[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
THE SALMONELLA OUTBREAK: THE CONTINUED FAILURE TO PROTECT THE FOOD
SUPPLY
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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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63-824 WASHINGTON : 2012
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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
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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
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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:]
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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.]