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



    DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE 
                         NATION'S FOOD SUPPLY?
=======================================================================

                                HEARINGS

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               ----------                              

                        APRIL 24, JULY 17, 2007

                               ----------                              

                        Serial No. 110-33 Part A


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



 
DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE 
                         NATION'S FOOD SUPPLY?
=======================================================================

                                HEARINGS

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                        APRIL 24, JULY 17, 2007

                               __________

                        Serial No. 110-33 Part A


      Printed for the use of the Committee on Energy and Commerce
                        energycommerce.house.gov
                               ------
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                    COMMITTEE ON ENERGY AND COMMERCE

                  JOHN D. DINGELL, Michigan, Chairman

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

                                 ______

                           Professional Staff
                 Dennis B. Fitzgibbons, Chief of Staff
                   Gregg A. Rothschild, Chief Counsel
                      Sharon E. Davis, Chief Clerk
                 Bud Albright, Minority Staff Director

                                 ______

              Subcommittee on Oversight and Investigations

                    BART STUPAK, Michigan, Chairman

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

                                  (ii)








                             C O N T E N T S

                              ----------                              

                             APRIL 24, 2007

                                                                   Page
Hon. Bart Stupak, a Representative in Congress from the State of 
  Michigan, opening statement....................................     1
Hon. Ed Whitfield, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................     2
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................     4
Hon. Henry Waxman, a Representative in Congress from the State of 
  California, opening statement..................................     6
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     7
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................     8
Hon. Jan Schakowsky, a Representative in Congress from the State 
  of Illinois, opening statement.................................    10
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................    11
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................    12
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................    15
Hon. Jay Inslee, a Representative in Congress from the State of 
  Washington, opening statement..................................    16
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    17

                               Witnesses

Michael and Elizabeth Armstrong..................................    18
    Prepared statement...........................................    19
Terri Marshall...................................................    25
    Prepared statement...........................................    27
Gary Pruden......................................................    28
    Prepared statement...........................................    30
Lisa Shames, Acting Director, Natural Resources and Environment, 
  U.S. Government Accountability Office..........................    50
    Prepared statement...........................................    52
    Answers to submitted questions...............................   134
Anthony DeCarlo, D.V.M., Red Bank Veterinary Hospital, Tinton 
  Falls, NJ......................................................    63
    Prepared statement...........................................    64
Paul K. Henderson, chief executive officer, Menu Foods, 
  Streetsville, Ontario, Canada..................................    78
    Prepared statement...........................................    80
    Answers to submitted questions...............................   131
Charles Sweat, president, Natural Selection Foods, San Juan 
  Bautista, CA...................................................    87
    Prepared statement...........................................    89
David Colo, senior vice president, operations, ConAgra Foods, 
  Incorporated, Omaha, NE........................................    97
    Prepared statement...........................................    98
Stephen Miller, chief executive officer, ChemNutra, Las Vegas, NV   100
    Prepared statement...........................................   102

                           Submitted Material

Hon. Rosa DeLauro, a Representative in Congress from the State of 
  Connecticut, and Hon. Richard Durbin, a Senator from the State 
  of Illinois, submitted statement...............................   131
Letter to California Firms that Grow, Pack, Process, or Ship 
  Fresh and Fresh-Cut Lettuce, U.S. Food and Drug Administration, 
  November 4, 2005...............................................   138
``U.S. Food Safety Strained by Imports,'' Justin Pritchard, 
  Associated Press, April 23, 2007, submitted by Ms. Schakowsky..   141
Subcommittee exhibit binder\1\...................................   148

                             JULY 17, 2007

Hon. Bart Stupak, a Representative in Congress from the State of 
  Michigan, opening statement....................................   359
Hon. Ed Whitfield, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................   362
Hon. Jay Inslee, a Representative in Congress from the State of 
  Washington, opening statement..................................   363
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................   364
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................   366
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................   367
Hon. Jan Schakowsky, a Representative in Congress from the State 
  of Illinois, opening statement.................................   368
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................   369
Hon. Henry Waxman, a Representative in Congress from the State of 
  California, opening statement..................................   371
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................   373
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................   375
Michael C. Burgess, a Representative in Congress from the State 
  of Texas, prepared statement...................................   375

                               Witnesses

David Nelson, Senior Investigator, Committee on Energy and 
  Commerce, U.S. House of Representatives........................   376
    Prepared statement...........................................   378
Caroline Smith DeWaal, director, Food Safety Center for Science 
  in the Public Interest, Washington, DC.........................   413
    Prepared statement...........................................   415
William K. Hubbard, Former Associate Commissioner, Food and Drug 
  Administration, Chapel Hill, NC................................   425
    Prepared statement...........................................   426
Carol A. Heppe, Director, Cincinnati District, Food and Drug 
  Administration, Cincinnati, OH.................................   432
    Prepared statement...........................................   434
B. Belinda Collins, Director, Denver District, Food and Drug 
  Administration.................................................   438
    Prepared statement...........................................   439
Ann M. Adams, Director, Kansas City District Laboratory, Food and 
  Drug Administration, Lenexa, KS................................   440
    Prepared statement...........................................   441
Richard M. Jacobs, Chemist/Toxic Element Specialist, San 
  Francisco District Laboratory, Food and Drug Administration, 
  Alameda, CA....................................................   442
    Prepared statement...........................................   444
Charles R. Clavet, microbiologist/IVD specialist, Winchester 
  Engineering and Analytical Center, Winchester, MA..............   445
    Prepared statement...........................................   448
Andrew C. von Eschenbach, M.D., Commissioner, Food and Drug 
  Administration, Department of Health and Human Services, 
  Rockville, MD..................................................   472
    Prepared statement...........................................   476

                           Submitted Material

Hon. Richard Durbin, a Senator from the State of Illinois, 
  statement......................................................   509
Hon. Ed Perlmutter, a Representative in Congress from the State 
  of Colorado, statement.........................................   511
American Society for Quality, submitted statement................   513
Michael McGinnis, senior vice president, meat and seafood, 
  Safeway, Inc., letter of July 16, 2007 to Messrs. Dingell and 
  Stupak.........................................................   519
Subcommittee exhibit binder\2\...................................   530

----------
\1\ Exhibits that have been omitted are on file in the committee 
    offices.
\2\ Ibid.


DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE 
                      NATION'S FOOD SUPPLY--PART I

                              ----------                              


                        TUESDAY, APRIL 24, 2007

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:30 a.m., in 
room 2123, Rayburn House Office Building, Hon. Bart Stupak 
(chairman) presiding.
    Present: Representatives DeGette, Melancon, Waxman, Green, 
Doyle, Schakowsky, Inslee, Dingell, Whitfield, Walden, 
Ferguson, Murphy, Burgess and Barton.
    Staff present: John Sopko, David Nelson, John Arlington, 
Keith Barstow, Kyle Chapman, Alan Slobodin, Peter Spencer, 
Krista Carpenter, and Matthew Johnson.

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

    Mr. Stupak. This hearing will come to order.
    Today we have a hearing on Diminished Capacity: Can the FDA 
Assure the Safety and Security of the Nation's Food Supply. 
Each Member will be recognized for 5 minutes for their opening 
statement.
    This is the first of two hearings the subcommittee is 
holding on the issue of whether the FDA can assure the safety 
and security of the Nation's food supply. In today's hearing, 
we will hear from three people with firsthand experience in 
dealing with the terrible illness that food poisoning can 
induce. Next month, we will hear from the FDA, which has the 
main responsibility for ensuring the safety of our fruits, 
vegetables, produce and other food sources from all around the 
globe.
    I am grateful for our first three witnesses and their 
families for their heart-wrenching testimony. I know it will be 
difficult for you to describe your experiences. But each of you 
give E. coli, Salmonella and noroviruses a human face, so 
Americans can understand and see the health hazard to all of us 
when the Federal agency in charge does fewer inspections, as 
more and more food is imported into this country.
    Michael and Elizabeth Armstrong are here with their 
children, Isabella, age 5, and Ashley, age 2, both of whom 
became critically ill from eating spinach. Worse, the nightmare 
is not over for them, as Ashley will probably need a kidney 
transplant as a result of severe kidney damage.
    Mr. and Mrs. Armstrong, you and your children have endured 
much; and we wish you all the best for your family now and in 
the future.
    We also have Ms. Terri Marshall, whose mother-in-law, Mora 
Lou Marshall, has been hospitalized since January 2 of this 
year after eating peanut butter, a source of protein 
recommended by her health care provider. Unfortunately, the 
Peter Pan peanut butter she ate was contaminated with 
salmonella.
    Our third witness is Mr. Gary Pruden, with his son, Sean. 
The Pruden family was on a Thanksgiving trip when they stopped 
at Taco Bell; and, unbeknownst to them, the meal included 
lettuce contaminated with E. coli. Sean wound up in the 
hospital as a result.
    The terrible food poisoning that continues to plague these 
families is a small part of a growing problem. The 2006 
outbreak of E. coli in spinach that sickened the Armstrong 
children was the twentieth outbreak of E. coli in fresh produce 
from the Salinas Valley in California since 1995 and second one 
in the past year. In the spinach episode, three people died and 
at least 102 were hospitalized. Another 70 people were 
hospitalized due to salmonella in peanut butter.
    What has the FDA done to prevent food-borne illnesses? It 
appears the FDA has decided to centralize food safety decisions 
made here in Washington, DC, cut back on field inspections and 
hope that the food producers and manufacturers will self-police 
their industry based on voluntary guidelines.
    Natural Selections' president will testify how his company 
just began to test all lots of leafy green produce. The result 
has been startling. Natural selections has found 35 lots of 
spinach with E. coli contamination. Is this the extent of E. 
coli in natural selection spinach? Or is it the tip of the 
iceberg? What about its other produce? What do other producers 
find? Do other producers even test? If Salinas Valley seems to 
have repeated outbreaks, what has the FDA done to protect our 
food coming from this valley?
    Not all the companies appearing this morning have been as 
forthcoming as Natural Selections. In the case of salmonella 
poisoning in Peter Pan peanut butter, the actions of ConAgra 
are cause for concern. Our investigation shows that ConAgra 
found salmonella in their peanut butter in 2004 but did not 
report it to the FDA, even when the FDA in 2005 requested 
ConAgra's records. Perhaps if the FDA had been more aggressive 
in learning what happened at ConAgra or if the FDA had subpoena 
power, the latter salmonella poisonings could have been 
detected, prevented or maybe even limited.
    Finally, we will also hear testimony from two companies 
involved in the recent outbreak of pet food contamination. In 
this case, wheat gluten imported from China by ChemNutra was 
contaminated with melamine, an industrial chemical that should 
not be anywhere near food of any kind. Menu Foods used the 
contaminated wheat gluten in producing wet cat and dog food. 
When reports of sick and dying cats and dogs began to mount, 
Menu notified the FDA; and now approximately 100 brands of pet 
food, involving more than 5,000 varieties, have been pulled 
from our store shelves.
    Over the past few days, there have been additional reports 
of contaminated rice protein concentrate and corn gluten, used 
in pet food. All of the wheat gluten, corn gluten and rice 
protein were imported from companies in China. There is concern 
that some of the rice gluten has been fed to hogs, thereby 
raising the possibility of melamine contamination in food 
destined for human consumption.
    Food-borne illnesses and pet food contamination 
demonstrates serious flaws in our food safety network. With 
more and more of our food, fruits, produce and vegetables being 
imported, there appears to be less and less Government 
inspection or oversight and no enforceable safety and health 
standards.
    Imported fruit from China and other countries does not have 
to comply with U.S. health and safety standards. Last week, 
China refused to permit FDA inspectors access to the plants 
that supplied the suspected contaminated wheat gluten to 
ChemNutra.
    The safety of the food Americans put on their table every 
night is more than just a trade issue. It is more than just a 
public health issue. Food safety has the potential of becoming 
a national security risk, a national security threat. I urge my 
colleagues to consider the pet food incident as a wake-up call. 
The poor pets that died remind me of the canaries brought into 
the underground mines to warn miners of imminent danger.
    The canary is at our door. I hope these hearings will help 
alert the American people, Congress and the administration to 
the seriousness of this issue. If it is not taken seriously, 
these kinds of poisonings can and will happen again. Food 
poisonings will happen to you, to me to our children and to our 
pets. The American people expect and deserve better from its 
Government.
    With that, I yield back the balance of my time and next 
turn to the gentleman from Kentucky, Mr. Whitfield, the ranking 
member of the Oversight and Investigations Subcommittee.
    Mr. Whitfield, 5 minutes sir.

  OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    Mr. Whitfield. Well, Mr. Chairman, thank you very much. I 
am certainly delighted that we are holding this hearing today 
on this important topic.
    I notice that the Centers for Disease Control has said that 
food causes may have accounted for as many as 5,000 deaths and 
325,000 hospitalizations each year. We know that the FDA cannot 
force a disclosure, cannot force a recall or even a plant 
closure except in cases of extreme circumstances; and I think 
that this will be the beginning of a series of hearings in 
which we are going to take a closer look at food safety. I know 
that back in the 1970s food safety took up one-half of the 
budget of FDA, and today it is my understanding that it is one-
fourth.
    Now we recognize that sometimes productivity and technology 
developments make it unnecessary to spend as much money, but 
that is an issue that we also want to look at. I know the FDA 
will be testifying, I suppose, maybe in May; and certainly it 
is an issue that we want to look at very closely.
    Today, I want to also thank the Armstrong family for being 
here and conveying to this subcommittee their personal 
experiences in this issue; and Ms. Terri Marshall, we 
appreciate her being here, as well as the Pruden family. And we 
will have two other panels of witnesses in addition to that, 
including representatives from ConAgra and some of the food 
companies.
    Today, we will also be focusing on the E. coli outbreak in 
the Salinas Valley which, as the chairman mentioned earlier, 
caused three deaths and 102 hospitalizations. We also will be 
looking at the salmonella outbreak in peanut butter primarily 
out of the ConAgra plant. I can't remember now if it is out of 
Georgia or Tennessee. I think that plants has now been closed, 
but there were 425 people affected with illness in 44 States as 
a result of that outbreak.
    And then all of us are very much concerned about increased 
imports into this country into our food supply, and it was 
particularly disturbing that the Chinese Government or 
officials would not even allow FDA to inspect the plant where 
the wheat gluten was processed.
    I know that in today's paper it says that the Chinese will 
allow a U.S. pet food inquiry, so we will have access to their 
plant. And that is something that we must demand, that we have 
access. Because when they are--if they--and I don't mean to be 
finger-pointing here, and we want to be sure that we have our 
facts correct, but if they are adding melamine, an industrial 
product, to wheat gluten and other glutens for the purpose of 
increasing protein content, then that is something that is 
quite serious and we have got to take steps to deal with that. 
We know that the U.S. does not have a lot of enforcement action 
related to imported food items.
    So I think all of these issues are vitally important to the 
American people, and I want to thank the chairman for 
instigating this hearing, and we look forward to the testimony 
from all the witnesses.
    Mr. Stupak. I thank you, Mr. Whitfield.
    Next for opening statement, Ms. DeGette.

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

    Ms. DeGette. Thank you very much, Mr. Chairman. This is an 
important topic, and I commend you for holding this hearing and 
continuing your push on rigorous oversight.
    Food safety is an issue that we don't have to think about 
very much in the wealthiest country on the planet because we 
take safe food for granted. But here is something else that we 
take for granted in this country, that our Nation's 
corporations and public officials are always acting in the best 
interest of our citizens. Sadly, that is not always the case, 
as we have seen in this latest string of incidents.
    Spinach, peanut butter, pet food, normal, ordinary, 
everyday items that make us think twice about our daily 
business. As I see these two girls here with the spinach, I 
think about how Moms like me--I also have two girls--are always 
trying to improve our children's diets by feeding them things 
like spinach, which we think will be good for them. But then we 
read the recent headlines and we know that calls into question 
everything that we thought we knew.
    Today, we are going to hear these heart-wrenching stories. 
And I want to take the opportunity to thank these families for 
having come today, because your stories are what give 
perspective to what we do here in Congress every single day. 
And although your testimony is difficult to give--not nearly as 
difficult as your daily lives--it will help shed light on 
exactly what happened, how it affects real families, and the 
real need to make sure it doesn't happen again. Your courage 
will not go unnoticed; and, hopefully, your message won't 
either.
    Mr. Chairman, we need real reform for our food safety laws. 
Some will argue that the recent E. coli in spinach, the 
salmonella in peanut butter and the contaminated pet food are 
isolated incidents. But I don't see the latest string of 
incidents as aberrations. It has become a systemic problem, and 
it calls for systemic solutions.
    I have been arguing for years that our Nation's food safety 
laws are broken. For the last three Congresses, I have 
introduced legislation that would tighten up our Nation's food 
safety regulations; and for that entire time I could not get a 
single hearing on these issues. That is why this hearing is 
even more important, Mr. Chairman.
    One of my bills would give the FDA and the USDA mandatory 
recall authority in event of an outbreak. It absolutely shocks 
people when I explain to them that during an outbreak in food-
borne illness--like the ones we will hear about today--the 
Federal Government's hands are tied when it comes to recalls. 
We must rely on the industry to voluntarily recall their 
products.
    We will learn today that the companies involved eventually 
did issue recalls. But I would argue--and I am sure the 
families here today would--it was far too little, far too late. 
During the foot dragging, more people got sick. And I think 
what we need is real Government oversight and Federal food 
safety laws that have real teeth in them. We need a mandatory 
recall bill.
    Another bill I have been working on for years is the bill 
to require unitary reporting systems for meat and poultry so 
that contaminated lots can be traced through and we can 
identify where it came from. These concepts could be examined 
for other food products as well.
    We also need to reform the system before there is an 
outbreak. The last Congress starved our food protection 
agencies for funding. The FDA has become more and more reliant 
on industry to police itself. Inspections are going down as 
imports are going up. And, unfortunately, the latest string of 
incidents seems to indicate the problem is getting worse and 
not better.
    We need to continue our oversight. We need to make 
progress. And I think these hearings will have an impact. Just 
yesterday, for example, the committee received a letter from 
ConAgra Foods detailing positive changes to company safety 
reporting at least as a result of this committee's 
investigation.
    Sometimes people ask me, why do you have O&I hearings? This 
letter from ConAgra is a good reason. Something almost always 
changes just the day before we have these hearings.
    But Congress needs to act as well. I hope this latest 
unprecedented series of outbreaks will give us the political 
will we need to begin to reform the broken laws so that we can 
regain some semblance of order though this country's food 
safety.
    Again, thank you to the witnesses for appearing today. My 
thoughts and prayers are with you as you move forward in this 
difficult process.
    And I yield back, Mr. Chairman.
    Mr. Stupak. I thank the gentlelady for yielding back.
    Just note you mention the legislative history, and you go 
back to the act of 1997 introduced by Frank Pallone of this 
committee. Mr. Brown is now a Senator. The following year, 
1998, Mr. Dingell, Mr. Brown, myself, Mr. Pallone, yourself, 
Ms. DeGette, Mr. Waxman, who is here, others on this side of 
the panel here, have been pushing for food safety food 
inspections. We even proposed a user fee. We could never even 
get a hearing on it. New Congress. There will be changes.
    Next, I go to Mr. Walden from Oregon. Mr. Walden, please, 
for 5 minutes.
    Mr. Walden. Mr. Chairman, I am looking forward to hearing 
from our witnesses today. I am going to yield on my opening 
statement and reserve the balance of my time for further 
questions.
    Mr. Stupak. Next, Mr. Waxman from California for an opening 
statement, please.

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

    Mr. Waxman. Thank you, Mr. Chairman Stupak, for holding 
this hearing.
    As you mentioned, many have tried to change the way the 
food safety issues have been handled. We couldn't even get a 
hearing. I found over the years that interest in food safety 
questions waxes and wanes. After a crisis, everybody wants to 
know about it and do something about it. But, too often, a few 
minor changes are made, the system is tweaked one way or the 
other, and the commitment to meaningful change disappears.
    I am hopeful that this Congress will end this cycle. We are 
at a critical moment for food safety. The FDA system for 
overseeing the safety of our food is all but broken. Outbreaks 
in fresh produce have doubled since 1998, we inspect only a 
tiny fraction of the food we import, and our food supply is 
deeply vulnerable to attack. As a result, over 300,000 people 
are hospitalized each year; and 5,000 die due to food-borne 
illnesses.
    Well, in addition to the human costs, there are economic 
costs. Recent outbreak of E. coli traced back to spinach caused 
tens of millions of dollars in financial harm; and these costs, 
of course, are magnified by the fact that we can't then export 
our food to the rest of the world without ensuring its safety.
    We need to do more than tweak the system in a piecemeal 
fashion. We need to examine the system as a whole to determine 
the proper solutions. There are looming questions about 
overlapping authorities and wasted resources that we need to 
explore.
    There are some things we ought to do about FDA. There are 
three fundamental problems in FDA's oversight of food safety: 
inadequate resources, inadequate standards and inadequate 
enforcement. FDA's own budget analysis estimated a decline of 
$135 million for food safety activities from just 2003 to 2006 
due to inflation and increased responsibilities, about a 24 
percent budget cut. This, of course, has led to a decline in 
staffing levels; and we now find that these inspections are not 
adequately addressing even the most critical problems. FDA 
records show that the agency inspected the ConAgra peanut 
butter plant during the period of apparent contamination, 
meaning that contaminated product was sold before, during and 
after an FDA inspection.
    Second, FDA must set clear, enforceable standards for food 
production, especially for fresh produce. These standards would 
address the primary sources of danger, such as soil 
contamination, unclean water, inadequate worker sanitation. 
Although FDA has issued a number of voluntary standards, it is 
clear that what we have seen in this year's, past year's, 
outbreaks, this voluntary approach does not work.
    It is not often that industry groups stand side by side 
with the Government and call for the same thing, stand side by 
side with consumers calling for the same thing: FDA issuing 
enforceable standards. FDA has the authority to do this now, 
and I hope they will act.
    And, third, FDA must enforce its own standards. In spite of 
repeated outbreaks, warning letters from FDA's food division 
have dropped by 45 percent under the Bush administration. FDA 
can and must do better. Each outbreak and each food recall has 
chipped away at the confidence that the American public has so 
long held in the safety of our food supply. We owe it to the 
consumers, food manufacturers to ensure that this confidence is 
restored.
    It will take getting FDA the increased resources and 
authority it needs to do its job, and I am hopeful it will do 
what it takes to address this very grave situation. I look 
forward, Mr. Chairman, to working with you and our colleagues 
to get the job done.
    I yield back the balance of my time.
    Mr. Stupak. Mr. Green for opening statement, please.
    Mr. Green. Thank you, Mr. Chairman.
    I would like to ask my full opening statement be placed 
into the record.
    Mr. Stupak. Without objection, so ordered.

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

    Mr. Green. The FDA's effectiveness on this issue is 
seriously questioned by recent high-profile contaminations of 
the food supply both for humans and pets, and I appreciate our 
subcommittee's interest.
    According to the Centers for Disease Control, approximately 
76 million Americans are affected by food-borne illnesses each 
year. More than any segment of our food supply, the 
contamination of produce is responsible for these food-borne 
illnesses. The appearance of E. coli in bagged spinach the most 
recent high-profile, with three deaths and 206 illnesses, 102 
hospitalizations, resulting from this outbreak. The outbreak of 
E. coli and spinach offers a textbook case from which to 
examine the regulatory framework ensuring the safety of our 
food supply.
    Unfortunately, this case has only underscored the gaps. The 
system is fragmented, at best, and needs new tools at its 
disposal. The Government Accountability Office agrees and 
dubbed the country's food supply program is high risk. I will 
repeat that. The GAO, who all of us depend on their research, 
agrees and dubbed our country's food supply is high risk. I 
don't think the average American would believe that. But when 
you have the Government Accountability Office saying it, then 
something needs to be done.
    The bulk of our food safety falls under the jurisdiction of 
the FDA, which continues to be responsible for regulating 
approximately 80 percent of our Nation's food supply. And after 
reading yesterday's Washington Post, which reported FDA had 
known for years about contamination problems in both spinach 
and peanut butter, I would like to have the FDA before us today 
to explain themselves; and our chairman assures us they will. 
FDA will appear at later hearings. So I look forward to hearing 
the FDA's perspective.
    There is no question the food supply gets short shrift at 
FDA. They have an enormous job and too little funding and too 
little authority. Its ability to recall food products is 
extremely limited, especially dependent on food manufacturers 
to voluntarily remove food from supermarket shelves. Too often, 
FDA actions occur so late that shelf life of the food product 
has already expired.
    This is inexcusable; and, Mr. Chairman, as a member of the 
Health Subcommittee, I hope we will take a serious look at 
expanding FDA authority in this area. And since you mentioned 
the Chair of our Heath Subcommittee is Frank Pallone, who 
introduced those earlier bills on the FDA, hopefully our 
subcommittee will go forward.
    The common denominator among the cases of spinach, peanut 
butter and pet food contamination is lack of appropriate 
testing. What we can and should do is have the appropriate 
testing mechanism in place to ensure that contaminated food is 
pulled and does not make it to our supermarket shelves and into 
the homes of our public.
    Like my colleagues, I want to thank all of our panel for 
being here today but particularly our first panel of witnesses, 
who are here to relate how the food safety issue affected them 
in their daily lives.
    I yield back my time.
    Mr. Stupak. I thank the gentleman for yielding back.
    Next, we will turn to ranking member of the full committee, 
Mr. Barton of Texas.

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

    Mr. Barton. Thank you, Mr. Chairman. I am pleased to join 
you and Mr. Whitfield and Mr. Dingell in this investigation in 
the safety and security of our food supply.
    We began the investigation last October into FDA's food 
security projects and whether these efforts were leveraged to 
prevent or detect outbreaks such as E. coli and spinach. We did 
gain some records and information from that inquiry that should 
be helpful in this investigation.
    This is really a preliminary hearing, since we are still 
gathering information and interviewing experts and fact 
witnesses. The FDA and other witnesses will be appearing in a 
hearing on this subject in a few weeks. I appreciate your 
interest in moving quickly in this investigation.
    Since we only have partial information at this time, I 
don't think we are in quite as good a position as I would like 
to be to question some of today's witnesses or to assess fully 
the accuracy and completeness of the answers to some of the 
questions that we are prepared to ask. Given such limitations--
and also since this subcommittee has always tried to be fair--I 
hope we don't rush to conclusions on some of the matters based 
on this hearing by itself.
    There is one ongoing matter in which I am prepared to 
comment, and that is the reluctance of the Chinese Government 
to cooperate in assisting the FDA in investigation of tainted 
pet food which is manufactured in China.
    Over the past few weeks, pet food manufacturers have 
recalled millions of cans pouches and bags of food after 
finding their products have been contaminated and have caused 
serious illnesses and in some cases even deaths in animals that 
had eaten these pet foods. The FDA has traced the problem to an 
industrial ingredient called melamine in samples of wheat 
gluten that was imported from a Chinese firm. In high-enough 
doses, this substance is believed to be toxic.
    A few days ago, it was detected in rice protein concentrate 
used in some pet food. FDA is also investigating whether 
tainted pet food containing this poisoning has been fed to 
hogs, possibly bound for the human food market.
    Melamine is used to make plastics and is not edible. In 
light of that fact, the FDA is investigating whether it was 
intentionally added to the wheat gluten or other ingredients to 
produce the protein content in order to make the bulk products 
more valuable.
    For the last 2 weeks, the FDA has been attempting to get 
visas from China so that its inspectors could join Chinese 
inspectors at the company listed as the manufacturer of the 
suspect wheat gluten. China rejected FDA's first request and 
only yesterday approved the second one.
    China's foot dragging in the public health incident is 
totally unacceptable. Building a great wall of bureaucracy 
between our experts and their problem isn't going to make the 
problem disappear. American consumers who buy these products 
have the right to know that they are safe, and that is why 
other nations routinely cooperate with the United States in 
food safety investigations, including giving USDA, FDA 
inspectors access to their manufacturing facilities.
    The suspicion of intentional contamination is eerily 
similar to past incidences in China.
    A dozen years ago, 89 children in Haiti died after taking 
cough medicine made with--believe it or not--antifreeze that 
was traced back to China. The world never got an answer from 
the Chinese on how this crime occurred.
    In an investigation started in 1998, when I was chairman of 
this same subcommittee, we found that 155 U.S. citizens were 
sickened by impure gentamicin sulfate made by a Chinese firm. 
We never got a definitive answer on how this unapproved, impure 
drug ingredient got into that particular product. Significantly 
counterfeit animal drug ingredients have been linked to the 
same Chinese firm before it moved to the human drug side.
    As in the counterfeit drug cases in this pet food 
investigation, we are confronted with numerous discrepancies. 
The Chinese firm listed as the manufacturer of the wheat gluten 
for food in the U.S. import record told Chinese Government it 
was exporting its product not for food purposes but industrial 
purposes. There is also a question whether the Chinese firm is 
in fact the actual manufacturer. Those questions can only be 
answered with confidence if the FDA is allowed into China to do 
the inspection themselves.
    My message and I think the message of this subcommittee on 
a bipartisan basis to the Chinese Government is pretty 
straightforward: Cooperate, stop these shenanigans.
    I want to thank you, Mr. Chairman, for your cooperation and 
your leadership on this issue. I want to welcome all of our 
witnesses today, and I want to thank the families who have 
suffered and come here to share their unfortunate experiences.
    With that, I yield back.
    Mr. Stupak. I thank the gentleman.
    Next, we will hear from Ms. Schakowsky from Illinois. Five-
minute opening statement, please.

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

    Ms. Schakowsky. Thank you, Mr. Chairman, for holding 
today's hearing on food safety. Not only is this a serious 
public health issue but it is also a matter of national 
security to which we should give our utmost attention.
    I want to especially thank the families that are here, the 
Armstrongs and Marshalls and Prudens for coming and a special 
welcome to Isabella and Ashley and Sean for being here today.
    I am going to cut straight to the chase. I think that in 
order to get a handle on the problem we have to follow the 
recommendation of the Government accountability office and 
consolidate Federal food safety programs.
    In February of this year, the GAO deemed Federal oversight 
of food safety as high risk to the economy and public health 
safety. So I support such legislation as the Safety Food Act 
sponsored by Representative DeLauro, which would consolidate 
all the food safety agencies--we spread it around to too many 
places--and establish the food safety administration that would 
bring it all together.
    The FSA would be responsible for the creation, 
administration and enforcement of our food safety laws which is 
currently lacking.
    When the news of the E. coli contamination of spinach broke 
out last year, Representatives DeLauro, DeGette and I called on 
Chairman Barton to hold a hearing on this bill which has been 
referred to in our committee. I am very glad that under your 
leadership, Chairman Stupak, we are discussing the issue today.
    I also want to add my support to Mr. Waxman's call for 
increased oversight right now by the FDA.
    We also have to start holding food, including pet food, 
conglomerates accountable now. For instance, ConAgra's 
corporate policy tries to keep the lid on what they are up to. 
Employees are told to never volunteer information and never 
give more information than necessary and are even told to hide 
product codes from the on-the-ground inspectors.
    This vital information that could alert the FDA and 
consumers to whether a questionable facility is being used to 
process food or whether a questionable supplier is providing 
ingredient is--it is vital, and a failure to share this 
information keeps us in the dark about what they are doing to 
the food that makes it to our kitchen tables.
    I wish I could say I was amazed at the incidence of 
corporate shenanigans that has been noted in the press and will 
be revealed at this hearing today, though I have seen it all 
before. When I was a very young mother--it is about 37 years 
ago--I fought another effort of food producers to keep us in 
the dark about the age of our food. Some of you are old enough 
to remember that everything was coded at that at that time--in 
1969, 1970--and a group of young mothers got together and said 
we want to know how old your food was. And believe you me it 
was a battle to get manufacturers and retailers to begin to 
freshness date their food. Now, of course, those dates are 
ubiquitous.
    I also think we need to look further into the lack of 
inspection of ingredients to food products that are being 
imported into the United States from countries like China.
    Because I am short of time, I would like to submit for the 
record the AP article, ``U.S. Food Safety Strained by 
Imports.''
     This article details how food products are not a priority 
for the FDA inspections, even as the import of ingredients has 
increased by 73 percent over the last 5 years. If someone 
wanted to attack the United States through its food supply, we 
have a frighteningly easy way for them to do it. It is time 
that we act to ensure that our food supply is safe.
    Thank you, Mr. Chairman; and I yield back.
    Mr. Stupak. I thank the gentlewoman.
    Next, we will hear from gentleman from Texas, Mr. Burgess.

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

    Mr. Burgess. Thank you, Mr. Chairman. Thank you for holding 
this hearing today.
    America has the safest, least expensive and most abundant 
food supply of any country in the world. In the past, whenever 
I went to the market to buy food for my family, I never stopped 
and wondered is it going to be safe to eat? Is it going to make 
anyone at home sick? The security of our food supply in my mind 
has really never been in question.
    I still believe that our food supply is generally safe and 
secure, but the recent outbreaks of both E. coli and salmonella 
have caught the country's and this committee's attention.
    Today, we will hear troubling stories from the Armstrong 
family, the Pruden family and the Marshall family. I thank you 
all for being here today and putting a human face on what has 
been an astonishing tragedy in this country. I am deeply sorry 
for the pain that you have all been through, and I sincerely 
appreciate your willingness to come to Congress to tell your 
story.
    Thank you.
    In addition to the food safety issue, I am pleased that 
this committee is also investigating the recent pet food 
recalls. Like many of my constituents back home in Texas, I 
have been struck by the contamination of pet food and the fact 
that thousands of beloved animals have died. The fact that 
companies mixed a form of plastic with wheat gluten to 
manipulate the protein levels in the food is not only wrong, it 
is criminal.
    As we have all learned during the aftermath of Hurricane 
Katrina, Americans view their pets as members of the family; 
and to put a pet's life in danger just to increase the profit 
line is completely unacceptable.
    While I realize that we have only begun our investigation 
into this matter this practice must be stopped. Earlier this 
month, I sent a letter to both Chairman Stupak and Ranking 
Member Whitfield requesting that we allocate an adequate amount 
of time on this issue; and I thank the leadership of this 
committee for doing so.
    I think it is important to remember that there are still 
many questions that need to be answered, and today is merely 
the beginning of the investigation into these troubling 
circumstances. I do welcome the companies here to tell their 
side of the story and what they have done and are doing and 
will do to remedy the situation and see that it never happens 
again. But we all know that nothing in the world is ever 100 
percent safe. However, I look forward to hearing what the 
companies view as their role and responsibility in this 
situation.
    Many of us in Congress may have a different opinion, but I 
think we can all agree that innocent people, innocent animals, 
should not have to die because of a mistake, negligence or 
especially criminally intent on another's behalf. I look 
forward to this investigation and learning what needs to be 
done so that this does not happen again.
    Thank you, Mr. Chairman, for your indulgence; and I will 
yield back my time.
    Mr. Stupak. I thank the gentleman.
    Next, turn to the chairman of the full committee, Mr. 
Dingell, for an opening statement, please, sir.

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

    Mr. Dingell. Mr. Chairman, thank you; and I thank you for 
conducting this hearing. I also commend you for the vigor with 
which you are proceeding. This is an important hearing on the 
threats to public health from contaminated food products and, 
very frankly, from the inadequacies of the Food and Drug 
Administration, their budget, the number of personnel that they 
have and their competence to carry out their responsibilities.
    Every American has reason to worry about pathogens in our 
food supply. They sicken 73 million Americans, and they kill 
5,000 of us each year. It is important that we learn of this. 
Death and illness could have been prevented by diligence and 
properly funded regulatory agencies, primarily the Food and 
Drug Administration. And this is not limited to foods, nor to 
cosmetics but also to pharmaceuticals.
    I want to begin by thanking our first panel of witnesses, 
the courageous and patriotic Americans who have come here at 
their own expense to recount the personal tragedies that have 
befallen them and their families.
    I also want to commend my colleagues, Mr. Pallone and Mr. 
Inslee, for their assistance in these matters.
    Now these are not easy matters for our witnesses to 
discuss. Two of our witnesses, Elizabeth Armstrong and Gary 
Pruden, will speak of the E. coli poisoning that caused grave 
harm and in one case is still causing grievous harm to their 
children because all of these kids ate their vegetables.
    The children who are victims of food contaminations, 
Isabella, Ashley and Sean, are also with us today. Terri 
Marshall will speak of the terrible infection that her aging 
mother-in-law has suffered from salmonella-contaminated peanut 
butter. These tragedies represent serious problems in our food 
supply that should and must be addressed.
    We will also hear today from two of the companies that sold 
tainted products. And we will hear from two witnesses that give 
us even more concern, because the source and breadth of the 
contaminated wheat, rice and possibly corn products that found 
its way into pet foods suggests an even more dangerous 
breakdown in the regulatory system that is supposed to protect 
Americans. These protein products are pervasive. They are used 
in all manner of human food.
    The principal seller of the tainted pet food, Menu Foods, 
tells us that only the highest grade of wheat gluten was 
ordered for their pet products. So these important proteins 
that are imported by the ton could easily wind up in our 
pantries, our restaurants, or snack food vending machines.
    Regardless of whether they are wheat, rice or corn based 
proteins, they share two important characteristics: First, they 
were contaminated deliberately. I will repeat that. They were 
contaminated deliberately. Second, they came from our trading 
partners in China. So far, the evidence suggests that the 
deliberate contamination was for greed and not as a trial run 
for terrorist purposes.
    But we certainly could look forward to some serious 
consequences where it to be the other way around.
    The chemical melamine, the component that poisoned the pet 
food, fraudulently elevates the measurement of protein in the 
gluten, thus increasing its market value. While it matters not 
to the victims whether they are poisoned for profit or for 
politics, we must be particularly concerned that these 
profiteers have drawn a road map to holes in our regulatory 
scheme, with serious consequences to our people.
    I recall an episode involving tainted canned mushrooms from 
China a few years ago. At that time, the FDA shut down all 
imports of mushrooms from China until FDA inspectors went there 
and approved each and every plant.
    We will expect that similar efforts and similar 
consequences will obtain as a result of the hearings of this 
committee today.
    Up to yesterday, China would not let our inspectors into 
the contaminated wheat gluten factories. In fact, they wouldn't 
even tell us where the plants were located, much less to whom 
they ship.
    The response of this administration was simply to shut off 
imports only from the trading company that shipped the poisoned 
product. Chinese wheat gluten continues to pour into this 
country.
    Relying on imperfect testing at the ports, the agency 
gambles with the health of Americans so as not to disturb the 
trading profits of the Chinese.
    I will note that the failure of this Government to properly 
fund the Food and Drug Administration and see to it that they 
have the adequate resources to address their important 
responsibilities is a national scandal and has been a concern 
to this committee for a number of years.
    In a couple weeks, we will note that we will hold a second 
day of hearings. At that time, we will have the FDA here to 
account for their imperfect stewardship of their public health, 
and we will expect them to tell us not only about that but what 
resources they have to address these problems and what 
resources they need to see to it that they can carry out their 
proper and very important mission.
    I have watched the Food and Drug Administration chase too 
many imports with too few resources for too many years. Whether 
the life-threatening product is a counterfeit drug or tainted 
food, the FDA lacks enough properly trained, properly motivated 
personnel to do an increasingly difficult job, particularly at 
the ports of entry of imported foods.
    Good people in the field continually report how 
disillusioned they have become with the management of FDA. Some 
are resigning. Some are being driven out. A curious pattern of 
closure of facilities of FDA at our ports now goes on and still 
threatens our food supply and our other health-related products 
in a very serious way.
    The FDA field management will be before us, as I mentioned, 
in a couple of weeks. They have some serious accounting to do 
regarding the game of roulette they are playing with the lives 
of Americans, and perhaps they will tell us about how they are 
being denied the adequate resources to carry out their proper 
responsibilities in protecting the American people.
    Thank you, Mr. Chairman.
    Mr. Stupak. I thank the chairman.
    Mrs. Blackburn for opening statement please.

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

    Mrs. Blackburn. Thank you, Mr. Chairman; and I want to 
thank you for holding the hearing. I want to thank our 
witnesses for their willingness to come before us.
    The food safety issue, as you have heard, is a high-
priority issue from a public health standpoint as well as from 
a national security issue. And you don't have to be a 
scientist. You simply have to be a concerned citizen or a 
parent to know that a very real threat exists when a terrorist 
could easily put some type of toxic chemical into some product 
that is moving through the food chain and that could go about 
causing a lot of damage before it is detected.
    Since September 11, our national sense of vulnerability has 
steadily risen; and we have been warned time and again of the 
vulnerability of our food and water supplies. We are now also 
facing up to a less publicized but potentially devastating 
threat, terrorism directed at the Nation's food and 
agricultural infrastructure; and I think it is something that 
we have to face up to and recognize that it is there. It is a 
threat that is very real. Derelict poisoning and deliberate 
poisoning to any of our food items will undermine confidence in 
the supplies. It would wreak havoc on the agricultural sector 
of this Nation's economy, which accounts for about a sixth of 
our GDP.
    Americans are consuming increasing amounts of imported food 
and drink, and the demand among U.S. makers for overseas 
ingredients is constantly increasing. However, according to the 
FDA, it only has enough inspectors to check about 1 percent of 
the 8.9 million imported food shipments that come into the 
country each year. One percent is all that gets checked. So we 
do have to realize this means we have an increased 
vulnerability, and it leads to some questions that we will be 
asking through this hearing and through some others.
    Is the FDA too large and too bureaucratic to respond? Has 
it not made it a priority to respond? And in a post 9/11 world 
have they chosen not to shift their priorities?
    Not everything is a matter of money. Many things are a 
matter of priority and taking the time to restructure to meet 
the challenges that are before you. Is the FDA capable of 
restructuring so that they have the ability to address these 
concerns? Or do they choose to turn a blind eye and a deaf ear 
to the concerns that we have?
    Do we need to apply the standards that we seek for imported 
foods and drugs? Does this need to be applied to reimportation 
of drugs if we allow reimported drugs into this country?
    What is the expected level of corporate, bureaucratic and 
personal responsibility? How do we make certain we don't see a 
new group of class action lawsuits?
    We must seek greater accountability in these questions and 
in our Nation's food and drug supply, and we must expect that 
all imports that are coming into this country are going to meet 
our U.S. safety standards. They are rigorous, but we intend for 
them to be met.
    According to the GAO, our food supply is generally 
considered to be safe. We realize that there are 
vulnerabilities. We look forward to working with the FDA to 
address these questions.
    And I yield back the balance of my time.
    Mr. Stupak. I thank the gentlelady for yielding.
    Mr. Inslee from Washington. Opening statement please.

   OPENING STATEMENT OF HON. JAY INSLEE, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF WASHINGTON

    Mr. Inslee. Thank you to my colleagues. I want to thank the 
witnesses, who are involved in an act of courage today. We very 
much appreciate their stepping forward in a difficult 
situation.
    I want to note our previous experience with meat. We had in 
the State of Washington an E. coli outbreak. A local 
establishment became the subject of national news and national 
debate on how to clean up the meat industry, and we were 
engaged in that in an effort to clean up that industry.
    We have had substantial progress. It was not without 
controversy, it was not without debate, it was not without 
effort, but we will note today the cases we are involved in 
today do not involve the meat industry because there has been 
substantial progress made. And that involved mandatory 
requirements, hazard point reductions, a whole slew of efforts; 
and we need to have this same thing now in another part of the 
industry.
    I want to note as well a constituent of mine, Bill Marner, 
who has worked very hard on eradicating food-borne illnesses; 
and he was part of the success in the meat industry. I am going 
to make his statement a part of my opening statement.
     It is clear to me and I think many of my colleagues that 
we need to have some much more rigorous food safety standards, 
and I want to note four things that I will be introducing 
legislation I believe with some of my colleagues on in the near 
future.
    First, we have got to have standards that are binding. 
Voluntary guidance is clearly a recipe for failure and injury 
and even death in our food safety standards.
    Quoting the 2007 March guidance from FDA, it says, ``the 
use of the word `should' in agency guidance means that 
something is suggested or recommended but not required.''
    We are not requiring food safety. We need to require food 
safety, not make nice, gentle suggestions in this context. It 
is not an accident that this is the twentieth time in a single 
decade that we have had leafy green vegetables involved in 
damages coming out of one single county in this country. That 
is inexcusable. We have got to have requirements for Americans, 
not simply suggestions.
    Second, we have got to establish hazard point 
identification programs, as we have done in the meat industry 
to great success. When we have adopted protocols like that we 
have found great improvement in food safety. We have to have 
the hazard point identification protocols used in this other 
industry.
    Third, we need to treat E. coli and salmonella as 
adulterants, with accompanying criminal and civil penalties. It 
is a step forward recognizing the severity of damages that we 
will hear about today. It is only common sense to do that.
    And, fourth, and this is perhaps the most obvious, we have 
to have mandatory recall authority. To not have mandatory 
recall authority in the context of these types of severe 
damages simply beggars belief that we don't have a mechanism in 
that regard.
    Now, as in the meat industry, there may be opposition to 
some of these suggestions. But I think that we should keep in 
mind we are going to hear some of the personal tragedies today 
involved in this.
    But the industry itself has a stake in the ability to stop 
loss of confidence in these tremendous products. The spinach 
outbreak has cost the industry somewhere between $37 million 
and $74 million already.
    There is an economic motivation as well as a personal one 
for us to have a food safety system that gives Americans 
confidence in the industry. They do not have that today. There 
is some meaningful things we can do that we know are going to 
be economically productive. We should take them.
    I look forward to our testimony. Thank you.
    Mr. Stupak. I thank the gentleman.
    Next, Mr. Murphy from Pennsylvania, opening statement.

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

    Mr. Murphy. Thank you very much.
    I just wanted to thank you for holding this hearing. It is 
so important in light of how much illness and how many deaths 
have occurred with a number of problems with food safety.
    But I am reminded of, as part of the time when I was on the 
Government Reform Committee, of some of the problems that also 
occurred with some of the waste, just redundancy and lack of 
coordination between the FDA and USDA. And I recall this. There 
was 12 different agencies that administered as many as 35 laws 
in regard with the Federal food safety program. But it was 
always odd to me that no single agency had oversight over 
everything. Because of this fragmented system, the USDA 
inspects open-faced meat sandwiches and frozen pepperoni 
pizzas, while the FDA inspects closed-faced sandwiches and 
cheese pizzas.
    Somehow in this we have to find ways of more efficient use 
of Government money as we go through this. I know there is not 
enough inspectors. I know that is part of what we should be 
hearing about today to find out what we need to do to improve 
this system. But in context of all as we go through witnesses 
today I hope a part of what we hear in improving the system is 
to make the system far more efficient in ways that we can 
eliminate the redundancy that is unnecessary, improve the 
efficiency, where we can let us know what we need in terms of 
increasing funding for more employees to do these inspections. 
And, above all, we will stand up for the safety of the American 
public.
    Mr. Chairman, I commend you for continuing to push this 
issue. Thank you, and I yield back.
    Mr. Stupak. Thank the gentleman for yielding back.
    That concludes the opening statements of the members of the 
subcommittee. I would like to note that all members of the 
subcommittee on both sides of the aisle have been here. Not all 
have chosen to give an opening statement, but they have all 
been here. That is the importance of this issue.
    There has been questions about the FDA. We will have FDA in 
the next few weeks. We thought it would be wise to use this 
first hearing just to lay out the scope of the problem but also 
to try to help the FDA in its effort to try to get into China, 
and I think our efforts by holding these hearings put pressure 
on. Now the FDA will be able to get into China. So when they 
come to testify in the next couple of weeks we will give a 
broader hearing and more in depth of what the problems are that 
we face, not only in access to foreign markets when you have to 
inspect something like food safety.
    So the purpose behind oversight and investigation is not 
only to investigate but also to use our oversight role to get 
Government agencies and others and corporations to change their 
behavior. And, once again, through bipartisan work on this 
committee, I think that has happened here.
    So let's call up our first panel to come forward.
    Our first panel we have Michael and Elizabeth Armstrong 
with their children, Isabella and Ashley; Mr. Gary Pruden and 
his son, Sean; and Ms. Terri Marshall.
    Would you please come forward, please.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised that the witnesses have the right 
under the rules of the House to be advised by counsel during 
their testimony. Do any of you wish to be represented by 
counsel? Ms. Armstrong? Mr. Armstrong? Ms. Marshall? Mr. 
Pruden?
    [Witnesses sworn.]
    Thank you. You may be seated.
    Let the record reflect that the witnesses replied in the 
affirmative. They are now under oath.
     We will hear an opening statement on behalf of the 
Armstrongs; and Ms. Armstrong or Mr. Armstrong, who would like 
to give the opening statement?

                 STATEMENT OF MICHAEL ARMSTRONG

    Mr. Armstrong. So our experience is actually with both 
girls. Isabella got sick after eating a salad of spinach. She 
was sick for 5 days with vomiting and diarrhea. And that was 
pretty bad. That was pretty rough. About the same time that she 
started clearing up, Ashley had a fever; and she started with 
the same symptoms. So we thought it was the same, and we 
thought she would get over it.
    Two days later, it wasn't getting better. It was getting 
worse. We called her pediatrician, and we went into the 
hospital. They said an IV will do the trick, and she will be 
feeling better.
    About 24 hours later, she was again even worse than before. 
In fact, she was in the hospital bed banging against the walls 
almost like a caged animal. She was inconsolable, trying to 
pull the IV out of her arm.
    At that point, we realized that there was something much 
more wrong with her.
    At that point, her pediatrician got a consult from an 
expert and really at the--because Elizabeth brought it up. She 
said, have you tested for E. coli or any other bacteria along 
those lines? And that is when she got the consult. And the 
expert said, oh, that is HUS, hemolytic uremic syndrome.
    Let me tell you why that came to her mind. Two years ago, 
my cousin, who had a 2-year-old son, was a missionary in 
Rumania; and his son actually had HUS from E. coli. They 
weren't able to get him back into the States for medical care 
anytime, and he died.
    To me, that really gives you a different backdrop here in 
that the United States and Rumania, really, when it comes to 
food safety, it is not much different.
    So, anyway, at that point we went into a special children's 
hospital; and she was diagnosed there officially with HUS.
    The next week, when we were in intensive care, it was 
pretty rough. We really didn't know if she was going to make 
it. The doctors couldn't really tell, of course. They were as 
optimistic as they could be at the time. She was on dialysis. 
She required blood transfusions. Her kidneys had shut down. She 
had pancreatitis. She had brain swelling. It is a really nasty 
syndrome.
    She was in intensive care for 3 weeks on dialysis; and at 
that point she was well enough to move to the regular ward 
where she was attached to, of course, an IV and what we call an 
octopus, which was several bags of a fluid for dialysis. She 
was there for about another 4 weeks, roughly. At that point, we 
were able to go home--on dialysis still.
    She is now off the dialysis but requires five medications a 
day, and we have to give her a shot once a week, and it is 
quite likely she will need a kidney transplant in the next 
several years.
    But she does pretty well. She does real well.
    Anything you want to tell them?
    Mrs.  Armstrong. [Shakes head.]
    [The prepared statement of Mr. and Mrs. Armstrong follows:]

              Testimony of Michael and Elizabeth Armstrong

                             Ashley's story

    Sunday, August 27, 2006 I went to Marsh, as usual, and 
purchased a bag of Dole spinach, like I always did. We had it 
for dinner that night as a raw salad with our spaghetti and 
meatballs. Both Isabella, my 5 year old, and Ashley, who was 2, 
and I had the spinach. We always worked very hard to make sure 
our girls ate healthy. This generally meant lots of fruits and 
vegetables and very little sugar.
    By Saturday, September 2, 2006, Isabella had come down with 
Colitis from the spinach. Of course at this point, we just 
thought she had a viral diarrhea. She had the diarrhea for 
almost a week when I finally took her to the doctor. It was on 
Friday, Sept 8, 2006, and the doctor just said that it was a 
viral diarrhea and there was nothing that she could do about 
it. She just said to keep her hydrated, and to let the doctor 
know if she had blood in her stool.
    Isabella started feeling better the next day, and we 
thought we were in the clear. Then, about mid-day on Saturday, 
September, 9 Ashley started having diarrhea. We just thought 
she caught the same bug that Isa did, and just kept giving her 
fluids and keeping an eye on her. She was pretty lethargic that 
day. She would drink fluids, but was not really interested in 
food (which is a shocker for anyone who knew her!). The next 
day, Sunday, she seemed to feel a little bit more like herself. 
She ate a little more, and she was more interested in playing. 
We even went to my sister's wedding shower, where she played 
with all of her cousins and seemed to us like she had got the 
bug out of her system. By Monday, however, she was feeling much 
worse. She was very lethargic, slept a lot and did not want 
anything to eat and very little to drink. She still had 
diarrhea. We went out and got haircuts for the girls that 
afternoon, but she definitely was not feeling like herself. At 
this point she was more lethargic again and wasn't interesting 
in playing.
    By Tuesday, September 12, 2006, she was getting worse and I 
knew something was really wrong. During one of the nearly a 
dozen diaper changes in a day we were doing at this point, I 
noticed she had some blood in her stool. I remembered what 
Isa's doctor had told me and I called and scheduled a sick 
appointment for Ashley that day. We met with the doctor and she 
still felt that it was viral diarrhea and nothing to worry 
about, but because I had brought the diaper with me, they 
tested it to see if it was in fact blood. The doctor felt that 
Ashley looked dehydrated and wanted me to go to their other 
office in Castleton to get a blood draw to find out for sure. I 
took Ashley to the other office, where the nurse there drew her 
blood samples and sent them to the lab for analysis. I then 
took Ashley back home to wait for the results.
    About an hour later I got a call from my doctor telling me 
that Ashley was in fact dehydrated and wanted me to take her to 
Community North hospital. They told me not to worry, that they 
would just admit her to get an IV in her and they would monitor 
her hydration levels and we would probably be out of there that 
same night. So, on Tuesday, September 12, 2006, we checked into 
Community North and they hooked her up to an IV to re-hydrate 
her.
    Right after checking in and getting her into her room, the 
nurses had to come in and hook up the IV and all of the wires 
to monitor her with. Also, because of the diarrhea in her 
diapers, the nurses could not tell if she was producing any 
urine so they inserted a catheter into Ashley to monitor this, 
as well. So, always having been a healthy baby, this was 
Ashley's first introduction to the world of pain and needles. 
She was such a trooper, but how sad to be grateful that God had 
blessed you with a cooperative child. How sad that at the 
tender age of 2, Ashley was about to learn that she just had to 
become resigned to being poked, prodded and generally tortured 
to get her better. She always had been a good, healthy eater 
and was plump with health. Seeing her lying in that hospital 
bed, she was so unnaturally skinny and sickly, it was so sad.
    It is now late afternoon on Tuesday and Ashley is still 
having countless diapers with diarrhea, not producing any 
urine, and now she has started vomiting. At first the vomiting 
was bile, yellow in color. But as the night progressed and it 
got into Wednesday, the vomiting started to get darker and 
darker green. Our Dr did stop by later that afternoon to see 
how she was responding. I asked her what else we should be 
doing because this did not seem to be helping. I also asked her 
if she had tested for E coli. I remember she looked at me 
strangely for asking, and I don't remember now exactly what she 
said, but I think the answer was yes.
    By Wednesday, September 13, 2006, the vomit was almost 
black, she could barely even sit up by herself, she still was 
having diarrhea, and that was when I had finally had enough. 
The IV was not making her better, her vomiting was getting 
worse, she was not producing any urine, and to me she looked 
like she was getting puffy. I had not seen my doctor since 
yesterday and I grabbed a nurse and told her to call her 
immediately. I told the nurse all of these things and told her 
she needed to get my doctor in to see me, now. About 15 minutes 
later the nurse came back into the room and told me that my 
doctor had ordered that Ashley have some labs run on her. So, 
the nurses came in drew a few tubes of blood and sent them to 
the lab. I don't remember how long we waited, watching poor 
little Ashley cry and lie in her bed, but I remember how small 
and helpless I felt. We did not know why at the time, but 
Ashley was inconsolable. She did not want to be held or even 
looked at! This just broke our hearts, because as a parent, you 
always want to comfort and take away the pain of your baby, and 
also because this was so out of character for little Ash. She 
always wanted to be held, especially when she was sick. To see 
her screaming and banging around in the crib like a caged 
animal was more than we could stand. When she was happy and 
healthy, people often asked us, ``is she always like that?'' 
referring to how smiley and friendly she seemed.
    When the nurse came back to tell us about the lab results, 
I knew something was wrong. She came in and told us that our 
Doctor was conferring with someone at Riley and would call us 
as soon as she was done. The nurse did not offer any other 
explanation, but did say that our Dr would call shortly. When 
our Dr did call, I spoke with her first. I don't remember all 
that she said, but I remember her asking if I was still there. 
I could not speak because I was choking back tears. She told me 
that Ashley's blood tests showed that her kidneys were shutting 
down. This was why she was not producing urine and why she was 
getting puffy. Her pancreas was also not working properly, 
which was causing the vomiting. I remember her telling me that 
as she was talking with this specialist at Riley, she 
remembered me asking her about E coli, and she brought that up 
with him. Apparently it was that question that made our 
situation crystal clear to what was happening to our baby. She 
mentioned something about HUS, but she said the specialist at 
Riley could explain it better once we got down there. I still 
do not know how our Dr got in touch with the person at Riley 
that she did, but I thank God for His hand in that today. The 
specialist she spoke with knew exactly what was causing 
Ashley's kidneys to shut down. As our Dr tried to explain to us 
what was going on, my brain shut down. All I could think about 
was that she said ``dialysis'' and not knowing exactly what 
that meant at the time and how scary it sounded. It was also 
scary when she said that the Lifeline ambulance from Riley was 
en route to take Ashley down there and that our Dr was 
transferring our care over to this specialist.
    I thank God that she knew enough to call Riley. I thank God 
that she got a hold of the specialist at Riley who knew about 
this rare disease. I thank God that He made me ask about E 
coli. And I thank God that He made me take Ashley into our 
pediatrician's office that day to ask about the blood in her 
stool.
    It was Wednesday, September 13, 2006, at about 4:30 pm when 
the ambulance arrived at Community North to take Ashley down to 
Riley. Three paramedics came into the room with this special 
gurney just for children and began unhooking her from her 
hospital bed and transferring her to the gurney. She looked so 
small lying there. We were told that we could not ride in the 
ambulance with her, so we just had to stand there while they 
wheeled our baby away. She was very brave and went quietly with 
the strangers as they wheeled her into the ambulance and took 
the trip down to Riley.
    We followed the ambulance in our car. It was a very quiet 
ride for my husband and I, each of us lost in our own thoughts. 
Each of us was trying to be brave and tried not breakdown as we 
worried about what was wrong with our baby. We did a lot of 
praying, that was for sure.
    When we got to Riley, we went straight to the ER where 
Ashley was. They were transferring her from the gurney to her 
new bed. They had to hook up all of the monitors all over again 
in her new bed, and then they had to insert a new catheter. I 
had to hold my baby down while they shoved the plastic tubing 
into her bladder again. I could do nothing to help relieve the 
pain and discomfort that they were causing. She just looked up 
at me and was probably wondering why her mommy was letting them 
hurt her like this.
    At this time, Michael had to leave to go home because 
Isabella was at home with my mother. He could not wait any 
longer for the specialist, but I assured him that I would put 
Michael on speaker phone when the Dr did arrive.
    The renal doctor on call, the one who spoke with our 
pediatrician, came in to talk to us (me in person, and Michael 
on the phone) about what was going on with Ashley. This was the 
beginning of our education about HUS and all of its 
ramifications. He described how in a small percentage of 
children, E coli can cause Hemolytic Uremic Syndrome (HUS). He 
described all of the various implications it can cause in the 
body, from the brain, pancreas, kidneys, liver, etc. He 
explained that HUS can cause swelling in the brain resulting in 
mood changes, which was what was causing Ashley to be so 
inconsolable and angry. HUS was also affecting Ashley's 
pancreas, which was causing the vomiting, and obviously her 
kidneys, which were shutting down. He explained everything that 
could happen, even death. The main problem with HUS, he said, 
was that there was nothing that doctors could do to prevent it 
or to treat it once a child had it. The only thing that we 
could do was watch what it affected and then treat the 
symptoms. So, for now, all we could do was wait and see if her 
kidneys continued to shut down, and if so, we would need to put 
her on dialysis.
    After he left and gave us time to digest, my husband and I 
were just speechless. We were terrified and did not know if our 
daughter was going to make it through the night. We prayed, 
called relatives, and then I settled in for a sleepless night 
in ER, and Michael to spend a scary night at home with Isabella 
and all of her questions. (Unbeknownst to us, this was to be 
our first of many of such long nights.) One thing I remember 
vividly is Michael telling me that as he was putting Isabella 
to bed that night she asked him, ``Daddy, is Ashley going to 
die?'' He answered her with tears in his eyes that, ``No, God 
is going to keep Ashley safe.''
    The next day, Thursday, September 14, it was decided that 
Ashley's kidneys were not improving and that we were going to 
need to put her on dialysis to keep her alive. The type of 
dialysis that they preferred for HUS kids was peritoneal 
dialysis, in which a catheter is inserted into the peritoneal 
cavity. She was taken in for surgery, where they implanted the 
catheter, as well as a central line for her IV and her blood 
draws. Surgery took an hour, and all we could do was pace the 
floor and hope that she would come out of anesthesia ok. We had 
never before had to deal with anything like this in our life.
    They called us to recovery after her surgery and a parent 
should never have to see their child lying semiconscious in a 
hospital cage, I mean crib. We were told that Ashley would be 
transferred up to the PICU as soon as a bed opened up. We 
waited for 5 hours in recovery. Luckily, I guess, Ashley was so 
sick that she just slept through this whole ordeal. Michael and 
I were not so lucky. We had to stand by her bedside waiting.
    They finally came in and announced that a room had opened 
up, so Ashley was wheeled into her new home-away-from-home; a 
tiny hospital room that could barely hold her hospital crib, a 
reclining chair for us to sleep in and all of her dialysis and 
medical machinery. It is hard to write all of the emotions and 
fears that we were feeling through all of this. It was just 
surreal.
    When we first got to the PICU, because Ashley's problems 
stemmed from E coli, she was in isolation. That meant that 
anyone coming in and out of her room had to put on a gown, 
mask, and gloves. For an entire week, we had to make sure that 
she and the rest of the hospital was safe from any possible E 
coli contamination. Luckily, since we were living in the room 
with her, we did not have to wear the gloves, but all of our 
relatives did not get to have any skin on skin contact with Ash 
the first week. This was very tough on Grandparents who wanted 
to hold their little granddaughter's hand.
    Another thing I remember vividly was that Ash was hooked up 
to so many wires, plus the IV, plus her dialysis line. I could 
not hold my child. I went for more than 2 weeks without being 
able to hold or comfort or rock my baby girl. This was the 
first time in the two years since we had her that I did not 
rock her to sleep. And then when I was able to pick her up, it 
was with all of those things attached to her and I could barely 
move away from her bed. But it was worth it just to be able to 
hold her and feel her little head rest on my shoulder.
    The next 6 weeks were somewhat of a blur. It is hard to 
explain to someone who has never lived through something like 
this how time just seems to stop. In the first few days and 
weeks we watched Ashley go from being swollen with excess 
fluid, to too much fluid being removed and she looked like a 
skeleton. I remember how Michael would not even let me mention 
how skinny she looked and how sunken her eyes were because we 
were just so terrified of what that might mean. Our lives were 
consumed by nurses coming in every 2 hours to check vitals and 
draw tubes of blood. Every time Ashley would move in her crib, 
she would set off her monitor alarms, so we never got any 
sleep.
    Ashley was on 24 hour dialysis while in the PICU. There was 
no doubt from any of our doctors that Ashley had HUS, but 
because there was nothing else to do but wait and see if her 
body got better, one of her specialists decided to run all of 
the blood tests he could think of to see if maybe he could find 
some other cause for her kidney failure. We think he wanted it 
to be something else that was treatable instead of just waiting 
and seeing. All of the tests came back negative. This was 
definitely HUS, and we would just have to see what would 
happen. They told us that most kids with HUS have their kidneys 
come back in a few weeks. They told us that they could not 
estimate when Ashley's would come back, but they did tell us 
that the longer she remained on dialysis, the more worried they 
became about permanent kidney failure. Again, nothing to do but 
watch and pray that her kidney function would return.
    Our lives revolved around blood test results, and seeing 
how much, if any, urine she produced. We prayed for pee. Any 
tenth of an ounce was celebrated. It was maybe a month in 
before we even saw that much. But, finally, Ashley's kidneys 
did start to pick back up again. They slowly weaned her off of 
24 hour dialysis by going from 6 exchanges with 4 hour dwells, 
to 4 times a day, the fluid dwelling for 6 hours.
    At some point Ashley's kidneys started picking up a little 
more to the point where she could be off of the dialysis 
machine, and she was put on to a manual form of dialysis. This 
was with a contraption called the ``octopus'' because this is 
exactly what it looked like. All of Ashley's dialysis bags for 
the day, or a few days, were placed on this huge IV pole, and 
she would then be manually filled and drained every 4 hours. 
This was another challenge we had to learn to deal with. The 
good part was that she was now ``mobile''. The bad part meant 
that if we wanted to take her for a wagon ride, we had to drag 
her IV pole and this dialysis pole along, too. This was not a 
one-man job. That meant that the only time Ash could go for a 
``walk'' was when both of us were there to help. But this was 
still a blessing. For the first time in over a month, Ashley 
was able to get out of her hospital room. This was the 
highlight of her day and ours.
    Finally we got to the point where her exchanges were 
stretching out longer and longer, we could take walks for 
longer periods of time. I remember the first day that we 
actually got to take her outside for the first time in over a 
month. When it just got too cold and we had to come back in, I 
remember how I thought her little heart would break having to 
go back into her hospital crib. A 2 year old should never have 
to be confined to a cage.
    And have I mentioned all of the medications this poor 
little child had to endure? Because kidneys touch every 
function of the body, and because hers were not working, they 
were not doing a lot of their jobs correctly, like being able 
to clear potassium, or other critical jobs. So, Ash had to take 
terrible tasting medicines, and still does. We would have to 
hold her down while we squeezed this black ooze into her little 
mouth. I don't remember what that medicine was for, but it was 
awful. There will be more about current medications later.
    When we got to the point where she could be on the 4 
exchanges a day, they transferred us to the regular pediatric 
unit. At first we were excited about getting out of the PICU, 
and avoiding the every 2 hour check-ups by the nurses. We 
quickly learned how wonderful we had, in fact, had it. Going to 
the regular floor meant sharing a room. We had the horrifying 
experience of living in a Jerry Springer episode. Our roommate 
was an eight year old girl, who was actually very sweet. 
Unfortunately, she had a mother and a sister who were not so 
considerate.
    Our girls have always gone to bed early, and then awoke 
very early. Ashley would go to bed about 6:30 or 7 p.m., and 
then she would wake up about 6 a.m.. Surprisingly we were even 
able to keep to a close proximity to this schedule in the 
hospital up until now. But now, we were living with extremely 
rude people who were not only awake until after 11:00 p.m. 
every night, but they also had countless visitors and were very 
loud. Poor little Ashley would finally just pass out at night 
because she was so exhausted. And of course, we never got any 
sleep because of them.
    We lived through weeks of that hell. Finally another room 
opened up and we were able to move, but again, it was still a 
shared room, and their schedules were always different than 
ours.
    Again, if you have never had a seriously ill child, it is 
hard to understand the strain that living in a hospital puts on 
you. You are, of course, worried sick about whether or not your 
child will make it through it all, let alone be normal again. 
But, there is also the strain of not getting any sleep. They do 
provide one chair that extends to be a ``bed'', but it is hard 
to sleep on it, especially when nurses come in every 2 hours, 
and her monitor alarms go off every hour or so. Then there is 
the minor detail of showers. I will say that Riley has the 
Ronald McDonald house, which was definitely a blessing. They 
had shower facilities that parents could use, so we did enjoy 
that.
    And through all of this we had to balance the fact that we 
were also the parents of a 4-year old, who was not old enough 
to understand where her Mommy and Daddy were and why they had 
essentially abandoned her with her Grandparents. For the 2 
months that we lived in the hospital, our 4-year old lived 
without us. We missed her so much, but the hospital was no 
place for her, plus she could not understand what was going on 
with her sister. We only got to see Isabella for a couple of 
hours each week. It was heartbreaking to have to say good bye 
to her each time she left again. I have it burned into my 
memory the sight of her staring out of the backseat window 
driving off with tears in her eyes. There is no way of knowing 
what affect all of this had on her. I do know that we are still 
dealing with the after effects of all of this. She still needs 
constant reassurance when we are leaving her that we will in 
fact be coming back. She is much clingier, and does not want us 
to leave her side.
    Another aspect that we had to deal with was the fact that 
both Michael and I had full time jobs. There was no question 
that one of us would always be in the room with Ashley, so it 
was extremely difficult to balance it all. We had our computers 
with us, and we were able to work a little bit while Ashley was 
sleeping, but in the end both of our boss's had had enough. The 
biggest issue this has all had with respect to our careers, is 
that we are both relatively young and had plans to advance our 
careers. Now, this is not so easy.
    When Ashley's dialysis got the point of 4 exchanges a day, 
her Doctor's felt comfortable with us going home. Michael and I 
went through several weeks of dialysis training at the 
hospital. We had to learn about care for the catheter exit site 
and how to give her shots several times a week (she requires 
shots of epogen because her kidneys do not properly control the 
production of new red blood cells). We also learned how to 
monitor her blood pressure.
    But we were finally able to go home and get our family back 
together. Once at home, we were able to figure out our new 
schedule. Dialysis exchanges were done 3 times a day, blood 
pressure was checked twice a day, her daily medications were 
spaced out throughout the day and shots were on Monday, 
Wednesday and Friday. We also had to drive down to Riley every 
week for Renal Clinic. There we would have to have Ashley's 
blood drawn and see the dialysis nurses and the renal 
specialist.
    Home dialysis came with several new worries. There was the 
constant fear of cleanliness and making sure our home was as 
germ free as possible, especially during exchanges. Then there 
was the new one of her blood pressure. Peritoneal dialysis uses 
fluid in the peritoneal cavity to filter out things that the 
kidneys normally would handle. A side effect of this is that 
the fluid can also be absorbed into the body. When there is too 
much fluid in the body, then blood pressure increases. We had 
one week where here bp spiked to 170 and we were right back at 
Riley for a weekend. That weekend we learned a lot about blood 
pressure and blood pressure medication. After that episode we 
spent a lot of time considering if Ashley seemed puffy and what 
dialysis solution we should use.
    We were constantly struggling with maintaining her blood 
pressure with being on dialysis. We were also struggling with 
seeing a different renal specialist every week at clinic, 
depending on who was on call. We finally called Dr Andreoli, 
one of her specialists, and requested we meet with her 
specifically since she was the expert in this area. We told her 
of our frustrations with clinic and the lack of consistent care 
we were receiving because each doctor had a different idea of 
what we should do with Ashley's treatment. We discussed the 
problems we were having keeping Ashley's blood pressure in 
check with the dialysis. Dr Andreoli felt that maybe it was 
time to consider coming off of dialysis, since it seemed to be 
doing more harm than good with respect to her blood pressure. 
She said that we would just need to do more labs on Ashley 
every week as we started to wean her off to make sure her 
Creatinine could remain stable.
    So, we began taking Ashley for blood draws twice a week to 
monitor her levels while we reduced the number of exchanges and 
then stopped them all together. (Let me tell you, trying to 
hold your child down while they stick a needle into her arm to 
draw out blood is an extremely painful task to ask of any 
parent and child.) So, even though her Creatinine levels are 3 
times the normal limit for a child her age, Dr Andreoli said 
that did not need to remain on dialysis. She told us that the 
percentage of her kidneys that were working would learn to take 
over for the damaged parts. She told us that this would 
eventually wear her kidneys out and she will need a transplant, 
but she hopes that it won't be for many more years.
    Ashley was on dialysis until the end of December. Even 
though she is off of dialysis, she will still be on medication 
the rest of her life. We also have to take her for blood draws 
every week to monitor her potassium and other levels. We have 
found that another side effect of kidney failure is a very 
strict dietary restriction of potassium, as well as other 
minerals. Her potassium levels are too high, so we have to 
monitor everything that she eats and drinks and she has to take 
a very disgusting, thick medication twice a day to remove the 
excess in her body since her kidneys cannot do it for her. So, 
our once healthy eater is now on an extremely strict diet that 
she, and for fairness to her, all of us are now on. Because her 
kidneys are not functioning properly, we have to maintain an 
extremely strict, potassium-limited diet. And potassium is in 
everything, literally. We just have to find foods that have 
less potassium than others. So, bananas are out, period. 
Avocados and chocolate are out. (Remember, this is a 2 year old 
we are restricting this from). What else? All leafy greens, 
melons, potatoes of any kind, dairy, yogurt, nuts, peanut 
butter, tomatoes and tomato sauce, and pizza to name a few. 
(Notice that most of these foods are a small child's 
favorites).
    So every day, at the time this was written, Ashley takes 
four different medications orally everyday, and then we have to 
give her a shot every week. I am sorry, but parents should 
never have to hold down a 2-year old and force them to drink 
nasty, thick medications that make them gag and want to throw 
up. Nor should a parent ever have to hold a child down to stick 
a needle in their back side to deliver the necessary 
medications to make up for something their little body should 
just produce naturally. And as I mentioned before, we take her 
for blood draws every week, as well.
    Ashley's condition seems stable now. The problem, and the 
constant cloud that is always over our heads, is that we don't 
know for how long. A kidney transplant WILL be required. That 
is a question of when, and not if. Michael and I spend a lot of 
time wondering how normal of a life Ashley will be able to 
lead.
    IT is hard to put down in words all of the fears that go 
through our heads on a daily basis now. We worry about Ashley 
and her future. We worry about when her kidneys are going to 
stop working for good, and if she will ever be able to get 
married and have children of her own one day. Our doctor has 
told us that the stress of puberty and pregnancy are serious 
concerns for Ashley.
    We worry about if she will grow normally. Because her 
kidneys do not function properly, her growth will always be an 
issue. We worry about numerous other complications and 
conditions that are brought about by renal failure. For 
instance, her PTH levels have been off lately, which is a 
measure that her Parathyroid gland not working correctly. Her 
carbon dioxide levels have also been off, which means that 
something with the lungs ``talking'' to the kidneys aren't 
working right either. The kidneys touch every part of the body, 
so we now have constant fear and worry in our lives that we 
never expected to have.
    We worry about what life is going to be like as she grows 
up and goes to school. We will always have to pack her a lunch 
now because she cannot eat most normal school foods. How is she 
going to feel while all of her other friends are eating pizza, 
and she just has to sit back and watch. We worry about how she 
will ever be able to play such sports as basketball, or even 
softball, because can we really afford for her to get hit and 
possibly damage one of her kidneys?
    We were a family that enjoyed cooking and eating new foods. 
We like to try new flavors and dishes. That part of our lives 
is over. Ashley just cannot have most foods. We also like to 
travel and had planned to take the girls to many places. We 
wanted them to experience other cultures. At this point, I 
don't see that kind of travel happening.
    Like we mentioned earlier, our careers have no been put on 
hold. Michael had begun a serious search that should have 
resulted in a big career move. This effort has had to be put on 
hold indefinitely. Michael and I will always have to weigh the 
pros and cons of moving jobs due to Ashley's now pre-existing 
medical conditions and that effect it will have on our 
insurance policies. We will always have to weigh job location 
and whether or not we will be able to have a renal specialist 
in the area. All career advancement plans have been put on 
hold.
    We also talk about how we can try and get our lives back on 
track. A baby sitter for a night is not a luxury we are really 
able to enjoy. We are hopeful that this will be possible in the 
future, but her medications and general condition make this 
difficult. We cannot just use a neighborhood babysitter, 
because of Ashley's specialized care she now requires. 
Vacations are now are harder because we cannot be too far away 
from home in case something should happen while we are gone.
    The only thing that we can do is focus on living day to 
day. Unfortunately, giving multiple medications and shots, and 
worrying about results of Ashley's blood tests are just a part 
of life now. We are hopeful that medical research will make 
things better in her future. We just pray that Ashley's kidneys 
can hold out for a few more years.

    Mr. Stupak. Your full statement is part of the record. It 
was a lengthy one, and I know everybody on the committee 
enjoyed the opportunity to read it. If you would like to have 
more time, you still have more time left, sir.
    I am sure members will have questions, but thank you and 
thank you for being here.
    Ms. Terri Marshall, if you would, please, for an opening 
statement.

                  STATEMENT OF TERRI MARSHALL

    Ms. Marshall. The purpose of my testimony here today is to 
tell the story of what happened to my mother-in-law, Mora Lou 
Marshall, after she ate Peter Pan peanut butter contaminated 
with the Tennessee strain of salmonella. Our story is simple, 
and yet it is also very complex. It seems as though our lives 
are segmented into two time periods. There was life before 
Peter Pan peanut butter, and now we have life after Peter Pan 
peanut butter.
    First I will briefly describe our lives before the peanut 
butter. My 85-year old mother-in-law moved in with our family 
in November 2006. At that time, Mora Lou was able to do very 
basic things like make her bed, shower, dress on her own, 
prepare her own breakfast. She read the newspaper. She loved 
flipping through magazines. She went to the beauty shop once a 
week, looked forward to that and was also able to ride in a car 
to go to the doctor or dentist for her appointments. She also 
enjoyed walking through the yard, coming to the table for 
dinner or even going out for meals or treats.
    It was not unusual for Mora Lou to help with light 
household duties for which I was very thankful. She lived in my 
home; light dusting, folding clothes and loading the 
dishwasher. She kept in touch with her Little Rock friends and 
family by visiting with them on the phone or reading cards and 
letters.
    Mora Lou kept a jar of Peter Pan Plus peanut butter by her 
bedside all the time. On her night stand in the room, she had 
it there as a supplemental way to increase her nutrition, with 
a spoon right there handy so she could have it. She would eat a 
spoonful or two several times a day or night just to supplement 
her nutrition. The reality is the very food she thought would 
improve her health began to ravage her body.
    And on January 2, we entered our life after Peter Pan 
peanut butter. Mora Lou had severe vomiting, diarrhea and pain. 
We actually had to call an ambulance to transport her to the 
hospital because she was so weak we could not get her into the 
car. She couldn't stand. And that was the last time she was at 
home.
    We first heard the news of the Peter Pan recall in 
February. I believe it was February 14. And my husband went to 
the nursing home where Mora Lou, his mother, had been living to 
check her Peter Pan. You see, she was back in the hospital at 
that time, so he had to go to the nursing home where we had to 
put her to check her peanut butter. And, yes, our worse fears 
were realized because the numbers did match the recall.
    And then another fear struck us because we knew she had 
been eating this contaminated peanut butter while in the 
hospital and at the nursing home. And I'm sure a lot of the 
medical staff that were there attending to her could attest to 
her many requests throughout the day, ``please get me another 
spoon so I can eat some more of my peanut butter.''
    The next week, a representative from the local office of 
the Department of Health in our parish called with the news 
that Mora Lou's lab report from January 3 testified positive 
for salmonella Tennessee. It was then the pieces to the puzzle 
began to fall into place. Mora Lou was on a vicious cycle of 
salmonella poisoning up until the recall, which was the middle 
of February.
    We are now in a more advanced stage of life after Peter 
Pan. It seems Mora Lou has literally lost her life without even 
physically dying. She has been either in the hospital or the 
nursing home since January 2 with that hospital ambulance ride. 
She cannot walk, get out of bed, use the bathroom, shower, read 
the newspaper, look through her magazines, talk on the 
telephone, ride in a car. All those aspects of her former life 
are gone. Her nutrition is now supplied from a feeding tube. 
She can't swallow even those pureed foods that they give you or 
even drink water without aspirating most of the time. And I 
talked to my husband yesterday. She's back at the nursing home 
from the hospital. She tried to eat food yesterday, and she 
cannot keep it down. So more than likely they're going to 
increase her stomach nutrition.
    The testimony I've given today is a very brief overview of 
what our family has experienced this year. We will forever be 
changed on how we purchase, prepare and trust whether the food 
we are buying is safe for us to eat. I will never eat peanut 
butter again. I hate to say that because I love it. And I won't 
feed it to any of my family. It would take more time than I'm 
allowed in this forum to fully explain our challenges so I will 
close with this final comment.
    The topic for this hearing is Diminished Capacity: Can the 
FDA Assure the Safety and Security of the Nation's Food Supply? 
And I would change it to relate personally to our own 
experience to read: Mora Lou's Complete Incapacity: Can Anyone 
Prevent it from Happening to Someone Else? Thank you.
    [The prepared statement of Ms. Marshall follows:]

                      Testimony of Terri Marshall

     The purpose of my testimony here today is to tell the 
story of what happened to my mother-in-law, Mora Lou Marshall, 
after she ate Peter Pan peanut butter contaminated with the 
Tennessee strain of Salmonella.
     Our story is a simple one, yet it is also very complex. It 
seems as though our lives are now segmented into two time 
periods: life before the peanut butter and life after the 
peanut butter.
     First, I will briefly describe our lives before the peanut 
butter. My 85 year old mother-in-law moved in with our family 
in November 2006. At that time, Mora Lou was able to do very 
basic things like make her bed, shower and dress on her own, 
prepare her breakfast, read the newspaper, or flip through 
magazines. She went to the beauty shop once a week, and was 
able to ride in the car to go to the doctor or dentist for her 
appointments.
     She also enjoyed walking through the yard, coming to the 
table for dinner, or even going out for a meal as a treat. It 
was not unusual for Mora Lou to help with light household 
duties like dusting, folding clothes, and loading the 
dishwasher. She kept in touch with her Little Rock friends and 
family by visiting with them on the phone, or reading their 
many cards and letters.
     Mora Lou kept a jar of Peter Pan Plus peanut butter on the 
nightstand in her room. She would eat a spoonful or two several 
times during the day or night to supplement her nutrition. The 
reality is the very food she thought would improve her health 
began to ravage her body.
     On January 2, 2007, we entered our life after the peanut 
butter. Mora Lou had severe vomiting, diarrhea and pain. We 
called an ambulance to transport her to the hospital because 
she was so weak we could not get her in the car. That was the 
last time she was at home.
     We first heard the news of the Peter Pan recall in mid-
February. My husband went to the nursing home where Mora Lou 
had been living to check her peanut butter. And yes, our worst 
fears were realized because the numbers matched the recall. And 
then another fear struck us. We knew she had been eating the 
contaminated peanut butter while in the hospital and at the 
nursing home.
     The next week a representative from the local office of 
the Department of Health called with the news that Mora Lou's 
lab report from January 3, 2007, tested positive for Salmonella 
Tennessee. It was then the pieces to the puzzle began to fall 
into place. Mora Lou was on a vicious cycle of salmonella 
poisoning up until the recall.
     We are now in a more advanced stage of life after Peter 
Pan. It seems Mora Lou has literally lost her life without 
physically dying. She has been either hospitalized or in the 
nursing home since January 2, 2007. She cannot walk, get out of 
bed, use the bathroom, shower, read the newspaper, or talk on 
the telephone. All aspects of her former life are gone. Her 
nutrition is now supplied from a feeding tube. She cannot 
swallow even pureed foods or water without aspirating most of 
the time.
     The testimony I have given today is a very brief overview 
of what our entire family has experienced this year. We will 
forever be changed in how we purchase, prepare and trust 
whether the food we are buying is safe for us to eat.
     It would take more time than I am allowed in this forum to 
fully explain our challenges, so I will close with one final 
comment.
     The topic for this hearing is ``Diminished Capacity: Can 
the FDA Assure the Safety and Security of the Nation's Food 
Supply?'' If I could change it to relate to our personal 
experience, it would read: ``Mora Lou's Complete Incapacity: 
Can anyone prevent it from happening to someone else?''
     Thank you.

    Mr. Stupak. Thank you, Ms. Marshall. And your full 
statement is part of the record. We appreciate your summary of 
it.
    Mr. Gary Pruden and Sean.
    Mr. Pruden, you're going to give the testimony.
    Mr. Gary Pruden. Yes, I am.
    Mr. Stupak. OK. You're recognized, sir, for 5 minutes.

                    STATEMENT OF GARY PRUDEN

    Mr. Gary Pruden. Thank you, Mr. Chairman.
    I have the written statement that has been submitted. I 
will not go through that in detail, but I would like to 
highlight four points from this testimony to the committee this 
morning.
    First of all, my son Sean is 11, and he contracted E. coli 
from eating at a Taco Bell in Brenigsville, PA, before the 
Thanksgiving break.
    The first point I want to make is that it is very difficult 
to diagnose this in its early stage. The E. coli takes about 4 
days to incubate in the human body before it takes effect. In 
exactly the 4 days after he ate, the symptoms began.
    But the problem is, as a parent, you don't know what is 
going on. The child is vomiting. The child has diarrhea. And we 
are not doctors, we are parents, and we just don't know. And 
meanwhile, during this time, the sickness is developing even 
further.
    I want to just make a quick point. Representative DeGette, 
you made a good point when you mentioned that we often want our 
kids to eat their vegetables. Well, at this particular Taco 
Bell, I have 2 younger kids who are very picky eaters, and my 
wife had to brush off all the lettuce and all that for them. I 
must say, it is one time I am glad that we capitulated to their 
needs. But Sean didn't; he ate lettuce, and he was infected.
    For about a week or 2 weeks, Sean was very sick with 
diarrhea and vomiting, and occasionally it would get better, 
but it always resurfaced. And our family doctor, who we visited 
twice, simply saw this as a virus of some sort and gave him 
some shots of Fenegrin and such and really didn't know what the 
diagnosis was.
    It got to the point where we had to take him to the 
emergency room. And that was prompted when the news reports of 
E. coli broke out at Taco Bell. We simply connected the dots 
and assumed that this was what he had. And those particular 
symptoms of course were the diarrhea and the vomiting. It also 
includes, your urine is very brown. I know that because my 
mother-in-law is a nurse and called us and asked about that 
when she heard of these news breaks. So we assumed at that 
point he had contracted it.
    He was rushed to the Penn State Hershey Medical Center in 
Hershey, PA, by an ambulance, admitted and stayed there for 
roughly I believe 5 days. There is no treatment for E. coli. I 
have learned this. It is simply a matter of waiting it out. And 
you either can have dialysis and of course blood transfusions. 
Fortunately, in our case, Sean missed dialysis by about 4 
hours. The blood work simply got better. But he was certainly 
in a very, very bad state in a hospital bed for 4 or 5 days, 
and we simply didn't know what the outcome would be. 
Fortunately, he did recover, although we are not certain what 
the long-term effects are at this point.
    I would like to also point out in my testimony the effect 
this has on the family. This whole experience was very 
exhausting to myself and my wife. As a businessman, and it was 
very busy, I had to take time away from my business. And 
certainly my wife was physically and emotionally exhausted as 
well. There was one point in the emergency room when Sean 
looked at my mother, and she was in tears because she simply 
had the guilt of not knowing and what should she have done. He 
looked at her and said: Are you OK, mom? And I thought that was 
a very striking moment for both of them.
    Finally, I just want to make a few quick comments which is, 
in my testimony, regarding public oversight, and I will read 
directly from my testimony this morning.
    A key element of successful commerce and trade is trust. We 
trust that the accountant hired to do our taxes is following 
the laws in preparing the tax return. And we trust that pilots 
are adequately trained to fly a commercial jet. And we trust 
that our auto mechanic is going to return our cars in safe 
conditions. That is also extended to the trust and food that we 
order or buy from a grocery store; that it is edible, and it is 
safe. Without this trust, commerce can't work. And where 
failure occurs oversight is required.
    We are fortunate that Sean has recovered and is back to a 
normal life of school activities, baseball, friends and 
constant activities. It is my hope that this testimony this 
morning will help compel action to provide better controls and 
oversight of our Government officials and agencies responsible 
for public food safety. As consumers and citizens, we should 
expect and demand this. Thank you for allowing me to testify 
before you this morning.
    [The prepared statement of Mr. Pruden follows:]

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    
    Mr. Stupak. Thank you, Mr. Pruden.
    Sean, did you want to add anything.
    Mr. Sean Pruden. Nope.
    Mr. Stupak. OK. Playing baseball, Jose Reyes, 14 homers and 
hit another one last night; is that pretty good?
    Mr. Sean Pruden. Yes, very good.
    Mr. Stupak. We begin with questions.
    Mrs. Armstrong or Mr. Armstrong, whoever purchased the 
spinach. I have one here. It is not spinach, but it is the 
spring mix. And it says right on here that it is field fresh 
and ready to eat. Did you ever think that someone would test it 
to make sure that it was good before it went from the field to 
your dinner table?
    Mrs. Armstrong. Well, I felt that if they said that it is 
ready to eat, then I assumed that it was safe and that they 
have done everything in their power to make it so. I trusted 
that it was safe.
    Mr. Stupak. Mr. Armstrong.
    Mr.  Armstrong. In fact, the bag we purchased said it was 
triple washed and ready to eat.
    Mr. Stupak. OK. Did you know what triple washed meant? And 
you're right, it does say on here--this one here says 
completely washed.
    Mr. Armstrong. I think it means nothing actually.
    Mrs. Armstrong. Now we know it means nothing.
    Mr. Stupak. Now you know. Hindsight.
    Mr. Armstrong. Right.
    Mr. Stupak. Let me ask this question. In your full written 
testimony you talked quite a bit about how your life has 
significantly changed and how Ashley's life will significantly 
be changed. There are many foods now she cannot eat. And the 
whole family's diet has changed, such as chocolate, pizza, 
other foods kids normally eat at home and at school. Could you 
talk a little bit about how this has changed your eating 
habits? Not just for fear of being sick, but how has this 
illness caused the whole family diet to be off and what's your 
future like as a young growing person?
    Mrs.  Armstrong. We always enjoyed eating very healthy. We 
loved fresh fruits and vegetables. Now we can't eat them, one, 
because of Ashley's illness. We have to watch the high 
potassium content. But also we just don't trust that they are 
safe any more. There have been no changes made to the way 
things are processed or packaged. So there are no guarantees 
that the food we're eating is safe. So we just have no faith 
that it is safe, so we just choose not to eat it.
    Mr. Stupak. Let me start with Mr. Pruden, Ms. Marshall and 
then we'll go back to the Armstrongs.
    We have Members of Congress here. We are investigating this 
thing. We will have FDA here in a couple of weeks. What would 
you like us as policymakers, what's the one thing you would 
like to leave with us as policymakers that we should be doing 
here on food safety, pet safety, because the next panel has 
some pet foods, an incident we have had? This is just from this 
one valley alone the 20th outbreak in the last 10 years.
    Mr. Gary Pruden. I would say in many of the opening 
remarks, you hit on what is really key. And that is the needed 
consistent oversight and kind of manage that with the funding 
that is also available. But it seems that these outbreaks 
occur, and there are a lot of press releases on them, and 
people get all up in arms, and it drops. And then 6 months 
later, a year later, it is going to happen again. I am here to 
tell you it will happen again. You will see it in news reports 
in a couple weeks maybe, who knows. I think that I would 
personally like to see more consistent oversight and more 
coordination between departments.
    I would also add that is required at the State and county 
level as well. I did not see a lot of coordination with the 
health departments in the State of Pennsylvania on this. There 
was some big operation in Montgomery County and in Lehigh 
County where our outbreak was. I didn't see coordination. So I 
think that is the key, is coordination and consistency.
    Mr. Stupak. Ms. Marshall.
    Ms. Marshall. I think one of the things that concerned our 
family is that the January 3 lab report from the hospital said 
salmonella. I don't think at that point it said Tennessee, that 
it was attached to that. We never heard the words salmonella at 
all until February 23 when the Department of Health called my 
house and inquired as to whether my mother-in-law was better. 
And I said, well, in fact, she's still in the hospital. And 
they wanted to know if anybody in the family was sick. And I 
still was a bit confused. And I said, why are you asking these 
questions? And she said, your mother-in-law has been diagnosed 
or the lab report says salmonella Tennessee. And that was our 
first time to know. That was some 9, 10 days after the recall 
that we heard that word. Had we heard salmonella, not even with 
the attached Tennessee word with it, the first week in January, 
we would have started a method of isolation to see what food 
had she eaten that the rest of the family had not eaten. It 
would have been so easy because she is the only one in our 
house that ate Peter Pan Plus peanut butter. I would have 
immediately pulled it. She would not have continued to eat it 
in the hospital for those periods of the weeks following up 
until the recall in the middle of February.
    So I guess to answer your question, if there was a way that 
anyone who tested for salmonella, that it had to be reported 
somewhere on either a local, State or national level so that 
then, obviously, we didn't get the information from our 
hospital, but it would be a requirement that just that word 
itself triggered something that would then say, this is a 
problem, we need to figure out what is contaminated in that 
Marshall family home that needs to be pulled. And we could have 
taken appropriate action. We didn't pull it until ConAgra and 
Peter Pan came out and said, pull it. We would have pulled it a 
lot sooner. So I don't know what could be done to actually make 
that happen.
    Mr. Stupak. Notice, then, is what you're concerned with?
    Ms. Marshall. Exactly. More immediate notice when that 
salmonella test comes up on a report.
    Mr. Stupak. Mr. Armstrong.
    Mr. Armstrong. You can see, these are my little girls. And 
I am their dad, obviously. And it is my job to protect them and 
my job to make sure they get a good education; they learn right 
from wrong and that I teach them everything I can. But the one 
thing I found out is that I can't protect them from spinach. 
Only you guys can. You can protect them. I can't. And I don't 
know what the right answer is, but I know what the wrong answer 
is. And that is to keep doing what we are doing when it is not 
working.
    Mr. Stupak. Thanks. You mentioned your cousin, the 
unfortunate loss of your cousin from the same thing, HUS. If 
that would never have happened, do you think you would have 
triggered this thought of E. coli in Ashley's illness?
    Mr.  Armstrong. I don't think so. Who knows what would have 
happened there. I don't think it would have been as positive an 
outcome if we hadn't thought of it.
    Mr. Stupak. Thank you. And thank you for sharing your story 
with us.
    Mr. Whitfield for questions please.
    Mr. Whitfield. Thank you, Mr. Chairman. We appreciate the 
testimony of all three families very much today. One of the 
questions that I would like to ask, in this process, and I 
would just ask all of you, did you ever have any discussion 
with or contact with the Centers for Disease Control or the 
Food and Drug Administration or local health authorities? Now, 
I think, Ms. Marshall, you said you had local health 
authorities contact you?
    Ms. Marshall. Yes. Late. It was February 23. The reason I 
remember that, it is my son's birthday. And that was the 
afternoon that the call came. Again, I said I was confused 
because I really didn't know what the purpose of the call was. 
And she was mainly calling to inquire was anyone else in the 
house sick. And of course, the sickness from my mother-in-law 
had been going on since January 2.
    Mr. Whitfield. And they called because they had received 
the medical reports?
    Ms. Marshall. That's correct. They had a lab report. I 
guess something from the Centers for Disease Control. But I 
have not heard from anyone on a national level, no.
    Mr. Whitfield. Mr. Pruden, what about your family?
    Mr. Gary Pruden. I reached out to the county health 
department where this outbreak occurred and was compelled to do 
that only from basically the news reports of this outbreak with 
Taco Bell in the northeast, particularly in New Jersey and 
eastern Pennsylvania. So I did reach out to them and explained 
to them, it seems to make sense that this is a connection. And 
I don't know that I saw the proper follow-up.
    Mr. Whitfield. But your mother-in-law is a nurse; is that 
correct?
    Mr. Gary Pruden. That's correct.
    Mr. Whitfield. And she told you that Taco Bell----
    Mr. Gary Pruden. That's correct. She heard it on the news, 
and she said, I think at that time, she said, check his urine, 
and if it is brown and you got all the symptoms, you better get 
him to the hospital.
    Mr. Whitfield. Mr. And Mrs. Armstrong, it is my 
understanding that it took quite a while for them to really 
diagnose the problem with your girls; is that correct?
    Mrs. Armstrong. It took a while for them to figure out 
where the kidney failure was coming from. The blood tests----
    Can you talk?
    Mr. Armstrong. It took quite a while. Like I said, it took 
several days to actually diagnose HUS. And after that, it took 
several days to figure out what the source might have been. We 
didn't know it was spinach. Kind of went through the list of 
the past fast foods and et cetera. But it took probably another 
week before we started zeroing in on the spinach.
    Mr. Whitfield. But this occurred in August of 2006. And I 
am assuming this Isabella seems to be doing relatively well. 
And Ashley is the one that is still having some significant 
issues; is that correct?
    Mr. Armstrong. That is correct.
    Mr. Whitfield. And so she is--how often do you take her to 
the doctor now?
    Mrs.  Armstrong. Right now it is every 6 weeks. We have 
extensive blood work that has to be done.
    Mr. Whitfield. Well, thank you all very much for taking 
time to be with us today, and we genuinely appreciate your 
testimony.
    Mr. Stupak. Ms. DeGette for questions.
    Ms. DeGette. Thank you very much, Mr. Chairman.
    I think that Ashley and Isabella are both candidates for 
future congressional careers, they are so personable.
    And Sean, I think that you are going to be doing all the 
high tech for some company. So listening to this today, it 
seems like we have issues with the reporting on both ends. 
Listening to all of your personal stories, here you have an 85-
year old mother-in-law who seems to be declining physically, 
which happens with 85 years old. Here you have three young 
children who have what appear to be viruses which kids get all 
the time. And it is really hard for parents to detect. And it 
is also hard for parents to figure out, or children, any 
families, to figure out, is your family contaminated? I was 
thinking about the spinach. And in fact, I don't buy the 
prewashed lettuce. I only buy the prewashed spinach because it 
says ``triple washed'' because I hate to wash spinach. And so 
you just don't know as a parent. And you can't be expected to 
be a diagnostician to find some kind of advanced condition. So 
this is the thing. Right now, staff tells me, for an outbreak 
of E. coli, for example, to be detected, what has to happen is 
the doctor has to order a stool sample to go to the lab, which 
then goes to the county health department, which then goes to 
the Centers for Disease Control in Atlanta. And about one out 
of every 20 or 30 of those are actually reported. And so the 
first thing is we have no mandatory reporting by the food 
processors to the FDA that there's some problem. So if ConAgra, 
for example, with this peanut butter had found salmonella in 
that peanut butter, there's no requirement that they have to 
report that to someone.
    Ms. Marshall, I would assume you would agree with me that 
it would be a good idea if that would happen.
    Ms. Marshall. If I had known prior to her illness that that 
salmonella was a problem in that brand of peanut butter, it 
would have been a huge red flag that that was what was making 
her sick. And possibly we could have prevented her from being 
totally disabled now.
    Ms. DeGette. Right. And then the second thing that 
happened, when the FDA investigators actually showed up at 
ConAgra, ConAgra refused to give them their records, which that 
sounds really outrageous, too, to me. You are nodding, Ms. 
Marshall.
    Ms. Marshall. Well, one thing that is interesting to us, my 
husband requested medical records for the hospital stay in 
January. And he picked them up. And it was just a short stack, 
which I thought was a little interesting because she had been 
there so long. And I said, flip through there and find the 
report that says salmonella. It wasn't there. And he called the 
hospital, medical records, and they said, oh, well, here it is 
right here. So I don't know if that has anything to do with 
anything, but it just was odd that out of that whole stack of 
papers the very piece of paper we wanted to see that we had 
been told by the local health department was there was not 
there. We did eventually get a copy of it.
    Ms. DeGette. Well, and this is the last question I want to 
ask all of you. And I want to start with you, Mr. Pruden. We 
seem to be relying--you said and actually everybody said, you 
put two and two together when you saw the news accounts of the 
Taco Bell recall. We seem to be sort of relying on parents or 
kids, relatives' deductive reasoning, looking at news accounts 
and figuring out, oh, that is what is wrong with my kid. If you 
hadn't known about those news accounts, do you think that 
Sean's problem would have been clearly diagnosed the way it 
was?
    Mr. Gary Pruden. I don't think it would have. I think 
eventually we would have continued to go back to our family 
doctor. But again, his diagnosis was, it is a virus. I think it 
is simply common sense. At some point, you have to connect the 
dots. And I am afraid that sometimes you get caught up with 
some of the bureaucratic activity with either the State or 
Federal level, and it doesn't seem to go anywhere.
    Ms. DeGette. A better reporting system, as you said in your 
testimony, would clearly help families to put two and two 
together without just having to rely vaguely on media accounts.
    Mr. Gary Pruden. Correct. A coordinating reporting 
strategy.
    Ms. DeGette. Ms. Marshall, do you agree with that?
    Ms. Marshall. I do agree. In our case, it would have made 
the difference of whether she is going to live or die.
    Ms. DeGette. What about you, Mr. And Mrs. Armstrong?
    Mr.  Armstrong. I would agree with that. In fact, we ended 
up tracing the SKU number ourselves from our receipt all the 
way back through the distribution chain. And we did that all 
ourselves.
    Ms. DeGette. Maybe we will give you some high level job at 
the FDA. Thank you very much for your testimony.
    Mr. Stupak. Thank you, Ms. DeGette.
    Mr. Burgess for questions.
    Mr. Burgess. Thank you, Mr. Chairman. I don't know that I 
have a lot to add over what has already been asked, except my 
children are now in their 30s, and I would just like to know 
how you get girls age 5 and 2 to eat spinach. I never had much 
success.
    Just because of my interest in clinical matters, what did 
they say to you was the reason for the delay in onset in your 
younger daughter, in Ashley's case, with the symptoms that she 
eventually came down with? There was a 5-day delay between 
Isabella's symptoms and Ashley's symptoms?
    Mrs.  Armstrong. We were told that E. coli can take up to 2 
weeks to start showing effects on the body.
    Mr. Burgess. But their time of exposure would have been 
identical, both eating at the same meal?
    Mrs.  Armstrong. Yes. It could have been maybe that her 
immune system was stronger at first. I have no idea.
    Mr. Burgess. Of course the witnesses in front of us today 
show us the particular vulnerability. It is not the same bug 
necessarily in every case, but individuals who are very young 
and individuals who are very old are the most susceptible to 
these problems.
    Ms. Marshall, following your testimony, which State was 
your mother in? Of the 50 States, what State?
    Ms. Marshall. She was in Louisiana. She had moved in with 
us.
    Mr. Burgess. I confess to you, I don't know. I know from 
years of practicing in Texas, there are a number of illnesses 
that are reportable conditions. And there is contact 
information and verification it goes through. Generally those 
are illnesses that are transmitted sexually. I don't know 
whether in your case it would have made a difference had the 
State had a reporting mechanism in place. Your story is the 
fact that she was continually fed the product that was causing 
the problem; I'll just tell you from a practitioner's 
standpoint, I can't imagine anything worse. It is tough enough 
when everybody else in the community has viral gastroenteritis, 
and the child with toxigenic E. coli comes in. Here in 
Washington, before I got here, the anthrax outbreak where the 
information was not disseminated quickly enough and the 
emergency room doctor missed the diagnosis on a gentleman from 
the Post Office who eventually died of that disease. And those 
are tragic terrible occurrences. But as bad as those are, they 
don't even compare with setting the jar of peanut butter by the 
hospital bed and continuing to spoon the poison into the mouth 
of the patient you are trying to get better.
    Ms. Marshall. It was horrible. When my husband went to the 
nursing home to pull her jars, one was almost completely eaten, 
and one was not opened. And the reason that she was not there 
to see him pick up her peanut butter from the nursing home, she 
had to be taken back to the hospital. They had found her 
unresponsive in her room.
    Mr. Burgess. And were those products themselves tested in 
the confirmation that the salmonella was present in those?
    Ms. Marshall. They were not. That was prior to the call 
from the Department of Health. So we did what they said to do 
in the media, take your peanut butter back to the grocery store 
where you bought it. And we did have them--we had to sign a 
receipt that we returned it. But because the Centers for 
Disease Control had a report that said salmonella Tennessee, 
she is one of the 400 that has been identified as having that. 
But, no, we did not have the product. We did what the media 
told us to do. We trusted what we were hearing in the news; 
take it back, throw it away. If you want to throw it away, 
here's how to do it. Because we never connected that that is 
why she was sick, didn't think it was an issue.
    Mr. Burgess. Well, this is of course a process that 
continues to improve. Mr. Inslee mentioned the difficulties 
that occurred with E. coli and ground beef back in 1992 and 
1993, and those were tragic occurrences. Different handling of 
the product now has resulted. We don't hear of those cases any 
longer. And I suspect there will be some further improvements. 
There of course was the story with the strawberries out of 
Mexico, and I don't remember the year, 1995 or 1996, with 
cryptosporidium on them. The microbes that perplex us as 
humans, there is no end to their creativity in the ways that 
they find their way into our environment. I think the ongoing 
work of this committee, to ensure that when problems are 
developed, and perhaps even preventing some problems that might 
occur in the future, has to be our goal.
    But as I said in my opening statement, we are never going 
to live in a world that is 100 percent safe. And it is 
incumbent upon all of us to be vigilant. That is why I really 
appreciate you guys sharing your stories with us today, because 
by doing so, you are going to alert families across the country 
of things that might not have come up in the course of their 
normal conversations at home.
    Thank you, Mr. Chairman. I yield back.
    Mr. Stupak. Next. Ms. Schakowsky for 5 minutes for 
questions.
    Ms. Schakowsky. Thank you. I agree with Dr. Burgess that we 
are never going to make the world completely safe. But a friend 
of mine, Nancy Donley's son, died in 1993 from that ground beef 
E. coli presence and created an organization at that time, Safe 
Tables Our Priority, STOP, and the idea was that there are 
actually things that we can do. And you have pointed up some 
things today I think that beg for addressing. Ms. DeGette 
talked about mandatory recalls. At the time, Nancy Donley was 
talking about not voluntary recalls, but voluntary recalls. And 
she was working with our Senator, Dick Durbin from Illinois, on 
creating a central food safety agency that would consolidate 
all of the different parts. So we don't have to worry, well, 
meat, is it under USDA or is it under the FDA or Interior 
Department, all these different agencies? And the timeliness of 
the reporting is definitely an issue.
    But I also want to tell you that ConAgra, who made the 
Peter Pan peanut butter, has actually--and we have the 
documents, our staff has done a good job--has instructed in 
their manual, instructed employees, quote, to answer only to 
direct questions--this is for FDA inspectors--only to direct 
questions. Never volunteer information or elaborate on answers 
beyond basic questions. And it says, quote, as a rule of thumb, 
it can be stated that the inspector will generally request to 
see more than is authorized by law.
    And then a really troubling procedure, which I intend to 
ask them about later, it states, I am quoting from their own 
reporting, FDA inspectors are generally not, capitalized and 
underlined, entitled to the following: If the inspector insists 
on any of the following and he is not claiming to be acting 
under the authority of the Bioterrorism Act, ask that he direct 
a written request to the corporate office in Irvine.
    And what are those things? Codes, which I know you had to 
work a long time to try to discover. It says: However, we do 
supply copies of all our codes to FDA regional officers, and 
inspectors should be referred to their regional office to 
obtain a copy. Records: This includes quality control records, 
examination records, warehouse records, production records, 
consumer complaint records, plant locations, distribution 
center locations, product formulae, product specifications, 
photographs, except State inspections in California, Wisconsin, 
names of suppliers. I am going to ask them if that is a correct 
reading of their instructions, but it sure sounds to me like 
there is an effort to hide information from those who would get 
it. I just wondered if you had any comments or any other 
suggestions of obvious holes that made your loved ones, made 
you, Sean, ill?
    Mr. Gary Pruden. It is easy in hindsight to look back and 
try to find those holes. I don't know what could have been done 
to prevent this. Again, I go back to the fact that you have a 
situation that to the average American citizen looks pretty 
suspicious. I have an outbreak in a county here. I have one 
here, and he happened to be at a Taco Bell in a county right 
next to it, but none of those Taco Bells were shut down. And it 
was confirmed that he had it. I don't know that----
    Ms. Schakowsky. Because it was in the neighboring county?
    Mr. Gary Pruden. Yes, I believe that to be the case. I 
don't know that for sure. But, again, when I explained the 
circumstances to the county health department I said, you 
realize you got these in Montgomery County, which is just south 
of Lehigh County and over in New Jersey?
    Ms. Schakowsky. And you didn't have to report it, right?
    Mr. Gary Pruden. No. That is the point, I did not have to 
but felt compelled to do that.
    Ms. Schakowsky. Well, I just think this has been such 
valuable testimony, and I really want to thank you and wish all 
of you the best. I know that there are ongoing issues that you 
are going to have to deal with. And I am so sorry about your 
mother-in-law, which sounds like this is not necessarily 
reversible. So I thank you very much, all of you.
    Mr. Stupak. I thank the gentlelady.
    Mr. Burgess and also Ms. Schakowsky brought up the meat 
situation. Last year we had a situation on the Floor that 
actually went to a vote where the FDA has allowed manufacturers 
to put carbon monoxide into meat to extend the shelf life and 
to make it look fresher and redder so consumers would buy it, 
because that is what we base our appearance upon. It looks like 
a nice fresh looking piece of meat. But you extend the shelf 
life which then runs the threat of greater exposure to E. coli 
if not properly taken care of. So the FDA seems to be going 
backwards allowing more things that are questionable on a 
market shelf longer with things like carbon monoxide. 
Unfortunately, we ran an amendment to try to stop that from 
happening, and we lost on sort of a party line vote.
    So there has been a lot going on in food safety and that is 
why your testimony is so important to bring this home to us.
    Mrs. Blackburn for questions please.
    Mrs. Blackburn. Thank you, Mr. Chairman. I am going to be 
very brief because our witnesses have been so incredibly 
patient, and we do appreciate so much of what they have had to 
say. I know last October I think it was, we sent a letter to 
the FDA to begin a conversation looking at the safety and with 
concerns about the safety of our Nation's food supply. I think 
that this points out when we need to do it. It also points out 
a couple of other things that, Mr. Chairman, I hope that we 
will continue to consider as we move forward in our work.
    Number 1 is the lack of a reporting process for consumers 
and also for the industry. We don't have a standardized process 
that we follow or expected steps that we would follow.
    The other is for consumer education and awareness. And this 
is something last fall that we talked about some as we looked 
at food safety and the expectations of that.
    So to our witnesses, I thank you for your patience and your 
willingness to be with us this morning. We hope that everyone 
will see a recovery and that there will be no long-term or ill 
effects. And again, we thank you for your testimony. And with 
that, I am going to yield back so that we can continue with our 
hearing.
    Mr. Stupak. Thank you.
    Mr. Inslee for questions please, 5 minutes.
    Mr. Inslee. Mr. Armstrong, I just want to tell you, as one 
father to another, we discovered a new thing today, that the 
one thing about E. coli, it could lead to irresistible 
cuteness, too, I can tell you that. That is the one bright side 
of this whole thing.
    The way I look at this, and I think, Mr. Armstrong, you 
said with great eloquence, essentially Congress is in loco 
parentis. We have got to be the parents in a sense for our kids 
in our food steps. And I appreciate you saying it that way.
    I will be working on a bill that its thrust is to prevent 
the contamination from starting in the first place. We've 
talked a lot about notification after the contamination gets 
out there which are important things. But I want to be focusing 
on preventing the contamination from getting into the food 
chain in the first instance. I think you may have heard me 
talking about it; there are four things we need. We need to 
make sure these things are enforceable standards, not just wish 
lists to make sure this contamination does not occur. We've got 
to make sure the industry adopts what the meat industry did, 
which is to identify the hazard points and then reduce and 
eliminate them. We have got to prevent this adulteration and 
make sure we have civil and criminal penalties for it. Fourth, 
we have to have mandatory recall authority.
    Now, this won't surprise you that sometimes when you 
propose things like this the industry doesn't like to kind of, 
quote, be told what to do. But I think these are some 
reasonable proposals. And I just would invite your comment 
about what you think we ought to, if the industry resists this, 
what should we tell them. What would be your response to their 
assertion that if this costs them some money, that these are 
things they shouldn't be required to do?
    Mr. Gary Pruden. I certainly understand that that would be 
a natural reaction from industry. Though I think that in the 
long-term, any business is better served by partnering in 
situations like this to prevent situations up front before they 
happen. Public companies or private companies have much more 
responsibility today than just broad profits and growth. It is 
a more broad range. There are a lot of tentacles. And I think 
there has to be some education and awareness to many companies 
that you are better served in the public by working with 
agencies to prevent up front these things from happening. There 
can be a lot of good out of that. And yes it is costly, but 
certainly the public image of your company will be enhanced for 
the long term.
    Mr. Inslee. Mr. Armstrong, did you want to add something?
    Mr. Armstrong. Yes. Actually, prevention I think has got to 
be the No. 1 priority. I think we heard here today a lot about 
information, however, after the fact. After the fact, I think, 
is important because the measurement of what is going on, the 
information getting out, in my opinion is a very strong 
argument for prevention. Because if the truth is in fact told, 
if information is available, I don't know how these industries 
can be profitable if nobody is going to buy their product. If 
the information was available, I don't think anybody would buy 
their product.
    Mr. Inslee. I want to give you confidence. I think 
something will come of your efforts today. I have seen that in 
the meat industry, where people stood up and were counted and 
really helped clean up that industry. And I know you have been 
working with Mr. Marler, who has worked with the meat industry 
to adopt some of these measures that reduce the incidence of 
people being poisoned like this. I just want to you give you 
some confidence that your coming here today, I hope, will 
result in some good things. We have seen it in meat. Now we 
need to extend it further. So thanks for your work. Take care.
    Mr. Stupak. Mr. Armstrong, if I may, you said you tracked 
your package all the way back; right, your spinach?
    Mr.  Armstrong. Right.
    Mr. Stupak. And it was Dole brand; right?
    Mr.  Armstrong. Yes.
    Mr. Stupak. I'm taking a look at this one here that we 
purchased in this area last night. And again, this is spring 
mix. But it says on the back, distributed Salinas, CA, product 
of USA and Mexico, processed in USA. Now, did you track yours 
back to Salinas Valley, your spinach?
    Mr.  Armstrong. What we did is we tracked our spinach back 
to the same SKU number. And that batch had been tested positive 
for E. coli. So I think it was from Salinas Valley, but that is 
how we were able to trace it back.
    Mr. Stupak. Salinas Valley is California, and you live 
where?
    Mr. Armstrong. Indianapolis, Indiana.
    Mr. Stupak. Mr. Pruden, did anyone ever tell you where the 
lettuce came from, which part of the country or world?
    Mr. Gary Pruden. No. It was only from news reports, it 
probably came from southern California through a distributor.
    Mr. Stupak. And that was purchased in Pennsylvania?
    Mr. Gary Pruden. Correct.
    Mr. Stupak. And the best you know from news reports, it 
came from California?
    Mr. Gary Pruden. That's correct.
    Mr. Stupak. Of course, Ms. Marshall, we know yours came 
from Georgia?
    Ms. Marshall. That's correct.
    Mr. Stupak. Any other members have any further questions 
before we let this panel go?
    On behalf of the full committee, and members have been in 
and out because we meet with constituents, we have other 
hearings. Actually there is a Telecommunications Internet 
Subcommittee hearing I am supposed to be at, but this hearing 
is a little bit more important, so Members are back and forth. 
But we appreciate your testimony. Your full statements are part 
of our record. Thank you again for putting a human face on this 
illness that Americans face each and every day. Thank you for 
being here. We will dismiss this panel.
    Mr. Stupak. Our second panel, if they would come forward, 
please, is Dr. Anthony DeCarlo of Red Bank Veterinary Hospital, 
and also Ms. Lisa Shames, acting director of the Natural 
Resources Environment at the Government Accountability Office, 
GAO.
    It is a policy of this subcommittee to take all testimony 
under oath. Please be advised that witnesses have the right 
under rules of the House to be advised by counsel during their 
testimony.
    Dr. DeCarlo and Ms. Shames, do you have counsel with you 
today for today's testimony? You both indicate not. I would ask 
you to please rise, raise your right hand and take the oath.
    [Witnesses sworn.]
     Let the record reflect witnesses replied in the 
affirmative. You are now under oath. We will now have a 5-
minute opening statements.
    Ms. Shames, please

 STATEMENT OF LISA SHAMES, ACTING DIRECTOR, NATURAL RESOURCES 
     AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

    Ms. Shames. Members of the subcommittee, I am pleased to be 
here today as part of your oversight of the safety and security 
of the Nation's food supply. Let me state at the outset that 
while the food supply is generally considered to be safe, the 
recent outbreaks of E. coli in spinach, salmonella in peanut 
butter, along with the contamination in pet food underscores 
the risks posed by accidental food contamination.
    Each year, as we've already heard, the Centers for Disease 
Control and Prevention reports that about 76 million people 
contract a foodborne illness; 325,000 people require 
hospitalization; and 5,000 people die. As the experiences we 
heard shared this morning, it gives us a personal face to these 
Government statistics.
    This morning I would like to focus on two key points. 
First, GAO designated food safety on its high-risk list because 
of the Federal Government's inconsistent oversight, ineffective 
coordination and inefficient use of resources. The Federal 
Government's oversight is fragmented; 15 agencies collectively 
administer over 30 laws related to food safety. Further, the 
Federal Government's resources spent on food inspections do not 
align with the risks of food contamination. For example, FDA is 
responsible for regulating about 80 percent of the food supply, 
but accounts for about 20 percent of food inspection resources; 
whereas USDA, the Department of Agriculture, is responsible for 
regulating about 20 percent of the food supply but receives the 
majority of food inspection resources.
    To address this fragmentation, we are calling for a 
fundamental reexamination of the Federal oversight of food 
safety. To this end, we have recommended comprehensive uniform 
and risk-based legislation, a blue-ribbon panel to study 
alternative organizational structures and a reconvened Council 
on Food Safety to facilitate a Government wide approach.
    Second, limitations in Federal agency's recall programs 
heighten the risk that unsafe food will reach consumers. Food 
recalls are voluntary. And both FDA and USDA do not have 
authority to issue a mandatory recall order. The exception is 
FDA's authority to require a recall for infant formula. In 
contrast other Federal agencies, such as the Consumer Product 
Safety Commission and the National Highway Traffic Safety 
Administration, have authority to require a company to notify 
the agency when it has distributed a potentially unsafe 
product, to order a recall, to establish recall requirements 
and to impose monetary penalties if a company does not 
cooperate.
    Even within the context of their limited recall authority, 
we reported in October 2004 that FDA and USDA could have done a 
better job in carrying out their food recall programs. 
Specifically, at that time, USDA and FDA did not know how 
promptly and completely companies were carrying out the 
recalls. It did not promptly verify that recalls had reached 
all segments of the distribution chain and used procedures such 
as press releases and Web postings that may not have been 
effective. According to agency officials, USDA and FDA are 
taking actions to address some of our recommendations. We have 
not yet reviewed these actions to determine if they are 
adequate.
    In addition, we have proposed that Congress enact 
legislation that would require companies to alert USDA or FDA 
when they discover they have distributed potentially unsafe 
food and give both agencies mandatory food recall authority.
    In summary, the recent food contamination outbreaks 
underscore the need to transform the Federal oversight of food 
safety. Today's hearing appropriately focuses on FDA's 
capacity. In the long run, the Federal oversight of food safety 
needs to be approached on a Government-wide basis. GAO's high 
risk designation in concert with congressional hearings such as 
today's can bring needed attention to address the weaknesses 
caused by the current fragmented system and restore public 
confidence in the Government's ability to ensure the integrity 
of the food supply. Mr. Chairman, this concludes my prepared 
statement. I would be pleased to answer any questions that you 
or members of the subcommittee may have.
    [The prepared statement of Ms. Shames follows:]

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    
    Mr. Stupak. Thank you. And thank you for your testimony.
    Dr. DeCarlo.

   STATEMENT OF ANTHONY DECARLO, D.V.M., RED BANK VETERINARY 
                   HOSPITAL, TINTON FALLS, NJ

    Dr. DeCarlo. Thank you, Mr. Chairman, and members of the 
subcommittee. And also thank you to Congressman Pallone, whose 
statement I have read, for an informed and heartfelt plea for 
better controls in reporting mechanisms when it comes to the 
health and safety of our pets. I consider it an honor to be 
here and appear and give testimony before this esteemed 
subcommittee.
    On April 5, Congressman Pallone visited Red Bank Veterinary 
Hospital to gather facts about how our hospital was dealing 
with suspected cases of contamination. Now he's working on his 
own legislation in the Health Subcommittee he chairs on ways to 
improve Federal regulatory oversight, including the 
establishment of a central registry to expedite the 
Government's response on any future situations.
    I don't feel that I can speak with authority on proving 
regulatory oversight because I'm not clear that there is a lack 
of oversight and is indeed the reason for the problem based on 
when the problem was first known to us.
    What we need as veterinarians is a better mechanism in 
place to track unusual occurrences, be able to get information 
to an appropriate centralized reporting agency and then back 
out to the veterinary community in a timely manner.
    Congressman Pallone has done an excellent job of distilling 
a large body of information into an accurate and concise 
statement. As a result of this consolidation of information, 
I'll be speaking this morning about an improved means of 
gathering and disseminating information from the veterinary 
perspective.
    There are many sites where veterinarians gather information 
regarding this recall, from the American Veterinary Medical 
Association to State veterinary medical associations and to the 
pet food manufacturers themselves and the media. While each of 
these organizations did a fine job of relating their real time 
information to their Web sites, the veterinary community does 
not have readily available resources to add to and retrieve 
this information in a focused timely manner.
    Many veterinary practices have only enough staff to meet 
the existing needs of that practice and its normal volume of 
cases. What happened in a situation such as this one is that 
many veterinarians were alerted by the breaking story on 
television long before they were alerted via e-mail or phone 
call from their clients, colleagues or other vendors. Having a 
central reporting agency and a way for that agency to quickly 
disseminate the information would be a key factor in heading 
off similar problems in the future.
    A possible solution to this problem would be a program 
utilizing a network of sentinel veterinary hospitals and 
institutions across the country as a way to quickly get 
information to a central agency and get feedback in a likewise 
timely manner. It would be the agency's responsibility to 
educate the sentinel hospitals on how to interact with the 
give-and-take information. It would be the responsibility of 
the sentinel hospitals to educate their staff as to how to work 
internally on organizing and reporting to the agency. The 
sentinel hospitals would be reporting on a regular basis in the 
ideal situation, thereby establishing a surveillance baseline 
to predict and forecast potential crises. This would allow the 
agency to report back to the sentinel hospitals the proper 
diagnostics to engage in how to deal with these results. This 
is not really the agency's responsibility reporting to all 
veterinarians when a crisis occurs. If you continue to build on 
the existing infrastructure and prove the ebb and flow of 
information to a central reporting agency, we as veterinarians 
will have better ability to work with the Government at all 
levels, to aid in the surveillance and reporting of potential 
animal health related situations. Thank you.
    [The prepared statement of Dr. DeCarlo follows:]

                  Statement of Anthony DeCarlo, D.V.M.

    Thank you Mr. Chairman and members of the subcommittee, and 
thank you to Congressman Pallone (whose statement I've read) 
for an informative and heartfelt plea for better controls and 
reporting mechanisms when it comes to the health and safety of 
our pets. I consider it an honor to appear and give testimony 
before this esteemed Subcommittee.
    On April 5, Congressman Pallone visited Red Bank Veterinary 
Hospital to gather facts about how our hospital was dealing 
with suspected cases of contamination. Now he is working on his 
own legislation in the health care subcommittee he chairs on 
ways to improve Federal regulatory oversight, including the 
establishment of a central registry to expedite the 
Government's response to any future such situations.
    I don't feel that I can speak with authority on improving 
regulatory oversight because I'm not clear that a lack of 
oversight is indeed the reason for this problem to have existed 
and grown. What we need as veterinarians is to have a better 
mechanism in place to track unusual occurrences, be able to get 
information to an appropriate centralized reporting agency and 
then back out to the veterinary community in a timely manner.
    Congressman Pallone has done an excellent job of distilling 
a large body of information into an accurate and concise 
statement; as a result of this consolidation of information, I 
will be speaking this morning about an improved means of 
gathering and disseminating information from the veterinary 
perspective.
    There are many sites where veterinarians gathered 
information regarding this recall, from the American Veterinary 
Medical Association, to the State Veterinary Medical 
Associations, to the Pet Food Manufacturers, to the media and 
more. While each of these organizations did a fine job of 
relating their real-time information to their Web sites, the 
veterinary community does not have readily available resources 
to add to and retrieve this information in a focused and timely 
manner.
    Many veterinary practices have only enough staff to meet 
the existing needs of that practice and its normal volume of 
cases. What happened in a situation such as this one is that 
many veterinarians were alerted by the breaking story on 
television long before they were alerted via email or phone 
call from their clients, colleagues or vendors.
    Having a central reporting agency and a way for that agency 
to quickly disseminate the information would be a key factor in 
heading off a similar problem in the future. A possible 
solution to this problem would be a program utilizing a network 
of sentinel veterinary hospitals across the country as a way to 
quickly get information to a central agency and to get feedback 
in a likewise timely manner.
    It would be the agency's responsibility to educate the 
sentinel hospitals on how to interact with the give and take of 
information. It would be the responsibility of the sentinel 
hospital to educate their staff as to how to work internally on 
organizing and reporting to the agency.
    The sentinel hospitals would be reporting on a regular 
basis to the appropriate agency, thereby establishing a 
surveillance baseline to predict and forecast potential crisis.
    This will allow the agency to report back to the sentinel 
hospital the proper diagnostics to engage and how to deal with 
the results.
    This does not relieve the agency of the responsibility of 
reporting to all veterinarians when a crisis occurs.
    If we can continue to build on the existing infrastructure 
and improve the ebb and flow of information to a central 
reporting agency, we as veterinarians will have a better 
ability to work with the government, at all levels, to aid in 
the surveillance and reporting of potential animal health 
related issues.
                              ----------                              

    Mr. Stupak. Thank you. And thank you both for your 
testimony.
    Doctor, if I may. There have been reports in news media of 
thousands of cats and dogs falling ill and dying due to the 
contaminated pet food. Is there any good way to get an estimate 
on that number?
    Dr. DeCarlo. We've tried. There has been so much reporting 
to multiple places it's hard to get a real number. There's some 
generalizations that can be made. It appears, of those animals 
that we feel comfortable were a result of this problem, 
probably less than two-tenths. It ranges from 1 percent to less 
than three-tenths of a percent of those animals.
    Mr. Stupak. Let me ask you this. The Michigan Veterinary 
Medical Association reports that, as of April 16, there were 
155 suspected cases of pet illnesses caused by contaminated 
foods, with 52 deaths. In Oregon, as of April 24, the State 
veterinarian reports 106 suspected cases of illness and 38 
deaths. Now, applying those numbers across the entire United 
States, that would imply probably about 6,500 ill dogs and 
cats, and 2,250 deaths. Would that seem consistent with what 
you've been able to gather?
    Dr. DeCarlo. No, the percentages have been all over the 
place, and that is the problem. Because we are a small 
profession, and that is an important part of the statistics, 
and who reports where is a very selective group of people.
    We have seen situations where the mortality rate was less 
than 1 percent and as high as 10 percent and even higher. We 
have also seen numbers of the percent of animals who we think 
were affected range from three-tenths of a percent to 10 
percent of the entire volume of a specific institution or 
hospital.
    That is why, after having done this investigation myself, 
there really needs to be an organized and focused place for 
veterinarians to report any kind of situation to you so you 
would have these facts and very accurate facts.
    Mr. Stupak. So even based your investigation you really 
can't today give us any kind of an estimate as to how many dogs 
and cats died, how many became ill, even a best guesstimate?
    Dr. DeCarlo. I think the range of--well, there is two 
different questions there, those who have had died and those 
are affected. I think the affected numbers vary more, because, 
again----
    Mr. Stupak. Greater than 6,500.
    Dr. DeCarlo. Right, I think that is probably going to be 
more than that that have been affected. I think the problem 
with that situation is it was only recently that there are ways 
to confirm whether or not it was affected, and that is where I 
am going with this.
    Second, the fatality rates from some universities as well 
has been extremely low. In some cases, like I said, less than 1 
percent of those cases that are affected and as high as 10 or 
15 percent.
    The statistics that you just mentioned are extremely on the 
high side from the data we have gathered. Our own particular 
situation--which is a very large hospital--it has been about 1 
percent of the affected cases, mostly cats. That has been 
consistent, the majority had been cats, and the minority had 
been dogs.
    Mr. Stupak. Have you seen melamine poisoning in dogs or 
cats in the past? Have you seen this type of poisoning?
    Dr. DeCarlo. Nobody has looked, so you can't answer that 
question. I don't know.
    Mr. Stupak. OK, thanks.
    Ms. Shames, you indicate that the food supply is relatively 
safe. Yet we have had 20 different outbreaks in Salinas Valley 
in the last 10 years. How do you determine safe? Volume? 
Outbreaks? Deaths? Illness? How do you determine it? Because we 
lose about 5,000 people a year to food poisoning. So where does 
it become safe and nonsafe? What is the tipping point?
    Ms. Shames. We say it is generally regarded as safe or 
considered safe based on the numbers that CDC report.
    Now, granted, any single death or hospitalization or 
sickness is one too many. But, nevertheless, compared to other 
countries' food safety systems, we have to say that, for the 
most part, we have a safe system.
    Nevertheless, if you--as you pointed out, the number of 
incidences have been identified, and I think the problem 
becomes more and more complex as our food supply becomes more 
and more globalized. We have heard about some of the 
complicated networks here among retailers and distributors and 
producers, and I think it is a problem that we have to 
recognize as something that will be increasing in light of the 
demographics of this population.
    Mr. Stupak. We saw today we had three young children here 
who were sick. Now nobody ever would have put it together that 
they had food poisoning but for either press reports or their 
parents. I would imagine with young children and even I am sure 
with older adults it is, oh, a viral infection, and it will 
pass, and they had food poisoning. Maybe not to the point where 
they may need a kidney transplant, but a lot of it is 
underreported.
    Ms. Shames. Yes, you are absolutely right. That is the 
case. For many people, you may go out for dinner, feel a little 
queasy a little later and in a day or two you are feeling OK. 
Others may not recover quite as quickly. Go to see their 
physician, their physician may or may not go on to report or 
diagnose it. So you are correct. So the tendency is to 
underreport these incidences.
    Mr. Stupak. In preparation for this hearing, many of us 
were surprised to learn about, other than baby formula, the FDA 
has no right to recall any product. But it seems like we recall 
toys and tires and everything else in this country. Is this a 
safety concern that they do not have recall authority on food, 
the FDA? Did the GAO find that?
    Ms. Shames. We believe it does heighten risk that there 
will be increased sickness and increased death.
    What the other Federal agencies have told us, such as the 
Consumer Product Safety Commission, the National Highway 
Traffic and Safety Administration, that, for the most part, 
companies do cooperate. In other words, they do have a business 
incentive to try to ameliorate or fix the problem. 
Nevertheless, they have told us that they have had to exercise 
their recall authorities in certain cases.
    Mr. Stupak. Also, with that business interest, as we saw 
with the first panel, they had talked about lack of notice; no 
one telling them; if we would have known, we would have done it 
quicker. Somebody has to take the bull by the horns and either 
recall or put out a warning or something that has the authority 
to back it up.
    Ms. Shames. Right. For example, the Consumer Product Safety 
Commission requires that within 24 hours, if a company suspects 
that one of the products is unsafe, it needs to report it to 
that agency.
    Mr. Stupak. Within 24 hours of notice.
    Ms. Shames. Yes.
    Mr. Stupak. For questioning, Mr. Whitfield.
    Mr. Whitfield. Thank you, Chairman Stupak; and thank you 
all for being with us this morning.
    Ms. Shames, you were with the GAO, and recently you all 
came out with your high-risk report on Federal oversight of 
food supply. Now was that a report that was requested by a 
Member of Congress or Senate or what is the difference in a 
high-risk report and a non-high-risk report?
    Ms. Shames. GAO has been preparing its high-risk series 
since the early 1990s, and we prepare it for each new Congress 
as a way of providing them information of what we think are the 
most pressing issues that Congress should address.
    The high-risk series has evolved over the years. At its 
outset, it was looking primarily at issues of fraud, waste and 
abuse. And that is why you would see, for example, the 
Department of Defense contracting as an issue there.
    But over the years we have recognized and the list has 
evolved so that we are looking at Government systems, and that 
is why we thought that food safety--based on identified 
criteria that we have issued to Federal agencies, we felt that 
food safety was an area that merited the high-risk designation.
    Mr. Whitfield. OK, and how many high-risk designations did 
you all prepare for this Congress?
    Ms. Shames. There are close to 30 high-risk issues.
    Mr. Whitfield. So this food safety is high up on your list 
of problem areas?
    Ms. Shames. It is a Federal issue. We consider it to be of 
topmost importantance.
    Mr. Whitfield. I was a little bit shocked that you had 
indicated that FDA is responsible for 80 percent of the food 
supply and USDA is responsible for 20 percent, but USDA 
receives 80 percent of the funding and FDA receives 20 percent 
of the funding.
    Ms. Shames. Yes.
    Mr. Whitfield. Now would there be any rational explanation 
for that kind of disparity?
    Ms. Shames. The Federal food safety system has evolved over 
the years. It has been piecemeal, as has been observed by many 
people already. It tends to react to a crisis and then 
attention subsides. So it really is a patchwork, and that is 
why we say that it is the fragmentation that really is the 
source of many of the problems.
    Mr. Whitfield. Because you have 15 organizations and 30 
separate laws, correct?
    Ms. Shames. Yes. Yes.
    Mr. Whitfield. But the FDA is responsible for the entire 
food supply, with the exception of meat, poultry and processed 
eggs, is that correct?
    Ms. Shames. That's correct.
    Mr. Whitfield. And yet they only receive 20 percent of the 
funding.
    Ms. Shames. Twenty percent of the funding, that's right, 
for inspection activities, that's right; and that is the bulk 
of the Federal expenditures.
    Mr. Whitfield. Now Chairman Stupak had mentioned, and we 
saw that earlier, that there are mandatory recalls available to 
the Federal Government for tires, for toys, for whatever, but 
there is no mandatory recall available for food. What are the 
arguments against mandatory recall for food?
    Ms. Shames. USDA and FDA could, if they needed to, seize 
products if they deemed them to be contaminated; and they could 
detain those products for up to 20 days. After that time 
period, there would need to be some sort of court injunction to 
say that the food needs to be condemned.
    Mr. Whitfield. But in the salmonella Peter Pan peanut 
butter case, if ConAgra had not recalled that peanut butter 
voluntarily, the Federal Government could not have recalled it?
    Ms. Shames. No. Could not have the mandatory. The recall 
authority is strictly voluntary. It would have been up to the 
companies to disclose that this was happening.
    Mr. Whitfield. Dr. DeCarlo, I know that FDA, for example, 
has a regulation that says if any animal has one of like 12 
different chemicals or medicines in its carcass it cannot be 
used for human consumption, and you may not be aware of that, 
but I am aware of that.
    Dr. DeCarlo. Yes.
    Mr. Whitfield. But yet USDA is the agency that is required 
to enforce that regulation. So FDA makes the regulation, USDA 
enforces the regulation, and it is my understanding, from 
analysis, that USDA really does not have a very good mechanism 
in place to detect those particular chemicals in those animals 
used for human consumption.
    But if a pig, for example, is down on a farm and digests 
melamine and then ends up being slaughtered for human 
consumption, is that anything that would really concern you? Or 
is that so remote that it is really not something we need to be 
concerned about?
    Dr. DeCarlo. It certainly would concern me.
    Again, I think the problem is how do we deal with that? I 
think, again, our biggest--our biggest problem is really 
getting information. And I think the multiple agencies out 
there makes it confusing for us on what to do and how to do it. 
It has only been recently that we have been notified that there 
are two places in the country that will test for this in the 
urine to help make a diagnosis. That took a long time coming. 
It was available.
    So, not to disregard your statement, I still think all 
these things are of concern. We just need a system that gets 
you the information quickly as well as you getting the 
information. The less agencies involved--I am not a politician, 
so I don't know how it all works, but simplicity works most 
efficiently. So that really is a concern.
    Mr. Whitfield. Thank you very much.
    Mr. Stupak. Ms. DeGette for questions, please.
    Ms. DeGette. Thank you, Mr. Chairman.
    Mr. DeCarlo, I think you hit on something. Simplicity is 
always good. And one of the things that we are concerned about 
is, with food safety, is that we have--and this isn't really a 
pet food issue, but with food for humans we have 15 agencies 
administering 30 laws, as Ms. Shames said in her paper, and so 
that is what we are trying to figure out.
    Ms. Shames, one idea that I have had for some time--and I 
have been working with Congresswoman Rosa DeLauro about this--
is the idea of having one agency sort of in charge of meat and 
other types of food. Because you have this weird situation 
which we have talked about in this committee before, like 
pizzas, and you raised this in your paper, where if you have a 
cheese pizza, then the FDA has jurisdiction over that. But if 
you have a pepperoni pizza, then that is the USDA, right?
    Ms. Shames. That is correct.
    Ms. DeGette. And those agencies have very different 
regulatory schemes, correct?
    Ms. Shames. Correct.
    Ms. DeGette. Can you describe for a minute about how those 
two pizzas would be regulated in a different way?
    Ms. Shames. Yes, I can. USDA, for example, is required by 
statute to have continuous presence in a processing facility. 
So, in other words, every carcass needs to be looked at every 
day.
    In FDA, that is not the case. There is no statutory 
requirement in terms of its oversight or inspection to the 
food; and, for that reason, FDA inspects the food as frequently 
as it can.
    Ms. DeGette. I guess maybe there was, in the long-past 
history, some sense maybe because meat could be more potential 
to be contaminated than cheese or something like that.
    Ms. Shames. That is possible. In truth, our diets have 
changed; and we are consuming less meat. We are eating more 
seafood. We are eating more fresh produce. So we need to make 
sure that the regulatory structure meets consumers' needs.
    Ms. DeGette. Right. And this is one thing when you were 
talking about the mandatory recalls of some of the other 
agencies, and I have been talking about that this morning, 
mandatory. If you had mandatory recalls, then it would seem to 
me that as with these--I am wondering what the Consumer Product 
Safety Commission and others have said to you. If you had 
mandatory food recalls, it would seem that would give more 
incentives for the industry to get ahead of the curve. What 
would your view be on that?
    Ms. Shames. That is what these other agencies told us, is 
that generally with that authority they know that businesses 
are likely to cooperate. But, nonetheless, there have been 
instances where they have had to rely on this mandatory recall 
authority.
    Ms. DeGette. So if you had the mandatory recall authority, 
they would probably be more forthcoming with their--from a PR 
standpoint--to get ahead of the curve to announce a recall.
    Ms. Shames. That is certainly how these other agencies 
feel.
    Ms. DeGette. I am wondering--the staff told me for the last 
panel that, right now, the food safety reporting is if a health 
care provider finds something in the stool, say, with these 
young girls who were on our last panel, then they report it to 
the County Health Department, who then reports it to the CDC, 
and then somehow some eager reporter gets ahold of it, it 
becomes publicized. Is there some more efficient way to, A, 
report and, B, to publicize recalls or outbreaks of diseases?
    Ms. Shames. It is certainly worth asking FDA how it breaks 
down or identifies if there is some sort of food contamination.
    What we did find out in our October, 2004, report is that 
what FDA had posted in terms of once it started to suspect that 
there was outbreak, that consumer groups told us that the 
information could have been more effective, and you have heard 
some of the concerns from the last panel.
    One thing that we were hearing is that they wanted more 
specificity, and I think FDA heard and certainly is following 
through on that one recommendation. For example, when we were 
preparing for this hearing, we found that FDA has a pilot in 
terms of the way it disseminates information for an outbreak, 
and they are now including a photograph of the product that is 
suspected or has been confirmed to be contaminated.
    Ms. DeGette. And are they doing anything with targeting 
where the outbreak is to be sure that they give the 
notifications to those geographic areas?
    Ms. Shames. They post it in a blanket e-mail or a Web site, 
so they have not targeted that way. Agency officials told us 
that they don't have the authority even to identify the place 
of retail where a certain product may have come from.
    Ms. DeGette. That would be problematic.
    Thank you very much.
    Mr. Stupak. Mr. Walden from Oregon, questions, please.
    Mr. Walden. Thank you very much, Mr. Chairman; and since I 
didn't get an opening statement do I get my extra 3 minutes?
    Mr. Stupak. We will let you go a little bit.
    Mr. Walden. I thought that is the rule.
    Mr. Stupak. We usually announce that at the beginning of 
the hearings. Go ahead.
    Mr. Walden. First of all, I want to go to Ms. Shames.
    I hear a lot from my constituents regarding the lack of 
inspection of imported foods, and I think this latest incident 
with the wheat coming from--wheat gluten coming in from China 
wholly elevates that issue. One of the things we are told is 
there are chemicals and things allowed to be used in foreign 
countries that are prohibited for use here. First of all, that 
is the case?
    Ms. Shames. We haven't looked at that specifically.
    What FDA does have the authority to do, though, is to have 
certain equivalency agreements with countries that import food 
to this country. We were looking specifically at seafood a 
couple of years ago and reported that FDA had not had any of 
those agreements for imported seafood.
    Mr. Walden. Was there not an outbreak a year or two ago 
involving--I think it was salmonella, it may have been E. coli, 
on melons? It was the outside of melons, and it turned out 
there was human waste perhaps being used as fertilizer in a 
foreign country and that the people--the melons then were 
imported here and people got sick.
    Ms. Shames. I am not familiar with that particular 
instance, but that was certainly one of the hypotheses for the 
outbreak of the E. coli contamination for the spinach.
    Mr. Walden. And did that turn out to be the case?
    Ms. Shames. CDC and California State Health Department is 
saying that it is from the runoff of wild animals and 
contaminating the water; and the water runoff was what then 
caused the pathogens in the spinach.
    Mr. Walden. From wild animals?
    Ms. Shames. Yes.
    Mr. Walden. Interesting.
    The bag of lettuce here that the chairman raised up, and it 
talks about how this is multiple washed, or at least one of 
them was three times washed, and this is completely washed. Can 
you wash lettuce or spinach and get rid of the E. coli 
pathogen?
    Ms. Shames. That is a good question, and certainly the more 
rinsing it helps. I couldn't tell you exactly how many times 
the food would have to be rinsed. Generally, those foods with 
the thinner skins such as grapes, strawberries tend to 
infiltrate the pulp of the food. Melons, for example, it is a 
little safer.
    Mr. Walden. If you would at some point take a look at this 
issue of inspections of imported foods especially relative to 
chemicals being used in foreign countries on producing 
foodstuffs that our providers, our agencies have said those 
aren't safe to use, I would sure like to know the answer to 
that at some point. If you could get a written answer for the 
record, that would be helpful, to the extent you can.
    Mr. Whitfield. Dr. DeCarlo, I appreciate your testimony 
today.
    Last fall, I toured a facility out in Oregon called the 
Banfield Pet Hospital that you may be familiar with.
    Dr. DeCarlo. Yes.
    Mr. Walden. Veterinarians of most of the pet companies, I 
think. We went through their new facility that included a 
computer room where I believe the storage capacity was 
something like three tetrabytes of computer storage, and they 
track everything related to the animals that come in. They look 
at what the symptoms are, then what the diagnosis is, and they 
follow it through, and they have review panels.
    In fact, when the gentleman was done showing me the 
facility, I said, gee, that would be great for human health 
care. I wonder if we could get there. But it strikes me that 
there are some databases such as that that might be available. 
Would accessing some partnership with organizations like that 
that have that those pool of data, would that help us in 
identifying these problems quicker?
    Dr. DeCarlo. Yes. However, what I would say to you about 
that in what I am proposing the selection of databases need to 
come from several areas. Because what we have in our 
profession, our general practice is, which is what Banfield is, 
we have specialty practices which consist of specialists. Then 
we have universities, and I would not eliminate shelters. 
Because I am approaching this from all possibilities, both 
infectious disease, toxins, all those things I think we need to 
do that.
    So the tendency for these different places to make their 
diagnosis are based on different criteria. So, for example, 
there may be one faction of the profession that may to some 
degree--I don't mean this in an inaccurate way--may tend to 
over-diagnose, others may under-diagnose because of training 
preferences and that kind of thing. And you also have to deal 
with volume of each one of these places versus--and you--
unfortunately, you also have to look at locations as well.
    But to your point, I think what is important to note if we 
go this route and choose hospitals and information, they do 
have to have sophisticated IT; and not all hospitals will have 
not only the computer equipment but also staffing. Veterinary 
hospitals, for the most part, 70 percent of our profession are 
small hospitals. They are working to the max already.
    So that is why I think the selection process with who you 
would choose should be a group effort and really span the 
different types of veterinary practice out there.
    Mr. Walden. Isn't it also true that some diseases that pop 
up in animals could be a link to a future human problem? For 
example, the bird flu, I understand, affects cats. And to the 
extent you would see a spike in cat illness related to the bird 
flu might be a precursor or at least an indicator that we might 
have a potential human outbreak.
    Dr. DeCarlo. Yes. This model is not new. There is a county 
in New Jersey that is testing this out. They are educating us. 
They are looking at more from a terrorist point of view and how 
it would present in animals. That is where the Sentinel Group 
idea came up.
    The mistakes--I shouldn't say mistakes, but the things that 
became obvious to us was that we had to choose the right place 
that could get the information back to these agencies and also 
some degree of funding as well. But there is no question for 
our profession we need a single place to send all this 
information to. Because it can predict problems ahead of time. 
But, more importantly, I think rules and laws are great and no 
matter how you make it things are still going to fall through 
the cracks. So when this happens that information highway has 
to be simple.
    Mr. Walden. I would conclude, and I thank the chairman for 
his generous allocation of time here, but as we look at how to 
coordinate agencies, we did that with Homeland Security, and 
that didn't necessarily solve the every problem related to the 
Nation's security. We need to continue a vigilant effort in 
terms of what is working and what is not.
    So I appreciate your testimony and that of the other 
witnesses. So thank you, Mr. Chairman.
    Mr. Stupak. Homeland Security, they are part of this whole 
food inspection aspect now, too. So it seemed like we added 
another agency involved in and made it more splintered, our 
inspection process.
    Ms. Shames. Yes, the Department of Homeland Security is the 
designated Federal agency to address any agra terrorism.
    Mr. Whitfield. Mr. Chairman, I appreciate your giving Mr. 
Walden the opportunity to go a minute and 54 seconds over, but 
I just want to just clarify. I know when he gave his opening 
statement--he did not give his opening statement and he said 
that, because of that, that he would get an additional 3 
minutes. And I was just curious, is that still the rules of our 
committee or what is our situation?
    Mr. Stupak. Rules of our committee does not address it. As 
you also know, many times we will go 10 minutes for a round. I 
think before each hearing we should probably sit down, you and 
I, and discuss it and get it down. And that is why I was more 
than happy to let Mr. Walden do it, because I did appreciate 
his waiving his opening statement. As a general rule, we try 
and move it along.
    Any more questions, Mr. Walden?
    I think we are next with Mr. Inslee.
    Mr. Inslee. I yield a couple minutes to Mr. Walden, if he 
needs any more.
    Mr. Walden. No.
    Mr. Inslee. Thank you.
    I was reading some reports about some potential melamine 
contamination of wheat gluten, and there was some suggestion 
that this actually was in wheat gluten originally that was 
actually food grade that would have been eligible for use in 
human consumption that, by luck--and I don't want to be 
disparaging our animals--but, by luck, was not in human 
consumption but was eligible for it.
    Is there any light any of you can shed on that situation at 
the moment?
    Ms. Shames. I can't speak specifically to that, to the 
melamine, except that it just underscores how the Federal 
oversight of food safety needs to be considered from a 
Government-wide perspective. Because we do have these 
interconnections with ingredients that may get into either pet 
food or possibly animal feed which then is ingested by hogs 
that may get into the food chain. It is something that needs to 
be addressed on a system-wide basis.
    Mr. Inslee. So coming back to this recall issue, to me it 
has always been stunning to me that the Government doesn't have 
recall authority for food. We have it for cars and various 
other consumer products but not the stuff we actually put into 
our bodies. That has never made a lot of sense to me, and it 
has worked I think fairly well in some of our industry.
    Could you talk about, as far as in a recall scenario, what 
mandatory reporting--what would trigger mandatory reporting to 
an agency of a problem that the industry has recognized or 
experienced? And could you describe at all how you consider 
recall authority has worked in other industrial applications?
    Ms. Shames. Well, we are looking at other countries and 
their food safety systems, and certainly one of the issues 
would be to see how they address recall. I can tell that you 
the Canadian food system does have mandatory recall, and it is 
something that they feel that at times they need to exercise.
    I think in terms of the specifics for either USDA or FDA, 
it is worth looking at what other agencies have and certainly 
to see if it is appropriate in the food instance. For example, 
24 hours may be the right number, it may be too long, it may be 
too soon for certain outbreaks, and what we need to do is just 
study and to see what makes sense, given these circumstances.
    Mr. Inslee. Thank you.
    Mr. Stupak. Does the gentleman yield back?
    Mr. Inslee. Yes, I would yield.
    Mr. Stupak. OK, Mr. Burgess for questions, please, 5 
minutes.
    Mr. Burgess. Thank you.
    Dr. DeCarlo, help me with something, if you would. When we 
first heard about the pet food problem, the original compound 
that was pinpointed was eminoptrin folic acid antagonist; and 
now we hear it is melamine, which is, I guess, a plastic 
polymer. What is the reason that eminoptrin first came to the 
news media's attention as the culprit in this?
    Dr. DeCarlo. I am probably not the right person to ask that 
question. I think you probably have your information from the 
same sources that I do.
    Mr. Burgess. CNN.
    Dr. DeCarlo. CNN. And, actually, there were many, many 
sites to get information from and some conflicting, so I don't 
have any factual information that would be helpful to that 
question. So I apologize.
    Mr. Burgess. We are now pretty certain in our assumption 
that it is melamine that is causing this?
    Dr. DeCarlo. Yes, I think from what I can read on the 
medical side that it certainly has affected cats more than 
dogs; and there is many reasons for that. One may be because of 
the foods they are eating but also because cats don't process 
toxins as well. They have a different system for that. There 
are--people feel that sometimes it doesn't explain the symptoms 
as well, but I think the majority of the literature is pretty 
comfortable with that association at this point.
    Mr. Burgess. Do we know the concentrations of this compound 
that they are detecting in the wheat gluten?
    Dr. DeCarlo. No, but that would be a great thing for us to 
know about.
    Mr. Burgess. Do we have an idea from previous laboratory 
analysis what is the LD 50 of melamine for cats and dogs?
    Dr. DeCarlo. I think that probably exists, but I don't know 
the answer to that.
    Mr. Burgess. Do you guys routinely suspect a food-borne 
illness when checking into outbreaks of disease in domesticated 
pets?
    Dr. DeCarlo. I think we do. It is probably a little bit 
easier with animals because they tend to eat a lot of things so 
that is high on our list of differentials, especially in this 
situation. Even though cats have high incidences of renal 
disease, usually it is chronic renal disease in older cats. So 
to cure renal disease one of the first things we look for is a 
toxin, because it is so unusual to see acute renal disease in 
young cats. But in our profession, since it is a common thing, 
food ingestion of toxins is the first thing we ask because it 
is in the nature of the cases we see.
    Mr. Burgess. When this outbreak first started, was there--
there was no difference between animals that were completely 
indoor animals versus outdoor animals. You mentioned that dogs 
and cats do eat a lot of things out in the environment.
    Dr. DeCarlo. I can't answer that. No one has looked at that 
indoor versus outside.
    Mr. Burgess. If I could, Ms. Shames, let me ask you, you 
referenced in some of your remarks that you have looked at the 
United States food supply in comparison with other countries, 
similar demographics, similar population, and said the United 
States' food supply on the whole is safe. Did I understand that 
correctly?
    Ms. Shames. Yes.
    Mr. Burgess. In that course of doing that part of your 
analysis, I guess one of the things that troubles me in reading 
your report, and it has already been referenced, you have 
different agencies looking at a pizza, depending on what the 
topping is, and you have a different agency looking at a 
sandwich, if it is an open-face sandwich versus a complete 
sandwich. Is there any country this has a more streamlined 
approach to the problem at hand? You reference that we have 
kind of grown up with a patchwork of regulations. Is there a 
model out there that suggests a better way to do this?
    Ms. Shames. We actually have an ongoing engagement to look 
at the other countries. Similar to ours, they started out as 
being fragmented. It was--they would describe it, too, as 
something that evolved piecemeal. They did go for a more 
consolidated approach.
    Now we are looking further at what they mean by 
consolidated. Some of them actually did go as far as merging 
all of their agencies into one single food agency. Others 
merely reduced the number of agencies. But we are now, at the 
request of Congresswoman DeLauro and Senator Durbin, looking at 
what actually are the positive consequences of these countries' 
reorganizations of their countries' food safety systems.
    Mr. Burgess. And certainly I think the committee would 
appreciate that follow-on information as well.
    You referenced in food safety you depend upon industries 
involved for a voluntary recall. Has there ever been a 
situation where a company or manufacturer has refused to issue 
a recall when asked to do so by the appropriate agency?
    Ms. Shames. Neither FDA nor USDA ever told us that there 
was a company that refused.
    Mr. Burgess. Has there been a pattern of foot dragging and 
not complying as quickly as the USDA or FDA normally would 
like?
    Ms. Shames. What we know from the other agencies that do 
have this mandatory recall authority is that it is something 
that--it is a tool that they have in their belt. It is 
something they don't use on a routine basis. Nevertheless, they 
have felt that they have had to use it in given instances. And 
similarly, for FDA and USDA, we feel it is a case where--to 
give them the same sort of authority and tools that the other 
Federal agencies have.
    Mr. Burgess. But has anyone in either other agency ever 
said to you, boy, if we only had the ability to do a recall, to 
mandate a recall, this would never have happened? Have we ever 
gotten a situation like that?
    Ms. Shames. No.
    Mr. Burgess. Thank you, Mr. Chairman. I yield back my time.
    Mr. Stupak. I thank the gentleman. Mrs. Blackburn for 
questioning, please.
    Mrs. Blackburn. Mr. Chairman, just three quick questions.
    Do you think the Federal Government needs the authority to 
mandate recalls?
    Ms. Shames. We have recommended that for both USDA and FDA.
    Mrs. Blackburn. So you would support that and you would see 
that as a positive thing to mandate?
    Ms. Shames. Yes.
    Mrs. Blackburn. OK, one of the things that seems to--and 
you have talked a good bit about the piecemeal approach and the 
fragmentation, but it also seems when you look at the FDA and 
USDA, we also have the medical community over here that is not 
accessing this information, even the CDC I think one of our 
earlier witnesses mentioned, there seemed to be a lack of 
communication there. So I feel like not only do we have a two-
tiered problem with the FDA and the USDA but being certain that 
we move this over for the medical community and the public at 
large.
    So as you go looking at the other countries, I think what 
we would like to have is not only the thoughts on this but 
looking at what would be the best recommendations, the best 
practices, that you would have for the agencies in streamlining 
their approach and making certain that the food supply systems 
are safer but also what the recommendations would be for the 
medical community to access this, our hospitals, our trauma 
care centers, et cetera, and then the public notification 
system on situations like this.
    What we heard from our first panel was they did the legwork 
themselves and that they got into this and realized there was 
no orderly process for reporting or for discovery. I think we 
would appreciate having your top recommendations for that, and 
you may have something right now that you would like to add for 
the record.
    Ms. Shames. Nothing that I can add for the record for 
specific recommendations, but surely, as we start to design 
this engagement, we will be looking at the pressing issues that 
this country is facing.
    One thing that the high-risk list does is that we report 
then on the progress that agencies have made in terms of 
addressing these high-risk issues. Certainly we can learn from 
other countries' experiences, and we will try to integrate as 
much information as possible from what we have learned 
overseas.
    Mrs. Blackburn. OK, when you are looking at other countries 
with our food supply, are we safer than or as safe as other 
countries and have our incidences of death and illness 
increased or decreased over the past decade?
    Ms. Shames. We haven't looked at the data longitudinally in 
terms of what their safety is. In fact, even CDC is trying to 
get behind the numbers that they have been publishing for the 
number of deaths, hospitalizations and illnesses. So it is 
something that the data reliability is very important and we 
would be looking for to see how complete and accurate and 
consistent the reporting system is.
    Mrs. Blackburn. I think we would like that qualified data 
once you have it and can say this is how we stack up in 
relation to other countries.
    One quick other question, mandatory recall, would it have 
made a difference in either the peanut butter or the spinach 
situation we have heard about this morning?
    Ms. Shames. Applying it to these specific instances, we 
haven't looked specifically for the peanut butter or the 
spinach. Just generally speaking, we feel that this authority 
is something that has the potential of expediting the recall. 
We found that when FDA and USDA did carry out their voluntary 
recall programs, oftentimes by the time the food was removed 
from the shelf it had expired from the shelf life. And this is 
especially important for fresh produce.
    Mrs. Blackburn. Thank you. I yield back.
    Mr. Stupak. Any further members have any further questions 
of this panel?
    Hearing none, I will excuse this panel and thank you again 
for your testimony.
    Mr. Burgess. Mr. Chairman, if I can follow up on that last 
point, I would agree that in the case of the E. coli 
contamination of the spinach I don't know of the mandatory 
recall because of the time involved would have made a 
difference. But on the peanut butter situation, where they 
continued to feed the patient the product in the hospital, in 
the nursing home, that one does bother me. If there had been a 
recall issued in January, that process might have been stopped.
    I am not smart enough to say it would have made a 
difference in the clinical outcome, but as somebody who has a 
background in health care I would have liked to have known that 
and stopped feeding the patient the product many months before 
it was actually discontinued.
    Ms. Shames. We did look at some of the recalls of FDA, and, 
clearly, for canned foods--in fact, we looked at a recall for 
canned soup and because the shelf life of that canned soup is a 
couple of years the recall was more thorough and more complete. 
It was less complete when you looked at ground meat, for 
example, that has a shelf life of a couple of weeks and surely 
the same thing for fresh produce. So it does get problematic 
the more fresh the produce or food happens to be.
    Mr. Stupak. Also, wouldn't there be a benefit if you used 
recall to help physicians and help diagnose situations such as 
we had with young children where they think it might be a viral 
infection where in fact you can focus in more clearly on 
another possibility? That is where I would see a recall would 
also help.
    Mr. Burgess. There is. Syndromic surveillance would play a 
greater role, and that ties into the whole heath IT argument 
debate we have back and forth on the ability to get information 
to emergency rooms and practitioners in a timely basis. That is 
what we saw here with anthrax.
    Mr. Stupak. It was amazing. In each one of the cases--the 
first panel, they learned it from the news media or it was Mr. 
Pruden's sister or sister-in-law who was a nurse that said 
check for the brown urine in order to check the problem, to 
diagnose the problem. Otherwise, we would still be treating a 
viral infection.
    Thank you. Anything further from any members? Thank you 
again to this panel.
    We will call up the third and final panel.
    Our third panel consists of Mr. Charles Sweat, president of 
Natural Selections Foods; Mr. David Colo, senior vice president 
of manufacturing at ConAgra Foods; Mr. Paul Henderson, CEO at 
Menu Foods Income Fund; and Mr. Stephen Miller, CEO at 
ChemNutra.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised witnesses have the right under 
the rules of the House to be advised by counsel during 
testimony. Do any of you gentlemen wish to be represented by 
counsel? Mr. Henderson? Mr. Sweat.
    Mr. Sweat. Yes.
    Mr. Stupak. Would you identify your counsel for the record 
please?
    Mr. Sweat. Marty Schenker.
    Mr. Stupak. Mr. Colo?
    Mr. Colo. No.
    Mr. Stupak. And Mr. Miller, sir, do you have counsel 
present with you?
    Mr. Miller. Yes.
    Mr. Stupak. Would you identify your counsel for the record?
    Mr. Miller. Mr. Marc Ullman.
    Mr. Stupak. Next, as you know, we do take testimony under 
oath, so I am going to have you ask you all to please rise and 
raise your right hand.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect all four witnesses 
answered in the affirmative. They are under oath.
    We will begin with the opening statements, 5-minute opening 
statement. Mr. Henderson, please, if you begin with your 5 
minutes, please, opening statement, sir.

 STATEMENT OF PAUL K. HENDERSON, PRESIDENT AND CHIEF EXECUTIVE 
                      OFFICER, MENU FOODS

    Mr. Henderson. My name is Paul Henderson, and I am the 
president and chief executive officer of Menu Foods. The 
subcommittee invited me today to discuss issues of food 
security and, in particular, the recent terrible situation 
involving pet food manufactured with contaminated Chinese wheat 
gluten supplied by ChemNutra to several pet food manufacturers, 
including Menu Foods.
    Let me begin by noting that I am a pet owner and many of 
our employees are pet owners. My dog eats food manufactured by 
Menu Foods. I understand and my employees understand the loss 
felt by pet owners as a result of the pet food made with 
contaminated ingredients. All of us at Menu Foods deeply 
sympathize with pet owners.
    Who is Menu Foods? Menu Foods has three manufacturing 
plants in the United States, employing more than 800 workers 
here; and the majority of our assets and sales are in this 
country. Menu is recognized in the pet food industry as a 
quality manufacturer. This might seem a little odd in light of 
the recent recall product, but, as I sit here today, I can't 
think of a more accurate description of my company.
    How can I say that? Well, for starters, just look at our 
customers, particularly the national brands for which we 
manufacture. They are the market leaders, and quality pet food 
is what they are all about. Each had a choice in who would 
manufacture for them and each turned to Menu.
    In reality, it wasn't that easy. For many, we first had to 
demonstrate an ability to manufacture at a level of quality at 
least as good as their own. These branded pet food companies 
sent their inspectors to our plants and satisfied themselves as 
to our abilities and our quality.
    Sometimes they identified a procedure that was standard 
within their plants and required us to adopt the same procedure 
in order to secure their business. By doing so, they 
contributed to our own improvement efforts, with the result 
that, today, we are one of the highest-quality operations in 
the United States.
    But we don't stop there. All of our facilities are 
routinely audited by outside experts. Many of our branded 
customers conduct annual audits of the menu plans manufactured 
for them.
    In addition, we are inspected by the USDA's Animal and 
Plant Health Inspection Service, the Canadian Food Inspection 
Agency, the European Food Safety Inspection Service, the 
American Institute of Baking, and Menu's Pennsauken plant was 
inspected by the FDA in 2006. In over 35 years of business, 
Menu has never had a food safety related product recall until 
the tragic events involving the contaminated wheat gluten.
    A lot of speculation has taken place concerning Menu's 
activities leading up to that recall. Much of that speculation 
has been inaccurate, and we are pleased to correct that record. 
A detailed timeline was provided with my written remarks, so I 
will not repeat that here. Instead, let me summarize the 
situation by describing what it is and what it is not. First, 
what it is not.
    This is not a situation caused by unclean facilities, poor 
manufacturing problems or similar problems. Our facilities are 
first rate. Our sanitation and manufacturing processes are 
state of the art. This is not a situation where lax inspection 
of Menu allowed a problem to occur. We have rigorous internal 
and external inspections. Inspections of our plants would not 
have prevented the melamine contamination of the wheat gluten.
    This is also not a case of reacting improperly to the 
situation facing us. We took appropriate actions based on the 
information available at the time.
    Let me put this situation into context. In 2006, Menu sold 
approximately 3.2 million containers of pet food per day. In 
contrast to this number, at the time we decided to initiate the 
recall, we had a handful of reports from consumers, three 
consumer reports passed along by a customer and reports from a 
taste test facility.
    None of these problems conclusively pointed to our food as 
the cause of the problems. At the same time, Menu had conducted 
tests of all industry recognized causes of renal failure, and 
these tests had revealed no problems at all with our pet food. 
In fact, it took the FDA, prestigious research organizations 
and commercial laboratories several weeks of hard work to 
identify melamine in ChemNutra wheat gluten as the source of 
the problem.
    However, in the face of the circumstantial information, we 
put the interests of pets and pet owners first and notified the 
FDA and began a voluntary precautionary recall.
    We have cooperated in every way with the FDA's 
investigations and the efforts to identify the source of the 
problem.
    Now let's consider what this is, or at least what it 
appears to be.
    What this appears to be is a deliberate case of 
contamination of wheat gluten in order to pass off substandard 
product. Melamine was previously unreported as a contaminant in 
wheat gluten. Melamine is high in nitrogen, which is 
significant, because the industry's standard test for protein 
content for wheat gluten is based on a quantity of nitrogen. 
Melamine would make wheat gluten appear to have a higher 
protein content than was actually the case.
    For a seller who knows how the industry testing methods 
work, this would allow them to cheat buyers; and if it were not 
for the previously unknown toxicity of melamine in cats and 
dogs, the scam would have worked.
    It appears likely that the public, Menu and other pet food 
manufacturers were the victims of a fraud.
    Menu has taken several steps to address the situation, 
including testing wheat gluten and other vegetable proteins for 
melamine, increasing our screening process of new suppliers, 
and discontinuing all business relationships with ChemNutra.
    We are also working with Congress, the FDA and the Pet Food 
Institute and other interested parties in their investigations 
and in formulating additional measures for preventing similar 
occurrences in the future.
    Thank you.
    Mr. Stupak. Thank you.
    [The prepared statement of Mr. Henderson follows:]

                     Testimony of Paul K. Henderson

    I am Paul Henderson, CEO of Menu Foods Income Fund. The 
subcommittee invited me today to discuss issues of food 
security and in particular the recent terrible situation 
involving pet food manufactured with contaminated Chinese wheat 
gluten supplied by ChemNutra Inc. to several pet food 
manufacturers, including Menu Foods.
    Let me begin by noting that I am a pet owner, and many of 
our employees are pet owners. My dog eats food manufactured by 
Menu Foods. I understand, and our employees understand, the 
loss felt by pet owners as a result of pet food made with 
contaminated ingredients. We deeply sympathize with these pet 
owners. However, we cannot turn back the clock, so now we must 
analyze what happened and how it happened and consider the 
steps that the pet food industry and Government agencies should 
take to try to prevent things like this from happening in the 
future.
    Much has been said and written about these recent events, 
and a lot of it has been inaccurate. I appreciate the 
invitation to appear before the Subcommittee today to explain 
what actually occurred and to share my thoughts on the future 
of food safety in the pet food industry.

                        Background of Menu Foods

    Menu Foods is the leading North American private-label/
contract manufacturer of wet pet food products sold by 
supermarket retailers, mass merchandisers, pet specialty 
retailers and other retail and wholesale outlets. Menu Foods 
was formed in 1971 and went public in 2002, trading on the 
Toronto Stock Exchange.
    Menu Foods was founded in Canada, but our U.S. operations 
are much larger than our Canadian operations. We have three 
manufacturing plants in the United States, which are located in 
Emporia, Kansas; Pennsauken, New Jersey and North Sioux City, 
South Dakota. Menu Foods employs more 700 workers in the United 
States, and the majority of our sales are in this country.
    Menu is recognized in our industry as a quality leader. We 
are known as the manufacturer of choice in the private-label 
pet food industry by retailers that value quality in their 
products. In over 35 years of business, Menu had never had a 
food safety-related product recall until the recent tragic 
events involving the contaminated wheat gluten. Menu produced 
over 1.1 billion containers of pet food last year, so this is 
quite a record, and we were very proud of it. We hope we can 
restore our reputation, and we are working hard to do so.

                          Menu Foods--Products

    Menu Foods manufactures two basic types of wet pet food: 
``loaf'' products, which have a pate-like consistency, and 
``formed'' products where formed, precooked pieces are put into 
the product. The formed products include ``cuts & gravy,'' 
which resembles stew, and products that include flakes or 
slices. Menu Foods does not manufacture dry pet food.
    The contaminated wheat gluten supplied by ChemNutra caused 
us to recall some of our products (primarily cuts & gravy 
products) manufactured at three plants from November 8, 2006 
through March 6, 2007.
    Wheat gluten is a natural vegetable protein extracted from 
wheat grains or flour and is a by-product of wheat starch. Only 
about 20 percent of the wheat gluten used by human food and pet 
food manufacturers in the US is produced in the US. Most of the 
wheat gluten is imported from Europe or Asia. Our United States 
plants buy wheat gluten from several suppliers around the 
globe. Wheat gluten is used by some pet food manufacturers, 
including Menu, as an ingredient in formed meat products. It is 
a source of protein and also has unique properties that help to 
hold together the chunks of meat. Wheat gluten is also used by 
manufacturers of human food products, mostly for baking.

       The Problem: ChemNutra's Sale Of Contaminated Wheat Gluten

    Wheat gluten has been in short supply, and in 2006 we 
decided we needed to add an additional source for this 
important ingredient. In November 2006, Menu Foods bought wheat 
gluten from ChemNutra for the first time. ChemNutra is a U.S. 
company, based in Las Vegas, that is an established supplier of 
ingredients to food, feed and pharma companies throughout the 
country. Although this was our first purchase of wheat gluten 
from ChemNutra, we had purchased other ingredients from 
ChemNutra in the past.
    As part of our program to ensure high-quality ingredients, 
Menu Foods provided ChemNutra with a Material Specification 
stating Menu Food's requirements for wheat gluten. The Material 
Specification provided detailed instructions and requirements, 
including but not limited to: material source, material 
description, physical requirements, chemical requirements, 
rejection criteria, packaging/shipping/storage requirements, 
microbiological standards, grind/particle size standards, water 
storage standards, ingredient manufacturing requirements, 
labeling requirements, and key performance/functionality 
requirements. The Material Specification expressly prohibited 
foreign material contamination. Each shipment of wheat gluten 
Menu Foods received from ChemNutra was accompanied by a 
Certificate of Analysis representing that the wheat gluten 
complied with Menu Foods' Material Specification.
    Our Material Specifications adhere to the standards of the 
Codex Alimentarius, which is a collection of internationally 
recognized standards for food developed under the aegis of the 
United Nations Food and Agriculture Organization and World 
Health Organization. There is no FDA standard for human grade 
wheat gluten, but Menu intends that all wheat gluten we use 
should be suitable for use in human foods.
    ChemNutra promised Menu Foods that it could deliver high-
quality wheat gluten that satisfied the requirements set forth 
in the Material Specification. Menu Foods relied on ChemNutra's 
promises. Unfortunately, we now know that ChemNutra provided 
Menu Foods and other pet food manufacturers with a product that 
was contaminated with melamine. Needless to say, following this 
incident, we no longer do business with ChemNutra.

      Menu Acted Aggressively to Identify and Address the Problem

    A lot of speculation has taken place concerning Menu Foods' 
activities leading up to the recall. Statements have been made 
in the media and in public forums and even by some of the 
participants in the supply chain of the contaminated wheat 
gluten. Much of the speculation and some of these statements 
have been inaccurate. A summary of the major events leading up 
to the recall appears below:

    February 22, February 28, and March 5, 2007
    The first complaints Menu received that we now believe were 
related to the contaminated wheat gluten were on February 22 
and 28. On those dates, Menu received calls from customers on 
our consumer response line (a toll-free number on the label or 
pouch of many of the private-label products we produce). Each 
call reported the illness of a cat. As part of Menu's follow-
up, we contacted the veterinarians who treated the cats. The 
treating veterinarians indicated that both cats had access to 
various contaminants and could have gotten into something they 
should not have, such as antifreeze.\1\
---------------------------------------------------------------------------
    1 Many pets die every day, and some die from antifreeze poisoning. 
Euromonitor International reports that there are approximately 82.2 
million cats in the United States. Using an estimated life expectancy 
of 18 years, this would mean that approximately 12,500 cats die every 
day in the United States. Dr. Ron Hines, a veterinarian, estimates that 
10,000 dogs and cats die of antifreeze poisoning each year in the 
United States.
---------------------------------------------------------------------------
    These cats were also noted as having been strays at some 
point in their lives. A third call (about March 5) was received 
from a consumer reporting a cat death. Menu Foods did not 
receive information from a veterinarian with this report.
    Tuesday, March 6, 2007 . 1On March 6 and 7, Menu learned of 
two additional cases of cat illness. Neither of these reports 
have resulted in cat deaths to Menu's knowledge.
    A company Menu Foods retained to perform routine, quarterly 
palatability studies/taste tests reported that cats involved in 
one of the studies became sick and died.\2\
---------------------------------------------------------------------------
    2 Pet food manufacturers, including Menu, regularly perform taste 
tests where food manufactured by one company is compared to food from 
another company. Since cats and dogs cannot tell us which food they 
like better, the only way to tell whether we are making a product the 
animals like is to feed it to them. These tests are not intended in any 
way to injure or endanger the participating animals, and Menu's tests 
are conducted in facilities that meet accepted standards for humane 
treatment of the animals.
---------------------------------------------------------------------------
     The panel consisted of 20 cats. Three had died (two of the 
three were euthanized), and six were sick. All of the cats were 
10 years old or older. The animals were being simultaneously 
fed a product manufactured by Menu Foods and products 
manufactured by other companies. The cats had been involved in 
taste tests for another pet food company the previous week. The 
company performing the palatability studies told Menu Foods 
that it also notified the ``other company'' of the health 
issues. Because the cats were exposed to several kinds of food, 
the source of the problem was unknown. There were at least six 
possibilities:

     Menu's food used in this taste test.
     The competitor's food against which Menu was 
conducting the taste test.
     The food of the company that used this same panel 
of cats for a taste test before Menu's taste test.
     The competitor's food against which the previous 
company was feeding.
     A hazard within the testing facility.
     An animal illness of an infectious nature.

    The company performing the palatability studies reported no 
problems with a second panel of twenty cats who were eating the 
same variety of food as the first panel. Both foods had been 
produced by Menu at the same time, leading Menu to believe that 
its food was not the source of the problem.
    Although Menu Foods did not then believe that its food was 
the source of the problem, out of an abundance of caution we 
stepped up our investigation. Our records showed that wheat 
gluten from ChemNutra was one of several ingredients common to 
the foods consumed in the cat illnesses and deaths referenced 
above and the product used in the palatability studies. As a 
precautionary measure, Menu Foods stopped using wheat gluten 
from ChemNutra.
    Friday, March 9, 2007. The company that performed the 
palatability studies reported that four additional cats (also 
of an advanced age) from the first palatability study were 
euthanized and nine were sick. The company also reported that 
two cats in the second study of twenty cats were euthanized, 
one of which was over 16 years old. Like the first study, the 
cats in the second study had eaten several products.
    By this time, Menu Foods' investigative team had traced the 
raw materials common to the reported incidents and identified 
wheat gluten, plasma, glycine, taurine, digest, caramel color 
and salt. Laboratories commissioned by Menu Foods to perform 
tests began testing the products consumed by the animals in the 
palatability studies and consumer complaints to try to identify 
any problems. At Menu's direction, they began tests for 
minerals, heavy metals, antifreeze, vitamin--D, fluorine and 
mold toxins, and for commercial sterility. These tests take 
several days to complete, but when we received the results, 
they showed nothing wrong.
    Meijer, a grocery store chain in the Midwest, relayed that 
a customer reported pet health problems. Menu Foods began 
trying to get in touch with the customer to determine what 
product was involved so it could be tested.
    Monday, March 12, 2007. The company that performed the 
palatability studies reported that independent tests conducted 
on the pet foods used in these studies (for heavy metals, 
antifreeze, pesticides and insecticides) were negative. Menu 
Foods requested its own pesticide/insecticide tests.
    Menu continued to try to reach the consumer involved in the 
report from Meijer.
    Tuesday, March 13, 2007. Menu Foods received results from 
the tests conducted at Cornell University on the product used 
in the palatability studies. Cornell University did not find 
any pesticides, insecticides or toxins. Menu requested that 
Cornell test for heavy metal and mycotoxin in samples of wheat 
gluten.
    The Iams Company contacted Menu to report renal issues in 
cats that consumed Iams flaked salmon. Iams explained that it 
had received telephone calls from three consumers: one involved 
death of a cat for renal failure, one involved vomiting within 
fifteen minutes of consumption, and one cat refused to eat the 
food.
    Wednesday, March 14, 2007. Menu reached the consumer 
involved in the report from Meijer's and learned that the 
animal consumed product manufactured in October 2006--before 
Menu Foods began receiving wheat gluten from ChemNutra. The 
consumer agreed to send Menu the remaining food for testing. 
The consumer did not know the cause of death. After the recall 
was announced, Menu received the food from this customer. 
Testing showed that it did not contain melamine.
    Menu and Iams shared with each other the information that 
each had obtained to that point.
    Menu received the results of tests performed on the 
ChemNutra wheat gluten for antifreeze, which were negative. 
Menu decided to begin testing for intentionally added toxins.
    Cornell University tested the product involved in the 
palatability studies for intentionally added toxins, but the 
tests came out negative. Menu continued to perform a broader 
series of tests on the wheat gluten from ChemNutra.
    The company that performed the palatability studies 
forwarded tissue samples from a deceased animal to Cornell 
University to perform tests in an attempt to discover whether a 
toxin killed the animal.
    At 8:30 p.m., Iams told Menu Foods that it intended to 
recall cat food manufactured by Menu Foods in Emporia, Kansas 
from December 17, 2006 through March 14, 2007.
    Thursday, March 15, 2007. On the morning of March 15, 2007, 
Menu Foods received a call from the owner of five indoor dogs. 
She reported feeding her dogs Menu-produced product. 
Thereafter, one of her dogs had died of renal failure, and the 
other four were ill. Shortly thereafter, Menu was notified by a 
testing facility that several dogs involved in a taste test had 
experienced a drop in food consumption similar to the cats in 
the taste tests described above and were ill and vomiting. 
These were the first reports of which Menu was aware of dogs 
being adversely affected by pet food manufactured by Menu.
    On the afternoon of March 15, 2007, Menu Foods notified the 
FDA of its decision to recall products manufactured with wheat 
gluten obtained from ChemNutra from December 3, 2006 through 
March 6, 2007. The recall included both dog and cat food. Menu 
Foods announced the recall the following morning. We chose 
December 3, 2006 as the start of the recall because the food in 
the first consumer complaint was produced during that week. 
Although we did not know whether the recalled product contained 
a contaminant or what the contaminant was, we recalled products 
produced with the ChemNutra wheat gluten while we and others 
continued to investigate the source of the problem.

   Menu Foods Responds By Voluntarily Recalling Potentially Affected 
                                Product

    Some people have suggested that Menu acted too slowly and 
should have contacted the FDA sooner. On the contrary, we acted 
quickly and took appropriate steps under the circumstances.
    Let me put this situation in context. Menu produces over 
1.1 billion containers of pet food each year--nearly 100 
million containers each month. As of March 15, 2007, Menu had 
directly received six reports from consumers of possible 
problems with its pet food--many of which appeared to be 
something other than pet food, in several cases confirmed by 
opinions of the animals' veterinarians. One of Menu's 
customers, Iams, had received, and eventually passed on to 
Menu, three complaints involving animal health issues. Both 
Menu and Iams had received complaints of a refusal to eat the 
food, which often happens when an owner changes to a different 
food or for other reasons completely unrelated to food quality. 
And the taste testing facility reported several deaths and 
illnesses, but nothing that indicated it was caused by Menu's 
food. Menu had conducted tests for all industry-recognized 
causes of problems with pet food, and these tests revealed no 
problems. In fact, it took the FDA, prestigious research 
organizations and several commercial laboratories many more 
days to identify melamine in ChemNutra wheat gluten as the 
source of the problem.
    Based on this information, any pet food manufacturer could 
well have decided to continue to try to find the problem, but 
not to contact the FDA or begin a product recall. Indeed, based 
on what was known at the time, there might well have turned out 
to be no problem with the food, and announcing a recall could 
have only resulted in an unnecessary panic among pet owners. 
And, the only indication we had of any issues with dog food was 
only hours old and as yet completely uninvestigated. However, 
Menu placed the interests of pets and pet owners first, so, 
like our good customer Iams, we decided that, notwithstanding 
the lack of scientific evidence, we should notify the FDA and 
begin a voluntary, precautionary recall.
    On March 16, 2007, Menu Foods voluntarily recalled pet food 
manufactured with wheat gluten obtained from ChemNutra, Inc. 
from December 3, 2006 through March 6, 2007. The FDA initiated 
an investigation of Menu Foods' formed meat products that same 
day. Menu Foods gave the FDA its full cooperation and continues 
to cooperate fully with the FDA.
    On March 24, 2007, in order to expedite the recall and 
satisfy concerns by the FDA, Menu Foods initiated a market 
withdrawal that included all production dates of the impacted 
products during the recall period. This change made it easier 
for retailers to get the identified products off their shelves 
and reduced the risk that a store clerk would mistakenly leave 
a recalled product on the shelf because he or she misread the 
date code on the product.
    On Friday, March 30, the FDA announced that researchers at 
Cornell University located melamine in the finished product 
that was the subject of the recall. Researchers also located 
melamine in samples of wheat gluten Menu Foods purchased from 
ChemNutra, Inc., which has stated that it imported the wheat 
gluten from Xuzhou Anying Biologic Technology Development Co. 
Ltd. (Xuzhou Anying) in China. Melamine was not found in wheat 
gluten Menu Foods obtained from other suppliers. Melamine is a 
chemical contaminant, not a microbial contaminant. According to 
the FDA, it is ``very unusual'' to find melamine in wheat 
gluten.
    On April 3, 2007, ChemNutra issued a press release 
announcing a recall of all wheat gluten it imported from Xuzhou 
Anying. ChemNutra admitted that melamine ``should absolutely 
not have been in wheat gluten.'' Four other pet food 
manufacturers obtained contaminated wheat gluten from ChemNutra 
and initiated recalls: Hill's Pet Nutrition, Del Monte Pet 
Products, Nestle Purina PetCare Company, and Sunshine Mills 
Company.
    On April 5 and April 10, Menu Foods expanded its recall to 
additional products manufactured with ChemNutra wheat gluten. 
On April 5, Menu Foods expanded the recall to include products 
manufactured with ChemNutra wheat gluten from the first date of 
manufacture (November 8, 2006) through December 2, 2006. (The 
previous recall included the period spanning from December 3, 
2006 through March 6, 2007.) At the time of the initial recall 
on March 16, 2007, Menu Foods was not aware of any complaints 
or reports of health problems relating to food manufactured 
from November 8th to December 2.
    On April 10, 2007, Menu Foods expanded the recall to 
include certain products manufactured at its plant in Canada 
after discovering through the ongoing investigation that the 
Canadian plant received a quarter of a load of the contaminated 
wheat gluten from the Menu Foods plant in Emporia, Kansas. The 
wheat gluten that was transferred between plants was 
subsequently used in production at the Streetsville plant 
during December 2006 and January 2007.
    Menu Foods is no longer purchasing any ingredients from 
ChemNutra and has taken steps to assure that none of the 
products that contain wheat gluten from ChemNutra are sold. The 
FDA is blocking all imports of wheat gluten from Xuzhou Anying.
    Menu's investigation has revealed a possible motive for the 
presence of melamine in ChemNutra's wheat gluten. Menu Foods' 
Material Specification for wheat gluten contains a chemical 
requirement that the wheat gluten contain no less than 75 
percent protein. This is a typical specification for wheat 
gluten for both human and animal food. In the human food and 
pet food industry, protein levels are customarily estimated by 
determining the quantity of nitrogen in a product.\3\
---------------------------------------------------------------------------
    3 In testing, crude protein is used as a key indicator of usable 
amino acids available in the pet food as a source of nutrition. The 
amount of usable amino acids in the pet food is estimated by 
determining the quantity of nitrogen in the product and multiplying 
that figure by an accepted constant.
---------------------------------------------------------------------------
     Melamine has a high concentration of nitrogen and, as a 
result, the inclusion of melamine into the wheat gluten would 
make substandard wheat gluten appear to meet industry standards 
for protein content.

   Menu Is Dedicated To Providing Safe, High-Quality Products To Its 
                               Customers

    The foundation of Menu's business is providing quality, 
nutritious food for pets. We have been doing so for over 35 
years. The safety of our products and the confidence of pet 
owners and our customers are our highest priorities.
    Menu Foods monitors for spoilage and has thorough quality 
control procedures. As is common industry practice, Menu Foods 
tests the wheat gluten it uses for vomitoxin caused by mold 
growth. This mold toxin is the only contaminant in recent 
history that has been associated with a pet food recall 
involving wheat used in dry pet food. Menu tests every load of 
wheat gluten it receives for vomitoxin using an approved test 
performed by trained personnel. Menu Foods did not detect 
melamine during its quality assurance testing because accepted 
screening procedures do not detect melamine. Melamine is not 
something that had ever been heard of before in connection with 
wheat gluten. To our knowledge, no pet food or human food 
manufacturer tested wheat gluten for melamine prior to this 
incident.
    Some people have noted that Menu's Emporia plant had not 
been inspected by the FDA. That is true, but not surprising 
given Menu's excellent performance record and reputation and 
the FDA's limited resources. However, additional plant 
inspections would not have prevented the problem in this 
instance--contaminated wheat gluten purchased from ChemNutra.
    Moreover, Menu's plants are subject to significant internal 
and external inspection and review. Menu has its own quality 
control systems, which have been reviewed and approved by our 
customers, including global companies with substantial 
experience in quality control. In addition to Menu's internal 
systems, all of our facilities are routinely audited by outside 
experts. Menu engages the American Institute of Baking to audit 
food safety and sanitation. These inspections are conducted at 
least annually, and Menu has consistently scored in the 
``excellent'' and ``superior'' range. Menu Foods' United States 
plants are inspected annually by the United States Department 
of Agriculture Animal and Plant Health Inspection Service 
(APHIS). Menu Foods' plant in Canada is inspected annually by 
the Canadian equivalent to APHIS, the Canadian Food Inspection 
Agency (CFIA). Menu Foods is also inspected by the European 
Food Safety Inspection Service, which is widely respected for 
HACCP (Hazard Analysis and Critical Control Point) and food 
safety concerns. Menu's Pennsauken plant has been inspected by 
the FDA. Finally, Menu is inspected by multiple global pet food 
producers with known high quality standards as a condition of 
manufacturing pet food for them.
    To ensure that we are producing the highest quality 
products, we have taken the following additional steps in 
response to the situation:

     First, like other pet food manufacturers, we have 
stopped purchasing wheat gluten from ChemNutra. In fact, we 
have stopped buying any ingredient from ChemNutra.
     We now test wheat gluten for melamine. Consistent 
with our desire for continuous quality improvement, we have 
extended melamine testing to rice protein and corn gluten meal.
     We will conduct additional tests of wheat gluten 
and other ingredients in the future to make it more difficult 
for a supplier to sell us substandard product.
     We will implement more rigorous testing and 
supervision for new suppliers.
     We continue to monitor developments in the 
industry and will update these measures as necessary to ensure 
the continued safety of our products.
     We are an active member of the Pet Food Institute 
and an active participant in its review of pet food safety 
issues. We will implement recommendations of the PFI review as 
appropriate for our business.
     We will work with the FDA and other regulatory 
authorities and Congress to develop additional measures to 
protect against future occurrences of this type.

    Finally, we have filed suit against ChemNutra. ChemNutra 
sold us contaminated wheat gluten that did not meet our 
specifications and did not conform to the promises of quality 
that ChemNutra made to us. ChemNutra's actions have caused 
tremendous injury to the public and to Menu.

           Suggestions for Improving Food Safety Protections

    Before concluding, let me share some thoughts on 
improvements that governments might make in the food safety 
protection system, based on Menu's experience and my 
observations of the system as a whole.
    First, we should recognize the extent to which opening 
global markets for U.S. products has also opened the U.S. 
market to foreign products, which, as in Menu's case, are not 
always in compliance with accepted standards. It is difficult 
for manufacturers to inspect each supplier. The Government, on 
the other hand, is in a better position to inspect and certify 
foreign suppliers of food products or ingredients in order for 
them to be permitted to sell their products into the U.S. 
Menu's plants and processes are inspected and approved for 
compliance with European standards and regulations as a 
condition of being able to export our products to Europe. These 
inspections are performed by APHIS in the U.S. and CFIA in 
Canada under an arrangement with the EU, no doubt because of 
the confidence the EU has in APHIS and CFIA. Perhaps, in order 
to sell their products in the U.S., foreign suppliers should be 
required to submit to inspection and certification by a U.S. 
agency or some other party accredited by the U.S. Government.
    Second, Government agencies could increase their 
inspections of imported products at the border. These 
inspections might not have identified the contamination in the 
wheat gluten from ChemNutra, because melamine was not 
recognized as a potential contaminant at the time, but we think 
in many cases problems could be detected at the border. Of 
course, now that we know about melamine, Government agencies 
can also test for it at the border, and perhaps prevent future 
incidents involving that substance.
    Third, Government agencies might increase plant inspections 
in the U.S. We do not believe this would have prevented the 
melamine problem, but there may be other more conventional 
hazards that might be detected through on-site inspection.
    We believe that the focus of inspections outside the U.S. 
might be based on the principle of reciprocity. Trading 
partners that have equivalent regulation to the U.S. might be 
allowed to import products based on inspection and 
certification by local authorities in which the U.S. Government 
has confidence. Suppliers in other countries might be inspected 
directly by U.S. agencies. Plant inspections in the U.S. might 
be conducted on the basis of the risks of the business being 
conducted at the plant. For example, good manufacturing 
processes, sanitation practices and inspections are important 
controls in meat processing plants, because of the risks 
associated with uncooked meat. By contrast, in human and pet 
food operations where products are heat treated to sterilize 
them, the risks are different and may warrant a different 
approach.
    Fourth, because understanding relevant risks is so 
important, Government could invest in development of better 
risk assessment processes. For example, central to the current 
pet food recall is the procedure that uses nitrogen testing to 
estimate protein content. It is possible that someone may have 
used melamine, which is rich in nitrogen, to pass off inferior 
product. The nitrogen test was not designed to deter cheaters 
but rather to estimate protein. What other rapid tests are used 
throughout the food chain to estimate quality? Is there a risk 
that these tests can be abused, as appears to have been the 
case with wheat gluten? If so, could mechanisms or processes be 
developed to identify and address that risk?
    Finally, Government might research or fund research of new 
technologies for fast, accurate and affordable detection of 
contaminants in food ingredients. One of the difficulties in 
the investigation of the wheat gluten situation was that there 
was no established protocol for testing for melamine. So, the 
researchers first had to develop a testing method before they 
could even check for its presence. Even more valuable might be 
a method for rapid, accurate and cost-effective determination 
of the presence of any contaminant in an ingredient or in 
finished product.
    Sometimes even well respected manufacturers, like Menu, 
suffer problems caused by others. We are working with the FDA 
and with our customers to resume our business of providing 
nutritious, high-quality pet food for animals throughout North 
America. We take pride in our products, and we also take 
responsibility for them. We intend to do everything in our 
power to make things right for our customers and to prevent 
this type of situation from ever occurring again.

    Mr. Stupak. And Mr. Sweat for 5 minutes, please, sir.

 STATEMENT OF CHARLES SWEAT, PRESIDENT, NATURAL SELECTION FOODS

    Mr. Sweat. Mr. Chairman and members of the committee, thank 
you for allowing Natural Selection Foods the opportunity to be 
a part of the important discussion about food safety in this 
country. We are pleased to cooperate with the subcommittee's 
investigation in this hearing.
    My name is Charlie Sweat, and I am the president of the 
company.
    Before proceeding, I want to say that everyone in our 
company remains deeply saddened by the human toll that this 
outbreak has wrought. We are a company founded on the 
commitment to providing the healthiest food possible, and to 
learn that food processed by us could have brought anything 
other than good health was devastating.
    On September 14, we received a call from the FDA and the 
California Department of Health Services that there was an 
outbreak of E. coli 0157:H7 linked to our fresh spinach. We 
were shocked to learn that some of our products might be 
involved. Within 24 hours, at the suggestion of the 
investigators, we voluntarily recalled all products containing 
spinach under all brands that were packaged in our facility.
    Recently, the FDA and CDHS released a joint report on this 
incident. The report clearly states that no specific 
transmission vehicle has been identified, but the report's 
findings point to what we believed from the beginning: The 
contamination appears to have been somehow linked to the 
natural environment in which the spinach was grown. Samples 
matching the outbreak strain were found on a cattle ranch just 
under a mile from where the spinach was grown but never on the 
spinach field it self.
    Prior to the outbreak, Natural Selection Foods' protocols 
met or exceeded industry best practices, including the FDA's 
suggested Good Agricultural Practices and even the FDA's very 
recently issued Guide to Minimize Microbial Food Safety Hazards 
of Fresh-Cut Fruits and Vegetables. We also followed Good 
Manufacturing Practices as outlined in the Code of Federal 
Regulations which are verified by daily audits.
    Further, we participate in the USDA's Qualified Through 
Verification program, a voluntary program of unannounced 
inspections for fresh-cut processors. Participation in QTV 
requires that our facilities are inspection ready every day, a 
demand far more rigorous than what is called for by programs 
whose inspection schedules are known in advance.
    Our experience strengthens our resolve to challenge the 
thinking about food safety in produce and develop new protocols 
that significantly heighten the safety of our products. Our 
efforts in this regard started almost immediately. While 
simultaneously working with the FDA and CDHS investigators and 
coordinating our recall, we worked tirelessly with some leading 
scientists in the country to completely reinvent what state-of-
the-art food safety means in fresh produce.
    Dr. Samadpour of IEH Laboratories, one of the country's top 
food safety scientists, has worked extensively in the beef 
industry in improving safety protocols and reducing outbreaks 
associated with beef. He has become a valuable consultant to 
our operations.
    In addition, we have established a food safety advisory 
panel consisting of some of the premier food safety scientists 
in the country from different academies, including University 
of Georgia, Rutgers and U.C. Davis.
    Within 2 weeks of the recall, we had launched an 
unprecedented program of pathogen-specific testing in all of 
our raw, leafy greens. We lab-test--independent third-party 
lab--all salad greens arriving at our facility for potentially 
illness-causing E. coli and salmonella. All greens are held 
until the test are completed, and only those greens that show 
no presence of these pathogens are released for processing.
    In February 2007, we launched a finished product testing 
program as a final hurdle of food safety, following the same 
protocols as our raw product test and hold program. We believe 
this kind of testing is a key safety measure for produce that 
will be consumed raw, since cooking is the only proven kill 
step for E. coli.
    We have also signed on to California's new Leafy Green 
Handler Marketing Agreement. Companies that have signed on have 
agreed to purchase only from those growers who have accepted 
the Good Agricultural Practices. This is a good first step for 
our industry.
    But the GAP metrics, in their current form, are not enough. 
Much more needs to be done, and we will continue to encourage 
development of standards to provide the strongest food safety 
program. We welcome regulation in this arena but also believe 
strongly that, with or without regulation, it is incumbent upon 
the individual companies and our industry as a whole to act to 
improve food safety. Private industry can and should move 
faster than the regulatory process. We have demonstrated that 
at Natural Selection Foods.
    Everyone at Natural Selection Foods cares deeply about this 
outbreak and its victims and is committed to solving this 
vexing problem. We have faced many challenges in our 23 years, 
but none as great or as important as this.
    Again, we appreciate the opportunity you have given us to 
be part of this important discussion. Thank you.
    Mr. Stupak. I thank you for your testimony.
    [The prepared statement of Mr. Sweat follows:]

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    
     Mr. Colo, please, for 5 minutes for your opening 
statement.

  STATEMENT OF DAVID COLO, SENIOR VICE PRESIDENT, OPERATIONS, 
                  CONAGRA FOODS, INCORPORATED

    Mr. Colo. Good morning, Mr. Chairman and members of the 
committee. My name is Dave Colo. I am the senior vice president 
of operations for ConAgra Foods, Incorporated. Thank you for 
your invitation to testify today about this important topic, 
the safety of the Nation's food supply. I want to assure the 
committee that we are fully aligned with its objective of 
ensuring that our food supply is among the safest in the world.
    I appreciate the opportunity to share with you ConAgra 
Foods' recent experience related to the finding of salmonella 
in our peanut butter products.
    First and foremost, we are truly sorry for any harm that 
our peanut butter products may have caused. As head of 
operations for this company, I can assure you that not only do 
we take these issues very seriously but we take them 
personally, as consumer safety and health is our top priority.
    There are four main messages that I want to discuss with 
you today.
    First, ConAgra Foods became aware of a potential issue the 
evening of February 13, 2007. The Food And Drug Administration 
contacted the company to schedule a call the following day to 
discuss a statistical study conducted by the Centers for 
Disease Control that suggested ConAgra's peanut butter products 
may have been linked to illnesses. The next day, February 14, 
after we spoke directly with the CDC and learned the basis for 
their conclusions, the company voluntarily recalled all peanut 
butter products and closed the Sylvester, GA, facility.
    Second, in addition to the recall, the company initiated a 
full investigation to determine the cause or causes of any 
potential salmonella in the product. ConAgra Foods worked with 
the FDA to identify any potential source of contamination.
    Based on its investigation, ConAgra Foods believes that 
moisture inadvertently entered the production process and 
enabled the growth of low levels of dormant salmonella already 
likely present in the plant environment from raw peanuts or 
peanut dust. We believe the moisture was likely the catalyst 
that temporarily allowed the salmonella to grow inside the 
facility. We believe the rate of subsequent contamination was 
low and, as such, was not detected by our finished product 
testing program, which employed standard industry testing 
methods.
    Third, the Sylvester Georgia facility is the only ConAgra 
Foods location where peanut butter is manufactured, and this 
facility has been idle since the recall was initiated on 
February 14.
    The company is committed to addressing the suspected causes 
of the contamination, and it will implement significant changes 
in the facility, including installing new, state-of-the-art 
equipment, technology and design standards throughout the 
facility. The estimated minimum cost of these facility 
modifications are 15 to $20 million.
    ConAgra Foods is committed to taking the time necessary for 
each of these steps, and we estimate that the facility is not 
likely to reopen until August of this year.
    Finally, in addition to our thorough investigation at the 
Sylvester facility, ConAgra Foods is conducting additional 
comprehensive inspections of our other manufacturing facilities 
throughout the company. We have assembled a team composed of 
internal experts, along with an external specialist in food 
safety risk, Dr. Mike Doyle, that is in the process of visiting 
ConAgra's Foods' facilities, contract manufacturers and 
suppliers.
    Taken together, these measures reaffirm our commitment to 
food safety and quality. The company will continue to work 
closely with the FDA going forward and appreciates the 
excellent work of the FDA and CDC throughout this process.
    To clarify our interest in effective dialog with the FDA, 
we have separately provided the committee with a summary of the 
procedures we will follow to assure rapid FDA access to company 
information.
    Again, we are truly sorry for any harm that our peanut 
butter products caused. We plan to make all changes necessary 
to the manufacturing environment to ensure the situation does 
not occur again. We are committed to the highest possible 
standards of food safety throughout our operations, and we 
believe that measures we have outlined today will clearly meet 
that commitment.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you.
    [The prepared statement of Mr. Colo follows:]

                        Testimony of David Colo

    Mr. Colo will convey the following four main messages in 
his testimony:
      First, upon learning of a potential of salmonella 
Tennessee in our peanut butter products, ConAgra Foods took 
prompt action to protect the public health by ceasing all 
production and distribution, and voluntarily initiating a 
recall of all peanut butter in the marketplace manufactured at 
its Sylvester, GA facility, the only ConAgra facility 
manufacturing peanut butter.
      Second, the company conducted an in-depth 
investigation into the potential root cause or causes of the 
salmonella Tennessee contamination.
      Third, ConAgra will ensure that, before it 
resumes operations at its Sylvester, GA facility, it will have 
addressed all the potential sources of salmonella 
contamination, such that the facility will serve as a model in 
the industry for the production of safe and quality product.
      And, fourth, ConAgra is taking steps to improve 
food safety standards for all its food products.
                              ----------                              

     Good morning Mr. Chairman and members of the committee. My 
name is David Colo, and I am senior vice president of 
operations for ConAgra Foods, Inc., where I have worked in 
various positions for the last 5 years. Thank you for your 
invitation to testify today about this important topic--the 
safety of the Nation's food supply. I want to assure the 
Committee that we are fully aligned with its objective of 
ensuring that our food supply is among the safest in the world.
     ConAgra Foods is one of North America's leading packaged 
food companies, serving grocery retailers, as well as 
restaurants and other foodservice establishments. Popular 
ConAgra Foods consumer brands include: Banquet, Chef Boyardee, 
Egg Beaters, Healthy Choice, Hebrew National, Hunt's, Marie 
Callender's, Orville Redenbacher's, PAM and many others, 
including Peter Pan. We operate over 100 manufacturing 
facilities in 30 States, as well as facilities in several 
international locations.
     I appreciate the opportunity to share with you ConAgra's 
recent experience related to the finding of salmonella 
Tennessee in our peanut butter products, including our Peter 
Pan brand peanut butter. First and foremost, we are truly sorry 
for any harm that our peanut butter products may have caused, 
and we intend to resolve any claims arising from the 
consumption of our peanut butter products as fairly and 
expeditiously as possible. As the head of operations for this 
company, I can assure you that, not only do we take these 
issues very seriously, but we take them personally because 
consumer safety has always been our top priority.
     There are four main messages that I want to convey to you 
today. First, within hours of its initial telephone conference 
with both the Food and Drug Administration (FDA) and the 
Centers for Disease Control (CDC) regarding this potential 
issue, ConAgra Foods took prompt action to protect the public 
health by ceasing all production and distribution, and 
voluntarily initiating a recall of all peanut butter in the 
marketplace manufactured at its Sylvester, GA facility, the 
only ConAgra facility manufacturing peanut butter. Second, the 
company conducted an in-depth investigation into the potential 
root cause or causes of the salmonella Tennessee contamination. 
Third, ConAgra will ensure that, before it resumes operations 
at its Sylvester, GA facility, it will have addressed all the 
potential sources of salmonella contamination, such that the 
facility will serve as a model in the industry for the 
production of safe and quality product. And, finally, ConAgra 
is taking steps to improve food safety standards for all its 
food products. I would add that, since this issue first 
surfaced in mid-February, we have worked cooperatively with 
FDA, CDC and the State of Georgia food safety officials. We 
have also been pleased to cooperate with this committee's 
investigation. Let me now describe these points in greater 
detail.

    1. ConAgra Foods took prompt action to protect the public 
health by ceasing all production and distribution, and 
voluntarily initiating a recall of all peanut butter in the 
marketplace manufactured at its Sylvester, GA facility, within 
hours of its first telephone conference with FDA and CDC.

     ConAgra first became aware of a potential issue the 
evening of February 13, 2007, when the FDA contacted the 
company to schedule a call the following day to discuss an 
epidemiological study conducted by the CDC that suggested 
ConAgra's peanut butter products may have been linked to a 
salmonella illness outbreak. The next day, February 14, after a 
series of telephone conversations with both the FDA and CDC, 
the company initiated a voluntary recall from the market of 100 
percent of the peanut butter manufactured at our Sylvester, GA 
facility. The company simultaneously ceased all production and 
distribution of peanut butter products from that facility. 
Throughout the process, ConAgra worked closely and cooperated 
fully with FDA in all aspects of the recall, including in the 
collective efforts of the company and FDA to inform the public 
about the scope of the recall.

    2. ConAgra Foods conducted an in-depth investigation into 
the potential root cause(s) of the salmonella Tennessee 
contamination.

     In addition to initiating this prompt and comprehensive 
recall, the company initiated a full investigation to determine 
the root cause or causes of any potential salmonella in the 
product. ConAgra worked with the FDA to identify any potential 
source of contamination.
     On February 22, 8 days after ConAgra first initiated the 
voluntary recall, it was notified by FDA of State laboratory 
findings confirming the presence of salmonella in the company's 
peanut butter products. ConAgra made a public announcement to 
this effect that same day, and FDA made a similar announcement 
the following day.
     Based on its investigation, ConAgra believes that raw 
peanuts and peanut dust introduced some low levels of 
salmonella Tennessee into the plant. The presence of salmonella 
is not unusual on raw agricultural products like peanuts. It 
appears that moisture then inadvertently entered the production 
facility and enabled the growth of low levels of dormant 
salmonella Tennessee. We believe the moisture was likely the 
catalyst that temporarily allowed the salmonella Tennessee to 
grow inside the facility. We further believe the salmonella 
Tennessee subsequently came into contact with peanut butter 
prior to packaging. Finally, we believe the rate of subsequent 
contamination was low and, as such, was not detected by our 
finished product testing program which employed standard 
industry testing methods.

    3. ConAgra will ensure that, before it resumes operations 
at its Sylvester, GA facility, it will have addressed all the 
potential sources of salmonella contamination, such that the 
facility will serve as a model in the industry for the 
production of safe and quality product.

     The Sylvester, GA plant is the only ConAgra location where 
peanut butter is manufactured, and this facility has been idle 
since the recall was initiated on February 14. No Peter Pan 
peanut butter has been sold by ConAgra to its customers since 
that date.
     ConAgra is continuing to work closely with the FDA to 
ensure that when operations resume in the Sylvester plant there 
will be no reoccurrence of this issue. The company is committed 
to addressing the suspected causes of the contamination, and it 
will implement significant changes in the plant, including 
installing new, state-of-the-art machinery, technology and 
designs throughout the facility. The estimated minimum cost of 
these facility modifications is $15-$20 million. These costs 
are in addition to the $50-$60 million cost associated with the 
recall and the significant costs associated with the ongoing 
loss of sales.
     Before resuming operations, the company will obtain an 
independent review by an expert third-party and seek the 
concurrence of the FDA as to the adequacy of the measures 
implemented. ConAgra is committed to taking the time necessary 
for each of these steps, and we estimate that the facility is 
not likely to reopen until August. While we are making these 
upgrades, we will partner with a reputable third-party 
manufacturer to produce Peter Pan peanut butter to the highest 
quality standards and to begin shipping product to retailers 
this summer.

    4. ConAgra Foods is taking steps to improve food safety 
standards for all its food products.

     In addition to its thorough investigation at the Sylvester 
facility, ConAgra is conducting additional comprehensive 
inspections of its manufacturing facilities throughout the 
company. We have assembled a team composed of internal experts, 
along with an external specialist in food safety, that is in 
the process of visiting ConAgra's plants, contract 
manufacturers, and suppliers.
     To bring additional focus and leadership to developing and 
implementing programs that continuously improve product safety 
and design, the company has appointed a recognized and well-
respected food safety expert to a company-wide leadership 
position, vice president for Global Food Safety. This action 
will bolster our existing, substantial food safety and quality 
expertise, and will consolidate responsibility for existing and 
future company-wide oversight of food safety initiatives and 
systems. The company has hired Paul A. Hall, a leading expert 
with more than 30 years of experience in microbiology, food 
safety and food quality, to fill this position. Hall joins 
ConAgra Foods from Matrix MicroScience, Inc., a leading 
producer of technology for the rapid concentration, capture and 
detection of foodborne pathogens, including salmonella. 
Previously, he held product safety and quality-related 
positions of increasing responsibility at another major food 
company.
     We are also forming a Food Safety Advisory Committee, 
composed of leading independent, third-party experts in food 
safety, which will provide guidance to the company as part of 
our ongoing work with Government agencies, research 
institutions, and scientists in the areas of food production 
and testing. This advisory committee will provide guidance to 
the company in the areas of food production and testing, and 
will advise the company in its plan to fund research involving 
the detection, control and elimination of foodborne pathogens. 
The committee will be chaired by Dr. Michael Doyle, director of 
the Center for Food Safety at the University of Georgia and one 
of the foremost authorities on foodborne pathogens in the 
world. The company is currently working with Dr. Doyle to 
identify other members of the committee.
     There is nothing more important to ConAgra Foods than the 
safety, quality, and wholesomeness of our products. Through our 
work with the Food Safety Advisory Committee, we will be able 
to leverage their expertise to ensure that we take all 
reasonable steps to minimize the risk of foodborne illness.
     Taken together, these measures reaffirm our commitment to 
food safety and quality. The company will continue to work 
closely with the FDA going forward and appreciates the 
excellent work of the FDA and CDC throughout this process. We 
also thank our consumers and customers for their understanding, 
as well as for the role they have played in ensuring public 
safety by returning and disposing of the recalled product.
     Again, we are truly sorry for any harm that our peanut 
butter products caused and intend to resolve claims arising 
from consumption of our peanut butter fairly and expeditiously. 
We plan to make all changes necessary to the manufacturing 
environment to ensure this situation does not occur again. We 
are committed to the highest possible standards of food safety 
throughout our operations and believe the measures we have 
outlined today will clearly meet that commitment.

    Mr. Stupak. Mr. Miller, please, for your opening statement.

     STATEMENT OF STEPHEN MILLER, CHIEF EXECUTIVE OFFICER, 
                    CHEMNUTRA, LAS VEGAS, NV

    Mr. Miller. Thank you, Mr. Chairman and members of the 
committee, for inviting me to testify today on the subject that 
is clearly important to many in this Nation--to everyone in 
this Nation, the safety of pet food and the food supply in 
general.
    My name is Steve Miller, and I am chief executive officer 
for ChemNutra. ChemNutra is a small business, headquartered in 
Las Vegas, Nevada. I am here today with ChemNutra's FDA 
attorney, Marc Ullman of Ullman, Shapiro and Ullman.
    Before I proceed on behalf of ChemNutra, I want to express 
our support and condolences for pet owners whose pets have 
fallen ill or died as the probable result of contaminated pet 
food as well as pet owners throughout North America who have 
become fearful about their pets' food following the news of 
contamination. We also offer our sympathy for the difficulties 
imposed on the pet food businesses that were negatively 
impacted by this situation.
    ChemNutra imports high-quality nutritional and 
pharmaceutical ingredients from China to the United States. 
Those products come from manufacturers either known to us 
personally or recommended to us by a number of reputable and 
well-qualified training agents with whom we have had long-
standing relationships. Our U.S. customers are manufacturers of 
pet food and nutritional ingredients who want high quality, the 
best service and competitive prices.
    Until March 8 of this year, ChemNutra had never had an 
issue or incident with its Chinese manufacturers, all of whom 
provide certificates of analysis with their products, which is 
standard operating procedure for U.S. importers. It was on 
March 8 that ChemNutra first learned that wheat gluten was one 
of many ingredients Menu Foods was investigating as suspect in 
cat illnesses. That was nearly 3 weeks, according to Senate 
testimony, after Menu Foods first learned of possible 
contamination of pet foods.
    On that date, March 8, notwithstanding what we believed to 
be a remote risk at the time, ChemNutra quarantined and ceased 
all shipping, sales and marketing of wheat gluten in our 
possession, from all sources. On March 16, Menu Foods issued 
its first recall; and in doing so made no mention of wheat 
gluten. In fact, Menu Foods said at that time it was testing 
some 20 ingredients, but to date we have not heard a word about 
those testing results.
    Shortly thereafter, on March 19 we received a request from 
the Food and Drug Administration for all documents relating to 
wheat gluten, to which we immediately and fully complied. 
However, it wasn't until March 29 that ChemNutra heard for the 
first time that the FDA had found melamine in ChemNutra's wheat 
gluten, without quantification as to how much.
    Between March 29 and April 1, I was in China and in 
communication with the FDA. Upon hearing of the traces of 
melamine, I spoke with the president of our supplier, XuZhou 
Anying Biologic Technology Development Company Limited, who 
said he didn't know there was melamine in their wheat gluten or 
how that could have happened. He promised to look into it and 
to this day has not provided us with additional information, 
despite many follow-up efforts on our part.
    On April 2, after receiving further information from the 
FDA, we issued a formal recall of contaminated wheat gluten. It 
is important to note that on March 8, when ChemNutra ceased 
shipments of its wheat gluten, we had only four customers for 
that product, one of which was Menu Foods. Prior to any 
scheduled shipment customers--after that date, prior to any 
scheduled shipment, customers were made aware that our 
shipments were stopping.
    It has been more than a month since this dreadful issue 
became manifest. Over this period there have been a raft of 
surmises and suppositions, but few facts. At this point, the 
only piece of information of which we can be certain is that 
melamine was contained in shipments of wheat gluten we imported 
through XuZhou Anying Biologic Technology Development Company 
Limited.
    However, we at ChemNutra strongly suspect, at this point, 
that XuZhou Anying Biologic Technology Development Company 
Limited may have added melamine to the wheat gluten as an 
economic adulteration designed to make inferior wheat gluten 
appear to have a higher protein content. They can sell it to us 
at the price we would pay for higher quality product because 
the melamine, our experts tell us, falsely elevates the results 
of a nitrogen contents test used to assess protein content. 
Melamine is not something that we or anyone else, including the 
FDA, was ever testing for in the past, though of course we are 
now.
    We have recently been told there was a prior history of 
this same kind of economic adulteration related to a similar 
agricultural commodity about three decades ago where this 
commodity was adulterated with urea, another nitrogen intensive 
additive, which had at the time become inexpensive enough to 
use economically to fool the protein testing. Subsequently, 
that commodity has been tested for urea.
    I want to thank the committee for this opportunity to tell 
the ChemNutra story in an unvarnished and factual manner; and I 
hope that my testimony will help you develop protocols, 
regulations or laws that will preclude this sort of event from 
occurring in the future.
    Mr. Stupak. Thank you.
    [The prepared statement of Mr. Miller follows:]

                       Statement of Steve Miller

    Thank you, Mr. Chairman and members of the Committee, for 
inviting me to testify today on a subject that is so clearly 
important to many in this nation, the safety of pet food and 
the food supply in general.
    My name is Steve Miller and I'm chief executive officer of 
ChemNutra. ChemNutra is a small business, headquartered in Las 
Vegas, Nevada. I am here today with ChemNutra's FDA attorney, 
Marc Ullman of Ullman, Shapiro and Ullman.
    Before I proceed, on behalf of ChemNutra I want to express 
our support and condolences for pet owners whose pets have 
fallen ill or died as the probable result of contaminated pet 
food, as well as pet owners throughout North America who have 
become fearful about their pets' food following news of the 
contamination. We also offer our empathy for the difficulties 
imposed on pet food businesses that were negatively impacted by 
this situation.
    We import high-quality nutritional and pharmaceutical 
chemicals from China to the United States. Those products come 
from manufacturers either known to us personally or recommended 
to us by a number of reputable and well-qualified trading 
agents with whom we have had long-standing relationships. Our 
US customers are manufacturers of pet food, and nutritional 
ingredients who want high quality, the best service, and the 
most competitive prices.
    Until March 8 of this year, ChemNutra had never had an 
issue or incident with its Chinese manufacturers, all of whom 
provide certificates of analysis of their products, which is 
standard operating procedure for U.S. importers. It was on 
March 8 that ChemNutra first learned that wheat gluten was one 
of many ingredients Menu foods was investigating as suspect in 
cat illnesses. That was nearly three weeks, according to Senate 
testimony, after Menu Foods first learned of possible 
contamination of pet foods.
    On that date, March 8, notwithstanding what we believed to 
be a remote risk at that time, ChemNutra quarantined and ceased 
all shipping, sales, and marketing of wheat gluten in our 
possession, from all sources. On March 16, Menu Foods issued 
its first recall and in doing so, made no mention of wheat 
gluten. In fact, Menu Foods said at that time that it is 
testing some 20 ingredients, but to date, we have not heard a 
word about those testing results.
    Shortly thereafter, on March 19, we received a request from 
the Food and Drug Administration for all documents relating to 
wheat gluten, to which we immediately and fully complied. 
However, it wasn't until March 29 that ChemNutra heard for the 
first time that the FDA had found melamine in its wheat gluten, 
without quantification as to how much.
    Between March 29 and April 1, I was in China and in 
communication with the FDA. Upon hearing of the traces of 
melamine, I spoke with the president of our supplier, XuZhou 
Anying Biologic Technology Development Co. Ltd, who said he 
didn't know there was melamine in their wheat gluten or how 
that could have happened. He promised to look into it and, to 
this date, has not provided us with additional information 
despite many follow-up contacts on our part.
    On April 2, after receiving further information from the 
FDA, we issued a formal recall of the contaminated wheat 
gluten. It's important to note that on March 8, when ChemNutra 
ceased shipments of its wheat gluten, we had only four 
customers for that product, one of which was Menu Foods. Prior 
to any scheduled shipment, customers were made aware that our 
shipments were stopping.
    It has been more than a month since this dreadful issue 
became manifest. Over this period there have been a raft of 
surmises and suppositions, but few facts. At this point, the 
only piece of information of which we can be certain is that 
melamine was contained in a shipment of wheat gluten we 
imported through XuZhou Anying Biologic Technology Development 
Co. Ltd.
    However, we at ChemNutra strongly suspect, at this point, 
that XuZhou Anying Biologic Technology Development Co. Ltd may 
have added melamine to the wheat gluten as an ``economic 
adulteration''-- designed to make inferior wheat gluten appear 
to have a higher protein content. They can sell it to us at the 
price we would pay for a higher-quality product because the 
melamine, our experts tell us, falsely elevates the results of 
a nitrogen-content test used to assess protein content. 
Melamine is not something that we or, anyone else, including 
the FDA was ever testing for in the past, though of course we 
are now.
    We have recently been told that there was a prior history 
of this same kind of economic adulteration related to a similar 
agricultural commodity about three decades ago, where this 
commodity was adulterated with urea, another nitrogen intensive 
additive, which had at the time become inexpensive enough to 
economically use to fool the protein testing. Subsequently, 
that commodity has been--tested for urea.
    I want to thank the committee for this opportunity to tell 
the ChemNutra story in an unvarnished and factual manner and I 
hope that my testimony today will help you develop protocols, 
regulations or laws that will preclude this sort of event from 
occurring in the future.

                  Chemnutra Frequently Asked Questions

    What Is Chemnutra's Responsibility In The Pet Deaths?
       What we know at this point (April 15, 2007) is 
that the FDA suspects there may be a direct or indirect 
connection between pet deaths and illnesses and the melamine 
found in the wheat gluten supplied to ChemNutra by a single 
Chinese manufacturer, XuZhou Anying Biologic Technology 
Development Co. Ltd.
       ChemNutra had no idea that melamine was an issue 
until being notified by the FDA on March 29. In fact, ChemNutra 
had never heard of melamine before. It's simply not a chemical 
even on the radar screen for food ingredient suppliers.
       Consistent with industry practices, we require 
that our suppliers test for protein content, moisture, ash, 
water absorption rate, particle size and appearance. We examine 
the Certificate of Analysis provided by our supplier to ensure 
it has complied. We now know that what we received was not food 
grade wheat gluten, as we had ordered and what appeared in the 
shipping documents, but wheat gluten adulterated to appear as 
food grade when it was in fact not. Food grade wheat gluten is 
always 75 percent protein content, but that's not what we 
received. The melamine content made it appear as if it had a 
higher protein content.
       Ingredient testings is not what one sees on CSI, 
where one sample is examined and it tells you every chemical in 
it. We require tests for pre-identified risk and quality-
related factors. Melamine was not one of those pre-identified 
risks before. Now, of course, it is and we have begun 
independently testing our wheat gluten from other suppliers.

    When Did Chemnutra First Learn There Was A Potential 
Problem With Its Product

    A specific timeline regarding the events accompanies this 
document and is available on our Web site at http://
www.chemnutra.com/media.htm and accompanies this document.
    According to Senate testimony, Menu Foods knew there was a 
potential problem long before we did.
       On or about March 6, Menu Foods informed 
ChemNutra that it didn't want any more wheat gluten. Menu Foods 
told ChemNutra that this was because of a need for a different 
water absorption factor in their wheat gluten; that type of 
requirement changes all the time.
       On March 8 Menu Foods told ChemNutra that our 
wheat gluten was one of many products it was investigating, so 
clearly Menu Foods already had an investigation well in 
progress. In response to what seemed to be an extremely remote 
risk at the time, ChemNutra quarantined and ceased shipments of 
all wheat gluten in its possession, from any manufacturer.
       Menu Foods asked ChemNutra questions for several 
days thereafter and each time we responded rapidly. Menu Foods 
wanted ChemNutra to ask XuZhou whether its wheat gluten had any 
of four substances that Menu Foods suspected might cause renal 
failure: propylene glycol, heavy metals, Ochratoxin or Easter 
Lily Flower. Menu Foods never asked about melamine.
       On March 16, Menu Foods issued its first product 
recall, but immediately after the recall, the company told 
ChemNutra that it was still investigating approximately 20 
ingredients. As of the date of this document, ChemNutra has 
heard nothing further about the ingredients other than wheat 
gluten Menu Foods claims to be investigating.
       On March 19, an investigator from the FDA's Las 
Vegas office told ChemNutra the FDA wanted to visit ChemNutra 
to obtain ChemNutra's records regarding wheat gluten supplied 
to Menu Foods. ChemNutra maintains thorough, accurate and 
comprehensive records and complied fully and promptly with the 
FDA's request.
       The aminopterin found in three cans of Menu 
Foods, reported by the State of New York on March 23, was 
inaccurately associated with wheat gluten from China and, in 
fact, aminopterin wasn't found in the wheat gluten we supplied. 
Aminopterin is illegal for use in China.
       The word ``melamine'' wasn't mentioned by any 
entity until late in the day on March 29, when the local FDA 
investigator returned to tell ChemNutra the FDA found melamine 
in ChemNutra's wheat gluten. However, the FDA investigator 
couldn't confirm the quantities until the next day, March 30. 
On March 30 ChemNutra Chief Executive Officer, Steve Miller met 
personally with the president of XuZhou Anying to demand more 
information. At that time, XuZhou's president claimed no 
knowledge of how melamine contamination could have occurred and 
promised to investigate. Since then he has been unresponsive to 
requests for information.

    How Does ChemNutra Identify And Screen Suppliers?

       XuZhou Anying was recommended to ChemNutra by 
one of China's leading trading companies, one with which we 
have had a long-term relationship. This is a standard way that 
American importers identify Chinese suppliers who are supposed 
to be reliable.
       Once suppliers are identified, ChemNutra 
examines samples from the recommended suppliers; checks their 
business certifications and conduct other research about them. 
XuZhou's paperwork indicated that it is ISO 9000 and HACCP 
certified; and ensures that they also hold Chinese 
certifications from five other organizations that attested to 
its credit quality, reliability and product quality.
       We are very distressed that to date XuZhou has 
not responded to our requests for more information nor, 
apparently, to U.S. Government requests.

    What Did Chemnutra Do To Prevent This From Happening/What 
Will It Do Differently Now

       ChemNutra has an excellent compliance record 
with all applicable regulatory authorities.
       If the Pet Food Institute, the FDA or 
ChemNutra's customers make further recommendations as a result 
of this situation, we will fully comply with them. Obviously, 
that will now include testing for melamine in wheat gluten.
       ChemNutra knows that procedures for evaluating 
suppliers and products for importation will change as a result 
of this pet food recall. We plan to be actively involved in 
developing and implementing these procdures. ChemNutra, as 
always, will fully assist all regulatory and standards 
authorities, including the FDA, in designing these procedures. 
This is a problem that needs to be resolved, and ChemNutra 
intends to take an active role in designing the solutions.

    How Many ChemNutra Products Are Affected?

       Only one, wheat gluten from only one supplier, 
XuZhou Anying Biologic Technology Development Co. Ltd., was 
affected. Most of our other ingredients are pharmaceutical 
grade, from suppliers already reviewed and approved by our 
customers.

    How Will This Affect ChemNutra's Business

       All of our customers except Menu Foods 
understand that ChemNutra was a victim in this situation. A 
number of them have been asking questions, but Menu Foods is 
only customer that has cancelled its contract with ChemNutra.
       ChemNutra has continued to receive new orders 
for wheat gluten that we obtain from other suppliers, which we 
will release only after we have tested it for melamine. We have 
also received orders for other products.
       We believe our customers understand that--just 
as with some of the recent e. coli cases that were tracked back 
to growers in California--that even when you have vendors with 
good reputations, product contamination does occur on rare 
occasion.
       ChemNutra is financially strong, and we're in 
this business for the long haul.
       We have excellent relationships with our 
suppliers in China, who also understand what happened in this 
situation. We represent several of them exclusively in the 
United States

    How Do You Know Your Other Products Are Safe?

       Wheat gluten was the only product ChemNutra 
purchased from XuZhou Anying.
       ChemNutra currently sells only nine ingredients. 
Each of them have their own testing requirements as dictated by 
regulation, our customers and/or ChemNutra's own high 
standards. While this situation will certainly make ChemNutra 
even more vigilant with all suppliers, we have had no health-
related issues with other products. Most of these products are 
pharmaceutical grade
       We will only add new ingredients when we can 
confirm quality control with Chinese manufacturers.

    What Are ChemNutra's And/Or Its Principals' Qualifications 
To Be In The Ingredients Business?

       Steve Miller has more than 20 years of 
experience in business management, finance, marketing and the 
law. Sally Miller, president, is Chinese, with wide-ranging 
experience doing business in China.
       Since ChemNutra's inception, it has been bonded 
with U.S. Customs, and registered with the FDA under the 
Bioterrorism Act. ChemNutra has all appropriate business 
licenses and registrations and fully complies with any 
inspection requests from regulatory authorities on any 
ingredients it imports.
       ChemNutra has always offered its customers an 
unconditional money-back guarantee on our products--they can 
return them if dissatisfied at any time, for a full refund
       Our policy is to provide the best customer 
service available and the most reliable delivery and timing for 
shipments from China of anyone in the industry, and thChemNutra 
far many of our customers have attested that we accomplish 
this.

    Why Does Wheat Gluten Need To Be Imported From China?

       Less than 25 percent of the United States' wheat 
gluten needs can be supplied domestically. As much as 30 
percent of this country's wheat gluten imports come from China 
and the rest from Europe, Russia and Australia.

    Does ChemNutra Import Rice Protein Concentrate From China?

       ChemNutra uses a large, reputable--trading 
company in China to import rice protein concentrate, Suzhou 
Textiles, which purchases ChemNutra's rice protein concentrate 
from Shangdong ShunFengFan. ChemNutra never bought--any rice 
protein concentrate from Xuzhou Anying, the manufacturer of the 
tainted wheat gluten. We are testing all imported rice protein 
concentrate through independent, third-party U.S. laboratories.

        Chemnutra Timeline of Events Related to Pet Food Recalls

    February 20, 2007: Menu Foods learns of contamination in 
pet food (Source: Senate Hearing)
    March 6, 2007: Menu Foods informs ChemNutra to stop 
shipments of wheat gluten, ostensibly because of a 
specification change relating to the water absorption factor.
    March 8, 2007: Menu Foods informs ChemNutra that wheat 
gluten was one of many ingredients it was investigating as 
suspect in cat illnesses. Menu Foods wanted information as to 
whether XuZhou Anying's wheat gluten had any of four substances 
that Menu Foods suspected might cause renal failure: propylene 
glycol, heavy metals, Ochratoxin or Easter Lily Flower. Menu 
Foods never asks about melamine. ChemNutra, notwithstanding 
what it believed to be a remote risk at that time, quarantines 
all wheat gluten--from all sources--in its possession.
    March 16, 2007: Menu Foods issues first product recall and 
related press release, which does not ID wheat gluten as the 
primary suspect source. (Cite: Menu Foods)
    March 19, 2007: Food and Drug Administration notifies 
ChemNutra that it wants records relating to wheat gluten 
shipments. ChemNutra immediately complies.
    March 23, 2007: State of New York reports aminopterin found 
in three cans of Menu Foods. This was inaccurately associated 
by some media with wheat gluten from China, as aminopterin 
wasn't found in the wheat gluten ChemNutra supplied. 
Aminopterin is illegal for use in China.
    March 24, 2007: Menu Foods recalls all varieties of ``wet'' 
pet food. (Cite: Menu Foods)
    March 29, 2007: Melamine is mentioned to ChemNutra for the 
first time by the Food and Drug Administration, which says it 
has found evidence of the chemical in the wheat gluten, but 
does not quantify how much until the next day.
    March 31, 2007: ChemNutra Chief Executive Officer Steve 
Miller meets in-person with the president of XuZhou Anying 
Biologic Technology Development Co. Ltd, who says he didn't 
know there was melamine or how it could have become mixed with 
XuZhou Anying's wheat gluten and promised to look into it.
    April 2, 2007: ChemNutra recalls all XuZhou Anying wheat 
gluten sold to ChemNutra's customers.
    April 5, 2007: All Menu Foods pet food in Canada and the 
United States using ChemNutra wheat gluten voluntarily 
recalled; expands recall to cover product distributed back to 
November 8, 2006. (Cite: Menu Foods)
    April 10, 2007: Menu Foods voluntarily recalls additional 
pet food made with ChemNutra wheat gluten manufactured at a 
Canadian facility. (Cite: Menu Foods)
    April 12, 2007: Government scrutiny, as reported by the 
media and at Senate hearings, focuses on possibility of 
deliberate contamination by XuZhou Anying Biologic Technology 
Development Co. Ltd and actions of Menu Foods during time 
period leading up to first recall.
                              ----------                              

    Mr. Stupak. Thank you all for your testimony and for being 
here.
    Mr. Miller, you indicated that your company had four 
customers. One of them was Menu Foods, the other three 
customers that you had shipped this wheat gluten to, too, is 
that correct?
    Mr. Miller. Yes.
    Mr. Stupak. What do they make?
    Mr. Miller. Two of them make pet food, and the third one 
distributed wheat gluten to pet food companies.
    Mr. Stupak. So it is basically pet food is where it goes?
    Mr. Miller. All pet food.
    Mr. Stupak. Once you realized that melamine may have 
something to do with these problems with the pets and their 
deaths and their illnesses, what did you do with your wheat 
gluten that you had left?
    Mr. Miller. All of the wheat gluten has ever since March 8 
been in our warehouse and basically quarantined.
    Mr. Stupak. Do you have any plans to dispose of it?
    Mr. Miller. We are working with the FDA right now to 
dispose of it in ways that are acceptable to the FDA.
    Mr. Stupak. OK.
    Mr. Colo, on behalf of ConAgra, in October 2004, you found 
salmonella poisoning or, I should, say salmonella in your 
peanut butter, right?
    Mr. Colo. That is correct.
    Mr. Stupak. And in I believe it was March 2005 the FDA came 
and asked about that salmonella, if you had any troubles, is 
that correct?
    Mr. Colo. That is correct.
    Mr. Stupak. And disagreement here. FDA tells us they asked 
for information. I understand ConAgra says, put it in writing. 
Either way, the FDA never obtained the information they were 
looking for based on that 2004 salmonella, right?
    Mr. Colo. The situation, just to be clear, was we had a 
positive salmonella on finished product that we held at our 
facility. The product was never shipped from our Sylvester, GA, 
facility. It was contained and destroyed in the process.
    Mr. Stupak. The FDA asked for those records in 2005.
    Mr. Colo. FDA asked for the records in February 2005, 
that's correct.
    Mr. Stupak. And they have never been provided to the FDA.
    Mr. Colo. We simply asked the FDA to request the 
information in writing and that we would be happy to forward 
them----
    Mr. Stupak. Have they ever put it in writing?
    Mr. Colo. The FDA never put it into a written request to 
us.
    Mr. Stupak. Did they follow up after--I believe this is 
after March 2005. Did they follow up with ConAgra and ask for 
the information again without putting it in writing?
    Mr. Colo. No, they did not; and it was February 2005.
    Mr. Stupak. Has there been any other time in which the FDA 
or USDA asked ConAgra, either on E. coli, salmonella, botulism, 
about possible contamination and ask for your records where 
ConAgra did not provide it to the FDA?
    Mr. Colo. Again, what we would typically do in those 
situations is simply ask for the FDA to request that 
information in writing
    Mr. Stupak. I am asking if there has been other incidences. 
There have been rumors circulating around here that ConAgra 
just sort of says, put it in writing, sort of stonewalls 
requests, never happens. We know of October 2004 in which they 
followed up in March 2005. The point I am trying to--is there 
any other time in which information was requested and not 
provided whether it is in writing or not.
    Mr. Colo. I am not aware of all the requests that would 
come from the FDA. So I am not sure that I can answer that 
question appropriately at this time.
    Mr. Stupak. Could you check and follow back with the 
committee? We keep this record open for 30 days, so you can 
follow and check up for that for us.
    Mr. Colo. Absolutely.
    Mr. Stupak. Mr. Henderson, you indicated that I think you 
used the word fraud in your testimony that this melamine put in 
there was a fraud. It was intentional.
    Mr. Henderson. Yes.
    Mr. Stupak. Wheat gluten is used in things other than pet 
food; correct?
    Mr. Henderson. That would be my understanding, yes. Pizza 
is an example.
    Mr. Stupak. I mean, food like tofu and other things like 
this; correct?
    Mr. Henderson. Correct.
    Mr. Stupak. Then what happened to you, is there any way we 
know then if other wheat gluten or other products or other 
things have been intentionally altered? You don't know until 
after the fact; right?
    Mr. Henderson. You don't know until after the fact. 
Certainly, the presence of melamine was a particular problem 
during this process simply because there was not--it was such a 
foreign additive or contaminant. There wasn't a testing 
protocol for identifying it. So we could have--what we are 
aware of is what has happened to us. Whether it happened before 
or is happening now, we couldn't comment.
    Mr. Stupak. You don't know. And you place your order then 
with Mr. Miller's company; right?
    Mr. Henderson. That's correct.
    Mr. Stupak. And then he ships it to you?
    Mr. Henderson. Yes, he does.
    Mr. Stupak. And Mr. Miller, you receive it from China; 
right?
    Mr. Miller. Yes.
    Mr. Stupak. And before this instance, did you ever do any 
testing of any of the products that came from China.
    Mr. Miller. No. There was no known issue to test for.
    Mr. Stupak. You indicated that your supplier in China 
basically was recommended by other people in the industry?
    Mr. Miller. By a trading company that we have that we 
worked with over a long number of years that we had a lot of 
confidence in.
    Mr. Stupak. Had you ever used this company before?
    Mr. Whitfield. Mr. Chairman, I would ask unanimous consent 
that we each be given 10 minutes and that you----
    Mr. Stupak. No objection, go ahead.
    Have you ever used these companies before that you got the 
wheat gluten from?
    Mr. Miller. Yes, we had.
    Mr. Stupak. And never any trouble?
    Mr. Miller. No trouble whatsoever.
    Mr. Stupak. Had there been any complaints about their 
products before, about the low protein content or anything?
    Mr. Miller. This was a new product for us.
    Mr. Stupak. From this company? You have used the company 
before in China but just not this product?
    Mr. Miller. This was the first company we imported--we just 
started last fall in this business. This is new product for us.
    Mr. Stupak. OK. Mr. Sweat, we heard testimony here earlier, 
and I have been showing this. On the back here, it says, 
Salinas, CA. Would this come out of your plant? Probably, this, 
I think it is fresh discoveries now.
    Mr. Sweat. I would have to look at the production code. 
Does it start with a J or a Y?
    Mr. Stupak. Y097B21.
    Mr. Sweat. That would have come out of our Yuma, AZ, 
facility.
    Mr. Stupak. You have a plant in----
    Mr. Sweat. We have a plant in San Juan Bautista, CA, and we 
have a plant in Yuma, Arizona.
    Mr. Stupak. Is San Juan Bautista, is that considered 
Salinas Valley?
    Mr. Sweat. It is about 25 miles north of Salinas.
    Mr. Stupak. There has been some discussion about completely 
washed. What does that mean?
    Mr. Sweat. What we do with the salad greens, after they are 
harvested and brought into our facility, we mix them into a 
mixing belt for the different ingredients, and then we put them 
through a chilled chlorinated wash, and that chlorine is used 
as a sanitizer for the wash system.
    Mr. Stupak. That does not a take out E. coli, though; does 
it?
    Mr. Sweat. No, it is not a kill step. It is a deterrent for 
microbial load, but it is not a kill step.
    Mr. Stupak. Prior to this incident, did you do any testing 
for E. coli?
    Mr. Sweat. In the 22 years we have been in business, we 
have never had a foodborne illness, so our GAP programs that we 
have in our fields, our GMPs in our plant and our HACCP program 
on inventory control----
    Mr. Stupak. But you were in the Salinas Valley where, in 
the last 10 years, you have had basically 20 different recalls 
or things like E. coli, and then the company never felt 
necessary to do testing?
    Mr. Sweat. We weren't involved in any of those. I don't 
know what the issues were in those. But what we did do as a 
result of this outbreak is we got outside the box a little of 
produce, and we went to the beef industry to learn a little bit 
about what they were doing. And that is where the testing 
programs that we implemented a couple weeks after the outbreak 
were derived from.
    Mr. Stupak. It says, Product of U.S. and Mexico. But you 
said this is from Yuma. Would part of this salad have come from 
Mexico, too?
    Mr. Sweat. Potentially, it could. We do have farms that 
grow in Mexico, that we bring product into the U.S. on.
    Mr. Stupak. I understand that it comes in to your plant. 
Once it comes in, out of the field, it is packaged right in and 
shipped right out in these plastic containers. Even though it 
may say Dole, it is your plant; right?
    Mr. Sweat. It is our processing facility, but then Dole 
picks that product up at our facility, and they distribute it 
out.
    Mr. Stupak. Has the FDA ever inspected your facilities?
    Mr. Sweat. Yes. We have worked with the FDA on a 
collaborative basis on our programs over the years. They come 
in frequently.
    Mr. Stupak. How frequently?
    Mr. Sweat. Last time they were there was in August, 
reviewing our facilities.
    Mr. Stupak. August 2006?
    Mr. Sweat. August 2006 the actual week of the spinach that 
was linked.
    Mr. Stupak. Did they do any testing or did they come in and 
look around?
    Mr. Sweat. What they do is they come in and look at our 
documents. We provide them with all our documents on our 
program, and they review all of our compliance with all our 
programs and controls.
    Mr. Stupak. But you're not required to do any testing.
    Mr. Sweat. Voluntary regulations and guidelines from the 
FDA do not require any testing.
    Mr. Stupak. So they are just looking at how you are 
handling a product?
    Mr. Sweat. They are looking at our processes; that is 
correct.
    Mr. Stupak. So other than making sure that the area is sort 
of sanitary, there is no testing for E. coli then that is done 
by the FDA?
    Mr. Sweat. There is none at this point in time.
    Mr. Stupak. Mr. Henderson if I may ask you on testing, now 
Menu Foods, you are in U.S. and Canada right?
    Mr. Henderson. Yes, we are.
    Mr. Stupak. Are you inspected by the FDA?
    Mr. Henderson. We have been inspected in the Pennsauken 
facility in 2006 by the FDA.
    Mr. Stupak. In 2006?
    Mr. Henderson. Yes.
    Mr. Stupak. Do you recall any time before 2006 by the FDA?
    Mr. Henderson. We have been inspected prior to that. I 
don't have the dates.
    Mr. Stupak. Every year do you think or----
    Mr. Henderson. Our head of technical services estimated it 
was about once a year.
    Mr. Stupak. Do other agencies inspect your plant?
    Mr. Henderson. USDA APHIS, inspects us once a year. The 
Canadian plant is inspected by the equivalent the CFIA. We are 
inspected by both the USDA and CFIA to allow us to export to 
Europe so they are looking at it not only from the Canadian and 
U.S. protocols but also from the European protocols.
    Mr. Stupak. We have had some outbreaks here with wheat 
gluten in San Francisco, France, Canada, Connecticut and in 
your place. Do you get together and share information when you 
hear of outbreaks in other areas, let's say, like France or up 
in Canada, or is it only if it involves your company?
    Mr. Henderson. Excuse me, get together with whom?
    Mr. Stupak. Other authorities from Canada, what is going on 
if you detected something, something in France? It is all wheat 
gluten; apparently wheat gluten is a big part of your product 
here.
    Mr. Henderson. Relative to this experience, which is the 
only one I can relate to, we have essentially coordinated 
through the FDA. FDA was in touch with European authorities and 
in touch with the Canadian authorities, and we relied on them 
to ensure the communication----
    Mr. Stupak. From a company-to-company point of view, there 
is no contact back and forth; just work through your regulatory 
agency?
    Mr. Henderson. In that particular case, the company is also 
a member of the pet food institute. At the time that there was 
something to talk about, which was the presence of melamine, 
that was the topic for discussion. When the recall was 
initiated, the recall was initiated on the basis of, we did not 
know what the problem was. We just have to recall.
    Mr. Stupak. All right.
    Mr. Whitfield, questions, 10 minutes.
    Mr. Whitfield. Thank you, Mr. Chairman.
    And Mr. Henderson, Menu Foods, is that a publicly traded 
company, or is it a private company?
    Mr. Henderson. It is a publicly traded income trust. It is 
essentially a publicly traded company in Canada. It is on the 
Toronto stock exchange.
    Mr. Whitfield. And I think you said you have been in 
business 35 years?
    Mr. Henderson. We were incorporated in 1971, so it is just 
over 36.
    Mr. Whitfield. And what would be the volume of wheat gluten 
that your company would use per year or per month, or do you 
have any idea?
    Mr. Henderson. I am afraid I don't. I can't give you a 
number that would be reliable.
    Mr. Whitfield. But you obviously purchase it from more than 
just Mr. Miller's firm.
    Mr. Henderson. We have been purchasing it from multiple 
sources in the United States, from Europe and from Mr. Miller's 
company.
    Mr. Whitfield. And of the total amount of wheat gluten that 
you purchase, what percent would you say comes from the United 
States?
    Mr. Henderson. Again, I don't have those numbers at my 
finger tips, so I can't give you----
    Mr. Whitfield. Mr. Miller you had mentioned in your 
testimony that, of the wheat gluten that is used in the United 
States, that only about 25 percent of it is produced 
domestically. Is that correct?
    Mr. Miller. I believe that to be true.
    Mr. Whitfield. So 75 percent of the wheat gluten used in 
the U.S. is imported from some other country, is that correct?
    Mr. Miller. Yes that is an approximate number that is, I 
believe to be, true.
    Mr. Whitfield. Now the president of your company is your 
wife; is that correct?
    Mr. Miller. Correct.
    Mr. Whitfield. And she is Chinese. She is from China.
    Mr. Miller. That's correct.
    Mr. Whitfield. One of the things I was a little bit puzzled 
about, I can understand why China, the company that you 
purchased this wheat gluten from would not be particularly 
responsive maybe from a company in the U.S., even though I am 
sure they want to cater to their customers, but since your wife 
is a citizen of China, she would--you would have some recourse 
against this company, I am assuming. Is that true or not?
    Mr. Miller. We haven't looked into it that. It may be true.
    Mr. Whitfield. But that is obviously something that you 
will be looking into.
    Mr. Miller. Yes.
    Mr. Whitfield. OK. One area that I wanted to look at 
briefly relates to finished product testing programs. And Mr. 
Henderson, in your finished product testing program, what is 
actually entailed in that? And I am assuming that that testing 
program would not detect melamine in the final product. Would I 
be accurate in that or not?
    Mr. Henderson. That would be accurate. The programs for 
testing it that are undertaken at Menu Foods as is the case 
with most pet food companies that we would certainly be aware 
of is the testing of the raw materials that go into the pet 
food, essentially the objective would be to detect it before it 
gets into the finished product rather than test it after the 
finished product is made.
    Essentially there is a commercial sterilization process by 
which the pet food is cooked which will essentially deal with 
any contaminant such as bacterial or E. coli or anything along 
those lines. But it is from a perspective of control we are 
looking at testing the raw materials. Relative to melamine, it 
was simply a substance that was not known. There was no testing 
protocol relative to wheat gluten; we would essentially test 
for the toxins we would generally associate with wheat. In this 
case, we would test every load of wheat gluten for a vomatoxin 
in accordance with protocols established by the appropriate 
authorities.
    Mr. Whitfield. Is that the only wheat gluten that your 
company used that had melamine in it, came from Mr. Miller's 
firm; is that correct?
    Mr. Henderson. That's correct.
    Mr. Whitfield. Now you sell a lot of pet food in the U.S., 
so this final product, this finished product testing program, 
are there regulations relating to that that comes from the FDA? 
Or are these just internal programs that you have in effect?
    Mr. Henderson. The programs that we have in effect are 
those that are established by Menu Foods based on essentially 
the experience of the organization and common practices within 
the industry.
    Mr. Whitfield. So FDA does not have any regulations 
relating to finished product testing?
    Mr. Henderson. Relative to finished product testing? Not 
that I am aware of, no.
    Mr. Whitfield. Do you agree with that, Mr. Colo? Does FDA 
have any regulations relating to finished product testing?
    Mr. Colo. Not that I am aware of, no, sir.
    Mr. Whitfield. You, of course, do finished product testing, 
but you have indicated that you did not detect the salmonella 
in the Peter Pan peanut butter; correct?
    Mr. Colo. In the current recall situation, that is correct.
    Mr. Whitfield. So wouldn't you want your finished product 
testing to detect salmonella or----
    Mr. Colo. Yes, absolutely. Our procedure is that we sample 
one jar of peanut butter per packing line per hour every day 
that the facility operates. We test for salmonella. We hold all 
finished product at our facility until we get the test results 
back to confirm that there is not the presence of salmonella 
prior to releasing the product for shipment.
    Mr. Whitfield. And for you and Mr. Sweat, is there some 
method that you could expose your product to that would 
definitively remove E. coli bacteria as well as salmonella?
    Mr. Sweat. At this point, we don't have a kill step as that 
would be defined for fresh produce. That is one of the reasons 
we have moved forward with our testing protocols is to help to 
detect it to prevent it from entering the chain of commerce.
    Mr. Whitfield. Now irradiation I guess can be used in meat 
products, but can irradiation be used in vegetables?
    Mr. Sweat. Radiation has not been approved for use by the 
FDA on fruits and vegetables.
    Mr. Whitfield. And certainly not on peanut butter, I 
wouldn't think.
    Mr. Colo. That is correct.
    Mr. Whitfield. Mr. Colo, you had stated in your testimony 
that you first became aware of possible salmonella in your 
peanut butter on February 13 when the FDA contacted you. But 
prior to that date, did ConAgra have any consumer complaints or 
reports of illnesses made by consumers directly to ConAgra or 
through your consumer hotline?
    Mr. Colo. No complaints were received relative to consumer 
illness for salmonella, no, sir.
    Mr. Whitfield. OK. I have no further questions.
    Mr. Stupak. Thank you. I go to the gentlelady from 
Colorado, Ms. DeGette, for questioning for 10 minutes.
    Ms. DeGette. Thank you, Mr. Chairman.
    Mr. Sweat, they never did find out what caused the 
contamination in that spinach, did they, definitively?
    Mr. Sweat. That's correct.
    Ms. DeGette. Are they still making efforts to find that 
out?
    Mr. Sweat. I think what I understand now that they have 
published their report that they have closed their 
investigation on that particular incident, but I know we are 
working collaboratively as an industry with the agencies going 
forward.
    Ms. DeGette. I'm sure you would like to know, for example.
    Mr. Sweat. Yes.
    Ms. DeGette. You said that after your company found out 
about the contamination, you instituted a 24-hour voluntary 
recall; is that correct?
    Mr. Sweat. That's correct.
    Ms. DeGette. I am wondering if you have any view on when, 
if we gave the FDA ability to do mandatory recalls, if they 
were aware of a situation?
    Mr. Sweat. I think, as a company, when you are concerned 
about public health and safety, you will recall product if 
there is any risk at all.
    Ms. DeGette. For one thing there is a liability risk, but 
what about giving the FDA----
    Mr. Sweat. We wouldn't have any problem if there was a risk 
to have mandatory recall authority with the FDA.
    Ms. DeGette. Great, thank you.
    I want to follow up with Mr. Colo on the questions that Mr. 
Stupak was asking you about the 2005 inspection of the ConAgra 
plants in Georgia. Yesterday, in the Washington Post, they made 
the allegation that the connection between the 2005 
connection--investigation--was that this was an ongoing problem 
with this plant. I don't know if that is true, but I was 
looking at some of the reports, and I was a little bit 
disturbed about what this inspection shows as a systemic issue 
in the foods, in the food industry. So if you can take a look 
at No. 16 in your notebook that you have there, the exhibit 16. 
What that is, is that is the FDA notes from the inspection into 
the Sylvester, GA, plants in October 2004; is that correct?
    Mr. Colo. In 2005, yes.
    Ms. DeGette. Yes. But in that report, though, they said 
that they were investigating complaints that had been received 
anonymously about various conditions; correct?
    Mr. Colo. Correct.
    Ms. DeGette. And one of the allegations was that I guess 
management acknowledged that there was peanut butter that was 
placed on a, quote, micro hold in October 2004 and was 
destroyed. Is that correct?
    Mr. Colo. That's correct.
    Ms. DeGette. And a micro hold is a holding of the product 
due to finding of micro organisms like salmonella or E. coli 
forms in the product; correct?
    Mr. Colo. Correct.
    Ms. DeGette. And then the report goes on to say, local 
management refused to provide details to include the exact 
cause of the hold and the type, amount of product involved; 
correct?
    Mr. Colo. Correct.
    Ms. DeGette. Now does that mean that ConAgra did not 
acknowledge much less supply the testing results regarding the 
positive finding of salmonella to the FDA?
    Mr. Colo. Our policy--which I believe you have a copy of--
states that if proprietary or confidential information is 
requested, we simply ask that the FDA provide the request in a 
written form, and then we will provide them with the 
information. That did not occur in this situation.
    Ms. DeGette. That was your previous policy that, even if 
there was an allegation of food safety problems, the FDA had to 
ask you in writing in case there might be proprietary concerns; 
right?
    Mr. Colo. Correct. That is correct.
    Ms. DeGette. So despite the fact that the FDA showed up 
there and related these concerns, you guys, ConAgra, never got 
a written request, so they just never presented any information 
to the FDA; right?
    Mr. Colo. That's correct.
    Ms. DeGette. Now, take a look at exhibit 17 in your 
notebook there. On the bottom of page 1, the FDA investigator 
notes that you stated you do test peanut butter for salmonella 
and coli forms prior to releasing the product for sale right?
    Mr. Colo. Correct.
    Ms. DeGette. And the inspector also notes that firm also 
acknowledged some of the peanut butter was put on a micro hold 
in 2004, and management would not provide the reason for the 
hold and the amount of product involved; 0correct?
    Mr. Colo. Correct.
    Ms. DeGette. Now I would assume ConAgra is one of the 
biggest food procedures in our country and I would assume that 
back in 2004 and 2005 ConAgra also had concerns about making 
sure that our food supply was as safe as possible.
    Mr. Colo. Absolutely correct.
    Ms. DeGette. But yet they refused to provide this 
information, how much product was held and what the reason was, 
because they didn't have a written request from the FDA; 
correct?
    Mr. Colo. Correct.
    Ms. DeGette. Now, on page 4 of that same document, exhibit 
17, the inspector notes that Mr. Maddis, the quality assurance 
manager at the plant explained the testing program and showed 
the inspector test summaries on finished product after 
receiving permission from the firm's legal counsel to do that.
    Do you know if your attorney told Mr. Maddis or Mr. Genoa, 
the plant manager or anybody else that they were not to provide 
test summaries that showed the salmonella findings that the FDA 
was asking about?
    Mr. Colo. I believe what this report refers to is, they 
showed finished product salmonella test results related to a 
question the inspector had relative to some new equipment 
installation, and that is what they verbally communicated to 
the inspector.
    Ms. DeGette. So how is that different from previous test 
results on product that had in fact been determined to have 
salmonella? Why do they get the information in that case but 
not in the other one?
    Mr. Colo. Again, it is simply a situation where they 
consulted our policy, asked that they consult with our 
corporate, or guidance; they did in that case. And the guidance 
they received was to share the information with them verbally 
relative to the equipment questions at the inspection.
    Ms. DeGette. So do you know, did they consult with legal 
counsel about the other question, about the micro hold in 
October 2004?
    Mr. Colo. I am not aware if they did or did not.
    Ms. DeGette. It seems a little odd that with respect to the 
equipment purchase, there is a call to legal counsel. Legal 
counsel says you can give this information but not with respect 
to contaminated peanut butter the year before.
    Mr. Colo. I don't want to speak for the FDA, but when the 
question was asked of our----
    Ms. DeGette. I am not asking you to speak for the FDA. I am 
asking you to speak for your company.
    Mr. Colo. Which I am. When we told the inspector that we 
test for salmonella and coli forms and that we had product that 
we put on hold due to micro concerns, and it was subsequently 
destroyed, there is only one of two things--one of two reasons 
why that product would have destroyed.
    Ms. DeGette. What are those?
    Mr. Colo. salmonella contamination or coli form, and again, 
our policy----
    Ms. DeGette. That doesn't really explain why they would 
refuse to provide the information in that instance, but why 
would they call legal counsel and be given the green light to 
provide the information with respect to the equipment?
    Mr. Colo. Again, our policy is written to reflect the laws 
that are we are afforded today. Our plant manager was simply 
acting under that authority. And as we published to the 
committee yesterday, we have made the decision to change our 
disclosure of information, guidelines, relative to routine FDA 
inspections, as well as under a recall situation to make sure 
that this situation does not occur again going forward.
    Ms. DeGette. Thank you for mentioning that. That is exhibit 
33 in your notebook, and I was just getting to that. And that 
is what I was talking about in my opening statement because 
some people say to me, why do you have these hearings? And I 
say, all you need to look at is ConAgra's April 23, 2007, 
letter which says they are now reversing their policy, and now 
you guys are apparently going to give information without a 
written request. That is kind of it in a nutshell; right?
    Mr. Colo. That is correct with the exception--I do want to 
point out that in the current recall situation, we provided all 
information without any written request to the FDA. So we are 
simply adopting the same procedure we followed during the 
recall----
    Ms. DeGette. This is your procedure now and going to be 
going forward in all instances? That is not just in reaction to 
the peanut butter situation; that is going to be ConAgra's 
general policy?
    Mr. Colo. That is correct.
    Ms. DeGette. Thank you very much, and I appreciate your 
honesty. Mr. Chairman, this only shows to me two things: No. 1 
giving the FDA mandatory recall authority would really help in 
terms of pushing industry to voluntarily report this so that 
there is not a mandatory recall; and second, that the FDA 
simply does not have enough authority to investigate these 
situations where it can be the company policy itself, that 
says, sorry, we are not going to give you information that 
could affect Americans' health from food. So we really have to 
look at beefing up the FDA's ability to oversee food. And with 
that, just the commercial part of the program, Congresswoman 
DeLauro and I have been working on mandatory reporting for meat 
safety. And we are going to start looking at other types of FDA 
oversight, and I will welcome input from all of the members of 
the committee on that.
    Mr. Stupak. Thank you.
    Mr. Walden for questions, 10 minutes.
    Mr. Walden. Thank you, Mr. Chairman, I have been shuttling 
back and forth to another hearing upstairs on telecom, and 
their meeting, too, as you all know that happens in this 
business.
    Mr. Colo, after the 2004 situation, did the company change 
in of its product testing procedures at the plant?
    Mr. Colo. Yes, after the 2004 incident, we increased the 
number of finished product samples that we take in the facility 
to one sample per hour per packing line in which the peanut 
butter is being produced.
    Mr. Walden. One sample per hour per packing line?
    Mr. Colo. Correct, prior to sampling protocol was three 
samples basically per shift per line.
    Mr. Walden. Do you feel that, well, if you were doing that, 
then how did this peanut butter get contaminated and you not 
catch it?
    Mr. Colo. Are you referencing the current situation? Well, 
again, when we conducted the investigation into this, what we 
believed is the most probable cause is that we had water 
contamination come into contact with dormant salmonella that 
was most likely in the peanuts or the peanut dust, and it was 
at low enough levels in the finished product that we were not 
able to detect it.
    Mr. Walden. As you determine the cause of the 2004 
contamination, does that have anything to do with the situation 
in 2007?
    Mr. Colo. No. The 2004 incident was a very isolated 
incident that we were able to, again, through our 
investigation, determine that we had received some peanuts that 
been rained on and led to the contamination. At that point in 
time, there was severe weather going on in the area related to 
hurricane activity. It damaged one of our suppliers' storage 
shed. The peanuts got wet, and that was part of it as well as 
we had some damage to one of our exterior bulk sugar bins that 
we believe may have contributed it to as well.
    In that situation, again, we contained all the finished 
product, our tests did show that it was positive under our 
control. Our procedures are that we do not release any product 
for shipment until we have the salmonella test results 
confirmed. In that case, they showed positive. We retained the 
finished product. We even went to the extreme of holding 
product and destroying it on both sides of the withhold period 
to make sure we did not release any product that was 
contaminated.
    Mr. Walden. Again how does that differ from 07 where 
contaminated product did get out into the market.
    Mr. Colo. Again, I think our belief is that the levels of 
contamination were so low that we were not able to detect it 
either in our environmental sampling programs within our 
facility or within our finished product testing methods.
    Mr. Walden. And when the FDA, they came in in the 2007 
recall, correct?
    Mr. Colo. Correct.
    Mr. Walden. And did you provide them with all the records 
they requested?
    Mr. Walden. Yes. As I had mentioned earlier, in the 2007 
recall, we provided all records to the FDA per the request.
    Mr. Walden. Now do you require a written request from FDA?
    Mr. Colo. We covered that previously here, but basically, 
prior to some changes that we had recently announced and 
discussed in this committee, our policy was to ask that any 
confidential or proprietary information that the FDA was 
requesting, that they simply provide us a written request, and 
we would provide them the information.
    Mr. Walden. This question may have been asked of all of you 
as well, and again, I apologize that I have had to come and go, 
but we have had a lot of discussion in this committee as we 
analyze America's food safety. None of us wants to get sick, 
including all of you. There has been this discussion that the 
FDA lacks the authority for mandatory recall and maybe you all 
touched on this, but for my benefit, if you could, what are the 
pros and cons of giving that agency mandatory recall that would 
make you operate differently?
    As you have heard, we do it for toys and tires and whatever 
else you want to talk about. Why not food? And maybe we can 
just go down the row.
    Mr. Henderson.
    Mr. Henderson. Relative to the FDA having mandatory recall 
authority, I can't think of a thing that we would have been 
doing differently had they had that, so if they were granted 
mandatory recall authority or not, we like to believe that the 
outcome would have been exactly the same.
    Mr. Walden. You wouldn't have done anything differently?
    Mr. Henderson. No.
    Mr. Walden. Mr. Sweat?
    Mr. Sweat. Once we were notified of a potential problem 
from the FDA, we went to a voluntary recall within 24 hours 
even before any of our product was specifically tied in with 
lab tests. So I think we would have done the exact same thing 
out of concern for public health and safety regardless. So 
having the mandatory would be fine, but it would not have 
changed what we did.
    Mr. Walden. Mr. Colo.
    Mr. Colo. ConAgra foods in the recent recall, I just want 
to point out as well, we voluntarily recalled, all the product, 
even without any indication that there was positive salmonella 
in any finished product samples either from CDC, the FDA or 
consumers.
    Having said that, I would say that it is incumbent upon 
ConAgra to take the responsibility for food safety and recall 
products when that is appropriate. The FDA having recall 
authority would be fine with us. It would not change anything 
that we have done today.
    Mr. Walden. Mr. Miller.
    Mr. Miller. Yes.
    Mr. Walden. Same question for you in terms of FDA's having 
the authority to do--the pros and cons of giving FDA authority 
to have mandatory recall capability. Would it affect----
    Mr. Miller. No, it wouldn't affect us in any way.
    Mr. Walden. You would still take the same actions?
    Mr. Miller. Yes.
    Mr. Walden. Then for the sake of consumers, what can be 
done differently to improve food safety from your perspectives? 
Because, obviously, there has been a lot in the news we see. I 
find it affects my shopping habits. Believe it or not, I am the 
one that generally goes to the grocery store when I go home, 
and I am making different choices now, which bothers me a 
little bit.
    What do we tell consumers about what we are doing to 
improve--what else can you recommend to us to improve food 
safety? I mean, your companies' bottom lines are the ones in 
the cross hairs here.
    Mr. Henderson. In my written statement, we gave a number of 
recommendations. Probably the most telling one is in regard to 
the ability of inspections to be undertaken by appropriate U.S. 
authorities in those jurisdictions in which exports are being 
made on the United States.
    For Menu Foods, at the present time, our plant in Toronto 
requires import permits in order to export products to the 
United States. That is as a result of BSE. Relative to our 
shipments into Europe, at the present time, in order for our 
plants to ship into Europe, our plants have to be qualified by 
the European authorities to ship product from the United States 
or from Canada into Europe.
    They delegate that responsibility to the USDA or the CFAA 
because of the trust that exists between those organizations. 
But essentially those activities, as is the case in the United 
States, of allowing product to ship from Canada to the United 
States already exists. And the notion that essentially the 
companies are obliged in order to transact business with the 
United States that they be accredited and certified and 
inspected before the product gets into the United States is a 
direct impact on the events that impacted on Menu foods, where 
you are getting into imports from China, et cetera, it would 
have been critical, and it would have been a very good positive 
step that somebody will have seen that, inspected that plant 
before it gets into the United States.
    Mr. Walden. Doesn't that really lend itself, too, for the 
call for food labeling, mandatory country of origin labeling so 
we know where this food is coming from as a consumer? You all 
keep records; don't you? Tell me you don't know back to the 
box. I have had fruit processing folks tell me they know back 
to the box from which orchard that the pears or apples or 
whatever fruit they are using originated.
    Don't you keep track of that anywhere?
    Mr. Henderson. My understanding of looking at the 
Bioterrorism Act, you essentially go forward one, back one, so 
you complete that chain, and you can get back to where you need 
to be. It is my understanding, relative to which hog was 
slaughtered to get products into our pet food, no. We don't 
know that; we don't have that information.
    Mr. Walden. Would you like to have that information in a 
situation like we see in the press these days?
    Mr. Henderson. From a commercial perspective, there has to 
be some element of accountability through the chain. The 
individuals with whom we deal with are essentially they are 
known commodities as far as people that we have dealt with 
before or have dealt with. In this particular issue, we had 
been dealing with ChemNutra before this, buying other 
ingredients.
    We buy from known suppliers. The idea that we have to go 
all the way back and that everybody in the supply chain has to 
go all the way back I don't believe is commercially practical.
    Mr. Walden. Mr. Sweat.
    Mr. Sweat. Well, I think on the confidence with consumers 
on food safety and fresh fruits and vegetables what we have 
learned from the scientists is this bacteria lives in the 
environment in which fresh fruits and vegetables are grown so 
there is a hazard and risk. And with that hazard and risk, what 
we have done is we have gone out to the International 
Commission on Microbiological Specification For Foods and 
classified fresh foods and vegetables as a class 15, which is 
the highest risk for pathogens because that means that it can 
actually grow beyond its process and can continue to grow.
    So with that, we have implemented raw product testing as a 
hurdle to prevent any sporadic contaminations from the 
environment on the crops from entering the process. And then we 
have implemented a finished goods testing program following 
that same class 15 sampling program that actually samples our 
production process every 2 hours. It is about 480 samples every 
2 hours off the production lines because of the high risk of 
bacteria with fresh fruits and vegetables. So we have to 
communicate that to consumers to re-instill confidence in what 
we are doing for food safety.
    Mr. Walden. I know my time has expired. Thank you all for 
your testimony. Thank you, Mr. Chairman.
    Mr. Stupak. Thank you, Mr. Walden, before you leave, I want 
to ask Mr. Henderson, do you wish to clarify an answer to your 
question about whether immediate recall is something we should 
have because the record is clear what we had this morning. That 
is why I am surprised at your answer, Mr. Henderson. If you 
take a look at the record and the timeline, on March 15 was 
your first recall for all wheat gluten manufactured between 
December 3, 2006, to March 6. March 24 was your second recall; 
you expanded to include additional dates.
    On April 5, you had your third recall. On April 10, you had 
your fourth recall. So an immediate recall authority by the FDA 
would not have taken a month for you to recall your products; 
correct?
    Mr. Henderson. I would have to say that is incorrect. The 
information that you are looking on--the recall that took place 
relative to the date of March 16, Menu Foods at that point in 
time did not know what the problem was.
    Mr. Stupak. I am not asking about the problem. The question 
was a recall. Should we give the FDA the right to immediate 
authority, and it wouldn't have made any difference in this 
case, you said; you don't think it would have made any 
difference in this case--but yet the recall went on for about a 
month--I don't think giving immediate recall authority for the 
FDA would have made any difference here.
    Mr. Henderson. The recall that was initiated by Menu Foods 
was essentially as a result or following conversations with the 
FDA. We identified, this was the scope that we are proposing to 
do. Whether or not they might have come up with a different 
scope, that is a valid point. They might have come up and said, 
recall more, recall less.
    Mr. Stupak. But even before you--I don't mean to be 
argumentative here--even before you at Menu Foods and FDA 
decided to recall, Iams had already told you they would no 
longer accept your product, and they were going to recall all 
food manufactured by Menu Foods at the Kansas plant; right? So, 
really, Iams was the first to really start the ball rolling 
here. Something is wrong, and I guess maybe what we are getting 
at here, there is also corporate responsibility instead of 
waiting for the FDA if Iams, the pet food manufacturer, sees a 
problem, and they are recalling it, I would have hoped that the 
corporations would have done it without FDA authority. But even 
with FDA authority, if we could grant that to them, I think we 
could have maybe limited the scope of the harm caused 
throughout our country.
    Mr. Henderson. Again, relative to the facts as they 
actually transpired, the conversation that took place with 
Iams, they essentially shared some information with us. We got 
together the next day, and essentially, in a rather lengthy 
meeting, both parties exchanged what they knew; that being 
that, individually, there wasn't enough information to draw 
conclusions, but together, it looked as though, from a 
circumstantial evidence perspective, as if we had the basis for 
recall. They opted to recall. We went along. We announced 
first.
    Mr. Stupak. Iams sees the need for recall, but almost 2 
weeks before that, your own taste-testing lab, out of 20 
animals, 3 died and 6 were dead. That is almost 60 percent. I 
would think that would cause Menu Foods to be concerned and 
talk about a recall and what is going on here quicker than 
waiting for Iams to force the issue and then the FDA and on and 
on.
    Mr. Inslee for 10 minutes please, questions.
    Mr. Inslee. Thank you, Mr. Sweat.
    Before the outbreak happened, were you given any warnings 
about a possible outbreak that may occur in suggestions that 
you should improve your practices?
    Mr. Sweat. We did receive a letter from the FDA some time, 
I want to say in November 2005. And with that letter, there 
were some steps that they asked us in our industry to go look 
at. And that was to look at our compliance with the recommended 
guidelines from the FDA on good agricultural practices, our 
good manufacturing practices and our HACCP programs. And we did 
that as an organization. And at that time, we were meeting or 
exceeding all of those guidelines published by those particular 
agencies.
    And about 2006, in the spring, as an industry, we met with 
the FDA and the CDHS to collaboratively share best practices 
within the industry and begin to work on technical committees 
across many companies within our industry in collaboration with 
the FDA and CHS to look for best practices that we could employ 
across the whole industry.
    Mr. Inslee. What practices are you now implementing that 
were not adopted then?
    Mr. Sweat. Subsequent to the outbreak, what we did was we 
reached out to the beef industry who had shown some success 
with reducing E. coli outbreaks and learned of a testing 
program that they had implemented from the international 
commission on microbiological specifications for food. And the 
scientists that had worked extensively in the beef industry 
helped, and we brought on board to consult with us and we had 
implemented a very similar testing program that the beef 
industry did using a class 15 high-risk statistical program.
    Mr. Inslee. And did you consider adoption of that earlier 
and reject it, or simply just not consider it?
    Mr. Sweat. At the time, we had not had any outbreaks in our 
organization for 22 years using our good agricultural 
practices, GNPs and HACCP programs, so we had not considered it 
prior to the outbreak.
    Mr. Inslee. And how many presumptive positives for E. coli 
015787 have you found since you instituted the program?
    Mr. Sweat. We implemented a raw product testing protocol 
within a couple of weeks of the outbreak. To date, and this is 
as of yesterday, we had a total of 39 positives, of which 23 
are E. coli related; 16 are salmonella related. They had been 
found in California, Arizona and Mexico, from various growers.
    In our finished goods testing program that we implemented, 
we have found none on our finished goods testing programs.
    Mr. Inslee. And is there anything to suggest that your 
circumstances now are different than they were before this? In 
other words, would you expect that is how many that was the 
situation before the outbreak as well?
    Mr. Sweat. I would hate to speculate since we weren't 
testing on what was prior to the outbreak. What we have learned 
from the scientists are these bacterias are prevalent in our 
environment, but since we weren't testing, I would hate to 
speculate on what was there.
    Mr. Inslee. The microbiological testing program that you 
have adopted, is there any reason that that should not be 
standard throughout the industry?
    Mr. Sweat. We would like to see that, plus more science, 
that become standard for the industry, but also we need more 
science to see what else we can do as an industry. This testing 
protocol is not a kill step. It is an intervention and a hurdle 
to help prevent these types of contaminations from occurring, 
but as an industry, we still need to continue to invest more in 
science and research on how we can combat this bacteria.
    Mr. Inslee. And why would you like to see the standard in 
the industry?
    Mr. Sweat. I think it adds additional hurdles and 
interventions for food safety. I think the good agricultural 
practices, as adopted today, are going to create, under the 
Leafy Green Marketing Agreement in California, a baseline for 
growers to comply with. But we think there needs to be more, 
and I think if we can test for these pathogens, then we may be 
able to detect and learn from them and also help prevent them 
from entering the chain of commerce.
    Mr. Inslee. Have you considered treatment from, like, 
Ozone? You talk about a kill technology. Is that being 
considered?
    Mr. Sweat. Yes, we have looked at ozone. The challenge with 
Ozone in water flume systems we use to wash lettuce, it is hard 
to control the ozones with the lettuce water combination. But 
we are looking at a lot of different sanitizers with the 
scientific panel board that we have brought on staff. We have 
actually set up a biohazard lab level 3, and we are testing 
different kinds of sanitizers to see if we can get larger 
microbial load reductions in our wash systems.
    Mr. Inslee. There is a new Ozone technology for 
sterilization. It happens to be in my district. Are you 
familiar with that, where you use one stream of high pressure 
water and one of a low pressure Ozone application? Are you 
familiar with that at all?
    Mr. Sweat. I am not familiar with the details on that 
particular----
    Mr. Inslee. I may actually shoot that to you and ask you to 
take a look at that. They have had good success on that.
    Mr. Sweat. I would welcome that.
    Mr. Inslee. How do you handle when you have your positive 
from a lot, from a field?
    Mr. Sweat. That particular lot gets destroyed, and then we 
open up a field audit from that lot, from that field, 
immediately, and we go out to look at the inputs on that field 
to see if we can have any trace back to the source. 
Unfortunately we have not been able to find anything link back 
to the field to those lots that we have tested positive.
    Mr. Inslee. You said that you thought it would make sense 
for the industry to have a standardized microbiological testing 
protocol like that. Would you have any difficulty, or the FDA, 
if we gave them the ability and they implemented the ability to 
adopt that as a requirement?
    Mr. Sweat. I would not.
    Mr. Inslee. I think given your experience, I can understand 
why that is.
    If you just give me one more moment, I had one more 
question I want to ask you. I'm told there have been 20 E. coli 
outbreaks from contaminated leafy greens from Monterey County 
before this one. Is that accurate?
    Mr. Sweat. I think that number sounds about right.
    Mr. Inslee. That strikes me as a lot from a fairly confined 
area. I have heard people suggest that there are problems with 
the water source from animals in general in that area. Is there 
anything different about that area relative to other growing 
areas that we should be concerned about?
    Mr. Sweat. We started testing all of the water sources on 
our growers' fields for pathogenic E. coli, and we have not 
found any positives in any water test to date during this 7, 8 
months since we have implemented these testing protocols. So I 
haven't seen anything in the test data yet that would indicate 
anything on the water systems, but I do think we have to look 
at the environment and all of those resources out there with 
science to better understand it.
    Mr. Inslee. Thank you.
    Mr. Miller, you may have covered this, but on the gluten 
that came in involved in this episode, was that food-grade 
gluten when it entered the United States? In other words, could 
it legally be used in human food?
    Mr. Miller. Yes, it was food grade.
    Mr. Inslee. So in a sense we just dodged the bullet, at 
least from the humans' perspective, that it went not into food 
for human consumption, but for animal consumption?
    Mr. Miller. Yes. We believe it was because of a fraud in 
China that this happened. Apparently they weren't expecting it 
to be discovered, and maybe there was less of a chance if it 
was pet food, or they knew it was going to pet food, but it was 
food grade.
    Mr. Inslee. So they knew this was going into the pet food 
stream, but legally you could have taken it, sold it to 
somebody, and they could have put it into human consumption?
    Mr. Miller. I believe so.
    Mr. Inslee. So what should that lead us to conclude about 
our current standards? You said that they thought since they 
knew it was going to go to pet food, they could maybe sneak it 
through or sneak it by. In what sense?
    Mr. Miller. I don't know. That is just a surmise. We 
believe that this was an intentional defraud or an intentional 
fraud to make money, and a fraud which we're a victim of and 
our customers are victims of. But I believe they were aware 
that our customers were pet food customers.
    Mr. Inslee. If the buyer here or the seller in China knew 
it was probably going into the human stream, would there have 
been any additional standards other than what exists right now 
in protocols and inspection or standards to make sure they 
were--I assume there were not, because if this was human, fit 
for human consumption, there would have been no additional 
standards from what they had for pet food gluten; is that a 
fair statement?
    Mr. Miller. I believe that is true. I mean, this was an 
adulteration that was just off the radar screen. No one was 
aware of it, no one had thought of it. I don't believe it had 
ever been tested for in wheat gluten.
    Mr. Inslee. So is it fair to say that as far as our concern 
for this episode, it ought to be just as high, we ought to 
consider it like a human adulterant?
    Mr. Miller. I would think that is a risk.
    Mr. Inslee. Which is bothersome. Thank you.
    Mr. Stupak. I thank the gentlemen.
    Mr. Burgess for questions, please.
    Mr. Burgess. Thank you, Mr. Chairman.
    Mr. Henderson, is it safe to assume that we just heard the 
discussion back and forth that perhaps it was someone with 
larceny in their heart that decided that the melamine would be 
a good way to make money, but we don't really know, do we?
    Mr. Henderson. No, we do not.
    Mr. Burgess. And, Mr. Sweat, you have as carefully as you 
can investigated the source of the outbreak in your industry. 
And although there are some cows across the way that might have 
been a source, you haven't really drawn a direct link from one 
to the other yet, have you?
    Mr. Sweat. No, we haven't been able to identify the 
transmission vehicle yet.
    Mr. Burgess. And I don't know about the peanut industry, 
but I guess if I were a conspiracy theorist, Mr. Chairman, I 
would start connecting dots that may be unrelated and ask if 
someone is trying to undermine the confidence of the United 
States food industry, because these are spectacularly unrelated 
and almost inconceivable events that have now coalesced around 
this hearing. I just can't help but wonder if there is perhaps 
something we are missing in this great debate.
    The other thing that comes up, and, of course, we heard the 
testimony from our friends with GAO, and looking into best 
practices in other countries, but here we sit talking about 
Chinese gluten and Canadian cat food, Mexican spinach, and 
maybe the best practices we ought to concentrate on are the 
ones here in this country. And maybe, in fact, we ought to look 
at--well, maybe you all can help me. Why do we even import 
gluten from China? Is it a cost factor, or is it an inability 
to produce gluten in our own country? Either end of the table, 
please feel free to answer. Mr. Henderson, we'll go with you 
first.
    Mr. Henderson. Essentially, from a wheat perspective, you 
are looking at the lion's share. My understanding of the 
numbers is that about 50 percent of the wheat gluten that is 
used in the United States, both in pet food and in human food, 
comes from Europe. Essentially it is a matter of capacity. 
There simply isn't enough capacity in the United States to meet 
the demands.
    Mr. Burgess. Mr. Miller, would that be your----
    Mr. Miller. Yes, except that I believe some of what comes 
from Europe originates in other countries.
    Mr. Whitfield. While you were out, Dr. Burgess, they said 
that the U.S. domestically can produce only 25 percent of the 
demand for wheat gluten in the United States.
    Mr. Burgess. But many of the wheat fields in north Texas 
are underutilized right now. I know that for a fact because I 
drive by them every day. But nevertheless, what steps are being 
taken--and this may be unrelated to this hearing--but steps are 
being taken to prosecute the people if there has been larceny 
involved in our foreign supplier? Where are we in that process? 
Are we trying to identify who did what to whom and whom to 
prosecute?
    Mr. Henderson.
    Mr. Henderson. At this stage my understanding is the FDA is 
trying to get into China to undertake and continue their 
inspections, essentially independent of their efforts. We are 
doing what we can, but there is very limited we can do beyond 
essentially understanding exactly what steps they are taking to 
get to the bottom of the question at hand.
    Mr. Burgess. Mr. Chairman, I hope this committee will 
continue to monitor that and stay closely involved in that, 
because it is disturbing to me that a foreign source of larceny 
could be inflicting such harm on our citizens.
    Let me ask you, Mr. Colo, on the issue of salmonella, just 
for my own edification, is salmonella a frequent hitchhiker on 
the back of a peanut? Is that something that comes up from time 
to time?
    Mr. Colo. Because peanuts are a raw agricultural commodity, 
obviously they are grown in the soil, soil and water is well 
known to contain salmonella, so it is a likely conclusion that 
in some cases peanuts will be a carrier for salmonella, yes.
    Mr. Burgess. Going back to my earlier conspiracy theory, 
though, you really have not yet been able to draw a bright line 
between--and say you know definitely where this came from in 
the process; is that correct? It is an assumption that there 
was some dust and some water and spontaneous generation, and 
the salmonella got into your product?
    Mr. Colo. Based on the investigation that we have done, 
that is what we consider to be the most probable cause of the 
source of contamination.
    Mr. Burgess. Again, just for my background information, how 
do you test for salmonella?
    Mr. Colo. Our sampling protocol is that for every packaging 
line that we are filling peanut butter jars on every day, we 
take one sample per line per hour within our facility. We then 
run the----
    Mr. Burgess. Right. I got that. But when the raw product 
comes into your facility, before you even start the 
manufacturing process for peanut butter, do you test the batch 
for the presence of salmonella in the raw peanuts?
    Mr. Colo. We do not test raw peanuts for salmonella. We 
test it for apitoxin, but do not test for salmonella.
    Mr. Burgess. In testing for salmonella, in the hourly test 
that you do on every line, what are the levels of detection, 
how many parts per million, or what is the level of detection 
for salmonella?
    Mr. Colo. It is considered negative if it is less than 1.0, 
and that is an absorbent value that is used in the test 
methods.
    Mr. Burgess. So you don't actually culture the peanut 
butter and grow colonies and count them off the Petri dish like 
we used to in high school biology?
    Mr. Colo. We do actually do that.
    Mr. Burgess. You do do that. Well, what do you think? Why 
wasn't the salmonella detected in the hourly checks on the line 
runs that you all were doing?
    Mr. Colo. We think that the levels were so low in the 
product that the tests were just not able to detect the 
positive salmonella.
    Mr. Burgess. So the numbers were too low?
    Mr. Colo. The level of contamination was so low in the 
peanut butter that we were not able to detect it.
    Mr. Burgess. And then over time the colonies grew and 
multiplied such that they became clinically significant by the 
time they were ingested by the end user?
    Mr. Colo. Maybe. I am not a doctor. I am not sure what 
manifested from our plant to the end consumer.
    Mr. Burgess. If it was so low, then why did people get 
sick? How did the clinical manifestation of disease occur if 
the count was so low to be undetectable by your routine testing 
methods?
    Mr. Colo. That is a very good question. If you look at the 
water activity of peanut butter, it is extremely low. And what 
that is a measure of is the available water in the peanut 
butter itself. And what may likely have occurred is that 
somehow there was this contamination of water in the facility 
that was not detectable at the time of packaging, but later 
over time that maybe the salmonella was allowed to grow due to 
the water availability.
    Mr. Burgess. What do you think going forward? Are you going 
to be able to be confident that the same mysterious set of 
circumstances is not going to happen again?
    Mr. Colo. Yes, we are very confident. And the reason for 
that is the approaches that we are taking prior to restarting 
our facility will include making sure that we have very robust 
food safety standards in place. We are in the process of 
looking at all of our both environmental and finished product 
testing methods and protocols.
    Mr. Burgess. So you are going to heighten the sensitivity 
of your testing?
    Mr. Colo. Absolutely.
    Mr. Burgess. Good.
    Mr. Sweat, on the spinach issue that came up, you said that 
some of the spinach you get is harvested in Mexico; is that 
correct?
    Mr. Sweat. That is correct.
    Mr. Burgess. And have you assessed these Mexican farms with 
as much scrutiny as you had with the California farms about 
wild pigs and cows across the hill and that sort of thing?
    Mr. Sweat. Yes. Most of the growers that grow product for 
us in Arizona and Mexico are the same growers that grow product 
in California. They migrate throughout the year based on 
seasonal climatic changes to grow the lettuces.
    Mr. Burgess. But my understanding, I think, from your 
testimony or from someone else's was that one of the 
possibilities was the E. coli existed in the stream water which 
may have flooded into wells which were used for irrigation. Is 
the same possibility present in Mexico, or is it more likely to 
be possible in Mexico, less likely to be possible? Is there any 
way to quantify the risk from the various farms from which you 
accumulate product?
    Mr. Sweat. What we have done is apply the same standards 
across all farms. So we test all the waters, the seed, the 
soil. Everything on our GPA program now tests for that across 
all farms that supply product, not just in California.
    Mr. Burgess. In November 2005, a series of outbreaks 
associated with the Salinas area farms, the FDA sent a letter 
to California farms that grow packaged spinach. Are you 
familiar with the letter that they sent?
    Mr. Sweat. That is correct.
    Mr. Burgess. It requested that you begin or intensify 
immediately various efforts. How did that intensification of 
efforts, how did that proceed?
    Mr. Sweat. We went back through the agricultural practices, 
the good manufacturing practices, in our HACCP program that we 
use, the FDA's guidelines and their updated guidelines as it 
related to leafy greens and fresh cut fruits and vegetables to 
make sure that we were meeting or exceeding all those 
standards.
    Mr. Burgess. So have you, in fact, implemented all of the 
guidelines that were listed by the NDA at that time?
    Mr. Sweat. They were actually already implemented when 
received a letter in 2005.
    Mr. Burgess. So accelerating that implementation, would 
that have made any difference in the September 2006 outbreak?
    Mr. Sweat. No. The GAPs and GMPs and HACCP programs that 
were implemented had been implemented and working for many, 
many years.
    Mr. Burgess. How can you be sure that area water doesn't 
contaminate the crops?
    Mr. Sweat. As part of our enhancements to the GAP programs 
that we have done is we have increased the frequencies of 
testing all the water for irrigation. And instead of testing 
for just generic E. coli, which is an indicator of a potential 
pathogen, we actually test for the pathogenic E. coli now.
    Mr. Burgess. Do you test for toxigenic E. coli?
    Mr. Sweat. We do.
    Mr. Burgess. To whom do you report that information?
    Mr. Sweat. That information actually from our growers gets 
reported in to us, and then we keep all that data there.
    Mr. Burgess. Do you follow on with the California 
Department of Health or the CDC? Do you tell someone about it?
    Mr. Sweat. If we were to have any positives on water, if 
it's a municipal water supply, we would notify that 
municipality that would be supplying it, and then we would also 
notify CDHS about the issues of finding anything that would 
test positive.
    Mr. Burgess. Just in regard to the spinach itself, how many 
positives for toxigenic E. coli, how many of those positives do 
you generally record in a year's time?
    Mr. Sweat. Well, we started the testing on raw product 2 
weeks after the outbreak, so that was about the first week in 
October when we implemented the raw product. To date there have 
been 23 raw product samples that have tested positive for E. 
coli, and those products have been destroyed. And about 16 have 
tested positive for salmonella, and those have been destroyed. 
But none of the finished goods that we have tested have tested 
positive for either E. coli or salmonella.
    Mr. Burgess. But prior to September 2006, that data would 
not be available?
    Mr. Sweat. No. We were not testing prior to the outbreak.
    Mr. Burgess. And what do you do with the affected crop? How 
do you destroy it?
    Mr. Sweat. We actually put it into an incinerator and 
document the photos of it that it's being destroyed.
    Mr. Burgess. And you conform with the Clean Air Act when 
you do that, correct?
    Mr. Sweat. Yes, we do.
    Mr. Burgess. Thank you, Mr. Chairman.
    Mr. Stupak. I thank the gentleman.
    Just a few questions from me for a wrap-up.
    Mr. Sweat, of those, I guess, 39 positives you've received 
now, all these washing, the good manufacturing and all these 
other operating procedures, none of that's going to detect E. 
coli or salmonella unless you test for it?
    Mr. Sweat. That's our understanding is that it will not 
detect it.
    Mr. Stupak. So all these voluntary standards, in-house 
testing, which I appreciate you doing, if you don't do it, 
there's no penalty to you, there's no stick, if you will, 
there's no enforcement?
    Mr. Sweat. To my knowledge we are the only company that has 
implemented this testing program to date.
    Mr. Stupak. I was going to ask you, we talked about Salinas 
Valley being the lettuce bowl of America. Do the other 
producers in that area do these testing that you are doing?
    Mr. Sweat. To my knowledge they don't.
    Mr. Stupak. And there's no requirement for them to do it?
    Mr. Sweat. There's no requirement. But early on we said 
food safety would not be a competitive advantage. Whatever we 
learned we would share with our industry. And we are doing 
that. We are sharing these testing programs that we have done 
with everybody in our industry and all the associations.
    Mr. Stupak. I appreciate you are doing the testing now, but 
if we did not have this spinach outbreak, you probably wouldn't 
be doing testing, would you?
    Mr. Sweat. That's a hard one to go back on now, because 
once you've crossed over and started it, it's hard to envision 
something you would do different.
    Mr. Stupak. I am not trying to discourage it.
    Mr. Sweat. But prior to that we had not had any reason not 
to think our GAPs and GMPs and HACCPs weren't doing their job 
of deterring that microbial contamination because we had not 
had any of those outbreaks for later tests over the years.
    Mr. Stupak. Well, it seems like our food safety in this 
country is reactive as opposed to proactive. I am disturbed 
when you tell me that FDA comes to your place, they look at 
things, and they never do any testing; they just look to see if 
you are washing this or making sure that conditions are very 
sanitary. They don't even do testing when they are there. It 
seems like we are waiting for something to happen, then we try 
to react. And our chance of recall can take some time, as we 
have shown. That's my only concern.
    Mr. Sweat. I think the testing is a way to validate the 
efficacy of all of the controls from field to finished product.
    Mr. Stupak. Let me ask you this. I realize you are not into 
marketing, but, Mr. Henderson, Mr. Sweat, Mr. Colo, has your 
company ever done marketing to test the attitudes of Americans? 
Would they pay an extra 5 cents for a package of lettuce to 
assure testing to be done? Is it a cost issue why it's not 
being done or just never been done? Mr. Henderson.
    Mr. Henderson. No. Our company has never undertaken such a 
study or formal inquiry with our customer base. Recognize that 
the majority of the customers that we market to are essentially 
selling their brands, and they are essentially the brand 
marketers in the countries in which they transact business.
    Mr. Stupak. Mr. Sweat.
    Mr. Sweat. We haven't done any research or focus groups 
from a marketing standpoint on the thought process of what they 
would pay. We haven't really looked at the cost of all these 
programs we have done. It's just doing the right thing for our 
consumers to improve our food safety program.
    Mr. Stupak. Mr. Colo.
    Mr. Colo. I am not aware of any particular marketing 
studies around that particular issue. Our approach is simply 
that you have to do everything possible to ensure that the food 
that you are producing is safe. So our policies are all geared 
towards that.
    Mr. Stupak. That's been passed by the last few Congresses. 
It says country of origin, but somehow that never seems to get 
implemented. Do you think that would help at all in this 
situation? Again, without testing, it doesn't make any 
difference where the product comes from, right? Mr. Sweat.
    Mr. Sweat. That's correct. I think the countries of origin 
labeling laws would help identify for the consumer where it's 
coming from, but you are still going to need to put in your 
testing protocols. And as you look at that bag of salad, Mr. 
Chairman, you'll notice there's lots of ingredients on there. 
So one of the challenges for us is that when you bring in 10 or 
12 ingredients from 10 or 12 different farms, you don't have a 
one-to-one correlation from a field-grown product to a finished 
product.
    Mr. Stupak. Mr. Burgess.
    Mr. Burgess. Mr. Sweat, if I could ask one last take-home 
question for the bag that has been famously passed around up 
here today. It says triple washed or final washing. Do you 
advise consumers to wash your product before they consume it?
    Mr. Sweat. What we do with our consumer Web site and when 
consumers call and ask should they wash their lettuce, we tell 
them if they want to wash it, then they should wash it.
    Mr. Burgess. But that's not a recommendation on the 
package. And just like we heard testimony from the folks who 
were here earlier today, they look at the package that says 
triple washed, ready to eat, so they pop the bag and put it 
into the bowl. Would it make any measurable difference if 
consumers, just like we tell them now to cook their hamburger 
until it's done, that we wash our spinach even though the 
product may say it's been triple washed?
    Mr. Sweat. I don't think washing would have any further 
impact on it, because typically just running water over it, 
there's not the chlorine that we use in our agitated work 
system as a deterrent for a microbial load. So I don't think 
washing would enhance that at home. But we encourage our 
consumers if they want to wash it, please do so.
    Mr. Burgess. So the bug is too sticky to just wash off the 
leaf of spinach?
    Mr. Sweat. It can be.
    Mr. Burgess. Thank you.
    Mr. Stupak. One more question, Mr. Henderson, if I may. I 
have a number of constituents and my dog. When are we going to 
get our pet food supply back to normal? Will it take a while? I 
mean, there's a lot of it off the shelves, and you seem to be 
the main manufacturer. When will we see the wet cat and dog 
food back up to where they are? We are still having trouble in 
some parts trying to find our favorite food, if you will.
    Mr. Henderson. Actually from a size perspective, Menu is 
actually quite small in the marketplace. But relative to our 
steps, we are still in the midst of the recall. That's going on 
as I sit here today. And the practice that we are going through 
is essentially to make sure that with working in cooperation 
with the retailers, that all of that product is back off the 
shelf so there's no possible way that it can get back. And once 
we have got certification that that product has been cleared 
from the retailers' shelves, cleared from the reclamation 
centers and from the warehouses, we will begin shipping them 
product manufactured with proven wheat gluten going forward. I 
expect that it will start in the next week or two.
    Mr. Stupak. For all of you, if you may, Mr. Henderson, Mr. 
Sweat, Mr. Colo, Mr. Miller, the committee would like you to 
give us the--present to the committee the inspections of the 
USDA and FDA at your plants, plural, if you have more than one. 
And if you could do that within the next week, we would 
appreciate it. We do have the FDA coming in in a couple of 
weeks. We are a little concerned about inspections; how often 
they occur, what do they do. There's some question whether they 
do any testing or not. So if you could provide those to us. So 
Mr. Henderson would you do that for us please, try to get that 
to us in a week? If you have trouble, get ahold of the 
committee.
    Mr. Henderson. Certainly. Can you tell me how far back?
    Mr. Stupak. From 2000 to April 2007.
    Mr. Henderson. Yes.
    Mr. Stupak. Mr. Sweat do you think you could do that?
    Mr. Sweat. Yes, we'll provide that.
    Mr. Stupak. Mr. Colo?
    Mr. Colo. Yes.
    Mr. Stupak. Mr. Miller?
    Mr. Miller. Yes. We have already done it. If you would like 
us to go back further, we have already done it.
    Mr. Stupak. From 2000 through April 2007, if you would.
    Mr. Miller. Yes.
    Mr. Stupak. I appreciate that.
    Mr. Burgess, I think, was questioned about the November 4, 
2005, USFDA letter to California firms on the grow, pack 
process for fresh-cut lettuce. That will be made part of the 
record.
    Also the statements of Representative DeLauro, 
Representative Pallone and Senator Durbin will also be made 
part of the record.
     We have to have the exhibit binder that's before us here 
without objection be made part of the record.
     That concludes all questioning. I want to thank our 
witnesses for coming today and thank you for your testimony. I 
ask unanimous consent that the record will remain open for 30 
days for additional questions for the record.
    That concludes our hearing. Without objection, this 
subcommittee is adjourned.
    [Whereupon, at 1:45 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

   Paul Henderson Answers to Submitted Questions from Hon. Jay Inslee

    Dear Congressman Inslee:

    This letter is written in response to the additional 
questions from you set forth in the letter dated June 21, 2007 
from Chairman Dingell with regard to the hearing ``Diminished 
Capacity: Can the FDA assure the Safety and Security of the 
Nation's Food Supply?'' on April 24, 2007.

    The following are the answers to your questions:
     Does Menu Foods sell ``salvaged'' and/or ``distressed'' 
pet food for use in livestock feed?

     No.

     Did Menu Foods sell ``salvaged'' and/or ``distressed'' pet 
food from the November 8, 2006 through March 6, 2007 production 
runs that have been recalled?

     No.

     If Menu Foods did sell ``salvaged'' and/or ``distressed'' 
pet food from recalled batches, has any effort been made to 
track down buyers and determine whether this food has crossed 
into the human food supply?

     No.

    We appreciate this opportunity to assist the subcommittee 
in its efforts.
                              ----------                              


      Statement of Hon. Rosa L. DeLauro and Hon. Richard J. Durbin

     Mr. Chairman, we want to commend you for calling this 
hearing and thank you very much for the opportunity to present 
written testimony.
     We all saw the disturbing article in yesterday's 
Washington Post that the FDA has known for years about 
contamination problems at a peanut butter plant in Georgia and 
on spinach farms in California, but took only limited steps to 
address the problems and relied on voluntary actions by the 
industry. Based on the evidence being compiled so far in the 
pet food recall situation, the FDA appears to be failing its 
responsibilities to protect pets from unsafe food as much as it 
is failing to protect American consumers.
     Mr. Chairman, the FDA's response to this situation has 
been tragically slow, and pet owners deserve answers. The 
uncertainty about which foods have been recalled and what is 
safe to feed their pets has gone on far too long. We also 
learned last week that the human food supply may be at risk 
because of contaminated pet food that was provided to a hog 
feeding operation in California. After the disturbing 
revelations that were outlined in the Post article yesterday, 
we fear that a full investigation will determine that FDA 
rarely, if ever, inspects pet food manufacturing plants, and 
that the agency desperately needs to modernize its regulations 
to protect our pets.
     As we all know, the problems that have resulted in the pet 
food recall are being traced to shipments of wheat gluten and 
rice protein and corn gluten from China that was discovered to 
be contaminated with melamine. As FDA's investigation 
continued, pet owners kept receiving assurances from the agency 
that only the foods on the recall list presented a danger to 
their pets. However, pets remained vulnerable despite these 
assurances because the recalls kept expanding dramatically. One 
of the central reasons the recall keeps expanding is that FDA 
has refused to identify the companies that have purchased rice 
protein concentrate batches from the same contaminated 
shipment. Of the five companies that purchased from the 
contaminated shipment, only two have been identified.
     The FDA knows the identity of the other companies that 
purchased ingredients from the contaminated shipments, but is 
unable to disclose the information and compel any action. Thus, 
consumers have not been able to avoid buying and feeding 
potentially contaminated products to their pets, and 
contaminated pet food still may be on store shelves. This is 
unconscionable.
     And of course, we do not have to remind you Mr. Chairman 
that the FDA has no authority to mandate recalls and instead 
relies on information submitted by companies. As the Post 
article yesterday noted, we saw how that situation played out 
in 2005 with the peanut butter plant in Georgia when company 
officials refused to provide information to the FDA when the 
agency was investigating complaints about a salmonella 
contamination--2 years later a salmonella outbreak in peanut 
butter sickens over 400 people in 40 States.
     Another very troubling aspect to this issue is the Chinese 
Government's delay in allowing FDA personnel to enter China to 
inspect the facilities suspected of producing the contaminated 
products. After FDA Commissioner Dr. von Eschenbach informed us 
of this situation in our meeting with him last week, we wrote a 
letter to the Chinese Ambassador to the United States asking 
that they allow our inspectors into the country. We also asked 
that the ambassador meet with us to discuss the larger issue of 
contaminated food being imported into the United States.
     Just today, we learned that China has agreed to allow U.S. 
regulators to enter China. Unfortunately, FDA's request has 
been pending since April 4, 2007, an unacceptable delay of 3 
weeks during which time the health of our pets has been at 
risk. Unlike the Food Safety Inspection Service (FSIS) of the 
U.S. Department of Agriculture (USDA) which has the authority 
to set up cooperative relationships with trading partners and 
inspect their facilities, the FDA has no such similar authority 
and must rely on ad hoc procedures when problems arise.
     We are all aware of the disturbing statistics related to 
imported foods. The U.S. now imports far more foods than it 
exports, but there are fewer inspectors for imported foods. 
Currently, FDA inspects less than 1 percent of the food 
imported into this country that it is responsible for 
regulating. Also, the FDA does not require exporting countries 
to have food safety regulatory structures that are equivalent 
to the U.S. standards. Given that the contaminated pet food 
appears to be connected to products imported from China only 
heightens our concern about the agency's ability to inspect 
imported products. It is this aspect of the pet food recall 
crisis that is particularly troubling and will be examined 
further in a follow-up hearing before the House Agriculture 
Appropriations Subcommittee.
     In addition, for the first several weeks of the pet food 
recall, the FDA did not clearly communicate which brands and 
products were on the recall list. Rather than bring together 
all of the relevant recall information in an easy to read, 
searchable document, the FDA relied on links to corporate press 
releases on the voluntary recalls, each of which had a 
different format. This format was confusing and time consuming 
for concerned pet owners. We are both glad that FDA has taken 
our advice and modified the format of their website.
     It very well may be that FDA lacks the resources to 
adequately inspect pet food facilities and imported products. 
And this is an area where we could work together to make a 
direct impact. However, we also should examine whether this is 
a management issue. In response to a letter that we sent to 
FDA, the agency said it has not determined whether changes in 
current law or resources are necessary based on the pet food 
recall. We find it difficult to understand that this agency 
always refuses to even consider requesting additional 
authorities or resources to help it do its job. This dismissive 
approach toward additional authorities is very frightening and 
could continue to have serious repercussions to the safety of 
both pet and human food.
     The FDA likes to demonstrate its commitment to food safety 
by pointing out that ``food'' is the first word in its name. 
However, its actions suggest otherwise, highlighting the need 
for legislation that would create a single food safety agency--
a bill that we have worked on for quite a long time now--the 
Safe Food Act of 2007.
     This legislation would consolidate the various cross-
cutting authorities in the area of food safety and move them 
within a single regulatory structure. The goal is to improve 
coordination, realize efficiencies, and streamline the number 
of oversight committees responsible for food safety. This new 
independent agency would better compete for resources and be in 
a position to strategically plot a national food safety 
strategy. Today's regulatory arrangement is fractured among 
multiple departments and sub agencies and is in major need of 
reform.
     In addition, we are working on legislation that will 
specifically address shortfalls in FDA's authority to prevent 
or react to situations similar to the pet food recall. We hope 
to be ready to introduce a bill this week or next. As Dr. 
Robert Brackett, FDA's Director of Food Safety (CFSAN), was 
quoted as saying, ``The outbreaks point to a need to completely 
overhaul the way the agency does business...We have to get out 
of the 1950s paradigm.'' Our legislation will focus on the 
following five proposals that, if in place, might have 
prevented or mitigated this recent contamination:

     1. Mandatory Recall Authority;
     2. Adverse Event Reporting Standards and Penalties;
     3. Standing FDA Authority to Inspect Overseas;
     4. Surveillance and Early Detection; and
     5. Standardization of Voluntary Standards.

     We look forward to FDA's analysis of their oversight of 
pet food manufacturing facilities and the final report on the 
actions that the agency took once the crisis finally ends. We 
also look forward to the results of your investigation, Mr. 
Chairman. We feel that it will play a key role in determining 
the best steps to take in moving forward.
     Thank you again, Mr. Chairman for allowing us to present 
testimony at this hearing and we look forward to continuing to 
work with you on this issue.
                              ----------                              


    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]




 DIMINISHED CAPACITY: CAN THE FDA SURE THE SAFETY AND SECURITY OF OUR 
                     NATION'S FOOD SUPPLY?--PART II

                              ----------                              


                         TUESDAY, JULY 17, 2007

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:30 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Bart 
Stupak (chairman) presiding.
    Members present: Representatives DeGette, Melancon, Waxman, 
Green, Schakowsky, Inslee, Markey, Dingell, Whitfield, Walden, 
Murphy, Burgess, Blackburn, and Barton.
    Staff present: David Nelson, Kevin Barstow, Richard 
Wilfong, Joanne Royce, Paul Jung, Scott Schloegel, Kyle 
Chapman, John Sopko, Alan Slobodin, Kristen Carpenter, and John 
Stone.

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

    Mr. Stupak. Today we have a hearing on Diminished Capacity: 
Can the FDA Assure the Safety and Security of the Nation's Food 
Supply? Before I begin the hearing, I would like to make a 
special announcement. As frequently happens with our Oversight 
and Investigation hearings, there is a change in policy that 
occurs on the eve of the hearing. This hearing is no exception.
    For more than a year, Chairman Dingell and I have been 
calling on the FDA to end the practice of allowing meat which 
is treated with carbon monoxide and being sold in American 
groceries stores. Treating meat with carbon monoxide allows the 
meat to keep its freshly ground red color even though the meat 
may have spoiled.
    I have a picture on the screen, or I should have a picture 
on the screen here. There are two packages of ground meat that 
were left out at room temperature for 27 hours. You can see the 
one which was treated with carbon monoxide looks fresh and red, 
while the other meat has turned brown and quite nasty looking. 
Late yesterday afternoon, following inquiries and discussions 
with the committee staff, Safeway Foods sent us this letter 
announcing that they will discontinue the sale of fresh meat 
products packaged using carbon monoxide. I wish to thank 
Safeway Inc. for their decision to stop selling fresh meat 
treated with carbon monoxide.
    And with that, we will begin our hearing. With each member, 
we will have 5 minutes for an opening statement. I will begin.
    Today we hold the second hearing by the subcommittee on 
whether FDA can assure the safety and security of the Nation's 
food supply. Since the subcommittee began investigating this 
issue early this year, the news on the food safety front has 
grown progressively worse.
    A steady stream of food safety disaster followed the tragic 
deaths and illnesses caused by the spinach outbreak last fall. 
Fresh spinach packaged in California was contaminated with a 
deadly strain of E. coli bacteria. The spinach tragedies were 
quickly followed by an outbreak of life-threatening illnesses 
caused by salmonella in Peter Pan peanut butter. Both of these 
outbreaks were preventable.
    Then there were the mysterious deaths of hundreds of 
cherished pets. We later learned that the American pet food had 
been contaminated by a wheat gluten from China. Wheat gluten is 
a vegetable protein found in everything from dietary 
supplements to baked goods to children's candy. Unfortunately, 
the Chinese exporters added a little something extra to its 
products: a poisonous chemical called melamine.
    Shortly thereafter, it was discovered that the same deadly 
additive, melamine, was fed to hogs, chickens, and fish 
destined for human consumption. Commissioner von Eschenbach 
claimed that the tainted pet food case ``demonstrated FDA's 
effectiveness at detecting and containing a problem.''
    His sunny prognosis has certainly been put to the test. The 
pet foods were soon followed by recalls of tainted cantaloupes, 
toothpaste, and the snack food Veggie Booty. And recent 
revelations about the scope of contaminated seafood imported 
from China are staggering. Our first hearing on April 24, 2007 
exposed a fragmented food safety system beset with inconsistent 
oversight, ineffective coordination, and ineffective use of 
minimal resources.
    How did the FDA respond? It announced, with great fanfare, 
the appointment of a food safety czar. In fact, Dr. David 
Atchinson, who received a glorified new title, has been central 
of FDA's food safety program for years. Promoting Dr. Atchinson 
does not begin to address the depth and chronic shortcomings in 
FDA's food safety program.
    Nearly 10 years ago, the National Academy of Sciences 
concluded that the Federal food safety system was not equipped 
the meet the emerging challenges. Since then, these challenges 
have expanded exponentially, while FDA's ability to protect the 
American people has declined even further. Dr. David Kessler, 
FDA commissioner under both former Presidents Bill Clinton and 
George Bush recently called the food safety system as broken.
    Sadly the primarily findings of our investigations support 
this assessment. Investigators with the subcommittee traveled 
to interview FDA field personnel in San Francisco; Los Angeles; 
Denver; Kansas City; Winchester, MA; Atlanta; New York; and San 
Jose, Puerto Rico. FDA field personnel were more forthcoming 
about gaping holes in FDA's food safety net than were 
headquarter officials.
    We learned, for example, that while the FDA inspects less 
than 1 percent of all imported foods, only a small fraction of 
that 1 percent is actually tested for contaminants. FDA 
requires only that a private laboratory test the suspect food 
for possible contamination. These private labs that are testing 
are not subject to Federal oversight. FDA field personnel were 
highly critical of private laboratory testing, which they 
described as shoddy or even scary.
    Another significant finding by staff investigators 
confirmed a concern that Chairman Dingell and I share with 
regarding the use of carbon monoxide to make meat and seafood 
appear fresh. I have repeatedly requested, to no avail, that 
FDA or HHS rescind the ruling that carbon monoxide can be used 
to treat meat, poultry, and seafood to make them look fresh 
regardless of their age or condition. In San Francisco, 
subcommittee investigators discovered large numbers of seafood 
imports from Asia and elsewhere arriving in airtight packages 
containing carbon monoxide. When tested, fully 20 percent of 
the seafood had to be refused because of contamination of 
decomposition. In other words, this was rotten seafood make to 
look fresh with the use of carbon monoxide.
    Our investigation also confirmed that FDA's food safety 
program is woefully understaffed. Entry reviewers, 
investigators, and compliance officers simply cannot keep up 
with the flood of imported food. We confirmed that the FDA's 
ill-conceived decision to close 7 of its 13 laboratories would 
likely expose Americans to even more dangers from unsafe food, 
particularly imports.
    We also learn from FDA staff that importers have found ways 
to circumvent even this minimal FDA authority all together by 
importing through ports with no FDA testing facilities. FDA 
field personnel, who answered our questions in a forthright and 
cooperative manner, were invaluable to our investigation. 
However, several FDA employees were fearful of retaliation and 
requested not to testify today, despite Commissioner von 
Eschenbach's promises of zero tolerance for retaliation against 
whistle blowers.
    This subcommittee has heard far too many reports of FDA 
retaliation against employees who criticized the agency. We do 
not wish to risk the careers of FDA field staff who talk to our 
investigators. So our first panel will be committee staff 
testifying about their investigation. Our second panel will 
consist of two expert witnesses and four FDA officials from 
labs that the administration plans to shut down. They have 
shown tremendous courage by agreeing to testify today. The last 
panel will be comprised of four officials from FDA 
headquarters, including Dr. Andrew von Eschenbach who will 
provide the administration's testimony regarding the efforts of 
FDA to protect Americans from unsafe food.
    The globalization of the American economy has resulted in 
dramatic increase in the volume of imported foods. Last year, 
China alone exported to the United States $2.3 billion worth of 
agricultural products, not including seafood, compared with 
$133 million in 1980. However, while food imports grew 
exponentially, FDA inspections dropped from 50,000 in 1972 to 
5,000 in 2006, a 90 percent reduction. Is it any wonder that 
one out of every four Americans suffer a food borne illness 
every year?
    There is a lot of question that our Federal food safety 
system is in need of a broad-based reform to reduce the risk to 
public health, national security and the economy. Today's 
hearing is to explore these risks and effort to pave the way 
for a reform.
    That is the end of my opening statement. I next turn to my 
friend, Mr. Whitfield from Kentucky, for his opening statement. 
Mr. Whitfield, sir.

  OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    Mr. Whitfield. Chairman Stupak, thank you very much for 
holding this important hearing on the ability of the FDA to 
protect the safety and security of America's food supply.
    Recent problems with imports in our food supply have been 
making national headlines, and I must say that a lot of those 
headlines comes from China. Tainted wheat gluten originating in 
China was found to be killing animals in America. Since then, 
Chinese shipments of toxic toothpaste, toys, and seafoods have 
caused safety scares in America.
    In 2004, bogus baby formulas killed dozens of infants in 
China. More recently, the Chinese media have reported half a 
dozen dead and many ill from a flawed antibiotic, 11 dead from 
tainted injections, 56 people ill from contaminated meat, toxic 
snacks pulled off shelves, and fake blood protein discovered in 
hospitals. Now, that is all domestic in China.
    And in May the head of the agency that regulates Chinese 
food and drugs was sentenced to death and was executed for 
accepting bribes in exchange for licenses, produce fake drugs 
and medical devices. He was executed, but we don't know what 
happened to those people who did the bribing.
    The general administrator of inspections and quarantines in 
China, China's standard watchdog, said that 20 percent of their 
domestic products have failed to meet safety standards. That 
kind of information should cause us pause to what is coming 
into America from China. Now, the FDA has the responsibility of 
regulating the safety of all domestic and imported articles 
used for food and drink, except for meat and poultry, and these 
include both animal and human foods. This means that FDA 
oversees 80 percent of the Nation's food supply. But the 
information I have, they only have 20 percent of the U.S. food 
safety budget. The U.S. Department of Agriculture has the 
biggest part of that budget.
    And over the past 35 years as biotechnology became a focus 
of FDA regulation, the food safety share of FDA's budget 
declined from about half of FDA's budget to about a quarter. As 
FDA's resources for food safety has declined, America has 
become more of an importer of food products. Food imports have 
risen 15 percent annually over the last 10 years, and it is 
suggested that today literally 50 percent of our food supply 
imported.
    So FDA has received more than 10 million imported food 
entries in fiscal year 2006 and just over 1 percent of those 
shipments were physically examined. FDA's main mission in food 
imports is, if possible, to prevent or lessen the chance of 
public health risks from FDA-regulated imports. FDA has relied 
upon border operations as a primary line of defense. The surge 
and volume, variety and complexity of imports as well as 
threats of terrorism are good reasons to overhaul FDA's system 
for the 21st century. Dr. Mark McClellan, when he was FDA 
commissioner, was right, I believe, when he said that FDA 
needed to adopt a risk-based import system to replace the 
current import program.
    Unfortunately, in 2007, the FDA lacks the health and safety 
information to make systematic risk-based decision. FDA makes 
initial screening decisions based only on the imports invoiced 
data, which is limited to seller, a description of the goods, 
and identification of the buyer. Recall information, laboratory 
results, facility inspection histories, and publicly available 
information related to possibly adulterated products from 
specific regions are not used to make decisions on which 
shipments to inspect.
    FDA needs also to profile food control agencies in foreign 
countries, understand what they do, and where they are 
developing new programs. Such a systems approach was 
recommended by the GAO in 1983 for the Department of 
Agriculture's Food Safety and Inspection Service.
    Second, FDA should establish an online training course for 
foreign regulators and food processors on good manufacturing 
practices. FDA may not be effectively using the authority even 
that it has today. While the Bioterrorism Act of 2002 gave FDA 
dramatically more authority over imported food, it took FDA 5 
years before it invoked the Acts Authority for the first and 
only time in the pet food investigation.
    There may also be gaps in FDA's law. Congress should pass 
legislation to make clear that FDA has authority to prosecute 
foreign food producers who tamper with food bound for the U.S., 
even when these acts occur outside U.S. territory.
    I would like to thank, at the outset, all of our witnesses 
today including FDA Commissioner von Eschenbach who have come 
this morning to talk about the steps that FDA has taken and 
will take in the future to further increase the safety of our 
food supply. We appreciate the witnesses' testimony. We look 
forward to it, and, Mr. Chairman, I have gone over my time.
    Mr. Stupak. I thank the gentleman for his opening. Next we 
will turn to Mr. Inslee from Washington for opening statement, 
please, sir.

   OPENING STATEMENT OF HON. JAY INSLEE, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF WASHINGTON

    Mr. Inslee. Thank you. I think that what Americans may be 
asking now is who needs Al Qaeda when you have E. coli? Who 
needs Al Qaeda when you have melamine? And the reason I say 
that is if Osama bin Laden was responsible for the E. coli 
poisonings of the Americans that is taking place and the 
melamine and the other contaminants that have come from foreign 
manufacturers, this country would act. We would actually do 
something. We wouldn't close half of our FDA offices in 
response to that threat. We wouldn't continue to allow the 
Federal agencies to have no meaningful requirements for 
policies and practices for leafy and green vegetables that lead 
to repeated E. coli poisonings. We would actually act.
    And I just think in light of the information that is now 
apparent the sieve that we have for food protection of 
Americans, that we have got to take some action. If we spent, 
invested one-tenth of the amount of time, money, and effort 
that we do on the war on terrorism on these food safety 
poisonings, we would reduce probably by a factor of 10 the 
poisonings of Americans, which are in the tens of thousands 
every year. So I would suggest during this hearing that if we 
think of this threat in these terms, and we will respond 
accordingly.
    I will be asking questions about why it makes sense to 
divide the compliance function in FDA to chop up the compliance 
responsibility between offices, which makes no sense to me. Why 
it makes sense in the first place to do this consolidation, I 
haven't seen evidence to support that. And why it makes sense 
to continue this path of having no practices to require certain 
clean policies when you handle vegetable material in the United 
States.
    We have adopted and we have seen where a risk-based 
management program can be effective in reducing poisoning in 
our meat-borne toxins. We have not done that for our green 
foods. We have got to do that. I know that this committee will 
be acting shortly to do that, and I will look forward to 
success. But I hope in this, we are invested with the theory 
during this hearing that we are going to act with the same 
degree of diligence we will as we do in the war on terrorism. 
Having a war on E. coli is not such a bad idea when you talk to 
the tens of thousands of Americans who have been affected by 
food poisoning in the last several years.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you, Mr. Inslee. Next turn to the ranking 
member of the full committee, Mr. Barton of Texas, for an 
opening statement please.

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

    Mr. Barton. Thank you, Mr. Chairman. Before I give my 
opening statement, I want to take a point of personal privilege 
to introduce a special guest that is with me today. I have 
Lieutenant Colonel Miguel Howell with me. He is a White House 
Fellow. He is a West Point graduate. He is a special services 
officer. He has been posted in Latin America and in the Middle 
East. He is one of a dozen or so White House Fellows this year. 
He is working at the Millennium Corporation.
    The White House Fellows Program was established by 
President Johnson in the mid-1960s, and it gives bright, young 
American men and women an opportunity to work with the 
President and the executive branch for a year, and then go back 
and pursue their ambitions in the private sector; although, 
some do go on into the public sector. Colin Powell is a former 
White House fellow. Senator Tim Wirth, who was a member of this 
committee, is also a former Fellow. So we want to welcome 
Lieutenant Colonel Miguel Howell to the Energy and Commerce 
Committee. I appreciate you being here.
    Mr. Chairman, I want to thank you and Mr. Whitfield for 
this important hearing as we look into the FDA's efforts to 
assure the safety and security of our drug supply and our food 
supply. And we also look into some of the management practices 
at the FDA. I am glad that we have Commissioner von Eschenbach 
here personally so he can listen to the testimony and 
participate in the hearing later on.
    Much of the focus of our hearing is going to be on the 
imported food primarily from China because of the recent news 
about tainted pet foods, antifreeze, fake toothpaste, and 
antibiotics and seafood. Fortunately, in this country when we 
have a problem, we try to solve it with civil means. One of the 
top Chinese officials was executed last week because of his 
alleged deficiencies in doing some of these things over in 
China. So we hopefully are not going to come to that here, 
certainly not in this hearing.
    We have to get this right, and we have to get it right 
sooner rather than later. This is easier said that done. It is 
a big challenge. The volume of our imports is surging. The 
variety and the complexity of the products that are arriving on 
our shores from overseas is increasing every day. We have to 
take a new look at this, and we have to do it hopefully in this 
Congress.
    I don't have all the answers, but in shopping for new 
ideas, some of the things that we have come up with on our side 
of the aisle starts with some of these type of ideas.
    First, we think that the FDA needs to make information 
about good manufacturing practices more available to our 
foreign food control agencies and foreign food processors. So 
that we can start to begin to build competency in those 
systems. FDA should consider training courses, both on-site and 
through the Internet, about the basics of safe manufacturing. 
We should translate some of these courses into more than just 
the English language, just as the FDA did when it published the 
rules for its Bioterrorism Act.
    Second, we think that the FDA needs to get more information 
about food safety risks by profiling food control agencies in 
all foreign countries, understanding what each agency can do. 
This type of information would help the FDA better manage its 
limited resources by targeting those countries that have 
particular problems with particular food product categories.
    Third, and this, I think, is a very important idea. It is 
time for the FDA to separate its foreign inspection activities 
from domestic activities. Currently, the FDA does not have a 
core of inspectors who specialize in foreign inspections. 
Instead, they treat foreign inspections as a stepchild of their 
domestic inspection program by borrowing inspectors from 
various districts here in the United States. I don't think this 
works in today's world. I think they should create a separate 
division of foreign inspectors who develop expertise about 
foreign regions and the products that come in from overseas and 
spend a fair amount of their time overseas working with foreign 
governments on sharing information and conducting these 
inspections.
    FDA would also need performance standards and objectives 
and a way to measure progress. For reasons that remain unclear, 
the FDA has not published a performance plan for the last three 
fiscal years on which it evaluates its own performance, 
especially in imports. I think this is a mistake, and I am 
puzzled that they haven't done so. It is one of the things that 
I am going to ask Commissioner von Eschenbach if I am here when 
he takes questions. I would like the FDA to be accountable and 
in compliance with the Government Performance and Results Acts.
    Finally, FDA should ensure that its import system is on 
solid legal ground by either publishing a rule on when the FDA 
can detain shipments without physical examinations or by 
working with the Congress on appropriate legislation. I read in 
the trade press that Chairman Dingell is considering 
legislation in this area. I can assure the chairman that we on 
the Republican side will work with him and other members of the 
majority if, in fact, that is their intention to move 
legislation in this area. I think that Congress should 
legislate in this area.
    So, Mr. Chairman, again this is an important hearing. Both 
political parties have been holding hearings on this for the 
last 15 to 20 years. Chairman Dingell held hearings when he was 
chairman back in the 1980s. You are not that old. I held 
hearings in my chairmanship, and now in Mr. Dingell's new 
chairmanship once again and rightfully so, he and Mr. Stupak 
are holding hearings. So we think it is important, and we also 
think it is time to legislate.
    With that, Mr. Chairman, I yield back.
    Mr. Stupak. I thank the ranking member for his opening 
statement. Next, Mr. Green from Texas, opening statement, sir.

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

    Mr. Green. Thank you, Mr. Chairman, for holding this 
hearing on food safety, which builds on our previous hearing on 
this topic earlier this year. That hearing was focused 
primarily on the contamination of produce and peanut butter in 
this country, and I join a number of my colleagues requesting 
that the FDA officials appear before us to give us some 
answers. And I am glad that the FDA is represented at the 
hearing; however, it seems that events of the past 3 months 
have raised more questions than answers.
    The cases of food safety lapses have only increased, and 
these cases are shining a bright light on imported food, with 
most of the high-profile problems stemming from Chinese 
imports. Unfortunately, the FDA simply isn't meeting its 
mission to protect the safety of the Nation's food supply 
regardless of the food's origins. Chinese imports of goods 
regulated by FDA was increased by 400 percent in the last 10 
years, yet the FDA has just over 1,300 field investigators that 
monitor food and other FDA-regulated items arriving in 320 
ports of entry.
    This lack of resources results in the inspection of less 
than 1 percent of all imports falling within in the FDA's 
jurisdiction. Despite the obvious need for more resources to 
ensure the safety of our Nation's food supply, the FDA has put 
forward a reorganization plan that would close regional labs at 
the very time we need to boost our monitoring and testing of 
potentially contaminated food.
    It is no surprise that the idea of reorganization that 
would not only close labs but would also cut the jobs of 200 
microbiologists, chemists, and engineers would have provoked 
the committee to express concerns and request more information. 
However, the FDA's release of information in dribs and drabs 
suggests the agency is withholding critical information from 
the committee. If I know our subcommittee and our full 
committee chairmen, I bet they would be the first to warn that 
the committee is not interested in a cat-and-mouse game with 
the FDA, that we expect full compliance with our request for 
information.
    The problem we are facing is too real. It requires 
immediate action, especially given the enormous amount of food 
imported from China where many of these problems have been 
uncovered. I am particularly troubled by the reports of 
contaminated Chinese seafood. China is the No. 1 exporter of 
seafood to our country with $2 billion worth of Chinese seafood 
entering our borders, restaurants, and grocery stores each 
year.
    Time magazine recently profiled a restaurant along the Gulf 
Coast in Mississippi that serves only U.S. farm-raised catfish 
because of the growing concerns over fish imported from China. 
This restaurant did not have the confidence in our Federal 
Government's ability to ensure the safety of the imported 
catfish. Apparently neither did State officials, which 
conducted a test of their own in most grocery store samples of 
catfish, and Mississippi State officials found residues of two 
antibiotics banned in the U.S. but widely used in China. This 
failed attempt at regulation leaves all our families, friends, 
and neighbors at a risk of consuming contaminated products and 
contracting potentially fatal illnesses.
    We need to do better by the American people, and if the FDA 
isn't going to do it on its own, we in Congress have to use our 
legislative power to steer the agency in the right direction. I 
want to thank our witnesses for being here today. Mr. Chairman, 
I yield back my time.
    Mr. Stupak. Thank the gentleman. Next, Mrs. Blackburn from 
Tennessee for an opening statement. Five minutes, please.

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

    Mrs. Blackburn. Thank you, Mr. Chairman. Thanks for holding 
the hearing, and I want to thank our witnesses for taking the 
time to come before us today. As you are hearing, food safety 
is an extremely high priority issue from a public health 
standpoint, as well as a national security issue. And as we 
talk about a security agenda, we hear more rather than less 
about this from our constituents.
    And as you are hearing also, the recent episodes of food 
contamination have highlighted weaknesses in the FDA's food 
safety review system. And we all are fearful, and we are all 
aware that terrorists could easily inflict harm upon our 
Nation's food supply because of the gaps that are becoming 
evident in this system. We know that we are vulnerable to harm 
from abroad where rules and regulations governing food 
production are often more lax than they are here at home.
    As you know, the FDA only has enough inspectors to check 
about 1 percent of the 8.9 million imported food shipments each 
year, and that was last year's number. According to USDA, the 
U.S. is expected to import a record 70 billion in agricultural 
products this year, which is nearly double the 36 billion 
purchased overseas in 1997. In addition, total food imports in 
the U.S. have risen by about 50 percent over the last 5 years. 
We are all aware that last year, our Nation was a net importer 
of food rather than having a domestically grown food supply.
    And while our food supply has generally been safe in the 
past, as you are hearing from other members, the Chinese-made 
food products have become the subject of an ongoing 
investigation and, of course, of the international news 
attention in recent months. The dangerous chemicals such as 
melamine and glycol have been found in food products intended 
for both human and animal consumption. This has lead to an 
unprecedented recall of pet foods, toothpaste, pizza, protein 
bars, baby formula, and most recently, seafood.
    We must seek greater accountability in the food supply 
through FDA reform of its antiquated food safety review system. 
The FDA must enter the 21st century where globalization has 
changed the needs of the food review process and presents very 
different challenges. Gone are the days when we can say our 
food supply is homegrown. We now live in a global economy, and 
free trade has opened the doors to increased interdependence 
among nations.
    The FDA is going to have to transition from defense to 
offense, like it or not. And they are going to have to 
implement a risk-based import control system to stop dangerous 
food imports from reaching our shores. It is vital that we work 
with other countries to prevent future bioterrorism 
opportunities in the country of origin and not when it has 
entered our food supply.
    A reformed import system will improve knowledge and 
assessment of public health risk. The FDA must focus on 
maximizing its resources toward this effort. They are behind in 
this. This is something that they are going to have to put 
their energy into, have more communication among their 
different branches and get in front of this problem. Make the 
changes that are necessary for policing this food supply. They 
should work with foreign governments to establish acceptable 
international food safety standards that encourage good 
manufacturing practices.
    The FDA should improve data collection from farm producers 
to ensure they have all the information necessary to conduct 
risk assessment abroad. It is imperative that the FDA improve 
dialog with these foreign governments to raise the bar on 
adequate standards and review of our food supply. Americans 
believe they can trust their food supply and place quality 
control in the hands of American buyers and their suppliers.
    We must keep all Americans safe by ensuring we have a 
strong risk-based food import review system. Thank you, Mr. 
Chairman. I yield back.
    Mr. Stupak. Thank you. Next we will turn to Ms. Schakowsky 
for an opening statement. Please, Ms. Schakowsky of Illinois.

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

    Ms. Schakowsky. Thank you, Mr. Chairman, for holding this 
hearing on FDA's ability to secure the Nation's food supply. 
This serious public health issue brings into sharp relief our 
reliance on other nations to keep our food safe. Recent high 
profile cases of tainted food have brought this issue that has 
been lurking in cupboards and cabinets to the public's 
attention. Poison toothpaste, antibiotic-laden seafood, and 
toxic pet food have brought FDA testing practices and the 
vulnerabilities of our system into American homes and lives.
    Although I was happy to see that the FDA stopped imports of 
certain seafood from China, unfortunately, it appears that 
action occurred only after this committee and members of 
Congress sounded the alarm on the issue of tainted fish. All 
too often, the FDA is only reactive and does not catch 
dangerous products before they cause illness or even death.
    Every year, 76 Americans suffer from food-borne illness. Of 
those individuals, approximately 325,000 will be hospitalized, 
and more than 5,000 will die. If lax inspections and disjointed 
oversight continue, if we continue to allow imported 
ingredients to enter our markets without inspection, we could 
see those numbers skyrocket.
    Tainted imports enter our borders from countries around the 
world, but recent cases of food and product poisoning point to 
China in particular as a repeated source of poison food and 
ingredients. And we can't rely on China to come up with a 
solution. As Newsweek documents in their July 23 special 
report, China lacks ``the will to overhaul a political 
structure that gives party officials down to even the smallest 
villages huge influence over many facets of economic life'' 
which has lead to the problems we are facing today. A few high 
profile executions of agency heads in China will not reform a 
system plagued by corruption or where enforcement of food 
regulations is left to local governments who are susceptible to 
buyoffs from local businesses.
    In order to get a handle on this problem and protect 
Americans from dangerous products, we must change the way we 
inspect imported food and ingredients. In February of this 
year, the Government Accountability Office deemed Federal 
oversight of food safety as ``high risk'' to the economy and 
public health and safety. We need to change our regulatory 
system so that it can effectively screen for dangerous 
substances and products. We must ensure that the FDA has the 
resources and authority it needs to increase inspections of 
imported foods and drugs.
    Finally, we must make sure that the FDA has access to 
sophisticated testing techniques to help inspectors identify 
adulterated imports. As the investigations by the subcommittee 
have shown, the FDA is a bureaucracy that is not responsive to 
investigators in the field. The FDA uses outdated computer 
programs to determine which foods are high risk. There are 
gaping holes in the FDA policy that allows importers to get 
around regulations. The agency is planning to close seven of 
its labs. Instead of working actively to reduce the risk of 
food-borne illness, the FDA has become almost totally reactive.
    I look forward to hearing the testimony of FDA officials, 
investigators, and food safety advocates to get answers to 
questions about the factors that have allowed unsafe foods to 
make it to our kitchen tables. It is time that we act to ensure 
that our food supply is safe.
    Thank you, Mr. Chairman. I yield back.
    Mr. Stupak. I thank the gentlewoman. Next Ms. DeGette from 
Colorado for opening statement please.

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

    Ms. DeGette. Thank you so much, Mr. Chairman, and I 
appreciate your continued diligence in these important 
investigative hearings on food safety. It is a topic that is of 
utmost concern to the American people.
    At our first hearing on this topic in April, we heard why 
we are doing this. Gut-wrenching stories from people whose 
children have been permanently disabled because of unsafe food.
    Today the focus is on the FDA itself where serious concerns 
have surfaced with regard to the recent spate of food-borne 
illnesses. It has become clear that the FDA's efforts to 
anticipate, prevent, and respond to these outbreaks is frankly 
far from adequate. The agency has also been far from 
forthcoming with this subcommittee in our attempt to 
investigate its actions leading up to and following the 
incidents.
    I expect to find out today why there has not been more 
cooperation with our investigation and maybe more importantly 
why the FDA has not been more proactive in its efforts to 
safeguard the Nation's food and drug supplies.
    I want to discuss one aspect mentioned by Ms. Schakowsky 
that is particularly disturbing in the investigation. In light 
of the problems with the FDA's oversight of food, which have 
been discussed by every other member on both sides of the aisle 
of this committee, it is just incredible to me that the FDA is 
proposing to close over half the food and drug safety field 
laboratories.
    One of those seven laboratories is located right outside my 
congressional district. It is the Denver laboratory, and its 
offices are at the Federal center in Lakewood, Co. Closing this 
lab would affect approximately 50 chemists, microbiologists, 
and analysts and the important work that they do for our 
community. These dedicated employees perform highly specialized 
analysis of BSE, or mad cow disease, food pathogens like E. 
coli and salmonella, food additives, and human and veterinary 
drugs. Seems like some work we need to be doing given the 
recent revelations.
    Today I would like to find out how the FDA can justify 
closing one of the Nation's preeminent food and drug research 
laboratories at a time when we have almost daily revelations 
about contaminated food. Today Ms. Belinda Collins, the 
director of the Denver district of the FDA, will testify about 
the important work currently being done at the Denver lab, as 
well as the risk to public health of shutting the facility. 
Welcome, Belinda, and thank you so much for being here.
    I am sensitive to the budgetary pressures facing Federal 
agencies, and frankly I am a reinventing government type. I am 
always willing to consider meaningful agency changes if there 
is demonstrated evidence that the changes will eliminate waste 
and duplication or trim costs or increase efficiency while 
improving public health, but in this case, I have not seen this 
evidence.
    In fact, just the opposite seems to be true. The FDA itself 
rated the Denver lab as in good condition, while the Atlanta 
lab, which will remain open under the current plan, was rated 
fair to poor. The GAO has determined that midsized regional 
labs like the Denver lab are more appropriate than the mega 
labs that the FDA wants to create. And in addition, Ms. Collins 
will tell us this morning that food safety and indeed homeland 
security in the Rocky Mountain region, where I might add, Mr. 
Chairman, the Democratic National Convention will be held next 
year, and in the Nation, will be compromised if the plan is 
carried out.
    So despite the overwhelming evidence of the Denver lab's 
effectiveness, the FDA is holding its position in moving 
forward with the closure, citing simply nebulous future cost 
concerns without providing this committee or the American 
people with evidence to back it up. I think we should look 
very, very closely at that, given the risks of the next food-
borne outbreak and the hope of detecting it quickly, and also 
the whole issue of losing employees who have years of 
scientific expertise who can help us in this endeavor.
    I also want to say, Mr. Chairman, that it is disconcerting 
that the U.S. at Food and Drug Administration does not feel 
compelled to answer questions put to it by the legislative 
branch. I have had questions for the last two hearings, not 
about food safety but on medical devices and other issues, that 
you might recall. I specifically asked the FDA to respond in 
writing to these questions, and I haven't had any response at 
all. This goes back to April, and I know Mr. von Eschenbach is 
testifying later. I want to know why we can't get questions by 
this committee answered .
    And finally, Mr. Chairman, people often say why do you have 
these oversight hearings? Is it just a grandstand? Well, every 
time we have a hearing, there is some new revelation, and 
something is fixed. Just by chance today, for example, Safeway 
announced that it is no longer going to package food with 
carbon monoxide, one of our committee's greatest concerns. And 
so you can see these hearings at least have some effect, and I 
hope they will have a lot more effect.
    Finally, Mr. Chairman, I would like to ask unanimous 
consent to insert into the record a statement by my colleague, 
Ed Perlmutter, whose Seventh Congressional District includes 
the FDA lab.
    And with that, I yield back the balance of my time.
    Mr. Stupak. The gentlelady yields back. Mr. Waxman for an 
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. When the 
American people hear about dangers in their food, a lack of 
food safety, whether it is from domestic-sourced food or 
imported food, they want to know where the Government is. They 
know the Government has to act. The Government is supposed to 
act. They want to the Government to protect the American people 
from unsafe foods.
    While we have for most foods in this country the Food and 
Drug Administration, with that responsibility, and it is easy 
to see that the Food and Drug Administration is not doing 
enough to protect our citizens from exposure to unsafe foods. 
But I think there is a responsibility that is a shared one 
because Congress hasn't done its part to make sure that FDA has 
both the authorities and the resources to do a job well.
    For example, FDA lacks the authority to demand access to a 
firm's records and data during routine inspections. It lacks 
the ability to detain a shipment of imported foods without 
evidence that the specific shipment of food is contaminated or 
may pose some other threat to the public health. The lack of 
these authorities limits FDA's ability to be proactive rather 
than reactive in protecting the food supply. Congress has also 
failed to give the FDA the needed resources. Of all the centers 
at FDA, the center for foods has been the most starved for 
resources. FDA oversees 80 percent of the food consumed in the 
United States. The U.S. Department of Agriculture overlooks 20 
percent, and yet USDA gets approximately 80 percent of the 
Federal dollars allocated to food safety, while FDA gets the 
remaining 20 percent.
    When it comes to the safety of the foods we eat every day, 
this funding structure makes no sense, and this has got to be a 
concern. To be sure, the administration and the FDA bears 
significant responsibility for the recent food safety crises. 
The administration has not asked for additional resources. They 
have not come forward with suggestions for how Congress should 
strengthen the FDA's authorities so that it can be more 
effective in dealing with these crises.
    And FDA itself bears significant responsibility here. One 
of FDA's major failures is in the area of inspections and 
enforcement. My own oversight committee conducted an 
investigation in FDA's mission, effectiveness, and challenges 
for the future. And as part of that investigation, we are going 
to release a report later this week that identifies major 
weaknesses in FDA's inspection and enforcement practices with 
respect to fresh produce firms. The report will demonstrate 
that FDA has failed to carry out its responsibilities for 
enforcement in this particular clinical area.
    Further, as this committee will hear today, the FDA has not 
always been forthcoming in getting us the information on its 
activities. Despite repeated requests, FDA has failed to get 
this committee information on important topics such as the 
closure of FDA labs, the safety of imported seafood, and 
efforts to safeguard fresh, leafy greens and other domestic 
foods. It is absolutely critical that this committee receive 
complete information in these areas, and I hope we get it in 
short order.
    We here in Congress stand ready to work with the FDA to 
ensure that the agency has everything it needs to fulfill its 
congressional mandate to protect American citizens from unsafe 
foods. But in order for us to do our job, we need FDA to be 
forthcoming in getting us the information. We need FDA to tell 
us about what actions it has and has not taken to prevent 
unsafe foods from entering the market. We need FDA to tell us 
what the agency needs, both in terms of authorities and in 
terms of funding to do this job, and to do it well. FDA needs 
to help us so we can help the FDA.
    So hearings like this, we will have an opportunity to get 
the facts. Once we get the facts, we can figure out what 
actions are needed. But it is important that Congress do this 
job, and I want to commend you for holding this hearing, for 
doing this investigation because the American people expect and 
demand that when they buy their food, whether it is from the 
United States or from China or from anywhere else, that 
somebody in this U.S. Government is making sure that this food 
is safe. Thank you, Mr. Chairman.
    Mr. Stupak. Next we turn to the chairman of the full 
committee of the Energy and Commerce Committee, Mr. Dingell 
from Michigan, for an opening statement please.

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

    Mr. Dingell. Mr. Chairman, I commend you for this hearing. 
It is extraordinary importance, and it could not be any 
timelier. Almost every day brings news of another threat to the 
public health posed by contaminated food products and 
parenthetically by prescription pharmaceuticals and other 
matters relative to the inadequacies of food and drug and the 
inadequacies of their budget. The recent series of tainted food 
recalls has focused America's attention on the sorry state of 
Federal oversight of the domestic food supply. Even more 
disturbing, however, is the virtual abdication by the Food and 
Drug Administration of oversight or inspection of the ever-
increasing flood of imported food.
    We could look back at the sorry mess which we saw when Food 
and Drug devoted almost its entire resources to finding just a 
few cyanide-contaminated grapes supposedly from Chile. And we 
are finding that a lot of this is not an inadequacy in terms of 
the dedication of the personnel at the agency, not much of it 
due to weakness of law, but a very large part of it due to 
inadequacies of funding and the inadequacies of the ability of 
Food and Drug to carry out its important responsibility.
    From time to time, this committee has had to go into the 
question of the inadequacies of the Food and Drug 
Administration. It appears that that is something which is 
becoming very timely at this time. The reality is at this time 
that the amount of food imported into the United States is 
double that which was imported 10 years ago. More than a 
quarter of all food purchased by Americans is imported. More 
than 80 percent of all seafood consumed in the U.S. is 
imported.
    Between 2002 and 2006, FDA-regulated food imports from 
China rose approximately from 100,000 shipments to nearly 
235,000 shipments. Experts expect and predict that these 
shipments will reach 300,000 this year. The number of 
personnel, the budget, and the ability to address these 
questions and the safety of these shipments, is, I think, 
fictional at best.
    The FDA examines less than 1 percent of these imports, and 
those imports examined bear test for only a small fraction. 
This is unacceptable, especially in the light of the horror 
stories coming out of China, such as poisonous melamine in food 
products, the anti-freeze chemical diathyline glycol in 
toothpaste, and illegal antibiotics and suspected carcinogens 
in farm-raised shrimp and fish.
    Even worse, China released a study recently showing that 
nearly one-fifth of all food and consumer products sold to its 
own people are tainted and substandard. Their cure appears to 
be to shoot the head of the Food and Drug Administration or 
whatever it might be called. Another Chinese Government reports 
rivers in China so contaminated with sewage, heavy metals from 
industrial byproducts, and pesticides, that fish farmers no 
longer have any choice but to use chemicals and antibiotics to 
keep fish alive. One must ask what are those doing to the 
United States and to our citizens.
    I would note that while all this is going on, the FDA is 
proposing to close labs because of budgetary constraints, and 
one must ask how is that going to better consumer safety in the 
United States. I would note that this country is supposed to 
have the best and the strongest laws to protect our consumers 
with regard to food products, with regard to drugs, and with 
regard to other matters under the jurisdiction of FDA. Clearly 
that situation is being worsened by budget inadequacies and 
probably statutory failures in terms of the ability of this 
country to address the situation as we now find it.
    Since is more than 20 percent of U.S. seafood imports come 
from China, I shudder to think how much of this tainted Chinese 
seafood has already reached American tables, and what the 
consequences of that are to American consumers. How has FDA 
responded to this increasing threat to American consumers? 
Well, they propose to name a food czar. Now, I note that they 
give him no real authority. They will propose a sweeping 
reorganization of their food inspection operations, close some 
of their most crucial laboratories including one at the third 
largest port in the United States that could be used to address 
the question of dangerous imports and threats to the well-being 
of our consuming public.
    As we will hear from the committee staff who have 
interviewed numerous FDA field employees as well as from a 
number of witnesses with actual hands-on experience in our 
Nation's ports, the FDA reorganizations programs and proposals 
will shift resources away from ports of entry, actions that 
will in all likelihood worsen our food safety crisis.
    Further, their proposal will eliminate much of the scarce 
laboratory expertise currently found at FDA. The Federal food 
safety system is in dire need of reform. It is fragmented, 
understaffed, inefficient, and lacking in state of our tracking 
programs in large part due to the inadequacies of its budget 
and the fact that the administration thinks that a leaner and 
meaner system is going to protect American consumers, but in 
fact, it puts them at still greater risk.
    Furthermore, FDA has largely abdicated its regulator role 
to the food industry itself. In other words, the fox is going 
to be addressing the safety of the chicken coop. This must 
change. I will soon introduce legislation to address this 
situation. I have sent a Dear Colleague letter out to my 
colleagues asking them to join in this because this is 
something that desperately needs to be done.
    Amongst other things, it will provide additional resources 
and authorities for FDA to ensure that it can effectively 
monitor and control food and drug imports entering the United 
States. It will also provide for additional research on 
effective testing techniques at the border to aid inspectors in 
identifying adulterated imports.
    I think we must hope together that senior FDA officials who 
comprise our third panel today will acknowledge the glaring 
structural deficiencies in existing food safety regime, stop 
the dangerous and wasteful reorganizations in their field 
inspection service, and work with us to craft a system truly 
capable of meeting the challenges of the global food market. I 
expect the assistance of the agencies. I look forward to 
cooperating with my colleagues, and I expect to have a vigorous 
effort to correct the abuses, which you are about to show 
today.
    Mr. Chairman, I thank you for your kindness and for your 
vigorous leadership in this matter.
    Mr. Stupak. I thank the gentleman from Michigan. Next Mr. 
Murphy, do you want to give an opening statement?

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

    Mr. Murphy. Thank you, Mr. Chairman. Just briefly, I wanted 
to point out that certainly the importance of this hearing 
can't be underestimated or understated not only because we have 
seen recent outbreaks of contaminated food from E. coli in 
spinach and salmonella in peanut butter and contaminated foods 
in pet foods, but understand the complexity of the importance 
of this all the way down the line, beginning with farms or 
ranches where we look at everything from farming practices and 
pesticides, hormones, herbicides, and washing of food there, to 
factories and processing centers to shipping things across the 
sea, what is done at our ports, what is done at our truck and 
train terminals and transporting those foods across and 
handling foods at warehouses and food distributors and grocery 
stores and restaurants, and then all the way down to food 
handlers and the households themselves.
    Every step of the way, the safety and cleanliness of foods 
must be protected, and it is important that we have an FDA and 
other Government agencies that review the whole food chain all 
the way through to make sure we are providing safe and secure 
food supply for our Nation.
    I wish that we had some jurisdiction over what other 
nations do when we are importing foods from other countries, 
and I am hoping along the way of this hearing and others that 
we can obtain more ideas of how to make sure we are securing 
the safety of that food supply as well.
    So with that being said, I am looking forward to this 
hearing and ideas that may come out of this panel of what we 
may do to move that forward. I thank the chairman.
    Mr. Stupak. I thank the gentleman.
    Any other statements for the record will be accepted at 
this time.
    [The prepared statement of Mr. Burgess follows:]

   Prepared Statement of Hon. Michael C.Burgess, a Representative in 
                    Congress from the State of Texas

    Thank you Chairman Stupak and Ranking Member Whitfield.
    With the ever increasing number of recalls, I continue to 
be extremely concerned with the safety and security of normal 
household products. While I remain confident that America has 
the safest food supply in the world, what I am more concerned 
about is the safety of imported goods, especially those from 
the Republic of China. My friend and colleague, Mr. Greg 
Walden, and I sent a letter to the committee calling for an 
investigation regarding the many food and consumer product 
safety recalls from China. I continue to urge the leadership of 
this committee to fully examine this matter.
    Today, however, we are focusing on the FDA's duty to 
safeguard our food supply. While I am pleased that we have Dr. 
von Eschenbach and others with us today I still believe that 
they should have had the opportunity to appear before us at the 
last hearing. This committee has many questions for the FDA 
regarding a host of issues, including the reorganization 
efforts. I took look forward to discussing the need to 
reorganize; however, I also hope that an adequate amount of 
time is spent on discussing the FDA's role and responsibility 
for ensuring that our imported foods are safe for the citizens 
of this country.
    Mr. Chairman, unfortunately I will have to leave this 
hearing in a little while to go up the road to Walter Reed; 
however, I have made arrangements to be back here in time for 
the third panel. I sincerely apologize to the witnesses on the 
first and second panel for my absence.
    Thank you, Mr. Chairman, and I yield back the remainder of 
my time.
                              ----------                              

    Mr. Stupak.Before we have our first panel, the gentlewoman 
from Colorado mentioned the fact that Representative Perlmutter 
would like a statement in the record without objection. We will 
do that. Also I mentioned the Safeway letter addressed to 
myself and Chairman Dingell as to they are going to discontinue 
use of the carbon monoxide in the sale of their fresh meat 
products. I would ask unanimous consent to place that letter in 
the file. And Mr. Whitfield, you had a unanimous request?
    Mr. Whitfield. I do, Mr. Chairman. This is a letter from 
Congress Luis Fortuno who represents Puerto Rico, and I would 
ask unanimous consent that we include in the record his letter 
expressing concern about the lab in San Juan, Puerto Rico.
    Mr. Stupak. Without objection, Mr. Perlmutter's statement, 
the letter from Safeway, and the letter from Congressman 
Fortuno about Puerto Rico be entered in the record. With that, 
we will call our first panel.
     And as all opening statements have been concluded by 
members, our first panel, would the witnesses please come 
forward? On our first panel, we have Mr. David Nelson, senior 
investigator for the Committee on Energy and Commerce; Mr. 
Kevin Barstow, investigative counsel for the Energy and 
Commerce Committee; Mr. Richard Wilfong, investigator with the 
Energy and Commerce Committee.
    Now, gentleman, it is the policy of this subcommittee to 
take all testimony under oath. Please be advised that witnesses 
have the right under the rules of the House to be advised by 
counsel during their testimony. Do any of you wish to be 
represented by counsel? Witnesses indicated they do not. I will 
ask you to rise, raise your right hand, and take the oath.
    [Witnesses sworn]
    Mr. Stupak. Let the record reflect that witnesses replied 
in the affirmative. You are now under oath. We will begin with 
an opening statement for 5 minutes. You may submit a longer 
statement for inclusion in the hearing record. I understand 
that, Mr. Nelson, you will be giving the statement on behalf of 
the three committee members there. And you may begin any time, 
sir.

 TESTIMONY OF DAVID NELSON, SENIOR INVESTIGATOR, COMMITTEE ON 
      ENERGY AND COMMERCE, ACCOMPANIED BY KEVIN BARSTOW, 
 INVESTIGATIVE COUNSEL, COMMITTEE ON ENERGY AND COMMERCE; AND 
RICHARD WILFONG, INVESTIGATOR, COMMITTEE ON ENERGY AND COMMERCE

    Mr. Nelson. Thank you, Mr. Chairman. As many of you may be 
aware, I am David Nelson. I am an investigator on the Energy 
and Commerce Committee staff. With me on my right are Kevin 
Barstow and on my left Richard Wilfong. They and several other 
members of the majority staff and Krista Carpenter of the 
minority staff have been investigating questions of food safety 
for the committee for the last 4 months.
    As part of the inquiry, we have reviewed tens of thousands 
of pages, some of which were delivered only last week of 
documents. We have conducted numbers interviews of industry 
experts, current and former FDA employees, per your 
instructions. We visited numerous ports, FDA laboratories, and 
field offices around the country. Minority staff participated 
in most of these interviews and site visits.
    Chairman Stupak, you asked us to focus on three critical 
areas of food safety that were raised by the testimony during 
the April 24 hearing of this committee. First was the extent to 
which FDA is protecting Americans from contaminated food 
imports. Second the extent to which FDA's proposed 
reorganization of its field operations, including FDA's 
decision to shut down or proposal to shut down 7 of its 13 
laboratories is consistent with the agency's charge to ensure 
the safety of the Nation's food supply.
    Finally, you asked us to explore the extent to which FDA's 
continued use of voluntary guidelines are adequate to ensure 
the safety of the Nation's food supply. And in the course of 
that inquiry, we examined a number of products in FDA's 
regulation thereof, domestic and imported leafy greens, peanut 
butter, imported vegetable proteins like wheat gluten, imported 
seafood and imported toothpaste containing a deadly chemical 
diathyline glycol.
    The preliminary findings confirm the results of the 
subcommittee's April hearing, that FDA has failed to adequately 
respond to increased imports of foreign food products. Recent 
accounts of tainted imports from China provide additional 
evidence. Simply stated, the FDA lacks sufficient resources and 
authority to ensure food safety, and legislation will be needed 
to correct these deficiencies.
    The current proposal to change FDA's structure and 
management would appear to exacerbate the current food safety 
situation.
    Lastly, FDA's current regulatory approach which relies upon 
voluntary guidelines, promotes domestic and imported foods, 
appears inadequate in responding to the changing food industry.
    I only have time to make a very few points that are made in 
the written testimony, Mr. Chairman. So let me just concentrate 
on a few. Our review of the operations in San Francisco reveal 
that it is physically impossible for that office to perform 
more than a cursory review of most imports. The San Francisco 
office has four entry reviewers to oversee 4,000 entry lines 
per day. A typical reviewer's day involves examining 600 food 
entries, 300 medical device entries, 25 reagent entries, and 25 
drug entries on a computer screen. That is about one entry 
every 30 seconds. That is the time they have to decide whether 
or not they even recommend sending an inspector out to inspect, 
physically look at the goods, or to take a sample.
    One of the problems that we found in every lab we traveled 
to was the unverified reliance by FDA on the use of private 
laboratory tests to release suspect imports. FDA permits 
importers to take possession of even highly suspect goods that 
arrange for their testing by private laboratories. Import 
alerts that contain the instruction, detention without physical 
examination, does not mean detain the ordinary use of that 
word. It means allow delivery to the importer. The importer 
then has to contract with a private lab, which FDA does not 
oversee, does not license, does not audit, and has no legal 
authority to direct importers to specific labs or away from 
specific labs, regardless of what the record of those labs are.
    If those laboratories provide a negative finding of 
pathogens or toxins in five consecutive shipments, then that 
exporter is removed from the import alert, and the Oasis system 
assures that all future shipments from that exporter are going 
to come into the United States without any further testing.
    Mr. Chairman, the rest of the report goes on and deals with 
the problems with the Oasis system, deficiencies we found in at 
least the enforcement of country-of-origin regulations, the 
seafood problems that are especially problematic, the carbon 
monoxide being used as atmosphere around imported fish was 
particularly troubling. Some 20 percent of the imports into the 
United States in San Francisco coming in in these atmospheres 
were found to be disguising decomposed fish. Now, despite the 
fact that that was the record in San Francisco and we confirmed 
it to a certain extent in New York, FDA nonetheless in 2001 
determined that consumers would be able to purchase fish that 
was made to look fresher than it probably is in those 
atmospheres. And in 2004, said it was OK for meat.
    The written testimony contains a lot about the proposed 
reorganization, the field staff, which I will be glad to answer 
any questions about, as will my colleagues. We don't have time 
to highlight those here.
    [The prepared statement of Mr. Nelson follows:]

                       Statement of David Nelson

     Mr. Chairman and members of the subcommittee, today the 
subcommittee begins the second in a series of expected hearings 
concerning the adequacy of Food and Drug Administration's (FDA) 
efforts to ensure the safety of the Nation's food supply. As 
part of this inquiry, committee staff have reviewed thousands 
of pages of documents and conducted numerous interviews of 
industry experts and current and former FDA employees. Per your 
instructions, we also visited numerous ports of entry and FDA 
laboratories and field offices. The FDA offices visited 
included the Detroit, San Francisco, Los Angeles, Denver, 
Kansas City, Winchester, MA, Atlanta, New York, and San Juan, 
Puerto Rico district offices and/or laboratories. Minority 
Staff participated in most of these interviews and site visits.
     Chairman Stupak asked the staff to focus on three critical 
areas of food safety that were raised by the testimony of the 
April 24, 2007, hearing:
      The extent to which FDA is protecting Americans 
from contaminated food imports;
      The extent to which FDA's proposed reorganization 
of its field operations, including FDA's decision to shut down 
seven of its 13 laboratories, is consistent with the Agency's 
charge to ensure the safety of the Nation's food supply;\1\
---------------------------------------------------------------------------
    1 Federal responsibility for food safety is shared by FDA and the 
U.S. Department of Agriculture (USDA). FDA's authority extends to 
approximately 80 percent of the food supply.
---------------------------------------------------------------------------
      The extent to which FDA's continued use of 
voluntary guidelines of certain products that have been 
implicated in recent food poisoning outbreaks are adequate to 
ensure the safety of the Nation's food supply. These products 
include both domestic and imported leafy greens, peanut butter, 
imported vegetable protein, imported seafood, and imported 
toothpaste containing the deadly chemical diethylene glycol.
     Preliminary findings confirm the results of the 
subcommittee's April 2007 hearing that FDA has failed to 
adequately respond to increased imports of foreign food 
products. Recent accounts of tainted imports from China provide 
additional evidence, simply stated, that FDA lacks sufficient 
resources and authority to ensure food safety and legislation 
will be needed to correct these deficiencies. \2\
---------------------------------------------------------------------------
    2 See appendix to staff statement that summarizes a sample of 
recent news articles concerning unsafe food products from China.
---------------------------------------------------------------------------
     The current proposal to change FDA's structure and 
management would appear to exacerbate the current food safety 
situation. Lastly, FDA's current regulatory approach, which 
relies upon voluntary guidelines for most domestic and imported 
foods, appears inadequate in responding to the changing food 
industry.

                FDA Regulation of Food Imports is Minimal

     Committee staff learned that FDA inspects less than 1 
percent of all imported foods and samples only a fraction of 
those it inspects. While the number of FDA inspectors has been 
falling since 2003, the importation of food products into the 
United States has nearly doubled.
     Our review of operations in San Francisco typifies the 
problem with the current FDA inspection system. It was apparent 
from interviews and observations that it is physically 
impossible for FDA's San Francisco staff to perform more than a 
cursory review of most imports. The San Francisco office has 
four entry reviewers to oversee thousands of entry lines per 
day. A typical reviewer's day involves examining 600 food 
entries, 300 medical device entries, 25 reagent entries, and 25 
drug entries on a computer screen. This is about 1 entry line 
every 30 seconds. However, due to the volume of entries and the 
time required to take action, less than 30 seconds is spent on 
most of them. A single entry of Chinese herbs can take more 
than an hour to review. Even the simplest action involves 
several minutes, e.g., e-mailing a broker for additional 
information. If an entry review results in a recommendation for 
a site visit, the Compliance office must make a determination 
of whether to send an investigator. Compliance must also decide 
on whether to sample the shipment.
     Determining what requires further examination is also 
complicated by differences and discrepancies in the way 
imported food is identified. For food, FDA categorizes entries 
by product codes, but Customs and Border Protection (CBP) 
categorizes entries by tariff codes, an entirely different 
system. Brokers often miscode entries and product descriptions 
are poor, particularly for products imported from China.

   FDA's Uncritical Reliance on Private Laboratories Causes Problems

     One particularly important problem that staff field 
investigation uncovered dealt with the unverified reliance by 
FDA on the use of private laboratory tests to release suspect 
imports. Committee staff was told by FDA inspectors that FDA 
permits importers to take possession of even highly suspect 
goods and arrange for their testing by private laboratories. 
Import alerts that contain the instruction ``detention without 
physical examination,'' such as the import alert issued on 
April 27, 2007, with regard to vegetable protein (wheat gluten, 
et cetera),\3\
---------------------------------------------------------------------------
    3 See FDA Import Alert No. 99-29 (April 27, 2007). do not literally 
mean ``detain,'' but allow delivery to the importer.
---------------------------------------------------------------------------
     Once there have been five consecutive analyses by private 
laboratories that find no violations, the importer is no longer 
required to conduct testing on products of that exporter and 
the goods may proceed into the consumer market without further 
action, even if the food is covered by an alert. FDA does not 
require a separate bond be posted by the importer taking 
delivery. Further, FDA neither accredits nor debars private 
laboratories that analyze imported food samples, despite the 
fact that these laboratories often use incorrect methods or 
report incorrect results.
     Officials at all FDA labs visited by committee staff were 
critical of private laboratory testing. An FDA Deputy Lab 
Director, who performs private laboratory reviews, said that 
some private laboratory work is ``decent,'' while some is 
``scary''. He believes that none of the private laboratory 
analyses are completely accurate. In general, he described 
private laboratory work as ``not good'' and ``spooky''. An FDA 
Science Branch Director concurred with this assessment. He 
commented that private laboratory work is ``shoddy'' because 
results are driven by financial rather than scientific 
concerns.
     FDA has the option of sending an inspector to gather 
samples to be examined in a FDA lab, but rarely does so--only a 
minute fraction of the 25,000 daily food shipments are ever 
tested by a Government laboratory. When analyzing samples of 
imported food, FDA labs often find problems that private labs 
did not uncover.
     Another problem related to imports identified by FDA field 
staff was that only 20 percent of food imports appear in FDA's 
food import computer system (OASIS) for review by the field 
inspection force. Review criteria are established by FDA's 
Division of Import Operations and Policy (DIOP) in Washington 
and FDA field input is minimal. FDA field inspectors complained 
to committee staff that 75 to 80 percent of all individual 
import entries are not flagged, and therefore, have never been 
subject to cursory computer inspection of their paperwork by 
field inspectors who are experts at identifying suspect 
shipments.

   FDA Can Learn from Other Federal Agencies to Better Screen Imports

     FDA's approach to this complex, large, and growing problem 
is strikingly different from the approach taken by other 
Federal agencies charged with equally important border 
inspection responsibilities. Although FDA's entry reviewers, 
investigators, and compliance officers are clearly unable to 
keep up with the flood of imports, FDA has no plans to increase 
its import staff, but does plan to shut its San Francisco 
laboratory. In contrast, CBP will be adding 35 new 
``agricultural specialists'' in San Francisco, funded by the 
user fees that CBP is authorized to charge. FDA has no user 
fees to pay the cost of monitoring food imports and its 
proposed fiscal year 2008 budget and proposed reorganization 
indicate that it is not seeking additional resources for this 
purpose.
     Compared to USDA, FDA's resources and activities appear to 
be woefully short of its food import responsibilities. FDA is 
responsible for assuring the safety of 80 percent of the food 
supply, but lacking a user fee system, is able to inspect only 
about 1 percent of all food imports, and does not ensure that 
foreign food processors and suppliers meet U.S. food safety 
standards. In contrast, USDA is responsible for only 20 percent 
of the food supply, but has a user fee system that allows it to 
inspect 16 percent of meat imports. In addition, USDA will not 
permit meat to be shipped to the U.S. unless the exporting 
country meets USDA regulatory standards. USDA also restricts 
the ports of entry of meat products to 10 ports. In contrast, 
FDA does not require comparable regulatory standards and 
permits imports to enter into the Customs territory of the 
United States at any of the 326 ports of entry, despite the 
lack of FDA presence at most of these ports.

Pet Food, Wheat Gluten, and other Vegetable Proteins May Highlight FDA 
                         Over-Reliance on OASIS

     The recent recall of contaminated wheat gluten and other 
vegetable proteins highlights the dangers from an over-reliance 
on the OASIS system that removes 80 percent of the so-called 
``low risk'' imports from any field inspection.
     On March 15, 2007, FDA was informed that pets had been 
dying from kidney failure from eating what was eventually 
determined to be 95 varieties of pet food manufactured by Menu 
Foods. Moreover, the common ingredient was wheat gluten, a 
widely used vegetable protein obtained from ChemNutra, a Las 
Vegas importer of Chinese ingredients for the pet food and 
dietary supplement industries. FDA labs in Cincinnati and 
Kansas City discovered that an industrial chemical, melamine, 
had been mixed with the wheat gluten in order to artificially 
elevate its protein content.
     An April 27, 2007, Import Alert issued by FDA provided 
that 8 vegetable proteins (wheat, rice, corn, soy, and mung 
glutens and proteins) covering 10 tariff codes be ``detained 
without physical examination,'' as described above. Despite the 
regularly accepted meaning of the word ``detain,'' this 
designation did not result in these vegetable proteins being 
embargoed. These products were delivered to the premises of the 
importer, and the importer was required to submit samples to 
private laboratories for testing. As noted above, FDA 
laboratory officials believe this is not a reliable means for 
determining the safety of food products.
     In contrast to FDA's handling of these imports, CBP, on 
its own initiative, decided to detain all such imports from 
China in the 10 tariff codes, pending testing by Government 
laboratories. All such imports were to be detained at a Customs 
Examination Station (a warehouse under CBP control), and 
samples from each lot would be taken and supplied to both 
Customs and FDA laboratories. FDA officials in San Francisco 
and Los Angeles were initially unaware of the CBP initiative 
and did not appear pleased with the deviation from established 
the FDA procedure. Ultimately the Agencies coordinated their 
efforts.
     CBP informed committee staff that those 10 tariff codes 
produced about 21,000 entry lines on 17,000 entries (many CBP 
entries contain more than 1 line because they contain more than 
1 product) from approximately 1,000 different exporters to the 
United States annually. This does not include human food, pet 
food, or animal feeds at risk of containing the suspect 
vegetable proteins.
     Until the high number of pet deaths became evident in 
March 2007, these vegetable proteins and the animal feeds that 
contained them had been among the imports FDA never inspected 
under their OASIS review system. Testimony from the April 24, 
2007, hearing reflects that there is no difference in the wheat 
gluten sold for human food, pet food, or animal feed. Vegetable 
proteins containing melamine have now been found in chicken, 
hog, and fish feed.
     On April 30, 2007, FDA made assignments to all Districts 
to inspect and gather samples from food processors that use the 
suspect vegetable proteins as ingredients in their food 
products. The number of firms to be inspected, however, is 
small. For the entire West Coast and for States as far away as 
Hawaii and Utah, only 34 food processors have been selected for 
inspection. Fortunately, no vegetable protein was found to 
contain melamine in any human food processor. A bakery in 
Seattle was found, however, to have a single unopened bag of 
ChemNutra wheat gluten.

            Country of Origin Regulations Appear Inadequate

     The true country of origin of imported wheat gluten and of 
vegetable proteins is also a matter of some controversy. 
Committee staff was told that Europe generally, and the 
Netherlands specifically, is the principal source of wheat 
gluten imports. Staff witnessed, however, the unloading of 
wheat gluten declared as coming from China in 50 pound bags 
marked with the ``Wind Mill'' brand of a Dutch firm, Meelunie 
(see attached photos). The bags gave no indication that the 
product was from China, but indicated the supplier was in 
``Amsterdam-Holland.''
     Customs officials informed committee staff that the 
Country of Origin regulations now merely require that the 
purchaser be aware of the correct source of the goods. When the 
staff inquired as to how any downstream purchasers were to know 
the true origin of this apparently- Dutch wheat gluten, CBP 
informed them that if the importer were not the end user of the 
product, they would have an obligation to inform all their 
customers of the true country of origin and so on throughout 
the supply chain. Once the Wind Mill bags enter commerce, 
however, CBP loses control. Apparently there is no requirement 
that the consumers of the bread, candy, dietary supplements, or 
other final products be told of the actual original source of 
the ingredients. Furthermore, the purchasers of pet food, meat, 
or fish that have been fed Chinese vegetable proteins are never 
informed of the country of origin of the final product 
components. CBP did indicate the importer might be required to 
mark the bags, since CBP had no assurance that the true origin 
would be known downstream.
     Since food processors are not required to inform consumers 
of the origin of its ingredients, Americans have no avenue with 
which to seek damages from companies that sell products whose 
ingredients are suspect. Further, the minimal inspection of 
imported food also means that false country-of-origin labeling 
is rarely detected.

             Seafood Imports Remain Especially Problematic

    On July 10, 2007, FDA issued Import Alert No. 16-131 
requiring that all catfish, shrimp, and other specified farm-
raised fish from China be ``detained without physical 
examination.'' China had been importing fish that were 
contaminated with fluoroquinolones and other antibiotics as 
well as malachite, an anti-fungal treatment that is a suspected 
carcinogen. Malachite is found in ponds and tanks containing 
fish not intended for human consumption. Other chemicals that 
are not approved for use in food have also been found in these 
imports. Antibiotics in food are a public health problem 
because they promote resistance to drugs that kill infections.
    The July 10, 2007, alert notes that 80 percent of the 
seafood consumed here is imported and 40 percent of that is 
farm-raised. China produces 70 percent of the farm-raised fish 
worldwide and exports about 80 percent of its production. The 
timing of the import alert, however, is curious. From the staff 
field investigation, it was learned that FDA has known for 
years about the widespread use of antibiotics and fungicides to 
treat farm-raised fish from China. It appears, however, that 
only after the subcommittee and other congressional committees 
began to investigate FDA's less-than-aggressive approach to the 
regulation of fish imports, did FDA issue its alert.
    FDA field staff expressed their hope that this will mark a 
renewed concern by their Agency of other known problems with 
the safety of fish imports. For example, melamine has recently 
been discovered in the feed for farm-raised fish in Canada, 
Washington, Alaska, and Oregon. The Canadian producer of the 
feed has recalled the product, but FDA has yet to announce 
plans to deal with the fish that were fed the contaminated 
feed. Committee staff learned that China and Vietnam are also 
the major source of fish with dangerous levels of histamines 
due to improper storage.
    Another safety concern uncovered by the staff's fieldwork 
relates to seafood products and the manipulation of laboratory 
testing. As noted earlier, one of the questionable activities 
that FDA policy permits is for importers to become exempt from 
import alerts by having their product test negative in a 
private lab five consecutive times. Import alerts have long 
applied to Mercury and other heavy metal contamination in large 
fish. Tuna and other large fish, such as Mahi-Mahi and 
swordfish, with time accumulate mercury from contaminated 
water. Smaller fish have less time to accumulate such toxins.
    FDA laboratory staff warned committee staff that one of the 
schemes employed by importers to evade the import alert is to 
import five separate entries of smaller fish from a certain 
country or importer covered by an import alert to more easily 
pass the private laboratory testing. Once their import alert 
status is removed, they can return to importing larger 
varieties of fish. One FDA San Francisco laboratory seafood 
expert told committee staff that over half of the swordfish on 
American tables would likely fail mercury testing because of 
this scheme.

             Carbon Monoxide Processing Masks Decomposition

     Committee staff learned from its field interviews that 
large numbers of seafood imports from Asia are arriving in 
airtight packages containing significant concentrations of 
carbon monoxide. Carbon monoxide treatment makes seafood appear 
fresh, regardless of its condition. In San Francisco, the staff 
learned that fully 20 percent of the fish tested that were 
imported in a carbon monoxide environment were rejected because 
of decomposition or histamine contamination. Based upon its 
investigation, the staff believes that this problem is not 
unique to San Francisco, but is widespread throughout the 
Nation.
     The issue of using carbon monoxide to manipulate the 
appearance of food products is not new. For example, Chairmen 
Dingell and Stupak, along with a number of food safety experts, 
questioned the safety of meat and fish packaged in an 
environment containing carbon monoxide with the FDA 
Commissioner and the HHS Secretary last year. In response, FDA 
assured them that there was no health concerns associated with 
artificially disguising the color of meat with carbon monoxide.
     Since then, the committee has sought from FDA any records 
regarding problems with seafood imports, generally, and those 
packed in atmospheres containing carbon monoxide, specifically. 
Although both Majority and Minority staff were shown such 
records in the field by concerned FDA inspectors, none of the 
documents examined or discussed during two staff visits to San 
Francisco have been delivered to the committee to date.\4\
---------------------------------------------------------------------------
    4 FDA has furnished the committee with documents reflecting their 
refusing entry to nine shipments of fish packed with carbon monoxide 
because of decomposition so far this year in the port of New York, but 
not the records in San Francisco or elsewhere. Given the paucity of 
testing done by FDA in general, even these records from one port 
demonstrate a troubling number of harmful entries disguised by this 
FDA-approved method.
---------------------------------------------------------------------------
     The problems involving packaging fish in an environment of 
carbon monoxide raise additional questions about FDA's approval 
of this process as GRAS (Generally Recognized As Safe) for food 
products. In San Francisco, the staff was told that the entry 
of decomposed fish packed in an atmosphere of carbon monoxide 
dates back to the 1990s. The problem reached such a level of 
concern in 1999 that FDA issued an import bulletin, advising 
inspectors to watch out for tuna packed in carbon monoxide.
     Despite the import bulletin issued in 1999, in 2001, the 
Center for Food and Applied Nutrition (CFSAN) approved the 
retail sale of tuna treated with carbon monoxide as GRAS. 
Technically, the CFSAN approval was for tuna packaged in 
``tasteless smoke,'' a packaging atmosphere containing carbon 
monoxide that, in fact, does not cure the fish, but merely 
preserves the color indefinitely like any other carbon 
monoxide-containing airtight packaging. The GRAS determination 
was made by FDA, despite the fact that the European Union bans 
this dangerous and deceptive practice. Although FDA has 
subsequently cancelled the import bulletin, the staff was told 
by FDA field officials in San Francisco and New York that the 
spoilage problem with carbon monoxide-treated fish has not 
abated.
     Despite these events, in 2004, FDA accepted petitions 
regarding meat packaged in carbon monoxide as GRAS. This 
decision permits meat that is well past the time when it is 
safe to consume to appear as red and fresh as when it was first 
packaged. The committee is in the process of trying to 
determine exactly what CFSAN analysts knew about the problem 
with decomposed fish, when they permitted both fish and meat 
packaged in an atmosphere of carbon monoxide to be sold to 
unsuspecting consumers.

           Poisoned Toothpaste Highlights Additional Problems

     While not a food per se, FDA handling of the toothpaste 
from China laced with diethylene glycol (DEG) is demonstrative 
of several shortcomings of FDA's handling of imports. In 1997, 
FDA witnessed 88 deaths in Haiti from cough syrup laced with 
diethylene glycol, the chemical most often found in antifreeze. 
The children's medicine was imported from China. The diethylene 
glycol was apparently substituted for the more expensive 
ingredient, glycerin. Last year, 100 people in Panama and 5 
people in China died from ingesting medications contaminated 
with this same chemical. This year, toothpaste imported from 
China into the United States and seven other countries has been 
found to contain this poison.
     It was not until June 7, 2007, however, that FDA issued an 
import alert to detain, on the importers'' premises, toothpaste 
containing DEG and named several Chinese exporters of the 
product to the U.S. The import alert was amended to include 
toothpaste packaged with toothbrushes after the San Juan FDA 
District decided, on its own authority, to inspect retail 
stores and discovered the presence of diethylene glycol in 
products that combined toothbrushes with the deadly toothpaste. 
Their investigation revealed that this combination product was 
still entering the U.S. market because brokers were declaring 
the shipments as brushes, not toothpaste.
     Counterfeit Colgate-brand toothpaste, labeled as 
originating from South Africa, that may contain DEG was also 
discovered during this investigation. Its true country of 
origin is in doubt. Pictures of some of the toothpaste entries 
from San Juan are attached.
     Committee staff has learned that the San Juan FDA 
laboratory is no longer permitted to analyze food samples--even 
though Puerto Rico, as an island, imports most of its food. 
Thus, FDA now requires that samples of fresh produce that 
regularly contains illegal concentrations of pesticides from 
the Dominican Republic must be shipped to Atlanta for analysis.

2. FDA's Proposed Reorganization of its Field Staff would Likely Expose 
 Americans to Even More Danger from Unsafe Food, particularly Imported 
                                  Food

             No Justification Given for Major Reorganization

     FDA has announced its intentions to conduct a sweeping 
reorganization of its field operations in the midst of probably 
one of the most serious assaults upon food safety since the 
Agency's creation. FDA proposes eliminating 5 current regional 
offices and reduce the districts from 20 to 16. The district 
offices to be eliminated in the consolidation are San Juan, 
Northern New Jersey, Cincinnati, and either Denver or Kansas 
City. As part of its reorganization plan, FDA is also proposing 
to close 7 of its 13 laboratories. These include Detroit, San 
Francisco, Denver, Kansas City, San Juan, Philadelphia, and 
Winchester, Massachusetts.
     Despite repeated requests from the committee, FDA has 
failed to provide any analysis justifying this radical 
reorganization. FDA has failed to provide us with any 
independent cost-benefit analysis for their proposal. The 
rationale for choosing which districts to close is not 
discernable from the documents supplied to the committee. 
Decisions regarding district closures appear to be related, in 
part, to prospective retirement or current vacancies among 
District Directors.
     On the surface, the proposed closings appear to be 
counterproductive and may needlessly increase taxpayers'' 
costs. For example, even though a very high percentage of drug 
manufacturing occurs in San Juan and New Jersey, FDA is 
proposing the closure of these offices and laboratories in 
Philadelphia and San Juan. The Puerto Rico closures will 
transfer oversight of drug inspections to the Orlando, Florida, 
District Office and testing to the Atlanta laboratory. 
Gathering relevant personnel will either result in tremendous 
additional expenses or, more likely, less enforcement.
     Committee staff was told that among the more indefensible 
parts of the reorganization proposal is the consolidation of 
the compliance function into 10 locations. This means, for 
example, that compliance recommendations regarding Agency 
action from a San Francisco inspection will be applied in 
Seattle. Compliance officers make decisions regarding which 
shipments to inspect, which to sample, and what actions should 
be taken in response to the inspection findings. No compliance 
officer that staff questioned thought having the Compliance 
Director located in a separate office made sense. It would 
appear that this proposal would make the decision to take 
regulatory action--an already cumbersome task--even more 
difficult.
    FDA is also proposing to consolidate the entry review 
function into six locations. Under the current program, a very 
high percentage of import review is already conducted at 
headquarters. As previously mentioned, the OASIS system 
currently removes 80 percent of so-called ``low risk'' imports 
from any field inspection. Thus, a very high percentage of food 
entries are not examined by inspectors at the port who are best 
positioned to judge the bad actors, the importers that cheat, 
the brokers that misclassify, and imported products that arrive 
in unusual locations. Under the new consolidation, those port 
inspectors will be totally removed from the identification 
process. All decisions concerning such inspections will be 
decided at the six designated locations, not in the field. 
Committee staff was told that this consolidation is equivalent 
to having bureaucrats in Washington and a few regional 
locations determine the assignments for the local police 
forces.
     Likewise, the committee staff was told that it would 
appear that the retirement of the District Director in Denver 
has prompted a decision to split the Kansas City District and 
move Denver into the District with Kansas and Nebraska, and 
placing Iowa and Missouri in the Chicago District. Given the 
character of the primary regulated industries in those States, 
it is difficult to understand how splitting up a District that 
requires experts in veterinary medicine and animal feed 
industries (and now apparently pet food as well) would be 
productive.
     The rationale for closing more than half of FDA's 
laboratories, at a time when food safety is considered a public 
health crisis, is not discernible from the records provided to 
the committee. The ostensible rationale is that there are a 
limited number of laboratories that FDA can maintain at a 
world-class level. Since FDA has not provided an analysis 
demonstrating any cost-savings associated with the lab 
closures, their rationale implies that synergies exist in mega-
labs; however, no documents have been produced by FDA to 
support that suggestion. When the Government Accountability 
Office examined this question, they found that midsize labs 
were more efficient.
     Committee staff was informed by FDA field staff that there 
will be a tremendous loss in experience as laboratory analysts 
retire or resign, rather than be relocated. In addition, recent 
history suggests that it will be extremely difficult to replace 
the scientists necessary to conduct high-level laboratory 
activities. When FDA closed labs in 1994, only 17 percent of 
the affected laboratory analysts elected to transfer. Under the 
current lab closure proposal, only two analysts in San 
Francisco, one in Denver, two in Massachusetts, and six in 
Kansas City have indicated that they may accept a transfer to 
another lab. Hence, a significant level of expertise is 
expected to be lost.
     Also, taxpayers will not benefit from the substantial sums 
of money FDA has recently spent accrediting these labs, signing 
new leases, and rebuilding or refurbishing offices that they 
now propose to close. For example, the staff noted that the 
food laboratory equipment, and all but one of the lab 
structures visited, appear to be modern with long-term leases 
or outright ownership at each location.
     FDA was given 4 months to produce the documents relating 
to the lab closures. Prior to last week, FDA has produced only 
four boxes of paper. Each production included an assurance that 
the production was essentially complete. The early document 
productions were noteworthy for the absence of internal 
documents critical of the reorganization and documents from the 
field.
     More importantly, FDA has not furnished the committee with 
documents that suggest the Agency has any plans to hire 
personnel with equivalent skills at its new locations. In fact, 
the experience it claims will be replaced cannot be duplicated 
by new hires over a reasonable period of years. Many of the 
laboratory employees are renowned in their fields.
     The staff was repeatedly told that the only credible 
explanation for this seemingly incredible decision is that the 
Office of Regulatory Affairs management intends to contract out 
the work. The staff was told, however, that State labs will not 
purchase the millions of dollars in equipment and hire the 
necessary analysts unless there is an expectation that the 
transferred work will be permanent. Private laboratories have 
the drawbacks noted previously.
     The critical question of how the work of half of FDA's 
current labs is to be performed after they are closed remains 
unanswered by FDA reorganizers. It is difficult to avoid the 
conclusion that, in fact, FDA management has decided to 
drastically reduce the sample analyses performed in its own 
labs and to contract out the remainder.

           Labs Due to Be Closed Possess Unique Capabilities

     The committee staff was able to visit all of these labs, 
except for Philadelphia, in the course of the subcommittee's 
investigation and questions the justification for such drastic 
actions, especially in light of the recent recalls and import 
alerts. Two of the labs visited by staff, Detroit and San Juan, 
are almost exclusively devoted to analyzing drugs. Detroit has 
been an important food lab given the volume of food imported 
over the Ambassador Bridge from Canada. In this regard, it is 
important to note that while Canada has a comparable regulatory 
system, not all imports crossing the border into Detroit 
originate in Canada.
    FDA has limited most of the Detroit laboratory's work to 
``drug stability analysis,'' which involves testing related to 
Government stocks of drugs. The staff has been advised by the 
Department of Defense that such activity saved the Government 
$600 million last year, or about one-third of the total FDA 
budget--a very profitable endeavor for the United States 
Government. The drug stability work was performed by eight 
full-time equivalents (FTEs) in Detroit and three FTEs each in 
Philadelphia and San Juan.
    It should be noted that 60 percent of U.S. pharmaceuticals 
are manufactured in Puerto Rico. Many of the inspections cannot 
be done without a laboratory analyst. Most of the private 
sector laboratory employees are far more comfortable explaining 
their work in Spanish. If the seasoned laboratory staff 
currently in Puerto Rico is lost, FDA will be forced to find 
comparably skilled bilingual chemists and, once trained, and 
pay their travel expenses to Puerto Rico. It should be noted 
that many inspections of drug manufacturing take longer than 
the FDA estimate of 5 days.
     Committee staff was initially sent to these laboratory 
locations to examine the work that FDA had done in the melamine 
investigation. Only Kansas City, a laboratory in the heart of 
the pet food and animal feed industries, was allowed to analyze 
food and feeds for melamine.
     Although the Kansas City lab has done yeoman's work, 
analyzing more than 400 samples in a little over 6 weeks time, 
it was not the only FDA lab capable of performing this work. 
Notwithstanding their capability, however, it appears that, for 
unexplained reasons, other FDA labs due to be closed under the 
proposed reorganization were denied the $20 standard test 
needed to detect melamine and were forbidden to analyze samples 
of pet food, vegetable proteins, or other materials that may 
have been contaminated by Chinese imports. Instead, the Agency 
spent some fraction of the $2.6 million in Food Emergency 
Response Network grants to pay some or all of the eight 
university laboratories that have cooperative agreements with 
FDA to complete testing. To what extent the results of these 
laboratories could be used in court is problematic, given the 
chain of custody issues raised by a number of FDA officials 
during the course of the committee's investigation.
     At best, this was a decision to waste Federal tax dollars, 
since the work was contracted out to State and university 
laboratories when in-house was available to perform at least 
some of the work. Moreover, there are indications that this 
type of out-sourcing is ineffective. It was an outside 
laboratory that first pronounced the contaminant in pet food as 
rat poison. The Cincinnati and Kansas City FDA laboratories 
discovered the melamine and developed the methods for 
detection. The Denver lab developed the method for analyzing 
melamine in fish.
     Kansas City, like other FDA labs, was the beneficiary of 
modern equipment and an expanded work force 5 years ago as part 
of the ramp-up decreed by Congress in the Bioterrorism Act. It 
is a centerpiece for rapid analysis of threats to our food 
security. Nevertheless, and again for no apparent reason, 
Kansas City has been identified for closure.
     The staff investigation also highlighted the importance of 
the San Francisco lab in dealing with unsafe imports, 
especially from the Far East, and with domestic issues related 
to the Salinas Valley. That laboratory has been a significant 
force in the interdiction of problematic seafood. The staff was 
told that FDA lab analysts are regularly recruited by FDA 
investigators to conduct pre-dawn inspections of seafood 
importers and processors because of their experience and 
training in identifying problem seafood. Committee staff 
learned that the lab's reputation for effectiveness is so well 
known that many unscrupulous importers of farm-raised shrimp 
and other fish are now sending their questionable products via 
air or ``in bond'' to be ``entered'' in Las Vegas, in part to 
avoid the scrutiny that the seafood would face in San Francisco 
and the other West Coast seaports.
     Both the State of California and FDA inspectors involved 
in the produce investigation told committee staff that the 
closure of the San Francisco lab would be a great loss to the 
California Food Emergency Response Team. Committee staff were 
told that laboratory analysts are often needed to go into the 
field with investigators. These officials feared that this 
would be unlikely if the lab were closed. They warned of a 
significant loss of expertise.
    Officials also advised the staff that it is crucial to have 
a local lab to analyze the samples. It takes less than 2 hours 
to get to the San Francisco lab from the Salinas Valley. The 
time it takes to get samples from the field to the lab is 
crucial because enrichment of the samples must be complete 
within 24 hours. If samples had to be shipped, it is likely 
that enrichment would not be timely. Further, samples cannot be 
shipped on the weekend. The FDA officials told committee staff 
that when samples are collected on the weekend, San Francisco 
provides an analyst in the lab. Another concern regarding 
samples that must be shipped is that they are temperature 
sensitive. The San Francisco lab puts a priority on analyzing 
produce and fish samples collected and warned that other labs 
may assign priority to the collections of investigators in 
their own District.
     The San Francisco lab employs a seafood sensory expert 
inspector with such unique skills that he appears to be the 
only FDA employee qualified to identify where to take samples 
in seafood shipments. In addition, State officials indicated 
their concerns that outbreaks in California involving produce 
will overwhelm the five microbiologists in the State lab, if 
San Francisco is shut down, and other labs are too distant to 
effectively analyze lettuce or spinach produce.
     Committee staff also learned that the Winchester 
Engineering and Analytical Center (WEAC) in Massachusetts is 
the only FDA lab that performs radionuclide analysis on food. 
This means that the WEAC lab is the only facility that has full 
analytical capability and expertise in detecting radiological 
contaminants in food products. Over 350 samples per year are 
analyzed for radionuclides in food. Analysis is done on both 
imported and domestic food, with domestic foods being analyzed 
the majority of the time. During and after the Chernobyl 
disaster and the Three Mile Island Accident, WEAC performed 
radionuclide analyses on food and ensured that the Nation's 
food supply was free from radiological contamination. WEAC's 
analytical capabilities and expertise are relied upon by 
Federal, State, and local governments for the investigations of 
food safety violations linked to radiological incidents.
     WEAC is part of the Food Emergency Response Network 
(FERN). FERN is a network of Federal and State labs that is 
responsible for analyzing food samples in the case of a 
biological, chemical, or radiological attack. WEAC's 
radionuclide section is the Lead Project Coordinator for the 
radiological component of FERN. In the event of an emergency, 
WEAC has emergency response responsibilities. WEAC is the sole 
FDA laboratory for radionuclide analysis in the event of a 
nuclear disaster and/or counterterrorist event. WEAC has a 
memorandum of understanding with USDA/Food Safety and 
Inspection Service, whereby WEAC would analyze USDA regulated 
products for radiological contamination as part of an emergency 
related to an actual or threatened act of deliberate 
contamination of the food supply. WEAC also will assist New 
England in the radionuclide analysis of food samples collected 
as part of an emergency. WEAC performs other FERN activities as 
well. WEAC is conducting counterterrorism food research at the 
University of New Hampshire due to a concern that the Plague 
bacterium might be used to deliberately contaminate the 
Nation's food supply. WEAC is evaluating a capture system in 
the hope that more laboratories might be capable of isolating 
and identifying the bacterium.
    The Denver lab is also a member of FERN. The Denver lab is 
the only full-service FERN laboratory slated to close under 
ORA's current plan. Six analysts at the lab currently are 
assigned to FERN work. The Denver FERN lab specializes in the 
analysis of cold sterilants used to decontaminate pathogens 
such as anthrax. The only other FERN lab that performs this 
type of work, WEAC, is also listed for closure.
     The Denver lab is also home to the Animal Drug Research 
Center (ADRC). While one or two other individuals within FDA do 
the same type of work as ADRC, no other lab has a center 
dedicated to the work. ADRC is staffed by three research 
chemists with doctoral degrees in analytical chemistry. None of 
these three doctors would transfer were the Denver lab to 
close. ADRC develops methods to detect animal drug residues in 
animal and seafood tissues and in products such as milk and 
honey. In the past 15 years, ADRC has developed methods for 
over 30 drug residues in fish and shellfish. The methods that 
are developed and validated by ADRC are then transferred to 
regulatory programs within FDA and to State, Federal, and 
international laboratories. ADRC is responsible for developing 
more than 60 percent of all seafood testing methods used by 
FDA. As noted earlier, ADRC recently developed a method for 
detecting melamine in fish tissue--a procedure the Center 
developed in only 4 days.
     The Denver Lab also has a Veterinary Drug Section. This 
section is responsible for analyzing products for illegal 
residues of various drugs, fungicides, and growth promoters. 
Animal feeds, farmed fish, seafood products, dairy products, 
honey, and a variety of other products are all analyzed at the 
lab. The Denver lab is the only FDA lab to have a section 
devoted to testing animal feeds and is the only lab to test 
milk for antibiotics. Analysts in the section average 22 years 
of experience and the section has two GS-13 Specialists.
     Other areas of expertise in the Denver lab include the 
following: a BSE (Mad Cow Disease) team; a Salmonella Serology 
Team that identifies organisms found in foods and animal feeds; 
and an Antibiotic Resistance Team that analyzes the 
susceptibility of organisms to antibiotics to track trends of 
antibiotic resistance. The Denver lab has a National Salmonella 
Expert and is the only FDA lab performing antibiotic resistance 
testing. Other food work that the Denver lab performs includes 
a variety of procedures to detect pathogens in domestic and 
imported food and filth detection.

 The Spinach and Peanut Butter Food Poisoning Outbreaks May Highlight 
        FDA Flaws in Voluntary Compliance Approach to Regulation

     The recent outbreaks of E. coli 1057H7 in spinach, the 
Tennessee strain of salmonella in peanut butter, and melamine 
contaminated pet food were highlighted at the committee hearing 
on April 24, 2007. The hearing featured the testimony of 
victims of the food poisoning and the companies responsible for 
processing the contaminated food.
     Committee staff was asked to analyze the two domestic 
incidents to understand their regulatory implications. In doing 
so, the staff visited both San Francisco and Atlanta and 
interviewed FDA personnel involved with inspection of the 
Natural Selections plant that shipped the contaminated spinach 
and the ConAgra plant that shipped the contaminated Peter Pan 
peanut butter.
     The staff investigation raises questions about the 
adequacy of FDA's regulatory approach to both domestic and 
imported food. Except for four food groups--fish, citrus juice, 
low-acid canned foods, and infant formula--FDA relies almost 
entirely on the voluntary efforts of domestic food processors 
to self-police their activities. Many industry experts and FDA 
staff insist that recent events require a different approach 
from FDA in the future.
     Committee staff learned that produce from the Salinas 
Valley of California has been the source of 10 food poisoning 
outbreaks over the past 11 years. FDA officials attributed the 
increase in outbreaks of contaminated spinach, and other leafy 
greens to a variety of reasons: changes in the diet of 
consumers, widespread distribution of produce around the 
country and world, larger lots of produce, and increased 
reporting and better tracking of outbreak statistics.
     The staff was told that FDA has refused to issue binding 
rules for the production and processing of fresh produce. 
Ironically, because of the serious serial outbreaks, some in 
the California produce industry have sought compulsory rules, 
but FDA still insists on only issuing voluntary guidelines. The 
most recent guidelines do not provide guidance for testing 
protocols.
     The California Department of Food and Agriculture does 
have a Marketing Agreement for the industry (http://
www.cdfa.ca.gov/mkt/mkt/pdf/lgph--agreement.pdf). Apparently, 
90 to 95 percent of the total volume of leafy greens produced 
in California is covered by the agreement. Buyers may only 
purchase produce from certified growers/producers. Being too 
close to a ranch or a stream and various other factors are 
reasons a grower would not be certified. Audits are performed 
and a certification stamp appears on the packaging of 
qualifying products.
     Investigators and compliance personnel in San Francisco 
advised committee staff that until compliance with good 
agricultural practices is mandatory, nothing will change. 
Likewise, they told the staff that FDA must be more forceful in 
demanding access to sites and records in the course of their 
inspections.
     Committee staff learned that during inspections, prior to 
the spinach outbreak last fall, Natural Selections had refused 
to supply test results. The staff was informed in late May 2007 
that the firm had not followed its own Standard Operating 
Procedures (SOPs) in that it used recirculated water that was 
not sanitized prior to its reintroduction into the production 
process Apparently, Natural Selections added chlorine, by hand, 
whenever the operator thought it necessary, rather than 
employing an automated injector. Further, the individuals 
employed as quality assurance analysts were not professionally 
trained and did not have scientific credentials. While the 
staff was informed of the aforementioned regulatory breach, we 
were told that the Establishment Inspection Report (EIR) of 
Natural Selections spinach investigation was not complete, 
despite that fact that CalFERT issued its report on March 21, 
2007.
     The inspectors were also hampered by the firm's refusal to 
permit photographs. Inspectors apparently found mold and other 
evidence of improper sanitizing in tubing and nooks and 
crannies of processing equipment. Produce investigations are 
hampered by the lack of mandatory good manufacturing practices 
and the right to examine test data and other records. 
Fortunately, the State of California has authority that FDA 
lacks, so they are a regular source of information and 
cooperation.

                             Peanut Butter

     A similar lack of aggressiveness on the part of FDA may 
have contributed to the peanut butter contamination deaths and 
illnesses. At the April 24, 2007, hearing, the committee 
learned that FDA received a tip from a former ConAgra employee 
that salmonella was found in the company's finished product 
testing on 2 days in October 2004. When FDA sent an inspector 
into the plant in February 2005, ConAgra refused to supply him 
with the October 2004 microbiological testing records except 
for 2 days that showed no contamination. The company claims 
that its plant management merely followed company protocol and 
asked that the request be submitted in writing.
     When interviewed, the FDA inspector did not recall that 
ConAgra agreed to supply the records upon written request, and 
the request is not noted in the Establishment Inspection 
Report. The inspector concedes, however, that such a request 
would have been a common occurrence for CongAgra and other food 
processors.
     Subsequently, committee staff learned that it is FDA 
policy not to request such records in writing. Section 703 of 
the Federal Food, Drug, and Cosmetic Act provides that if a 
firm supplies records in response to a written request, they 
cannot be criminally prosecuted for the information contained 
in such records. Large food processors understand this 
provision and have policies, such as ConAgra had in place in 
2005, that dictate test results and other critical records such 
as the Standard Operating Procedures (SOPs) for plants only be 
furnished to FDA in response to a written request. ConAgra 
announced a change in policy shortly before they testified on 
April 24, 2007.
     In an attempt to understand why FDA does not routinely 
request such critical records in writing, particularly when a 
threat to the public health has been alleged and/or when the 
failure to obtain such records results in a NAI (No Action 
Indicated) for an investigation, the committee staff directed 
the question to officials in Atlanta, Kansas City, San 
Francisco, and ORA headquarters. The field inspection manual 
only provides that an investigator obtain his or her 
supervisor's permission to request records in writing. In 
practice, any such request would go to the District Director. 
Inspectors told committee staff that most often they had never 
heard of such a request being approved or, if they had heard of 
such an approval, it was a ``once in a career event.''
     Committee staff was told in San Francisco that if an 
allegation were received regarding such a serious health threat 
as salmonella being found in testing and the lot destroyed, as 
was the case in the 2004 Peter Pan peanut butter case, they 
would notify the State of California, who would acquire the 
records under separate authority. This was not described as the 
usual practice elsewhere.\5\
---------------------------------------------------------------------------
    5 When CDC traced the food poisoning outbreak to Peter Pan Peanut 
Butter last winter, ConAgra shut down the plant and FDA went in for 
another inspection. FDA withheld the inspection report from the 
committee, claiming that the inspection was still on going. During the 
Atlanta visit, committee staff was provided with a copy of the EIR for 
the plant inspection from February 14, 2007, through March 2, 2007. In 
fact, this EIR was approved on April 10, 2007, 2 weeks before the April 
24, 2007, hearing. ORA headquarters was upset that the committee 
obtained the report even well after the hearing. Atlanta also furnished 
the staff with the lab results of the peanut butter jars obtained from 
the ConAgra inventory during and after the inspection. The FDA lab 
analysis found 14 out of 130 jars tested were contaminated with the 
Tennessee strain of salmonella.
---------------------------------------------------------------------------
    ConAgra maintained that their micro testing had not turned 
up any salmonella since the October 2004 results. When 
confronted with the outbreak phenomena, the company blamed a 
roof leak in late July or early August as the source of the 
contamination. The positive FDA test results, however, involved 
lots of peanut butter with production dates as late as January 
2007. This EIR and test results indicate that the problem was 
not related to a finite period of time. More importantly, the 
fact that ConAgra did not detect the salmonella in their in-
house testing suggests that the testing protocol was not 
sufficiently sensitive.
     With the exceptions of the four food categories noted 
above, FDA has no rules governing testing protocols, record 
retention, SOP adequacy, manufacturing, quality assurance and 
control, or the right to examine any records that a food-
processing firm chooses to keep voluntarily. While the impact 
of the absence of effective regulation is more obvious in fresh 
produce, the staff learned that even fully-processed foods such 
as peanut butter can be a threat to the public health when 
voluntary controls fail.

                               Conclusion

     It is important to stress the preliminary nature of these 
findings. As of the writing of this testimony, the committee 
has not yet received all of the documents requested from FDA. 
Some of these requests are nearly 6 months old. In addition, 
committee staff has not had the opportunity to fully explore 
new technologies or industry proposals potentially available 
for better food safety, or to fully explore FDA's international 
program and the unique challenges and opportunities that it may 
face both logistically and politically.
                              ----------                              

    Mr. Stupak. I thank the gentleman for his statement. In 
order to proceed in a more orderly and efficient manner, each 
member will be recognized for 5 minutes. We will more than 
likely go more than one round with this panel. Mr. Wilfong, if 
I may, have you had an opportunity to review the report, 
provide input, and review the final product as submitted here 
as a staff report?
    Mr. Wilfong. Yes, I have.
    Mr. Stupak. Same with you, Mr. Barstow?
    Mr. Barstow. Yes, I have.
    Mr. Stupak. OK. Mr. Nelson, if I may, you had a chance to 
visit Puerto Rico district lab in San Juan?
    Mr. Nelson. Yes, we did.
    Mr. Stupak. OK, did you see any counterfeit toothpaste 
there?
    Mr. Nelson. We did and in----
    Mr. Stupak. Exhibit 62, 63, 64, 65. Is that correct?
    Mr. Nelson. That is correct.
    Mr. Stupak. We have those up on the chart?
    Mr. Nelson. That is correct, and the members should have 
them in their folders as well.
    Mr. Stupak. And this toothpaste contained diathyline 
glycol?
    Mr. Nelson. That is correct.
    Mr. Stupak. OK, and I am going to ask that exhibit No. 63 
be put up, and I want the toothpaste--did you see the 
combination toothpaste and toothbrush kits?
    Mr. Nelson. Yes, and initially after the FDA put out its 
initial import alert only dealt with toothpaste, and what the 
San Francisco office found, because they went on a sweep with 
the commonwealth of Puerto Rico's health officials----
    Mr. Stupak. OK, I am going to interrupt you there. They put 
out an alert for toothpaste containing the diathyline glycol, 
right?
    Mr. Nelson. Right.
    Mr. Stupak. OK, then what happened to get around this 
alert?
    Mr. Nelson. The importers were entering the combination 
toothpaste and toothbrush as toothbrushes, and therefore they 
weren't being detained.
    Mr. Stupak. So if they had the toothpaste with the 
toothbrush attached, they would call it toothbrush. Therefore 
they avoided the FDA's import alert?
    Mr. Nelson. Initially that is true until the Puerto Rican 
FDA, the office in San Juan discovered the fraud.
    Mr. Stupak. All right, now, have the combinations been 
recalled or an import alert issued on----
    Mr. Nelson. Yes, they are not covered.
    Mr. Stupak. OK, because there has also appeared in my 
district in Penn County, MI, these combinations like this has 
also been. Where would these products be found?
    Mr. Nelson. In small stores. In the U.S., they are called 
dollar stores, and actually I think that is a trade name. In 
Puerto Rico, you don't have big Wal-Marts, K-marts, Safeways. 
Food and drugs are purchased in relatively small stores, and so 
there is a lot of them. And the Puerto Rican authorities did a 
good job in trying to get this stuff out of those stores.
    Mr. Stupak. But they are not just confined to Puerto Rico. 
They are found throughout the country.
    Mr. Nelson. Throughout the country. Yes, sir.
    Mr. Stupak. OK, Mr. Barstow, if I may, explain a little bit 
more about the FDA import alerts, specifically where you first 
learn of import alerts with the detention of the wheat gluten. 
And that import alert was issued on April 27 regarding the 
vegetable proteins wheat gluten, and then an import alert was 
issued on July 10 regarding certain farm-raised fish from 
China. Both of these are import alert. Is correct?
    Mr. Barstow. Yes, they are.
    Mr. Stupak. The word detention, because in import alert, it 
says ``detention without physical examination'' correct?
    Mr. Barstow. Correct.
    Mr. Stupak. The word detention, does it actually mean that 
the FDA detains the product?
    Mr. Barstow. No, it does not.
    Mr. Stupak. What does it mean?
    Mr. Barstow. It means that the FDA allows the product to be 
shipped to the importer. The importer then hires a private 
laboratory to test the product.
    Mr. Stupak. OK, so the private lab then tests the product, 
correct?
    Mr. Barstow. That is correct.
    Mr. Stupak. Is there any way for a firm to free itself from 
requirement of having its products tested?
    Mr. Barstow. Yes, there is.
    Mr. Stupak. How does it go?
    Mr. Barstow. If a firm has five consecutive clean test 
results that are released by the FDA, then they are not subject 
to the requirement any longer.
    Mr. Stupak. OK, then after five tests, is it automatically 
lifted, or does the FDA lift the import alert?
    Mr. Barstow. The import alert stays, but that firm who was 
exporting the goods into the United States is no longer subject 
to having their products tested.
    Mr. Stupak. OK, you had the opportunity to visit some of 
the FDA field labs. Is that correct?
    Mr. Barstow. Yes, I did.
    Mr. Stupak. Which labs did you visit?
    Mr. Barstow. I visited the San Francisco district 
laboratory, the Denver district laboratory, the Winchester 
Engineering and Analytical Center, and the Northeast Regional 
Lab in New York.
    Mr. Stupak. At these labs, were you able to speak with FDA 
lab analysts regarding the private lab work?
    Mr. Barstow. Yes, I was.
    Mr. Stupak. What did you find out from speaking with these 
analysts?
    Mr. Barstow. Well, every analyst I spoke to about this 
issue on private laboratories was very critical. I can think of 
one deputy lab director who performs private lab reviews said 
that none of the testing results are completely accurate that 
he has seen. I think he used the words ``not good'' and 
``spooky''.
    Mr. Stupak. OK, and these very private labs are responsible 
for analyzing dangerous and potentially deadly food that enters 
into the country?
    Mr. Barstow. That is correct.
    Mr. Stupak. Does the FDA accredit these labs?
    Mr. Barstow. No, they do not.
    Mr. Stupak. Did this deputy laboratory director, does he go 
through and inspect these private labs?
    Mr. Barstow. No, he doesn't.
    Mr. Stupak. Does the FDA debar, so to speak, or prevent 
certain labs from performing tests on food coming into the 
United States?
    Mr. Barstow. No.
    Mr. Stupak. So these private labs are free without any kind 
of accreditation, review of procedures, process, or anything 
from the FDA?
    Mr. Barstow. Yes.
    Mr. Stupak. OK. Well, my time is up. I still have many more 
questions. We may come back for a second round. I next turn to 
Mr. Whitfield for questioning please.
    Mr. Whitfield. Thank you, Mr. Chairman. And, Mr. Nelson, in 
our hearing binder, you have already referred to a number of 
pages regarding toothpaste, and these toothpastes were 
discovered in Puerto Rico. But all of them came from China. Is 
that correct?
    Mr. Nelson. Well, you have pictures there of the Crest 
knockoff that is called ``Crust''. The Colgate knockoff is 
called ``Colgate'', and the country of origin on the tubes--
remember these were pulled from shelves. They were pulled from 
store shelves. They weren't pulled out of an import shipment 
coming in. The country of origin is listed as South Africa. 
Colgate/Palmolive tells us that they do not produce in South 
Africa that size of tube, and it is suspected that they have 
come from China.
    Mr. Whitfield. So it is suspected, but we don't have proof 
that it came from China?
    Mr. Nelson. No.
    Mr. Whitfield. But we do have some verification that some 
toothpaste recently came from China.
    Mr. Nelson. Yes, all the rest of the pictures shows 
toothpaste that was imported from China.
    Mr. Whitfield. And in this toothpaste, there was actually 
diathyline glycol in the toothpaste?
    Mr. Nelson. There was diathyline glycol largely replacing 
the glycerin that is a more expensive component in things like 
cough syrup and toothpaste.
    Mr. Whitfield. So it could simply be manufactured more 
cheaply?
    Mr. Nelson. That is right.
    Mr. Whitfield. And yet the diathyline glycol obviously is 
harmful to people?
    Mr. Nelson. It is antifreeze.
    Mr. Whitfield. Yes, it is antifreeze. Now, how did you 
first discover this? It was brought to your attention by 
merchants in Puerto Rico?
    Mr. Nelson. Well, the initial attention was spurred by 
pressure ports and then FDA's import alerts.
    Mr. Whitfield. OK. Now, in your testimony, you also stated 
that the Center for Food and Applied Center for Nutrition, that 
they had known for some time about the carbon monoxide 
processing of meat and fish and the problems that arise from 
there, that they had known about that for years. Is that 
accurate?
    Mr. Nelson. FDA has known about that. We know for sure that 
the San Francisco lab has been finding about 20 percent of such 
fish imported that they have tested to be decomposed, and the 
carbon monoxide atmosphere to hide that decomposition. We have 
not received any of the documents that we have requested 
relating to carbon monoxide in fish, except for nine entries 
that have come in just this year and were rejected by the New 
York lab for decomposition.
    In 2001, the FDA went ahead and approved as GRAS, generally 
recognized as safe, the use of carbon monoxide atmospheres for 
retail sales of tuna.
    Mr. Whitfield. And why would they do that?
    Mr. Nelson. I have no idea. It is an ongoing inquiry. We 
don't have the documents from the FDA yet.
    Mr. Whitfield. And they designated the treatment as 
generally regarded as safe since when?
    Mr. Nelson. For fish, since 2001. For meat, since 2004.
    Mr. Whitfield. But we don't have any documentation on the 
reasons for that?
    Mr. Nelson. We have some documentation they supplied us 
last year when Mr. Stupak and Mr. Dingell, as the ranking 
members of this committee and subcommittee, wrote them. So they 
have delivered a few of the meat documents but none of the fish 
documents.
    Mr. Whitfield. Well, from your analysis and your 
investigation with minority staff and your staff, you only have 
about a minute left, but what would you say would be the three 
or four most important recommendations that you would make to 
this committee based on your investigation?
    Mr. Nelson. The investigation is very preliminary. One of 
the more immediate recommendations would be to stop the 
reorganization of the FDA that has been proposed. We have found 
in the documents they have supplied us no justification, no 
hard cost, no hard savings estimates that would show that the 
Government save money. A lot of indication that it would cost 
far more than it would save.
    More importantly, the structural changes that take place 
are not easily reversible. So if in the end the FDA decides 
that the experiment didn't work, the cost of returning to the 
status quo would be extraordinary.
    Mr. Whitfield. Mr. Chairman, my time is expired.
    Mr. Stupak. Thank the gentleman. Next Mr. Inslee for 
questions please.
    Mr. Inslee. Thank you. I would like to ask you first about 
the issue of leafy and green vegetables and these horrific 
injuries we have heard testimony about for some children and 
others coming out of places. There have been 10 outbreaks in 
Salinas Valley and others. And I am reading your staff report 
where you say that the staff was told that FDA has refused to 
issue binding rules for the production and processing of fresh 
produce. You go on to say that ``investigators and compliance 
personnel in San Francisco advised committee staff that until 
compliance with good agricultural practices is mandatory, 
nothing will change.''
    Now, do I take it from that that the word from the 
inspection people is that they believe we have got to have 
mandatory protocols for the inspection and processing of this 
material, or we are going to continue to have episodes of this 
E. coli damage to Americans. Is that correct?
    Mr. Nelson. To a person, yes.
    Mr. Inslee. You seem sort of unequivocal about that. You 
say it is to a person. We are hearing from the inspectors, the 
cops on the beat, and they are telling us that if we don't get 
mandatory requirements, people are going to continue to get 
sick. And you are telling me that was a unanimous opinion from 
the people on the beat?
    Mr. Nelson. Yes, during my discussions of produce with the 
San Francisco district, we probably had 20 people in the room 
that had some relationship to either the labs, the inspectors, 
the compliance personnel, and the management of the district. 
And they were all very concerned that issuing one more round of 
voluntary guidelines, which the FDA did in March, would have no 
real impact. In fact, we were told that the industry itself 
would prefer mandatory guidelines and that the agency has 
refused to issue such.
    When Mr. Barstow spoke with them, he actually spoke with 
the State inspectors as well.
    Mr. Barstow. Yes, I did, and they also agree with the FDA 
inspectors that there should be some sort of mandatory 
guidelines.
    Mr. Inslee. Well, I agree with them, and I think that the 
cops on the beat needs to be listened to in this regard. And 
Congress has got to mandate these, and it is just unforgivable 
to me that the administration refuses to move forward when 
there is such unanimity in their own enforcement staff and now 
it is increasingly in the industry as well to have mandatory 
protocols. So Congress is going to have to act if the 
administration is not, and we are prepared to do so, I think. 
Mr. Nelson?
    Mr. Nelson. One question that we have not examined that was 
just raised in a newspaper article--you may want to ask the 
third panel about this--was that FDA had gone to the Department 
of Health and Human Services with a proposal for mandatory 
rules. And it was rejected by higher levels in the Department 
of HHS.
    Mr. Inslee. Tell me again now which level was proposing it, 
and which level was rejecting it?
    Mr. Nelson. FDA was proposing it. The powers that be in the 
Department of Health and Human Services rejected it.
    Mr. Inslee. Well, that is disturbing given the depth of 
this injury to Americans and the obvious risk and the fact that 
we are on a path of failure. This is a known path of failure, 
and continuing on this path of failure makes no sense to me 
whatsoever. And it is regrettable that the administration will 
not act. If they will not act, we will. I will be proposing, 
with some of my colleagues, a proposal in that regard shortly.
    I want to ask you about the splitting of the compliance 
function. I was very impressed with the FDA inspectors 
themselves individually. I used to be regional director of HHS 
for the northwest region and got to know some of the FDA 
inspectors in the Bothell labs in Bothell, WA. And they showed 
me how sensitive their noses were, and really finding out if 
fish was unfit or not is pretty incredible sensitive 
instrument, the human nose.
    But tell me how it is going to work now that you are going 
to separate the decision for compliance between the inspection, 
the people right there who really know the traders, know the 
brokers, know this histories of these people, know the history 
of the product, and then send that decision somewhere else 
geographically across the country. It seems to me a very 
awkward and unmanageable proposal.
    Mr. Nelson. Well, it seems to us that way too. They are 
proposing to set up 10 regional offices that will handle the 
compliance function. In the case of the west coast, San 
Francisco's investigators will report to a compliance officer 
in Seattle. They are proposing even more drastic changes in 
their entry review process. Right now, the inspectors acting as 
an entry reviewer, reviewing the computer screens deciding 
which entries should be inspected, they don't determine that. 
They send that recommendation to a compliance officer who is 
looking at a national work plan that comes to them from 
Washington, and if that inspection of that kind of 
establishment or that kind of food entry fits within the work 
plan, then it is probably going to be inspected. If it doesn't 
we are told it takes an extraordinary justification to go out 
and inspect something outside of the work plan. That compliance 
officer is probably going to be Seattle and even further 
removed from the information that local officials have about 
local trade.
    Mr. Inslee. I don't think it is a good idea if cops on the 
beat are told if it is not in the work plan, they can't pay 
attention to a miscreant who is causing suspicion. And I trust 
these people. These people are pros. If we give them the 
resources and the authority, maybe they can do their jobs. 
Thank you.
    Mr. Stupak. Thank the gentleman. Next ranking member of the 
committee, Mr. Barton of Texas, please.
    Mr. Barton. Mr. Chairman, I am not going to have any 
questions for this panel. I would hope that in the future, 
apparently for mechanical reasons we only have one of the big 
data notebooks, and I hope that we could get several more so 
that members could have them. I understand it was tough to get 
ready for this hearing, but I don't have any questions for this 
panel.
    Mr. Stupak. Point well taken. Next we will go to Mrs. 
Blackburn. Questions?
    Mrs. Blackburn. Thank you, Mr. Chairman. I do have just a 
couple of quick questions that I wanted to ask you all. 
Listening to your responses and the way the staffs deal with 
some of the technicalities in looking at the product and the 
items that are moving into the consumption check here at the 
U.S., I was curious about the district labs and the 
attentiveness of the staff to the issue and wanted to see have 
they begun to develop their own best practices?
    Are they developing mechanisms where they taking the 
initiative in this and coming up with their own criteria, or 
are they waiting for that to be handed to them from Washington? 
So are they taking the lead, and what is their attitude? Are 
they adjusting their workload so that they are responding to 
the increase of imports? Or are they frustrated with it?
    Mr. Nelson. There is a lot of frustration. We visited two 
labs that are not proposed to be closed, Atlanta and New York. 
So it is not just the labs that are going down. One of the 
things that we learned is that an awful lot of methods for 
analysis for important things like melamine and fish are 
developed by the FDA labs, by the experts in the labs. They 
determine how you find what is food, and I suppose that other 
methods are developed in Washington by the Center for Food 
Safety and Applied Nutrition, but we weren't told that. It is 
an assumption on my part.
    The work plans for the labs though, what the labs are 
supposed to look at and which labs look at what things are 
dictated in Washington. They don't have an ability to 
independently determine what they look at, what kind of samples 
are there to analyze. It has to fit into a work plan that is 
sent to them on an annual basis, and their performance is rated 
entirely upon how close to that work plan they come.
    Mrs. Blackburn. OK, so they are functioning under a top 
down?
    Mr. Nelson. Yes.
    Mrs. Blackburn. Or a deductive approach to this, if you 
will. So their criteria is coming from Washington. The methods 
they are to use to evaluate the product is coming from 
Washington, and so are their work plans. And as they have 
things making their way into the offices, they don't have the 
flexibility. The bureaucracy doesn't allow them the flexibility 
to turn on a dime and say let us try this or this or this?
    Mr. Nelson. Well, the bureaucracy from time to time tells 
them to turn on a dime, and they have done a pretty good job of 
it. The Kansas City lab, for example, in a matter of 6 weeks, 
was able to process 400 samples of wheat gluten and pet food. 
The direction is entirely from Washington.
    Mrs. Blackburn. OK, thank you. One other thing. You 
mentioned in your testimony that primarily the products are 
coming from China and that they are for a group of stores. And 
you gave the name of the stores, but I couldn't find where you 
had that in writing. Is it the Dollar Store? Is that what you 
said?
    Mr. Nelson. Yes, I am taking that from press accounts.
    Mrs. Blackburn. OK, so these are products that are being 
produced specifically for a chain of stores?
    Mr. Nelson. I don't know the answer to that question.
    Mrs. Blackburn. OK, all right. And so are our district 
staffs developing the ability to look at products coming from 
certain provinces in China and developing an awareness there? 
Or are they using that to red flag any of these products that 
are coming in?
    Mr. Nelson. I don't think there is a single answer to that.
    Mrs. Blackburn. OK.
    Mr. Nelson. It depends on the product and depends on the 
district, but the national prerogatives, the national 
priorities established----
    Mrs. Blackburn. OK. So basically what we need is more 
flexibility given to those in district offices so that they can 
begin to make some determinations about what is coming from 
where and what they think may be the potential dangers within 
that consumption item. And I think my time is about out, so I 
will reserve those questions. But thank you very much.
    Mr. Nelson. Surely.
    Mr. Stupak. The gentlewoman from Illinois, Ms. Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. Mr. Nelson, first 
I want to thank you and the staff for the good work that you 
did on these investigations. I wanted to get a sense--Ms. 
DeGette was talking about the lack of response from the FDA 
when she has written letters, and Members of Congress. What was 
the response from the FDA in terms of responding to your 
questions and your inquiries? It sounded like you still don't 
have all the information that you had asked for?
    Mr. Nelson. Well, the committee's document request, it is 
like pulling teeth to get FDA to respond. Actually, they have 
responded very, very well in the last 5 days as the hearing 
approached. But generally the delays are substantial. The 
document production is usually incomplete and often not 
identified as incomplete, or what is missing is not identified. 
That is the way to put it.
    In terms of the interviews in the field with the staff, 
they have been incredibly cooperative. Just about everywhere we 
went, the local district offices assembled the people that were 
doing the work in the areas that we have asked for, seafood or 
wheat gluten or whatever, and the field people were entirely 
candid.
    Ms. Schakowsky. But it sounds like there is a real 
disconnect that what they see as important to do, what they 
would like to do, they are either prohibited because of some 
bureaucratic rule that they don't have the authority to do it.
    Let me ask a couple of specific questions about the 
laboratories. You have in your testimony only a minute fraction 
of the 25,000 daily food shipments are ever tested by a 
Government laboratory. What percentage is that?
    Mr. Nelson. Far under 1 percent.
    Ms. Schakowsky. Under 1 percent. So what are those 
laboratories doing? And is that the excuse then for shutting 
them down?
    Mr. Nelson. The laboratory system is divided by caste. So 
for example, Puerto Rico, San Juan, Philadelphia, and Detroit 
aren't really food labs at all. They are entirely drug labs, 
and drugs from all over the country are sent to those labs for 
analysis. Likewise, the heavy food labs, Denver, Kansas City, 
that are being shut down get food from all of--Kansas City does 
an awful lot of the food analysis stuff coming across the 
southern border from Mexico. They have larger labs in Los 
Angeles and New York that, in fact, do both, I think. But for 
the labs that we looked at, there is a lot of specialization. 
Atlanta is almost all food, for example, not drugs.
    Ms. Schakowsky. But not among their functions is to do 
these inspections of food shipments that are coming from many 
other places?
    Mr. Nelson. Yes, the work plan, the national work plan, 
designates the number of samples that will be tested in FDA 
labs for the year, and it specifies them by labs and by kind of 
food. And except for emergency situations, like the wheat 
gluten situation, those work plans are expected to be followed 
pretty precisely. So it is Washington that decides what will be 
sampled. The labs do the analysis of that minute fraction of 1 
percent of the food coming in that is determined to need 
sampling.
    Ms. Schakowsky. I want to ask you about the Oasis system. 
Is that what you are really referring to? Because you say that 
only 20 percent of food imports appear in the FDA's computer 
system, which is called Oasis, right?
    Mr. Nelson. Right.
    Ms. Schakowsky. For a review by the field inspection force. 
So there is just this huge category of foods that aren't even 
included for inspection?
    Mr. Nelson. That is right. FDA-regulated products, not just 
foods. And it is a risk-based system. And when you have got 
limited resources and a big problem out there, you have to do 
some sort of risk-based analysis.
    Ms. Schakowsky. But obviously that risk has not been 
properly calculated because we are at risk.
    Mr. Nelson. Well, the wheat gluten sort of drew a road map 
for anybody that wanted to attack our food supply maliciously. 
You don't go to milk and water and the things that are fairly 
obvious targets. You find stuff that is not being reviewed at 
all. There was no wheat gluten ever----
    Ms. Schakowsky. And that is in the 80 percent?
    Mr. Nelson. Yes, that is in the 80 percent. Also in that 80 
percent are exporters that are sending food into the United 
States subject to an import alert that have those five 
consecutive positive tests. So while the product and the 
country of origin may still be on import alert, as the 
exporters get out from underneath, they drop into that 80 
percent.
    Ms. Schakowsky. Thank you very much.
    Mr. Stupak. Next Mr. Burgess for questioning.
    Mr. Burgess. Thank you, Mr. Chairman. And I appreciate that 
I am relatively new here, but I just have to say this is kind 
of an unusual situation for me to be asking questions of a 
panel that is composed entirely of staff from the other side. 
Structurally, was our side involved in this at some level?
    Mr. Nelson. Yes, sir, and they were invited to testify.
    Mr. Burgess. OK, and our staff was present at these 
inspections?
    Mr. Nelson. Most of them, yes.
    Mr. Burgess. OK, and again this is just, Mr. Chairman, 
strictly housekeeping and structural. Perhaps my general 
knowledge should be better than it is, but are Members ever 
involved in this type of field hearing or field questioning?
    Mr. Nelson. They have been in the past. There was an 
intense investigation by this committee while you guys were in 
the Majority that involved the import of drugs, personal 
importation, and Members went out with the staff to look at the 
international mail facilities, to look what the postal 
authorities were doing.
    Mr. Burgess. I don't want to use all my time on this, but I 
just would say for the future that this Member would be 
interested in this type of activity if time and scheduling 
would permit if future activity is planned.
    Mr. Stupak. We plan on sending these guys to China and 
probably to India over the August break.
    Mr. Burgess. Well, that would actually be the other part of 
my question, Mr. Chairman. As I look at this, and clearly we 
have a system that was designed for the world as it existed 50 
or 60 years ago. And now we have the world as it exists today, 
and it doesn't seem like the system has kept pace.
    First off, is there ambiguity between who is in charge here 
between the FDA, Department of Commerce, the USDA? Do all of 
those three agencies mesh seamlessly in this process?
    Mr. Nelson. Most of the time I would think so. Their 
responsibilities are distinct. Their statutes are distinct. 
They all ultimately rely on Customs and Border Patrol to 
enforce the enforcement actions, the detentions, the denial of 
entry, the destruction of goods, that sort of thing.
    Mr. Burgess. Well, because I remember Tommy Thompson's 
comments as he was leaving as the Secretary of HHS, and he 
alluded to the food supply in the country. And I don't know 
that I really appreciated at that point how significant the 
problem was.
    I will just tell you in my district, I had a veterinarian 
in who was up for a social visit last week, and I asked him 
about the pet food problem. And I did not appreciate that even 
in my little district in north central Texas how severe the 
problem was. And, of course, now looking back on animal records 
of animals that came in with kidney disease during that time 
span, he suspects that that problem was significantly more 
widespread than was appreciated at the time and probably 
involved pet food brands that weren't those that were the 
subject of the recall because there was a spike in otherwise 
unassociated kidney disease in the pets that he was seeing or 
that were brought into his office during that time.
    Do we have to get wheat gluten from China? Can't we get it 
anywhere else? We grow some in Texas, I know, and I think they 
do in other States.
    Mr. Nelson. Actually, yes, Canada supplies wheat gluten to 
us. Russia supplies wheat gluten to us.
    Mr. Burgess. Is there still wheat gluten coming in from 
China at this point?
    Mr. Nelson. I presume so.
    Mr. Burgess. Why don't we just stop any importation of 
wheat gluten from the People's Republic of China until we 
ascertain that it is safe?
    Mr. Nelson. Well, that is a question for the FDA. I will 
say that----
    Mr. Burgess. I thought this was an FDA hearing, Mr. 
Chairman.
    Mr. Stupak. They are our employees, not FDA's----
    Mr. Burgess. All right, I will ask the commissioner. I will 
reserve the question.
    Mr. Nelson. I will say that FDA did a lot of testing, and 
except for the melamine in the Chem Nutra imports that went 
into the pet food, they found very little other batches of 
wheat gluten or any of the vegetable proteins as containing 
melamine. As I understand it, even the animal feed where it was 
found came indirectly from the discards of the pet food company 
that had imported the melamine-laced----
    Mr. Burgess. So it was just one rogue operator that was 
injecting this poison into the pet food supply or the wheat 
gluten supply?
    Mr. Nelson. That is what their testing, I think, showed. 
The reports that we have heard from China though suggests that 
it is a much more widespread problem over there. And sooner or 
later, there will be another one.
    Mr. Burgess. Well, again this was a scientific study, but 
talking to this one veterinarian who happened to be up showing 
his kids the Washington Monument. And I just asked him about 
this, and he didn't have any data for me. But his impression 
was it was a much more widespread problem than was initially 
reported because of the number of cases of kidney disease and 
otherwise previously healthy animals that he was seeing during 
the winter and spring of last year.
    But thank you, Mr. Chairman. Are we going to have a second 
round, or can I press on for a while?
    Mr. Stupak. Yes, we will.
    Mr. Burgess. OK, I yield back.
    Mr. Stupak. Thanks. Ms. DeGette from Colorado please.
    Ms. DeGette. Thank you very much, Mr. Chairman. Mr. Nelson, 
you had testified in response to Mr. Inslee's question that the 
FDA employees that you and your staff talked to in general 
supported mandatory guidelines. I'm wondering if you can 
describe for the committee what kinds of guidelines you mean 
when you say mandatory guidelines?
    Mr. Nelson. Well, the agricultural practices are voluntary. 
They are voluntary guidelines that the industry is supposed to 
abide by, but there is no standard to test against. One of the 
things they were most concerned about was that even in the 
voluntary guidelines, there were no testing protocols, there 
were four possible sources of contamination in the spinach that 
were identified in the CalFerd's. CalFerd being FDA and the 
State of California together, their report back in March.
    But the FDA investigations that we talked to, and we talked 
to them all. They were all there. All seemed to think that the 
real problem was water. It could have been some of the other 
sources, but it was most likely water. And what they say would 
actually solve the problem or come close to--what they thought 
was the best solution to the problem was mandating that field 
that supply vegetables that are not cooked.
    Ms. DeGette. So it is really mandating certain testing 
protocols and also certain agricultural practices?
    Mr. Nelson. That is right, yes.
    Ms. DeGette. OK, I am wondering if the FDA presented you or 
your committee with evidence that showed cost savings for 
closing these field labs particularly the Denver lab?
    Mr. Nelson. We were shown no numbers, no solid cost numbers 
in all of the documents that they produced to us. There was one 
early analysis that was sort of back of the envelope. It was 
exhibit 40 in your exhibit books. That was the sum total of the 
cost analysis, and it is, as you can see, filled with 
assumptions that are assumptions and undocumented assertions as 
to cost.
    Ms. DeGette. And you didn't receive the supporting 
documentation to this?
    Mr. Nelson. There is no supporting documentation.
    Ms. DeGette. Were you given any information by the FDA in 
your investigation about the impact of shutting the Denver lab 
and other field labs on food safety?
    Mr. Nelson. They did no such analysis. But they supplied 
us--mind you, they are still supplying--they supplied documents 
as late as 4:30 yesterday afternoon that we haven't been able 
to go through entirely.
    Ms. DeGette. Did they give some reason for their delay in 
supplying these documents to the committee?
    Mr. Nelson. Every time we asked about the documents--the 
first letter was written in February requesting these 
documents. And every time that we would say look, this can't be 
a full production. There is nothing from the field here. There 
is nothing critical of your plans here. There is no substantive 
cost analysis here. There is no saving analysis here. We would 
get another batch of documents that were also non-responsive 
until----
    Ms. DeGette. But did they give reasons why they have not 
produced these? I understand you haven't been given them. Did 
they tell you why they haven't been giving them?
    Mr. Nelson. Not formally.
    Ms. DeGette. OK, now the Denver lab in particular, 
according to your report, does a number of things like it has a 
lot of responsibility for food research and animal research, 
correct?
    Mr. Barstow. That is correct.
    Ms. DeGette. Mr. Barstow, you are the one that visited the 
Denver lab?
    Mr. Barstow. Yes.
    Ms. DeGette. Now, the Denver lab is the only FDA lab to 
have a section for testing animal feeds and the only lab to 
test milk for antibiotics. Correct?
    Mr. Barstow. That is correct.
    Ms. DeGette. And the Denver lab is the lab that developed 
the test for melamine in fish, and they did it pretty quickly, 
didn't they?
    Mr. Barstow. They did. I believe they did it in 3 or 4 
days. And it is an animal drug research center, and it is three 
analytical chemists. They all have Ph.Ds, and they are in 
charge of developing methods that are used agency-wide and by 
States and by even other countries to test food.
    Ms. DeGette. Now, when you visited the Denver lab, Mr. 
Barstow, did you get a sense that it was antiquated and run 
down?
    Mr. Barstow. No, not at all.
    Ms. DeGette. Were there problems with staff morale there?
    Mr. Barstow. Morale at every laboratory we visited was very 
low.
    Ms. DeGette. I imagine it was particularly low at the labs 
slated to be closed.
    Mr. Barstow. Exactly.
    Ms. DeGette. Did those scientists tell you that they were 
going to transfer to the other labs?
    Mr. Barstow. No, very few did. I believe the numbers were 
two in San Francisco, two in Denver, six in Kansas City, and 
two at the Winchester lab.
    Ms. DeGette. Two that planned to transfer, and all the rest 
were not going to?
    Mr. Barstow. That is correct.
    Ms. DeGette. That is experience we would just lose if we 
closed those labs?
    Mr. Barstow. Probably thousands of years.
    Ms. DeGette. Thank you. Thank you, Mr. Chairman.
    Mr. Stupak. Mr. Murphy for questions please.
    Mr. Murphy. Thank you, Mr. Chairman. A couple things I want 
to know about. In your statement, you talked about how the FDA 
relies heavily on some labs, these private labs. But I think 
you are saying we don't have a list of unapproved labs or 
things like that. What kinds of problems are there with some of 
these labs in terms of equipment or procedures? Are they 
substandard, or are there some actions that you are finding 
exist at those places which is of concern?
    Mr. Nelson. FDA doesn't inspect the labs.
    Mr. Murphy. They do not?
    Mr. Nelson. And we certainly didn't. The complaints from 
FDA laboratory employees were improper methods of analysis and 
shoddy work in terms of recording the information that was then 
sent to FDA. And then there was a general complaint that we had 
at a couple of labs that essentially they believed there were 
labs--not all private labs mind you, but there were labs in 
each of the districts were importers knew the results were not 
going to be positive on their shipments. And FDA had no power 
to not accept those laboratory results. All they could do was 
send an inspector out to take a sample from the same shipment 
and have it analyzed in FDA labs. And when that happened, often 
is what we were told, the results were different.
    Mr. Murphy. So you are saying the importers know how to 
maneuver around FDA? What are some examples of how do they do 
that?
    Mr. Nelson. Yes. Well, one of the examples is fish, large 
fish, tuna, swordfish, the like. Fish that grow to that size 
accumulate chemical toxins, mercury, arsenic, cadmium, heavy 
metals from the pollution in the ocean waters where they swim. 
And the older the fish, the larger the fish, the higher the 
toxin level. So because the FDA policy permits an exporter into 
the United States to come off of an import alert for, say, 
mercury and tuna if they have shown five consecutive private 
laboratory analyses of five different shipments, consecutive 
analyses, that they can be removed from the alert all together. 
So the game that is played is that they ship in the first five 
samples of small fish, fish that haven't grown, haven't been 
around long enough to accumulate the toxins. And then once they 
are off the import alert, then they don't have to worry about 
the size of the fish that they are importing.
    Mr. Murphy. Are there any kind of other things they use 
besides avoiding the big fish? I am just curious. This is 
important to know these kind of things. I just wonder what 
other kind of techniques they use to get around the system.
    Mr. Barstow. Well, they know what ports to go into. They 
know where the FDA does not have an inspector or where they 
don't have a lab. Often those foods will not be tested either 
by the FDA. They also, as we said earlier, they know what 
private labs to go to. One FDA employee told me that with the 
private labs, the bottom line is money so----
    Mr. Murphy. Do we have statements or responses from these 
private labs to these accusations?
    Mr. Barstow. I spoke with one owner of a private lab, and 
he says that his lab is good but that he can point to numerous 
private labs that will guarantee you good test results.
    Mr. Murphy. Well, who pays the private labs? Is it the 
importer that pays them?
    Mr. Nelson. The importer pays. The theory is that once a 
product is detained at the importer's premises, it is the 
importer's responsibility to prove to the FDA that the import 
is safe. And so the importer pays for the private lab test.
    Mr. Murphy. So just to make sure I understand, these are 
not labs that contract under the FDA. They are ones that 
contract with the importers who present some sort of a 
documentation that say our products are clean. The FDA accepts 
those documents then, and that is all that is needed?
    Mr. Nelson. They have to accept those documents unless they 
are going to try and take a duplicate sample. And they have a 
limited capacity to do that.
    Mr. Murphy. And then you are saying the FDA does not 
inspect these private labs?
    Mr. Nelson. They don't inspect the labs themselves.
    Mr. Murphy. But they accept the documents from the labs?
    Mr. Nelson. They have to.
    Mr. Murphy. Why?
    Mr. Nelson. I don't know. I don't know whether it is a 
function of the regulations or a function of guidelines, but it 
is FDA policy.
    Mr. Murphy. Thank you very much. Thank you, Mr. Chairman.
    Mr. Stupak. Thank the gentleman. Next will be Mr. Melancon 
for questions please.
    Mr. Melancon. Thank you, Mr. Chairman. First let me 
apologize for being late. Seems like we are still doing 
hurricane stuff in my office.
    Mr. Stupak. That hearing will be August 1.
    Mr. Melancon. Thank you. I appreciate that. And let me 
maybe not change so much as to try and expand. We were talking 
about the lead in the fish and the small fish being brought in. 
How many ports of entry are there where USDA checks products 
coming into the country as opposed to FDA checking the products 
coming into the country?
    Mr. Nelson. USDA restricts the imported meat to 10 ports. 
There is no such restriction for FDA. So all 326 ports of 
entry--these are ports where there are Customs personnel, but 
in very, very few are there FDA personnel.
    Mr. Melancon. So if I were an importer, I could send it 
almost any place I wanted to and specifically if I was gaming 
the system, send it in a place where I knew there weren't any. 
FDA has seafood, and, of course, that is one of the things I am 
concerned about because of the shrimp contamination and the 
basa and such. How many FDA facilities do we have, and at what 
ports do we have them, or what is the number that are 
available?
    Mr. Nelson. I don't know. You should ask the FDA that 
question.
    Mr. Melancon. OK.
    Mr. Nelson. I don't have an answer to that.
    Mr. Melancon. At any of these ports where they have the 
physical facility as well as the scientist that could do the 
testing, do they do any of that?
    Mr. Nelson. Well, there are only 13 labs right now 
throughout the whole United States that are FDA labs. Customs 
has labs. USDA has labs. So there is more than 13 Government 
labs. There are only 13 FDA labs, and they are proposing to 
reduce it to six. In terms of where there are FDA inspectors, 
at relatively few of those 326 ports. I don't know whether the 
number is 50 or 70 or 80, but it is certainly not 300 of the 
326.
    They do have arrangements with Customs. When an airplane 
comes in to one of these smaller airports, or right now, for 
example, there is no FDA presence in the Virgin Islands. There 
hasn't been since last October. They are trying to fill the 
position, but they haven't filled it yet. So Customs in the 
Virgin Islands is tasked to alert the FDA officials in San 
Juan, Puerto Rico of any shipments that Customs thinks might be 
problematic. And then a phone conversation occurs, and FDA asks 
them to let the goods go through or to hold them up for FDA to 
get a sample.
    Mr. Melancon. Or then the importer gets a private company 
that he pays to come test it and sends the result to the FDA, 
and they have to accept it?
    Mr. Nelson. That is when there is an import alert, yes.
    Mr. Melancon. OK.
    Mr. Nelson. Like there is now on farm-raised fish from 
China, certain fish and shrimp.
    Mr. Melancon. Is there some reason why crawfish didn't get 
included in this list of fish?
    Mr. Nelson. That is a good question for FDA. I don't know. 
Maybe no crawfish comes in from China, but I don't know.
    Mr. Melancon. I think China and Vietnam, I think, send 
crawfish if I remember correctly.
    Mr. Nelson. Yes, they have had problems. San Francisco told 
us a lot about seafood problems from Vietnam, not just China.
    Mr. Melancon. Yes, and as I understand it, that as soon as 
they crack down on them either for the dumping or because they 
have product that is contaminated, whoever it is over in the 
foreign country just started putting them in a different 
manufactured name bags and sending them through somebody else 
or sending them through another port.
    Mr. Nelson. That is certainly a common method of avoiding, 
of shopping for ports. But we didn't have any specific evidence 
of that. We didn't ask those question.
    Mr. Melancon. OK, let me just ask because I came in late. I 
apologize for that. You all talked about detention and what 
exactly detention was?
    Mr. Nelson. Yes, sir.
    Mr. Melancon. And it is not really detention in the sense 
of being the dunce in the corner if you get caught. The 
question was asked of me yesterday, and it was about how is 
beer and booze and wine handled coming into this country?
    Mr. Nelson. There is a different agency than FDA deals 
with.
    Mr. Melancon. And is there some testing or validation, or 
is it restricted to certain importers who are regulated? How do 
we do that?
    Mr. Nelson. I have idea. That wasn't part of our inquiry.
    Mr. Melancon. And the reason I asked that is, I mean, 
booze, which of course all the generations and still some 
people believe is the evil spirit. In Louisiana, we don't look 
at it that way. We look at it as the fun spirit. Yet at the 
same time, we get this product in, or alcohol products, and we 
don't seem to have any problem with it. But food that is part 
of everyday nourishment that is part of what we need to 
survive, we are not checking.
    Mr. Nelson. Very, very little.
    Mr. Melancon. Most people run around worrying about booze. 
I think that is all I have for right now. Thank you, Mr. 
Chairman.
    Mr. Stupak. Thank you. We have gone through one round, and 
we will go through a second round. I know Mr. Burgess has other 
questions. So we will be recognized for 5 minutes, those 
Members who would like to ask other questions. Mr. Barstow, you 
indicated you were in the San Francisco area. I understand that 
you had the opportunity to visit Customs and Border Patrol and 
a centralized examination station. Is that correct?
    Mr. Barstow. Yes, at the port of Oakland.
    Mr. Stupak. OK, what was the focus? Why did you go there?
    Mr. Barstow. They had pulled shipments of wheat gluten, and 
we were going to go there and watch them pull samples from the 
base.
    Mr. Stupak. OK, and what did you observe when you were 
there at Oakland?
    Mr. Barstow. That is where we observed the wheat gluten.
    Mr. Stupak. Well, go to exhibit No. 16 in the main binder 
there. If we can have that photograph up.
    Mr. Barstow. That is what we observed.
    Mr. Stupak. OK, these bags don't appear to have any 
markings on which would indicate the country of origin. When 
you were doing wheat gluten, were you looking for Chinese wheat 
gluten?
    Mr. Barstow. Yes, we were.
    Mr. Stupak. OK. Well, if they don't have any writing on and 
you have a windmill. You have wheat gluten. You have melamine, 
whatever it is there. You have Amsterdam pollen it says on 
there. Why would you believe that this came from China?
    Mr. Barstow. We had the opportunity to view the entry 
documents.
    Mr. Stupak. So is this just another way of getting around 
the import alerts that you spoke about earlier?
    Mr. Barstow. I don't know if it is a way to get around the 
import alerts, but----
    Mr. Stupak. These bags have no markings whatsoever to 
indicate they are from China, right?
    Mr. Barstow. None whatsoever.
    Mr. Stupak. But there is no doubt in your mind or to 
Customs Border Patrol that this was from China wheat gluten?
    Mr. Barstow. That is correct.
    Mr. Stupak. OK, San Francisco has quite a reputation of 
being very good at detecting problems with seafood, the FDA 
inspection team there, correct?
    Mr. Barstow. That is correct.
    Mr. Stupak. Did I read somewhere in report that to avoid 
San Francisco they now go to Las Vegas?
    Mr. Barstow. Yes.
    Mr. Stupak. You mean imported seafood instead of going to 
San Francisco, which is our best lab, they go to a different 
point of entry?
    Mr. Barstow. Right, they know the expertise in San 
Francisco is so good, and there are inspectors there that are 
looking for these kind of problems. Instead, they import into 
Las Vegas.
    Mr. Stupak. We mentioned the quality of the work done in 
San Francisco. In the report, it indicated that--Mr. Nelson, 
your answer is that--what is all the stuff that comes through 
San Francisco? A lot of food, medical, drugs?
    Mr. Nelson. A lot of food. Basically San Francisco, 
Seattle, and Los Angeles get the imports from the Far East.
    Mr. Stupak. OK, but I read somewhere in your report that 
they only have like 30 seconds to take a look at a shipment or 
documents of a shipment?
    Mr. Nelson. They only have an average of 30 seconds. For 
most entry reviews, it is a lot less than 30 seconds because if 
they take any action on one, it cuts down on their time. They 
have got about 30 seconds to look at a computer screen and 
decide whether or not to recommend the inspection of that entry 
or not.
    Mr. Stupak. Now, the FDA put out--we have been talking 
about these voluntary guidelines, and these guidelines relate 
to the use of pesticides, chemicals, sanitation, handling of 
food, food products, packaging, irrigation. And that is 
strictly a voluntary guidelines.
    Mr. Nelson. As I understand it, yes.
    Mr. Stupak. And that applies to U.S. producers and 
manufacturers?
    Mr. Nelson. Yes, also Mexican producers.
    Mr. Stupak. And also Chinese producers?
    Mr. Nelson. And Chinese products.
    Mr. Stupak. Chile, I think, was another country mentioned 
today, those voluntary guidelines, Chilean producers?
    Mr. Nelson. Yes, they are voluntary. They don't bind 
anyone.
    Mr. Stupak. OK, in this country it might be a little 
easier, but are there any FDA inspectors in China or Chile or 
any other countries that ship food?
    Mr. Nelson. Very food foreign food processors are 
inspected, and they are almost all low-acid canned food plants.
    Mr. Stupak. At canned food plants?
    Mr. Nelson. Low-acid canned food plants.
    Mr. Stupak. OK, you mentioned wheat gluten at the Kansas 
City lab, but I thought I read in the report that while the 
Kansas City lab did a good job on wheat gluten, a lot of this 
work to detect the wheat gluten is also turned over to private 
labs?
    Mr. Nelson. They were turned over to university labs that 
are part of the FERN Network. What was remarkable about----
    Mr. Stupak. FERN is Federal Emergency Response----
    Mr. Nelson. Response Network. I am sorry, yes. And what was 
remarkable is that none of the labs except Kansas City, which 
is right there where the Menu Foods plant was, none of the rest 
of the labs that were being closed were allowed to do the 
analysis on this emergency basis. Instead, they contracted out 
work to university labs, and we were told that there are often, 
maybe always--I am not sure--chain of evidence issues with 
university labs. State labs and FDA labs know how to handle 
samples from a legal standpoint, but not university labs.
    Mr. Stupak. OK, there are 326 ports of entry for food in 
the United States. Is that correct?
    Mr. Nelson. Yes, there is 326.
    Mr. Stupak. Do you know how many of them have an FDA 
inspector at?
    Mr. Nelson. No, but I would be surprised if it was more 
than a quarter of them.
    Mr. Stupak. So you would anticipate maybe one-fourth of 
them have a FDA inspector?
    Mr. Nelson. Right.
    Mr. Stupak. OK.
    Mr. Nelson. The rest are very small.
    Mr. Stupak. The USDA now--and they deal mostly with meat, 
correct?
    Mr. Nelson. Yes.
    Mr. Stupak. The Agriculture Department, they only allow 
food to come in to 10 sites in the country, right, not 326?
    Mr. Nelson. That is my understanding. Yes, sir.
    Mr. Stupak. OK, my time has expired. Mr. Burgess for 
questions.
    Mr. Burgess. Now, Mr. Nelson, did you and your group go to 
the place where they inspect fish in Los Angeles?
    Mr. Nelson. No, we went to Los Angeles, to the port of Los 
Angeles, and we spent some time in the Customs area, discussing 
wheat gluten imports with Customs. We then went to the port of 
Los Angeles, but we were only in their offices and only met 
with officials of the district there. We did not talk to any 
inspectors or compliance people or laboratory people in Los 
Angeles.
    Mr. Burgess. My understanding is that at Los Angeles for 
fish inspection, they have a prototype or a demonstration 
project of the new way forward that truly does have an 
automated system, a risk-based analysis of the imports as 
opposed to just inputting economic data, a system that can take 
into account perhaps the local conditions where the product was 
obtained, a very dry year or a very wet year or something that 
might affect the overall quality of the product coming into the 
country.
    Is this type of concept--you talked about an inspector 
having to pass on a specimen on a 30-second time interval. 
Someone said they have got great noses, but my wife does too. 
But even she need more than a 30-second break in between 
assessing things at the meat market.
    Are we getting to a point where again we have the 21st 
century of food stuffs coming into this country from around the 
world, and we are dealing with a system that was set up after 
the Second World War, as far as dealing with imports. We have 
to do one of two things, either close the borders, which some 
of us might favor, no more imports from the People's Republic 
of China. I am told that is not feasible so we are going to 
have to be much smarter about the way forward from this. From 
your observations in all of these labs, did you get any sense 
of the way forward, the way out of this conundrum in which we 
find ourselves?
    Mr. Nelson. One of the principle caveats to the testimony 
today is that we have not done extensive examination of the 
possible technological solutions to some of these problems. It 
is one of the deficiencies of the investigation to date that 
will correct as we go along.
    Mr. Burgess. And yet, if I may interrupt, that is one of 
the most critical things ahead of us. I see in the testimony 
here a comment about user fees, and we just went through a big 
that the FDA doesn't collect user fees from the food importers, 
and perhaps that is something we should consider. But remember 
we just went through an agonizing several weeks with 
reauthorization of the prescription drug user fee and the 
medical device user fee. And on the floor of the House, Members 
from the other side were coming to the floor saying user fees 
are wrong because the people that want to get the stuff in the 
country are the ones that are going to be paying them.
    In this case, the drug companies are paying the fees. So 
inherently there is a conflict of interest that cannot be 
overcome. Well, do we want to develop that same system with our 
food importation? I am not saying whether it is right or wrong. 
It seems to work, in my opinion, fairly well for prescription 
drugs and medical devices. And maybe this is something we need 
to explore if funding is an issue and the speed, the rapidity 
with which we are able to get inspection sites and labs up 
until the 21st century, maybe that is something that needs to 
be evaluated.
    But I think a part of it may be inspectors and analysts and 
numbers of square feet that we have in labs. But part of it 
also is going to have to be capturing the innovation of the 
technology that we all know is out there and likely could cut 
some of the problems off the list for us if we would embrace 
that and explore that. I hope that you all will continue, as 
you continue to make these inspections and make these analyses 
of the labs--and I am grateful that you do it. And I do hope we 
have more budget space from the minority side in the future. 
But I hope you will keep in mind about some of the changes that 
are taking place.
    In my opinion, we have to get to some sort of risk-based 
management of this problem. We cannot just simply input 
economic data and trade data from the countries that expect to 
be able to overcome it. We could hire inspectors from now until 
doomsday and still not be able to--just the shear volume of 
stuff that is coming in now. Again if we don't have the 
institutional courage to close the border, which some people 
would say would solve the problem for us as well, then we are 
going to have to be much smarter about the way we do this 
process.
    Thank you, Mr. Chairman. I will yield back my time.
    Mr. Stupak. Second round of questions, Mr. Inslee. If I may 
before you start. Mr. Burgess, you mentioned a couple times 
about minority, and every time we have a hearing, every time we 
have an interview, every time we have done anything on this 
committee, especially in this panel, the minority staff was 
always welcome to attend. Sometimes they chose to. Sometimes 
they chose not. This has been a bipartisan investigation. It 
will continue to be bipartisan with that great cooperation. 
Please don't make any kind of reference that somehow the 
minority was excluded from all this. They were with these 
gentlemen on some of the trips. Some of them, they chose not 
to. Sure, go ahead if you want to respond.
    Mr. Burgess. I think the comment I made was that I hope the 
minority would participate in the future. And if there is a 
question, I will be glad to participate in the future because 
this issue is that important, then we should assume it can't be 
left to just business as usual here in Congress. We have to be 
able to get on top of this issue.
    Mr. Stupak. Great. Talk to the minority staff. Urge them to 
participate fully with us. And with that, I will turn to Mr. 
Inslee please.
    Mr. Inslee. Thank you. The staff report suggests that a 
lack of aggressiveness may have had some role in the peanut 
butter salmonella issue, and it makes reference to a disclosure 
on April 24--excuse me. I have the wrong date. Anyway, there 
was a disclosure of some potential salmonella toxicity in some 
peanut butter associated with ConAgra. And then there was in 
the report a description of the FDA not obtaining the 
microbiological testing by the producer because they had not 
issued a written request. Apparently the producer said we won't 
give it to you unless you give us a written request, and the 
FDA would not give them a written request. Could you illuminate 
what is going on there? Is this a policy of the FDA? Is it 
confusion between FDA and producers? What is going on?
    Mr. Nelson. Well, it is apparently a policy. Let me be 
clear. First of all, the inspector that did the February 2005 
investigation based on the informant's information that there 
were microbiological tests showing salmonella in October of 
2004 did not recall being told that they could have the records 
upon a written request. But he said it was not extraordinary 
that they would do that. That is sort of standard operating 
procedure for large food companies because they know that in 
almost all cases FDA will never ask for the documents in 
writing.
    And the rationale dates back to section 703 of the Act. It 
provides, with legal interpretations that courts have made, 
that manufacturers provide records in response to written 
requests, they can't be held criminally liable. And so no 
written request is made. But in the case of this peanut butter 
and a whole lot of other things, we talked to people in Atlanta 
and San Francisco as well as--talked to people in Kansas City 
and San Francisco as well as Atlanta. And we are told that 
written requests simply aren't made. And it is amazing to me 
that where you have an allegation from a credible informant, 
somebody that worked for the company, that the company found a 
toxin pathogen in their product and refused to voluntarily give 
you the records, that you wouldn't write for them just as a 
matter of the agency's responsibility to protect the public 
health whether you could prosecute them or not.
    Mr. Inslee. Even after going through Katrina and 
everything, I still have a hard time understanding why the 
Government would not do that. Is there some rational, like if 
they would not issue written requests? Unless it was they don't 
want to shield the producer from the community? But that seems 
shortsighted to me. What is the reason?
    Mr. Nelson. We were not provided a reason except that it is 
not policy. One inspector told us that it had happened once in 
his 33 years on the job. Another thought that they had heard of 
it happening two other times, but they weren't directly 
involved in their 20 years on the job. The field instruction 
manual only says that if a company insists on written records, 
that the inspector has to go to a supervisor.
    But apparently at minimum, this raises to the level of the 
district director because nobody below a district director 
writes for records. And district directors, it just doesn't go 
up there. The agency just doesn't do it, and it is one of the 
simple things that the agency could commit to correct today 
that would make things a little bit safer.
    Mr. Inslee. Is it a lack of aggressiveness or is it concern 
about liability, or what is the rationale that was offered?
    Mr. Nelson. Well, the inspectors don't have any liability. 
I mean the Act, as interpreted, says they can't get a criminal 
conviction based on those records. But it doesn't say anything 
about not being able to get a seizure or an injunction or a 
voluntary compliance from the company on a better testing 
program. To me, it was nonsensical that the records weren't 
asked for in writing in the case of ConAgra----
    Mr. Inslee. Was it your sense, at least in that case, had 
there been a written request, the records would have been 
provided?
    Mr. Nelson. The manual that was entered into the record in 
the last hearing, I believe, said that they would make an 
evaluation at their headquarters about responding to it. There 
is nothing in the law that requires them to provide those 
records.
    Mr. Inslee. Of course, we haven't had a lot of luck getting 
written answers to our written questions either, but that is 
another matter. Thank you.
    Mr. Stupak. Mr. Murphy, questions? Ms. Schakowsky, please 
questions?
    Ms. Schakowsky. I wanted to ask about the country-of-origin 
regulations. In terms of processed foods in particular, how can 
we protect ourselves if ingredients within those products that 
may come from the Netherlands or wherever, like wheat gluten, 
whether it would come from China? Are country-of-origin 
regulations potentially misleading and provide false comfort if 
we don't know where the component parts come from?
    Mr. Nelson. It is my understanding that no one has to label 
ingredients as to country of origin.
    Ms. Schakowsky. Right.
    Mr. Nelson. We label them with regard to grams of this, 
that, or the other. But we don't label them with regard to 
country of origin, and----
    Ms. Schakowsky. So was it just chance that we are able to 
find out that the windmill product came from China or at least 
parts of it came from China?
    Mr. Nelson. Well, what Customs told us is that under the 
country-of-origin rules that exist, the importer of that wheat 
gluten, as the distributor, importer, would have to tell the 
next guy he sells it to that it was Chinese. He couldn't sell 
it to them without telling them it is Chinese. And presumably, 
they have an obligation up until it reaches the final processor 
who puts it into the food.
    Ms. Schakowsky. Right.
    Mr. Nelson. Then there is no obligation any further, but 
Customs also told us that this is the kind of situation where 
they could require--I don't know whether they did or not, but 
they could require the bag to be marked as a product of China 
because almost certainly in that procession of trade, the 
identity of the true source of the wheat gluten would be masked 
by this packaging which suggests that it comes from Holland.
    Ms. Schakowsky. So they could, on their own initiative, 
require that it be identified?
    Mr. Nelson. Customs has that discretion to require that bag 
to be marked. Once it is out of that bag, even then there is no 
requirement that consumers be notified of where the ingredients 
in the food comes from.
    Ms. Schakowsky. In looking at your testimony, it sounds as 
if that the CBP, Customs and Border Protection actually did act 
on its own initiative and detained all imports in 10 specific 
tariff codes. But was there not coordination with the FDA? I 
wonder if you could talk to us a little bit more about that and 
how those agencies do or don't work together to protect our 
food supply.
    Mr. Nelson. In almost every case, Customs defers to FDA to 
make the decisions on what is entered into the commerce of the 
United States because FDA has the responsibility to determine 
whether it is safe or not, not Customs. But I think because of 
the publicity--I don't know--Customs exercised the authority it 
always has to shop a shipment and test it in their own labs. 
And that is what they did at Oakland when we were there.
    Ms. Schakowsky. Do you know had they requested the FDA to 
act, or did they just act on their own initiative?
    Mr. Nelson. In the case of San Francisco when we were 
there, clearly FDA had not been notified of what Customs was 
doing. And I mean within 2 or 3 days, they coordinated it.
    Ms. Schakowsky. So is there any problem that we have in 
assuring that kind of coordination?
    Mr. Nelson. It is just a very rare event that Customs would 
act without FDA's request to detain something. When Customs 
detains something, they detain it in their control. When FDA 
detains it, they ship it on to--they let the supplier hold it.
    Ms. Schakowsky. Yes.
    Mr. Nelson. The importer hold it.
    Ms. Schakowsky. I am just about out of time. I thank you 
very much.
    Mr. Nelson. Sure.
    Mr. Stupak. I thank the gentlelady. Mr. Melancon, any 
further questions?
    Mr. Melancon. Thank you, Mr. Chairman. Do we have any idea 
of the total budget and the total employees of FDA and the 
total budget and the total number of employees that are within 
FDA just for testing and purposes of checking imports?
    Mr. Nelson. We have that data. I don't have it at the top 
of my head.
    Mr. Melancon. If we could get that information, I would be 
interested in seeing. We talked about the ability to check all 
the products. What has happened in America, and a lot of people 
don't realize it, but about 2 years ago for the first time in 
the history of this country, we became a net importer of 
agricultural products, of foodstuffs. For the history before 
that, 200 plus years, we were producing more food than we 
consumed and a net exporter.
    And when I look at what has gotten us to where we are not 
checking the food, I guess the question is when you analyze the 
reasons for FDA looking at closures, is it just dollars? It is 
budget cuts that have caused this?
    Mr. Nelson. I actually don't think it is dollars because I 
don't think they are going to save anything with these 
closures. It is really more consolidation of power, 
centralization of power away from the districts and the 
inspectors and into Washington and into regional centers. Part 
of the reorganization plan that receives the most derision in 
the field is their plan to take those entry reviewers we talked 
about that are in each district, that they are sort of the last 
line of local control over inspections, and put them into six 
regional offices. So the inspectors in the field at that point 
will be entirely reactive to the instructions of people miles 
and miles away.
    Mr. Melancon. So they don't have any authority to speak of 
whatsoever?
    Mr. Nelson. Under the proposal, the inspectors in the field 
will just be sort of soldiers going out in response to whatever 
Washington or the regional centers that are doing the entry 
review determine they should do. As far as I can see, there are 
no lines of import of the information back in. Sort of like it 
is consolidation--when I say consolidation of power, I am 
really talking about consolidation of policy so that the policy 
that is established, good, bad, or indifferent, the policy 
established in Washington is the sole source of activity in the 
field.
    And most people in law enforcement will tell you that the 
key to effective detection in information. And so essentially 
what this plan does is remove from the agency its principle 
source of information about what is going on in the 
marketplace.
    Mr. Melancon. In other words, taking eyes and ears on the 
ground out of the circulation.
    Mr. Nelson. Right.
    Mr. Melancon. One of the statements about closing the 
borders, we do that, then we close off food, oil, gas and 
everything else. So I have a problem with that, but as I have 
noted, when I look at the trade agreements that we have done, 
which ought to be a place that we could put some teeth into 
enforcement of food stuffs particularly coming to this country.
    Is there any logic why none of the trade negotiators, USTR, 
ever wants to discuss or put in country of origin or sanitary 
regulations or any of these things? Is there something out 
there that I don't understand? Is it the major corporations, or 
is it just the small guys? I don't understand why we wouldn't 
ask for that.
    We make our domestic producers abide by very strict 
standards for sanitary purposes, for what they put in their 
products and labeling. And yet you saw the bag. I have no clue 
where it came from other than I thought maybe Holland.
    Mr. Nelson. The question you are asking is way beyond our 
investigation.
    Mr. Melancon. OK.
    Mr. Nelson. It is an interesting question, but it is beyond 
what this specific investigation is about.
    Mr. Melancon. I guess that my curiosity got peaked because 
I used to be in the sugar business in Mexico, which has a NAFTA 
agreement. Most years can't produce all the sugar it needs for 
its own domestic use yet. When they run their final numbers in 
the year, they have hundreds of thousands of tons of sugar 
extra. Guatemala just happens to be a border, and the bags come 
across maybe and change labels. But anyway that is a whole 
other issue that we have.
    And I would like if we could just for the staff to check 
and see number of people employed by the agency, the budget, 
and the budget specifically on those agencies that are affected 
by the labs and on the ground at the ports.
    And I guess the last thing real quick is do you have any 
specific recommendations of things that we ought to be looking 
at consolidating, like USDA, the number of ports that certain 
imports can come through, putting the labs maybe at those 
particular ports of entry? As attention rules being changed or 
tightened up, is anything that you all might suggest?
    Mr. Nelson. The investigation really isn't at that stage 
yet. It is still preliminary, but I am sure that Mr. Dingell 
and everyone on the panel will be asking us questions as they 
begin to draft the food safety legislation.
    Mr. Melancon. Thank you. I appreciate it.
    Mr. Stupak. OK, all time has expired for questioning of 
this panel. We will excuse this panel. Thank you, gentlemen, 
for the work you have done and also the minority staff for 
helping you with this investigation, and we look forward to 
your continued work. And you are excused for now. Thank you.
    We will call up our second panel of witnesses to come 
forward. On out second panel, we have Ms. Caroline Smith 
DeWaal, director of food safety at the Center for Science in 
the Public Interest; Mr. William Hubbard, former associate 
commissioner of the FDA; Mr. Charles Clavet, microbiologist at 
the Winchester, MA FDA Engineering and Analytical Center; Ms. 
Belinda Collins, director of the FDA's Denver District; Mr. 
Richard Jacobs, chemist and toxic element specialist at the FDA 
San Francisco District Lab; Dr. Ann Adams, director of the 
FDA's Kansas City District Lab; and Ms. Carol Heppe, director 
of the FDA's Cincinnati District.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised that witnesses have the right, 
under the rules of the House, be advised by counsel during 
their testimony. Do any of you wish to be represented by 
counsel? Everybody indicated no. I will ask you to rise. You 
all have. Please raise your right hand to take the oath.
    [Witnesses sworn]
    Mr. Stupak. Let the record reflect all witnesses answered 
in the affirmative. They are now under oath.
    We will begin with opening statements. We will start with 
Ms. DeWaal if you could limit to 5 minutes. If your testimony 
is longer than that, it will be submitted for the record. Thank 
you. Ms. DeWaal, if you would please.

TESTIMONY OF CAROLINE SMITH DEWAAL, DIRECTOR, FOOD SAFETY, THE 
           CENTER FOR SCIENCE IN THE PUBLIC INTEREST

    Ms. DeWaal. Thank you very much, Mr. Chairman. I am 
director of food safety for the Center for Science in the 
Public Interest. CSPI is a non-profit organization representing 
over 900,000 consumers.
    The CDC estimates that 76 million Americans get sick and 
5,000 die from food-borne hazards each year in the United 
States. And today, over 10 percent of the average American diet 
is imported food products. For certain commodities like 
seafood, imported products form the bulk of the American diet. 
But recent events have really increased consumer concern about 
imported food coming from China. In fact, over 80 percent of 
consumers believe that ``made in China'' equates to ``may be 
contaminated.''
    The Food and Drug Administration and the U.S. Department of 
Agriculture each manage food import programs. USDA's Food 
Safety and Inspection Service is responsible for ensuring the 
safety of imported meat and poultry products, but they use very 
different tools than FDA.
    Foreign countries wishing to export to the U.S. must 
undergo two levels of in-country review before they can ship 
products: an evaluation of the food safety program followed by 
an on-site review of all aspects of the food system, including 
plant facilities, laboratories, training programs, and in-plant 
inspection operations.
    Upon arrival at the U.S. port of entry, this same meat that 
is subject to inspection in the country has to be approved by 
FSIS before it can be allowed into the U.S. Every lot is 
visually inspected, and then FSIS conducts random statistical 
sampling of lots. These more stringent inspections could 
include sampling of the product for microbial analysis, 
physical examination for visible defects, sampling for drug and 
chemical residues, and food chemistry analysis. An average of 
15 percent of products presented for importation are physically 
examined or sampled by USDA.
    Compare this to the program at the FDA, which is 
responsible for all other foods, including produce and seafood. 
It is import inspection program is anything but comprehensive. 
FDA does not evaluate national programs to determine 
equivalents or visit foreign countries to verify compliance 
with food safety procedures. Instead, FDA relies on border 
inspections but inspects less than 1 percent of the food 
crossing the border. While these products can enter any of many 
hundreds of U.S. ports, the vast majority of these ports have 
no FDA inspectors on site. And products come in with only 
nominal record checks.
    The failure of FDA's import program has been demonstrated 
with the recent outbreaks related to imported food items. First 
the deaths and illnesses among American pets caused the largest 
ever pet food recall. Next, lethal pufferfish imported under 
the label of monkfish from China caused several illnesses from 
a severe marine toxin, one of the most severe toxins known in 
the human food supply. And most recently, FDA took action to 
ban five species of fish from China for illegal antibiotic 
residues, a problem the agency said it had been watching since 
2001.
    Throughout the years there have been many other outbreaks 
linked to imported food, proving the FDA cannot rely on other 
countries to ensure the safety of imports to the U.S. The gaps 
in protection from this system are indeed alarming, 
particularly as imports in some commodities and from some 
regions grow.
    In recent years, China, for example, has become the third 
leading foreign supplier of agriculture and seafood products to 
the U.S. CSPI is supporting a number of bills which have been 
recently introduced, but the bottom line here is the U.S. food 
safety laws are more than 100 years old. And they were not 
designed to deal with these modern problems such as escalating 
imports, bioterrorism, and tainted produce.
    It is critical that Congress take action this year to 
develop a comprehensive modern law, one that can encompass all 
the problems, produce, imports, peanut butter. Consumers would 
like you to take action this year. Thank you.
    [The prepared statement of Ms. DeWaal follows:]


    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    
    Mr. Stupak. Thank you for your testimony. Mr. Hubbard 
please, 5 minutes.

 TESTIMONY OF WILLIAM HUBBARD, FORMER ASSOCIATE COMMISSIONER, 
                  FOOD AND DRUG ADMINISTRATION

    Mr. Hubbard. Thank you, Mr. Chairman. I have extensive 
written comments, but I will just make a few remarks if I may. 
I am William Hubbard. I served at the FDA for 27 years before 
my retirement in 2005, and there are many, many food safety 
issues to talk about. But I would like to focus just on a 
couple today, particularly on imports.
    I believe we are at a critical point in FDA's history in 
terms of their ability to protect the food supply, and I think 
that we are at a point where we need to make some serious 
decisions. Please forgive for using a well-worn cliche, but I 
think we are approaching a perfect storm risk for American 
citizens in which you have a flood of imports from other 
countries, more and more threats to food, and an ever-weakening 
FDA. And I believe that.
    In fact, what I am seeing is a hollowing out of the FDA's 
food program. That really underlies all of the issues we are 
talking about today. And the horror stories we are hearing from 
China and other developing countries are of no surprise to me 
and I am sure not to my former colleagues at the FDA. Gross 
violations of sanitation, widespread use of industrial 
chemicals and pesticides in food. There are fish and other 
animals fed drugs not allowed in the United States. Many more 
examples of practices that were common in this country in the 
1880s or early 1900s but not today.
    But trade from these countries is a reality, and we have no 
hope that these developing countries, in my view, will adopt 
and enforce the kinds of safety standards that we expect any 
time soon. So our citizens must depend on one mechanism to 
protect them, and that is the FDA. But when we provide that 
agency with only 450 inspectors to screen almost 20 million 
imports of foods and drugs, the situation approaches 
hopelessness in my view.
    There are many ideas that you will hear mentioned today for 
improving the FDA. Better management, new legislation, more 
regulations, better training all may be good ideas. But in my 
view, unless you deal with the basic fact that the FDA needs 
people to do these things, we are not going to fix this 
problem.
    Please understand that FDA's food program has undergone a 
decade of budget cuts. The current budget does it again. Let me 
give you a couple of examples. The administration's fiscal year 
2008 request for the Department of Agriculture request $163 
million of new money to protect farms against bioterrorism, 
zero for the FDA. That same budget request seeks $131 million 
in new money for food safety research at the Department of 
Agriculture and cuts food safety at the FDA. In total, the 
agency has lost an appropriated staff, 1,000 people in the last 
decade. Most of those have come out of the food safety program. 
This just has to stop in my view.
    The empty desks among the FDA's food scientists are a stark 
testimony that things aren't getting done, the imports are not 
being inspected, and the risky food is not being excluded from 
our country. So I urge you to make strengthening the FDA a 
priority. This committee has come to the FDA's rescue many 
times in the past with dangerous drugs and foods and medical 
devices. And I certainly hope that you will do that again in 
this case because that agency needs help, and you may be the 
only ones that can provide it. Thank you.
    [The prepared statement of Mr. Hubbard follows:]

                    Statement of William K. Hubbard

    Mr. Chairman and members of the committee, I am William K. 
Hubbard. Before my retirement after 33 years of Federal 
service, I served for many years with the U.S. Food and Drug 
Administration, and for my last 14 years was an FDA Associate 
Commissioner responsible for, among other things, FDA's 
regulations and policy development. Although I have remained 
retired since my departure from FDA in 2005, I have agreed to 
provide advice to a remarkable group of patient, public 
interest, and industry groups that have recently formed 
themselves into a Coalition for a Stronger FDA (whose mission 
is to urge that FDA's appropriations be increased). Throughout 
my career at FDA, I was deeply involved in seeking improvements 
in one of FDA's most important functions: the safety of our 
food supply, with particular concern for the massive increase 
in foods being imported into the United States from around the 
world. Accordingly, I wish to thank the committee for inviting 
me to testify on that subject today.

                               Background

    As you know, Congress established the Food and Drug 
Administration in 1906 as a result of concerns about the safety 
of our food supply. In those days, it was common for foods to 
be subjected to all manner of problematic practices: filthy, 
unsanitary conditions were common in food processing 
facilities; talcum powder, sawdust and many other contaminants 
were added to deceptively increase the weight or value of 
foods; and chemical preservatives were used in food that were 
untested and often highly toxic. As the 20th Century 
progressed, FDA's scientists and those in the emerging food 
processing industry slowly built a food safety infrastructure 
for the United States that enabled us to claim that we had the 
safest food supply in the world. And the standards established 
by the FDA for the production of safe foods became the model 
for protection around the globe. But I believe those 
accomplishments are at great risk today, and I would like to 
use my testimony at this hearing to describe why I think FDA is 
no longer able to provide the assurances of safe food that were 
once taken for granted in this country. While food safety 
domestically is a major concern, I will focus my comments today 
on the problems posed by foods imported from other countries.

                 FDA's Statutory Construct for Imports

    FDA's authority over imported foods actually pre-dates the 
agency, as the original statutory construct was created in 
1896, and allowed Federal inspectors to examine foods as they 
passed through U.S. ports. That authority was included in the 
Pure Food and Drug Act of 1906, which established the FDA, and 
again authorized port inspectors to open food cargo containers 
and examine their contents. In those early days, it was a 
fairly simple process. Most imported foods were staple goods, 
such as flour and molasses, and a visual inspection was often 
the appropriate means to assure that the food did not contain 
mold, insect parts, or other visible contaminants. When 
Congress radically revised FDA's authorizing statute in 1938 to 
create the modern FDA, it discarded all of the provisions of 
the 1906 Act, which it concluded were inadequate, except for 
the import provision, which appeared to have worked well up to 
that date. Thus, FDA's statutory authority over imported foods 
remains essentially the same as it was in that much earlier, 
simpler day. The authority, embodied in Section 801 of the 
Food, Drug and Cosmetic Act, permits FDA to examine foods, 
drugs, and other FDA-regulated products when they are arrive 
for entry into the United States. If the product appears to be 
in violation of U.S. standards, it can be refused admission. 
Unlike the Department of Agriculture's meat inspection program, 
FDA cannot require the exporting country to make assurances 
that it applies an equivalent safety standard to exported 
foods, cannot pre-certify foreign food processors, cannot 
designate the U.S. ports at which the food can be entered, and 
cannot remove the exporting country from a list of authorized 
exporters if it fails to maintain U.S. standards. So, the 
burden is primarily on the FDA to find a problem in an imported 
food and deny its admission into this country. . And, as I will 
discuss later, the agency has few resources with which to 
effectuate that authority.

                       Globilization and the FDA

    As I have noted, FDA's import screening process was 
designed for an earlier era, and there is ample evidence that 
it is not adequate in today's world. The changes wrought by a 
globalized economy are stark, and even alarming, in the context 
of FDA's responsibility to assure the safety of our food:

      First and foremost, there is the matter of 
volume. Whereas imports of FDA-regulated products from other 
countries were about 10,000 in 1920, by 1993 they were up to 2 
million, to 9 million only a decade later, and are approaching 
20 million today. In any given year, about 65 percent of such 
imports are food; but, of course, FDA is responsible as well 
for screening the millions of shipments from abroad of 
pharmaceuticals, medical devices, dietary supplements, 
cosmetics, animal feeds, microwave ovens, and other consumer 
goods under its regulatory purview.
      Second, the nature of imports has changed. The 
staple goods of a century ago have expanded to every 
conceivable commodity--fresh fruits and vegetables, canned and 
other processed foods, food preservatives, emulsifiers and 
stabilizers, seafood, apple juice, cheeses and many more.
      Third, the threats to food have increased greatly 
since the turn of the century. Pesticides, industrial chemicals 
and heavy metals often contaminate imported foods, either as 
result of intentional acts, such as appears to be the case with 
the recent melamine contamination, or via environmental 
pollution that is commonplace in some exporting countries. 
Also, disease-causing pathogens, such as E Coli 0157:H7, which 
were unknown in nature a century or even a few years ago, can 
infect food and present life-threatening risks, especially to 
children and the elderly.
      And finally, so much of our food is coming today 
from developing countries, which have weak regulatory systems 
and that simply cannot assure the safety of food exported from 
producers within their borders.

               Foods From China and the Developing World

    The exporting country most in the public eye today in 
relation to contaminated food is, of course, China. FDA has 
long identified problems with food imported from China, but in 
the past it was often with ``ethnic'' foods and other low-
volume commodities, many of which would seem strange to the 
average American's palate. A favorite example of mine was a 
product known as Gecko-On-A-Stick, a dried lizard impaled on a 
wooden skewer that one would dip into hot water to make a 
presumably flavorful tea. It was heavily infested with mold and 
bacteria and, of course, denied admission to the United States.
    But today, products from China fill our supermarkets. Whole 
foods such as apple juice, garlic, honey, mushrooms and several 
types of seafood frequently are of Chinese derivation. And it 
appears that many, in some cases a majority, of the ingredients 
American food manufacturers use to make our processed foods are 
purchased from China--constituents such as wheat and corn 
gluten, rice protein concentrate, soy lecithin, ascorbic and 
citric acid, and xanthan gum. In fact, U.S. food processors 
report difficulties in even identifying sources of some 
ingredients outside of China.
    Chinese food imports are increasing at a rate exceeding the 
rapid increase in imports generally. In 2002, 82,000 food 
shipments were presented to FDA inspectors, yet last year the 
number was 199,000, and it will likely be at 300,000 in another 
year or two. The foods appear to be coming from an enormous 
network of food producers across China, a large percent of 
which are farmers deep in the Chinese provinces. Indeed, 
estimates of the number of Chinese food producers are as high 
as 1.5 million, and the Chinese Government has acknowledged its 
difficulties in reaching into their country's hinterlands to 
regulate such a vast cottage industry.
    With such a huge, fragmented food production system, in a 
nation rapidly developing, it is no surprise that we see 
examples of food processing mistakes that border on horror 
stories--poultry cages suspended over fish farm tanks, so that 
the fish will consume the bird droppings; substitutions of safe 
and approved pesticides and food additives with chemicals known 
in the West to be hazardous; polluted water used in food 
production; and reports of filthy processing conditions that 
would be alien to most American food manufacturers. I recall an 
FDA inspector's story of his visit to a Chinese herbal tea 
manufacturer, where the normal process for drying the leaves 
was laying them out in the sun. But the firm's desire to speed 
production caused them to spread the leaves out on the concrete 
floor of a huge warehouse, over which large trucks would be 
driven, using the exhaust to hasten drying. The trucks used 
leaded gasoline and did not have catalytic converters, so lead 
and other heavy metals were being spewed directly onto the 
leaves.
    These concerns are not just our view of the problems. 
Chinese food safety officials have publicly acknowledged that 
the reports of substandard foods and improper processing 
methods are ``not isolated cases,'' to quote a Chinese food 
safety official, and that 75 percent of that nation's food 
processors are small, privately-owned entities over which the 
central government has exerted little regulatory control. 
Chinese regulators announced in late June that a recent 
investigation of processing facilities had found 23,000 food 
safety violations, including the use of industrial chemicals, 
banned dyes, and other illegal ingredients in food.
    Despite the widespread publicity associated with Chinese 
imports, it should be recognized that FDA commonly finds 
problems with foods from many other countries as well, 
especially less developed nations. Raspberries from Guatemala, 
catfish from Vietnam, melons from Mexico, and other products 
from countries such as India, Malaysia, Thailand, Pakistan, the 
Dominican Republic and the Philippines have often been found in 
violation of FDA's food safety standards. Indeed, Mr. Chairman, 
one of our most common confectionary and soft drink 
ingredients, gum Arabic, comes often from Sudan and Somalia, 
countries with arguably no functioning government, and thus no 
discernible food safety system.
    In a world in which global trade is an acknowledged fact, I 
believe we must accept the reality that foods will be imported 
into the United States from countries that simply do not have 
the regulatory infrastructure, industry resources or scientific 
expertise to be a model of safe food production. One recent 
study, for example, concluded that China alone must invest $100 
billion in its food safety system in order to bring it up to 
Western standards. That analysis, by the global management 
consulting firm A.T. Kearney, noted, for instance, that China 
must insure against food spoilage by better refrigerating 
products during shipment, but found that the entire country 
possessed only 30,000 refrigerated trucks and 250 million cubic 
feet of cold storage (yet that it would need 365,000 such 
trucks and 5 billion cubic feet of cold storage). For its part, 
the Chinese Government has said it intends to improve its food 
safety procedures and has suggested that it may be able to have 
better functioning rules in place by 2012.

                FDA's Capacity to Oversee Imported Food

    Although it has become somewhat of a cliche, let me 
describe the emerging problems with food imports as a ``perfect 
storm''--a scenario in which the United States is flooded with 
an enormous volume of food from abroad, where the risks to food 
are greater than ever before, and at a time in which FDA's 
ability to protect our food supply is growing ever weaker. I 
have described the first two parts of that scenario; now, let 
me elaborate on the third.
    When I began service in the Federal Government, in 1971, 
FDA's food program comprised almost half of the agency's total 
budget. Today, it is about a quarter. During the intervening 
years, there has been a dramatic drop in FDA's oversight of the 
food supply. One stark example domestically is the drop in FDA 
inspections of food processing facilities, from 35,000 in the 
early 1970s, to fewer than 8,000 today.
    More recently, FDA's budgets have been particularly 
alarming for their effects on food safety. On first blush, it 
appears that FDA's budget has been rising, but that is due to 
increased user fees paid principally by drug firms for the 
review of new drugs. Those funds cannot be used for programs 
such as food safety. The appropriations for FDA have been 
inadequate to fund even the staffing level that the agency had 
in the early 1990s. Thus, the agency has lost 1,000 people over 
the last decade in non-user fee programs such as the food 
program. [The attached graph illustrates the drop in non-user 
fee staffing.] Why has this severe drop in staff occurred?
    In most FDA budgets since the mid-1990s, the 
administration's annual budget request for appropriations for 
FDA has not included the inflation ``catch up'' that Federal 
agencies routinely expect. Thus, the agency must absorb each 
year's inflation-driven costs, and if any new funds are 
requested, they must go to offset the additional costs of 
employee pay, building rent, and other expenses--which for FDA 
have averaged about 6 percent in recent years. This means that 
the food program, in particular, has undergone steady budget 
cuts: the staff of FDA's headquarters food program has been 
reduced from almost a 1000 scientists to fewer than 800 in just 
five years; and FDA's field force, which includes its 
inspectors and import staff, has dropped during that period 
from over 4000 to about 3300 today. Of course, this is at a 
time in which the problems are growing and food imports are 
skyrocketing. The current budget request for Fiscal Year 2008 
is a good example of the recent trends. Although the official 
budget request states that it includes an ``additional'' $10 
million for food safety, the food program's inflation needs are 
not covered by the request, so the practical effect of that 
budget is a 3 percent (or $14 million) decrease (even with the 
$10 million ``increase'').
    How does this effect FDA's import coverage? This year, FDA 
has 450 inspectors to cover more than 400 ports at which 
imported foods can enter the United States. With those 450 
inspectors, they are asked to screen almost 20 million imports 
of food, drugs, and other products, which average a staggering 
44,000 shipments per inspector. I suggest to you, Mr. Chairman, 
that no ``efficiencies,'' ``better management'' or ``working 
smarter''--all solutions suggested for FDA--will significantly 
improve this picture. The agency needs to open and examine a 
significant portion of these food containers, send samples to 
laboratories for analysis, and refuse entry to those foods 
deemed unsafe--and only people can do that.
    Perhaps another China example will be helpful in 
understanding the workload dilemma. Last year, 199,000 food 
imports from China arrived at U.S. ports. Also last year, FDA 
was able to take 19,000 samples of imported food for laboratory 
analysis. So, if the agency had sampled only Chinese food 
imports--and none from more than 130 other countries--it would 
have been able to sample and test only 10 percent of those 
imports. And, of course, one could easily argue that, given the 
large number of Chinese imports turned away for violations, far 
more than 10 percent should be analyzed.

                          A History of Failure

    It has been suggested, Mr. Chairman, that FDA's inability 
to protect our citizens from contaminated imports is a failure 
on FDA's part. That may be true, but I suggest that there is 
ample evidence that the cause of that failure lies beyond that 
agency. Let me support that contention that by describing a 
recent pattern of events:
      In the mid-1990s, FDA, USDA, and EPA began a 
major initiative to identify threats to our food supply, 
improve our scientific knowledge of foodborne threats, and act 
against them in a coordinated, aggressive fashion. It was 
called a ``Farm to Table'' approach intended to ``fix'' food 
safety both domestically and in terms of imported foods. 
Despite a promising beginning, it eventually withered away due 
to lack of funding.
      In 1999, with no prospect for additional funds 
for food imports and a rising tide of incoming products, the 
agency drafted a legislative proposal that would have given FDA 
authority to require foreign countries to take more 
responsibility for the foods they send to us. It would have 
allowed FDA to embargo a given food from a given country if 
there were repeated instances of that food being found 
contaminated when it arrived here. Countries that sent safe 
food would have no reason to be concerned, as they would be 
unaffected. But countries that demonstrated a pattern of 
disregard of U.S. safety standards would have to step up their 
oversight of food exported from their country. Congress did not 
accept the recommendation; indeed, no hearings were ever 
scheduled.
      In 2002, with statutory change and funding 
denied, the agency formulated a thorough reinvention of its 
import program to rely more on modern risk assessment 
procedures, to develop better intelligence about foreign food 
processing practices, and to design a sophisticated computer 
data base to make the few inspections that could be done more 
targeted and thus more effective. Result: denied due to even 
the fairly minimal funding it would have required.
      Just this year, FDA's food safety scientists 
proposed to the administration new rules for fresh fruit and 
vegetable production that promised perhaps a 50 percent 
reduction in foodborne disease from domestic and imported 
produce. Despite the support of such rules from the produce and 
food manufacturing industries, the proposal was denied.
      And during this entire period, FDA officials 
repeatedly pointed out to officials in the Clinton and Bush 
Administrations that food safety should be a priority, that 
imports were reaching alarming dimensions, and that the 
agency's food safety program was severely under funded.FDA has 
seen the problem, proposed several different solutions, tried 
to raise an alarm, and been met with relative indifference at 
higher levels. Therefore, Mr. Chairman, I believe that it is 
fair to conclude that FDA has not failed us so much as we have 
failed the FDA.

                         Options for the Future

    We have all heard the story of the English livery stable 
owner, Mr. Hobson, who gave everyone who hired a horse his 
option of whichever horse he wished, so long as it was the one 
nearest the door. Unfortunately I believe that we are faced 
with a series of Hobson's choices in the case of food safety--
in other words, no real choice at all. Banning food importation 
is obviously not a serious option, nor is authorizing FDA to 
implement a USDA-like program that would require the agency to 
certify hundreds of countries and hundreds of thousands of food 
processors. Demanding that FDA ``do better'' and solve the 
problem without new resources sets vastly unrealistic 
expectations. And country of origin labeling is, in my opinion, 
neither practical nor a substitute for safe food. I suggest to 
the committee that the only effective option is to give FDA the 
resources to design and implement an effective food safety 
program. The Coalition for a Stronger FDA is recommending an 
initial increase of at least $450 million, but it is likely 
that more would be needed to be truly successful.
    The default, of course, is to do nothing, which means that 
imports will continue to soar, foreign exporters will believe 
they can send food of any quality to our nation's dinner tables 
with impunity, we will continue to blame FDA for problems they 
cannot fix, U.S. food processors will bear an ever larger 
burden of concern and liability for food ingredients they 
purchase on the world market, and Americans' confidence in our 
food supply--and in their government's willingness to protect 
them--will deteriorate further.
    I urge the committee to find ways to help the agency solve 
this dilemma. When similar problems have occurred in the past--
drug deaths in 1937 and 1962, pesticide fears in 1955, medical 
device failures in 1975, counterfeit drugs in 1985, and many 
other times--this committee has come to FDA's rescue. I hope 
that this will be another of those times when you bring to bear 
your determination to correct a problem that threatens us all.
    Thank you for inviting me to give my views on this subject.

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    
    Mr. Stupak. Thank you, Mr. Hubbard. Ms. Heppe. We are going 
to have votes here, but let us get your testimony and Ms. 
Collins before we have to break. In 1 second. It is going to 
ring here for 1 second.
    Ms. Heppe. I am glad you understand those signals.
    Mr. Stupak. I guessed. Ms. Heppe, go ahead. Five minutes 
please.

 TESTIMONY OF CAROL HEPPE, DIRECTOR, CINCINNATI DISTRICT, FOOD 
                    AND DRUG ADMINISTRATION

    Ms. Heppe. Thank you, Mr. Chairman, for inviting me to 
testify at this hearing, and I request that my formal statement 
be made part of the hearing record. I am Carol A. Heppe, 
District Director in FDA's Cincinnati District Office. I have 
almost 35 years of service with FDA in both the field and 
headquarters offices.
    On February 6, 2007, some information about the Office of 
Regulatory Affairs Field or Reorganization was provided at an 
Office of Regulatory Affairs senior staff meeting, which 
includes all the senior managers of the field operations. Along 
with lab closures, it was announced that a number of the 
district offices in the field would be reduced from 20 to 16. 
Also, some district boundaries would be realigned.
    The plan given us was this: Cincinnati would merge with 
Detroit, New Jersey with Philadelphia, Denver with Kansas City, 
San Juan, Puerto with Florida. And there would be a realignment 
of the district of Kansas City to put the States of Missouri 
and Iowa with the Chicago district.
    We were not given any information on how they reached this 
new structure, and quite honestly, I still don't know how they 
came up with it. However, I did learn through the grapevine 
that there was a goal to have no districts with fewer than 50 
investigators. I don't know why 50 was selected.
    At this meeting, we were asked to do evaluations at the end 
of each day. A common complaint reported from the evaluations 
was that communication on the reorganization has not been done 
well in the last year. We had been told the previous year in 
February 2006 there would be a reorganization, but in the field 
and probably headquarters too, we did not know what was going 
to happen.
    It is true that we have received several e-mails from 
associate commissioner for regulatory affairs, Ms. Glavin, and 
have a transformation leadership team Web site that we can go 
to for information. These have provided broad goals ORA 
attempts to achieve with the reorganization and other 
information; however, there is nothing to tie these broad goals 
and intentions with the newly planned reorganization.
    In other words, field employees have not been given a 
justification or criteria that has been used by those 
developing this reorganization to indicate this reorganization 
will result in achieving these goals. We were also told that 
the reorganization included reducing the number of compliance 
branches from 20 to 10, which meant that several of the 
districts would not have a compliance branch, 6 of them out of 
the 16.
    For a better understanding of the compliance branches, I 
would like to explain them a little, what they have to do. 
There are two branches in the district offices. One is 
compliance, and one is investigations. Investigations develops 
evidence if they find a violation at a firm through 
inspections, investigations, and sample collections. They write 
a report tying all this evidence together, and then they submit 
it to the compliance branch.
    The compliance branch takes all this information along with 
the lab results from the FDA laboratories and decides whether 
they want to do a recommendation for an enforcement submission 
to headquarters.
    As you can see, this could be quite problematic under the 
new compliance branch merger because the district director is 
the one that normally makes the decision on whether we will go 
forward or not if there is a disagreement between 
investigations and compliance.
    And at this point, if we do not have a compliance branch at 
some of these districts, the district without the compliance 
branch will have to go to the compliance branch at another 
district and try to get them to go along with their decision 
whether to take the case or not.
    Unfortunately, the group devising this plan has not 
consulted the people who have the most knowledge of their 
districts, the district directors who manage the districts and 
their staff before proposing this reorganization. Now that we 
have been told of the plan, we see inefficiencies related to it 
and many concerns if it is implemented. I have included some of 
those inefficiencies in my formal statement.
    Some of these concerns are it appears to be threatening our 
relationships with the States with which we often leverage 
resources. It is disrupting important cultural and long-term 
working relationships with the States that the States have with 
the district they have been in. There has been no clarification 
of duties for managers in these structures. And given the 
restructure, it is likely that many of the positions are not 
supportable under OPM rules.
    Headquarters' staffs appear to be building at the expense 
of the field forces, which do the core functions of 
inspections, investigation, sampling, and analysis. Lines of 
authorities will be muddled due to the cross servicing of 
compliance units and also related to the imports where they 
want to have the import entry reviewers report to headquarters.
    Districts and compliance branches still vary greatly in 
size under this plan. Some directors of compliance branches 
will have as many as 17 to 18 employees reporting to them, 
while others will have as few as 10. Currently they now have on 
an average of eight. However, like most of the decisions on 
this reorganization, there has been no discussion of their 
basis and ultimate direction. And we are concerned that their 
final plan may be that we will go down to 10 districts because 
there are 10 compliance branches.
    The current proposal could reduce our effectiveness at 
regulating an ever-expanding and growing industry. ORA needs 
solid and effective leadership at all levels in the 
organization. We need managers and leaders who are well 
informed and conversant on the issues and compliance profile of 
forms around the country. Each State has its own way of doing 
business. Each industry has its characteristics.
    It is not the number of 50 investigators that should 
dictate the size of a district. Factors to use are industry 
concentration, number of States, population centers, border 
coverage and type, cultural similarities of the States within 
the district, size of the various industries, travel distances, 
and industry startup plans, and States prone to national 
emergencies, such as hurricanes.
    I believe it would be impossible to understand the 
implications of these factors from headquarters since they do 
not work with these factors on a daily basis. And it is not 
just about making decisions for a one-time reorganization. It 
is about the daily decisions that need to be made in the field 
every day. There is nothing to indicate that this proposal will 
result in our better serving our constituents----
    Mr. Stupak. Would you please summarize? We are way over.
    Ms. Heppe. I have a concern that when we increase the 
number of these districts to as big as they are, we will have a 
more difficult time managing emergencies locally. And we will 
have more cases to review, more personnel issues and union 
issues to resolve. The managers in the field would be spread 
very thin with these much bigger districts, and I just want to 
point out that a lot of employees are so unhappy that we are 
hearing we could have a mass loss of institutional knowledge in 
the field with this reorganization, which would hurt us at a 
time when we are trying to be proactive in emergencies and do 
something about them before they happen. And we are now going 
through a big hire, and we need those people to mentor them.
    Thank you, and I will be happy to answer any questions.
    [The prepared statement of Ms. Heppe follows:]

                      Testimony of Carol A. Heppe

    Mr. Chairman, I want to thank you for inviting me to 
testify at this hearing on the reorganization of the Food and 
Drug Administration's (FDA) field offices.
    I am Carol A. Heppe, District Director of FDA's Cincinnati 
District Office (CIN-DO). I have almost 35 years of service in 
FDA. My first 12 years were as an investigator in four field 
offices: Minneapolis; Portland, Oregon; Boise, Idaho; and Los 
Angeles. The next 14 years were in headquarters'Center for Food 
Safety and Applied Nutrition, Office of Legislative Affairs, 
and Office of Executive Secretariat. In 1999, I went back to 
the field as CIN-DO Director of Investigations Branch and later 
went into my current position.
    In the afternoon of February 2, 2007, I received a call 
telling me that my job as District Director in CIN-DO was being 
eliminated due to the field reorganization.
    On February 6, 2007, some information about the Office of 
Regulatory Affairs (ORA) field reorganization was provided at 
an ORA Senior Staff meeting in Maryland. Along with the lab 
closures, it was announced that the number of district offices 
in the field would be reduced from 20 to 16. Also, some 
district boundaries would be realigned. The plan given us was 
this: Cincinnati District (CIN-DO) would merge with Detroit 
District (DET-DO) with Detroit being the district office. New 
Jersey District (NWJ-DO) would merge with Philadelphia District 
(PHI-DO) with Philadelphia being the district office. Denver 
District (DEN-DO) would merge with Kansas City District (KAN-
DO) with Kansas City being the district office. San Juan, 
Puerto Rico (SJN-DO) would merge with Florida District (FLA-DO) 
with Florida being the district office. The realignment of 
district boundaries was: the states of Missouri and Iowa would 
be moved from KAN-DO to Chicago District (CHI-DO). Although I 
don't remember this being announced at the Senior Staff 
meeting, I later learned that the state of New Mexico was being 
moved from DEN-DO to Dallas District (DAL-DO).
    We were not given information on how they reached this new 
structure. The one criterion I saw in a draft document and 
heard mentioned by a couple of managers wasa goal of no 
district under 50 investigators. I did not hear any reason why 
50 or more is the correct number for a district. It should be 
noted that with the hiring of investigators we are being 
authorized to do now, few to no districts will be under 50 
investigators in the next year.
    At this meeting, we were asked to do evaluations at the end 
of each day. A common complaint reported from the evaluations 
was that the communication on the reorganization has not been 
done well in the past year.
    It is true that we have received several emails from the 
Associate Commissioner for Regulatory Affairs (ACRA) and have a 
Transformation Leadership Team (TLT) web site that we can go to 
for information. These have provided the broad goals ORA 
intends to achieve with the reorganization. However, there is 
nothing to tie these broad goals and intentions with the 
planned reorganization. In other words, field employees have 
not been given a justification or criteria, which have been 
used by those developing this reorganization, to indicate that 
this reorganization will result in achieving those goals.
    We were also told that the reorganization included reducing 
the number of compliance branches from 20 to ten. We were not 
told where these compliance branches (CBs) would reside but 
were told which ones were merging. PHI-DO CB (containing NWJ-DO 
CB) and Baltimore District's (BLT-DO) would merge. DET-DO CB 
(containing CIN-DO CB) and CHI-DO's would merge. KAN-DO CB 
(containing DEN-DO CB) and Minneapolis District's (MIN-DO) 
would merge. DAL-DO CB and SW Import District's (SWID) would 
merge. Seattle District (SEA-DO) CB and San Francisco's (SAN-
DO) would merge. Atlanta District (ATL-DO) CB and New Orleans 
District's (NOL) would merge. FLA-DO CB having merged with SJN-
DO would have the CB. New York District (NYK-DO), New England 
District (NWE-DO), and Los Angeles District (LOS-DO) CBs would 
remain the same. We were told it had not been decided where the 
CBs would reside when merged.
    For a better understanding of CBs, the compliance branch is 
one of two branches that have (at least during my time in FDA) 
been in an FDA district office. The other is investigations 
branch (IB). IB develops evidence for the enforcement cases 
through inspections, investigations, and sample collections. IB 
then writes a report tying the evidence together. The report is 
given to CB along with any sample results from an FDA lab to 
decide whether there is a viable case for writing an 
enforcement recommendation. Sometimes IB and CB disagree on 
whether there is a viable case. The District Director (DD) is 
ultimately responsible for deciding whether the recommendation 
for submission to HQ should move forward. As you can see, this 
could be quite problematic under the CB merger when there is a 
disagreement about a case between a district office that no 
longer has a compliance branch and the CB within another 
district.
    In April 2007, ORA TLT Inspection Compliance Directorate 
implementation three member team (ICD) asked, in writing and 
during a teleconference, the district directors of the merging 
districts to develop and write a report to identify issues to 
be addressed in the merger/realignment, propose strategies and 
time lines to address those issues to make implementation 
successful, and ensure uniformity and minimize negative impacts 
on meeting core mission objectives during planning and 
implementation.
    This implementation group, in writing and during a 
teleconference, also asked all Directors of the Compliance 
Branches (DCBs) and DDs to discuss obstacles and opportunities 
that need to be addressed for the new CB structure, propose 
strategies and solutions and timelines for implementation, 
effect a uniform transformation with minimum disruption of core 
functions, and keep the ICD in the loop. We were told that this 
new organization would save 80 FTE although it was not clear 
whether this was just from the CB reorganization or the whole 
field reorganization. We were not given any charts to 
demonstrate how these FTE would be saved.
    The ICD gave an approximate June 1, 2007 due date for a 
finished report from both projects.
    I actively worked in both groups. I was specifically on the 
compliance merger committee personnel and resource management 
workgroup, which reviewed the impact of the merger on personnel 
and ways to operate the new structure. This was one of seven 
groups in the compliance merger committee. It was around that 
time that we learned where the ten CBs would be located: PHI-
DO, DET-DO, SEA-DO, KAN-DO, DAL-DO, ATL-DO, FLA-DO, NYK-DO, 
NWE-DO, and LOS-DO. We were not told the reason for locating 
the CBs in these district offices.
    Our work on the district merging document indicated 
problems with the proposed new structure. We understood we were 
to work with the structure proposed because it had already been 
agreed to by ACRA Glavin. However, in reviewing the plan, there 
were some glaring issues with the boundaries and locations of 
the main offices. For example, it was clear to our group of DDs 
that KAN-DO should not be the district office site because it 
was on the extreme eastern edge of the new merged over 1000 
mile across district that stretched through Utah; with Missouri 
going to CHI-DO, the split of the Kansas City inventory left 
little to be covered in the new DEN/KAN merged district, and 
inventory and case work shifted west making Denver the logical 
site for a district office.
    Other questions came to mind:

     How would CHI-DO cover western Missouri firms with 
the current major office located and staffed in Lenexa?
     Should CHI-DO and KAN-DO have a partnership for 
KAN-DO to do the work for CHI-DO because it would save 
resources?
     Should CHI-DO have a small group of employees 
housed in the same office with the KAN-DO employees to do the 
work?

    The complications and loss of efficiency in trying to make 
a border between Missouri and Kansas begged the question, why 
was Missouri put in CHI-DO and not kept with KAN-DO?
    This led to a concern that there may be other unknown 
efficiencies related to the reorganization because we had not 
had time to look at all the issues. The problem we found may 
have been avoided and possibly a better reorganization proposed 
if the group devising this plan had consulted the people who 
have the most knowledge of their districts--the DDs who manage 
them and their staff--before proposing the reorganization.
    In the compliance merger committee meeting, which consisted 
of DCBs and DDs, we found it was difficult to proceed because 
our project was related to the results of other groups' 
projects such as the import group project. Our concern was we 
could be making decisions in a vacuum that may not coincide 
with another groups' decisions. The leader of our committee 
mentioned this concern to the ICD team. He reported back to us 
that we were just to continue our work.
    Because of these concerns, the compliance merger 
committee's personnel and resource management work group, of 
which I was a member, submitted a document recommending that 
the reorganization be implemented by sequencing. We recommended 
that HQ be reorganized first, the districts next, with the 
compliance branches last. We questioned whether this proposal 
was the best fit and suggested a CB in each district to avoid 
conflicts with duel district management structures. We were 
concerned that having a CB reporting to one DD but doing work 
for up to three districts could create conflicts in case 
management. Who ultimately decides which cases have priority 
and which cases will go forward? We noted that the 
reorganization did not resolve the issue of the disparity of 
district and CB size, which we had been told at the February 
Senior Staff meeting, was the driving factor. Districts and CBs 
still varied greatly in size. Under the reorganization plan, 
some DCBs have as many as 17-18 employees reporting to them 
while others have as few as 10. Currently, on an average, eight 
employees report to a DCB. I am not aware that our document was 
addressed by the ICD team although I was told at least two of 
the three ICD members saw it.
    Furthermore, geographic dispersion of such a large 
supervisory group would only complicate matters. Managing this 
many employees would be difficult because they would be located 
in up to three offices, separated by hundreds of miles with the 
increased geographical area resulting from the mergers. This 
was noted as a grave concern in compliance merger committee 
discussions. Their report noted that employee morale is already 
being affected by the proposed reorganization because employees 
do not know where or what their next job is or will be.
    In addition, ORA headquarters has expressed concern about 
the decrease in ORA's enforcement actions. Most of the field 
managers believe the CB merger will result in a further 
decrease. The DCB will have more employees' work to review and 
they may be located in up to three offices separated by wide 
geographical distances. It will also make interacting with 
firms much more difficult because they will be located further 
from the DCB (and DD where the districts have merged).
    My discussions with other DDs and DCBs confirm widespread 
belief that these are major concerns for the workability of the 
CB merger. Furthermore, the role of the DCB has not been 
defined relative to ORA headquarters Office of Enforcement.
    Regarding the field reorganization plan as a whole, I have 
the following concerns:

     It appears to be threatening our relationships 
with the states with which we often leverage resources.
     I understand that one of the states moving into 
CHI-DO has threatened to discontinue their inspection contracts 
with FDA unless they can continue to work with the KAN-DO 
employee. Loss of these vital inspections from any state places 
even more pressure on our districts.
     After the Association of American Feed Control 
Officials Board of Directors was briefed on the reorganization 
in the spring, concern was expressed about the distance they 
would be from FDA employees they need to work with on a 
continuous basis.
     Both Kentucky and Ohio State officials have told 
me that they prefer to have the district office remain in the 
much closer Cincinnati, OH.
     This is resulting in a disruption of important 
cultural and long term working ties the states have with the 
district they have been in.
     There has been no clarification of duties for the 
managers of these structures, and given the restructure, it is 
likely that many of the positions are not supportable under 
Office of Personnel Management (OPM) rules.
     Headquarters staffs appear to be building at the 
expense of the field forces which do the core functions of 
inspections, investigations, sampling and analysis.
     Lines of authority will be muddled due to cross 
servicing of the compliance units and integration of directions 
from headquarters in the import programs. Daily activities at 
the field level cannot wait for decisions and directions out of 
distant units, be they a consolidated compliance function or an 
import entry review unit directed by HQ.
     There is speculation that the development of only 
ten CBs is a prelude to reducing district offices further to 
ten. However, like most of the decisions on this 
reorganization, there is no open discussion on their basis and 
ultimate direction. We were told the plan would go until 2011 
so other changes must be under consideration.
     The current proposal could reduce our 
effectiveness at regulating an ever expanding and growing 
industry. ORA needs solid and effective leadership at all 
levels in the organization. We need managers and leaders who 
are well informed and conversant on the issues and compliance 
profile of firms around the country. Each state has its way of 
doing business; each industry has its characteristics. It is 
not the number of 50 investigators that should dictate the size 
of a district. Factors to use are industry concentrations; 
number of states; population centers; border coverage and type; 
cultural similarities of the states within the district; size 
of the various industries; travel distances; industry start up 
plans; and states prone to natural emergencies such as 
hurricanes. I believe it would be impossible to understand the 
implications of these factors from headquarters. And, it is not 
just about making decisions for a one-time reorganization. It 
is about the daily decisions that need to be made to manage our 
regulatory operations.
     The proposed reorganization will create confusion 
of direction, delay in implementation of programs, and sever 
many of our current working relationships with critical state 
and local governments and industry groups. Oversight of daily 
work will be difficult if not unachievable due to the overly 
wide span of control of the remaining managers. Concerns for 
quality of work do not appear to be addressed with this 
reorganization. We should not be making district offices larger 
and then correcting any problems with quality of work by adding 
more FTE in headquarters to review and correct it. We should 
address work quality issues where they originate.
     There is nothing to indicate that this proposal 
will result in our better serving our constituencies--the 
states, the industry, the broker and importer community and, 
ultimately, the consumer.
    Furthermore, I am concerned that there is no indication 
that this reorganization will strengthen the way we regulate 
industry. As our emergencies have shown, we need to do a better 
job of regulating industry. I have not seen that any revisions 
made in the plan to strengthen our regulation of industry to 
prevent emergencies. Instead the reorganization continues as 
told to us in February--several districts will be increased in 
size and the number of CBs will be reduced. Those, who will be 
managing the emergencies locally, will have more industry to 
cover and thus greater potential for multiple emergencies and 
recalls, more cases to review and more personnel issues and 
union issues to resolve. They will be spread very thin, 
resulting in their having less time to concentrate on the work 
of consumer protection.
    I am also concerned that many employees (managers and non 
managers) will retire or leave ORA because they disagree with 
the reorganization This will result in a mass loss of 
institutional knowledge and expertise at a time when the agency 
is trying to be proactive in our operations to prevent more 
emergencies. Then, couple that with a current increase in 
hiring and not having these experts to mentor and train the new 
hires while we carry on the daily business of consumer health 
protection.
    These issues must be considered if FDA's public health 
mission is to be sustained.
    This concludes my formal statement.
                              ----------                              

    Mr. Stupak. Thank you. For Members, we are going to try to 
get Ms. Collins' testimony in before we break for a vote. We 
have three votes on the floor. Ms. Collins, if you would for 5 
minutes please, and your full statement will be entered in the 
record.

  TESTIMONY OF B. BELINDA COLLINS, DIRECTOR, DENVER DISTRICT, 
                  FOOD AND DRUG ADMINISTRATION

    Ms. Collins. Mr. Chairman, distinguished members of the 
committee, I am the director of the Denver district office of 
the Food and Drug Administration, which includes the Denver 
district laboratory. I have been responsible for the operations 
of this office for a little over 5 years.
    I would like this committee to know that the Denver 
district employees are dedicated to the public health mission 
of the agency for the good of all American consumers. The work 
we do for the agency begins when our investigators conduct 
investigations regulated industry to determine their compliance 
with the regulations we enforce.
    The Denver district investigations branch has been 
operating with approximately 50 percent of the investigators 
needed to get the work done, and that is mandated by the 
agency. Despite that diminished staffing, Denver district has 
consistently met and even exceeded those goals based on their 
employees' determination and dedication.
    They have worked tirelessly to get the job done. They put 
their personal lives in abeyance to respond to national 
emergencies, such as the recent findings of melamine in pet 
food. During the melamine emergency, Denver district's animal 
drug research center developed a scientific method for 
detecting the presence of melamine and its analogs in animal 
tissue. Within 72 hours from the start of that process, the 
method was validated and shared with other FDA and private 
laboratories and was distributed internationally. This 
technology was not available prior to its development in the 
Denver district.
    Mr. Chairman, I am very proud to be working with this very 
dedicated and talented staff of investigators, scientists, and 
managers. As part of the proposed FDA reorganization, the 
Denver district office is scheduled to merge with Kansas City 
district on October 1 of this year. This reorganization will 
affect employees who work in the investigations branch, the 
laboratory branch, and those in my immediate office, and will 
include the reassignment of job functions.
    The next milestone in the reorganization will be the 
closure of the Denver district laboratory. The approximately 50 
employees of the laboratory have told me they will not leave 
the Denver area. The loss of the laboratory staff will result 
in a significant shortage of expertise and skill. The same can 
be said for the other district employees who will be reassigned 
to other positions.
    The result of such a reorganization will result in a brain 
drain within the FDA field organization. The work that the 
Denver district laboratory does cannot be successfully 
accomplished with novice employees that will be hired to 
replace our scientists, as has been proposed. It is important 
to note that it takes a minimum of 3 years for an analyst or an 
investigator to become trained to conduct the complex work that 
we do. At a time when our baby boomers are retiring from 
Federal service in record numbers, it would be a travesty to 
lose the institutional knowledge of the seasoned and 
experienced field staff members that we do have.
    The Denver laboratory is a go-to laboratory in this agency. 
We are efficient, cost-effective, and scientifically solid. We 
were the leader in laboratory accreditation for FDA 
laboratories. And once accredited, the Denver district 
laboratory served as the gold standard of accreditation for all 
other laboratories in the agency.
    I am confident that without the Denver laboratory, the food 
we eat as well as the human and animal drugs we use would be 
much less safe. Thank you, Mr. Chairman.
    [The prepared statement of Ms. Collins follows:]

                    Testimony of B. Belinda Collins

    I am the Director of the Denver District Office of the Food 
and Drug Administration, which includes the Denver District 
Laboratory. I have been responsible for the operations of this 
office for over five years.
    I would like this Committee to know that the Denver 
District employees are dedicated to the public health mission 
of this agency, for the good of all American consumers.
    The work we do for the agency begins when our investigators 
conduct inspections of regulated industry to determine their 
compliance with the regulations we enforce. The Denver District 
Investigations Branch has been operating with approximately 50 
percent of the investigators needed to meet the performance 
goals mandated by the Agency.
    Despite that diminished staffing, Denver District has 
consistently met and even exceeded those goals, based on their 
employees' determination and dedication. They have worked 
tirelessly to get the job done. They put their personal lives 
in abeyance to respond to national emergencies such as the 
recent findings of melamine in pet food.
    During the melamine emergency, Denver District's Animal 
Drug Research Center (ADRC) developed a scientific method for 
detecting the presence of melamine and its analogs in animal 
tissue. Within 72 hours from the start of that process, the 
method was validated and shared with other FDA and private 
laboratories, and was distributed internationally. This 
technology was not available prior to its development in the 
Denver District.
    Mr. Chairman, I am very proud to be working with this very 
dedicated and talented staff of investigators, scientists and 
managers. As part of the proposed FDA reorganization, the 
Denver District Office is scheduled to merge with the Kansas 
City District on October 1 of this year. This reorganization 
will affect employees who work in the Investigations Branch, 
Laboratory Branch, and those in my immediate office, and will 
include the reassignment of job functions.
    The next milestone in the reorganization will be the 
closure of the Denver District Laboratory. The approximately 50 
employees of the laboratory have told me that they will not 
leave the Denver area. The loss of the laboratory staff will 
result in a significant shortage of expertise and skill. The 
same can be said for the other district employees who will be 
reassigned to other positions. The result of such a 
reorganization will result in a brain drain within the FDA 
field organization.
    The work that the Denver District Laboratory does cannot be 
successfully accomplished with novice employees who will be 
hired to replace our scientists, as has been proposed. It is 
important to note that it takes a minimum of three years to for 
an analyst or investigator to become trained to conduct the 
complex work that we do. At a time when our baby boomers are 
retiring from Federal service in record numbers, it would be a 
travesty to lose the institutional knowledge of the seasoned 
and experienced field staff members.
    The Denver Laboratory is a ``Go To'' lab in this agency. We 
are efficient, cost effective and scientifically solid. We were 
the leader in laboratory accreditation for FDA laboratories. 
Once accredited, the Denver District Laboratory served as the 
``gold standard''of accreditation for all other laboratories in 
the Agency.
    I am confident that without the Denver laboratory, the food 
we eat as well as the human and animal drugs we use would be 
much less safe.
    Thank you, Mr. Chairman and Distinguished Committee 
Members.
                              ----------                              

    Mr. Stupak. Well, thank you, and thank you for your brief 
statement. We are going to recess probably about 20 minutes. We 
have three votes on the floor. We will be back in about 20 
minutes. Thank you.
    [Recess.]
    Mr. Stupak. Sorry about the interruption. We will get back 
to it. We are not supposed to have votes for a couple hours, so 
hopefully we can move right along. Let us see, Ms. Collins. Dr. 
Adams, you will be next for your opening statement. I remind 
the witnesses you are still under oath. Dr. Adams, if you would 
please your opening statement.

TESTIMONY OF ANN M. ADAMS, DIRECTOR, KANSAS CITY DISTRICT LAB, 
                  FOOD AND DRUG ADMINISTRATION

    Ms. Adams. Mr. Chairman and distinguished members of the 
committee, I am Dr. Ann Adams, director of the Kansas City 
district laboratory located in Lenexa, KS. The lab and district 
office in centrally located in our country. In addition to many 
drug firms and agricultural industries, the Kansas City area is 
home to an international railroad center and two more smart 
ports under development, both within an hour's drive from the 
lab.
    These centers are intended to unload and distribute imports 
which will be directly shipped to the KC area from San Diego 
and the west coast Mexico prior to their introduction to the 
domestic commerce. The largest FedEx trucking center is about 
10 miles from the lab. We are about 35 miles from the Kansas 
City International Airport, which is also developing a large 
distribution center.
    My lab relocated to its present location in 1992 and was 
remodeled in 2001. We are well equipped with numerous 
scientific instruments, including approximately $2 million 
worth of equipment purchased in 2002. A large portion of that 
equipment expanded and enhanced our ability to respond to 
emergencies and to terrorist events. We are the sixth largest 
lab in ORA with about 56 employees in the lab branch with three 
chemists and a total diet research center.
    We are a full service chemistry lab, analyzing both human 
and animal drugs and foods. We are ISO-17025 accredited for 
numerous programs, including drugs, dioxins, micotoxins, 
elemental analysis, pesticide residues, industrial chemicals 
such as acrilymide, perchlorates and now melamine, and the 
total diet study.
    My lab also provides chemists for participation in both 
foreign and domestic drug inspections and for the deployment of 
FDA's chemistry mobile lab. We are the national center for the 
total diet study, coordinating, processing, and analyzing four 
collections a year, each containing about 280 separate food 
items from around the country for volatile organic compounds, 
over 350 pesticide, herbicide, and fungicide residues, toxic 
elements, such as lead, cadmium, arsenic, and mercury and 
nutritional elements including iodine, calcium, sodium, and 
magnesium.
    We have also analyzed samples for acrilymide and 
perchlorates. We provide total diet samples to three other ORA 
labs for analysis of folic acid, dioxins, and radiological 
elements. The total diet study began in 1961 and has become a 
complex and unique program by which the actual consumption of 
residues and elements from common foods in the American diet 
can be monitored. Foods are purchased from grocery stores and 
prepared as if they are to be consumed by the public.
    Each year, we analyze over 1,100 samples and report over 
45,000 data points in this program alone. These data are used 
by toxicologists, nutritionists, and other scientists in FDA, 
USDA, academia, and other organizations for their studies. Our 
program is recognized by the WHO as the standard for other 
countries to model their programs. We have regularly 
participated in the International Total Diet meetings sponsored 
by WHO, providing guidance and instruction to numerous 
countries in various stages of developing their own programs. 
Many countries have sent their analysts to our lab for 
training, including Australia, Canada, Kuwait, New Zealand, 
Pakistan, Sweden, the Philippines, and Saudi Arabia.
    We also have a research center with a primary mission to 
develop or improve methods for the total diet study. Many of 
these methods have been published, validated, and incorporated 
into other FDA State and national programs in addition to the 
total diet.
    Our lab is one of two ORA labs which analyzes for dioxins. 
We have four chemists working our dioxin program analyzing for 
dioxins, furiens and PCBs in fish and shellfish. Our analysis 
group tests regulatory samples of human and animal foods and 
ceramicware for toxic elements.
    Our micotoxin group analyzes 800 to 1,000 samples a year of 
various grains, nuts, apples, and finished products for toxins 
produced by molds. And lastly, our drug lab analyzes a wide 
variety of human and veterinary pharmaceutical products and 
participates in FDA's drug survey program. We participate in 
both foreign and domestic drug inspections providing expertise 
for the evaluation of labs in drug firms. Thank you very much.
    [The prepared statement of Ms. Adams follows:]

                       Statement of Ann M. Adams

    Good Morning. I'm Dr. Ann Adams, Director of the Kansas 
City District Laboratory located in Lenexa, Kansas. The lab and 
district office is centrally located in our country. The Kansas 
City area is home to an international railroad center and 2 
more Smart Ports under development--both within an hour's drive 
from the lab. These centers are intended to unload and 
distribute imports which will be directly shipped to the KC 
area from San Diego and the west coast of Mexico. The largest 
FedEx trucking center is about 10 miles from the lab. We're 
also about 35 miles from the Kansas City international airport 
which is also developing a large distribution center.
    My lab relocated to its present location in 1992 and was 
remodeled in 2001. We are well equipped with numerous 
scientific instruments including approximately $2 million worth 
of new equipment in 2002. A large portion of that equipment 
expanded and enhanced our ability to respond to emergencies or 
terrorist events.
    We are the sixth largest lab in ORA with about 56 employees 
in the lab branch and three chemists in the Total Diet Research 
Center. We are a full service chemistry lab, analyzing both 
human and animal foods and drugs. We are ISO 17025 accredited 
for numerous programs including drugs, dioxins, mycotoxins, 
elemental analysis, pesticide residues, industrial chemicals 
(such as acrylamide, perchlorates and melamine), and the Total 
Diet Study. My lab also provides chemists for participation in 
both foreign and domestic drug inspections, and for the 
deployment of FDA's mobile chemistry lab.
    We are the national center for the Total Diet Study--
coordinating, processing, and analyzing four collections a 
year, each containing about 280 separate food items from around 
the country for volatile organic compounds; over 350 pesticide, 
herbicide, and fungicide residues; toxic elements such as lead, 
cadmium, arsenic, and mercury; and nutritional elements 
including iodine, calcium, sodium, and magnesium. We have also 
analyzed samples for acrylamide and perchlorates. We provide 
Total Diet samples to three other ORA labs for analysis of 
folic acid, dioxins, and radiological elements.
    The Total Diet Study began in 1961 and has become a complex 
and unique program by which the actual consumption of residues 
and elements from common foods in the American diet can be 
monitored. Foods are purchased from grocery stores and prepared 
as if they are to be consumed by the public. Each year we 
analyze over 1100 samples and report over 45,000 data points in 
this program. These data are used by toxicologists and 
nutritionists in FDA, USDA, in academia, and other 
organizations in their exposure studies.
    Our program is recognized by the WHO as the standard for 
other countries to model their programs. We have regularly 
participated in the international Total Diet meetings sponsored 
by WHO, providing guidance and instruction to numerous 
countries in various stages of developing their own programs. 
Many countries have sent their analysts to our lab for 
training, including Australia, Canada, Kuwait, New Zealand, 
Pakistan, Sweden, the Philippines, and Saudi Arabia.
    We also have a research center with a primary mission to 
develop or improve methods for the Total Diet Study. Many of 
these methods have been published, validated and incorporated 
into other FDA, state and national programs in addition to the 
Total Diet.
    Our lab is one of two in ORA which analyzes for dioxins. We 
have 4 chemists working in our dioxin program analyzing for 
dioxins, furans, and PCBs in fish and shellfish. They also 
analyze dietary supplements and vitamins that contain fish oil 
for these contaminants. With these data, FDA can perform risk 
assessments comparing the benefits versus the exposure levels. 
This program is important to FDA and the American public 
because even at low levels, these chemicals can increase rates 
for cancer and birth defects.
    In addition to Total Diet samples, our elemental analysis 
group tests regulatory samples of human and animal foods and 
ceramic ware for toxic elements. We are one of the primary 
servicing labs for metals for FDA's import district. We analyze 
many samples of imported products including seafood, candies, 
snacks, seasonings, and juices for toxic elements, particularly 
lead and mercury.
    Our mycotoxin group analyzes 800 to 1,000 samples a year of 
various grains, nuts, apples and finished products for toxins 
produced by molds. Mycotoxins can cause cancer, liver damage, 
reproductive failure, and even death. Our lab is currently the 
only lab in ORA analyzing for fumonisins in cereal products. 
These mycotoxins can cause neurotoxic effects in animals, 
particularly in horses.
    Lastly, our drug lab analyzes a wide variety of human and 
veterinary pharmaceutical products and participates in FDA's 
drug survey program. We participate in both foreign and 
domestic drug inspections, providing expertise for the 
evaluation of labs within drug firms.
                              ----------                              

    Mr. Stupak. Thank you. Dr. Jacobs, do you have an opening 
statement, sir?
    Mr. Jacobs. Yes.

    TESTIMONY OF RICHARD JACOBS, CHEMIST AND TOXIC ELEMENT 
     SPECIALIST, SAN FRANCISCO DISTRICT LAB, FOOD AND DRUG 
                         ADMINISTRATION

    Mr. Jacobs. Good afternoon. My name is Richard Jacobs. I am 
a chemist with the laboratory branch of the San Francisco 
district. I have 44 years of Government service, 40 of which 
were spent with the FDA. I was located at Su San for 19 years 
and in the field activities since that time. Thank you for this 
opportunity to bring to your attention those critical 
capabilities and functions that the San Francisco district 
laboratory provides, not only the agency but our partners in 
public health to the public in general and to our commercial 
industry.
    Our lab is 17025 accredited. Our scientific staff include 
10 chemists, 14 microbiologists, and 3 biologists, and 1 
technician. Many of our scientists have advanced degrees. Some 
have doctoral degrees. While our laboratory management staff 
includes a science director supervising analysts and a district 
quality assurance manager, the laboratory lacks a sample 
custodian and safety officer, glassware, dishwasher, and two 
media prep technicians. And those duties are presently being 
performed by scientific staff.
    Additionally, we have lost several journeymen scientists in 
the last year that haven't been replaced. With the exception of 
filth analysis, drug analysis, and micotoxin and pesticide 
analysis, our lab covers the rest of the program in field 
program areas.
    Our lab houses two specialty functions for the Pacific 
region: toxic elements and food and color additives. I believe 
that the closure of our laboratory facility will lead to a 
critical loss of expertise, functionality, and capacity in 
certain programs, some of which will never be regained. 
Critical relationships with the State of California that will 
be lost without having FDA analytical experts nearby are also 
critical. Our laboratory has been a pioneer in introducing many 
technologies to the field. Examples include elemental analysis 
techniques such as ICP mass spec, XRF, which is x-ray 
fluorescence spectrometry, and methods to actually measure 
mercury and methyl mercury in seafood.
    Our laboratory is piloting the use of x-ray fluorescence 
devised by investigators in field examination of hazardous 
levels of toxic elements in food, Asian, herbal, and patent 
medicines. This device can detect certain elements in a matter 
of seconds with little or no preparation of the sample.
    Together with State of California, our group was 
instrumental in developing information to support new policy 
with regard to lead in candy. The laboratory performs seafood 
sensory analysis, widely used for detection of spoilage in 
imported seafood as well as analyzing for histamine and indull, 
two compounds that are indicative of microbiological spoilage.
    Our local analytical presence and the participation of 
analysts and inspections are essential for having impact on the 
local and import seafood industry. San Francisco district also 
has a unique expertise in interric viral analyses, especially 
norwal virus and hepatitis A. Analytical methods for these two 
viruses are in preparation for in-laboratory validation.
    Over recent years, numerous outbreaks of norwal virus 
indicate a need for sensitive method for detection of this 
virus on foods and in food handling environments. The San 
Francisco district laboratory contribute very importantly to 
the detection of E. coli 015787 in last year's investigation of 
spinach and later on an outbreak found to be in lettuce.
    This laboratory performed approximately half of the 900 
samples analyzed by Bay area laboratories and found several 
strains that were linked to clinical cases using PULSENET. 
Outbreak investigations would be severely hampered by not 
having analysts and analytical activity available locally. 
Moreover, many microorganisms, for example E. coli 015787 can 
be negatively affected by shipping practices. So having a 
nearby lab where samples can be delivered in a few hours is 
critical.
    Our microbiology section is capable of handling all food-
related pathogen detections and is the only laboratory in the 
Pacific region able to analyze drugs and medical devices for 
sterility and mematoxin. The laboratory is well-equipped for 
many analytical programs and state of the art for microbiology 
and toxic elements. Aside from the typical equipment, we have 
clean facilities for sterility testing of drugs and medical 
devices and toxic element testing.
    We also have special sample preparation rooms, equipment, 
rooms specifically designed for viral analytical methods and a 
BSL2 suite illustrates its CDC standards for working with 
several select agents. We possess a number of other analytical 
equipment that gives us flexibility such as responding to the 
recent melamine related compound outbreak in pet foods.
    As a member of FERN and the CDC's laboratory response 
network, our laboratory heavily contributes to the national 
trading programs, and most of our analysts are very well 
trained. The laboratory collaborates and maintains contacts 
with the California Department of Health Services and their 
subservient agencies, the USDA and the Lawrence Liverbore 
National Laboratory and the University of California at Davis. 
Thank you.
    [The prepared statement of Mr. Jacobs follows:]

                     Testimony of Richard M. Jacobs

    Good morning. My name is Richard Jacobs, and I am a chemist 
with the Laboratory Branch of the San Francisco District. I 
have 44 years of Government service, 40 of those have been with 
the FDA. Most of my career has involved the work with the 
essential and non-essential elements.
    Thank you this opportunity to bring to your attention those 
critical capabilities and functions that the San Francisco 
District Laboratory Branch provides not only the agency, but to 
our partners in public health, to the public in general, and to 
our local commercial industry.
    The San Francisco lab is: Q03
     ISO 17025 accredited.
     Lab scientific staff includes 10 chemists, 14 
microbiologists, 3 biologists, and 1 technician. Many of our 
scientists have advanced degrees. Some have doctorates.
     While laboratory management staff includes a 
Science Branch Director, 3 supervisory analysts, and a district 
quality assurance manager, the laboratory is currently lacking 
a sample custodian, a safety officer, glassware washer, and 2 
media preparation technicians. Those duties are presently being 
performed by scientific staff. Additionally, we have lost 
several journeyman scientists in the last year that haven't 
been replaced.
     With the exception of filth analysis, drug 
analysis, mycotoxin analysis, and pesticide analysis our lab 
covers the rest of the field program areas.
     Our lab houses two specialty functions for the 
Pacific Region: Toxic Elements (in foods and ceramicware) and 
Food and Color Additives.
    I believe that the closure of our laboratory facility will 
lead to a loss of critical expertise, functionality, and 
capacity in certain critical programs, some of which may never 
be regained. Critical relationships with the State of 
California will be lost without having certain FDA analytical 
experts nearby:
     Our lab has been a pioneer in introducing many new 
technologies to the field. Examples include elemental analysis 
techniques such as ICP-MS, XRF techniques, and methods to 
accurately measure mercury and methylmercury in seafood.
     Our group is piloting the use of X-Ray 
Fluorescence by investigators in the field to detect 
potentially hazardous levels of toxic elements in foods and 
Asian herbal and patent medicines. This device can detect 
certain elements in a matter of seconds with little or no 
preparation of the product.
     Together with the State of California our group 
was instrumental in developing information to support new 
policy regarding lead in candy.
     The laboratory performs seafood sensory analysis, 
widely used for detection of spoilage in imported seafood, as 
well as analyzing for histamine and indole, two compounds 
indicative of microbial spoilage. A local analytical presence 
and the participation of analysts in inspections are essential 
for having impact on the local domestic and the import seafood 
industry.
     San Francisco district laboratory also has unique 
expertise in enteric viral analyses, especially Norwalk Virus 
and Hepatitis A. Analytical methods for these two viruses are 
in preparation for inter-laboratory validation. Over recent 
years, numerous outbreaks of Norwalk Virus indicate a need for 
a sensitive analytical method for detection of this virus on 
foods and in food handling environments.
     The San Francisco district laboratory contributed 
very importantly to the detection of Escherichia coli O157:H7 
in last year's investigation of the incidence of clinical 
infections due to this organism traced to spinach, and later, 
in a different outbreak, to lettuce. This laboratory performed 
about half of the approximately 900 samples analyzed in the San 
Francisco Bay Area and found several strains which were linked 
to clinical cases using PULSENET. Indeed, one isolate matched 
about 63 clinical cases that had not previously been identified 
by the CDC as an outbreak and which occurred during the 
previous summer. Outbreak investigations would be severely 
hampered by not having analysts and an analytical activity 
available, locally. Moreover, many microorganisms, e.g. E. coli 
O157:H7, can be negatively affected by commercial shipping 
practices. So having a nearby lab where the samples can be 
delivered in a few hours is critical.
     The Microbiology section is capable of handling 
all food related pathogen detections and it is the only 
laboratory in the Pacific Region able to analyze drugs and 
medical devices for sterility and endotoxins.

    The laboratory is well equipped for many analytical 
programs. It is ``state of the art'' equipped for Microbiology 
and Toxic Elements:
    Aside from the typical equipment the lab is equipped with:

     Clean room facilities for sterility testing for 
drugs and medical devices and toxic element testing.
     Specialized sample preparation rooms and 
equipment.
     Room for specifically studying viral analytical 
methods
     A BSL2+ suite and ten analysts trained to CDC 
standards for work with several select agents.
     Possession of analytical chemistry equipment 
allowing flexibility in adapting to novel analytes, such as, 
currently, melamine and related compounds (cyanuric acid, 
ammelide and ammeline).

    The lab is a member of FERN (microbiology, toxic elements) 
and CDC's Laboratory Response Network. San Francisco analysts 
have participated in training elemental analysis, E. coli 
O157:H7, FERN (Food Emergency Response Network) methods, Select 
Agent analytical methods, basic microbiology FDA analytical 
methods and Mobile Laboratory Training.
    The laboratory actively collaborates or maintains contacts 
with the California Department of Health Services, USDA, the 
Lawrence Livermore National Laboratory and the University of 
California at Davis.
    Thank you again Mr. Chairman for this opportunity, I will 
be glad to answer any questions that you or the other committee 
member might have.
                              ----------                              

    Mr. Stupak. Thank you, Dr. Jacobs. Mr. Clavet, opening 
statement please.

    TESTIMONY OF CHARLES CLAVET, MICROBIOLOGIST, WINCHESTER 
       ENGINEERING AND ANALYTICAL CENTER, FOOD AND DRUG 
                 ADMINISTRATION, WINCHESTER, MA

    Mr. Clavet. Good afternoon, Chairman Stupak, Ranking Member 
Whitfield, and members of the subcommittee. I thank you for 
your interest in allowing me this valuable opportunity to speak 
on behalf of my friends and colleagues at the Winchester 
Engineering and Analytical Center and the citizens of the 
Nation at this critical juncture, at a time when the Office of 
Regulatory Affairs is redefining its commitment to its mandated 
public health mission.
    My name is Charles Clavet, and I have worked for the past 
16 years as a microbiologist at the Winchester Engineering and 
Analytical Center, which is located in Winchester, MA. I would 
like to take this time to briefly describe many of the unique 
public health functions and capabilities WEAC possesses and to 
discuss openly our concerns and questions regarding the 
impending laboratory closures.
    The closing of WEAC and subsequent loss of virtually all 
analysts will have an impact on ORA's ability to continue to 
fulfill its public health mission. In order to comprehend the 
full impact of losing this facility and personnel, it is 
imperative that the wide range of WEAC's capabilities be made 
known. In fact, the list of capabilities and interactions is so 
extensive and impossible to cover in the time allotted that I 
would like to submit for the record several documents that 
elaborate upon WEAC's immense contribution to ORA's mission.
    WEAC is a truly unique laboratory asset with many 
experienced, motivated scientists, radio chemists, chemists, 
biologists, microbiologists and engineers working in harmony to 
provide specialized analytical capabilities utilizing their 
respective disciplines. We are an American Association of 
Laboratory Accreditation, 82L8, certified ORA field laboratory 
that specializes in regulatory testing of foods for 
radionuclides and the analysis of medical devices for safety 
and efficacy. This accreditation would not easily be 
transferable to another location without the associated 
movement of the personnel currently performing this work.
    WEAC Laboratory provides services to the Center for Food 
Safety and Applied Nutrition, the Office of Criminal 
Investigation, the Center for Devices and Radiological Health, 
States and local governments with a legacy of proven 
performance in fulfilling ORA's public health mission while 
continuously enduring budget constraints.
    WEAC is the only facility that has full analytical 
capability and expertise for the analysis of foods for the 
detection of gamma, beta, and alpha contamination. WEAC holds 
the only Nuclear Regulatory Commission license and handles 
radiation equipment, calibration, and radiation safety training 
for all ORA field personnel. WEAC is the sole laboratory 
providing food expertise to the CDC, the EPA, the Department of 
Defense, the USDA, and the Department of Homeland Security 
under the Interagency of Consortium of Laboratory Networks.
    WEAC has a memorandum of understanding with USDA Food 
Safety Inspection Service for the radionuclide analysis of 
USDA-regulated products in case of an emergency. WEAC also has 
an MOU with the United States Department of State and 
Department of Energy. If WEAC closes, the NRC license will have 
to be reestablished, and all current radiological arrangements 
and agreements will be cancelled.
    In addition to our radionuclide specialty, WEAC is the 
servicing lab for the Center for Devices and Radiological 
Health, providing a wide range of engineering and analytical 
capabilities--microbiological, biological, and chemical--for 
medical device evaluation. Historically, CDRH has relied 
heavily on the scientific and regulatory expertise of WEAC and 
anticipates both continuing and growing needs into the 
foreseeable future. For this reason, CDRH has requested that 
ORA commit a single physical laboratory site to the CRH work 
plan and method development goals.
    We are confused. The continuous flow of rhetoric does not 
agree with the actions. On one hand, we have been praised for 
our commitment, our dedication, and knowledge and skills that 
we possess. There is talk about the need for retention and 
recruitment, yet when 100 new positions were recently made 
available, personnel at the affected laboratories were excluded 
from applying for these jobs. One high level ORA manager from 
the TLT committee States that we are committed to going outside 
the agency. An FDA spokesperson says ultimately we want new 
people and new equipment.
    Why was this done? I can tell you, Mr. Chairman, the 
puzzlement I have expressed is not solely mine but is shared by 
my colleagues and peers at WEAC. I have discussed this with the 
elected leaders of NTEU, our union at WEAC, and with many of 
the dedicated professionals I work with. None of us see any 
merit in the lab closure proposal. NTEU officers have been in 
communication with employees at other labs proposed for 
closure, and their views are the same.
    In conclusion, as I prepared this testimony, I began to 
realize that it was going to be very difficult to articulate 
and convey the complete picture of WEAC and its personnel in 5 
minutes. I came to the realization that I could only highlight 
some of its responsibilities, contributions, and interactions 
that occur on a daily basis as this group of dedicated 
scientists carry out ORA's public health mission. The more time 
I spent on trying to condense the information, the more puzzled 
I became. Why would anyone want to close this facility? At this 
point in time, Mr. Chairman and members of this subcommittee, 
WEAC's fate is in your hands. I hope you can find a way to 
allow WEAC to continue its vital public health service to the 
citizens of this Nation, and I would be happy to answer any 
questions members of the committee may have. Thank you.
    [The prepared statement of Mr. Clavet follows:]

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    
    Mr. Stupak. Thank you, and thank you all for your 
testimony. We will begin questioning. Ms. DeWaal, you indicated 
that China is one of the leading suppliers of U.S. agricultural 
and seafood imports. In fact, Canada is No. 1, Mexico is No. 2, 
and China is No. 3. But then you are talking about the 
rejections and food problems. I find that Mexico, which is No. 
1 in rejections, but India is No. 2. Why India?
    Ms. DeWaal. India probably for the same reason that China 
is having so many problems. They don't have regulatory 
structures nationally that would help to ensure that the food 
products they are shipping to us are of a quality that meets 
the standards for U.S. consumers.
    Mr. Stupak. But if the quality is voluntary, the standards 
are voluntary, what basis do you reject it then? There has to 
be something more than just voluntary standards.
    Ms. DeWaal. They can find problems, for example, with 
filth. If products are coming in with visible filth, clearly 
they can reject for that matter.
    Mr. Stupak. Is it salmonella in Indian spices?
    Ms. DeWaal. Yes, sometimes they find problems with 
salmonella, which again for ready-to-eat product shouldn't be 
there. So even without those mandatory standards, but really 
the best thing, the best system would be one where we had 
mandatory standards and on-site, in-country review.
    Mr. Stupak. Correct. To the lab directors, Ms. Heppe, Ms. 
Collins, Dr. Adams, Dr. Jacobs, Ms. Clavet, any reasons given 
why your lab was chosen to close? Can anyone particulate a 
reason? I didn't hear any in the testimony.
    You are all silent, so I take it no one has an answer. Dr. 
Adams, it has been mentioned to me that Kansas City lab played 
a prominent role in the wheat gluten case. Correct?
    Ms. Adams. That is correct.
    Mr. Stupak. How did your role, the samples analyzed by 
Kansas City lab, compare to those wheat gluten sent to other 
labs?
    Ms. Adams. Our laboratory is an hour and a half away from 
Emporia, KS where the firm was located, so when this first 
occurred, it was investigators from our district that went down 
there. And it was very easy for them to bring samples up to our 
laboratory. As a result, we received a lot of samples, which 
pertained to the actual components of the foods being produced 
in addition to the finished product. So we have got the wheat 
gluten, the rice proteins, the amino acids, all the different 
components for us to test.
    Mr. Stupak. Was the test going to other labs, like 
university labs, also did testing on wheat gluten, did they 
follow your lead. Did they develop their own standards or 
testing? How did that occur?
    Ms. Adams. I wasn't involved in that assignment.
    Mr. Stupak. OK.
    Ms. Adams. I am assuming that was through a FERN program, 
and if that is the case, then they should be following the same 
methodology that we used.
    Mr. Stupak. How many of your employees at the Kansas City 
lab would be willing to transfer to another lab if you were to 
close?
    Ms. Adams. Right now, I have about six employees who said 
that they would consider moving. However, that was contingent 
on their being able to move to the laboratory of their choice.
    Mr. Stupak. I see.
    Ms. Adams. And also you have to remember that most of these 
people who are willing to move are fairly new employees. They 
don't have the same kind of ties to the community that other 
employees have, and they just don't have the level of 
experience.
    Mr. Stupak. You mentioned the total diet study. That 
program would be relocated then if your lab is closed, right?
    Ms. Adams. Correct.
    Mr. Stupak. And how many of those employees are willing to 
leave?
    Ms. Adams. Right now, I know about three of the people who 
would be willing to move.
    Mr. Stupak. OK, thanks. Dr. Jacobs, we have held hearings 
on the spinach. It was our first hearing on April 24, and you 
are located probably the closest proximity to Salinas Valley, 
correct?
    Mr. Jacobs. Yes.
    Mr. Stupak. The Salad Bowl of America they call it?
    Mr. Jacobs. Yes, that is true.
    Mr. Stupak. Dr. Adams mentioned it, but why is the close 
proximity? Is there an advantage to having the lab close to, 
let us say, like fresh produce or wheat gluten, whatever it 
might be?
    Mr. Jacobs. First thing is getting the samples into the lab 
as fast as possible so you can get results. In the follow-up 
investigation we had water samples, we had fecal material, we 
had spinach samples and other samples that needed to get to the 
lab very quickly. We relied on, say, FedEx to send them out the 
next day. Many of those would not have been worth analyzing 
so--
    Mr. Stupak. Why? Because it----
    Mr. Jacobs. The organisms are fairly----
    Mr. Stupak. Fragile?
    Mr. Jacobs. Yes. And you may cause an enhancement in other 
organism, or it may not reflect what actually occurred in that 
particular sample. So having a lab nearby is very critical.
    Mr. Stupak. The last panel mentioned the California food 
emergency response team. Now, sort of like the primary 
investigative lead. But they work very closely with you, and I 
think CalFerd said that they would not want to see your lab 
close down.
    Mr. Jacobs. Yes, I am sure that CalFerd doesn't want to see 
us close down. We make up half the investigators and people who 
participate in that.
    Mr. Stupak. Do you work well with CalFerd?
    Mr. Jacobs. I am not personally involved, but as I 
understand, they work quite well with CalFerd and the food and 
drug branches in the State of California.
    Mr. Stupak. Well, besides proximity to Salinas Valley, why 
would the closing of the San Francisco lab be of great loss to 
this country?
    Mr. Jacobs. Well, we do approximately half of the samples. 
The California food and drug branch has five employees. They 
did half of the samples also or approximately half. I am not 
exactly sure of the numbers, but we give them no surge control. 
We have a lot of people who are analysts who work as partial 
investigators and go out in the field and try to develop a 
sharpening of what samples are collected and how they are 
tested. So having somebody nearby that has analytical expertise 
is really critical.
    Mr. Stupak. I have more questions, but my time is up. 
Before I turn to the gentleman from Kentucky for questioning, 
Mr. Laurel from Connecticut is very interested in food safety 
and has a number of pieces of legislation. But more 
importantly, she is also chair of the appropriations committee, 
which deals with the FDA. And I think you--I know she is trying 
very hard to put forth language or the money to make sure these 
labs don't close but no results yet. We are working on it. 
Don't lose heart in it yet.
    Mr. Whitfield.
    Mr. Whitfield. Thank you, Mr. Stupak. I want to thank all 
of you for being with us today as we look at this very serious 
issue. And, of course, we welcome your testimony because all of 
you have valuable experience at FDA and have insights that 
certainly we do not have. And, Mr. Hubbard, you had mentioned, 
I believe in your testimony, that USDA had been plussed up for 
food safety and plussed up for some other programs. I think you 
mentioned $163 million and $130 million, and yet FDA had been 
reduced.
    Now, in fact, any of you can answer this question, but if 
it true that FDA is responsible for 80 percent of food safety 
in America and only has 20 percent of the budget, and USDA is 
responsible for 20 percent and has 80 percent of the dollars, 
what is the rationale for that? And is it defensible?
    Mr. Hubbard. It boils down to the way Congress set up the 
meat inspection program back in 1906, which requires meat to be 
continuously inspected. In other words, if a meat packing plant 
operates, it must have USDA inspectors in the plant, inspecting 
the meat at all times. So that essentially requires Congress to 
provide full funding for that program every year plus inflation 
because if the meat inspectors aren't there, the plant can't 
legally operate. So even though they only have 20 percent of 
the food supply, the paradigm forces Congress to be given 80 
percent of the money.
    And so I don't think anyone is suggesting that money be 
taken away necessarily from USDA but that the FDA part, which 
is so underfunded, be strengthened.
    Mr. Whitfield. OK, and, of course, when this program was 
first set up, the situation was certainly a lot different 
because today we have all these imports coming in of fish and 
seafood and so forth. So do all of you agree that FDA does not 
have sufficient money to inspect these food items the way they 
should be inspected? Do all of you agree with that or--OK, and 
when I listen to this testimony today, it really is sort of 
scary because of the amount of contaminated food that we see 
coming in from China and other countries. And all of you have 
been quite straightforward and even critical in your opening 
statements. But if we put this on a scale of 1 to 10 and 10 
being a perfect job of inspecting food for the American people, 
where would you on a range of 1 to 10 put the FDA today in 
protecting the American people in guaranteeing food safety. 
Would you assign a number for that, Ms. DeWaal?
    Ms. DeWaal. I assume 1 is low and 10 is high?
    Mr. Whitfield. One is low, and 10 is high.
    Ms. DeWaal. I feel bad having to do this, but we are in the 
range of 1 because FDA isn't preventing problems.
    Mr. Whitfield. OK.
    Ms. DeWaal. They are acting as a fire department running 
around putting out fires.
    Mr. Whitfield. OK, so on 1 to 10, you would put FDA at 1 
right now? OK.
    Mr. Hubbard. Well, I would divide it, Mr. Whitfield, I 
would say that if you look at the scientific expertise, the 
credibility, the global reputation, and the dedication of the 
employees, I would put it at 9 or 10. But if you are looking at 
capacity, the capability, I would be down here with Ms. DeWaal.
    Mr. Whitfield. And I don't think anyone is questioning the 
dedication, the expertise, the commitment of the people that 
work there. But looking at the totality, what is the job that 
is being done for the American people in providing safe food? 
So both of you said 1 maybe. What about you, Ms. Heppe?
    Ms. Heppe. I would probably give it a 5 because we do not 
have enough resources, but we try to do the best we can with 
what we have.
    Mr. Whitfield. OK.
    Ms. Heppe. We try to concentrate on the areas we need to.
    Mr. Whitfield. Ms. Collins?
    Ms. Collins. I would probably give it a 3 or a 4.
    Mr. Whitfield. OK.
    Ms. Collins. However, if we lose the expertise that we have 
in the field right now, I would give it probably a minus 2.
    Mr. Whitfield. OK. Dr. Adams?
    Ms. Adams. I would probably divide it up. I would give a 7 
to the drugs and devices, parts that have much more personnel 
and much more income. And I would probably lower food to a 4 or 
a 5.
    Mr. Whitfield. OK, Dr. Jacobs, do you have any thoughts?
    Mr. Jacobs. I would give a low number, but I can't give you 
a quantitative----
    Mr. Whitfield. Mr. Clavet?
    Mr. Clavet. Two or 3.
    Mr. Whitfield. OK. Well, that is pretty astounding because 
we are the leading nation in the world. We talk about our food 
safety. We talk about our institutions, and yet for you experts 
who work in this area who have the responsibility of doing 
this, to give that kind of rating certainly does not speak well 
for where we are. And we have a lot of work to do. So thank you 
very much.
    Mr. Stupak. Thank you, Mr. Whitfield. Mr. Burgess for 
questions.
    Mr. Burgess. Thank you, Mr. Chairman. Dr. Jacobs, I 
apologize. I hadn't made it back from the vote when you gave 
your testimony, and I don't see written testimony in the stuff 
in front of me. But I would like to ask you a question, if I 
could, just for my general knowledge. I get the part about 
using the carbon monoxide on beef because cosmetically it 
improves its color. What is the rationale for treating fish 
with carbon monoxide?
    Mr. Jacobs. It turns the hemoglobin bright red, or the 
myoglobin, in the sample.
    Mr. Burgess. Most of the fish I buy is white though, so I 
don't get----
    Mr. Jacobs. It wouldn't help in those fish.
    Mr. Burgess. So it is the salmon in particular?
    Mr. Jacobs. Yes.
    Mr. Burgess. OK. Mr. Hubbard, I really appreciate you being 
here, having your perspective over--you were at the FDA, I 
guess, starting right after the earth cooled and have been 
there----
    Mr. Hubbard. Not quite that far.
    Mr. Burgess. But it is an amazing length of time that your 
career spans at the FDA. So you have seen it all through 
various administrations, through various iterations of 
Congress. And I am really struck by your comments in your 
written testimony about how perhaps it is not the FDA that has 
failed, but the body responsible for funding the FDA has been 
the failure. And I suspect that point is one that you would 
want to make fairly strongly. Is that correct?
    Mr. Hubbard. Well, I do feel that way, Mr. Burgess. I think 
that the agency scientists have identified these problems for 
years. They have brought forth suggestions for regulation, for 
legislation, and for funding. And they have been denied, and 
now for them to be criticized and be told that you are the 
problem I don't think is entirely fair.
    I won't say the FDA is perfect by any means, but I do 
believe that they have been denied the opportunities to fix 
some of these problems when they have identified them, brought 
them forward for solution, and then told no, you can't do that. 
You can't have that regulation. You can't have that 
legislation. You can't have that funding. And so they are to 
some extent as much victims of this as, I think, we all are. 
And that is why I hope this committee will be looking at a 
broad range of issues and understanding there may be management 
issues and deal with that, but also understand there are some 
of these other issues about authority and resources that need a 
look.
    Mr. Burgess. And these are not entirely new problems.
    Mr. Hubbard. No, I think the FDA folks have been raising 
the alarm about this for years, and import flares up about 
every 2 or 3 years, and it dies down. And I hope that doesn't 
happen this time. I hope this time Congress acts.
    Mr. Burgess. I hope so too. Now, you think it is an 
inability of the FDA to articulate the problem and the funding 
requirements, or is it indifference on the part of the 
particular Congress or particular administration?
    Mr. Hubbard. No, this is not a partisan issue. The problems 
cross political parties and political administrations. I think 
that priorities have been shifted in the 1980s and 1990s toward 
some of the drug issues. Money needed to be found for 
biotechnology, for blood safety, for AIDS. And commissioners 
and secretaries essentially shifted money out of food. I think 
if they had been able to see to the future that one day food 
would be biting us back, that these imports would skyrocket, 
maybe decisions would have been made differently. But they 
weren't. Now, we are at a point where the food program has 
essentially been taken down, and I think unless we build it 
back up, all of these other ideas we have are not going to be 
very meaningful. You can't implement a regulation without 
people. You can't implement legislation without people. You 
can't manage better without people.
    Mr. Burgess. Now, I seem to recall--I was just a regular 
guy back in the 1990s, but I seem to recall--well maybe 1993 or 
1994--a bad outbreak of E. coli at some fair or something. A 
big push was made to fix this problem. And in fact, I remember 
the administration signing a bill and making a big deal out of 
the fact that finally at long last our food safety is now in 
the right hands and going forward. We won't have this problem 
to deal with any longer. What happened there?
    Mr. Hubbard. Well, you are absolutely right. FDA took the 
lead first with seafood and doing preventative controls and 
largely addressed that. Then they did it with juice after, I 
guess, there. The meat program at the USDA essentially followed 
FDA's lead and did it for meat, and meat outbreaks have dropped 
precipitously. And so meat is a much safer product now. But FDA 
recently tried to do that with fresh fruits and vegetables, and 
reports are they were denied the ability to do that. And so I 
think those are the kinds of things you need to look at. Where 
do the scientists think the fixes are? And can you help them 
get them?
    Mr. Burgess. And let me just ask you one other thing before 
my time expires. We heard some comments about country-of-origin 
labeling and how that would be an improvement, but in your 
testimony, you cast some doubt on the fact that the country-of-
origin labeling will actually get us where we want to be. I got 
to tell you I got people in my district who are very 
suspicious. They are suspicious of the Government anyway, but 
they have the feeling that this is a way to get the small 
farmer to pay for the sins of the big agricultural 
conglomerate.
    Mr. Hubbard. I do not think country-of-origin labeling 
works. I think it should not be, first of all, a substitute for 
safe food. No matter where the food comes from, it should be 
safe. And Canada has country-of-origin labeling, and I saw a 
bottle of olive oil the other day. It said ``product of 
Canada''. I don't think you are going to find many olive trees 
in Canada or in a hothouse, because in Canada, they allow the 
final value to go into what country is labeled. And so 51 
percent of the value of that bottle of olive oil is Canadian, 
so it says product of Canada. And there are lots of other 
examples around the world.
    And the other issue is that if you had country-of-origin 
labeling, I think that would be an administrative nightmare for 
Customs or FDA or whomever to enforce it. Because you would be 
wasting resources chasing all these labels around. As you saw 
from the wheat gluten, very easy to change a label or fake a 
label.
    In fact, one of the big problems with these Chinese product 
is the difficulty tracing back because they find counterfeit 
labeling, counterfeit shipping invoices. And that is true in 
the drug world as well. So I don't see labeling being an 
answer. We need safe food, not better labels, in my view.
    Mr. Burgess. Well, I appreciate your testimony, and I know 
I am over my time. If they are growing olive trees in Canada, 
that global warming thing may be worse than we thought. I will 
yield back my time.
    Mr. Stupak. Mr. Walden for questions please.
    Mr. Walden. Thank you, Dr. Burgess. I want to thank all of 
you for being here today. Mr. Hubbard, you mentioned in your 
testimony the FDA-regulated food imports are approaching 13 
million entries a year, I believe. What percent of our American 
food supply does that represent?
    Mr. Hubbard. I think about 15 percent of our total food 
supply is imported from other countries.
    Mr. Walden. One-five?
    Mr. Hubbard. One-five.
    Mr. Walden. Fifteen percent?
    Mr. Hubbard. Yes, 15.
    Mr. Walden. OK, how many of the food illness outbreaks are 
related to imported food?
    Mr. Hubbard. There is no decent data on that. CDC generally 
can only identify about 5 percent of food-borne outbreaks to 
their source. I think certainly FDA has found examples of 
raspberries and mushrooms from China, or raspberries from 
Guatemala, mushrooms from China, seafood from Asia where there 
have been specific illnesses. But I don't think anyone has a 
decent database that says food from this source or this source 
are more or less dangerous.
    Mr. Walden. Do you think that the meat products we are 
exporting to China represent a food threat?
    Mr. Hubbard. I certainly wouldn't think. The American beef 
industry would say so, and I think that the meat industry in 
this country meets these regulations. USDA requires Cohassa 
which are state-of-the-art controls for ensuring safe meat. So, 
no, I think that our exports are very safe.
    Mr. Walden. This is probably out of your realm, but I read 
a story today that China has now stopped allowing the 
importation of certain meat products. So do you think that is 
maybe more in retaliation of our concerns over the poisoning of 
the dog and cat food and----
    Mr. Hubbard. Well, there certainly has been speculation to 
that effect. It is very clear the Chinese have been stung by 
this, and they did mix messages. Some officials in their health 
industry have acknowledged there are lots of problems with 
their food. Others have said wait a minute, our food is not so 
bad either. And that implies that they are going to be looking 
at more American food. These trade issues do get thorny as you 
know.
    Mr. Walden. I am aware of that. I actually have supported 
country-of-origin labeling, and I appreciate what you had to 
say in opposition to that. But I will tell you as a consumer, 
it does affect my purchases where it is labeled. I do a second 
look. Maybe I shouldn't, but I do because I think about well, 
what are the food safety requirements of that country? What do 
their ag producers do versus what we do? And who is inspecting 
this stuff coming in? And you all have sat here today and 
basically said our food supply safety is in peril if you are 
relying on imported foods.
    So I am at a loss how you can sit here and tell us that we 
are not going a good job, that we are 1 or minus depending on 
where you are at, and then say but don't worry to the consumer. 
You don't need to know where it is coming from, and I am not 
trying to throw a big rock at any particular country. But it 
just strikes me that, as consumers put a lot of pressure on a 
country too. And I understand China has some pretty tough laws, 
regulations, but they don't have enforcement mechanisms. Is 
that an accurate assumption?
    Mr. Hubbard. I have talked to trade officials who tell me 
that the central government is woefully incapable of regulating 
out in the hinterlands.
    Mr. Walden. Right.
    Mr. Hubbard. You know an estimated one-half million small 
producers of food in China, some of which export to other 
countries, and then the central government simply cannot reach 
to these small farmers. Said in some cases, it might be someone 
who might produce four or five bags of wheat gluten a week. We 
are talking about essentially a farmer making something in a 
shed behind his house that gets rallied into a larger 
distribution point. And so to try to regulate an entity like 
that efficiently for sanitation and other means is just an 
enormous task.
    Mr. Walden. And so to whom should that task fall, the 
United States taxpayers through FDA to inspect these coming in 
or not, Ms. DeWaal?
    Ms. DeWaal. Thank you. First of all, I did participate in 
an export consultation with the Chinese Government. Their food 
law is in the process of being modernized, but what Mr. Hubbard 
said is all accurate about the failure to regulate.
    What U.S. consumers though are looking for is a system 
whereby they can trust the food that is coming here. So that 
has got to start at the country of origin, and we can't rely on 
the Chinese Government or the Indian Government. So it has 
really got to be through a certification program where either 
governments, like for example Australia or New Zealand have 
very up-to-date food systems. They could certify for the whole 
country potentially. Or individual plants might get certified 
to ship product in. And there is legislation currently that has 
been introduced that Congress is currently considering to do 
that.
    Mr. Walden. Because I know I have talked to some food 
processors in my State who say we have to track everything 
clear back--if it is peaches or pears or something, back to the 
box it came from in the orchard. And they make the thing that 
goes into various food items that are manufactured, and they 
have told me look, we already have to have these data available 
to us. And other countries require us to label everything as 
the country of origin and document everything. And it always 
sort of confused me that if our producers have to do that to 
get into many industrialized countries, why wouldn't we protect 
our consumers coming this way.
    How big does FDA need to be to guarantee safety and move up 
that chart? You have all told us that you are at a 1 or minus 1 
or 2 or 3 or 4 in terms of safety. So how big do you have to 
be, and how many more labs do you need?
    Mr. Hubbard. Well, I will begin the answer, which is a few 
years ago we did do an analysis and well, what would the ideal 
food safety system look like? How many inspectors would you do? 
How many scanners would you have? How many imports would you 
look at? And that suggests that about a doubling of the agency. 
That is out of date now, but clearly it is a big number. If you 
really want to fix it I am afraid, there is going to have to be 
a substantial increase in staff and other scientists to fix the 
problem. And that includes lots of inspectors.
    Ms. DeWaal. And it is not just the number that is 
important; although, the number is important.
    Mr. Walden. Sure.
    Ms. DeWaal. It is also modern mandates, and the work of 
this committee is very important to ensure the FDA is actually 
working off of a law, off of legal structures that are more 
modern. And so it is going to require both authorizing and 
appropriation.
    Mr. Walden. It just seems to me we are working off a 1906 
strategy to protect American-raised meats. That worked great, 
cleaned up the problem, gave us safety and security. And now we 
are importing this enormous amount of food from countries that 
may not have anything close to what we had back in 1906 even 
today. And now all of a sudden we are at peril when we go into 
local groceries store potentially or buy dog food for our 
animals. And I think most Americans are going what happened? 
How did this get to this point? I have way overshot my time, 
Mr. Chairman. Thanks for your indulgence. Thank you.
    Mr. Stupak. The gentleman from Oregon, Mr. Melancon, for 
questions.
    Mr. Melancon. Thank you, Mr. Chairman. And I guess I might 
go back and visit what I had asked Mr. Hubbard if you can maybe 
help me with this. I heard your explanation about the country 
of labeling concern that you have. Would that be for all 
products or could you at least find the ability to police bulk 
products or for instance the gluten was brought in large sacks. 
If you had to go look at every bottle of olive oil, I think it 
would be tough.
    Mr. Hubbard. First of all, there is absolute validity to 
the concept of the bulk product that the shipping invoice says 
as they come through Customs into the FDA should show country 
of origin. I fully agree with that. I think the question really 
is should the consumer see it on the label. There is some 
country-of-origin labeling for seafood. But with all of these 
ingredients in foods, it is very difficult to do that.
    Plus the manufacturers bring all these products from 
different sources. I saw a country-of-origin labeling on a jar 
of apple juice the other day, and it said apple juice from 
Turkey, Greece, Germany, United States, China, and a couple of 
other countries. So what that meant was they were buying from 
all those sources, mixing it all together.
    And I think to tell the food industry that they would have 
to separate all that and label each bottle differently would 
just be a logistical nightmare for manufacturers. Plus you have 
got to understand the ingredients. Soft drinks contain 
something called gum araby which comes from places like the 
Sudan and Somalia. Are you going to put product of Sudan on 
there? I don't think you are going to see the soft drink guys 
wanting to do that, but there are these products in soft 
drinks.
    Mr. Melancon. Well, the soft drinks guys didn't want to put 
fructose and/or sugar. They wanted to leave you believe it was 
sugar, but they were selling you fructose for a bunch of years. 
But all that took was a change in the computer program. It is 
easy enough. And I agree. Maybe that is where people like 
yourself can help us find some remedies to some of this to 
where there is documentation by the importers and exporters, 
the product manufacturers where there is a trail. When we get a 
tag on a cow that came from Canada, we know where to go look 
for the disease and to track it where it came from. So it has 
got to be--if it can be done on a cow, it can be done on 
products.
    But the other thing that has always bothered me in 
international trade is vital sanitary. Why does our country 
walk away from that issue and doesn't want to put it in any 
agreement? Or so it appears to me.
    Mr. Hubbard. Well, there are trade agreements that set 
vital sanitary standards and----
    Mr. Melancon. But the Europeans are not using those with 
the same standards that we have in America.
    Mr. Hubbard. I think the problem is, as Ms. DeWaal said, 
the current law doesn't give FDA authority to impose its 
standards on the exporter. The paradigm is that FDA can open 
the container, examine the food, and refuse it if it is unsafe 
or contaminated or appears to be unsafe. It doesn't allow FDA 
to go to those other countries and say here are the standards 
you must meet. We can do that for meat, but we cannot do that 
for the FDA-regulated products.
    Mr. Melancon. And I think that is why we are here today to 
talk about what we need to do to bring these standards up to 
modern times if you would and try and make sure that our food 
supply is safe. And from a standpoint of dealing with other 
countries, and you obviously have had some of that experience, 
is there some way to put the mandates on there, to have 
laboratories that are either accredited or some way or another 
controlled by FDA to make sure that there is not collusion, 
that we are not getting fish that has actually been shipped 
around the world three times before it finally lands somewhere 
because they are trying to avoid inspection? Anybody want to 
address that? Mr. Hubbard, if you have some thoughts.
    Mr. Hubbard. Well, obviously certifying labs would a good 
thing. If the facts are accurate that these laboratories are 
not up to snuff, that certainly needs to be fixed.
    Ms. DeWaal. Can I just add I mean we have a different model 
for import inspection at USDA. And while that model may not 
completely fit all FDA-regulated products, it is certainly 
that, I think, this committee should look at as they move 
forward. There are different models than the one FDA is using, 
and I think it is just a matter of putting those pieces 
together.
    Mr. Melancon. Is there someone in the--probably not in the 
agency because they have got their own model that they are 
designing. Can we look to someone that can give us an objective 
viewpoint, past experience, seeing what was good, seeing what 
was bad, maybe giving us some insight views on why we need to 
do things? My personal feeling is we need to constrain the 
number of ports that we have of entry for different products or 
confine entry of certain products to certain ports so that we 
can have expertise on the ground there.
    This thing of backing off, if we are going to back off, 
just bring everybody back to Washington, let them sit in an 
ivory tower surrounded by the Beltway. And we will never know 
what is going on out there at the ports. Of course, that speaks 
something for what DHS does sometimes, but that is a whole 
other issue. Now, I see my time is running out, but thank you 
for your input. I hope that maybe we could look to some of you 
to help us with devising the mechanisms legislatively that will 
protect America's food in the future. Thank you, Mr. Chairman.
    Mr. Stupak. I thank the gentleman. We will go for a second 
round of questioning if anyone has further questions. Mr. 
Hubbard, if I may, you are the associate commissioner of 
policy, planning, and legislation. In the mid 1990s, Mr. 
Dingell, myself, we all had legislation on trying to strengthen 
these laws to give the FDA the authority that the USDA has to 
impose inspection fees, to make sure the countries have same 
standards we have in this country. But yet you always opposed 
that legislation. Why was that? Now you are saying we should 
have this stuff. When you were in the position to do something 
as associate commissioner, you opposed us.
    Mr. Hubbard. Well, certainly there were provisions that the 
administration opposed, and as the administration official, I 
needed to support those. But I think we agree with you on a 
number of----
    Mr. Stupak. Well, are you testifying now as concerned 
citizen or if you were still associate commissioner, you would 
not be here today?
    Mr. Hubbard. I think I worked with your staff on a number 
of items of legislation in this area that we absolutely agree 
with you on. The most important one, you may recall, was one 
that was often dubbed USDA Light, which say that FDA could, if 
it found repeated instances of contaminated food from a given 
country, it could then say to that country you have now earned 
your right into further regulation. You can't send any more of 
that food that we found to be contaminated until you have shown 
that you would fix the problem at your end.
    Mr. Stupak. Sure, why should we accept food from countries 
that don't have the same standards as us?
    Mr. Hubbard. And I thought that was a very reasonable 
concept.
    Mr. Stupak. But you didn't support it.
    Mr. Hubbard. Well, no we absolutely supported it, but 
Congress didn't----
    Mr. Stupak. Let me ask you this. Do you support inspection 
fees where the USDA gets their money to do this inspection 
system? Do you support inspection fees?
    Mr. Hubbard. Speaking for the Coalition for a Stronger FDA, 
I don't have a position. But personally, yes, I think anything 
that can get the FDA the resources it needs to do more 
inspectors is a good idea.
    Mr. Stupak. No, on your testimony--you don't have it 
numbered, but fifth to last page, you talk about the current 
budget request for fiscal year 2008 as a good example of recent 
trends. Although the official budget request states it includes 
an additional $10 million for food safety, the food program's 
inflations needs are not covered by this request. But if we did 
$10 million, what good is that if the FDA is going to give away 
$9.5 million in bonuses to drug approval process? So the money 
that should be going into food safety is going for bonuses in 
another part of the FDA without some control over that money. 
So what is an extra $10 million going to do if they are going 
to give it away anyways like has happened in 2006?
    Mr. Hubbard. So the $10 million in inadequate to fix food 
safety. In fact, it doesn't even offset their inflation at 
cost.
    Mr. Stupak. Well, during your tenure as associate 
commissioner, you approved retention bonuses for some FDA 
employees, didn't you?
    Mr. Hubbard. I don't recall approving any. I received one 
my last year or so, but I----
    Mr. Stupak. Well, don't you remember approving the 
retention bonuses for Margaret Glavin, director of FDA's Office 
of Regulatory Affairs?
    Mr. Hubbard. I may well have.
    Mr. Stupak. In 2003, you signed off on a retention bonus of 
Ms. Glavin. That amounted to more than 12 percent of all the 
top bonuses of ORA. Is that correct?
    Mr. Hubbard. I don't recall. I didn't have any control over 
ORA, but the retention bonuses were intended to try to induce 
people to stay that might have retired or otherwise left the 
agency.
    Mr. Stupak. OK. Well, look at tab 59 there in that big book 
right there. We have it all there where you approved those 
bonuses, and your logic for that for Ms. Glavin was that you 
were signed off on her bonus, and the justification was it 
indicated that she would seek employment in a private sector if 
the FDA could not provide a salary comparable to a top 
Government affairs executive. In other words, Ms. Glavin, the 
way to retain her was to give her this bonus, and it was 
calculated not based upon top Government affairs executive, but 
based upon the average income of a lobbyist in Washington, DC. 
It is in tab No. 59. You want to look at that and answer that 
one for me?
    Mr. Hubbard. Would you like me to take a moment to look at 
it now?
    Mr. Stupak. Sure.
    Mr. Hubbard. Hand me the book.
    Mr. Stupak. Third page in, under tab 59, page 3 you will 
see your signature on there about Ms. Glavin's bonus.
    Mr. Hubbard. Before I read this, we had recruited Ms. 
Glavin from the Department of Agriculture where she had been a 
senior official, and we felt she could be a tremendous benefit 
in the bioterrorism area. But one of the inducements was to--
obviously when she was freemarketable outside the agency, the 
law allows an agency to give people a thing called a retention 
bonus which says if you will stay and then you agree to a 
certain amount of time to stay, you will receive this $10,000 
or $20,000 bonus.
    Mr. Stupak. Correct, but Congress did not intend $10 
million for a food safety program that would turn around and be 
used for $9.5 million in bonuses for drug approval. That is 
completely separate divisions. That is what happened in the 
last year.
    Mr. Hubbard. I can't link the food safety request to Ms. 
Glavin's retention bonus but----
    Mr. Stupak. Well, if you go on to read that there, you said 
you based it upon what a lobbyist would make, so therefore are 
we now basing retention bonuses not on value but on where a 
lobbyist is because we don't have an exact description of a top 
executive----
    Mr. Hubbard. The principle was to try to get people a 
slight bump up in pay to induce them to stay yet another year 
or another year and not retire at that point.
    Mr. Stupak. Let us go on to country of labeling. You said 
you are not in favor of that, but the 2002 farm bill actually 
had country-of-origin labeling and a schedule to be implemented 
in 2004. For 5 years, that COOL, as they call it, country-of-
origin labeling for meat, produce, and peanuts have been 
blocked. In fact, in fiscal year 2004, House agriculture 
appropriations included the language to prohibit 
implementation.
    And then we brought a bipartisan amendment to strike the 
provision failed 193 to 208. And then again in June 2004, House 
Agriculture Committee Chairman Goodlatte introduced legislation 
H.R. 4576 to repeal the mandatory COOL and make it voluntary. 
Yet 92 percent of the people in the country want country-of-
origin labeling. They want to know where their food comes from. 
Don't you think the American people have a right to know where 
their food comes from?
    Mr. Hubbard. You are absolutely correct if people say they 
do want that, and the seafood provision in COOL went into 
effect.
    Mr. Stupak. Yes, it did.
    Mr. Hubbard. The others have not, and I----
    Mr. Stupak. There hasn't been these problems that you 
complained about with COOL under seafood, has it? It worked 
pretty well.
    Mr. Hubbard. That is a whole food, and I think it probably 
worked reasonably well for a whole food.
    Mr. Stupak. My time is up. Mr. Whitfield, any questions?
    Mr. Whitfield. No, sir.
    Mr. Stupak. Mr. Burgess, any questions?
    Mr. Burgess. Yes. First, Mr. Chairman, may I ask unanimous 
consent that my opening statement be made part of the record? I 
wasn't here when you----
    Mr. Stupak. Absolutely. And also Senator Durbin who also 
wanted to testify today has submitted his statement. So I will 
put that in the record also at the same time. Thank you.
    Mr. Burgess. OK, and there is no particular relevance, but 
since it is in the evidence binder, if everyone can turn to tab 
70 and see the insightful letter that I wrote to you, Mr. 
Chairman, I think that would be instructive about Tommy the 
Train. That is not a food item, but we are concerned about 
imports from China.
    Mr. Hubbard, I have one last thing to follow up on your 
testimony. In 1999 with no prospect for additional funds for 
food imports and a rising tide of incoming products, the agency 
drafted a legislative proposal. It would have given the FDA 
authority to require foreign countries to take more 
responsibility. I really think that is a key point here. If 
there were some way to hold accountable those countries who are 
guilty of the most egregious behavior, perhaps they would have 
an incentive to not behave in that way. As you say in your 
testimony, countries have demonstrated a pattern of disregard 
of U.S. safety standards would have to step up their oversight 
of food exported from their country. Congress did not accept 
the recommendation, and indeed no hearings were ever scheduled.
    Would you include this as a hearing on that matter?
    Mr. Hubbard. I sure hope so. I sure hope you take a look at 
it. The concept was that a country that had no problems would 
have no problem, would do nothing additional. But a country 
that kept sending bad food here would be told you are going on 
essentially an embargo list until you fix the problems at your 
end. So don't put the food on the boat to send to us until you 
have shown us that you have corrected the problem over at your 
end.
    And they would essentially earn their way into a stricter 
regulatory regime, which I thought made a lot of sense at a 
time.
    Mr. Burgess. But if you couple that with a risk-based 
assessment here in our country, as opposed to simply trying to 
cover--assuming everything is bad and trying to cover every 
eventuality. One last thing I just wanted to ask about since 
you and Mr. Stupak were talking about numbers. You had 
mentioned the number of $131 million for food safety research 
centers, which I believe is in this year USDA appropriation.
    Mr. Hubbard. It is in the President's budget request to 
Congress. $131 million for food safety research that would go 
to the Department of Agriculture.
    Mr. Burgess. OK, and in the Department of Agricultural 
appropriation bill, my understanding is that number is pretty 
close to the President's request.
    Mr. Hubbard. I understand that to be the case too, yes.
    Mr. Burgess. And the actual number reported out of 
committee for food inspection is a little bit lower than that. 
Is that not correct?
    Mr. Hubbard. It is $28 million, and then if you subtract 
the inflation cost the program will have, which is $14 million, 
under the subcommittee action, the food safety program will get 
an increase, as I understand it, of $14 million, which is not a 
lot, but it sure helps.
    Mr. Burgess. But does that reflect an imbalance then of 
putting this money toward the food safety centers? Why would 
there be more of an effort to fund that activity as opposed to 
the inspectors?
     We heard the other side talking about needing cops on the 
beat, and it would seem to me you don't need the precinct house 
if you don't have enough cops on the beat to further that 
analogy. Well, we are going to be voting on that bill, and 
again I think these are numbers that are reported on committee. 
So it is important to bring it up, and it is important for 
Members to understand exactly what they are voting on. Do you 
think is there any opportunity to try to--on the appropriations 
bill, is it open rule? We can amend these things as they come 
through? Would you like to see some of the money perhaps moved 
from the food safety research centers to the food inspectors?
    Mr. Hubbard. Speaking personally, absolutely. I think that 
food safety research is important. But when the crisis is 
facing us, that FDA doesn't have a strong food safety program. 
Anywhere you can find funds to beef that up, in my view, is a 
good idea. But I think you will get push back from the USDA 
folks.
    Mr. Burgess. From the USDA? Are these food safety research 
centers in any way, are they part of the earmark process? Do 
Members ask for those in their district?
    Mr. Hubbard. I don't know. I am not familiar with their 
process.
    Mr. Burgess. Well, again I really appreciate you being 
here. I appreciate your valuable insight. You have been at this 
problem a long time, and I think you brought a lot to this 
hearing. I thank you for being here. I will yield back, Mr. 
Chairman.
    Mr. Stupak. Thank you, Mr. Burgess. Mr. Markey, a member of 
the full committee, wishes to ask questions, I think, of Mr. 
Clavet. You can state your objection. Wait a minute. I want to 
hear from Commissioner von Eschenbach as much as anybody 
because I have a lot of questions for him, but it is a courtesy 
given to anyone who is a member of the full committee, they are 
not allowed to give opening statements, but they are allowed to 
ask questions. I certainly would wish that Members would come 
from the opening bell to the last bell so we could do it in an 
orderly process. Unfortunately, that is the way it goes. OK, 
objection overruled. Go ahead, Mr. Markey.
    Mr. Markey. I thank the gentleman very much, and I hope 
everyone appreciates that I am not allowed to speak until the 
very last moment so it makes no difference if I arrive in the 
beginning. I can only speak at this moment after everyone else 
is done. So that is the courtesy I, as the subcommittee 
chairman, give to every Member as well.
    What is unique, Mr. Clavet, about the Winchester 
Engineering and Analytical Center? Can you move the microphone 
over please?
    Mr. Clavet. It is unique because it is the only FDA 
regulatory lab that does analysis for foods and for 
radionuclides. It is the only laboratory that does it, and 
besides that, we are also the only laboratory--there is no 
other--that does medical devices from an engineering, chemical, 
biological, microbiological perspective.
    Mr. Markey. Now, when I was a boy and I had no scientific 
ability at all and I wanted to do a science fair project as an 
overachieving sophomore, I went over to the Hood Milk Company 
where my father drove a truck. And they explained to me that 
because the United States and Soviet Union were exploding these 
nuclear bombs that Linus Pauling and others said that the 
stronskium 90 was being carried by clouds, going down into the 
grass, cows were eating the grass, and children were now 
drinking the milk with stronskium 90. So in addition to 
homogenization and pasteurization, we needed also a stronskium 
90 remover.
    And I did the science fair project with my father's help, 
of course, because I had no mechanical abilities either, but I 
got honorary mention. I was only a sophomore, and this was 
actually a chemistry thing for the juniors. So I was quite 
proud of myself, and I am not saying it is exactly because of 
me, but 1 year later, the United States and Soviet Union signed 
the Atmospheric Nuclear Test Ban. I am not taking full credit 
for it, but I think it is related.
    And so here now we have a new threat from Al Qaeda, new 
threats of dirty bombs, new threats of potential nuclear 
meltdowns, and what is the FDA doing? The FDA is actually 
shutting down, by the way 2 miles from my house, the very 
facility, the only facility in the country that has the 
capacity for doing the testing for radiological impacts on 
children across the country.
    It seems so, Mark Twain used to say that history doesn't 
repeat itself, but it does tend to rhyme. And so this rhymes a 
lot with the people who really did not understand how important 
that danger was back in the late 1950s and early 1960s. Can you 
give the committee some examples of when the Winchester lab has 
tested food for radiological contamination?
    Mr. Clavet. Well, during the Chernobyl incident, the WEAC 
laboratory insured that the food in this country coming from 
that area was safe. During the Three Mile Island incident, the 
Mass Bay foul area survey, we participated in that. And the 
recent outbreak--not the recent, UK poisoning of the Soviet KGB 
agent, the CDC asked us to participate and stand ready to 
assist them and to help them develop a method for food analysis 
for polonium 210.
    Mr. Markey. Great. So the same kind of partnership that 
Kennedy constructed with Khrushchev you have with the former 
Soviet Union as well; although, we are not sure who actually 
gave that polonium over but--who used it on who, but who 
utilizes the capabilities of Winchester?
    Mr. Clavet. Well, State and local governments, ORA, all the 
field laboratories, the inspectors using TLD badges utilizes 
WEAC's capabilities, the CDC, the Department of Defense, USDA 
FSIS, Food Safety Inspection Service. We have an agreement with 
them to analyze food in case of an emergency. One of the 
important things is we have a lead lab in the FERN, which is 
the Food Emergency Response Network for radiological and 
terrorist acts. We are the lead laboratory.
    Mr. Markey. What do we lose, Mr. Clavet, if this laboratory 
shuts down?
    Mr. Clavet. You will lose the ability to oversee the FERN 
for one thing. You will lose our radiological component of the 
FDA.
    Mr. Markey. Have they given you a reasonable explanation 
yet from the FDA why they are going to shut it down?
    Mr. Clavet. I can't say. No one has really told us why we 
are closing.
    Mr. Markey. Mr. Clavet, I sincerely appreciate your 
willingness to come forward and to testify today at a time when 
the FDA has been struggling and in many occasions, failing to 
keep the Nation's food supply safe from contamination. It is 
totally unacceptable to further weaken the FDA's field 
operation and inspection system by closing this critical field 
lab. I am very concerned about the FDA's proposed plans and 
look forward to getting answers from the commissioner as to why 
he thinks it is a good idea to shut down the Winchester 
laboratory when it serves such an important and unique public 
health function. Mr. Chairman, I thank you for your 
graciousness, and I yield back the balance of my time.
    Mr. Stupak. Thank you for your questions. Ms. DeGette, your 
questions.
    Ms. DeGette. Thank you, Mr. Chairman. I apologize for my 
absence. I was downtown speaking about an issue that everyone 
here would care about, which is conflicts of interests. And I 
was speaking to high-level researchers who I suggested they 
might perfect the cloning technique so that we could all be 
both in the hearing and making speeches and on the floor.
    I want to extend another welcome to Ms. Collins for being 
here today, and I want to follow up on Mr. Markey's question 
about the Massachusetts firm lab because the Denver lab is also 
a member of the FERN network. Correct, Ms. Collins?
    Ms. Collins. That is correct.
    Ms. DeGette. And tell me about the kind of work that the 
Denver lab does with the FERN network.
    Ms. Collins. We do both microbiological as well as 
chemistry. We test foods. We test feeds. We have an extensive 
amount of work that we do to help with the FERN capabilities.
    Ms. DeGette. And so that is a different type of FERN work 
than the Massachusetts lab does, correct?
    Ms. Collins. A little, yes.
    Ms. DeGette. And, as I understand it, Denver will be the 
only full-service FERN lab that would be closed under the 
current plan?
    Ms. Collins. I believe that San Francisco is also FERN 
laboratory.
    Ms. DeGette. But that lab is not scheduled to be closed.
    Ms. Collins. Yes.
    Ms. DeGette. It is? OK. Now, after the recent food safety 
outbreaks, did the Denver lab have any involvement with those 
outbreaks?
    Ms. Collins. Yes, absolutely we did.
    Ms. DeGette. Could you describe that for me, Ms. Collins?
    Ms. Collins. Well, of course, we had a lot of work to do 
with melamine. We had facilities within our district that had 
contaminated products with melamine that we had to go out and 
inspect and collect samples. Additionally, one of the most 
important things that we did was in the Animal Drug Research 
Center or ADRC. We developed the methodology to test for 
melamine in animal tissue, and the remarkable thing about that 
was when we were able to do that within 72 hours after we 
started on the project so that we could test immediately what 
was in animal tissue, fish tissue, in order so that there would 
be a method out there for our laboratories, for international 
laboratories, State laboratories, and even private labs.
    Ms. DeGette. And why do you think that you were able to 
develop that method within 72 hours?
    Ms. Collins. Several reasons. One is the dedication of the 
staff to get the job done. Second was the amount of expertise 
that we had from the three Ph.Ds that work in ADRC, and the 
fact that one of those Ph.Ds has been with us for a long number 
of years and is very experienced in developing these kind of 
processes.
    Ms. DeGette. Now, how many employees are located at the 
FDA's Denver lab?
    Ms. Collins. We have anywhere from I think it is about 47 
or 48 right now.
    Ms. DeGette. And how many of them are experienced Ph.Ds 
like the one you have been talking about?
    Ms. Collins. We only have three Ph.Ds. We do have several 
specialists that are at the GS-13 level pay grade. We have 
quite a bit of experience just in our chemistry section alone. 
Most people have an average of 22 years experience.
    Ms. DeGette. Of all those experienced folks, how many of 
those are going to be willing to relocate to other parts of the 
country after the closure of the FDA's Denver lab?
    Ms. Collins. Personally, I have only heard one person 
within that group that said that they would be willing to move.
    Ms. DeGette. And so in your opinion if the Denver lab is 
closed and that one person moves and everybody else leaves or 
finds something else to do, what impact is that going to have 
on our ability to research these different issues?
    Ms. Collins. It will be tremendous.
    Ms. DeGette. Can you give me a couple of examples of things 
that people do who have said that they won't relocate?
    Ms. Collins. Well, we have the drug residue testing. We 
have antibiotic resistance testing. Antibiotic resistance 
testing is only done in Denver district. We have seriology 
testing. There is only one other lab that does that.
    We have several things like that that will be lost, and so 
when you move those processes to other laboratories, you are 
going to have to train the people that are either there, or you 
are going to have to bring in new people. And if you bring in 
novice employees, chemists, microbiologists like we have, then 
you have got to train them. And that is going to take 
approximately 3 years to get them at what we consider the 
journeyman level to be able to do this work.
    It is very complex. It requires experience, and you can't 
pull someone off the street to start doing this in any less 
than 3 years with confidence.
    Ms. DeGette. Thank you. That is about all I need to know. I 
appreciate you coming today.
    Mr. Stupak. That is all the questions for this panel. Thank 
you all very much, and thank you for your expertise in the 
field you testified on today. Thank you. I will now call our 
third panel of witnesses to come forward.
    On our third panel, we have the Honorable Andrew von 
Eschenbach, Commissioner of the Food and Drug Administration, 
Mr. Stephen Mason, Acting Assistant Commissioner for 
Legislation at the FDA; Margaret Glavin, Associate Commissioner 
for Regulatory Affairs at the FDA; and Dr. Robert Brackett, 
Director of the FDA's Center for Food Safety and Applied 
Nutrition.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised all witnesses have the right 
under rules of House to be advised by counsel during their 
testimony. Do any of you wish to be represented by counsel? 
Everyone is saying no. Please take the oath.
    [Witnesses sworn]
    Mr. Stupak. Let the record reflect all witnesses answered 
affirmatively. They are now under oath.
    Commissioner von Eschenbach, I understand you are going to 
take the opening statement for all. Is that right?
    Dr. von Eschenbach. Yes, sir.
    Mr. Stupak. Did you want to give an opening? But first 
before you do, thanks for being here today. I know you stayed 
through the whole thing. Hopefully you learned a few things. 
Hopefully we all learned a few things, and I am sure with your 
testimony we will learn a few more things. And I know you had 
to be at the Senate at 2 o'clock, and you moved it back for an 
hour. We appreciate that. Hopefully we can get this in. There 
are a series votes to be coming up here fairly soon. So if you 
would want to begin with your opening statement, sir. Thank you 
again.

TESTIMONY OF ANDREW C. VON ESCHENBACH, M.D., COMMISSIONER, FOOD 
 AND DRUG ADMINISTRATION, ACCOMPANIED BY STEPHEN MASON, ACTING 
   ASSISTANT COMMISSIONER, LEGISLATION; MARGARET O'K GLAVIN, 
   ASSOCIATE COMMISSIONER,REGULATORY AFFAIRS; AND ROBERT E. 
    BRACKETT, DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED 
                           NUTRITION

    Dr. von Eschenbach. Thank you very much, Mr. Chairman, and 
I do appreciate the fact that this has been a very long day for 
everyone, and it is testimony to the importance of this 
hearing. I want to thank you and all the members of the 
committee for your attention. And I do also want to express my 
gratitude for your consideration of my prior commitment to 
testify at the Senate, and the fact that I will be able to 
leave at 3 o'clock
    With regard to my statement on behalf of the Food and Drug 
Administration, I am very pleased to be joined at the table by 
Margaret Glavin, our FDA's associate commissioner for 
regulatory affairs, and Dr. Bob Brackett, the director of FDA's 
Center for Food Safety and Applied Nutrition because I think 
they are very critical and key to many of the questions and 
issues that have been raised today. And they will actively 
participate on behalf of FDA to provide the committee with 
insight into these very important issues. And Mr. Mason has 
also joined us.
    The Food and Drug Administration came into existence in 
this country 100 years ago, in fact, because of critical 
problems in the safety of our Nation's food supply. And over 
that past 100 years, the agency has had to constantly adapt and 
respond to emerging challenges, but I am here today very proud 
to lead an agency that is, in fact, recognized around the world 
as the gold standard for ensuring the health of our food and 
our medical products.
    But I am not here today, Mr. Chairman, to defend the FDA of 
the past but to continue the discussion with you as to how to 
create an FDA of the future. Because once again, FDA is facing 
challenges that have been brought on by recent changes in the 
production, distribution, and consumption of food.
    Today, we no longer bring home spinach to be washed 
multiple times and cooked before we eat it. But rather we 
purchase a bag off the shelf, take it home, open it, turn it 
over, and dump out the fresh cut spinach or lettuce along with 
the salad dressing and immediately eat it raw. We have become 
accustomed to being able to walk into a supermarket 365 days a 
year and purchase fresh fruit and watermelon, even though they 
are not grown in this country during the winter months.
    The American people will not go back to previous practices. 
And, in fact, given the importance of fresh fruits and 
vegetables in our nutrition and diet, nor should they. Recent 
events have riveted our Nation's attention on the fact that the 
modern production, distribution and consumption techniques and 
patterns have created not only unique health benefits but also 
unique risks. And once again, FDA is challenged to rapidly and 
effectively respond to this changing reality around us.
    How does an agency like FDA respond to these recent events 
while continuing to maintain an exceptional record of promoting 
and protecting the public health? Well, in short, Mr. Chairman, 
we also, the FDA, must radically and rapidly change. But change 
is difficult and requires meticulous planning, and it is also 
painful to implement. Let me just mention some of the changes 
that we have engaged in to attempt to respond to these 
challenges.
    You reflected on the fact that I created within the Office 
of the Commissioner the new role for coordinating food safety 
work across the entire agency by appointing Dr. David Acheson 
to the newly created position of assistant commissioner for 
food protection. This is not simply window dressing, but Dr. 
Acheson's role is to provide leadership to create an agency-
wide strategic planning protection plan that builds on the 
excellence that already exists in our centers, like CFSAN, like 
the Center for Veterinary Medicine, ORAand all of the rest.
    This plan will enable FDA to be engaged in quality 
assurance through the total life cycle of food from its very 
production all the way through to consumption. If you will, 
FDA's commitment is to be engaged from farm to fork. And to do 
that in the context of a comprehensive, well-developed plan 
that includes prevention so that we can eliminate food safety 
problems by building quality into our very production of food, 
intervention strategies that will preempt problems by virtue of 
enhanced inspections and detection, and certainly enhancing our 
response to any outbreak. This plan will also address domestic 
as well as imported foods.
    And we clearly must build on the quality not only of 
production but also in strengthening our surveillance and 
detection, particularly by paying very close attention to our 
ability to have a modern, well-equipped field force of the 21st 
century.
    Much is being discussed today about FDA's proposal to 
modernize our laboratory capabilities. These are intended for 
the sole purpose of strengthening our capability to increase 
and enhance our frontline inspections, giving our inspectors 
modern tools of science and detection along with better systems 
of communication, while streamlining and enhancing and 
modernizing our backup laboratory facilities so that we can 
serve this entire Nation with an infrastructure that is now 
modern and adequate.
    We recognize in this planning process not only the need to 
come forward with an importantly well-developed strategy, but 
we recognize that these will require additional resources. We 
have been persistent in requesting additional resources and 
have received such in 2007. We are grateful for Congress's 
consideration of our 2008 increases, and we are working with 
the department and the administration to prepare our 2009 
implementation plan and additional resources.
    Let me be clear that we are also examining our legal 
authorities. We recognize that we must explore ways to use our 
current existing authorities more efficiently, more 
effectively, and with greater clarity.
    Second, we must work collaboratively and cooperatively with 
other agencies and their opportunities and their resources, and 
it is not our intention to work and function in a vacuum. This 
is particularly true with our ability to address food imports.
    Last May when we held the strategic economic dialog with 
China here in Washington, DC, Secretary of Health and Human 
Services Michael Leavitt, Secretary of Agriculture Michael 
Johanns and myself met simultaneously with all the Chinese 
leaders and counterparts to begin to address the important 
problems that have been referred to today with regard to our 
increasing awareness of imports of food and other products from 
China.
    FDA is working with the Department of Health and Human 
Services towards creating a memorandum of understanding with 
China to enhance ability to build quality into these products 
before they are shipped to this country. Secretary Leavitt will 
be going to China in December. I am going to be there in 
October. We recently last week had a meeting here of our 
bilateral counterparts in China.
    And third, we are in fact examining whether we need new 
authorities that will enhance our ability to oversee our food 
supply. Current authorities that make it possible for us to be 
more effective with regard to being adapted to our food defense 
activities for imported food, being able to look at issues as 
to whether voluntary recall structure provides sufficient 
incentives in a global marketplace, and what we need to do to 
help to continue to enhance the prevention aspects of our 
effort by building quality at the outset.
    We are working very hard at a comprehensive food protection 
plan, and it is a process that is innerative and underway as we 
speak. And I look forward to continuing to work with you and 
other Members of Congress and other stakeholders, and 
especially the staff of the Food and Drug Administration to 
further refine, develop, and implement these comprehensive 
plans.
    I look forward to continuing to even more effectively 
dialog with this committee by providing documentation 
immediately upon being requested. I have changed the policy 
within the agency so that we respond immediately to requests 
for documents even if we are not able to provide the full 
complements of the documents requested.
    I have appointed Matthew Lyons in our Office of Legislation 
to specifically oversee and take responsibility for an 
accelerated effort in our oversight activities. I have created 
an agency taskforce that will bring components of the agency 
together to specifically focus on the preparation and rapid 
dissemination of these documents.
    And most recently, I was able to procure additional 
resources on a temporary basis from the Department of Health 
and Human Services that quite frankly enabled us to be able to 
meet more recent demands without further deploying people from 
their daily commitments to the overwhelming mission of 
responsibilities that you have heard about today.
    We at the FDA must and will radically change and will do 
that in an ongoing dialog in consideration to do the right 
thing and to do it in the right way. Thank you, Mr. Chairman.
    [The prepared statement of Dr. von Eschenbach follows:]

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    Mr. Stupak. Thank you. Anyone else care to give an opening 
statement at this time? OK, we will go right to questions.
     Mr. Commissioner, you indicated you are going to China in 
the fall. I would suggest maybe you want to go August 17 with 
our investigators. They are going to China to work just on food 
safety and also drug safety. Could some of your people 
accompany them on this trip or yourself?
    Dr. von Eschenbach. Yes, sir. I would be happy to entertain 
it. I mentioned my own participation, but there is other 
participation that is underway as well. And we would be happy 
to work with you and the committee staff to accommodate that.
    Mr. Stupak. OK, the other thing that you heard today 
Members are--I have a whole series of questions on documents we 
have not received. Ms. DeGette has mentioned documents she has 
not received. I think most of us have mentioned documents we 
have not received. So this individual you have selected to 
provide documents is not providing documents.
    Dr. von Eschenbach. I was concerned when I heard Ms. 
DeGette's comments, and I must confess it was my understanding 
that the particular documents I thought she referred to had 
been provided to you. But I will double check on that to be 
certain.
    Mr. Stupak. Well, we are still looking for documents from 
the peanut butter case, ConAgra. We are looking for documents 
from Ketek. There are numerous documents I am looking for with 
Accutane. There are a number of things we are looking for, not 
just all food safety, but there is a number of them
    Ms. DeGette. And if the chairman will yield. It is not even 
just documents. I sent the FDA a letter on the 24th of January 
with Senator Salazar and Congressmen Udall and Perlmutter about 
the Denver lab closure that I never received a response to. On 
June 12, 2007, there was a hearing on medical devices, and I 
asked if I could submit questions. And the FDA representative 
said that they would respond to them, and I have never since 
then received that information. And at that same hearing then, 
I was talking about a May 16, 2007 hearing, and that was post-
market surveillance for medical devices relating to children 
and other kinds of things relating to children. And frankly, 
sir, I haven't received any responses to any of those requests.
    Dr. von Eschenbach. Well, Congresswoman, please accept at 
this point that it is my intent and absolute commitment that we 
be completely responsive to the appropriate requests of this 
committee and every other appropriate request by committees in 
Congress. And we have, as I indicated in my opening remarks, 
recognized that the very intensive effort that is currently 
underway has placed great strain on us, and I am attempting to 
respond to that as rapidly and as quickly as possible.
    One letter that is unresponded to is one letter too many, 
and I want this agency to be responsive to your appropriate 
requests, and I am working towards that. And I will certainly 
look into those specific issues personally, but I am 
anticipating that we will get this down to zero defects.
    Ms. DeGette. I appreciate my chairman yielding, and I yield 
you some of my time. Thanks.
    Mr. Stupak. Mr. Commissioner, there are 12 agencies that we 
know of that deal with food safety. Have you been coordinating 
your efforts with these 12 agencies?
    Dr. von Eschenbach. We have been working very extensively, 
for example, with USDA to continue that relationship, and I 
think that was very apparent----
    Mr. Stupak. USDA. Who else have you been----
    Dr. von Eschenbach. One of the other important elements has 
been CDC as it relates to outbreaks and illnesses. That is 
another important part. So we have continued to look at various 
opportunities. A lot of discussion has----
    Mr. Stupak. Have you asked these 12 agencies about your 
reorganization plan, about whether these labs should be closed? 
You started off talking about spinach, but yet the lab that is 
responsible for the spinach by Salinas Valley is one you want 
to close.
    Dr. von Eschenbach. One other point was raised earlier 
today, and I want to emphasize. We are working very closely 
with the Department of Homeland Security because of the issues 
that were discussed earlier about Customs and border 
protection.
    Mr. Stupak. Right, so why do you want to close the West 
Chester lab?
    Dr. von Eschenbach. With regard to reorganization, I know a 
great deal has been raised today about that reorganization 
proposal, and I want to make it very clear that this is 
intended for one purpose and one purpose only. And that is to 
bring FDA's laboratory infrastructure into the 21st century. I 
personally went to a laboratory in New York when I first took 
over this position and asked them how did they inspect seafood 
for its freshness. And I was told that we use taxpayer dollars. 
Somebody goes out to the docks and goes around and buys 
seafood, shrimp, brings it back to the laboratory, and then we 
have an expert there who smells it and determines whether it is 
fresh or not.
    That, Mr. Chairman, is not my view of the FDA of the 21st 
century.
    Mr. Stupak. That is why Mr. Dingell and all of us had 
legislation after legislation in the 1990s trying to bring the 
FDA into the 100th year of it, not 1906 standards. And FDA has 
always fought us on those. You wouldn't even comment on our 
legislation. It was a non-starter.
    Dr. von Eschenbach. May I give you one example as to some 
of the misconceptions that I think have occurred in today's 
testimony about what we are trying to do?
    Mr. Stupak. I don't think----
    Dr. von Eschenbach. This is not to eliminate laboratories 
or eliminate the ability to test products. It is to be able to 
consolidate science in a way that our laboratories are much 
more effective, but at the same time to increase our inspection 
force out there on the cutting edge and to do it by giving them 
the modern tools of science and technology with which they can 
actually do these analyses----
    Mr. Stupak. By closing these labs, how are you going to 
increase your inspection field?
    Dr. von Eschenbach. Let me give you a specific example.
    Mr. Stupak. Sure.
    Dr. von Eschenbach. Today, this bottle of water--and we 
have recently had a problem with a concern of arsenic 
contamination of water being imported from another country. The 
way it happens today is an inspector seizes or takes a bottle 
of water. It has to be sent to a laboratory and undergoes 
laboratory analysis that takes hours, and then finally there is 
a report. We have a modern tool of science and technology that 
we can deploy to inspectors in the field and by simply pointing 
this instrument at this bottle, it can register whether there 
are any heavy metals like arsenic, possibly strontium, and do 
that rapidly and efficiently in the field. That doesn't require 
a laboratory.
    Mr. Stupak. That is great, but my question is how many 
employees or inspection people will have those little handguns 
so you can go do his thing by closing these labs?
    Dr. von Eschenbach. My expectation and intent with regard 
to the strategy that we are employing, which is to create 
state-of-the-art, multidisciplinary, well-staffed laboratories 
with modern robotic technologies. And then deploy many, many 
more investigators and inspectors than we currently have at all 
of the ports where we never could have that opportunity.
    Mr. Stupak. What number? That is what I am looking for.
    Dr. von Eschenbach. Well, we have talked----
    Mr. Stupak. I won't have to ask you all these questions 
because if the FDA would have provided the information we asked 
on our reorganization plan, we wouldn't have had to have all 
these questions. They provided us zero information because it 
is pre-decisional. So we have no information on your 
reorganization plan even though we have been promised time and 
time and time again we will have the information before this 
hearing. It will be timely. It will be worthwhile. It was 
pathetic, to say the least, what we received.
    Dr. von Eschenbach. Well, Mr. Chairman, as I indicated in 
my opening statement, our reorganization and our strategic plan 
is a proposal. It is in process. It is being developed. There 
are parts and pieces of it that have become public, for which 
we have been looking at response and reaction, and quite 
frankly, this hearing has been a very important part of that 
giving us impact and insight from the inspections that occurred 
that your staff carried out.
    These plans will need to be further refined and developed, 
but the expectation is although the changes may be painful, we 
cannot depend on the current laboratory system that exists 
today to carry out the responsibilities of tomorrow. And this 
will require change, consolidation, reorganization, but not 
loss of function.
    Mr. Stupak. My time is up, but when you have these plans, 
give them to the committee. And most of all, give it to your 
lab people so they know what is happening. There is probably 
nothing worse than FDA employees not knowing what their future 
is and no one knows why they are being let go. In fact, in your 
testimony, you said these were backup labs that could be 
duplicated elsewhere, done elsewhere. Watch that word. I don't 
think West Chester or some of these others would consider 
themselves a backup lab. With that, I will turn to Mr. Barton.
    Mr. Barton. Thank you, Chairman Stupak. Welcome, 
Commissioner.
    Dr. von Eschenbach. Thank you, sir.
    Mr. Barton. I have a series of questions on the issue at 
hand, but I want to first pile on a little bit with Ms. DeGette 
and Mr. Stupak on non-response to letters. Back on April 18, 
Mr. Whitfield and myself wrote you about the issue of FDA 
warning letters and what the appeal process is, how many 
companies have appealed an FDA warning letter. We asked you a 
series of, I think, three or four questions. I have to get in 
line with Congresswoman DeGette and Congressman Stupak. We have 
not received a response either. Could you check into that? This 
is an April 18 letter from Mr. Whitfield and myself, and I 
assure you that we are asking for factual information in this 
letter. But there is no hidden agenda. We are not trying to 
``got you'' the agency.
    Dr. von Eschenbach. Thank you, sir. May I apologize to you 
and the committee. It is not our intention to withhold 
information. It is not our intention to be delinquent in 
immediate response to you, to every member of this committee, 
and to the entire Congress.
    In defense of what has occurred at FDA, we happen to be in 
an extremely intensive period of time with regard to the 
request for documents and information from the agency. And at 
the same time we have been engaged in many significant 
legislative changes like for our FDARA et cetera, our 
appropriations.
    Mr. Barton. We may complain once we get your answer, but we 
are darn sure going to complain if we get no answer.
    Dr. von Eschenbach. Well, and I am attempting within that 
context, without diverting people from missioncritical 
activities day in and day out, to shift resources, find 
resources, find systems and processes so that we are not 
delinquent in response.
    Mr. Barton. We are the committee of jurisdiction, and this 
is the subcommittee of oversight. And any reasonable response 
effort in your office would prioritize responses to members of 
this subcommittee and which Congresswoman DeGette is a senior 
member, Mr. Stupak is the chairman, Mr. Whitfield is the 
ranking Republican, and I am the ranking Republican on the full 
committee. So we ought to be somewhere up in the hierarchy of 
you get an answer to us even if it is an answer that is going 
to upset us.
    Dr. von Eschenbach. Mr. Barton, I fully respect and 
appreciate the authority that this committee exercises, and it 
is not my intention to, in any way, shape, or form----
    Mr. Barton. I don't want to belabor it, but we will get you 
a copy of the letter before you leave. And we hope you will 
reply. My policy questions are dealing with how to modernize 
the FDA process for inspecting and overseeing the food imports. 
In my opening statement, I listed four points that I wanted the 
FDA and the committee to consider if we decided to move in a 
legislative approach. In a nutshell, I suggested that we do 
something to make our good manufacturing processes information 
more available internationally. We do something to help profile 
the foreign food control agencies and their processes for food 
safety inspections before it leaves their country. And third--
this is one that I think is very important--that you consider 
separating the foreign inspection activities and setting up a 
separate office just for foreign inspections. And then fourth, 
that you consider issuing a rule on the import alert program 
and specifically make a determination if you need congressional 
legislation, can the FDA detain shipments from overseas without 
physical examination. Do you care to comment on any of those 
ideas?
    Dr. von Eschenbach. Yes, sir. I took notes during your 
opening statement, and we will be happy to address those in 
great detail. Let me just say at the outset I recognize the 
importance of really strengthening our ability to build quality 
into the products that are being produced outside of our 
borders but that ultimately come to us.
    I was in Belgium and met with the European Union and the 
European Commission, signed a memorandum of understanding with 
our counterparts there with regard to food safety and food 
protection so that we will be mutually sharing and interacting 
with regard to information.
    I indicated earlier about the important role we will be 
playing in developing relationships with our counterparts in 
China to contribute to their ability to put a system in place 
that will assure the quality of what comes to our borders, as 
we also strengthen the protection at our borders. So I am 
committed to increasing foreign inspections, to increasing our 
foreign presence, and our interaction with our foreign 
counterparts to build quality in at the outset.
    Mr. Barton. My time has expired. I just want to ask one 
final question on the closure program or the reorganization 
program that there have been some questions about. Three or 4 
months ago, you and your staff came by and briefed me on that, 
and I think you also briefed Mr. Whitfield. I suggested that 
you brief Mr. Dingell and Mr. Stupak. I know you attempted to 
set those meetings up. Were those meetings ever successfully 
set up, and have the majority also received a briefing that you 
gave to myself and, I think, Mr. Whitfield?
    Dr. von Eschenbach. I have not had the opportunity 
personally to be able to brief Chairman Dingell or Chairman 
Stupak, but I have continuously encouraged our staff to find 
opportunities to do that at a staff-to-staff level. But, no, I 
have not had an opportunity.
    Mr. Barton. All right, is there a reorganization formal 
proposal that is in written form, or is this still an internal 
concept within the agency?
    Dr. von Eschenbach. The reorganization is still very much 
an internal document in terms of its development, and I call it 
a proposal. We have crystallized it to the point where we have 
specific initiatives that we are now presenting as options and 
opportunities, and there clearly have been discussion about 
each of those in terms of its own unique features.
    I think what is important to point out is this is not a 
workforce reduction plan. This is not being done simply to save 
money. Just the opposite. It is being done to sort of enhance 
our ability to respond to the challenges that we now are 
facing.
    Mr. Barton. Well, I think Mr. Stupak's comment is well 
taken. If you are really going to try to implement it, the 
sooner you formalize it and let the people know what it is, the 
greater the potential for having it accepted and having less 
kickback from the political system. When it is a great unknown, 
everybody is going to oppose because there is no certainty. It 
is just normal for Congressmen to try to protect projects and 
facilities in their district, but it is also quite possible 
that if there is a coherent, well-organized plan that makes 
sense, you can get a majority of the committee to support it.
    Dr. von Eschenbach. Well, I very much appreciate that 
advice and wisdom, and we will continue to follow that 
principle. I would also add, of course, that one of the other 
things I want to be clear about is that we are not closing 
laboratories with the idea of eliminating functionality. This 
is not the case, and I think that just occurred with the 
discussion of our ability to address radionuclear materials and 
health.
    It is to be able to consolidate our assets in a way, 
enhance our assets in a way that gets the maximum impact, but 
that will require change. And it may require movement and 
shifts of those resources so that we have a national network, 
not a regional or local network. And when Ms. DeGette related 
to the issues, for example, in Denver, clearly it is not a 
factor that that laboratory is inadequate or the people have 
not been exceptional. In fact, they have been.
    But as you pointed out, there are three Ph.Ds in that 
laboratory, and quite candidly, that is not necessarily 
critical mass for the kinds of things that we need to be able 
to analyze and do at these reference laboratories as we move 
forward into the future. So how do we create that kind of 
modern, multi-disciplinary infrastructure is very difficult and 
very painful, and I welcome critical input as well as 
reinforcement when it is appropriate.
    We are also looking at asking independent organizational 
management experts to look at this and view this and give us 
the benefit of their perspective as well before we carry this 
forward as a concrete proposal to Congress to be implemented.
    Mr. Stupak. Ms. DeGette for questions.
    Ms. DeGette. Thank you very much, Mr. Stupak. I think that 
we have beat the lack of response issue to death, and I am 
really serious, Dr. von Eschenbach. We just need to get this 
resolved. I think you have that message.
    I want to ask you some questions about the topic of the 
hearing. The first thing I want to ask you, one thing you said 
that I agreed a lot with what you said is that the FDA is 
reviewing its current levels of authority, particularly with 
respect to food safety to decide whether it needs more 
authority. As you may know, I have been working on a bill for 
several years to give the FDA mandatory recall authority with 
respect to meat. But now I am actually getting ready to 
reintroduce the bill, giving broader authority for mandatory 
recall of all food.
    Do you think that kind of authority would help maybe 
prevent some bad actors from trying to sell contaminated food?
    Dr. von Eschenbach. This is precisely one of the areas that 
I was referring to, and I do agree with you that this is an 
area of the impact of a mandatory recall authority for FDA and 
its ability to take care of the bad actors, if you will, is one 
of those explicit things that I am hoping to pursue.
    Ms. DeGette. When I talk to people about how the FDA 
doesn't currently have mandatory recall authority, they are 
shocked because they are thinking about the Consumer Products 
Safety Commissioner. And it seems like if we can recall child 
safety seats, we should be able to recall food. Would you agree 
with that?
    Dr. von Eschenbach. I do, and we have been fortunate in 
that the voluntary system has worked exceedingly well, and 
voluntary recalls by the manufacturers and producers of food 
have worked well. We just recently had one with baby food where 
Gerber, without any intervention on our part, voluntarily took 
the initiative to remove a product they were concerned about.
    The issue I would like to pursue is exactly the one that 
you raised, which is if there are ``bad actors.'' Those are the 
ones we want to focus on.
    Ms. DeGette. But even with legitimate actors, at the peanut 
butter hearing we had, while it is true that the company 
voluntarily eventually recalled the peanut butter, if the FDA 
had mandatory recall authority, I bet you there would have been 
much faster cooperation.
    Dr. von Eschenbach. Possibly so.
    Ms. DeGette. I want to talk to you for a minute about--I 
know you will be shocked--the Denver lab closure, and you 
talked to several members about this is a modern era, we need 
to look and see whether we are working the most effectively.
    The thing is though, as I understand it, these regional 
labs don't all do the same thing. Is that correct? The Denver 
lab does some different things than San Francisco or 
Massachusetts or the other labs, correct?
    Dr. von Eschenbach. That is correct.
    Ms. DeGette. And at least in looking at, you know, I live 
in a State where everybody wants to live there in Colorado, 
which is part of the reason you are having a hard time getting 
your senior scientists to be willing to relocate. But the way 
that private business is operating is with the advent of 
electronic communications and computers, people are more and 
more working from remote locations. It seems to be, if you want 
to look at a modern era of working, oftentimes you can 
effectively and efficiently use smaller locations that network 
together. And I am wondering if the FDA has looked at that kind 
of alternative for some of these labs where you have scientists 
who have years and years of experience?
    Dr. von Eschenbach. Yes, if I may with your permission, I 
would like to turn the microphone over to Ms. Glavin who has, 
for the past 2 years, really been working through this in a 
layer-by-layer fashion. And the answer to your question is yes, 
we have looked at it, and I would like her to give you the 
detail.
    Ms. Glavin. Certainly some of the proposals to have some 
districts remain in place but report into another district are 
exactly what you are talking about so that we don't need as 
many managers, and we can have more cops on the beat I think 
was the term you used earlier.
    With respect to labs, of course, working at home isn't 
really an issue.
    Ms. DeGette. Well, I am not talking working at home.
    Ms. Glavin. Right.
    Ms. DeGette. The Denver lab is at the Denver Federal 
Center, which is a secured facility with a number of Federal 
agencies there.
    Ms. Glavin. Right.
    Ms. DeGette. And my question is if you have the expertise 
there, if you have senior scientists who have been there for 
20, 25 years and put down their roots, why wouldn't you want to 
try to find a way to help them do that job and reporting in and 
working with other agencies, which they are apparently doing 
very effectively now?
    Ms. Glavin. Well, and I agree that that can be done from a 
variety of locations, but as the commissioner has said, we have 
labs in 13 locations at this point. And that makes it very hard 
to have a coordinated approach, and we would like to see if we 
can bring people together, provide them with the tools and the 
technology that they need and deserve to do 21st century 
science.
    Ms. DeGette. And just one last question. Has the FDA 
considered the balance of the hope of bringing people together 
doing 21st century science with the deep loss of expertise that 
the FDA is going to suffer when it closes these offices?
    Dr. von Eschenbach. Yes, we have, and can I just add 
specifically, I think your point about there being three Ph.Ds 
in that laboratory in Denver, and the question we have to ask 
is would they benefit by being nested with a lot of other Ph.Ds 
with other kinds of disciplines that would enhance their 
impact, and at what loss? What would we give up in that regard? 
And I think that the other side of that is can we give them an 
infrastructure that is adequate? Can we give them modern 
facilities that have robotics so that they could high 
throughput analyses and things of that sort?
    It is the people, and they are the most important. But then 
it is also the infrastructure that we provide for them.
    Ms. DeGette. But there----
    Dr. von Eschenbach. It is a little bit of all of that.
    Ms. DeGette. There is nobody else that does what----
    Mr. Stupak. OK, got to go now. Other Members have to ask 
questions.
    Ms. DeGette. I would ask unanimous consent for just 15 
additional----
    Mr. Stupak. Seconds. I am counting.
    Ms. DeGette. There are only three people that do that job, 
and those are those three Ph.Ds in Denver. Has anybody talked 
to them about whether they are going to leave and become nested 
in the robotic area?
    Dr. von Eschenbach. I can't speak specifically to a 
conversation with those three people. We would want those three 
people to move if that was what was necessary because we don't 
want to lose those people. This is not about losing expertise 
or eliminating function.
    On the other hand, if they don't, we have to believe that 
there are at least in this country three other Ph.Ds that we 
could attract and recruit to the modern, sophisticated, 21st 
century environment. That is the strategy that we are applying.
    The chairman asked me about our reorganization plan and 
other agencies. Well, we talked a lot about the USDA with all 
of its array of inspectors, and yet it only has three 
laboratories. And we are talking about going from 13 to 6.
    Ms. DeGette. Thank you.
    Dr. von Eschenbach. USDA has three.
    Mr. Stupak. Mr. Burgess for questions.
    Mr. Burgess. Thank you, Mr. Chairman. Dr. von Eschenbach, 
too let me commend you for being here through this entire day, 
and I know we have kept you a very long period of time. I 
cannot recall having ever seen the head of a Federal agency who 
has been made to sit through three panels, and it is a 
testament to your abilities and willingness to get this problem 
solved. And I appreciate so much you being here and listening 
to the testimony today. If I could, it is on my mind because I 
heard--it was either CNN or NPR this weekend--the two little 
girls who ate the contaminated spinach from out in Salinas, CA 
year. And it kind of brought home to me again that there was 
actually a problem that was sort of identified earlier before 
that outbreak had occurred. And somewhere along the line, we 
sort of lacked the follow-through to make certain that that was 
taken care of. Do I remember that correctly?
    Dr. von Eschenbach. I quite honestly can't recall to 
testify that that is a correct recollection.
    Mr. Burgess. But we had in testimony that we had when we 
did the first series of hearings on this last spring. Said in 
November 2005, the FDA sent letters to growers, packers, and 
processors and shippers, warning them to improve safety in view 
of continuing outbreaks. The agency wrote we encourage firms to 
consider modifying your operations accordingly to ensure that 
they are taking the appropriate measures to provide a safe 
product to the consumer something we would all be in favor of. 
What can we learn from that experience? How can we make sure 
that those products are indeed safe? Are there other tools that 
you need that you need us to give you so that going forward, we 
can be certain that that doesn't happen?
    Dr. von Eschenbach. Well, as I indicated in my opening 
statement, in addressing this radical change that has occurred 
in production and consumption and distribution of food, the 
fact that there is no such thing anymore as made in America, 
made in China. It is more assembled, and even the products we 
are talking about have ingredients that come from all over the 
place. We have to look at this in a comprehensive way, and that 
is why I talk about production to consumption or farm to fork.
    So that we have a multipronged strategy to address this 
across that entire continuum. One of the things FDA has not in 
the past is really emphasize the front end of that, emphasize 
prevention. And so prevention is going to be an extremely 
important part of the plan that Dr. Acheson will be bringing 
forward.
    And part of that prevention is to work with the producers 
in terms of these good agricultural practices based on science 
that Dr. Brackett is formulating so that we can assure that we 
are enhancing the quality before it actually even comes into 
our system.
    And I would like to turn the microphone to him to talk a 
little bit about how we could really enhance the front end 
using modern science.
    Mr. Burgess. Very quickly.
    Mr. Brackett. Thank you, Dr. von Eschenbach.
    Mr. Burgess. The chairman has a sharp gavel when it comes 
to me.
    Mr. Brackett. Yes, Mr. Burgess. I think one of the things 
that we have learned a lot from that is the impact that one 
small tiny mistake that can happen on the front end, as Dr. von 
Eschenbach, can have radical change and disastrous consequences 
that you mentioned before with the young children that became 
ill.
    I think some of this has been addressed from the research 
needs that have come from this. We have learned a lot in that 
particular instance about how produce can become contaminated, 
what the results are, and getting some ideas of where to best 
test.
    From that, what we are looking for are devices, as Dr. von 
Eschenbach mentioned earlier, with the x-ray fluorescence 
detector, to do the same sort of things with microbial 
contamination, to have indicators to try to find out where are 
the hot spots because we know that the vast majority of the 
fields are fine. But whenever you have contamination in a 
concentrated area, that is where the trouble starts.
    And we need to have the scientific basis on which to 
develop techniques and methods but also for our regulatory 
strategies as well. It doesn't do any good to have guidance and 
regulatory strategies aimed at things that are not actually 
going to improve public health.
    Mr. Burgess. Would part of that regulatory strategy be to 
beef up the recall process so that FDA has the ability to issue 
mandatory recalls?
    Mr. Brackett. Well, I think that fits right in it, and also 
encouraging such things as perhaps a more modernized traceback 
system so that we can trace these things back much faster, 
minimize the damage to the patients and to the consumers as 
well as to the industry as a whole.
    Mr. Burgess. Now, part of the bioterrorism or mitigating 
the threat of bioterrorism is syndromic surveillance where 
products that are bought over the counter at drugstores, for 
example cold medications, cough medications, medications to 
treat an upset stomach, if there is a sudden spike in the 
purchase of those products, the emergency rooms and public 
health sectors are notified that there may be something going 
on and to watch out for it. Are you keyed into that syndromic 
surveillance so that the FDA knows to look at perhaps a 
foodborn source as well and perhaps get a day or two's lead 
time on that?
    Dr. von Eschenbach. Dr. Burgess, very recently, Dr. 
Gerberdin, head of the CDC, and I have put together an 
interagency effort to specifically link our ability to be more 
effective at data sharing, information sharing because CDC is 
that first line of defense that you just talked about in 
recognition of a foodborn illness. And then when it becomes 
obvious, as it did with the spinach, that it is an outbreak by 
virtue of the fact it is the same organism causing these 
problems in multiple places, then it becomes FDA.
    We need to be much more seamless in that recognition, 
detection, identification continuum, and we are working on that 
as we speak with CDC to enhance our data information sharing 
systems.
    Mr. Burgess. Do you have the----
    Mr. Stupak. Gentleman's time. We want to get to, Mr. 
Burgess, we are going to have votes here in a few minutes.
    Mr. Burgess. Thank you.
    Mr. Stupak. Trying to get everybody in. If we have time, we 
will come back again. Ms. Schakowsky.
    Ms. Schakowsky. Thank you. Commissioner, I really do 
appreciate the fact that you have been here the whole time. Had 
you checked with the San Francisco district office, as our 
investigators did, they would tell you that in the last 10 
years, there have been 10 outbreaks in leafy green vegetables 
in the Salinas Valley. So Dr. Burgess is right, and that is an 
important fact. And to a person, our investigators said that 
your staff there believe that voluntary guidelines have not 
worked and that concrete rules for both the farm and processing 
operation are necessary. Do you agree?
    Dr. von Eschenbach. Let me be clear because this is an 
important issue of the distinction between a mandatory 
regulation and a guidance, which is voluntary.
    I have discussed this at great length with the experts, and 
I consider Dr. Brackett to be my most important expert, in 
which there are areas, quite frankly, where the science is not 
mature enough for us to be able to define a regulation that is 
mandatory for everyone all the time. And so what we have 
pursued is use of guidances in good agricultural practices.
    Ms. Schakowsky. There are no instances where you think you 
have enough information to introduce mandatory rules as opposed 
to voluntary guidelines? The science just isn't there anywhere?
    Dr. von Eschenbach. I am not going to say the science isn't 
there anywhere. I think in large part we heard earlier today in 
one of the testimonies that someone thought it might have been 
the water. I have heard other people think it might have been 
wild pigs running through those spinach fields. And the science 
is going to have to decide what is the source of that 
contamination with E. coli, and then we can put in place a 
regulation that would address that.
    In the meantime, what we are using are guidances that will 
enable us to be flexible as the science continues to evolve 
before we lock into something.
    Ms. Schakowsky. OK, but there is certainly a lack of 
confidence right now that the FDA is doing all that it can and 
the Government is doing all it can. I wanted to ask you about 
water. Does the FDA need congressional authority to regulate 
water quality and other controls for the farm that supplies 
spinach and lettuce for our grocery stores?
    Mr. Brackett. Well, certainly the water, that surface water 
and others, there is EPA authority to look at the quality of 
that water. And I guess what you are asking is should 
agricultural water be regulated as such. At this point, water 
quality is one of the things that is addressed in good 
agricultural practices. That was introduced in 1998 to make 
sure that the water is not looked to be contaminated, such as, 
perhaps outwash from rivers. And so that is one of the things 
that the producers are actually supposed to be looking at is 
the water quality--are you sure of the water quality.
    Ms. Schakowsky. The producers are supposed to be looking at 
that.
    Mr. Brackett. The producer.
    Ms. Schakowsky. But what is the role of Government? Does 
FDA need congressional authority to regulate water quality when 
it comes to it being involved in our food production?
    Mr. Brackett. Well, again EPA has that for total water 
quality. Whether we would need it on the food production side 
of it, that is one of the things we are considering in looking 
at that. It wouldn't do any good to go requesting authority if 
we found out that it wasn't, in fact, going to be the problem 
or was duplicative of what is already out there.
    Ms. Schakowsky. So you are examining whether or not you 
need that authority?
    Mr. Brackett. Yes, we are.
    Ms. Schakowsky. And are you also looking at voluntary 
versus mandatory?
    Mr. Brackett. Well, yes. Already water quality is part of 
good agricultural practices, which is the voluntary part of it. 
And that states that one must use water of acceptable sanitary 
quality. So that is already there, and that is something that 
we do.
    Ms. Schakowsky. That is a guideline?
    Mr. Brackett. It is a guidance, yes.
    Ms. Schakowsky. OK, and so none of this is mandatory?
    Mr. Brackett. Not at this point.
    Ms. Schakowsky. Are you examining that in your 
reorganization and looking at your authorities?
    Dr. von Eschenbach. We are reexamining that in the food 
protection plan that I alluded to earlier, which the 
reorganization is a part and separate.
    Ms. Schakowsky. Right.
    Dr. von Eschenbach. There is a larger, more strategic 
agenda that is agency-wide, and our reassessment of authorities 
is a part of that.
    Ms. Schakowsky. I think it is really important that you 
communicate with the committee about that because we may act 
anyway, and so it would be a really good thing.
    Dr. von Eschenbach. Agreed.
    Ms. Schakowsky. The other thing I want to say is that you 
looked annoyed when another example was given of not answering 
a letter, but it looks to me from what we heard from our 
investigators that there is a systematic withholding of 
information. When our investigators say it is like pulling 
teeth to get information, we have a responsibility too. Our 
responsibility is oversight. We don't want to have to fight 
with you. We don't want to have to wait. We want to be able to 
get the information that is needed for us to do our job which 
is equally mandated as your job is.
    Dr. von Eschenbach. I apologize if my nonverbals appeared 
that I was annoyed.
    Ms. Schakowsky. No, you should be annoyed.
    Dr. von Eschenbach. I am frustrated.
    Ms. Schakowsky. You should be annoyed and frustrated that 
Members of Congress didn't get an answer.
    Dr. von Eschenbach. I agree.
    Ms. Schakowsky. But it is not some sort of unique 
oversight. What we are finding is that it is systematically, 
when we ask questions and our investigators, who we give 
authority to ask questions, aren't given the answers that we 
need. So this is a more pervasive problem. That is all I am 
saying. It is not like we messed up again, again and again and 
again and again. And I thank you, Mr. Chairman.
    Dr. von Eschenbach. Thank you. And I am committed to 
addressing that.
    Mr. Stupak. We have a series of votes, but I think it is 
only fair to ask you about the bonuses. I want to ask you a 
couple questions about that. I mentioned it publicly. We are 
perplexed as to why we put in fiscal year 2006 $10 million for 
bonuses, and what we can determine from data collector for HHS, 
just on employees who receive $5,000 more, you gave out $9.5 
million in bonuses. Seems like the extra money for food safety 
and food inspection went to bonuses and then not to personnel.
    Dr. von Eschenbach. May I take a few moments to put that 
into perspective? First of all, when I arrived at the FDA, I 
quickly came to the realization that our most precious asset at 
FDA is our people.
    Mr. Stupak. Then why don't you ask for the bonus money and 
retention things in salaries and not in food safety money?
    Dr. von Eschenbach. Well, we haven't quite done that the 
way I think it has been perceived.
    Mr. Stupak. Well, members are----
    Dr. von Eschenbach. But the bonus dollars that are being 
allocated are coming from each individual allocation. We have 
not transferred dollars from drugs to some place else to pay 
bonuses. The bonuses that are applied, are applied out of each 
center's individual allocation.
    Mr. Stupak. So then you have to cut back food safety money 
in order to get the bonuses to your people?
    Dr. von Eschenbach. No, sir.
    Mr. Stupak. Where are you getting the money then for the 
bonus?
    Dr. von Eschenbach. The bonuses that have been paid for 
people who are in, for example, the Center for Food Safety and 
Applied Nutrition come out of Dr. Brackett's budget. The 
dollars that are paid for bonuses for people who are----
    Mr. Stupak. Then how come we can't find that extra $10 
million that Congress put in for food safety and inspection? We 
can't find where that money went. We just have this bonus money 
that shows up----
    Dr. von Eschenbach. It wouldn't go to bonuses in somebody 
else's center, I can assure you that.
    Mr. Stupak. Well, the part that bothered us was if you take 
a look at employees in your office, OK, Office of the 
Commissioner, collected more than 30 percent of all the top FDA 
cash awards in 2004, 2005, 2006. And the Office of Regulatory 
Affairs only received 19 percent of all the FDA's top cash 
awards, yet they have 35 percent of all the FDA employees. So 
if you take a look at it, cash bonuses in your office these 
last few years went up 80 percent, where in the same Office of 
Regulatory Affairs only went up 30 percent.
    So as imports have increased, the FDA's workload to do more 
and more with fewer resources, the field employees' cash awards 
have actually gone done, where your office, Office of 
Commissioner, the executive level, has gone way up. How do you 
explain that?
    Dr. von Eschenbach. Well, I need to look at that specific 
data to give you detail as to where those dollars are going, 
but I will tell you in principle we have put in place across 
the agency now a committee to look at bonuses so that we are 
certain that the criteria that are being used are uniform and 
applicable across the agency. But it is individual centers that 
use their own individual budget as a percentage of that to use 
for bonuses within that center. We don't take money from one 
center and give it to another to be used for bonuses.
    Mr. Stupak. Well, we have asked for that criteria, and we 
can't seem to find the purpose of it because it bothers some of 
us that the FDA's inspector of the year received a $1,000 
bonus. And I don't think that is fair to your best investigator 
to get only $1,000 bonus while your management team gets like 
20 times more in bonuses each year. How is that fair to that 
inspector who is doing the legwork on food safety?
    Dr. von Eschenbach. You have performance bonuses. There are 
retention bonuses, and there are different mechanisms for 
giving bonuses.
    Mr. Stupak. But back to the same point. Get us the 
information so we can ask the questions because from this 
perspective, you get $10 million for extra in food safety in 
2006, and you got $9.5 million in bonuses. It looks like all 
the money that went to food safety went there. We wouldn't be 
asking the questions if we have the information.
    Dr. von Eschenbach. I will provide you the----
    Mr. Stupak. Damned if you do and damned if you don't. That 
is basically what it comes down to.
    Dr. von Eschenbach. I will be happy to provide that to you.
    Mr. Stupak. All right, let me ask you--I have 55 seconds. 
Does USDA get bonuses?
    Dr. von Eschenbach. I am assuming that other Government 
agencies give bonuses.
    Mr. Stupak. Don't assume.
    Dr. von Eschenbach. Certainly it is true at NIH.
    Mr. Stupak. USDA requires certification from a foreign 
country that their safety regulations are at least as strong as 
ours in order for them to export to the United States. Do you 
support a similar certification for imports under FDA's 
jurisdiction?
    Dr. von Eschenbach. I support working with foreign sources 
to be able to continuously enhance their ability to assure the 
quality of product of foods that are coming to our borders.
    Mr. Stupak. So the answer is no?
    Dr. von Eschenbach. At this point, I don't have enough 
information to answer whether that should be mandatory across 
the board. I think it is something that, as we have looked at 
imports, we need to address.
    Mr. Stupak. Let me ask you this. USDA restricts imports of 
products under their jurisdiction to 10 ports of entry. You 
have somewhere between 326 to 361. We are still trying to get 
the exact number of your ports of entry. Would you be in favor 
of bringing it down to the 91 ports where you have FDA 
inspectors?
    Dr. von Eschenbach. At this point, Mr. Chairman, I could 
not be in favor of that because I don't have a careful analysis 
of what that might imply. To decide to take all of our----
    Mr. Stupak. Don't you think that should be in your 
reorganization plan?
    Dr. von Eschenbach. Not from a perspective of forcing 
producers in foreign countries to only send their food to 
certain ports.
    Mr. Stupak. How else are you going to get it inspected?
    Dr. von Eschenbach. That is not part of our reorganization 
plan.
    Mr. Stupak. How else are you going to get them inspected?
    Dr. von Eschenbach. By having inspectors with modern tools 
of science deployed at the ports of entry----
    Mr. Stupak. But if you only have 91 ports of entry covered. 
You only have 91 covered out of 326.
    Dr. von Eschenbach. Today.
    Mr. Stupak. Today.
    Dr. von Eschenbach. And we will look forward to continuing 
to expand that as we make this transition into the FDA of the 
21st century.
    Mr. Stupak. All right, if Congress puts in reports language 
that you do not close these labs until we have approved a 
reorganization level, will you follow that in the report 
language?
    Dr. von Eschenbach. Well, obviously, I will always follow 
the dictates of Congress, but I will----
    Mr. Stupak. But will you do it? You always say you are 
going to provide information, and you don't. But will you do 
it?
    Dr. von Eschenbach. I would hope that we would have the 
opportunity to further dialog on the rationale behind the 
proposal and allow us to go forward with the reorganization, 
modernization of FDA. We may have differences about unique 
features of it, but I don't think we should have a difference 
that if we continue the way we are today we will be inadequate 
to address the problems we have been talking about throughout 
this entire day.
    Mr. Stupak. I will bet you you will have your 
reorganization done before we get the information we requested. 
Mr. Burgess had a question.
    Mr. Burgess. Thank you, Mr. Chairman. And I would just like 
to offer the observation--I haven't been here that long, but it 
is hard to keep and train and retain good people. So I have no 
problem at all with you offering retention bonuses. Just don't 
tell my staff that I said that, and we will all be in good 
shape.
    On the FDA's reorganization, you said that you think you 
can do that without disrupting the functionality of the FDA, 
and yet one of the reasons for the reorganization or one of the 
consequences will be reduction in staff by perhaps several 
hundred full-time employees. How is that going to keep from 
disrupting the functionality?
    Dr. von Eschenbach. May I first correct that particular 
issue? This is not intended to reduce FTEs. There may be a 
shift in the nature of that FTE. For example, a shift from 
someone who happens to be a technician in a laboratory perhaps 
to shift to someone who is a field-deployed inspector using the 
modern technical devices I alluded to. There may be a shift but 
not a reduction. So I hope that this is not viewed as a 
workforce reduction plan because it is not that.
    Mr. Burgess. So it is redeployment of existing forces?
    Dr. von Eschenbach. It is very much redeployment, in 
certain cases, consolidation, modernization. It is more than 
just simply we need to do something to save money. That is not 
the point.
    Mr. Burgess. So going forward in this process during the 
reorganization, can I ask that you keep the committee updated 
as to how this is going and demonstrating that functionality is 
not being impaired or lost as employees are being reassigned 
within the organization?
    Dr. von Eschenbach. We are not going to allow a loss of 
functionality, and we will phase this in over years. This is 
not something that will happen precipitously. It is expected it 
may take 3 years to do whatever ultimately comes out of this 
plan.
    The other thing I want to make absolutely clear is the 
people who have testified earlier today from these laboratories 
are FDA's finest. The people in these laboratories are working 
extraordinarily hard, and they are superb people. I had the 
privilege of giving someone in Denver an award very recently, 
and I have seen the pain that they have of facing the 
possibility of a relocation.
    This is not about our people not having done a good job or 
being inadequate or these laboratories having been failures. 
Just the opposite is true. These laboratories and this work 
force is something I am extraordinarily proud of, but the world 
has radically changed around us. And we must radically change 
in order to adapt and adjust to that. And we would like to do 
that in a deliberative thoughtful fashion so that we serve the 
American people to protect and promote their health. And that 
is the whole purpose of this.
    Mr. Burgess. Very well. Just one last thought, Mr.----
    Mr. Stupak. Quickly. We have 2 minutes left to vote.
    Mr. Burgess. You are fast. Mr. Hubbard, when he testified 
put forward the concept that we need to have some way of 
holding countries that export to the United States accountable 
for the stuff that they send to this country. Would you be in 
favor of that type of process?
    Dr. von Eschenbach. That is also one of the authorities 
that we are exploring so that we have much better security in 
protecting what is coming into our borders, if we are unable to 
get the kind of quality built in on the front end that we want. 
And we will be coming back to Congress through the appropriate 
channels as we further mature this protection plan.
    Mr. Burgess. I want you to have that. I hope you do come 
back and ask us if you need--when I address additional tools, 
that would be one I would be very happy to put in your hands.
    Dr. von Eschenbach. And we are also working, as the 
chairman indicated, in close coordination with the Department 
of Health and Human Services and all of its agencies as well as 
counterparts outside of the agency as we address this 
protection of our borders and homeland security.
    Mr. Burgess. Thank you, Mr. Chairman. I will yield back.
    Dr. von Eschenbach. Mr. Chairman, I will leave my 
colleagues with your permission.
    Mr. Stupak. We have seven votes. I don't think it would be 
fair for your colleagues to sit for another hour unless Mr. 
Burgess has questions of other. So we will excuse this panel 
and thank you very much for coming.
    Dr. von Eschenbach. Thank you, Mr. Chairman, and thank you, 
all the members of the committee, for your commitment to the 
FDA.
    Mr. Stupak. That concludes our questioning. I want to thank 
all of our witnesses for coming today and for your testimony. I 
ask unanimous consent that the hearing will remain open for 30 
days for additional questions for the record. No objection. The 
record will remain open. I ask unanimous consent the contents 
of our document binder be entered in the record. I will also 
note that the documents provided by the FDA to justify the 
bonuses in exhibits 47 through 56 are included in the binder, 
but the volume of supporting documents, several boxes, will be 
retained in the subcommittee files for access and review. No 
objection. Documents will be entered into the record. That 
concludes our hearing. Without objection, this meeting of the 
subcommittee is adjourned.
    [Whereupon, at 3:10 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

 Statement Hon. Richard J. Durbin, a Senator from the State of Illinois

    Mr. Chairman, I want to begin by commending you for calling 
this hearing and to thank you very much for the opportunity to 
present written testimony.
    The issue of food safety has been one of my top legislative 
priorities for more than 10 years. I am disappointed to report 
that the recent string of food recalls does not surprise me. 
Unfortunately, Mr. Chairman, we have an antiquated food safety 
system that is in desperate need of additional resources and 
updated statutory authority. While the United States continues 
to have the safest food supply in the world, our food safety 
standards and practices have been eclipsed by some of our major 
competitors.
    Our food safety system is particularly deficient in the 
area of food imports. The recent recalls of contaminated pet 
food, seafood, toothpaste, and other imported food products 
have demonstrated that we need to make changes in this area.
    The volume of food that the United States imports has 
increased significantly in recent years, from $45.6 billion in 
2003 to $64 billion in 2006. According to the USDA, imported 
food accounts for 13 percent of the average American's diet, 
including 31 percent of fruits, juices, and nuts; 9.5 percent 
of red meat; and 78.6 percent of fish and shellfish.
    This upward trend in imported food has been accompanied by 
an increasing number of health and safety incidents related to 
imported food products. In the past 6 months, we have seen what 
appears to be the intentional contamination of wheat gluten and 
rice protein concentrate with melamine, which is an industrial 
product that should never find its way into food products. In 
addition, we recently learned that a significant volume of 
imported seafood products from China have been contaminated 
with chemicals and residues, including Malachine green and 
Nitrofuren. We have found imported Chinese toothpaste in the 
U.S. that was contaminated with diethylene glycol, which is a 
toxic component used in antifreeze.
    Unfortunately, the FDA currently lacks the resources and 
authority to adequately determine the quality and safety of 
food imports, inspect an adequate volume of imported food, and 
rapidly detect and respond to incidents of contaminated 
imports.
    What has been made clear by the pet food recall and other 
outbreaks of food borne illnesses is that the FDA is a severely 
under funded and understaffed agency. Much of the 
responsibility for overseeing and inspecting the safety of 
imported food rests with the FDA. However, due to flat budgets 
and increasing responsibilities, the number of inspectors 
looking at these shipments has actually decreased from more 
than 3,000 inspectors in 2003 to the present level of around 
2,700 inspectors.
    The Centers for Disease Control, CDC, estimates that 76 
million Americans become sick from food borne illnesses each 
year. More than 300,000 are hospitalized and 5,000 die each 
year. Less than 1.5 percent of imported food is inspected by 
the FDA and the FDA lacks the resources and authorities to 
certify the standards of our trading partners. This situation 
presents an economic, public health, and bioterrorism risk to 
the U.S.
    The FDA office that is responsible for regulating more than 
$60 billion of imported food, the Center for Food Safety and 
Nutrition, CFSAN, is also responsible for regulating $417 
billion worth of domestic food and $59 billion in cosmetics. 
All of this activity is regulated by an office for which the 
President requested $467 million in fiscal year 2008. Only $312 
million of that amount would be for inspectors. We clearly need 
to review FDA's funding to make sure that it has the resources 
necessary to safeguard the 80 percent of our food supply that 
it is responsible for regulating. For this reason, a group of 
my colleagues and I sent a letter earlier this year to the 
Agriculture Appropriations Subcommittee, which funds the FDA, 
asking for a significant increase in the level of funding for 
the FDA foods program.
    In addition to working for increased appropriations for the 
FDA foods program, I recently introduced legislation in the 
U.S. Senate, the Imported Food Security Act of 2007 (S. 1776), 
that is designed to close the gaps in FDA's imports program and 
improve the standards for imported food.
    The legislation does three things. First, the bill would 
impose a fee for the FDA's oversight of imported food products. 
These fees would generate revenues to be used for increased 
inspections of imported food and critical food safety research. 
The legislation would also establish a food importer 
certification program that would require foreign firms and 
governments to demonstrate that their food safety systems are 
equivalent to ours.
    Imports present a special challenge to the FDA. It may cost 
more to ensure the safety of food produced in other countries, 
and the logistical challenges are greater. It is important that 
we supplement the FDA's budget with additional funding streams 
to make sure that it has the resources necessary to safeguard 
our food supply from contaminated imports.
    This legislation would direct the FDA to collect a user fee 
on imported food products, for the administrative review, 
processing, and inspection costs borne by the FDA. The 
legislation directs the FDA to use some of this funding to 
perform cutting-edge research to develop testing technologies 
and methods that would quickly and accurately detect the 
presence of pervasive contaminants such as E. coli and 
listeria.
    In addition, the legislation would use this funding stream 
to bolster FDA's import inspection program, which currently 
inspects less than 1.5 percent of all imports. My hope is that 
this legislation would give the FDA the resources it needs to 
double or triple the percentage of shipments that are inspected 
each year and focus its limited resources on the shipments that 
present the greatest risk to human health.
    Lastly, this bill would establish an imported food 
certification program. Today, any country and any company can 
export food products to the United States as long as they 
inform regulators of the shipment. No checks are performed to 
ensure that the producer has adequate sanitary standards. The 
FDA does not ensure that trading partners have equivalent 
regulatory systems or inspect overseas plants when problems 
arise.
    When the FDA does want to investigate an outbreak, it can 
be delayed by uncooperative foreign governments. For example, 
during the pet food recall, U.S. regulators were delayed three 
weeks in their request for visas to inspect facilities.
    This new program would mark a watershed change in the food 
import safety posture of the U.S. This bill says that if you 
want a slice of the lucrative U.S. market, you have to comply 
with the same common-sense standards that apply to U.S. food 
producers. You have to have equivalent food safety systems and 
processes in place to those of the Unied States. You need to 
give U.S. regulators access to your facilities and records so 
they can check your safety record without unnecessary delay. In 
addition, U.S. regulators would have the power to revoke the 
certification of a company or country that fails to comply, and 
to detain products that fail to meet U.S. standards.
    For too long, we have gone without a solid safety standard 
for imported foods. Instead, our regulators jump from alert to 
alert and recall to recall. This legislation would close these 
loopholes that allow dangerous imports into our country and put 
a solid, proactive system in place to protect our food supply.
    In addition, Mr. Chairman, I would like to mention one 
other issue that I believe would significantly improve the food 
safety system we have in place today. Because the FDA lacks the 
authority to order recalls, we depend on a system of voluntary 
or cooperative recalls, in which the FDA works with companies 
to pull products from shelves and notify consumers and 
retailers of defective products.
    In most instances, this system functions well because food 
companies have a concerted interest in protecting their brands 
and taking aggressive action to ensure the health and safety of 
their customers. However, in some instances, food companies do 
not fully cooperate with the FDA--they delay in sharing 
information or implement recalls slowly and unevenly. Part of 
the reason why these situations occur is because there is no 
requirement in statute, regulation, or even guidance that 
informs companies of when they are required to report serious 
adulterations of food and what notifications they are required 
to make.
    The net effect of this is that human health is put at risk, 
consumer confidence in food decreases, and companies find 
themselves in uncertain situations about when and how to 
conduct recalls. It is inevitable that at least once a year, we 
see slow, uneven, and ineffective recalls that don't remove 
product from shelves and that need to be expanded.
    The Senate-passed Prescription Drug User Fee Act of 2007 
(PDUFA) contains language that I co-authored with Chairman 
Kennedy that would fix this shortfall in our regulatory 
environment. The language creates a reporting system for 
significant adulterations of food that clarifies when food 
companies are required to report adulterations of food to the 
FDA and what they are then required to do to notify retailers, 
suppliers, and consumers of these health risks. It is a non-
controversial approach that clarifies the legal requirements of 
food companies and improves the FDA's ability to protect 
consumers from adulterated food.
    In the next couple of weeks, the House and Senate will go 
to conference on PDUFA. I believe that including the language 
from the Senate bill would make a significant step toward 
improving our food safety system.
    Thank you again, Mr. Chairman for allowing me to present 
testimony at this hearing and I look forward to continuing to 
work with you on this issue.
                              ----------                              


Statement of Hon. Ed Perlmutter, a Representative in Congress from the 
                           State of Colorado

    I would like to go on record to voice my strong opposition 
to the proposed closure of seven of the 13 FDA field 
laboratories, including the Denver District Laboratory, located 
in the Seventh Congressional District, in Lakewood, Colorado. 
The Denver District Laboratory, located at the Denver Federal 
Center, a GSA owned and operated facility, is an award winning 
lab. Many of the employees at this facility have vast 
experience and an invaluable research knowledge base. 
Furthermore it is doubtful these same employees would move to 
any of the consolidated laboratories, which under the proposed 
consolidation would be in Arkansas.
    The FDA has yet to provide any evidence supporting that the 
proposed closures and consolidation would lead to better safety 
standards for our Nation's food supply, pharmaceutical 
products, medical equipment, cosmetics and other health-related 
products for safety and effectiveness and ensuring that the 
products are labeled properly.
    The fact of the matter is these FDA lab closures are purely 
economic in nature and do not take into account the safety of 
our citizens. I understand the need to be good stewards of our 
tax dollars, but we must not risk or compromise the health and 
safety of our Nation. As a proud member of the House Homeland 
Security Committee, I understand the importance and 
responsibility entrusted to Members of Congress to ensure the 
safety of our Nation and the FDA's closure of these 
laboratories is contrary to that duty.
    Time and again the Denver District Laboratory has performed 
critical research for our Nation. Recently, the FDA asked the 
Denver laboratory to assist in evaluating the levels of the 
contaminant melamine in animal feed used to raise food for 
human consumption. The FDA asked the Denver laboratory to 
quickly develop a methodology to quantify melamine residues in 
fish tissues. Because melamine has not been approved as a food 
additive, no published types of analysis were available for its 
determination in fish. In less than 2 weeks, the lab developed, 
validated and submitted the method for publication, and made it 
available for national distribution to all state and Federal 
laboratories. As of June, the Denver District Laboratory 
continues to be the only FDA laboratory capable of testing 
seafood samples for the presence of melamine.
    The FDA failed to address several key components for their 
rationale for justifying the closure of seven field 
laboratories including how they are going to fund the 
laboratory closures. The agency has yet to reveal a plan to 
recover the loss of experience, knowledge and scientific 
expertise resulting due to potential FDA laboratory 
consolidation. Additionally, the FDA has yet to explain why 
they are displacing their more senior employees while hiring 
new employees.
    The closing and consolidation of the Denver District 
Laboratory would leave a large geographic gap in the Nation's 
ability to monitor and maintain food and drug safety and 
research. Under the FDA's closure plan, the closest lab to the 
two on the west coast (Seattle and Los Angeles) would be in 
Arkansas. This would leave the entire Rocky Mountain region and 
large parts of the Midwest without a close field lab. Denver is 
a major transportation and commerce hub with major links to a 
vast portion of our country. I believe these lab closures will 
compromise the safety and security of our nation.
    In light of the increased contaminants found in both 
domestic and imported food sources, and in particular recent 
contaminations of both pet and human food from China, I fail to 
see how the closures of seven FDA field laboratories will 
assist in making our Nation safer. The FDA has failed to 
provide adequate reasons for justifying these closures.
    In conclusion, I would like to reiterate my opposition to 
closing these field labs and in particular the Denver District 
Laboratory in the Denver Federal Center in Lakewood, CO, in 
Colorado's Seventh Congressional District.
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