[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
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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
------
U.S. GOVERNMENT PRINTING OFFICE
45-731 PDF WASHINGTON : 2008
----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free(866) 512-1800; DC
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Washington, DC 20402-0001
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
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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
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\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
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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\
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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\
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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\
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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.
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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\
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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.
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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\
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2 See appendix to staff statement that summarizes a sample of
recent news articles concerning unsafe food products from China.
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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\
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3 See FDA Import Alert No. 99-29 (April 27, 2007). do not literally
mean ``detain,'' but allow delivery to the importer.
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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\
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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.
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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.
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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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