yourself? Do you think 
labs that do testing, labs should be certified by the FDA, that 
people doing the testing should be registered or make sure they 
have proper qualifications, and that the results of every test 
whether it is positive or negative be electronically submitted 
to the FDA?
    Mr. Deibel. In regards to laboratory accreditations, I mean 
certainly laboratories should be using the published methods. 
They should be using good practices in regards to laboratory. 
We call them GLPs, good laboratory practices. In regards to 
having a laboratory, mandating that the laboratory would submit 
those test results to government, I don't believe that would be 
a good practice.
    Mr. Stupak. How do you prevent lab shopping then, as has 
been alleged in this case?
    Mr. Deibel. That I don't know. The overriding concern of 
this, and I am a consumer, my laboratory does a lot of testing 
for food safety, we want to have safe food. The entire industry 
at large, if you look at all the foods that we consume on a 
daily basis, and I am not just talking the foods that we make 
but the ingredient companies that manufacture ingredients for 
those, you know, finished product manufacturers, it is an 
enormous industry, and on a day-to-day basis most of us eat 
safe foods and we don't have an illness, and I think based on 
the huge amount of food companies that are out there, 
generally, you know, there isn't--my concern, I guess, in 
reporting those positive results is that you would actually 
encourage those businesses to test less. There are different 
types of tests that are done all along the manufacturing 
process. A raw ingredient before you use it, you do process 
validation work. You test your environment. We want to 
encourage that. We want to encourage companies to find problems 
if they exist, and again, my overriding concern----
    Mr. Stupak. Then how do we ever know then if a company is 
having positive test results if they are not reporting it to 
anybody but themselves?
    Mr. Deibel. Every year millions of pounds of products feed 
landfills so companies find a positive result, destroy product, 
do not ship it----
    Mr. Stupak. In theory. In theory they do that, right? 
Because obviously here they didn't do it.
    Mr. Deibel. Correct. I guess a food company, it is a 
business, and they are not in business to manufacture a product 
that will get somebody sick and they are at their best when 
they can make safe, wholesome products that a consumer will 
buy, enjoy and buy again. If a company manufactures a product 
where somebody eats it, falls ill, they are likely not to be in 
business.
    Mr. Stupak. So it is just a cost of doing business then 
when people get sick?
    Mr. Deibel. Most food companies do spend, I would say in my 
experience, a lot of money and a lot of their efforts, their 
resources in making safe and wholesome foods, and we would want 
to have them be able to have the right to test as much as they 
can, find the problem----
    Mr. Stupak. Right, but this is our ninth hearing in 2 
years. If we don't get on this thing, if we don't require some 
kind of reporting, how are we ever going to end this? I mean, 
we can't be doing this every--let us see, nine times in 2 
years, every, what, 2 months, a new outbreak?
    Mr. Deibel. Testing though is just one aspect of the 
overall food safety program.
    Mr. Stupak. I agree.
    Mr. Deibel. And we really need to be focusing more on 
preventative strategies because even in testing, I mean, we see 
this with PCA. Even when several labs were involved testing, 
you always didn't find it, even though we knew it was there.
    Mr. Stupak. Because no one was reporting it.
    Mr. Deibel. It became known that it was----
    Mr. Stupak. Because nobody was reporting it. I agree with 
you, we should be proactive as opposed to reactive. Right now 
we are reactive. If we had reporting, mandatory, maybe we could 
be proactive.
    With that, I will turn to Mr. Walden for questions.
    Mr. Walden. Thank you, Mr. Chairman.
    I guess that a question I want to go to the FDA on. 
Wouldn't you benefit from knowing the lab results?
    Dr. Sundlof. Thank you, Congressman, yes. FDA like any 
other enforcement organization wants all the information we can 
get.
    Mr. Walden. And you don't get those lab results today, 
correct?
    Dr. Sundlof. That is correct.
    Mr. Walden. And would you be overwhelmed with the number of 
lab results you would get?
    Dr. Sundlof. It is hard to say, I mean, but certainly 
having that information available would be very helpful.
    Mr. Walden. Only if it is in a form that could be readily 
accessed and utilized. It seems to me like there ought to be in 
the modern era of computers a way where those lab results could 
go in and then flag if there is a facility that repeatedly 
tests positive for salmonella. It would help you identify where 
you need to go inspect, wouldn't it?
    Dr. Sundlof. I believe that is right.
    Mr. Walden. Now, let me go back to Mr. Deibel. I am 
troubled with this notion that those lab results shouldn't be 
shared with the FDA or the Georgia Department of Agriculture or 
whomever, and I don't disagree that I think they should be 
inspected. I think they should seek out, I think as a small 
businessperson I had nothing to do with food, but it seems to 
me in their best self-interest to make sure their product line 
works and is sanitary. In theory, most don't want to make 
somebody sick. So what is the harm in sharing those positive 
results with the regulators so that they are on notice there 
may be a problem here?
    Mr. Deibel. From a laboratory level, we always don't 
understand what types of samples are coming into our 
laboratories.
    Mr. Walden. Right.
    Mr. Deibel. So it could be part of environmental monitoring 
where product fell on the floor and they want to test that. It 
could be----
    Mr. Walden. OK, but couldn't we----
    Mr. Deibel. --processed samples. They could be doing a new 
R&D project.
    Mr. Walden. Right, but----
    Mr. Deibel. We just don't know.
    Mr. Walden. OK, but how hard would it be to have a row of 
boxes that says this is an R&D sample test, this is an off-the-
floor sample, this is something that is going into the Austin 
crackers that some 3-year-old is going to eat? Is that that 
hard?
    Mr. Deibel. That wouldn't be hard, however, I don't know 
that that would happen.
    Mr. Walden. All right. So if the private lab doesn't 
collect the samples, how can you ensure the integrity of those 
samples? Can you, Ms. Cowart? They just send you whatever, 
right?
    Ms. Cowart. Correct. What happens with our company is, we 
receive samples into our laboratory with a request for analysis 
and we do the analysis that was written on the request form. We 
do not know where the samples came from. We don't know the 
history of them. And so our obligation as an independent 
laboratory is to run the test and to notify them with the 
accuracy and speed that we can to get them to them.
    Mr. Walden. And it sounds like you have a very thorough 
process to do that, which I commend you for, both e-mail and a 
voice process.
    Ms. Cowart. Thank you.
    Mr. Walden. So let me go back to this notification. We 
learned yesterday or sometime this week that there is this 
mystery peanut-processing plant in Texas that apparently has 
never been reviewed by the FDA, no regulators have been in 
there. Is that correct?
    Dr. Sundlof. No, sir. The FDA was in there in 2001 
inspecting but at that time they were not producing peanut 
butter or peanut paste.
    Mr. Walden. Have you been back since they have been 
producing peanut butter or paste?
    Dr. Sundlof. Yes. I am sorry. Which plant are we talking 
about?
    Mr. Walden. The one in Texas.
    Dr. Sundlof. Oh, the one in Texas. I am sorry. Let me 
retract that. No, we had not been in there.
    Mr. Walden. Were you aware it even existed?
    Dr. Sundlof. We were.
    Mr. Walden. You were aware? Some of the news accounts 
indicate nobody knew this thing was going on, it wasn't 
registered, wasn't inspected. Do you know if it had been 
inspected?
    Dr. Sundlof. I don't believe it had been inspected.
    Mr. Walden. So Mr. Deibel, if I understood you correctly, 
your company was actually doing tests from peanut product from 
that plant and discovered there was salmonella in some of that 
plant's product. Is that accurate?
    Mr. Deibel. The Texas facility?
    Mr. Walden. Yes, sir.
    Mr. Deibel. That is correct.
    Mr. Walden. So if you had had to report that to the FDA, 
then the FDA would have known there was salmonella in a plant 
they had never inspected?
    Mr. Deibel. We did report that.
    Mr. Walden. To the FDA?
    Mr. Deibel. We reported this to the subcommittee. I am 
unsure if we reported it to----
    Mr. Walden. Wait a minute. When did you do the salmonella 
test?
    Mr. Deibel. The result just came off this last Sunday.
    Mr. Walden. OK. So you just found out about this?
    Mr. Deibel. Yes.
    Mr. Walden. But you didn't report that--I mean, you knew we 
were doing an investigation so you shared it with us in that 
context. You wouldn't normally have sent us just sort of 
randomly test results, right? Of course not. But had you 
reported test results to anybody before?
    Mr. Deibel. We report test results to our clients but there 
is no mechanism currently in place to----
    Mr. Walden. Right. And that is what we in the other context 
of the full are going to debate is, what is the mechanism that 
should be there. I mean, I am not an advocate of just sending 
enormous amounts of data to another government agency that will 
put it in boxes, it will go in a warehouse that will probably 
leak and we can produce peanuts there too. But, you know, it 
doesn't make sense so it has got to be something that is 
usable. And so had you done tests prior to the ones this week 
on that plant in Texas?
    Mr. Deibel. We have been doing results for them for a 
number of years.
    Mr. Walden. A number of years, and had you spotted 
salmonella in any of those tests?
    Mr. Deibel. No, everything was negative up to the point of 
the results on Sunday.
    Mr. Walden. Dr. Cowart, did your firm do any tests on that 
plant in Texas?
    Ms. Cowart. On the Texas facility, no, sir, we did no 
microbiology testing.
    Mr. Walden. And why do you think--I find it curious that 
your firm consistently found salmonella, you said six times in 
2007 and four in 2008?
    Ms. Cowart. That is correct.
    Mr. Walden. And then it sounds like PCA decided we are 
going to go somewhere else. Is that your read of it?
    Ms. Cowart. After reviewing the documents and talking with 
our associates back at the laboratory, it appears that way, 
yes, sir.
    Mr. Walden. And then they sort of sent you one under the 
name of an internal operation just to, I guess, have you do 
that test.
    Ms. Cowart. That is right, and again, not knowing the 
history of the samples, we just took the sample----
    Mr. Walden. You do the test.
    Ms. Cowart. --and we did the test. That is correct, yes, 
sir.
    Mr. Walden. Did you know whether or not PCA went to any 
other labs?
    Ms. Cowart. We were aware of, they were asking us about a 
high coliform count and an aerobic plate count and so in an 
effort to answer their question, we did ask them if they could 
send us the results of the aerobic plate count and the coliform 
count just to compare, because we obviously go into a 
diagnostic mode also.
    Mr. Walden. Sure.
    Ms. Cowart. And so we did know that they had used another 
lab for that, yes.
    Mr. Walden. And then do you like check the calibration of 
your equipment and all of that to just see?
    Ms. Cowart. Yes, sir, we do, and we also run quarterly 
proficiency sample tests so that we can be able to check 
against an unknown sample that would come in from a proficiency 
organization.
    Mr. Walden. All right. And Mr. Deibel, do you have any idea 
why your data would be different than JLA's data?
    Mr. Deibel. Just based on----
    Mr. Walden. How does that all work?
    Mr. Deibel. We are dealing with a dry commodity good, and 
as had been mentioned before, you know, water does play a role 
in these organisms, and so the results are not always going to 
be consistent within that sample and so you will get some 
degree of variability in those test results.
    Mr. Walden. I want to thank the witnesses for your 
testimony and for answering our questions. It is helpful in our 
efforts.
    Thank you, Mr. Chairman, for your indulgence.
    Mr. Stupak. Thank you.
    Mr. Braley for questions, please.
    Mr. Braley. Thank you.
    Dr. Sundlof, as I understand it, the FDA did not conduct 
inspections of the PCA plant in Blakely, Georgia, from 2001 
until January of 2009. Is that correct?
    Dr. Sundlof. That is correct. Now, we did again inspect in 
2001 and at that time they were not producing peanut butter or 
peanut paste. In I think it was 2007, the State of Georgia 
inspected under contract from FDA, so in essence, that was an 
FDA inspection in 2007 and one in 2008.
    Mr. Braley. Well, after the recent salmonella outbreak was 
traced to peanut products in January of 2009, FDA conducted a 
detailed inspection of the PCA facility and issued an 
inspection report called a 483 report, and in that report you 
listed 12 occasions in 2007 and 2008 when private labs informed 
PCA that its products tested positive for salmonella. I want to 
ask you about one of those. According to the 483 report, in 
June of 2008 the company received a private lab test that was 
positive for salmonella, and according to your report, the lot 
was manufactured on June 9 and the sample that tested positive 
was provided to the private lab on June 10. Is that correct?
    Dr. Sundlof. I believe that is correct.
    Mr. Braley. Dr. Sundlof, wasn't June 10 the same day the 
Georgia Department of Agriculture inspected the facility on 
your behalf?
    Dr. Sundlof. I would have to check my records.
    Mr. Braley. Well, if that is the case and that is what the 
records show, the day after the company produced peanut 
products with salmonella, your inspectors were inside this 
facility but they didn't detect salmonella because you didn't 
direct them to test for it. Isn't that true?
    Dr. Sundlof. That is true.
    Mr. Braley. And you had the legal authority to order those 
tests, didn't you?
    Dr. Sundlof. Yes.
    Mr. Braley. So why didn't you order salmonella testing that 
day?
    Dr. Sundlof. Well, first of all, we did not know of the 
test results at the time. We did not know those until January. 
Secondly, our policy had been that on routine inspections, and 
this is not for-cause inspections, in other words, where we 
don't suspect that there is a problem in the plant, we have not 
asked our inspectors in general whether it is the FDA 
inspectors of the inspectors under contract to collect samples 
or obtain environmental samples. We are changing that now as a 
result of this.
    Mr. Braley. Well, does your office and do your inspectors 
apply a heightened degree of suspicion when there are other 
things going on in the food production business that might 
alert you to potential problems?
    Dr. Sundlof. Yes, we do. I mean, we take the entirety of 
all of the findings into account to determine whether or not it 
raises us to the next level where we would issue an inspection 
report of action, that there would be required actions to be 
taken by the company. In this case, I think all of the 
inspections that were conducted indicated that there were some 
infractions, that they didn't immediately pose what appeared to 
be a risk to the safety of the food supply and that the company 
was correcting those deviations either while the inspector was 
in the plant or gave assurances that those would be corrected.
    Mr. Braley. Well, the reason I ask you that very specific 
question about a heightened index of suspicion is because in 
April of 2007 this subcommittee held a hearing on a salmonella 
outbreak at the ConAgra peanut butter plant in Sylvester, 
Georgia, which is only 75 miles from the PCA plant, and that 
outbreak resulted in over 400 illnesses in 44 States. Wasn't 
that cause enough for FDA to order testing for salmonella at 
the PCA plant?
    Dr. Sundlof. After that outbreak of Peter Pan, we went back 
and did a lot of education for the peanut industry. There was a 
seminar that was given in Atlanta in which the entire peanut 
industry was invited. We had FDA people there. They had other 
people talking about the kinds of measures that should be put 
in place in order to prevent this from happening in the future. 
We looked back at our records and determined that four people 
from PCA were registered to attend that particular symposium.
    Mr. Braley. So then you would agree with me that in this 
geographic area, in your State, there was certainly a 
heightened degree of suspicion about the potential for 
salmonella outbreak at the time these inspections were 
performed?
    Dr. Sundlof. Yes.
    Mr. Braley. And are there any written standards that apply 
to determine when there is for cause to test for salmonella?
    Dr. Sundlof. I don't believe there is any written ones. I 
would ask Mike Chappell if he can comment on that.
    Mr. Chappell. Well, after the ConAgra series, we did indeed 
provide some additional guidance to our field staff, and as Dr. 
Sundlof just mentioned, the realization is that we probably 
need to depend more on environmental sampling than we have in 
the past, not just the for cause, which means the conditions in 
the plant suggest there are serious problems.
    Mr. Braley. Mr. Chairman, it seems to me that private labs 
detected salmonella at the PCA facility but since they only 
reported it to PCA, the public never found out about it and 
that is a difference that we can't afford to have in our food 
safety system, and I yield back.
    Mr. Stupak. I thank you, Mr. Braley.
    Mr. Deal for questions, please.
    Mr. Deal. Thank you, Mr. Chairman. My line of inquiry is in 
two areas. First of all, what are manufacturers required to do, 
and secondly, what are State and federal authorities allowed to 
do. Now, in that regard, I would ask first of all, has peanut 
butter been classified by FDA as a high-risk product?
    Dr. Sundlof. I don't believe it has. That may change in the 
near future.
    Mr. Deal. Do you think that would be an appropriate 
classification?
    Dr. Sundlof. I believe so.
    Mr. Deal. If it is so classified, what would change with 
regard to what the manufacturer must do and what the FDA and 
State authorities can do?
    Dr. Sundlof. Well, certainly considering it high risk, we 
would change the way that we inspect, and I think we just 
addressed that, that in the future we are in the process of 
writing all of our guidance to our inspectors that they will be 
taking samples of the product and the environment in the future 
and that will go a long way I think to detecting these problems 
earlier, but there is no--in terms of what is required under 
Good Manufacturing Practice standards, they are written rather 
broadly and they are written more for all foods than specific 
products, and as such they are not very prescriptive. You know, 
what will probably result from this is some stronger guidance 
that will be more specific about peanut butter as it pertains 
to the kind of manufacturing controls that need to be put in 
place and the kinds of inspections that we will do.
    Mr. Deal. Can anything that FDA does by way of 
classification or otherwise require a peanut butter 
manufacturer to do product sampling with a specified period of 
regularity?
    Dr. Sundlof. Currently, the Good Manufacturing Practice 
standards are not written that way.
    Mr. Deal. Do you think maybe they should be?
    Dr. Sundlof. Well, in my testimony I talked about putting 
more preventive controls, mandatory preventive controls in 
place in certain food facilities, and what we are talking about 
here, the term is the Hazard Analysis Critical Control Point, 
type of quality systems in which all of those kinds of things 
would be documented for any food process that falls under that 
kind of preventive control.
    Mr. Deal. In the absence of requiring things like sampling 
and testing of those samples, then sampling and testing is a 
voluntary action on the part of the manufacturer. Is that 
correct?
    Dr. Sundlof. Currently, that is correct.
    Mr. Deal. And the concern that some people have of 
requiring disclosure of those voluntary samples of disclosure 
of the results is that as long as it is voluntary, all that may 
very well do is to have less testing rather than more testing. 
Do you share that concern?
    Dr. Sundlof. Yes.
    Mr. Deal. I am sorry I don't have time for you to elaborate 
much on it. If you have that concern then, is that one of the 
things that your recommendations to Congress has included? Is 
that one of your recommendations?
    Dr. Sundlof. We will be working--we are more than happy to 
work with the Administration and the Congress to craft any new 
legislation authorities that we need. I mean, I think the 
concern with us is that we need to make sure that it doesn't 
discourage additional testing. In other words, if it is 
required, will companies actually do less testing because they 
know that the FDA will have access to those records. So it 
needs to be very carefully thought through how that process 
works.
    Mr. Deal. Now, one of the problems I understand existed was 
that you could not access internal records and only had to go 
under the bioterrorism statutory authority in order to be able 
to get those internal records. Have you recommended or would 
you recommend that that be changed in terms of what the FDA or 
State authorities acting under your jurisdiction have the right 
to access internal records? Should they have that right?
    Dr. Sundlof. Yes. That is the other--again, we are working 
with the Administration on that but certainly if we had greater 
authority to access those kinds of records outside of the 
threshold that is required under the Bioterrorism Act to access 
those records, we would get a lot more information in a timely 
manner.
    Mr. Deal. Mr. Garrison, I know that you act in conjunction 
with your contract authority with FDA to do inspections on 
their behalf that you are contracted to perform. Is that 
correct?
    Mr. Garrison. That is correct.
    Mr. Deal. And you have outlined the fact that money is a 
shortage factor and the number of inspectors are in short 
supply to do all that you undertake to do at the State level as 
well as in your contract capacity. Is that right?
    Mr. Garrison. Yes, sir. Currently, we receive funding of 
about $123,000 through our FDA contract. The State funding for 
our food protection program is some $6 million.
    Mr. Deal. I would ask this of both you, Mr. Garrison, and 
you, Dr. Sundlof, and that is, especially in the area of the 
FDA, we have seen that one of the ways to augment and get 
better results is through a user-fee program in which the 
producer has an incentive to have the testing done and in 
effect pays for that extra cost. We see it in other areas under 
FDA's jurisdiction. Have you considered a user fee to fund the 
cost for additional inspections at the federal level and/or the 
State level?
    Dr. Sundlof. Thank you. We are responding to legislation 
proposed, the Food Globalization Act, in which user fees are 
part of that, and we will be submitting formal responses and 
technical assistance on that bill.
    Mr. Deal. At the State level, Mr. Garrison, are user fees 
contemplated?
    Mr. Garrison. I would have to say that would be a pay grade 
above myself. That would be something that Commissioner Irvin 
and the State legislature and the governor would have to take 
up.
    Mr. Deal. It is not in the current proposed legislation 
then?
    Mr. Garrison. Not that I am aware of, no, sir.
    Mr. Deal. Thank you for the extra time.
    Mr. Stupak. Ms. Christensen for questions. Oh, I am sorry, 
excuse me, Mr. Dingell for questions, please.
    Mr. Dingell. Well, Mr. Chairman, first I want to commend 
you. This is a continuation of the excellent hearings which you 
had in the last Congress, and I want to commend you for your 
vigor and your energy and your enthusiasm and for the success 
of your efforts. You are going to make possible major reform 
here and I want to commend you for that.
    These questions are all to Dr. Sundlof. Please, Doctor, 
answer yes or no because we have relatively little time in 
which to do this. Food processors should be made to notify the 
FDA when they begin producing products that have not previously 
been registered. Do you agree, Doctor, yes or no?
    Dr. Sundlof. I am sorry. Could you repeat the question?
    Mr. Dingell. Please pay attention because we do have 
limited time here. Food processors should have to notify FDA 
when they begin producing products that they had not previously 
registered. Do you agree?
    Dr. Sundlof. Yes.
    Mr. Dingell. In light of the current crisis with regard to 
Food and Drug and producers, should foreign and domestic food 
facilities be required to have safety plans in place to 
identify and to mitigate hazards?
    Dr. Sundlof. In some cases, yes.
    Mr. Dingell. Now, what should these plans, rather should 
these plans be subject to review by FDA inspectors?
    Dr. Sundlof. Yes.
    Mr. Dingell. Would increase in inspections by FDA have 
potentially prevented the salmonella outbreak?
    Dr. Sundlof. It is potentially possible, yes.
    Mr. Dingell. In other words, more frequent and more 
thorough inspections by Food and Drug would have done so. Is 
that right?
    Dr. Sundlof. Yes.
    Mr. Dingell. Now, if FDA had better traceback capabilities, 
would that have helped prevent this salmonella outbreak?
    Dr. Sundlof. It would have helped us recall product 
quicker.
    Mr. Dingell. Now, should testing done on food products be 
subject to certain safety requirements and be performed only by 
a laboratory accredited by FDA?
    Dr. Sundlof. I have no opinion on that at this time.
    Mr. Dingell. You will note that you had a number of 
laboratories which performed tests that either didn't reveal 
the presence of salmonella or that were not reported to FDA. If 
FDA had had reliable reports from reliable laboratories, would 
it not have been better able to protect the public?
    Dr. Sundlof. Yes. I want to just say about salmonella 
testing, you can test the same product several times and not 
find the salmonella and it can be still in there. We suspect 
that these were all good laboratories and that the failure to 
confirm a positive was not the laboratory's fault but the 
sampling.
    Mr. Dingell. I am driven to the unfortunate conclusion that 
if that statement is true, Food and Drug probably could have 
done without laboratory inspections at all because apparently 
the laboratory inspections either didn't get communicated to 
FDA or they didn't reveal the presence of salmonella, and how 
does Food and Drug do its job without proper assistance in 
identifying the presence of pathogens like salmonella?
    Dr. Sundlof. We rely heavily on States and private 
laboratories and others to help us in our mission.
    Mr. Dingell. It sounds like you are saying trust everybody. 
I would add to that my dad's abjuration that you should always 
cut the cards. Now, in light of the salmonella outbreak caused 
by PCA's products, could this crisis have been mitigated if 
testing laboratories were required to send their testing 
results to FDA?
    Dr. Sundlof. It would have alerted us a lot sooner, yes.
    Mr. Dingell. I am sorry?
    Dr. Sundlof. It would have alerted us sooner than that 
there was a problem.
    Mr. Dingell. So you need both qualified and competent 
laboratories and you need to have them registered and you need 
to have them send their results to Food and Drug so that you 
know what is going on, right?
    Dr. Sundlof. Again, we appreciate all the information that 
we can get.
    Mr. Dingell. OK. Should FDA have authority to issue 
mandatory recalls of tainted foods?
    Dr. Sundlof. We are more than happy to discuss that. It 
depends, I believe, on how the law is written and what----
    Mr. Dingell. You do not have that authority now.
    Dr. Sundlof. We do not.
    Mr. Dingell. And you need it if you are to do your job 
effectively, do you not?
    Dr. Sundlof. It would be helpful, yes.
    Mr. Dingell. More than helpful, it is necessary. Isn't that 
so?
    Dr. Sundlof. I can tell you that almost in every case when 
we ask companies to recall product, they do it voluntarily.
    Mr. Dingell. Now, Food and Drug was not able to visit or 
inspect the Peanut Corporation of America for about 8 years. Is 
that right? And then they turned the matter over to Georgia, 
which in 2 years is supposed to have visited PCA but they 
didn't find a thing. What caused the failure of FDA to be able 
to inspect the people who were subject to their jurisdiction? I 
am told that the Department of Agriculture can investigate and 
can visit and inspect dog food producers oftener than Food and 
Drug can inspect food producers. Do you need more resources at 
Food and Drug to carry out proper inspections or not?
    Dr. Sundlof. We would like to do more inspections, yes.
    Mr. Dingell. Well, you are not doing the inspections that 
need to be done so you are not able to protect the people. PCA 
tells us clearly that the consumers were not protected because 
tainted and unsafe salmonella-infected peanut products and 
peanut butter got on the market, and with more resources you 
could have done a better job of protecting the public. Is that 
not so?
    Dr. Sundlof. It is not clear in this case.
    Mr. Dingell. It is not clear?
    Dr. Sundlof. It is not clear----
    Mr. Dingell. In 8 years you couldn't investigate them. That 
is clear to me. Then Georgia investigated them and they 
couldn't do a good job. So that tells me that Food and Drug 
does not have either the resources--you are caught in a cleft 
stick here. Either you don't have the resources or you are 
incompetent to do the job you are supposed to do. Which 
conclusion am I to arrive at?
    Dr. Sundlof. I would hope the former.
    Mr. Dingell. That you don't have the resources? I am 
content to believe that you are incompetent but I have tried to 
defend you against that and point out that you need resources. 
What I get from you, however, is, a modified reluctance to have 
more resources, and I am distressed because I think that the 
only way Food and Drug is going to amount to a hill of beans is 
to have the resources that it needs and to have the statute 
that it needs and to have the leadership that it needs. I find 
the leadership lacking, I find the resources lacking, and you 
are driving me to the conclusion that perhaps maybe Food and 
Drug is not as diligent as it should be because it might have 
the resources. Now, what is your response to that?
    Dr. Sundlof. Well, obviously we need to be inspecting more 
frequently. In this particular case, we should have been taking 
environmental samples. That would have led us to find problems 
earlier. We should have been more directed to the State of 
Georgia in directing them to take environmental samples. Had 
they done that, we might have detected this sooner.
    Mr. Dingell. Mr. Chairman, my time has expired. You have 
been very gracious. I thank you.
    Mr. Stupak. Well, thank you, Mr. Dingell, and on behalf of 
all the members, when they were doing the tribute on the floor 
on your resolution, we all would have liked to have been there 
but we were doing as you have taught us to do, oversight, so 
forgive us for not being there when they did the House 
resolution in tribute to your longevity on the floor. I know 
some of us after hours tonight will be paying tribute to your 
length of service, but more than that, the quality of service 
you provided to the American people.
    Mr. Gingrey for questions, please.
    Mr. Gingrey. Mr. Chairman, thank you, and following up on 
the chairman emeritus's line of questioning, let me address my 
first question to Dr. Sundlof of the FDA. You know, I think as 
I read your testimony that FDA actually went into Blakely, 
Georgia, to inspect this PCA plant on January 9, 2009, and this 
was based on the information that had been obtained by 
Minnesota Department of Public Health that clearly there was 
salmonella in an open container of this peanut butter product, 
and yet you go there and you find pretty quickly in going 
through the records of the company that some of the lab reports 
that were submitted by these two labs, these private labs, 
which by the way I don't feel are necessarily responsible for 
not notifying the FDA. I mean, their job is basically a 
contract with the company. It is just like if a physician does 
a blood sample on someone and sends it to a lab and it is a low 
hemoglobin, as an example. Well, the laboratory is going to 
report back to the doctor and maybe even flag that, 
particularly if it is a dangerously low number, but that is 
where their responsibility ends. I mean, they cannot run down 
every patient and interfere with a doctor-patient relationship. 
So it may be that that is something that we should change, and 
I will get to that question in just a minute. But my question 
to you is, FDA went in and knew on January 9 beyond a 
reasonable doubt that this was the source of the contamination 
and yet waited another 10 days or so to get some unopened can 
of peanut butter from somewhere in Connecticut to absolutely, 
unequivocally prove it. Couldn't you have had the ability to 
say to the company, cease and desist until we can prove this? 
If we disprove it, then, you know, you continue operations and 
maybe the Federal Government, the FDA mitigates any financial 
loss but when you just continue to get to the nth degree for 
another 10 days, I don't now how many more hundreds of people 
got sick or maybe even additional deaths because of that delay. 
Why couldn't you have issued a cease-and-desist order at that 
time?
    Dr. Sundlof. I believe we went in on the 9th. I believe 
that was a Friday. The company recalled on the following 
Monday. So we did move very quickly.
    Mr. Gingrey. Well, the company recalled a certain product 
that was produced and then it was later that they recalled it 
and then finally they had another recall that went all the way 
back to January 2007, but that probably should have been done 
immediately.
    Dr. Sundlof. We can only work with the information that we 
have at the time. At that time we only knew of the products, 
the King Nut products as being the source. We moved quickly. 
They quit producing on that date and quit marketing on that 
date, on the 9th of January, and started recall of the products 
that we knew were affected by the following Monday.
    Mr. Gingrey. Let me move on to Mr. Garrison with the 
Georgia Department of Agriculture. Do you feel like the 
Department under contract with the FDA had sufficient training? 
Were there any manuals in regard to the inspectors that work 
with the Department of Agriculture? Did you have enough 
training and guidance to properly inspect?
    Mr. Garrison. Training is always a continual issue when you 
are looking at the evolving food continuum that we see. There 
have been a lot of advances in food processing, a lot of new 
programs brought online, as Dr. Sundlof stated, Hazard Analysis 
Critical Control Point. Those inspections are now required in 
seafood processors and in juice processors. So where there is 
specific training required of an operator of a facility, then 
our inspectors are also provided with that training. We have 
taken the Good Manufacturing Practices from FDA. Those are 
adopted in the State regulations and those are also in our 
performance manual that----
    Mr. Gingrey. And Mr. Garrison, did the Department abide by 
the terms of the contract in regard to the frequency of 
inspections?
    Mr. Garrison. Yes, sir. The terms of the contract only lays 
out one inspection in the assigned facilities during a calendar 
year unless there is an indication by FDA that a follow-up 
would be necessary based on documentation.
    Mr. Gingrey. Let me real quickly ask our lab folks, if you 
will bear with me, Mr. Chairman. If you were required to submit 
a copy of your report, certainly a positive report, let us say, 
to the FDA, how much more expense or burden would that be for 
the laboratories? How much more would you have to charge the 
food processor that contracted with you to do the lab testing 
if you were required to submit a duplicate copy to the FDA?
    Ms. Cowart. Mr. Gingrey, I can speak specifically for our 
company. All of our documents are e-mailable in a new system 
that we have put in place since August of 2007 so it would be 
very simple to e-mail to whoever in FDA would be the 
appropriate person.
    Mr. Gingrey. Mr. Deibel, would you agree with that?
    Mr. Deibel. Yes. We have a system where we can plug in on 
each client each client contact that would want a report. The 
system, once we go through our checks and balances to ensure 
that the result is accurate and authorized, once that is 
authorized, it is automatically either e-mailed or faxed to 
whomever.
    Mr. Gingrey. So easily done, not expensive and nothing you 
would object to if we decide that that should be done in the 
future?
    Mr. Deibel. If that was something that this body decided, 
it would not be a problem.
    Mr. Gingrey. Mr. Chairman, I will yield back. I know my 
time has expired.
    Mr. Stupak. Ms. Christensen for questions, please.
    Ms. Christensen. Thank you, Mr. Chairman.
    I would like to direct my first question to Dr. Sundlof 
also. I had a chance to look through some of the Senate 
testimony and the director of food safety for the Center for 
Science and Public Interest had what I am going to read to you 
in her testimony. She says that in April of 2008, Canada 
rejected a shipment of peanuts from PCA as unfit for food. PCA 
attempted to clear the peanuts for sale in the United States 
but FDA rejected its test results and eventually the peanuts 
were destroyed. During that period--well, wouldn't that have 
sent a red flag up to FDA and shouldn't that have caused FDA to 
require more inspections of PCA, given the fact that this is 
April of 2008? Because the testimony goes on to say that FDA 
did not follow up with inspection of the plant.
    Dr. Sundlof. That is not entirely true. The shipment was 
rejected because it was peanut granules and it was determined 
that it contained some metal fragments in there. It was 
returned back to PCA. FDA witnessed its destruction so that it 
did not move into commerce. At that time we also asked that the 
State of Georgia do an additional inspection in that facility. 
That was one of the two that was conducted under FDA contract 
and they went in there I think in May or June was when they 
went back in to inspect. I believe they determined what the 
source of the metal was and the firm took corrective action.
    Ms. Christensen. And Mr. Garrison, you are familiar with 
those inspections.
    Mr. Garrison. Yes, ma'am.
    Ms. Christensen. Was it your testimony that you found no 
evidence for any contamination in those inspections? Was it a 
complete inspection or was it just related to the metal?
    Mr. Garrison. What the e-mail that we received from FDA 
stated was, it was to be a contract inspection and focusing on 
GMPs, which is what the contract states, and also looking for 
any metal inclusion that may have occurred and to check out the 
metal detector. What we reported back to FDA was a couple of 
metal scrubbers, which we would call a brillo pad, that were 
inside the facility and also a scraper----
    Ms. Christensen. But that would not have precipitated any 
other inspections? Was it focused just on the metal?
    Mr. Garrison. No, ma'am. We actually had done a Good 
Manufacturing Practice inspection during that time.
    Ms. Christensen. And there was nothing to suspect that 
there would be any other contamination in those inspections?
    Mr. Garrison. Like I said, there was no red flags that 
would indicate an imminent health hazard inside that facility.
    Ms. Christensen. My understanding, Mr. Garrison, is that 
between 2007 and 2008, PCA had 12 positive salmonella tests 
reported to them, and in that time the Department tested 35 
product samples from five Georgia facilities. How many of those 
were from the Blakely plant?
    Mr. Garrison. There were three samples taken from the 
Blakely plant in believe August of 2007.
    Ms. Christensen. And their first positive was in June of 
2007, but you didn't find any in your three?
    Mr. Garrison. No, ma'am, we did not.
    Ms. Christensen. Since there has been a salmonella outbreak 
the year before that was in peanut butter, when this outbreak 
started to surface, did that not raise concern and should not 
that have precipitated some increased inspection at peanut 
butter plants, for either Dr. Sundlof or Mr. Garrison.
    Mr. Garrison. From the State perspective, when the outbreak 
began we worked closely with our department of Public Health 
and their epidemiologists were monitoring the CDC calls looking 
for potential causes and implicated foods and then they would 
bring those to us. You know, once the peanut butter was brought 
forward as a potential, then at that point the State along with 
FDA began looking at potential problems that may be associated 
with those facilities.
    Ms. Christensen. But nobody seemed to think back to March 
of 2007 to say well, this is salmonella, we had a salmonella 
outbreak a year before where the source was peanut butter?
    Mr. Garrison. From a State perspective, we are constantly 
shuffling resources. You know, when we can run 45 samples 
through our laboratory, you know, coming into June we were 
dealing with imported jalapeno peppers that, you know, actually 
tainted our tomato industry in Georgia. We had melamine in 
products coming from China that the State was running tests on 
in October so, you know, with very limited lab resources, we 
are constantly moving around what we are testing and what we 
are looking for from a State standpoint.
    Ms. Christensen. If I can get just one more question, a 
quick question, to Mr. Deibel and Ms. Cowart. The fact that 
there was a negative follow-up test after a positive one, how 
many negative tests would you consider enough to convince you 
that the positive test result could be ignored? Can you ignore 
a positive test just because you get another follow-up?
    Mr. Deibel. Absolutely not. If you tested 50 samples for a 
given lot and 49 of those were negative and one was positive, 
that one positive must trump the 49 negatives. The 49 negatives 
should never have more precedence over that one positive. You 
cannot retest away a positive result.
    Ms. Cowart. And I will agree with that statement 
wholeheartedly.
    Ms. Christensen. Thank you, Mr. Chairman.
    Mr. Stupak. Thank you.
    Ms. Schakowsky, questions, please.
    Ms. Schakowsky. Thank you, Mr. Chairman.
    Mr. Deibel, on April 28, 2008, your lab confirmed that a 
PCA sample tested positive for salmonella contamination. Is 
that correct?
    Mr. Deibel. I believe so. Yes.
    Ms. Schakowsky. I think you said before, what would you 
have expected a manufacturer to do with that information?
    Mr. Deibel. We do a lot of consulting services for our 
clients and most of what we try to get involved with is more on 
the front-end quality control procedures, working with clients 
to have----
    Ms. Schakowsky. What would you have expected that they 
would do?
    Mr. Deibel. In the event of a positive occurrence, we would 
expect that they would shut that line down or stop that 
production, quarantine that lot, try to figure out how that 
positive occurred in retesting.
    Ms. Schakowsky. OK, but----
    Mr. Deibel. But ultimately throw it out.
    Ms. Schakowsky. But actually following that initial 
positive, PCA sent you additional samples from the same lot and 
they also went to Dr. Cowart's firm and provided an additional 
sample, and those tests came back negative for salmonella, 
right?
    Mr. Deibel. Correct. That is not unheard of.
    Ms. Schakowsky. Dr. Garrison, what is a company expected to 
do if there is a positive? And do you also agree that negatives 
don't erase the positive that has been found?
    Mr. Garrison. The State of Georgia Department of 
Agriculture would expect that company to immediately destroy 
the product. If it has been put in commerce, it would expect 
them to recall that. During our testing procedures, when we get 
what Ms. Cowart had referred to as a presumptive positive from 
a facility we regulate, we will notify industry at that point, 
and in most cases, as a matter of fact, in all cases from that 
presumptive positive, the processing facility will either hold 
the product if it hadn't went out or go ahead and issue a 
recall just based on that presumptive.
    Ms. Schakowsky. OK. Now, between June of 2007 and September 
of 2008, private lab testing found salmonella on 12 separate 
occasions. You inspected the plant on June 10, 2008. Did you 
ask if there had been any laboratory tests?
    Mr. Garrison. There is no evidence on our inspection 
reports that we asked but that is something that the company 
does not have to supply to the State. That is the reason----
    Ms. Schakowsky. Do you ask though?
    Mr. Garrison. I can't say in this particular instance if we 
asked or not.
    Ms. Schakowsky. Is it on your report form to ask?
    Mr. Garrison. No, ma'am, it is not something that is 
required of----
    Ms. Schakowsky. I know it is not required. I am just 
wondering if you asked and if the company refused to tell you 
because they don't have to, would that not indicate that there 
might be some sort of a problem? I mean, I don't understand. If 
there has been test after test, I think everybody here agrees 
that a positive test should result in a product being taken 
away. I think we will change that. I hope we will change that 
so they do have to inform you, but I can't understand why that 
question wouldn't be asked. Can you explain that to me?
    Mr. Garrison. When companies are not required to give 
records, we don't even know if tests have been conducted.
    Ms. Schakowsky. Exactly.
    Mr. Garrison. And when you are dealing with the elements 
that we are dealing with in this case, if we think by simply 
asking they would tell us that they didn't have the results or 
that they were all negative, you know, we are dealing with a 
different element here. We are dealing with something that at 
this point appears to have intention based in it.
    Ms. Schakowsky. There is at tab 42 an e-mail from Stewart 
Parnell, the owner of PCA, and in these e-mails with the plant 
manager, Sam Lightsey, Mr. Parnell inquired about the results 
of a subsequent test from Deibel. Mr. Lightsey informed Mr. 
Parnell that the subsequent tests were in spec, meaning they 
came back negative for salmonella. Although Mr. Parnell knew 
that this lot previously received a confirmed positive for 
salmonella, Mr. Parnell instructed this plant manager, ``OK, 
let's turn them loose then.'' Dr. Sundlof, is this the 
appropriate response to these two tests, to turn the product 
loose on American consumers?
    Dr. Sundlof. No, it is not, and I don't believe that is in 
any way the industry practice. I think this is a case in which 
one company has violated what I think all other companies know. 
It is well known within the peanut manufacturing community that 
testing, even finding a negative is not conclusive, that you 
have to take many tests, and that certainly once you find a 
positive test, that that product cannot be considered to be 
safe.
    Ms. Schakowsky. When you conduct tests as the FDA, do you 
ask if any tests have been conducted?
    Dr. Sundlof. I think we do but I am going to ask Mike 
Chappell to speak to that.
    Mr. Chappell. It certainly depends on the nature of the 
inspection. If you are asking whether it is a routine 
requirement for our investigators to ask for whatever testing, 
that is not our procedure, but we are changing that procedure 
to require that our investigators do ask what testing is being 
done and ask to have access to those records.
    Ms. Schakowsky. Well, hopefully, Mr. Chairman, we are going 
to require that those tests get reported back to the FDA. I 
just want to say that it is really unbelievable that Mr. 
Parnell knew that the food that he produced was contaminated. 
It escaped any inspections by the State. Even though the 
testing laboratory found that there was a positive, nothing 
happened, and rather than be responsible, destroying these 
tainted products, he chose to test the same lot over again 
until he got the result that he wanted and then released the 
product to the public. We have a responsibility to change that. 
Thank you. Thanks for the extra time.
    Mr. Stupak. That concludes all the questions of the members 
in this round. I am sure we are going to go a second round but 
we do have two members of the full committee who are not 
members of the subcommittee but they are allowed to ask 
questions under the rules of the subcommittee. So Mr. Barrow, I 
know you have been here all day. Would you like 5 minutes of 
questions?
    Mr. Barrow. Yes, sir. Thank you, Mr. Chairman.
    I am not as good a cross-examiner as my hero, Mr. Dingell 
here, and I am not as good as Mr. Braley over there so I am 
going to throw you guys a softball. I want to ask you a wide-
open-ended question, but listen to the conditions of it because 
it might not seem that way, especially you, Dr. Sundlof. If you 
believe that the integrity of testing cannot be separated from 
the integrity of sampling, and the sampling and testing are 
both things that have to have integrity, if you want to 
preserve the existing regime of voluntary inspections and 
confidential reporting with the testing community but you feel 
it is necessary to mandate and superimpose on that a mandatory 
sampling and testing regime, if you want to make sure that the 
sampling and testing that is done isn't too rigorous that you 
put folks out of business but isn't too lax to miss stuff you 
need to know, in other words, if you want to do everything you 
reasonably can to make sure first that the manufacturer knows 
what the manufacturer needs to know when the manufacturer needs 
to know it and you want to make sure that the regulator knows 
what the manufacturer knows, whatever it is, when they know it, 
how do we go about doing that? Dr. Sundlof, you go first, 
please.
    Dr. Sundlof. Thank you. One of the things that again we 
will be asking for more authority, and that is to issue 
preventive controls in plants. That is, they have to have a 
quality system in place that specifies where the critical 
control points are, where contaminants can be introduced----
    Mr. Barrow. Is a sampling and testing regime going to be a 
part of that?
    Dr. Sundlof. Absolutely.
    Mr. Barrow. Is there going to be goals or is it going to be 
quotas? Is it going to be something we think folks out to look 
at or is it going to be something folks are going to be 
required to do? Are you going to have different protocols for 
different sectors of the food-processing industry?
    Dr. Sundlof. Manufacturers will have to develop their own 
HACCP plan which is specific to their particular manufacturing 
facility.
    Mr. Barrow. Are you going to require sampling be done by 
folks who have an independent stake in their work, folks who 
don't work for just one person or work within the community but 
who have a whole bunch of clients who actually stand to lose a 
lot if they don't do their sampling and their testing in a 
credible manner?
    Dr. Sundlof. I mean, I can't speak about how the exact 
program would work but certainly there has to be these checks 
and balances in there that can be verified by the FDA.
    Mr. Barrow. You will agree with me that folks can't be 
allowed to sample and test themselves?
    Dr. Sundlof. I am not completely sure about that.
    Mr. Barrow. When I was a boy, I learned at my daddy's knee 
that no person can be the judge of his own case. Don't you all 
know that?
    Dr. Sundlof. There may be ways that we could ensure the 
integrity even if they sample their own product and test their 
own product.
    Mr. Barrow. I am not saying folks can't be allowed to do 
that. I am saying we need to have a sampling and a testing 
regime in place in addition to the powers of mandatory recall 
that folks have talked about. We need to have a system in place 
where the manufacturer really doesn't have the option of 
knowing what they need to know when they need to know it and 
they don't get to be the only ones who decide to act on that 
information. The public regulator needs to know what they know 
and when they know it. Don't you think that is necessary, that 
that is a goal we need to reach for?
    Dr. Sundlof. Yes, and that is what we are requesting.
    Mr. Barrow. Well, that remains to be seen. Thank you.
    Anybody else want to take a stab at any of that with a 
little time left? How about you, Mr. Deibel? I understand the 
point you are making but you realize the point I am making, 
don't you? I am not trying to drive people out of the business 
knowing more than they need to know but I want to make sure 
they know what they need to know and that we know what they 
know when we need to know it.
    Mr. Deibel. I think there are a lot of opportunities in the 
subcommittee and in the discussions that we are going to be 
having to really build stronger bridges between government and 
industry and agree upon best practices that we can all use. I 
hope those best practices include preventative approaches 
rather than reactive approaches----
    Mr. Barrow. Well, what I want to do is, I want to take you 
guys out of the situation of having to rat out a client, an 
existing regime where folks have the right to come to you and 
ask as a matter of entering into the contractual relationship 
with you that you will keep quiet but that puts you in an 
untenable position. That is unacceptable. I recognize your 
interests there. Nobody can go forward, no part of the existing 
system can go forward to start doing the right thing if 
everybody else is going to continue to be allowed to do the 
wrong thing. So I want to put in place something that doesn't 
let that happen.
    Ms. Cowart, do you have anything to add to that?
    Ms. Cowart. No, sir, I agree with that in terms of what you 
are talking about. I think the broader picture of how that gets 
done is something that we would really like to be a part of 
helping with the solution.
    Mr. Barrow. Well, get ready because I think you are going 
to have a chance to play a role in that.
    Ms. Cowart. Thank you.
    Mr. Barrow. Thank you, Mr. Chairman.
    Mr. Stupak. Mr. Pallone for questions. You are the chairman 
of the Health Subcommittee with our legislation and FDA 
globalization bill that we are trying to get through for food 
and drug safety, so glad to have you here.
    Mr. Pallone. Thank you, Mr. Chairman. I wanted to be here 
for the whole hearing but I had a hearing on offshore drilling 
in my other committee, and that is important in my district so 
that is why I couldn't come until now. But I did want to 
mention, you mentioned the comprehensive FDA bill that you and 
Mr. Dingell have introduced and I just wanted to say that I was 
pleased to see that we included some of the provisions in a 
food safety bill that I have been trying to push for a number 
of years that are now in that comprehensive bill, specifically 
preventative measures to ensure that food safety has been 
addressed.
    I wanted to ask Mr. Sundlof a question. In the case you are 
examining today, many more companies than just PCA have been 
involved. In fact, over 50 companies use PCA's peanuts in their 
finished products, and what worries me about the situation is 
that first PCA did nothing to prevent their contamination, and 
as others have highlighted, knowingly put contaminated products 
on the market, but second, none of those other companies 
conducted adequate tests on their food items to detect and stop 
the tainted peanut products from making their way to consumers, 
and under current law there is no requirement that the 
companies who are actually putting food into the hands of 
consumers audit or check up on their supplies to ensure the 
ingredients they are getting from these suppliers are safe. 
Now, I believe that we need to give the FDA the authority to 
require food manufacturers to establish food safety plans and 
these plans would require food companies to evaluate what food 
safety risks exist, determine how best to address and protect 
against those risks and establish processes and procedures to 
control those risks. Finally, these food safety plans would 
require companies to maintain records documenting that they 
have complied with those plans and those of course would be 
available to the FDA. You mentioned all this in your testimony 
but I just wanted to make it clear, you do agree that the FDA 
should have this authority to require these manufacturers to 
establish food safety plans?
    Dr. Sundlof. Yes, I do, and in fact, we do have two areas 
of food that do require these kinds of preventive control 
systems. One of them is seafood and the other one is juice. 
They have to produce them under a HACCP program.
    Mr. Pallone. Now, do you also agree that having these sorts 
of requirements in place would have gone a long way towards 
avoiding the kind of major catastrophe that occurred here?
    Dr. Sundlof. It is unclear because the company, it is not 
clear they would have kept adequate records in this case 
because they did get positive samples and those chose or they 
shipped product anyway. If we had gone in and inspected their 
records and had gotten access to those records before this 
outbreak, certainly that would have been a warning to us and we 
potentially could have prevented this.
    Mr. Pallone. I mean, just in a general sense, would you 
agree that each company in the chain of manufacturing has an 
obligation to ensure that the ingredients they are using as 
well as their final products are safe for Americans to consume?
    Dr. Sundlof. Yes, absolutely.
    Mr. Pallone. And then the second thing, Mr. Chairman, I 
wanted to ask was about the fines. Mr. Sundlof again, PCA 
knowingly put contaminated products on the market. They knew 
their ingredients were going to be used by many companies in 
their various products. They knew the risks of this disease and 
yet they did nothing, but the most alarming thing to me is the 
lack of repercussions for the behavior. Under current law, the 
more severe penalty available for committing a single 
prohibited act with respect to foods is a misdemeanor, which 
carries a potential sentence of imprisonment of up to 1 year or 
a monetary fine. But the FDA to successfully prosecute these 
companies and impose a penalty has a lengthy investigation and 
has to coordinate with the Justice Department and it is highly 
intensive in terms of the resources of the FDA and Justice. I 
also question whether the threat of a misdemeanor conviction 
has any deterrent effect at all, especially in light of the 
situation. FDA now has the authority to levy civil monetary 
penalties for certain drug and medical device violations, an 
administrative authority that permits FDA to proceed without 
involving the Justice Department, and for certain drug 
violations FDA can impose a fine of up to $1 million for all 
violations adjudicated in a single proceeding but FDA does not 
have that authority with respect to foods with the exception of 
illegal pesticides. In your opinion, are civil monetary 
penalties less burdensome for the agency to impose than 
criminal penalties, and do you agree that having the ability to 
impose an administrative monetary fund would be a useful 
enforcement tool for the FDA?
    Dr. Sundlof. Congressman, it is not something that I have 
had discussions with. Certainly it is something that we will be 
talking about in the wake of this salmonella outbreak but it is 
not something I have an opinion on at this point.
    Mr. Pallone. And you don't want to express an opinion at 
this point?
    Dr. Sundlof. I don't.
    Mr. Pallone. All right. I wish you would, but I can't force 
you.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you, Mr. Pallone.
    Let us go for another round. I think we are going to have 
votes here soon but let us try to get a couple more questions 
in before we release this panel.
    Mr. Garrison, when I take a look at the document binder, it 
seems between Exhibits 15 to 37 are Georgia's inspections of 
this place, and if I am correct--by ``this place'' I mean PCA. 
That is about 22 different inspections, and it looked like 
early on, 2004, 2005, 2006, you did not only inspections but 
also scale inspections. Is that correct?
    Mr. Garrison. Yes, sir, that is correct.
    Mr. Stupak. Then why the drop-off after 2006? I think you 
had one in 2007 and one in 2008?
    Mr. Garrison. On the scale inspections or on the food 
inspections?
    Mr. Stupak. Both.
    Mr. Garrison. The scale inspections were conducted under 
another section of my division. On the food inspections, it was 
basically due to attrition throughout the department.
    Mr. Stupak. And budget cutbacks you spoke of?
    Mr. Garrison. Budgetary issues and those type of things.
    Mr. Stupak. So you never did any inspection of this plant, 
the Blakely, Georgia, plant, for salmonella then even though 
that was sort of the goal to do it once a year, right?
    Mr. Garrison. No, sir. We would have done an inspection at 
least twice per year during this period of time.
    Mr. Stupak. But let me ask you this. Had you ever had any 
knowledge, anyone in your department or agency, that they were 
having trouble with salmonella at this plant in Blakely, 
Georgia?
    Mr. Garrison. No, sir, it was never reported to any of our 
inspectors or even through our consumer complaint logs.
    Mr. Stupak. OK. Your last inspection was October 23, 2008, 
and when you take a look at it, it has a little bit of history 
of past problems that they had in this place, especially water. 
Water is sort of a red flag in peanut butter that there could 
be contamination or salmonella. Isn't that so?
    Mr. Garrison. You want to eliminate moisture from the 
peanut process.
    Mr. Stupak. And that is even one of the reasons why you 
roast peanuts and heat them up is to get rid of the salmonella? 
It has to be more than 170 degrees, if I remember correctly, 
correct?
    Mr. Garrison. The temperature would really depend on the 
roaster speed and the temperature there. It is a combination of 
the two during the roasting procedure.
    Mr. Stupak. OK. On October 23, when you take a look at it, 
and I am looking at the FDA's report in January, they indicate 
even in October like they are missing dates as to the firm's 
temperature inadequate or just left off the reporting charts, 
and that was never noticed by your inspectors. Wouldn't they 
look for the temperatures for roasting peanuts if you are doing 
an inspection?
    Mr. Garrison. When our inspectors go in, they will look at 
the current temperatures are being observed at the time that 
they are inside.
    Mr. Stupak. They wouldn't look at past temperatures to see 
if they are being reported?
    Mr. Garrison. Those would be records that they would not 
have to supply us with.
    Mr. Stupak. I had asked Ms. Cowart, and it was Exhibit 38 
there, when she did a walk-through when she was consulting with 
PCA and she found three reasons why there could be salmonella, 
number one, the Chinese product could have already been 
contaminated before it got there, but then after that it was in 
the production and packaging. If Ms. Cowart, if she just does a 
walk-through and notices these things in this plant, why 
wouldn't your inspectors notice them because they are looking 
for the same things, aren't they?
    Mr. Garrison. Ms. Cowart had knowledge that the facility 
had a problem with salmonella. That is something that the State 
didn't have and that is what we are pushing for is for these 
plants in Georgia if they have problems, they have to let us 
know. We have to have every tool available to us.
    Mr. Stupak. Sure, but as inspectors, salmonella, water, 
peanuts, bad combinations. I just think you would pick up on 
those things.
    Mr. Garrison. Exactly. You know, the inspections are a 
snapshot in time. What Ms. Cowart had seen during her 
inspections may not have necessarily been there when our 
inspectors went through.
    Mr. Stupak. Well, that is why you look at the temperature 
records and things like that, correct?
    Mr. Garrison. When they have to supply them to us. That is 
why we go back to the HACCP requirements that Dr. Sundlof spoke 
about with the juice HACCP and the seafood HACCP. They are 
required to maintain those records, to sign off on those 
records----
    Mr. Stupak. But there is no way you can get those records 
unless they voluntarily give them to you, right?
    Mr. Garrison. In these type facilities, that is correct.
    Mr. Stupak. Dr. Sundlof, I have been asking this question 
for 2 years and the answer has always been no. Go back to 2007, 
Peter Pan, you mentioned in your testimony here today, did you 
ever get those records for Peter Pan from ConAgra?
    Dr. Sundlof. I don't know the answer to that. I will ask 
Mike Chappell if he knows.
    Mr. Stupak. So 2 years and you don't have the records from 
2007 and yet you continue to say you don't need subpoena power. 
Don't you think you subpoena power?
    Dr. Sundlof. Again, I don't know whether or not we do have 
the records, sir.
    Mr. Stupak. I have just been handed a report. Ohio 
officials now have linked a woman's death to nationwide 
salmonella outbreak, so I guess we are now up to nine deaths 
and growing.
    Let me ask you this, Dr. Sundlof. Go to tab 11 there, which 
is FDA's amended 483 report from January inspection. I would 
like to know about each of these violations. Should they be 
caught in a Good Manufacturing Practices inspection, and if you 
could do a yes or no, like observation number three on page 
five, this is about the temperature being not recorded. I 
mentioned in October six times it wasn't recorded, November 
2008, 24 days you never recorded the temperature, in December 
and January, nothing was recorded. Should that have been caught 
by inspection, a GMP inspection?
    Dr. Sundlof. Yes.
    Mr. Stupak. All right. How about the pallets being three 
feet, observation number four, three feet from the finished 
product, and water stains running down in the cooling unit fans 
in the cooler. Should that have been observed by GMP 
inspection?
    Dr. Sundlof. I am going to have to ask Mike Chappell.
    Mr. Stupak. Mr. Chappell, should that have been caught, 
water stains, with the GMP?
    Mr. Chappell. Certainly one of the things that we do during 
inspection is look for environmental situations and a water 
stain is indication of a previously----
    Mr. Stupak. In observation number five, plant is not 
constructed in such a manner to allow ceilings to be kept in 
good repair. Should that have been caught in a GMP inspection?
    Mr. Chappell. One of the things that we look for to see the 
general condition of the building, and there are certain things 
that we look for, and if the building is properly constructed, 
it is easy to repair those, and if not, it is not.
    Mr. Stupak. So that is yes then, they should have caught 
that in the GMP?
    Mr. Chappell. Yes.
    Mr. Stupak. OK. How about observation number six, design of 
equipment and utensils failed to preclude adulterated food with 
contaminants, specifically felt material is present on the 
final roller at the discharge. This material cannot be 
adequately cleaned or sanitized. Should that have been caught 
in a GMP inspection?
    Mr. Chappell. If indeed that particular equipment was in 
place and in use at that time, that would be an----
    Mr. Stupak. That would be a yes then. OK. How about number 
seven, proper precautions to protect food and food contact 
surfaces from contamination with microorganisms cannot be taken 
because of deficiency in plant construction and design. So that 
would be there all the time. So that should have been caught by 
GMP, would it not?
    Mr. Chappell. I think plant design is certainly one of the 
things that we would look at, especially at it relates to 
product flow and segregation.
    Mr. Stupak. So that is a yes. How about number eight, 
specifically the sink located in the peanut butter room is used 
interchangeably as a point for cleaning hands and utensil tools 
and for washing out mops. That is not Good Manufacturing 
Practice, is it?
    Mr. Chappell. It is not, but again, though, if indeed the 
investigator was there at a time it was not being used for both 
things, they might not necessarily have pointed that out.
    Mr. Stupak. Right, but a sink shouldn't be in the final 
product area anyway, should it? Because that is water again, 
isn't it?
    Mr. Chappell. Yes.
    Mr. Stupak. OK. How about number 10, besides the dead and 
live roaches, let me ask you this. The bumper pads were 
inadequate, openings of six inches or more were observed along 
sides and tops of trailers. These trailers contained raw and 
roasted products, can be left backed up for 7 to 5 days leaving 
openings in the plant. Is that GMP? Is that Good Manufacturing 
Practice?
    Mr. Chappell. That should have been observed, yes.
    Mr. Stupak. These violations I have just listed here, all 
six or seven of them, all should have been caught in a normal 
GMP inspection. Then why weren't they in the prior inspections?
    Mr. Chappell. The prior inspection the FDA conducted was 
2001, so I think it depends on the conditions at the time----
    Mr. Stupak. Well, there was a GMP inspection, there was an 
inspection for cause on the metal shavings, but some of these 
are just structural. You can see water stains, things like 
that. That should have been caught, should it not?
    Mr. Chappell. It certainly should be observed during the 
inspection.
    Mr. Stupak. All right. I guess my time is up. Mr. Deal?
    Mr. Deal. Thank you. First of all, let me clarify some 
things that I think may have been confused here. First of all, 
peanuts are not an inherently dangerous product. In fact, they 
are inherently safe. Some of us still eat them raw. Isn't that 
correct?
    Dr. Sundlof. Peanuts, because they lack water, do not 
support the growth of bacteria. What we have seen in the 
ConAgra case and in the recent case with PCA is that once 
salmonella is introduced into these peanut products, it doesn't 
die, it just stays there, and then when it becomes ingested, 
then the bacteria is able to reproduce and cause disease.
    Mr. Deal. But that is further in the process. Inherently 
they are a safe product unless you get the occasion for 
something like the Chinese organic and there you are talking 
about something in the organic area where the fertilizer, it 
contains salmonella in many instances and that is not the 
traditional method and not the traditional peanut product that 
comes to these plants. Am I correct?
    Dr. Sundlof. Just let say, you know, peanuts are grown in 
the dirt and in the dirt there are lots and lots of bacteria 
and salmonella can certainly be one of those. Generally the 
peanut processors require a roasting step----
    Mr. Deal. And that is the kill cycle?
    Dr. Sundlof. That is the kill cycle.
    Mr. Deal. So whatever might have been there, even though 
they are not inherently dangerous, a proper kill cycle would 
supposedly eliminate that?
    Dr. Sundlof. That is correct.
    Mr. Deal. And that is why the temperatures of the roasters, 
etc., are critical pieces of information?
    Dr. Sundlof. Yes.
    Mr. Deal. All right. Once you get through the kill cycle, 
then it should not have salmonella in the peanut?
    Dr. Sundlof. Right, and that is when the Good Manufacturing 
Practices have to make sure that salmonella is not reintroduced 
after the roasting process?
    Mr. Deal. And that is the reason you can get inconsistent 
samples one day versus the next day. Presumably if you get a 
bad sample and a bad report that the lab reports back to the 
manufacturer, their presumption, and I think anybody's 
commonsense presumption is that they not only would destroy the 
product that is bad but also that they would take the 
corrective action in cleaning up the facility, doing the other 
good management practices that would have caused the bad sample 
to occur. Am I not correct, Dr. Cowart?
    Ms. Cowart. Yes, sir. That insurance, yes, sir.
    Mr. Deal. So it is not then inconceivable or totally within 
reason that you might get a bad sample, somebody gets the 
results, they clean it up, they don't get a bad sample the next 
time somebody comes by or the next time an inspection takes 
place. But I think the thing we all are focusing on is the 
kinds of things that will be able to prevent the bad actors 
from coming along. We have a bad actor here. He did not respond 
in a way that would be a normal response that everybody had 
reasons to expect they would respond. So I guess the thing we 
are trying to do is to come up with ways and methods whereby we 
can try to prevent the bad actor from being able to slip 
through the holes, and that would be including maybe reporting 
of internal testing to outside agencies such as the State 
department of agriculture or perhaps even the FDA, the 
mandatory keeping of internal records that would be required to 
be disclosed to the inspectors when they come by so that they 
would know whether or not there had been periods where the kill 
cycle was not operating properly or they would know if they had 
gotten a bad test result back. I think those are the objectives 
that all of us have in mind. Is that not the general format, 
Dr. Sundlof, that we should be approaching this from?
    Dr. Sundlof. Certainly I think we need to have systems in 
place that are, number one, preventive, and number two, alert 
us early on when there is a problem.
    Mr. Deal. And I think we all agree with that, and the 
question is, how do we achieve that goal, and since we are in 
the middle of a vote, I am going to conclude, but let me 
conclude by having thanks to all of you for your participation 
here. You have enlightened us and we do appreciate your 
attendance at this hearing.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you.
    Mr. Braley, any questions?
    Mr. Braley. Yes, thank you.
    Dr. Cowart, I would like to ask you about a document known 
as a certificate of analysis. As succinctly as possible, tell 
us what a certificate of analysis is.
    Ms. Cowart. A certificate of analysis for our laboratory is 
the final results that we have obtained through our testing 
program that is issued to the client for the sample they 
submitted.
    Mr. Braley. And what does a company do with a certificate 
of analysis?
    Ms. Cowart. With a certificate of analysis, they would look 
at their sample description and understand where that came 
from, and based on the results they need to take action, 
depending on the positive or negative results they get.
    Mr. Braley. And let me just show you why what we are 
talking about is so important. This is a list of the 1,900 
product recalls at the FDA as of February 10, 2009. So when you 
issue a certificate of analysis, you are issuing a 
certification from your company to be relied upon, which has 
legal consequences. Isn't that correct?
    Ms. Cowart. I think for the company, it is their 
responsibility to do with it what they need to do so it is our 
result on the sample, yes, sir.
    Mr. Braley. And you have a contractual obligation to make a 
good-faith effort to perform that test to the best of your 
abilities because you know they are relying on your analysis 
for their business purposes and their regulatory compliance?
    Ms. Cowart. When we issued our certificate of analysis, 
yes, sir, we believe they are relying on us to do that.
    Mr. Braley. So I would like you to take a look at a 
certificate generated by your company, JLA, which is at tab 51, 
page 1, and we have got it up on the monitor so you can follow 
along. In this certificate of analysis, your company confirmed 
the product from Peanut Corporation of America tested positive 
for salmonella, and you can see the lot number is 8168-ABCD and 
it is dated June 23, 2008. Is that correct?
    Ms. Cowart. Yes, sir.
    Mr. Braley. Mr. Deibel, let me show you another certificate 
of analysis on the same tab, 51, page 3. This is your private 
lab's analysis of the same lot number on the same date but your 
result shows that salmonella is negative. Is that correct?
    Mr. Deibel. That is correct.
    Mr. Braley. So just to understand, PCA sent two samples 
from the same lot to two private labs, JLA found salmonella and 
Deibel did not, so let us see what PCA did. PCA generated its 
own certificate of analysis. This is in the same tab, 51, on 
page 2, and PCA's report shows that its product tested negative 
for salmonella. This is a certificate of analysis that PCA 
prepared for its customers, correct? You will have to answer 
affirmatively.
    Mr. Deibel. Based on what we are looking at, yes.
    Mr. Braley. Dr. Sundlof, what is FDA's position on this? 
Isn't it true, Doctor, that is illegal for a company to report 
on a certificate of analysis a negative salmonella report when 
it knows that there is another lab test that shows a positive 
result?
    Dr. Sundlof. I cannot speak to the legality of that. That 
certificate of analysis is between the laboratory and the 
company. Certainly, you know, if we find that they did 
introduce contaminated food into the marketplace, then they are 
in violation of the Food, Drug and Cosmetic Act.
    Mr. Braley. Well, are you saying that you don't know or 
that it doesn't apply in this context whether that would be 
illegal for a company to do?
    Dr. Sundlof. I think that is part of the criminal 
investigation and I can't expand on that.
    Mr. Braley. Well, based on everything we have heard today, 
wouldn't you agree that if that is not in an illegal practice, 
it certainly should be?
    Dr. Sundlof. Certainly if they were supplying false 
information to the FDA, that would certainly be an illegal 
practice.
    Mr. Braley. Well, and we have heard testimony here that if 
any lot result tests positive, that takes precedent over any 
comparative negative test result, correct?
    Dr. Sundlof. That is not written anywhere in the law or the 
regulations but it is common knowledge within the industry that 
you can't test your way to negative.
    Mr. Braley. So if it is common knowledge within the 
industry, isn't it true that it would make sense to have that 
also be applicable in the statute and the regs?
    Dr. Sundlof. We would be happy to work with that.
    Mr. Braley. And can you tell us how can this practice be 
allowed, because it is not just egregious, it is really 
fraudulent to the American people, isn't it, the American 
consumers who purchase these products?
    Dr. Sundlof. If they are purchasing food that is purported 
to be something that it is not, absolutely.
    Mr. Braley. Thank you.
    Mr. Stupak. Mr. Walden has a question.
    Mr. Walden. Well, Mr. Chairman, I know we have to get to 
the floor for a vote. I do have a couple of questions I would 
like to be able to submit in written form to the panel for your 
written response. Unfortunately, we have run out of time, but I 
would concur with my colleagues and thank you for your 
participation today. It has been helpful in our efforts, and 
obviously we have got some changes to make in the Federal 
Government to protect the food supply for all Americans, and we 
are going to do that, so thank you. Thank you, Mr. Chairman.
    Mr. Stupak. And that concludes all questioning. I know 
there are many other questions members have. I want to thank 
all of our witnesses for coming today and for your testimony.
    The committee rules provide that members have 10 days to 
submit additional questions for the record. I ask unanimous 
consent that the contents of our document binder be entered in 
to the record provided that the committee staff may redact any 
information as business proprietary, relates to privacy 
concerns or is a law enforcement-sensitive matter. Without 
objection, documents will be entered in the record.
    That concludes our hearing. This meeting of the 
subcommittee is adjourned. Thank you all again.
    [Whereupon, at 2:17 p.m., the subcommittee was adjourned.]

                                 
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