[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
THE RECENT SALMONELLA OUTBREAK: LESSONS LEARNED AND CONSEQUENCES TO
INDUSTRY AND PUBLIC HEALTH
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
JULY 31, 2008
__________
Serial No. 110-142
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
__________
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COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California BARBARA CUBIN, Wyoming
BART STUPAK, Michigan JOHN SHIMKUS, Illinois
ELIOT L. ENGEL, New York HEATHER WILSON, New Mexico
GENE GREEN, Texas JOHN SHADEGG, Arizona
DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING,
Vice Chair Mississippi
LOIS CAPPS, California VITO FOSSELLA, New York
MIKE DOYLE, Pennsylvania ROY BLUNT, Missouri
JANE HARMAN, California STEVE BUYER, Indiana
TOM ALLEN, Maine GEORGE RADANOVICH, California
JAN SCHAKOWSKY, Illinois JOSEPH R. PITTS, Pennsylvania
HILDA L. SOLIS, California MARY BONO MACK, California
CHARLES A. GONZALEZ, Texas GREG WALDEN, Oregon
JAY INSLEE, Washington LEE TERRY, Nebraska
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
DARLENE HOOLEY, Oregon SUE WILKINS MYRICK, North Carolina
ANTHONY D. WEINER, New York JOHN SULLIVAN, Oklahoma
JIM MATHESON, Utah TIM MURPHY, Pennsylvania
G.K. BUTTERFIELD, North Carolina MICHAEL C. BURGESS, Texas
CHARLIE MELANCON, Louisiana MARSHA BLACKBURN, Tennessee
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
______
Professional Staff
Dennis B. Fitzgibbons, Chief of Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
David L. Cavicke, Minority Staff Director
7_____
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
DIANA DeGETTE, Colorado JOHN SHIMKUS, Illinois
CHARLIE MELANCON, Louisiana Ranking Member
Vice Chairman ED WHITFIELD, Kentucky
HENRY A. WAXMAN, California GREG WALDEN, Oregon
GENE GREEN, Texas TIM MURPHY, Pennsylvania
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee
JAY INSLEE, Washington JOE BARTON, Texas (ex officio)
JOHN D. DINGELL, Michigan (ex
officio)
(ii)
C O N T E N T S
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Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 4
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 5
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 7
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 8
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 10
Prepared statement........................................... 11
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 12
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 14
Witnesses
Charles H. Bronson, Commissioner of Agriculture, Department of
Agriculture and Consumer Services, State of Florida............ 16
Prepared statement........................................... 18
A.G. Kawamura, Secretary, Department of Food and Agriculture,
State of California............................................ 21
Prepared statement........................................... 23
Reginald L. Brown, Executive Vice President, Florida Tomato
Growers Exchange............................................... 26
Prepared statement........................................... 27
Edward Beckman, President, California Tomato Farmers............. 31
Prepared statement........................................... 33
Parker Booth, President, Delta Prepack, Inc. and Ace Tomato Co.,
Inc............................................................ 68
Prepared statement........................................... 70
Thomas E. Stenzel, President and Chief Executive Officer, United
Fresh Produce Association...................................... 82
Prepared statement........................................... 84
William K. Hubbard, Senior Advisor, Coalition for a Stronger FDA. 91
Prepared statement........................................... 93
David W.K. Acheson, M.D., Assistant Commissioner for Food
Protection, Food and Drug Administration, U.S. Department of
Health and Human Services...................................... 130
Prepared statement........................................... 133
Answers to submitted questions............................... 291
Lonnie J. King, D.V.M., Director, National Center for Zoonotic,
Vector-Borne, and Enteric Diseases, Centers for Disease Control
and Prevention, U.S. Department of Health and Human Services... 150
Prepared statement........................................... 153
Kirk Smith, D.V.M., Ph.D., Supervisor, Foodborne, Vectorborne,
and Zoonotic Disease Unit, Acute Disease Investigation and
Control Section, Department of Health, State of Minnesota...... 170
Prepared statement........................................... 171
Timothy Jones, M.D., State Epidemiologist, Communicable and
Environmental Disease Services, Department of Health, State of
Tennessee...................................................... 173
Prepared statement........................................... 174
Michael R. Taylor, J.D., Research Professor of Health Policy, The
George Washington University, School of Public Health and
Health Services................................................ 203
Prepared statement........................................... 205
Henry Giclas, Vice President, Strategic Planning, Science and
Technology, Western Growers Association........................ 233
Prepared statement........................................... 235
Donna Garren, Ph.D., Vice President, Health and Safety Regulatory
Affairs, National Restaurant Assocation........................ 245
Prepared statement........................................... 248
Robert E. Brackett, Ph.D., Senior Vice President and Chief
Science and Regulatory Affairs Officer, Grocery Manufacturers
Association.................................................... 260
Prepared statement........................................... 262
Submitted Material
Salmonella Saintpaul Outbreak Timeline........................... 282
Subcommittee exhibit binder...................................... 293
THE RECENT SALMONELLA OUTBREAK: LESSONS LEARNED AND CONSEQUENCES TO
INDUSTRY AND PUBLIC HEALTH
----------
THURSDAY, JULY 31, 2008
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, D.C.
The committee met, pursuant to call, at 10:01 a.m., in room
2123, Rayburn House Office Building, Hon. Bart Stupak (chairman
of the subcommittee) presiding.
Present: Representatives Stupak, DeGette, Schakowsky,
Inslee, Dingell (ex officio), Shimkus, Murphy, Burgess,
Blackburn, and Barton (ex officio).
Staff Present: Scott Schloegel, John Sopko, Chris Knauer,
Kevin Barstow, Calvin Webb, Alan Slobodin, Krista Carpenter,
Whitney Drew, and Kyle Chapman.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. This meeting will come to order.
Today we have a hearing titled ``The Recent Salmonella
Outbreak: Lessons Learned and Consequences to Industry and
Public Health.'' Each member will be recognized for a 5-minute
opening statement. I will begin.
Since the 110th Congress began in January 2007, this
subcommittee has been investigating the adequacy of the Food
and Drug Administration's efforts to protect Americans from
unsafe food.
Today we hold the subcommittee's ninth hearing regarding
the safety and security of the Nation's food supply. The
purpose of today's hearing is to examine the events surrounding
a recent Salmonella Saintpaul outbreak. We will consider the
implications to public health and industry and will examine
what lessons can be learned to better safeguard our food
supply.
Since April, at least 1,304 people in 43 States, the
District of Columbia, and Canada have been infected with
Salmonella Saintpaul. These illnesses have resulted in at least
252 hospitalizations and may have been a contributing factor in
two deaths. This outbreak is one of the largest outbreaks of
Salmonella ever in the United States, and based on the number
of confirmed cases it's the largest food-borne outbreak in the
last decade.
The Centers for Disease Control and Prevention, CDC, and
the Food and Drug Administration, FDA, have struggled to
identify the cause of Salmonella outbreak. Originally CDC and
FDA identified tomatoes as the most likely cause of the
outbreak. However, as the outbreak continued and the number of
illnesses soared the FDA was unable to definitively identify
tomatoes as the source of contamination. In late June CDC
expanded its epidemiological investigation to include food
items that are commonly served in combination with tomatoes.
This study found that people who became ill were more likely to
have recently consumed raw tomatoes, fresh jalapeno peppers,
and fresh cilantro. However, the CDC still could not determine
the exact cause of the outbreak.
Finally, on July 21, nearly 2 months after the outbreak was
first discovered, the FDA announced a significant break in its
investigation when they confirmed the presence of Salmonella
Saintpaul in a Mexican-grown jalapeno pepper. The jalapeno had
the same Salmonella genetic fingerprint as the strain linked to
the outbreak. Despite this discovery in jalapenos, the FDA
still refused to rule out tomatoes as the original source of
the outbreak, which has angered many tomato growers.
Today we will examine why it took the FDA, CDC and State
public health agencies so long to identify jalapeno peppers as
a source of Salmonella Saintpaul. Further, we will explore what
lessons for industry and government should be garnered as a
result of this outbreak. Perhaps most importantly we will try
to determine which aspects of this outbreak investigation
worked well, and which failed so that regulators, and the
affected industry will be better prepared to rapidly respond to
future outbreaks.
For example, we will examine a portion of the Bioterrorism
Act of 2002 which was designed to ensure the traceability of
food. The act directed Secretary of Health and Human Services
to issue regulations regarding the establishment and
maintenance of records by most people and companies that
manufacture, possess, pack, transport, distribute or receive
food. Most notably exempt from this requirement are farms and
restaurants. The regulation requires that records must be kept
to allow federal investigators to identify the immediate
previous sources and subsequent recipients of food in order to
be able to quickly respond to threats to our food supply.
However, in discussions with committee staff, Dr. David
Acheson, FDA's Assistant Commissioner for Food Protection,
otherwise known as the Food Czar, stated that the Bioterrorism
Act did not function as intended during this outbreak. Because
the Bioterrorism Act does not require a particular format for
maintaining records, most food companies have their own unique
system of recordkeeping which, according to FDA officials, has
caused significant delays in FDA's trace-back investigation.
While FDA has ultimately been able to trace back commodities
associated with this outbreak it has been too time consuming of
a process, requiring countless hours trying to link one
company's records to the next. Today we will explore what
specific problems FDA had in its trace-back investigation and
whether alterations to the Bioterrorism Act or other additional
regulations are needed to allow federal investigators to
quickly trace back suspected commodities during an outbreak.
We will also explore what the industry can do to maintain
traceability of its products. While there has been discussion
by FDA and the media that loose products, like tomatoes, are
difficult to trace due to their complex processing and
distribution chain, some of the industry maintain that such
commodities are rapidly traceable from the farm to the end
user. Indeed, some tomato companies visited by committee staff
did provide evidence that tomatoes could be rapidly traced back
if the need arose. However, these sophisticated systems appear
to conflict with statements by FDA officials who claim that
tracing this commodity has often been a time-consuming and
daunting task. Today we will discuss whether there are
particular systems that can be adapted by industry to enhance
traceability, particularly for high risk commodities.
Finally we will also hear a host of criticism from industry
directed at the FDA and CDC for the way they conducted its
outbreak investigation.
For example, we will hear that the FDA often did not share
or solicit critical data and other information from food safety
agencies.
We will hear that the way State health agencies interact
and share data with key federal agencies such as the FDA and
CDC is often inefficient, overly bureaucratic and sometimes
even counterproductive.
We will hear that by failing to adequately coordinate with
key State agencies both FDA And CDC missed important
opportunities to leverage scarce federal resources with State
resources to conduct investigation and field work related to
the investigation.
We will hear that neither CDC nor FDA worked closely enough
with State agencies to understand key produce distribution
patterns and, if they had, they would have realized early that
based on geographic distribution patterns of the illness the
source of the Salmonella was likely not from Florida.
Finally, we will hear that because there were over 3,000
local health departments and 50 State health departments
working under different public health laws there is a
tremendous variability in the capacity to respond to these
outbreaks which can have produced consequences on the ability
to pinpoint a contamination source.
These and other troubling issues related to this outbreak
continued to be uncovered as we move forward with this
investigation. While we understand the FDA's and CDC's
investigation into this outbreak is ongoing, it's important to
find answers and solutions to the key failures that have been
identified up to this point.
At a minimum, the FDA and the CDC must convene and
independent post-mortem task force which includes local, State,
federal, scientific and industry officials related to this
outbreak to study which features of the investigation broke
down and how the system can be improved. While this Salmonella
outbreak has sickened scores of people and caused great
economic damage to the produce industry, we are fortunate that
this does not appear to be an intentional contamination of our
food supply. If we do not learn from this case and rapidly
improve our food safety system we will be doomed to repeat the
failures of the current outbreak. The American public deserves
better from industry and our State, local, and Federal
agencies.
That completes my opening. I will next turn to Mr. Shimkus,
the Ranking Member of the subcommittee for his opening
statement please, sir.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman.
I want to welcome this panel and the succeeding panels to
follow. This is our ninth hearing we have held on food safety
this Congress to identify ways to ensure the safety and
security of our nation's food supply. At the beginning of our
last hearing in June, grocers and restaurants nationwide had
begun pulling tomatoes from the shelves and menus at great
economic cost until the cause of the Salmonella outbreak could
be identified.
Since then, 2 months after FDA's initial notice, not one
contaminated tomato has been found. Instead, the outbreak
strain of Salmonella Saintpaul was originally traced back to a
jalapeno pepper that was grown in Mexico and imported and
distributed through a warehouse in Texas. Yesterday afternoon
the FDA learned that the same genetic strain of the Salmonella
that was found in the serrano pepper on a different farm in
Mexico and in a nearby water reservoir.
Today nearly 1,300 illnesses have been reported in over 43
States, and local State and national public health officials
and regulators have been working to protect Americans during
the outbreak. Outbreaks of this magnitude cause serious concern
and warrant our close attention to help better prepare our
nation for the future.
Today we will explore the dynamics of the marketplace in
which federal agencies are trying to do the right thing and
prevent harm to consumers while their decisions often result in
economic losses to the industry. Witnesses from the tomato
industry will discuss their frustration of how the outbreak
gets handled and explain the effect the government's actions
had on consumer confidence and industry revenues.
A question to consider today is: Is there a way to limit
unnecessary collateral damage to the industry, and effectively
address a food-borne illness outbreak? A lot of the hearing
will focus on traceability. Trace-back is an important tool
used to rapidly and accurately identify the source of
contamination. This issue was supposed to be addressed in the
Bioterrorism Preparedness and Response Act of 2002. The act
directed the Secretary of Health and Human Services to issue
regulations regarding records kept by those who manufacture,
process, pack, transfer, distribute, receive, hold or import
food. Current regulations required that records must be kept to
allow federal investigators to identify the immediate previous
sources and subsequent recipients of food. This is known as the
one step forward, one step back.
In light of recent outbreaks and events it may be time to
evaluate the intent of the act and determine if clarification
or additional regulations are needed to improve our trace-back
ability. Witnesses today from different states and industry
will discuss their current practices and proposals to establish
more robust traceability systems. FDA's current traceability
system is not without flaws. We need to identify and understand
the system's limitations and explore and implement realistic
ways to make it faster and more cost efficient.
A critical part of this hearing is how a contaminated
product or commodity is identified in the first place. It seems
to me that without reliable information about the contaminated
product or commodity, traceability will be ineffective. Among
today's witnesses are two epidemiologists and a representative
from the Centers for Disease Control. I hope they can explain
the process of identifying suspected contaminated commodities
and highlight the strengths and the weaknesses of our current
system. I want to understand the role epidemiology plays in
relation to nationwide food-borne illness outbreaks. If there
are gaps in epidemiology that we can avoid and traceability is
only as good as the science that is guiding it, we might want
to focus our limited resources to improving the science and
statistics and not in requiring more regulations. We may not be
able to create a perfect system but we must have a more
reliable and efficient one.
There is a lot to be learned from this outbreak, and a
thorough post-mortem should be conducted by FDA and CDC with
input from local and State governments and the affected
industries. We need to determine where the breakdown in the
epidemiology, and in trace-back, and interagency, and
intergovernment communication occurred and then decide how we
need to allocate our resources to provide the most protection
to Americans against food-borne illnesses.
Finally, if there are legal walls blocking the States, CDC,
and FDA from fully communicating and cooperating during an
outbreak investigation, then those walls need to be torn down.
We have 16 witnesses here to help explore these issues and
discuss possible solutions. And I look forward to hearing their
testimony. Again, welcome to this panel and the succeeding
panels.
Mr. Stupak. I thank the gentleman.
Ms. DeGette for an opening statement, please.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you, Mr. Chairman.
Mr. Chairman, as a mom I have spent a lot of time with
people who are like me, people who are trying to raise their
kids and do the right things. And, unfortunately, even though
in some prior life they may have been very interested in
politics and public policy, they are more interested in the
safety of their kids and making sure their families work. But
they have been perking up lately because there have been a
whole series of threats to their family life and to the safety
of their kids.
We dealt with the consumer product safety yesterday and the
toy safety, but with food it has just been one thing after
another the last few years. First we had the spinach recall,
then we had the peanut butter recall, then we had the pet food
recall. And the saga of the Salmonella outbreak has been going
on now since last spring. And, frankly, this is the kind of
thing that people really take notice of because they think that
the main job of government is to protect their families'
safety. And, frankly, we could be doing that. We have the
technology.
In mid-April people started getting sick in this country.
Then in late May the CDC and the State health departments
identified that it was Salmonella Saintpaul. But not until June
did the FDA warn consumers not to eat red tomatoes. And so
consumers all around America quit eating tomatoes. And what
that did was that caused tons and tons of tomatoes to be
discarded at a cost of millions and millions of dollars to the
tomato industry. But now we learn in July, 4 months later,
that, oh, it is probably jalapeno and serrano peppers. This
makes consumers very nervous, and rightfully so.
And the thing is, it does not have to be this way. Many of
you know that I have been working on food traceability issues
now for about 6 years. And I have legislation, H.R. 3485, which
would require the USDA and the FDA to get moving on a system to
track food products throughout the supply chain. For a long
time I found a very difficult time trying to convince people
that we should have traceability. They said, we cannot afford
to do that. And I am here to tell you today with the loss of
consumer confidence with the latest outbreak I think we cannot
afford not to do traceability.
We have the technology to do traceability for produce, for
processed foods, and for other types of foods. In fact, as we
will hear today, the tomato industry and many other industries
are using traceability right now. We have the technology to
trace a tomato from field to fork, but we do not do it in any
kind of organized way nationally. So while you might be able to
trace a tomato in one particular industry, you cannot do it
across industries, and you cannot do it on a national level.
And so if we institute simply voluntary trace-backs, those
programs will still have cracks and all of the participants
will suffer if an outbreak occurs.
On the other hand, if we have a national system of
traceability where we might not have just one system in place
but the systems are interoperable, that we will be able to
effectively trace outbreaks. This will both protect consumers'
health and it will protect business because we will not have
over-broad recalls and we will not be losing consumer
confidence in the system. To me it is an essential part of any
food safety legislation that we might do.
Finally, I think all of us up here want to know what we
could be doing better from a public health standpoint to trace
outbreaks once we identify that there's a problem. Is there
some better way we could communicate between health departments
and the CDC? Is there some better way we could communicate
between the CDC and the FDA and the other various regulatory
agencies? This is not rocket science. We have technology to do
it. We have the know-how to do it. We simply need to have the
will to make it work.
And, Mr. Chairman, I am hoping this investigative hearing
will go a long way towards making all of these things work
together to protect consumers from unnecessary disease in foods
and other consumer products. With that I yield back.
Mr. Stupak. Thank you.
Ms. Blackburn for opening statement please.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Ms. Blackburn. Thank you, Mr. Chairman. I want to thank you
for calling the hearing today.
And I would like to recognize Dr. Tim Jones who is an
epidemiologist from the Tennessee Department of Health. He is
going to be a witness before us today. I am pleased that he is
here with us.
As our witnesses can tell, we are fully aware, everybody in
America is aware of the food contamination issues that are
before us. And this time it is the largest Salmonella outbreak
in our nation's history and it has affected tomatoes, it has
affected jalapenos and the supply of those. And while the
various federal and State agencies work to pinpoint the source
of the dangerous bacteria too much time passed at the peril of
public health and hundreds of millions of dollars of produce
was lost.
And for those of us that have agricultural groups and farms
in our districts this is something that we have heard so very
much about as we have met with these individuals. Plus, this
committee has spent countless hours listening to testimony on
FDA's inability to protect the nation's food supply as a result
of limited resources, insufficient personnel, lack of
interagency communication, and a lack of best practices to
streamline safety review efforts. And I am still waiting to
hear what those best practices are and looking forward to
hearing from the FDA what their best practices are, how they
follow these in their communications and their efforts to
streamline safety review efforts. I will welcome that
information when it makes it to my desk.
I think it is indeed ironic that we are sitting here today
for another investigative hearing to scrutinize the nation's
food safety review capabilities when yesterday this body, the
House of Representatives, took a vote to force the ill-equipped
FDA to regulate tobacco products. The FDA is saddled with so
many unfunded mandates that placing additional stress on a
broken federal bureaucracy will eventually lead to disaster.
And I hope that this is not lost on my colleagues and on
those of you that are here. We are talking about an FDA that
cannot get information from one division to another and cannot
seem to figure out how in the world to police food and drugs
and yet, indeed, we are talking about tobacco. For the past few
months federal, State and local officials, as well as the
industry, were all involved in the Salmonella investigation. I
am looking forward to testimony that explains the complex flow
of information, or maybe it is the lack of flow of information
between all the stakeholders, the lack of clearly-established
protocols and lines of communication between different
jurisdictions in the industry and the agency seems to be
troubling. It is troubling to me. I would think it is troubling
to some of you. And as a result from all of this
miscommunication and lack of established flow of information
the tomato industry was devastated and public panic ensued.
I believe the hearing will be a good opportunity to learn
what worked and what changes need to be made to protect
consumers in the industry from future outbreaks. It is critical
that a coordinated outbreak response further evolve to protect
Americans and to ensure consumer confidence. As I have said in
the past, the FDA needs to shift its focus from reacting to
food safety breaches following contamination and instead
implement policies to prevent food safety problems before they
occur. The recent outbreak is a clear example of defensive
action and a lack of best practices to efficiently solve this
issue.
I thank the Chairman and I yield the balance of my time.
Mr. Stupak. Thank you. Mr. Dingell, Chairman of the full
committee, for an opening statement.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, thank you. I congratulate you on
the vigor with which you are approaching the problem before us
today. I note this is the ninth hearing on the safety and
security of the nation's food supply and, interestingly enough,
on the inadequacies of Food and Drug and the resources of that
agency. There are good people there. There are not enough of
them. They do not have the money. They do not have the
resources. They do not have the leadership. And they do not
have the support of the Administration.
Today's hearing will examine those matters, and in the
light of a major food contamination outbreak involving
Salmonella Saintpaul. This has again shaken public confidence
in Food and Drug and our food industry and has devastated an
important industry. Today we are going to learn how important
it is not just to the public whose health is at risk but how
important it is for the industry because without an adequate
way of addressing the problem of ensuring safety of the
nation's food supply, confidence in that industry and the costs
to that industry are going to be at levels and places that that
industry cannot tolerate.
Since April, at least 1,304 people in 43 States, the
District of Columbia, and Canada have been infected with
Salmonella Saintpaul. These illnesses resulted in 252
hospitalizations or more, and contributed to at least two
deaths. This is one of the largest outbreaks of Salmonella in
the United States. And based on the number of confirmed cases,
the largest food-borne outbreak in the past 10 years.
While it has caused personal and financial tragedy to many,
this outbreak should also be another wake-up call to everyone
in our system who are responding to unintentional or
intentional contamination of the nation's food supply and
pointing out that that ability on our national capability is
very much at risk and very much wanting.
Our investigation to date has uncovered, among other
things: 1) a breakdown in the way the Centers for Disease
Control and Prevention, CDC, and the Food and Drug
Administration shared critical data with key State agencies; 2)
The failure of FDA and CDC to leverage state resources; and 3)
More than 3,000 State and local health departments working
without any adequate coordination with each other or with the
federal government, and with grotesquely limited resources
considering the needs of the times. And they are, I note,
supposed to serve as an identifying agent to help bring to our
attention the existence and the cause of outbreaks like this.
Finally, Mr. Chairman, we are going to hear today that key
sections of the Bioterrorism Act of 2002 which was designed to
ensure the rapid traceability of foods in a situation such as
this has failed to perform as intended. And I note in good part
because the system cannot talk to each other, it does not have
resources, and it does not have leadership and proper support
from the agencies involved, including the Department of
Homeland Security.
This act directed the Secretary of Health and Human
Services to issue specific recordkeeping requirements to allow
federal investigators to quickly respond to threats to our
national food supply.
We have learned, however, that key portions of this act
designed to allow for rapid traceability do not work. While the
FDA was ultimately able to trace commodities associated with
this outbreak, the process was slow and cumbersome. And it
reminded me very much of the kind of Keystone Cops situation
which we saw when we had the Chilean grapes situation. And this
is interesting to note that what should have taken hours or
days has taken months or more.
Today we will not only explore the failures of FDA and CDC,
but also what industry can and should do to improve the
traceability of its products. And we are going to have to
explore what we have to do to see to it that the money and the
resources are available for this and who is going to pay for
that in times of a tight budget. While some in the FDA have
argued that loose produce like tomatoes are too difficult to
trace, some of our industry witnesses will describe systems
currently in place that can rapidly trace their products. And
we are going to want to hear why it is that Food and Drug
cannot or will not or does not support efforts to get us to the
point where we could properly address the traceability of
products.
We can and must learn from industry. And rather than be at
odds with the government on improved safety, the industry must
be our partner. And we are going to find out whether they want
to do that today or not. If parts of the tomato industry can
develop an efficient traceability system, why cannot other
parts of the food industry do likewise? Why cannot FDA mandate
it? And why not the industry voluntarily adopt such a
thoughtfully crafted and well-done system? Perhaps it is time
to revisit what additional changes to existing regulations may
be required to achieve this goal.
We have a number of outstanding witnesses today. I want to
thank them for coming forward. And I look forward to hearing
their views on what needs to be done to prevent more debacles
of this sort which seem to occur on a weekly or daily basis.
With the help of the industry I believe we can restore public
confidence and the safety of our food supply, we can prevent
suffering, loss and hurt and death to our people, and we can
prevent significant damage to industry at all levels for want
of the ability to maintain public confidence and to properly
trace and manage our nation's food supply. And we need to see
what we have to do to see to it that the regulatory agencies
have the resources, the willingness, the enthusiasm and the
leadership to protect our Nation's food supply.
I thank you, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Chairman.
Mr. Barton for an opening statement please.
OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Barton. Thank you, Mr. Chairman. Thanks for the prompt
response to this problem and the hearing today and all our
witnesses for being here. We have invited 16 witnesses to tell
us what went right, and what went wrong in the search for the
source of the latest Salmonella outbreak in fresh produce.
Nearly everybody seems to think that more went wrong than went
right, and I think we need to explore the complex reality if we
are really going to try to fix the problem.
First of all we want to know why it took so long to figure
out that it was Mexican peppers instead of American tomatoes
that were making people sick.Many innocent farmers in the
United States lost thousands and thousands of dollars because
we at first identified tomatoes, and it hurt their crop. You do
not have to be a detective to know that the initial
investigation did not really help anybody. As I just said, it
did harm to a lot of people. I understand that the
investigators followed clues until they found the culprit but
it is arguable that our public health agencies should have
found the source of contamination much sooner than they did.
Identifying tomatoes I believe according to this timeline, Mr.
Chairman, in early June, and we did not really begin to look at
or identify the jalapenos until late June. And it was not until
July that Minnesota authorities actually pinpointed the
jalapenos as the source of the Salmonella-induced illnesses. So
that is a month that really hurt in terms of the tomato crop
situation.The point of doing trace-backs, spending millions of
taxpayer dollars is to contain an outbreak quickly and prevent
any future contamination. The first response, unfortunately, to
this outbreak fingered the tomato industry and caused growers
all across America to suffer a devastating loss.
This hearing is also going to examine a portion of the
Bioterrorism Preparedness and Response Act of 2002 which
required the Food and Drug Administration to establish
procedures on trace-back and recordkeeping. The rationale
behind passing the act was to enable federal investigators to
have access to records that could help trace-back and lead
quickly to the source of contamination during an outbreak.
This is important. To meet these regulations the records
kept by those who manufacture, process, pack, transport,
distribute, receive, hold or import food need to clearly
identify the immediate previous source and subsequent recipient
of that food. If the records that are kept by industry are not
meeting these standards and the trace-back and trace-forward
process is not being achieved then industry needs to tell us
and the regulators need to find a way to improve compliance.
However, if industry is meeting these standards and it is the
regulations themselves that are limiting our regulators, then
perhaps a change in the law or the regulation may be needed. I
am really not interested in trying to find a bad guy in this
story. I want to get it right. If the current system is broke,
let us figure out what is wrong with it and fix it together. If
it just needs a tune-up, then let us start tuning it up.
Mr. Chairman, I have three more pages of specifics but I
will submit those for the record. Let me simply say that this
is an important hearing, and I know that my folks down in Texas
are very interested in this. And as I just said, let us figure
what is broke and fix it or let us figure out what needs to be
tuned up and tune it up.
Thank you, Mr. Chairman.
[The information follows:]
Prepared statement of Hon. Joe Barton
Thank you, Mr. Chairman. The Committee has invited 16
witnesses here today to tell us what went right and what went
wrong in the search for the source in the latest salmonella
outbreak in fresh produce. Nearly everybody thinks more went
wrong than right, but we need to explore the complex realities
if we're going to fix the problem.
For starters, we want to know why it took so long to figure
out that Mexican peppers instead of American tomatoes were
making people sick that innocent tomato farmers lost their
crops and lost their shirts.
You don't have to be a detective to know that the initial
investigation here helped nobody and harmed many. I understand
that investigators follow clues until they get to the culprit,
but our public health agencies should have found the source of
contamination much sooner than they did. The point of doing the
trace-back and spending millions of taxpayers dollars is to
contain the outbreak and prevent future illness. The first
response to this outbreak fingered the tomato industry and
caused growers all across America to suffer a devastating loss
of consumer confidence and revenues. We cannot let this happen
each time a food-borne illness outbreak is identified.
This hearing will also examine a portion of the
Bioterrorism Preparedness and Response Act of 2002, which
required the Food and Drug Administration to establish
procedures on trace-back and record-keeping. The rationale
behind passing the Act was to enable Federal investigators to
have access to records that could help ``trace-back'' and lead
to the source of contamination during an outbreak.
To meet regulations, the records kept by those who
manufacture, process, pack, transport, distribute, receive,
hold or import food need to clearly identify the immediate
previous sources and subsequent recipients of food. If the
records kept by industry are not meeting these standards, and
the trace-back and trace-forward process is not being achieved,
then industry and regulators need to find ways to improve
compliance. However, if industry is meeting these standards and
it is the regulations themselves that are limiting our
regulators, then a change in law or regulation may be needed.
Concerns have also been raised regarding the barriers to
and lack of sharing data and information between local, state
and federal agencies and industry. I want to know what these
barriers are. Are state and federal agencies and governments
taking unreasonable positions under the Bioterrorism Act
concerning sharing information? Do we need to clarify the law?
Do we need to create a carve-out in the regulations to allow
for information sharing when a serious public health threat
exists? We are in the business of legislating, and we want to
pass laws that enable our government to work seamlessly with
local, state, and inter-agency personnel to respond, react, and
coordinate quickly to contain an outbreak. The communication
problems revealed in this outbreak response trouble me greatly
as to our preparedness to respond to an intentional act of
contamination, tampering, or bioterrorism.
This hearing will also examine the facts of this case and
evaluate the success of the agencies and regulators based on
what the facts support. It seems to me that one inconvenient
fact is that the investigators identified the wrong commodity
in the first epidemiological case study. I realize CDC and FDA
may take the official position that tomatoes have not been
ruled out as a potential source of contamination, but the facts
remain that not one contaminated tomato has been identified out
of the 1,400 samples taken. On July 21st, a positive sample of
the outbreak strain of Saint Paul salmonella was found on a
jalapeno pepper and yesterday afternoon, FDA investigators
found the same salmonella strain on a Serrano pepper in Mexico
and in a nearby water reservoir. How can we measure the
performance of a trace-back system in which the original
commodity identified may not have been the source of
contamination? How do we judge the success of a trace-back and
consider the case solved and closed?
One last point about FDA--I would note that at the same
time we are having this latest food safety hearing, my staff is
continuing to have discussions with Chairmen Dingell, Pallone,
and Stupak's staffs about food and drug safety improvement
legislation, including the issue of mandatory recall authority
for FDA. Given FDA's performance in this instance, and how
devastating this has been for our nation's tomato producers, I
shudder to think how much more financially devastating it would
have been had FDA been given mandatory recall authority.
Tomatoes may have been recalled earlier; producers would have
lost more money; and people would continued to have gotten sick
from tainted peppers. And I think that we need to consider
exactly how effective mandatory recall authority would be if it
is given to an agency that seems to have a lot of logistical
problems communicating with state and local public health
officials.
Thank you Mr. Chairman. I look forward to hearing from our
witnesses and thank them in advance for being here today.
Mr. Stupak. Thank you. And I know members will be in and
out; there is another hearing going on. So we look forward to
your submission and we will put it in the record at the
appropriate time.
Mr. Burgess next for opening statement please.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thanks, Mr. Chairman. And I guess I did not
realize this was the ninth hearing but I appreciate the
Chairman of the full committee bringing that to our attention
because I do think it is instructive. I want to thank the
panelists for being here with us today. Many have been here
with us before and some are new to the process but we welcome
you all here to the committee and we are anxious to hear your
testimony.
This issue, suffice it to say, has been at the forefront of
our nation's consciousness the past few months. And we know
that it is impossible to reduce food, there is an irreducible
minimum beyond which you cannot go with food-borne illness, but
still it is our obligation and it is the FDA's obligation as
the premier federal agency to ensure that the products that
come to our nation's tables are indeed safe so people can feel
safe and secure in the purchases that they make. Now, the Food
and Drug Administration has been diligently trying to do the
trace-back. And we will hear a lot about trace-back and how
perhaps there are some ways that this can be streamlined and
improved. And I am anxious to hear from the individuals at the
Department of Health in Minnesota because it seems like they
got to the root of the problem much more quickly.
In the meantime, of course, our distributors, our
retailers, our restaurants have suffered many, many millions of
dollars in loss as a result of the public health risk. But the
fundamental issue here is that the Food and Drug Administration
is in desperate need of help. And this committee, this is the
committee that should be helping beyond just holding nine
hearings. And we do it over and over again, hearing after
hearing. And when, Mr. Chairman, are we going to take some
action. And we sit here, we have all the levers of government
ahead of us, in front of us that we can pull and all the powers
of Congress and the only thing we have managed to do so far is
hammer the FDA. And while that may make for good sound bites
and that may make for good television on cable, it is not good
enough for the American people. As the consequence, the image
of the FDA has suffered and I would submit that the image of
the United States Congress has suffered as well, and that is
something that I think we must stop.
We do need to give the FDA more resources. We need to give
the FDA more personnel. We all get that. There has been a small
attention, a small amount of attention paid to that as a
supplemental. But it is not good enough just to put a bunch of
funds down the pipeline and then think we have done our job,
there has to be the steady state, there has to be the ongoing
appropriations process needs to behave as it is supposed to
behave not in this stop and start fashion that we have done the
past 18 months. The FDA needs to know that they have a steady
supply of funds on which they can depend. And we have not been
able to manage even that simple task.
Probably almost 18 months ago we had one of these food
safety hearings, and I do not even remember then what we were
investigating, but as a consequence of that investigation I see
Mr. Hubbard here again and I welcome him back to the committee,
he has been very helpful in working with our office in trying
to craft legislation that will just simply allow us to stop a
problem when we encounter a problem. H.R. 3967 was developed as
a consequence of one of the hearings we had in this committee,
the Imported Food Safety Improvement Act, and as yet we have
had no legislative hearing on that or any other measurable
improvement.
The fact remains that after the FDA did their work, after
they finally found the problem it is Friday. And on the Lou
Dobb's Show when the commentator asked the reporter, well, what
is the FDA recommending that consumers do to protect
themselves? Well, ask, ask where the peppers were bought? We
did not have even the ability to say no more imported peppers
for at least this weekend until we figure out this problem. We
have to have the ability once we identify where the problem is
we have to have the ability to put an immediate stop so the
American people will have at least some confidence that, yes,
they may still need to ask where this pepper came from if it
came into last week but no new sources of contamination are
going to come across our borders until we have figured out the
problem.
So I am glad we are here today. I am glad we are having a
hearing. I wish we would do something concrete. And let us do
focus our energies on providing Food and Drug Administration
the resources and the authority and the improved processes that
it needs to protect our food supply.
So I will continue to work to draft legislation to improve
the Food and Drug Administration's ability to stop products
from entering the American marketplace. If this committee ever
actually gets around to legislating on the issue I would
appreciate the opportunity to work with the Chairman so that
the fact that one of every four Americans is almost daily
touched by the Food and Drug Administration's activities that
they can feel safe and secure the Food and Drug Administration
has the cops on the beat for them.
And I will yield back.
Mr. Stupak. Thank you. I thank the gentleman and as the
gentleman pointed out, it is the ninth hearing and for the
ninth time we do have Mr. Dingell's global drug and food safety
act which is being negotiated with all the parties including
many of the people in this room and with the minority side.
Mr. Burgess. If the gentleman would yield.
Mr. Stupak. Sure.
Mr. Burgess. My staff and I stand ready to participate in
those negotiations but as yet we have not been asked. And I
would greatly appreciate the Chairman offering my office the
courtesy of participating in that activity. And I will yield
back.
Mr. Stupak. Sure. We have been working with Mr. Barton and
the Republican side and we hope to have a bill up as soon as we
get back. In fact most of the food provisions have been pretty
much negotiated. So it's been an inclusive process, both
Democrats and Republicans have been doing it, and they are
bringing it up every hearing. And I just wanted to remind you
for the ninth time we have been working on it and we will have
a bill.
And with that it is Mr. Murphy's turn for an opening
statement please, sir.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Thank you, Mr. Chairman. I appreciate these
hearings and also look forward to continuing to work with you
on these food safety issues.
You know, oftentimes when we are concerned about something
the size of a food outbreak the call is for more government. Of
course, government has its own problems as well whenever we are
working on any issue, we need a system that can constantly
learn from itself and adapt from its errors in reviewing
problems. And we are immersed in that situation right now.
Families across America want fresh, safe, affordable food
year-round. And that is a formidable task. The FDA is tasked
with inspecting and ensuring the safety of products, and
protecting our citizens from food-borne illnesses and dangerous
chemical alterations and acts of terrorism. The number one goal
is to prevent this contaminated food from getting to the table.
But unfortunately a lot of problems get through.
Some 76 million people contract food-borne illnesses,
325,000 get hospitalized, and 5,000 die. Four hundred to 500
food-borne illness outbreaks are investigated each year by
state and local officials. Let's keep in mind a lot of those
food-borne illnesses have nothing to do with the food handling
industry, many of those are what happens once it's in the
consumer's home not properly handled, refrigerated or cleaned.
And to the add to the formidability of this task, some $2
trillion in imports each year, 60 percent of that is food.
Eighty percent of our seafood is imported and 40 percent of
that comes from China. Many of those have been found with some
chemical alterations. And we have had other hearings on some
things that are downright poisonous added.
We have passed some bills to help traceability but we need
to have Congress and the food industry be able to review these
records quickly. I am pleased to hear that some of the private
groups are working with the FDA to do that. But the FDA needs
to be sufficiently staffed and funded to do this. We have
appropriated funding for this purpose. GAO concluded that the
FDA did not reveal any planned process yet by which this plan
will be implemented, and we want to see that.
Consumers need to be responsible for their actions. The FDA
needs to follow through on the proper epidemiological evidence.
And I am hoping that one of the things we can review today is
just what happened. My understanding is one of the things that
occurred is people who contracted illnesses were interviewed
but those who ate the same food were not interviewed. If that
is the case, it is a serious epidemiological research issue
which we may need to review. I would like to find out if that
is the truth.
We also need to find ways to make whole the farmers and
those in the food industry who were damaged by this scientific
error. And I put ``scientific'' in quotes. But also let us keep
this in mind: our food industry here is among the safest, if
not the safest in the world. And what has happened with public
health efforts have improved the lifespan of Americans. You
know, earlier in the 19th Century when the average person lived
to be 40 or so and by the end of the 20th Century living up
into the 70's was basically because of public health issues,
primarily with clean water and sanitation and some food issues.
We need to continue with our history of success in this. But
this just shows what happens when you import so much food from
around the world that we cannot possibly have an inspector
standing at every plant and watching every vegetable and fruit
come across the border ever moment of the way. Now I believe
only 1 percent of foods are inspected.
We also need better communication with the public when
these things get out. I saw signs appearing everywhere when the
concern was about tomatoes but, unfortunately, when the things
came out about jalapeno peppers I was surprised in a
bittersweet way to see the warnings were saying such things as
do not feed contaminated food to infants. I cannot imagine many
parents of a wise interest who are actually deciding whether or
not to feed jalapeno peppers to their infants. I guess they
think that spices up the applesauce or something.
But the issues, however, are formidable and ones we have to
properly address here. And I want to say this, I certainly
believe that the people in the FDA want to do this in the right
way. I also believe there are people in the food industry who
want to do this in the right way. There are a lot of
intelligent people in this who want to fix this system. And my
hope is that whatever bill we come out with is a way of opening
up a door so we have a system where people with real expertise
who are motivated to fix this, because I do not believe anybody
wants to hurt consumers. There are no farmers out there that
want to see anybody sick. There are no food processors or
companies that want to see their own children or grandparents
ill from these foods. We are Americans caring about Americans
and we are going to fix this problem.
And I want to make sure that we have a bill shaped by the
intelligent statements coming from people on these panels today
that will make sure we have a good, open process that can learn
and evolve as we go on.
And with that I yield back, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Murphy. That concludes the
opening statements.
We will have our first panel which is a panel of growers
and producers. On my far left is the Honorable Charles H.
Bronson who was Commissioner of Agriculture at Florida's
Department of Agriculture and Consumer Services; the Honorable
A. G. Kawamura, who is the Secretary of California's Department
of Food and Agriculture; Mr. Reginald Brown, who is the
Executive Vice President of Florida Tomato Growers Exchange;
Mr. Ed Beckman, who is President of the California Tomato
Farmers; Mr. Parker Booth, who is the President of Ace Tomato
Company in California; Mr. Thomas E. Stenzel, who is President
and Chief Executive Officer of United Fresh Produce
Association; and Mr. William Hubbard, who is a Senior Advisor
to the Coalition for a Stronger FDA. Welcome all of our
witnesses.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that you have the right to be
represented by counsel or advised by counsel during your
testimony. Do any of you wish to be represented by counsel
during your testimony?
[No response.]
Mr. Stupak. Everyone is shaking their heads no, so I will
take it as a no. Therefore, let me ask you to please rise and
raise your right hand to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect that the witnesses
replied in the affirmative. Each of you are now under oath.
We will now hear a 5-minute opening statement from our
witnesses. You may submit a longer statement for inclusion in
the hearing record.
Mr. Bronson, can we start with you, please, sir. Pull that
mike up a little bit, turn on that button there, you should get
a green light.
And you are on for 5. Thank you.
STATEMENT OF CHARLES H. BRONSON, COMMISSIONER OF AGRICULTURE,
DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES, STATE OF
FLORIDA
Mr. Bronson. Thank you, Mr. Chairman, Ranking Member and
members of the committee, for allowing us to come today to talk
about this issue of the FDA, CDC, and the States working on
this issue of trying to get to the bottom of potential
contamination of the food supply. I am the elected Commissioner
of Agriculture for the State of Florida. Food safety is part of
my main function for the people of the State of Florida to
protect the people against plant and animal pests and disease
from causing any type of problem in the State of Florida.
We have 3,700 employees. We are the largest Department of
Agriculture, State Department of Agriculture in the country
because I do also have law enforcement and forestry
firefighters underneath my office as well as laboratories for
food safety and approximately 158 personnel that are food
safety specialists with the State of Florida and 50 lab
personnel. And we are part of the FERN program with FDA and CDC
to test for their particular issues.
I think that I would indicate to you that thanks to the
cooperation of the tomato industry and the University of
Florida's Institute of Food and Agricultural Science at the
University of Florida's land grant college we put together a
program specifically on tomatoes at the request of the industry
3 years ago. And we have the toughest inspection/verification
program in the nation for tomatoes. That was a voluntary
program the past year-and-a-half. We put into rule July 1 all
of those provisions that we had been working under. We made FDA
aware of that. And that is why I consistently said over and
over that I was 99.99 percent sure that Florida-grown tomatoes
was not a part of this problem. As we now find out that not
only was Florida-grown but there are no tomatoes that have been
shown so far to have Salmonella Saintpaul.
I think if I could get anything out of this meeting today I
sit on an advisory group for the National Association of State
Departments of Agriculture, one of two members sitting on that
group who is working on issues with USDA and Customs/Border
Patrol specifically on plant and animal pests and disease
brought into our states from offshore which is where I would
like this committee to consider is where this all begins, not
necessarily with FDA and CDC. However, it starts with USDA
inspection, Customs/Border Patrol come into our states and then
filtrates throughout the United States.
My point to you would be today that we have 158 inspectors
that are just as qualified as any federal inspector out there
today. We have lab technicians that are just as qualified with
Ph.D.s, our medical teams with our public health are bona fide
medical doctors, just as you will find anywhere in the country.
We work very closely between our food safety laboratory, our
Department of Agriculture inspection teams, and our local
health departments and state health department on potential
food-borne illnesses.
We also have protracted outbreaks of Avian Influenza and
gone through the whole process of how we will handle that, how
we will work with the different federal, local, and other State
agencies. And I would hope that if we get anything out of this
meeting that we can work some type of MOU out since we are
using the same process that the federal agencies use, including
trace-back and trace-forward, that the use of the personnel
that I can call within a moment's notice and put then on the
road in the area where the problem may be, not is, but may be.
So that we can take inspections of the field, we can take
inspections of the produce, we can take inspections of the
animals if this happens to be an animal situation, and we can
send it to our FERN-approved laboratory that works with the
federal government and we can start on it immediately. We do
not have to wait for a group at any level of the federal
government to decide when we are going to do it, how many
people we are going to send, how we are going to react to it. I
can do it by a phone call.
On 9/11 at the incident of 9/11 we were sitting in our
office or we actually were having a cabinet meeting in the
State of Florida, we pulled all of our agricultural leadership
together for the State of Florida's department. We were not
only taking pictures of people driving hazardous materials at
our interdiction stations, which I have 23 of them that we
operate in the State of Florida, but we sent our food
inspectors out to the grocery stores to make sure no one was
tampering with the food supply on the shelf on the day of 9/11.
So we have the capabilities of doing these programs in concert
with the federal FDA and CDC. We do not want to take over their
jobs, what we want to do is do an MOU that says if you do not
have the personnel available let us use our people to go get
this done immediately so we can clear the State of Florida if
that is the case or prove we have a problem.
We do not want people in the State of Florida sick any more
than any of the people in your states do. We certainly believe
in protecting the public and our tourists that come to the
State of Florida. And we want to get to it as quickly as
possible. But I think the way this will work the best is if we
can work an MOU out so that we can put these people working
together on the same issues to protect the people of this
country.
Thank you very much.
[The statement of Mr. Bronson follows:]
Statement of Charles H. Bronson
Summary of Key Points
FDA did not share or solicit critical information from
state food safety agencies. State resources could have
augmented FDA's efforts if more information had been shared
such as where to target our sampling and laboratory analysis.
FDA also failed to ask states to provide them with information
we now know they needed such as where were tomatoes being grown
at the time and at what stage of harvest. This information
would have allowed FDA to immediately target their efforts and
potentially lessened the impact on the industry as a whole.
States found themselves having to exonerate themselves by
asking to be put on the ``safe list''.
Florida is the only state to have adopted mandatory
regulations for the production and safe handling of tomatoes.
These were developed as a cooperative effort between the
Florida Department of Agriculture and Consumer Services and the
Florida tomato industry. FDA dismissed our industry's
participation in this program as though it had no bearing on
the risk Florida presented in potentially being part of the
outbreak.
FDA did not employ a common sense approach to assessing the
source of the outbreak.
Florida tomatoes were implicated as much as Mexican
tomatoes by FDA in the investigation because our product
happened to be in the market at the same time as Mexico's. The
number of salmonella cases per state showed that the vast
majority were concentrated in the West, with Florida having
only three cases (a state of over 18 million people). If
Florida grown tomatoes were the source, one would logically
expect us to have a high number of cases. While it may have
been theoretically possible for Florida to be the source, it
was not plausible based upon the geographic distribution of
illnesses.
We do need to improve traceability on all levels, but
particularly at the re-packing house level. We know that
Mexican tomatoes must be labeled as such when they come into
the country. Labels, bar codes or some type of additional
identifier indicating where the product was grown should have
to travel with the product to the final point of sale.
Roles and responsibilities of each governmental agency,
both state and federal, in response to food-borne illness
outbreaks need to be clearly defined.
Every agricultural producer in this country is familiar
with the risk they take every time they put a crop in the
ground and there are tools available to mitigate that risk but
we never anticipate that our business will be destroyed by an
action of the federal government.
Testimony
My name is Charlie Bronson and I am Florida's Commissioner
of Agriculture. I want to express my appreciation to the
Chairman and Ranking Member for holding this hearing to examine
the ongoing salmonella outbreak and the government's response
to it. As Florida's food safety regulator, I believe it is
critical that we make whatever changes are necessary in the
system to protect public health and safety, limit the financial
damages that accrue on the industry that is implicated in
situations like this and restore consumer confidence that our
food supply is safe to eat.
To give you a little bit of background on the Florida
Department of Agriculture and Consumer Services (FDACS), we are
the largest state department of agriculture in the country with
over 3700 employees. FDACS has a broad and varied statutory
mission in Florida that covers everything from food safety and
forestry to consumer services and aquaculture. These are in
addition, of course, to the plant and animal duties borne by
most state departments of agriculture. Put another way, we have
a great deal of ``boots on the ground'' that can be activated
quickly and efficiently to assist federal agencies during times
of crisis.
Florida has quite a bit of experience working cooperatively
with federal agencies, sometimes under less than ideal
circumstances, notably in the aftermaths of hurricanes. I feel
we are well prepared, therefore, to offer great assistance
during outbreaks such as this. Unfortunately, if FDA chooses to
limit the information they share with states, we are likewise
limited in how useful our assistance will be to them. State and
federal agencies have got to work together to protect public
health and safety whether it be law enforcement officials or
food safety officials.
Obviously this outbreak has exposed vulnerabilities in our
nation's food safety net which is widely viewed as the best in
the world. It has now been over 3 + months since the first
exposure occurred and FDA still does not know the source of the
salmonella contamination. In fact, they are stating publicly
that they may never know the source. Frankly, as an elected
official charged with protecting food safety in Florida, that
is an unacceptable outcome in my opinion.
From the very beginning, it was clear to us that FDA was
not sharing important information with state regulators. In my
department, three people hold FDA commissions, myself included.
These commissions should have allowed FDA to share information
with us that was not publicly available. Throughout the course
of this outbreak, states have not been told much more than what
FDA made available to the media. In addition, we also became
aware of a disconnect between the information that was being
provided to state epidemiologists and state food regulators.
Oftentimes, information the CDC was providing on their calls to
state public health agencies was more thorough than what FDA
was providing to the state food safety regulators. Since these
two functions are often in two different state agencies, the
information does not always flow quickly between the two.
Luckily for Florida, FDACS works very closely with our public
health officials and they allowed us to sit in on the CDC
calls. However, this is not the case in every state and I
believe it is cause for concern. It is important to note that
most states have laws that protect information we receive
during the course of a food-borne illness investigation. Even
Florida, which has one of the broadest public record laws in
the country, known as the Sunshine Law, has public records
exemptions that protect this type of information. Perhaps a
compromise to FDA's confidentiality concerns on information
sharing is for FDA to provide more detailed information in a
timely fashion to those states that perform inspections and
collect samples under contract with them. This will allow us to
move more rapidly and coordinate our efforts with our FDA
partners to get a mission accomplished.
As I stated earlier, we have many resources at our disposal
that could have augmented FDA's efforts yet without information
on initial results of their investigation, we didn't know how
to target our efforts. FDA also failed to ask states to provide
them with information we now know they needed and of course, we
had no way of knowing what kind of data that was without them
telling us at the time. As an example, in the initial days of
the investigation, FDA could have asked states if their
producers were even growing the suspect product and what stage
of harvest it was in. Having this information would have
allowed FDA to immediately focus their efforts and eliminate
some states from further scrutiny. FDA would then have been
able to target their resources more effectively. I should say
that states, including mine, eventually started providing FDA
with this information, but for a much different reason. Given
the broad brush of the outbreak and the financial impacts
associated with consumers avoiding all tomatoes, states
provided this information in an effort to get on the FDA ``safe
list.'' Had FDA immediately asked for this information, not
only would it have helped narrow the focus of their
investigation, but providing it to the public might have
lessened the financial impacts to the industry as a whole.
Florida was the first, and to my knowledge, is still the
only state to have adopted mandatory regulations on Good
Agricultural Practices (T-GAP) and Best Management Practices
(T-BMP) for the production and handling of tomatoes. The T-
GAP's and the T-BMP's are based upon sound scientific research
and establishes practices and procedures for the safe handling
of tomatoes. It was developed as a cooperative effort between
the Florida Department of Agriculture and Consumer Services and
the Florida tomato industry. There were many reasons for doing
this, but an important consideration was the need to limit or
avoid food safety issues associated with Florida's products,
many of which are perishable. Like many of the perishable
commodities that Florida produces, tomato growers can't simply
hold on to their product until the crisis passes.
Following FDA's announcement that tomatoes were the product
suspected of being the source of the outbreak and Florida
tomatoes in particular, we reminded FDA that we had this
program in place. We thought that this information would allow
FDA to more specifically target their resources based on risk
as well as keep our growers from being caught up in the
dragnet. Unfortunately, FDA dismissed our industry's
participation in this program as though it had no bearing on
the risk Florida presented in potentially being part of the
outbreak.
One of our greatest frustrations is that Florida was as
implicated as Mexico from the very beginning of the
investigation yet a simple review of the number of salmonella
cases per state showed that the vast majority were concentrated
in the West. Florida had only three cases in a state of 18
million people. Given the large amount of Florida tomatoes that
are consumed in our state, if Florida grown tomatoes had been
the source, one would logically expect us to have a high number
of cases. Since our tomatoes were in the marketplace at the
same time as Mexico it may have been theoretically possible for
Florida to be the source. It was not, however, plausible that
we were based upon the geographic distribution of illnesses. We
have repeatedly raised this issue to FDA yet they continue to
maintain that Florida could have been the source out the
outbreak and Florida grown tomatoes have yet to be exonerated
officially. In fact, Dr. David Acheson, FDA's Associate
Commissioner for Foods told the New York Times as late as June
19th that the ``tainted tomatoes were probably grown in Mexico
or central or southern Florida''. A statement like this without
strong data to corroborate this allegation is tantamount to a
death knell in terms of consumer confidence in an agricultural
commodity.
We have learned some lessons from this situation that will
help us be better positioned to respond to outbreaks like this
in the future. One is that we need to improve traceability on
all levels, but particularly at the re-packing house level.
Companies, which may have their business operations based in
Florida yet grow in both Florida and Mexico, often label their
boxes and their invoices with their Florida business address.
This resulted in FDA finding invoices in their traceback that
indicated a product was from Florida but in fact came from
Mexico. We know that Mexican tomatoes must be labeled as such
when they come into the country. Labels, bar codes or some type
of additional identifier indicating where the product was grown
should have to travel with the product to the final point of
sale.
We also need to clearly establish the roles and
responsibilities of each governmental agency, both state and
federal, in response to food-borne illness outbreaks. This
could be accomplished through a Memorandum of Understanding
(MOU) between the FDA, CDC, state public health agencies and
state departments of agriculture. This MOU should outline the
expectations and actions that should be taken to timely gather
evidence in an investigation.
I would also like to highlight legislation introduced by a
member of Florida's Congressional Delegation, Representative
Adam Putnam, that would help strengthen the safeguards on our
nation's food supply. H.R. 5904, The Safe Food Enforcement,
Assessment, Standards and Targeting Act or ``Safe FEAST Act'',
co-sponsored by Representative Jim Costa of California, would
put in place new food safety standards throughout the food
chain. To ensure the highest level of food safety to American
consumers, the legislation requires all domestic and foreign
food companies selling food in the U.S. to conduct a food
safety risk analysis that identifies potential sources of
contamination, outlines appropriate food safety controls, and
requires verification that the food safety controls implemented
are adequate to address the risks of food-borne contamination.
In addition, to ensure that food products coming into the
United States from international sources are safe, imported
goods would have to adhere to the same safety and quality
standards as set by the FDA. This would be accomplished by
their completion of a Foreign Suppliers Quality Assurance
Program as well as documenting their food safety measures and
controls for FDA review. I would respectfully urge you to adopt
this legislation.
The losses that have been sustained by this industry are
still being calculated. You will hear from Reggie Brown with
the Florida Tomato Exchange shortly and he will be able to talk
more specifically to those losses. Millions of dollars lost and
yet there is still not one shred of evidence suggesting that
Florida grown tomatoes were the source of this outbreak. They
were implicated simply because they happened to be in the
market at the same time as Mexican tomatoes. There has got to
be a way to protect public health while minimizing collateral
damage to an industry.
Mr. Chairman, as a 6th generation farmer and rancher, I
know every time a growers puts something into the ground we
take a risk that it may be destroyed by a weather-related event
such as a hurricane or a drought. Pest and diseases can also
wreck havoc on a crop, a fact that Florida growers know all too
well. But I can tell you we never anticipate that our business
will be destroyed by an action of the federal government. As
Florida's Commissioner of Agriculture, I don't know how to tell
my agricultural producers to prepare for something like that
and there is certainly not a crop insurance tool out there to
guard against these types of losses.
Again Mr. Chairman, I want to thank you for having this
hearing on an issue that you can see I feel very strongly
about. Florida stands ready to assist both the FDA and CDC on
their efforts to improve the current system in any way we can
and I would be happy to answer any questions you may have.
----------
Mr. Stupak. Thank you.
Mr. Kawamura, your opening statement please. And please
pull that mike up a little bit so we get to hear you clearly.
Thank you.
STATEMENT OF A.G. KAWAMURA, SECRETARY, DEPARTMENT OF FOOD AND
AGRICULTURE, STATE OF CALIFORNIA
Mr. Kawamura. Thank you, Chairman Stupak and members of the
committee. It is a pleasure to be here. I appreciate this
opportunity to address the committee about the food supply of
the 21st Century.
As the leading producer of fruits, vegetables, and nuts,
and the leading producer of dairy products, milk, with a farm
gate of over $32 billion, California is a diverse supplier of
food and other products to this Nation, and we are a leader on
food safety programs.
In dealing with human health and the kind of outbreaks that
we have seen, human health is always going to be paramount. We
recognize that that is a priority when we are looking at any
kind of an outbreak. And we know that the focus then also must
entail recognizing that this food supply that we enjoy today
does come with tremendous balance, tremendous abilities to
deliver food, and especially perishable foods in a safe manner.
The difficulty of having a quick and reliable trace-back
system I think is one of the main focuses of this committee
because by having a trace-back system we are able to quickly
identify which products are and which products are not a part
of any outbreak. And I think that is one of the focuses that we
will have to get to at the end of this session today.
We recognize and understand that the Centers for Disease
Control and Prevention and the FDA have been working very hard
with their resources to identify the sources of this recent
outbreak and others in the past and will undoubtedly initiate
more of a full review of their processes as we move forward.
We have directed growers and processors in our State to
develop and implement written and scientifically-based
guidelines for food safety and food safety prevention. We must
also ensure that the public health and regulatory agencies
develop and implement their written and scientifically-based
procedures for conducting these very complex investigations.
We recognize that it is easy to look for quick fixes. And
while we look for someone to blame for the current Salmonella
Saintpaul outbreak we must recognize that the complexities of
our modern food system are actually quite remarkable. It is a
remarkable system that continues to improve with new
technologies and advances through research. I would like to
mention that I think after every outbreak, which we would like
to prevent in the first place, but after every outbreak this
system improves, the system tightens down, we are able to use
the technologies of the day to modify, to improve, to eliminate
those kind of threats to the food supply. And that process
takes place every day.
I think Mr. Barton from Texas mentioned that is this system
broken or does it need a tune-up? And I would submit to you
today that this system needs a tune-up basically using the 21st
Century tools that we have today. And my colleague Mr. Bronson
mentioned again the many resources and tools that we can
converge to deal with food safety in our nation.
We also recognize that in our State of California good ag
practices has been a hallmark of what we continue to provide
for this country, whether it was dealing with pistachios years
ago, with the challenges of fungus disease that is found with
them, whether it is the almond industry and the adopted federal
regulations that they put into place requiring raw almonds to
undergo an approved pasteurization process. The California
tomato industry as well in our State has developed tomato-
specific best practices to ensure that their tomatoes are
produced under safe guidelines.
These programs also require USDA-trained inspectors to
conduct random and continuous audits to ensure compliance with
these programs. We recognize that the leafy green marketing
agreement which brought together not only spinach but all the
different vegetable products that are of the leafy green
nature. This was accomplished last year and has completed a
successful year of voluntary compliance and audits that involve
not only the Departments of Agriculture here and at USDA but
FDA, Departments of Public Health and the industry in dealing
with solutions using the technologies of today to get to the
bottom of these causes of food-borne illnesses.
In closing I would like to mention that we have many next
steps that we need to deal with. And let me go through those
now.
We must balance then the ability to make sure and ensure
public health and a public warning system when we do have an
outbreak with also the very important desire to make sure that
our producers that are not implicated in an outbreak are not
damaged.
We encourage a better dialogue then between the FDA,
States, growers, handlers and retailers to identify good ag
practices at all levels of the food chain.
Prior to making a food-borne illness announcement FDA
should solicit states to provide commodity harvest data. This
can minimize the guesswork and can limit the number of growers
implicated in any outbreak.
Growers, shippers, and distributors and retailers must
agree on a standardized, uniform set of criteria that will
follow a product from farm to point of service, enabling quick
and accurate identification of the routes and sources of all
products and all produce.
We encourage more research dollars be spent on identifying
the life cycle of food-borne illnesses, potential points of
entry and kill-step technology to ensure safe products. In our
state we work closely with the Western Institute for Food
Safety and Security as well as the newly established Center for
Produce Safety at U.C. Davis to improve methods of growing and
safe handling of food products.
Better surveillance of imported products is critical.
Consumers are relying more and more on a year-round supply of
products that come from outside the United States. Programs
must be established to do a better job of monitoring and
testing food product imports. By monitoring our points of entry
for repeat violators of false import declarations, making
changes in import volumes at points of entry, and random
sampling of products for contaminants we can more effectively
identify sources of potential risk.
We also then urge Congress to support States in the
development of programs that result in the implementation and
auditing of Good Agricultural Practice.
And lastly, there must be funding to implement a uniform
system for epidemiological reporting and investigating
outbreaks in all states.
And with that I will submit the rest of my testimony for
the record and look forward to continuing with this
conversation today.
[The statement of Mr. Kawamura follows:]
Statement of A.G. Kawamura
Summary of Major Points
We must balance warning the public while minimizing the
impact to growers.
1AWe encourage a better dialogue between FDA,
states, growers, handlers and retailers to identify Good
Agricultural Practices at all levels of the food chain.
1APrior to making a food borne illness
announcement FDA should solicit states to provide commodity
harvest data. This can minimize the guesswork and can limit the
number of growers implicated in an outbreak.
1AGrowers, shippers, distributors and retailers
must agree on a standardized, uniform set of criteria that will
follow a product from farm to the point of service, enabling
quick and accurate identification of the routes and sources of
all produce.
1AWe encourage more research dollars be spent on
identifying the life-cycle of food borne illnesses, potential
points of entry and kill-step technology to ensure safe
products. We work closely with the Western Institute for Food
Safety and Security as well as the newly established Center for
Produce Safety at University of California at Davis to improve
methods of growing and safe handling of food products.
1ABetter surveillance of imported products.
Consumers are relying more and more on a year-round supply of
products that come from outside the United States. Programs
must be established to do a better job of monitoring and
testing food product imports. By monitoring our points of entry
for repeat violators of false import declarations, making
changes in import volumes at points of entry, and random
sampling of products for contaminants, we can more effectively
identify sources of potential risk.
1AWe urge Congress to support states in the
development of programs that result in the implementation and
auditing of Good Agricultural Practices.
1AThere must be funding to implement a uniformed
system for epidemiology reporting and investigating outbreaks
in all states.
Statement
Good morning Chairman Stupak, and esteemed members of the
committee. I appreciate the opportunity to address this
committee and also I would like to thank Congress for its
support of 21st Century agriculture in the 2008 farm bill. As
the leading producer of fruits, vegetables and nuts, and the
top producer of milk, with a farm gate of $31.4 billion,
California is a diverse supplier of food for the nation and a
leader on food safety programs.
Human health is paramount in any foodborne illness
outbreak. Outbreak investigations are complex and resource
intensive, particularly those involving perishable foods such
as fresh produce. By the time the surveillance system
recognizes clusters of illnesses, 2-3 weeks have passed from
the initial exposure. In this timeframe, entire fields or
growing areas have been replanted and no samples remain.
Epidemiological investigations rely on consumers to remember
the foods they ate days or weeks ago and thus include some
degree of uncertainty. Trace back investigations depend upon
firms providing accurate and complete records in a uniform
format to investigators and may involve detailed assessments of
dozens of firms and fields. Agencies must have adequate
resources and laboratory surge capacity to conduct these
investigations in order to quickly, accurately, and narrowly
pinpoint the source of an outbreak.
We recognize and understand that the Centers for Disease
Control and Prevention and the Food and Drug Administration
have been working very hard with the resources they have to
identify the source of the most recent outbreak and will
undoubtedly initiate a full review of existing epidemiologic
and regulatory approaches to implement needed changes. As we
have directed growers and processors to develop and implement
written, scientifically based guidelines, we must also ensure
that public health and regulatory agencies develop and
implement written, scientifically based procedures for
conducting these complex investigations.
Unfortunately, a false implication has an impact on the
state's commodities and the ability for farmers to sell and
market their products. In 1996, an epidemiologic investigation
of cyclospora illnesses incorrectly identified California
strawberries as the likely source of contamination. Subsequent
investigations revealed that the actual source was Guatemalan
raspberries. Initial epidemiologic information in the most
recent salmonella investigation implicated tomatoes, possibly
from California. However, subsequent investigations appear to
point to imported peppers.
To be a farmer means to take risks due to weather, pests,
market fluctuations, and other influences. Yet there is nothing
more devastating to a farmer than to dump a perfectly good crop
due to suspicion of contamination. However, public health
agencies and regulators may occasionally have to take actions
to protect the public without incontrovertible evidence.
Without clear communication, the message to consumers is
often misunderstood and the reaction is swift in the
marketplace. Retailers, in order to reduce their risk of
liability, act to pull products off the shelves despite general
advisories that a product is declared ``safe'' to eat. The
economic domino effect is felt all the way down the food chain
from the farmers, to the workers, to their families and to the
communities.
For all tomato and jalapeno growers in the country, the
promise of a successful marketing season is lost for the
summer. The consumer who is rightly concerned about the safety
of food products has lost confidence in tomatoes in this
incident, even if the outbreak was not associated with our
state, or any other.
Economic Impact of Association of Salmonella with Tomatoes
The impact to California tomato growers directly and
indirectly is significant. According to one commodity group,
our tomato growers suffered a 40 to 50 percent drop in retail
sales, or $300,000 in a direct loss due to the dumping of good
product, a loss of $1 million in product sales right after the
announcement, and an estimated nearly $20-24 million in
indirect losses due to low demand and poor prices.
While it is easy to look for quick fixes and someone to
blame for the current Salmonella Saint Paul outbreak we must
recognize the complexities of our modern food systems. It is a
remarkable system that continues to improve with new
technologies and advances through research. However, the lack
of adequate personnel and resources of regulatory agencies
charged with protecting public health and our food supply are
challenges and weaknesses we must address. There must be
funding to implement a uniformed system for epidemiology
reporting and investigating outbreaks in all states. Right now,
we are relying on what state and local resources are available
for gathering data and investigating outbreaks.
Agricultural Food Safety ProgramsCalifornia has implemented various
food safety programs that have been innovative and successful.
The California Leafy Green Marketing Agreement is an
example of how federal and state agencies, can work together
with industry to create a program that uniformly applies best
management practices that are designed to improve safety and
quality to handlers throughout the state. Jointly developed by
industry, CDFA, USDA and with input from California Department
of Public Health and the FDA, the Leafy Green Marketing
Agreement was created in 2007 as a response to multiple
outbreaks of E. coli O157:H7 illnesses over several years. The
leafy greens industry led the effort to craft Good Agricultural
Practices and a mechanism for verifying practices through
mandatory government audits under the authority of the
Agreement.
While membership in the marketing agreement is voluntary,
nearly 100 percent of California's leafy green handlers are
participants. Once a signatory to the program, compliance with
the commodity specific program is mandatory, and violators are
subject to discipline. The strength of the Leafy Green
Marketing Agreement program is the mandatory government
inspection program that certifies member companies are
complying with the food safety Good Agricultural Practices.
These standards were developed by industry, academia and
regulators, and reviewed by state and federal government health
agencies. Random inspections are conducted by the California
Department of Food and Agriculture inspectors who are trained
and certified by the USDA. Operators are required to take
corrective action on all findings within an audit and follow up
audits are required to verify compliance. Handlers that fail to
meet the conditions of the program can lose their
certification, therefore losing their ability to sell in the
marketplace. A service mark assures buyers of California leafy
greens that the product bearing the mark has been grown
according to the food safety practices accepted by the LGMA.
These Good Agricultural Practices are being mirrored in
other commodities.
The almond industry adopted federal regulations requiring
raw almonds to undergo an approved pasteurization process, or
be labeled as ``Un-Pasteurized''.
The California tomato industry has developed tomato
specific best practices. These programs also require USDA
trained inspectors to conduct random and continuous audits to
ensure compliance with these programs.
The California Set Labeling Requirements for Tomato Industry
California has also implemented tomato-labeling
requirements that are unique to handlers in the state. Existing
California Food and Agriculture Code provides the authority to
require certain labeling and quality standards. All shipping
containers of fruits, nuts and vegetables are required to have
basic labeling including: Identity (the commodity);
Responsibility (name and address of handler or packer or
shipper); and Quantity (weight or volume).
In addition to the existing labeling standards, California
tomato handlers are required to have the lot and grower ID on
the container. This was established in 2006. In the event of
violation of this article, a handler shall provide, upon
request of the Secretary or his representative, records related
to field location, grower, harvest date, pack date,
transporter, and purchaser of packed tomatoes. These records
shall be maintained for the current marketing year.
This identification provides a better mechanism for
traceability of a product in the marketplace. The produce
industry is focusing significant attention on the improved
traceability of produce. Industry associations have voiced
concerns about the inability to track produce in a
standardized, electronic format from farm to point of service.
Industry groups have been meeting for several months to develop
new standards for traceability from farm to table. Growers,
shippers, distributors and retailers must agree on a
standardized, uniform set of criteria that will follow a
product from farm to the point of service, enabling quick and
accurate identification of the routes and sources of all
produce.
Next Steps
We must balance warning the public while minimizing the
impact to growers.
1AWe encourage a better dialogue between FDA,
states, growers, handlers and retailers to identify Good
Agricultural Practices at all levels of the food chain.
1APrior to making a food borne illness
announcement FDA should solicit states to provide commodity
harvest data. This can minimize the guesswork and can limit the
number of growers implicated in an outbreak.
1AGrowers, shippers, distributors and retailers
must agree on a standardized, uniform set of criteria that will
follow a product from farm to the point of service, enabling
quick and accurate identification of the routes and sources of
all produce.
1AWe encourage more research dollars be spent on
identifying the life-cycle of food borne illnesses, potential
points of entry and kill-step technology to ensure safe
products. We work closely with the Western Institute for Food
Safety and Security as well as the newly established Center for
Produce Safety at University of California at Davis to improve
methods of growing and safe handling of food products.
1ABetter surveillance of imported products.
Consumers are relying more and more on a year-round supply of
products that come from outside the United States. Programs
must be established to do a better job of monitoring and
testing food product imports. By monitoring our points of entry
for repeat violators of false import declarations, making
changes in import volumes at points of entry, and random
sampling of products for contaminants, we can more effectively
identify sources of potential risk.
1AWe urge Congress to support states in the
development of programs that result in the implementation and
auditing of Good Agricultural Practices.
1AThere must be funding to implement a uniformed
system for epidemiology reporting and investigating outbreaks
in all states. What we learn from this hearing can set the
stage for improved collaboration between the state and federal
agencies and farming community. Thank you for inviting me to
speak with you today and thank you for your support.
----------
Mr. Stupak. Thank you.
Mr. Brown, you might want to use that mike right there. We
have a large panel. We usually do not have that many people on
the panel but there is such great interest from the growers and
producers and the commissioners we wanted to give everyone an
opportunity. So, Mr. Brown, if you would start your 5-minute
opening please, sir.
STATEMENT OF REGINALD L. BROWN, EXECUTIVE VICE PRESIDENT,
FLORIDA TOMATO GROWERS EXCHANGE
Mr. Brown. Thank you, Mr. Chairman, members of the
committee.
The producers of tomatoes in Florida represent the largest
single State fresh tomato production system in the country. We
dominate the supply of fresh tomatoes in the United States from
May to November. We have in fact been the primary injured
parties in this entire process and we look forward to Congress
addressing that concern and our injuries at some point in the
future.
We have a few recommendations we would like to pass on to
the Committee and to the Congress.
First of all, it is critical to the entire tomato industry
that FDA exercise its authority to establish mandatory guidance
based on the ``Commodity Specific Guidelines for the Tomato
Supply Chain.'' This document was created by the industry in
conjunction with science and with FDA. And we would offer that
up as a program that could be implemented immediately by the
FDA in a mandatory way as a guidance document for tomato
production throughout the country and throughout North America.
We also call for the initiation of regulations for
mandatory food safety programs for tomatoes throughout the
country. This is important that we do not establish a single
program that forces programs on various segments of the
industries are inappropriate because one size of a regulatory
program will not fit all. But we encourage FDA to move forward.
And we would encourage the Congress to move forward on bills
such as H.R. 5904 to provide basis for those regulations going
forward.
We would encourage that the FDA through consulting
committees or some other structure create a mechanism for the
industry and other representatives to be involved in these
outbreaks. These consultants could be integrated early in the
outbreak and we can avoid many of the complications and
problems that I think we encountered in this unfortunate
circumstance. These consulting groups could be constructed to
where conflicts of interest and confidentiality could be
maintained. And we also have the overriding common interest of
the industry and public in making sure that we get this thing
right.
We would encourage FDA to expand their current tomato
initiative program that they have operated for the last year-
and-a-half in both Virginia and Florida. We think those kinds
of initiatives are important in giving the experiences and
understanding and knowledge to the agency. It would assist in
their understanding the industry. And we would encourage them
to incorporate in those tomato initiatives trace-back exercises
for small, medium, and large type growers and packers and
repackers so they have a very functional understanding of our
industry.
We would encourage the FDA and CDC to develop the improved
risk communication tools for the future outbreaks that would
increase the understanding of the actual risk probability in
suspected items and the risks posed to the public. Good risk
analysis, informed assumptions and recommendations would
facilitate greater understanding for all concerned. Such
improved communications would improve public health rather than
promote public hysteria.
We strongly urge the formation of a blue ribbon group of
experts both inside and outside government to conduct an
interview or a review of the handling of the 2008 Salmonella
outbreak by state and federal agencies. The purpose of this
review would be to improve the effectiveness in handling future
outbreaks. Learning from mistakes made is the only way to make
the world a better place as a result of our unfortunate
experience.
We share the same interest in producing the safest tomatoes
possible for consumers. It is a trust that we take extremely
seriously in the tomato industry and we look forward to
continuing to be leaders in the food safety arena for the
American consumer.
Thank you for the opportunity to be here this morning. And
I will submit the rest of my testimony for the record in
writing.
Thank you.
[The statement of Mr. Brown follows:]
Statement of Reginald L. Brown
Summary
At the time of the salmonella outbreak in April 2008,
Florida was the only state in the country growing tomatoes. In
early June 2008, the FDA indicated there was a connection
between the salmonella outbreak and tomatoes from Florida. It
is difficult to challenge the Center for Disease Control's
(CDC) and the Food and Drug Administration's (FDA) decision in
associating some tomatoes with the outbreak because we are not
privy to the information they had before them.
FDA failed its principal task of finding the source of the
salmonella and failed to promptly release those areas which
were ``cleared'' by FDA's own testing or by the fact that
tomatoes from these areas were not in the marketplace. As a
result, the Florida tomato industry has suffered tremendously.
Everyone associated with Florida's tomato industry, all the
workers, farmers and packers in the designated areas and
outside those areas have been harmed. We estimate the loss to
the growers and packers to be $100 million, and they will
continue to lose sales due the decline in consumer confidence
caused by FDA.
The Florida tomato industry has taken the lead position in
food safety for fresh tomatoes. Tomatoes from Florida are the
only tomatoes in the U.S. subject to government-administered,
mandatory food safety regulations. Further, these regulations
were established at the request of the industry with the
specific purpose of reducing food safety risks and the
probability of such an outbreak.
Recommendations
1. Congress should provide relief to growers, packers, and
repackers in Florida and throughout the U.S. for real losses
suffered to date and those they continue to suffer through no
fault of their own.
2. It is critical to the entire tomato industry that the
FDA exercises its authority to establish mandatory guidance
based on ``Commodity Specific Guidelines for the Tomato Supply
Chain.'' We also call on the agency to develop a mandatory food
safety requirement for fresh tomatoes throughout the supply
chain.
3. We strongly encourage FDA to create consulting
committees made up of industry representatives and others.
These consultants could then be integrated into outbreak
management teams in the event of an outbreak so that
experiences such as those suffered in the 2008 salmonella
Saintpaul outbreak could be minimized.
4. We encourage FDA to continue to expand their current
Tomato Initiative to all points in the tomato supply chain.
5. The development of improved risk communication tools for
future outbreaks would greatly increase the understanding of
the actual risk probability in ``suspected'' items and the risk
posed to the public.
6. We strongly urge the formation of a ``Blue Ribbon''
group of experts from both inside and outside the government to
conduct a review of the handling of the 2008 salmonella
outbreak by state and federal agencies.
Statement
Introduction
My name is Reggie Brown. I am the Executive Vice president
of the Florida Tomato Exchange (the Exchange). We generally
harvest from November through May. Almost half of all the fresh
tomatoes consumed in the United States year-round come from
Florida. During the winter months from October to about the end
of May substantially all of the domestically produced fresh
tomatoes in the marketplace come from Florida.
Tomato growers have seen major challenges in recent years
from hurricanes, invasive pests and diseases, to increased
international competition from Mexico and Canada. The fruit and
vegetable industry is a critically important sector of Florida
agriculture, which is second only to tourism in importance to
the state's economy. According to a 2006 University of Florida
study, agriculture, food manufacturing, and natural resource
industries in Florida directly create more than 400,000 full-
time and part-time jobs, with a total employment impact of more
than 700,000 full-time and part-time jobs. The direct value-
added contribution is estimated at $20.32 billion, with a total
impact of $41.99 billion. Florida tomatoes are the largest
vegetable crop in the state, with a value of over a half-
billion dollars annually.
During the winter, Florida competes in the U.S. marketplace
with Mexico and Canada. During the six-to-seven-month
harvesting season, Florida's tomato growers employ more than
30,000 tomato workers.
Background
At the time of the outbreak of salmonella in April 2008,
Florida was the only state in the country growing tomatoes. In
early June 2008, the FDA indicated there was a connection
between the salmonella outbreak and tomatoes from Florida. It
is difficult to challenge the Center for Disease Control's
(CDC) and the Food and Drug Administration's (FDA) decision in
associating some tomatoes with the outbreak because we are not
privy to the information they had before them. However, we do
think that decision was highly questionable and that once it
was made, FDA failed to take appropriate actions in associating
salmonella with tomatoes from a source other than from Florida.
In summary, FDA failed its principal task of finding the
source of the salmonella and failed to promptly release those
areas which were ``cleared'' by FDA's own testing or by the
fact that tomatoes from these areas were not in the
marketplace. As a result, the Florida tomato industry has
suffered tremendously. Everyone associated with Florida's
tomato industry, all the workers, farmers and packers in the
designated areas and outside those areas have been harmed. We
estimate the loss to the growers and packers to be $100
million, and they will continue to lose sales due the decline
in consumer confidence, caused by FDA. More immediately, FDA `s
recent ``release'' of tomatoes by removing the listing from
their website placed Florida's growers in a very difficult
position as to planting for next season. It is not an
exaggeration to say that the availability of tomatoes from
Florida may be reduced for the upcoming season as a result of
FDA's actions. Our growers and shippers should be compensated
for their losses.
We strongly urge the FDA to develop mandatory trace-back
regulations for the entire tomato industry, from the farmer's
field to the last retailer, based on the mandatory rules for
food safety and trace-back in Florida, the guidelines adopted
by the California tomato growers, and the national guidelines
for tomatoes prepared by industry leaders (described in more
detail below). This course of action will provide the consuming
public with additional safety and confidence and will provide
the CDC and FDA with the ability to quickly trace back an
outbreak involving tomatoes to the source of the contamination,
thereby avoiding injury to innocent tomato growers, packers,
and others in the distribution system. Other recommendations
are proposed below.
Florida's Tomato Growers Lead the Country in Food Safety and Trace
Backs
The Florida tomato industry has taken the lead position in
food safety for fresh tomatoes. Tomatoes from Florida are the
only tomatoes in the U.S. subject to government-administered,
mandatory food safety regulations. Further, these regulations
were established at the request of the industry with the
specific purpose of reducing food safety risks and the
probability of such an outbreak.
The Florida tomato growers, along with University of
Florida faculty and state regulators, developed a comprehensive
food safety system for growing and packing fresh tomatoes.
Details of the program can be found at www.floridatomatoes.org.
This program employs the most current good agricultural
practices and best management practices and includes third-
party audits for packinghouses and for farms and greenhouses.
It is a mandatory food safety system for all tomatoes grown in
Florida and has been reviewed by the FDA. For many years,
Florida's tomato growers have used a trace back system, called
``positive lot identification.'' Using this system, the first
buyer of Florida tomatoes can easily obtain the name of the
farm and the location of the specific lot where the purchased
tomatoes were grown.
We have also been proactive at the national level regarding
food safety, working with our counterparts in California,
Mexico, and Canada, as well as the United Fresh Produce
Association and other groups. We have published the second
edition of, ``Commodity Specific Food Safety Guidelines for the
Fresh Tomato Supply Chain.'' These guidelines recommend food
safety practices to minimize the microbiological hazards
associated with fresh tomatoes and fresh-cut tomato products at
all points of the fresh tomato supply system.
Certainly, the adoption of Florida's requirements, the
trace-back program employed by the California tomato farmers,
and the commodity-specific guidelines mentioned above can be
adopted for the entire tomato industry. We are strongly
supportive of mandatory regulations modeled on these programs
as proposed in HR 5904.
Issues Regarding the Handling of the Salmonella Saintpaul Outbreak
We believe a number of things went wrong from the beginning
of this investigation, and it warrants oversight by this
Committee and, we believe, by others as well. We raise the
following issues and comments based on incomplete information
because complete information was not provided to us by either
the CDC or the FDA. While we truly believe mistakes were made,
the damage has been done. We hope we can regain our market and
convince our consumers that the tomatoes we grow and ship from
Florida are among the most wholesome and safest in the world.
The food safety system we have adopted is unprecedented in the
fresh tomato industry and uses the best practices available. We
raise these issues to be constructive so that next time CDC and
FDA can make the right association and find the source of
contamination in short order. And, there will be a next time
for tomatoes and for other perishable commodities because no
system is 100% risk free. Risk reduction is the realistic goal
of all food safety programs.
We believe the CDC and the FDA incorrectly presumed
tomatoes to be associated with the salmonella outbreak. We
believe the data reviewed indicated tomatoes and salsa items
together were the original problem. Indications that tomatoes
and salsa coming from Hispanic outlets were associated with
salmonella and that the saintpaul strain of salmonella has not
previously been associated with tomatoes should have been given
more weight.
We believe the FDA erred in indicating that the outbreak
was associated with tomatoes from Florida. While it is easy to
suggest that the salmonella came from Florida tomatoes since
Florida was the only state in the U.S. producing tomatoes in
late April, we believe additional information should have been
factored into this decision. Most importantly, it appears the
FDA totally ignored the locations of the first outbreaks: the
Southwest U.S., New Mexico and Texas. In so doing, it ignored
the most likely source of tomatoes and/or salsa: Mexico. In
addition, given the cost of fuel, it was most unlikely that
tomatoes consumed in New Mexico came from Florida.
We believe the CDC needed to share its first questionnaire
and the information that led it away from Mexico as a source.
We believe the FDA erred in not finding the source of this
outbreak, and we believe the FDA erred in not promptly
``releasing'' tomatoes from Florida given the fact that the
test done on Florida tomatoes showed no signs of salmonella.
We believe the FDA erred in not bringing experts from the
industry to assist with the trace back efforts.
We believe that the FDA erred in not providing and
communicating standards used to determine the risks to
consumers from the beginning when a warning was issued, when
all tests came back negative, when other items (peppers) were
added, to the end.
We believe the FDA erred in not exploring the tomato
distribution system in the U.S. prior to this outbreak. During
this outbreak, an FDA official described the tomato
distribution system as ``complex.'' FDA has had prior
experience in dealing with trace backs involving tomatoes and
should have developed a trace back plan prior to this outbreak
as well as a procedure for industry assistance.My industry
colleagues on the panel will, or have already, addressed the
structure of the industry and the trace back system that exists
for tomatoes.
Recommendations
As the group most economically harmed by the salmonella
outbreak due to the CDC's and FDA's actions and/or lack of
actions in associating fresh tomatoes with the outbreak and in
failing to quickly find the source of the outbreak and failure
to promptly remove Florida as a source of the outbreak, we have
a number of recommendations for this Committee to consider.
1. Congress should provide relief to growers and packers in
Florida and throughout the U.S. for real losses suffered to
date and those they continue to suffer through no fault of
their own. From our perspective, we are in the identical
situation as growers of other commodities whose crops were
destroyed by natural disasters. The difference is only that our
disaster was government driven.
2. It is critical to the entire tomato industry that the
FDA exercises its authority to establish mandatory guidance
based on ``Commodity Specific Guidelines for the Tomato Supply
Chain.'' We also call on the agency to develop a mandatory food
safety requirement for fresh tomatoes throughout the supply
chain. Such a program could be modeled on the Florida and
California programs, allowing for slight modifications to
accommodate regional conditions as they exist. A one-size-fits-
all approach to food safety is inappropriate. FDA should be
encouraged to continue consultations and cooperation with
industry groups to accomplish this goal. Current legislative
proposals such as HR 5904 call for such regulations, and we
fully support them.
3. We strongly encourage the creation of consulting
committees by FDA be made up of industry representatives and
others. These consultants could then be integrated into
outbreak management teams in the event of an outbreak so that
experiences such as those suffered in the 2008 Saintpaul
outbreak could be minimized. These consultant groups could be
structured to avoid concerns about confidentiality and conflict
of interest. Everyone has a common interest in identifying and
removing the source of any outbreak as quickly as possible.
4. We encourage FDA to continue to expand their current
Tomato Initiative to all points in the tomato supply chain. We
also encourage FDA to expand their efforts to include trace
back exercises that include small, medium, and large growers,
packers, and repackers as well as any others who are part of
the distribution system. Such efforts would improve the level
of knowledge within the FDA and provide experiences designed to
expedite future trace back efforts in the event of an outbreak.
5. The development of improved risk communication tools for
future outbreaks would greatly increase the understanding of
the actual risk probability in ``suspected'' items and the risk
posed to the public. Good risk analysis and informed
assumptions and recommendations would facilitate greater
understanding for all concerned. Such improved communications
would improve public health rather than promote public
hysteria.
6. We strongly urge the formation of a ``Blue Ribbon''
group of experts from both inside and outside the government to
conduct a review of the handling of the 2008 salmonella
outbreak by state and federal agencies. The purpose of this
review would be to improve their effectiveness in handling
future outbreaks. Learning from mistakes made is the only way
to make the world a better place as a result of our unfortunate
experiences.
Thank you for the opportunity to present these comments for
your review.
----------
Mr. Stupak. Thank you, Mr. Brown.
Mr. Beckman, your opening statement please.
STATEMENT OF EDWARD BECKMAN, PRESIDENT, CALIFORNIA TOMATO
FARMERS
Mr. Beckman. Thank you, Mr. Chairman, members of the
subcommittee. California Tomato Farmers Cooperative is the
largest producer of fresh tomatoes for all of North America
during the summer and fall. Our cooperative was formed in 2006
by 54 growers, large and small, who represent 80 percent of the
fresh tomato production in California. And we require
production based upon a higher food safety standard.
As noted by the secretary, we require mandatory, random and
unannounced food safety audits of all ranches, all packing
houses by the California Department of Food and Agriculture. We
are also the co-author of the new Commodity Specific Food
Safety Guidelines for Fresh Tomatoes. And we support mandatory
trace-back at all levels.
Although California was never associated directly with the
Salmonella Saintpaul outbreak, our members have indeed lost
millions in sales in both domestic and international markets
due to the broad warnings related to tomatoes. But our very
real concern is that this may happen again, putting the
consumer at risk, and that we may see a prolonged investigation
that will further weaken trust in our food supply. FDA publicly
noted the difficulty of their investigation and we cannot help
but ask specifically, Where was the problem? Trace-back should
be able to trace fresh tomatoes from point of service to the
field in hours, not days or weeks.
Trace-back of fresh tomatoes is based upon lot
identification codes which travel with the product. The code is
printed on all containers, included on all quality control
records, production reports, and forms used in the shipping of
the product; it is the foundation of traceability. As you know,
we recently hosted a tour for the investigative staff of this
committee demonstrating traceability of fresh tomatoes across
state lines. The investigative staff directed the case study
that I will detail to you today.
In the slides provided to the committee we will be tracing
tomatoes from a single restaurant back to the grower through
five handling points. And while the tomatoes move in one
direction, trace-back requires a two-way flow of information
among all who handle the product: the store, the distribution
center, the repacker, shipper and grower. There are six steps
to this trace-back investigation.
[Slide shown.]
We begin with the quality assurance vice president phoning
a restaurant to obtain the date code on a random carton of
tomatoes. That date code is relayed to the distribution center.
[Slide shown.]
In step 2, the distribution center uses the date code to
learn the product came in on July 7 from a repacker supplier.
[Slide shown.]
In step 3, the supplier is phoned, provided with a purchase
order for the shipment. This is the document. Using the
purchase order the supplier then determines the origin of the
product in a single document.
[Slide shown.]
In the next step the supplier holds the critical document
to maintain traceability. It is a single document that
documents the purchase order for incoming product and the final
lot I.D. for unfinished product. It is this one single document
that determines whether not there had been any commingling of
product and the source of all tomatoes used in the final
product.
[Slide shown.]
In the final slide we look at the role of the supplier who
phones the shipper and using the purchase order obtains the
original lot I.D. The lot I.D. includes the complete field
history and it is passed forward. The supplier, using this
document, now has all records they need to pass forward to the
food service chain.
[The information appears at the conclusion of the hearing.]
The time required for this trace-back as done for the
investigative committee was 35 minutes. Why did this trace-back
work? Well, the answer is the use of electronic recordkeeping
that is based upon lot identification and also the Bioterrorism
Act. What we did was linking one step up and one step back
requirements of this act at each level of the supply chain.
We believe that we must learn from this outbreak and
investigation to ensure that future investigations do not take
months, they should not. And we therefore recommend that
Congress require an analysis of the FDA tomato investigation to
include individual trace-back records to effectively determine
why this investigation of tomatoes was so lengthy, that FDA's
tomato initiative be expanded to include tomato repackers,
wholesalers and traceability throughout the supply chain, and
that FDA establish a pilot project that would establish
mandatory food safety production and handling requirements
based upon the just-published Commodity Specific Food Safety
Guidelines for the Fresh Tomato Supply Chain.
I would like to note this standard is already employed by
our members in California and Florida. Together we represent 70
percent of the fresh tomatoes produced in the United States. By
taking these already high standards national we would improve
preventative measures by all who produce and handle tomatoes,
including smaller farms. But we caution, food safety is not
limited to the grower in the packing house, it is the
responsibility that must be shared by all, including
supermarkets and restaurants, if we are to truly protect the
consumer.
This concludes my testimony. And I will welcome any
questions the committee may have. Thank you very much.
[The statement of Mr. Beckman follows:]
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Mr. Stupak. Thank you, Mr. Beckman.
Mr. Booth, an opening statement please, sir.
STATEMENT OF PARKER BOOTH, PRESIDENT, DELTA PRE-PACK, INC. AND
ACE TOMATO CO., INC.
Mr. Booth. Thank you. My name is Parker Booth and I am
President of Delta Pre-Pack, a repack company, and Ace Tomato
Company, Inc., a grower, packer, and shipper of tomatoes. Both
entities are part of the Lagorio Family of Companies based in
Manteca, California. Today, while farming over 10,000 acres,
3,000 of those acres are planted with a wide variety of
tomatoes.
Thank you, Chairman Stupak, Ranking Member Shimkus, and
members of this subcommittee for the opportunity to testify
before you on the topic of traceability within the fresh tomato
industry and the impact this outbreak investigation has had on
our two companies.
A critical component of a food safety program is having the
ability to trace where the product we pack for our customer
comes from all the way back to the field. Trace-back is not a
passive process for any company, it must be aggressively
managed every step of the way. This process requires a
commitment from top to bottom within an organization with a
culture of accountability, not matter what the size of the
company may be.
Trace-back from our customer to the field can rapidly be
completed using existing software programs. As a grower and
shipper and also as a repacker we are required to conduct mock
recalls that test our ability to trace-back product. Trace-back
is not an option, it is a requirement of doing business and it
works.
I want to show you an example of a box that we had with our
investigator team that came out just last month. And it has on
it the markings. You probably cannot see it from your seat
there. But the essence is from looking from the left side as
the lot number. There is a lot number 23. There is also our
State, Federal I.D. code which is the number for our shed which
tells us that is who packed it. And finally on the far right-
hand side is the date that we actually packed the product.
The lot code which is on the far left, number 23, is the
essence of the trace-back. This is the number that starts
everything. So when we actually harvest a field we identify and
label that particular field with a lot number. And that is what
goes through the whole process.
This is information--there is no way you can see this--but
this is documentation paperwork that actually supports that,
from pallet tags to lot I.D. numbers. And this is the
information that will go all the way to a distribution house,
all the way to a retail store, or all the way to a national
chain distribution with this information.
Although Ace Tomato Company was not in production at the
onset of this outbreak, Delta Pre-Pack was marketing fresh
tomatoes from both Mexico and Florida. The financial
consequences of the inconclusive FDA trace-back increased
greatly as the Center for Disease Control expanded their
warning beyond the original states into Mexico and Texas. As
the warning was expanded to all 50 States our suppliers in
Florida and Mexico were considered suspect, as they remained
within the scope of FDA's investigation.
We have full confidence in our suppliers as we apply the
same standard to the product they grow as we place on our own
selves. It is important to note that we work closely each year
with our growing partners along with our customers calibrating
our food safety standards. This means we are on site in the
fields, in the packing sheds verifying protocols we have
established in an effort to gain agreement between ourselves
and our customers that the supply chain is as safe as possible.
But that confidence was not sufficient to retain our customers.
Due to blanket warnings by the FDA that Mexico and Florida were
not safe our customers were forced to require that we source
from other states outside of our normal supply chain. In
effect, we moved away from the supply chain that both our
customers and ourselves had worked hard to ensure was as safe
as possible. In effect, money, the money and resources we
invested in our food safety efforts went for naught.
Consequently, in the first week alone we had to dispose of
several hundred thousand dollars worth of perfectly good
tomatoes, with the total impact from the 2-month outbreak still
being tallied.
As a grower, shipper, and repacker of fresh tomatoes, we
urge that Congress address the economic significance to all
levels of the tomato supply chain that broad-based warnings may
have unfairly associated safe tomatoes with food-borne illness.
Consideration needs to be given to the development of a more
effective warning system that would allow companies to assess
their particular positions much further in advance as
information from the investigations are being collected.
There is a critical time early in the suspected outbreak
where the industry can provide supplemental guidance to the
government investigative efforts in order to obtain quicker
answers. This industry support could be from a panel of
industry advisors whose purpose would be to work closely with
the FDA to gain them a better understanding of our industry's
distribution system before an outbreak occurs and to provide
guidance during any future investigation. As it is, we caused
undue alarm to consumers of fresh tomatoes and undue financial
hardship on an industry that contributes better than $1 billion
in sales to the U.S. economy each year.
This concludes my testimony and I welcome any questions
that the Committee may have.
[The statement of Mr. Booth follows:]
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Mr. Stupak. Thank you.
Mr. Stenzel, your statement please, sir.
STATEMENT OF THOMAS E. STENZEL, PRESIDENT AND CHIEF EXECUTIVE
OFFICER, UNITED FRESH PRODUCE ASSOCIATION
Mr. Stenzel. Good morning, Chairman Stupak, Ranking Member
Shimkus, and members of the Committee. My name is Tom Stenzel.
I am President and CEO of United Fresh Produce Association, a
total supply chain association representing the fresh produce
industry, multiple commodities from grower, packer, shipper all
the way through retail and restaurant.
Let me broaden my testimony a bit now from specifically the
tomato industry but speak on behalf of our entire sector in
fresh produce. We are totally committed to food safety and hold
ourselves to rigorous standards in growing, handling, packing,
and tracing our fresh foods. We strongly support federal
oversight, mandatory federal oversight of commodity-specific
risk-based rules.
This outbreak also shows us that government and industry
alike have not spent sufficient time in the investigation
process after an outbreak as we are spending in prevention of
those. Today I want to broaden the conversation a bit to some
of the lessons I think we can learn from this investigation and
hope to engage in a dialogue with the committee about some of
these issues.
Number one, there is no one in charge. Throughout the
investigation it became clear that no one was in charge,
leaving local, State and federal officials blind for
leadership, various agencies pursuing different priorities, and
well-meaning individuals reacting independently to events
rather than part of a coordinated investigation moving forward
in a logical and expeditious manner.
We recommend that Congress require a command and control
structure with a clear chain of command, take the guesswork out
of who is in charge, drive real accountability and authority
into this process.
Second, we need better crisis preparedness and transparency
in the process. The dispute today over the validity of early
work by the states and CDC with food recall surveys in which
tomatoes were indicted could have been avoided with properly
vetted and peer-reviewed epidemiological tools ahead of time.
Instead we find CDC rewriting questions that they asked
consumers in the middle of the outbreak and not sharing that
data broadly.
Even when FDA tried to do the right thing by creating a
cleared list of regional tomato production areas it was
responding logically to the fact that many areas were not in
production. But the cleared list became problematic and there
was no easy way to explain how to get on the cleared list.
Individual States were left having to call FDA to advocate for
their areas of production. And there is a serious question of
equal treatment for all producers.
And there was constant confusion about what data could be
shared with industry and what could not. We went weeks asking
for simple data such as the onset of illnesses, the geographic
patterns of illnesses. We could have used knowledge from our
food distribution systems to help in that process and were told
the data simply was not available.
Number three, the current system does not use expertise
outside of the agencies that is available. Let me first say
that industry input needs to be transparent and squeaky clean.
We are not asking to run the investigation. But there is an
abundance of knowledge in the industry about specific
commodities, growing and handling practices and distribution
systems, as you have heard from my colleagues, that can help
protect public health.
As this outbreak expanded to dozens of states around the
country we knew very early that it was highly unlikely that a
single contamination point for tomatoes was possible, whether a
single farm, packer or repacker. But industry's knowledge was
ignored when it could have helped shift attention quickly to
some other product, perhaps jalapenos.
The FDA and CDC should also welcome outside expertise not
just from industry but also from academia, from USDA and state
departments of agriculture.
Number four, we believe government is ill prepared to make
complex risk/benefit decisions in the food area. Every health
or safety regulatory decision requires an assessment of risk
and benefits. Yet in the case of food-borne disease FDA and CDC
seemed ill prepared to grapple with risk management other than
an all or nothing approach. This leads to the extreme measures
of banning all tomatoes or banning all jalapenos in the quest
for zero risk. But is it really zero risk when 99.999 percent
of the tomatoes available in the market are perfectly safe and
we are scaring consumers away from a high-lycopene product that
can protect against prostate cancer? There is another part of
public health that we have to take into account here as well as
the concept of talking about the entire tomato supply.
Finally, the risk communication process that is in use is
unacceptable. These are tough issues. They are tough to
explain. But how many times have we listened to CDC and FDA
media calls where the first 5 minutes was explaining there is
nothing new in the investigation and the next 55 minutes are
explaining and speculating about what may have happened, what
may be happening, what may be plausible, what may be
theoretical, but not what the facts are. Yet any risk
communication expert would advise precision and care in
communicating exactly what you want to say and not speculating
beyond what is known.
Mr. Chairman, much of the discussion today I think is going
to focus on traceability. I would like to add some perspectives
on that perhaps in the question session. My colleagues I think
have shown you some of the industry experience with
traceability. Frankly, we are confused. We do not understand
where some of the problems the FDA is reporting in our system
so it is something that we really do want to address.
Thank you.
[The statement of Mr. Stenzel follows:]
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Mr. Stupak. Thank you.
Mr. Hubbard, we will turn to you for your opening
statement. And we all talked about our ninth hearing, I think
you have been here for all nine. We appreciate your work and
willingness to work with us and your patience and your insight
to this issue. So we look forward to your testimony, please.
STATEMENT OF WILLIAM K. HUBBARD, SENIOR ADVISOR, COALITION FOR
A STRONGER FDA
Mr. Hubbard. Thank you, Mr. Chairman. I do have written
comments but I will make just a few oral ones.
It is unfortunate that we are here yet again talking about
yet another failure by the FDA. And I am sorry you are having
to go through that but I think the public is sorrier.
As you know, I have expressed the view that many of the
problems have not been of FDA's doing, that there have been
shortfalls other places that have caused FDA to be ineffective.
And I think there are many issues for Congress to deal with in
this particular outbreak, how the government is organized, how
the FDA is organized, how federal/state relations occur, how
well the industry can track and otherwise do its job. But I
would like to focus my comments, if I could, just on three
areas all dealing with FDA's capacities.
First, the agency's food safety resources have not kept up
with the responsibility they have been given. And in fact, we
have been taking down the food safety system at FDA for several
years. We are reducing staff at a time in which we need people
even more at the agency. We need more inspections. We need the
scientists to deal with these emerging pathogens. And it has
been going the other way. So I think that is a tremendous piece
of the problem at FDA. By taking down a program at a time it
needs to be strengthened we are simply going the other way.
But FDA also needs to be able to acquire a food process to
implement a system of preventive control. We need to prevent
these things from occurring, not just chase them after the
fact. As you know, preventive control is a well-proven
mechanism for keeping food safe in the first place from being
contaminated. Mr. Dingell's bill attempts to do that. And I
certainly wish you well in that effort.
You may know that FDA tried to use its existing authority
last year to impose preventive controls over produce. But the
Administration rejected the recommendations of the agency
scientists to do that. And I think that has proven to be a
grievous mistake. Just think, we could be well on our way to
having regulations for preventive control for produce in effect
today but essentially we are nowhere because of that denial. So
I think that was a tremendous mistake. And I urge Congress to
proceed with its efforts to establish a system of preventive
control.
My third point relates to traceability. When Congress
enacted the Bioterrorism Act in 2002 it intended to give the
agency the authority to track these products so that you would
have a rapid ability to follow up on a potential terrorism
attack throughout the supply chain. But instead of having a
robust recordkeeping system that allowed for rapid access to
complete records by all participants, the agency got, ended up
with delayed access to partial records from only some elements
of the supply chain. So we have weakened those regulations
tremendously.
And I think the Salmonella incident demonstrates how the
weakening of those rules essentially negated the intent of
Congress.
So just imagine, Mr. Chairman, if the Salmonella outbreak
had been a terrorist attack and thousands or hundreds of
thousands of people had been at risk from death and disease how
much of a failure those rules, that recordkeeping requirement
would have been. And I think we need to look at in that context
for future consideration.
Now, the good news is, as Ms. DeGette and others have said,
there are effective technologies available to provide for
successful trace-back. Some produce firms have demonstrated it.
But the problem is we are only as strong as our weakest link.
And those small firms that have not been able to do effective
trace-back I think need to be addressed. So the means are
available to improve the situation. And I hope you will be a
strong supporter of those means.
Now in conclusion, Mr. Chairman, we talk a good game about
food safety. We say we care about it, we say we are going to do
more, but we just have not backed it up, that rhetoric up with
necessary support in my view for FDA. I do not believe we can
make FDA an effective agency without giving it additional
resources and authority. These problems that we are talking
about are they going to keep going? We are going to have more
of these outbreaks? This is going to be an endless process
until we fix the system. So I hope Congress will agree with
those and move to make it so.
And thank you for giving me the opportunity, Mr. Chairman,
to prevent those views.
[The statement of Mr. Hubbard follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Mr. Hubbard.
We will begin questioning. I guess the last 12 hours
epitomize how this whole investigation has gone. About 9:00,
10:00 last night we got a release from the FDA about jalapenos
in Mexico. And about 10:15 we had a correction. And 8:00, 9:00
o'clock this morning we had another one. So we have had about
three releases in the last 12 hours on what is going on with
this investigation. Now I do not know if that is the quality of
the investigation or the fact we are having this hearing here
today.
But let me ask this question of this panel. Now, this
investigation started out with Salmonella Saintpaul and
detailing tomatoes. Has there been any Salmonella Saintpaul,
Salmonella found in any tomatoes in the United States? I take
it none; correct?
None? OK.
Then at the time when we started this May 22, the only
State I understand that was growing tomatoes at the time would
have been Florida; right?
Mr. Brown. That is correct.
Mr. Stupak. OK. So any other tomatoes would have had to
come either from Florida or I guess Mexico would be the other
source; right? OK.
Mr. Brown. Florida.
Mr. Stupak. I am sorry, put that up there, Mr. Brown. It
would have been Florida?
Mr. Brown. The primary source, Florida was the primary
domestic supplier at that point.
Mr. Stupak. Right. And then the other one would have been
foreign countries----
Mr. Brown. Other one was primarily Mexico.
Mr. Stupak [continuing]. Mostly Mexico?
Mr. Brown. And as a matter of fact, Mr. Chairman, the
morning after we were informed there was concern we provided
data for a period of 30, 60 days----
Mr. Stupak. OK.
Mr. Brown [continuing]. Prior to that where every tomato in
the country came from.
Mr. Stupak. OK. Now, we eventually get to the jalapenos,
right, after Minnesota gets there. And believe it or not we got
one today, OK. But Florida, Mr. Booth, you mentioned about
Florida and, Mr. Brown, you mentioned it, your process you have
for tomatoes, the box and all the markings. Did the FDA help
you with that? I mean were they aware of your system? Did they
help you develop it?
Mr. Brown. We have had positive lot identity for round
tomatoes in Florida for going on close to 20 years under a
federal marketing order.
Mr. Stupak. OK.
Mr. Brown. We had worked with the FDA in working up on
state regulatory program that we were voluntarily implementing
and we now have under state regulation.
Mr. Stupak. OK. But as of today tomatoes are still suspect;
correct?
Mr. Brown. Unfortunately.
Mr. Stupak. Or as we call it, the vegetable of interest;
right? The person of interest, it is still the vegetable of
interest?
Mr. Brown. Yes, sir. We are still indicted and convicted in
the media.
Mr. Stupak. OK. But yet we have never had any. And now we
are at jalapenos from Mexico; right?
Mr. Murphy. Do not touch it.
Mr. Stupak. OK. I have a double dare with Shimkus, we are
going to eat it yet today.
This is a box we got today. There is no markings like you
had to show your area; right? All this says is ``Produce of the
United States, net weight 25 pounds.'' And just says tomatoes
on it. OK, we got it at a local retailer here today.
Now, Mr. Booth, your box had those markings on it. Is it
legal to use your box? I mean you ship it to, let us say you
ship it up here to Washington, D.C., OK. And can a grower take
that box with those markings on put tomatoes in it even it was
not from Florida? In other words can you re-use that box again
and again and again?
Mr. Booth. As long as they maintain the records.
Mr. Stupak. OK. But they would have to wipe out the coding
that you have on it?
Mr. Booth. They would have--when a repacker takes that they
are going to have to when they repack it they are going to have
to take the original lot number----
Mr. Stupak. OK.
Mr. Booth [continuing]. The original information and put
their own information on it.
Mr. Stupak. OK. Now, only California and Florida have that
system; right?
Mr. Kawamura. Yes.
Mr. Stupak. So the other 48 States are, they can be sending
boxes like this here; correct?
Mr. Brown. Mr. Chairman, this is why the industry has
stepped forward in conjunction with FDA and the----
Mr. Stupak. Correct.
Mr. Brown [continuing]. Research community and created this
document which would resolve and solve that issue in requiring
that every person in the country that grows and handles
tomatoes maintains that information, passes it up.
Mr. Stupak. So you want a federal regulation saying----
Mr. Brown. Yes, sir.
Mr. Stupak [continuing]. You must do it this way?
Mr. Brown. We want a double-phase procedure----
Mr. Stupak. Whether it is tomatoes, jalapenos, whatever it
might be?
Mr. Brown [continuing]. Because the public trust is so
important to us we cannot afford to do it any other way.
Mr. Stupak. OK. What is the cost of doing that, of putting
that code on there and have that trace-backs? Can anyone give
me an estimate? Because that is always a question we ask, What
is it going to cost us? Mr. Booth?
Mr. Booth. Yes, it is----
Mr. Stupak. Mr. Stenzel?
Mr. Booth. I am not sure what the cost is. In the largest--
--
Mr. Stupak. Is it minimal or?
Mr. Booth. It is minimal.
Mr. Stupak. It is minimal?
Mr. Booth. It is minimal.
Mr. Stupak. OK.
Mr. Booth. Anyway, the point being is that any size firm,
large or small, can do this.
Mr. Stupak. OK.
Mr. Booth. It does not have to be fancy and it does not
have to be expensive.
Mr. Stupak. OK. Now, you said, Mr. Beckman, you traced back
that tomato that you did in California for the staff and they
learned a lot from you guys. That was all within California
though; right?
Mr. Beckman. It was. But----
Mr. Stupak. So what if that tomato goes to Michigan where I
am from?
Mr. Beckman. We actually were able to produce for the
investigative staff a number of trace-backs throughout the
United States. That included product from California, Florida
and Virginia going into multiple states. For example, one of
the trace-backs was from California to Colorado.
Mr. Stupak. How long did that take?
Mr. Beckman. That one took about 5 hours.
Mr. Stupak. OK.
Mr. Beckman. But I can give you a story that took place
yesterday if you would like?
Mr. Stupak. OK. But the point is you can do it; right?
Mr. Beckman. Yes, we can.
Mr. Stupak. And there is minimal cost?
Mr. Beckman. Cost actually that we can say it is a part of
a business culture and it is not significant. The cost that we
pay in California to validate our process runs about a penny a
box.
Mr. Stupak. OK. So let us go back to Florida, let us go
back to May 22. We have Salmonella, Florida is the only place
growing, but Florida has this system, right, to track
everything? So if people were getting sick in New Mexico and
Texas that seemed to be June 3 is when they put the place out,
could they not have gone and said, OK, Florida, have you sent
to Texas and New Mexico in this area, wherever it is? Could
they have done that?
Mr. Brown. Yes. They were advised in early conversations
that the supply chain or supply system for tomatoes in the
country is basically bifurcated by east and west.
Mr. Stupak. Yes.
Mr. Brown. Florida dominates the eastern supply system, the
Mexican supply source dominates the western supply system. And
because of the energy costs we do not move them back and forth
very often.
Mr. Stupak. Right.
Mr. Brown. And there may have been some minimal amount of
tomatoes in that marketplace but they would have been
insignificant.
Mr. Stupak. California then would have been the big
supplier to Texas, New Mexico then at that time?
Mr. Brown. Only when they come into production. And they
follow us. We were at a transition zone between.
Mr. Stupak. When does California go in production?
Mr. Kawamura. California had started this year on May 17
was the first field harvest of California.
Mr. Stupak. OK. So we are on June 3, so they could have
possibly been?
Mr. Kawamura. No. At that point knowing what the initial
outbreaks as they took place we knew that California had not
been in production at that time and were able to verify that
with FDA at the time.
Mr. Stupak. So why did we make tomato vegetable of interest
then?
Mr. Kawamura. It was still a vegetable of interest
throughout the rest of the production areas of the state. I
know one of the early announcements from FDA was that
California was not a part of this outbreak based upon the
harvest schedules that we were aware of.
Mr. Stupak. OK. Could country of origin labeling have
narrowed the focus here in your estimation, anyone? Mr.
Beckman, anyone, would that have helped?
Mr. Beckman. It could perhaps help. But the problem was
that the association was with all tomatoes. And so we had a
scenario where all tomatoes were suspect. And then as the safe
list was produced we are essentially trying to back individual
states away from an association of guilt, and that is extremely
difficult.
Mr. Stupak. So the thing we need right now from the FDA is
a firm statement that tomatoes are not even vegetable of
interest, they have nothing to do with this Salmonella
outbreak. Because we still, if I look at the last line here, it
says, ``FDA announced that it has determined that fresh
tomatoes now available in the domestic market are not
associated with the current outbreak. As a result, the agency
removed its June 7 warning.'' And my problem is with that is
they never cleared tomatoes from the original outbreak.
Mr. Beckman. Correct. You are correct, Mr. Chairman.
Mr. Stupak. So we still have the suspicion over the----
Mr. Bronson. Well, Mr. Chairman, if I----
Mr. Stupak. Yes, go ahead.
Mr. Bronson [continuing]. Might as well enter in this, one
of the things that we noticed very early on was when the
outbreak took place in Texas and New Mexico and began to go
north of there we were selling tomatoes out of Florida all over
the southern United States, all over Florida, but we did not
have sicknesses in Florida. So we were suspicious right then--
--
Mr. Stupak. Right.
Mr. Bronson [continuing]. That Florida tomatoes, grown
tomatoes were not a part of this problem from the very
beginning. And I think we need to while we have to follow the
scientific method, we also should not throw away common sense
and risk assessment that says if you know this is where the
outbreak is the most seen there is a good chance it is coming
either across the border or from within a state or two of that
outbreak because the south had no cases at the time.
And the other issue, Mr. Chairman, that I would like for
you to consider, because someone from Florida goes to the
doctor with a sickness that ends up being Salmonella Saintpaul
they may have gotten it in Texas. They should not be----
Mr. Stupak. Sure.
Mr. Bronson. They should not be counted as a Florida
sickness because it may have been picked up while they were
traveling. And that is the case in a number of these cases.
Mr. Stupak. Well, I am looking at the CDC investigation
outbreak of infections caused by Salmonella Saintpaul, dated
July 29. And when you look at it they have the breakdown of
1,319 people, 1,319 people infected, only 11 are from
California and 4 from Florida. So with the math of course being
Texas with 502 and New Mexico 106, so I guess that proves your
point.
One question and my time is way over, and I just want to
ask Mr. Hubbard a question. Because we are talking a lot about
traceability here and suspect vegetables or not, but let me ask
you this one. On July 25 the Associated Press ran an article
entitled ``Food Industry Bitten by its Lobbying Success.
Companies Oppose Electronic Tracking that Could Locate Outbreak
Source.'' The gist of this article is that there were some with
the FDA that were advocating a much stronger recordkeeping and
trace-back system than what we currently have today underneath
the Bioterrorism Act. However, due to heavy pressure from
industry many of the requirements were watered down.
Mr. Hubbard, you were an associate commissioner of policy
at the FDA at that time. What systems were being proposed? And
how did these systems differ from what we are using today or
what we have seen in California and Florida?
Mr. Hubbard. Well, as I said, I think the agency wanted a
lot of the things that folks are talking about here now: lot
numbers, rapid access, recordkeeping throughout the chain. I
will not deny that the industry may have had a ``Come to
Jesus'' moment in recent years, but in 2003 the message from
the industry to the Office of Management and Budget which was
reviewing the regulation was too expensive, too hard, do not do
this.
So again I am very gratified to hear the progress that has
been made, but when FDA was doing its regulations it was being
literally hammered for proposing things that were viewed by
many members of the industry as too much.
Mr. Stupak. One more. Mr. Beckman, did it not really say,
tell our staff that to do that tracing on that box there is it
not like a penny a box?
Mr. Beckman. It is a penny a box for the verification. The
actual costs are, again, insignificant.
Mr. Stupak. OK. Mr. Shimkus for questions. Thank you,
gentleman.
Mr. Shimkus. Thank you, Mr. Chairman. Good round of
questions. Maybe we should go ten minutes one round or
whatever, so. Whatever.
But it is all, you know, I like to talk about on the
business end and talk about raising of capital, assumption of
risk, return on the investment. And part of this is a payment
to lower the risk. And obviously there has been a big loss.
Now, the growers have intimated that obviously there should be
some recovery. And there could be a debate on takings based
upon response. And I do not know if and how that will resolve
itself but, you know, the thing I want to focus on to begin
with, I had a whole bunch of scribbled notes from the
testimony, it is very good.
But first-off for Mr. Bronson. And we have the time line
here and so June 3, 2008, FDA warned consumers in New Mexico
and Texas not to eat certain types of raw red tomatoes. Now,
your opening statement said you were 99.9 percent sure it was
not Florida. On June 3, how close to June 3 did you know there
is no way it was a Florida tomato?
Mr. Bronson. Congressman, we, because of our program that
we implemented and third party verification which is as close
to ``HASUP'' in most other fields of food safety as you can get
the fact that we had no single person in the State of Florida
that was showing Salmonella Saintpaul or any other kind of
Salmonella that we were aware of because our people in our
county and State health departments would have been in touch
with us if it had shown up, we had that good a working
relationship, and the fact that we were shipping all over the
southeast United States and there was no cases.
Mr. Shimkus. But what is the date? How close were you to
that June 3 time frame you said it is not here? It highlights
the communication of the FDA; that is the only reason why I am
asking it.
Mr. Bronson. June, well, I am saying, I am hearing now from
my deputy commissioner who is in charge of food safety, around
they were very sure by the time we analyzed what we were
getting by the 15th of June----
Mr. Shimkus. All right.
Mr. Bronson [continuing]. There was no way Florida was
responsible because no Florida tomatoes----
Mr. Shimkus. Well, the only thing I am highlighting, we
know there are areas to be fixed. One is communication, you all
mentioned it, communication across the board with all agencies,
transparency. And an early notification of information and
acceptance could help limit losses I, you know, I think, and
that is an issue.
But I want to highlight, I mean we are all FDA, beat up
FDA. Trace-back although it was slow, Mr. Stenzel, trace-back
worked in this system, did it not?
Mr. Stenzel. I think, Mr. Shimkus, that you have identified
a very key part of our discussion here. The real issue where
this started is in the identification of tomatoes at the CDC.
Everything in trace-back would prove that tomatoes were not the
cause. Everything that was traced back showed tomatoes came
from different sources. There was no common point of
contamination.
Could that have been done more quickly, more effectively?
If it could I want to know how. I want the FDA to show us where
they ran into roadblocks. These types of systems that my
colleagues have talked about are precisely in place also for
many Mexican tomatoes. So many of the tomato products in this
industry, because it has been bitten in the past, have done a
fantastic job of putting in place extensive traceability. So we
do not understand what that slowness was.
But in this case traceability showed tomatoes were not the
cause.
Mr. Shimkus. 1,400 samples, not one--all right, one
positive. And the key, you know, really we ought to have a
hearing from the CDC and the State health departments. I mean
that is the hearing today ought to be. I mean because that is
where in this case the system failed.
Mr. Stenzel. Mr. Shimkus, I think it is very difficult, and
this is an issue that I think you have got to grapple with with
the agencies, is how do they back away from an initial
association? They still will not do it. They are still even in
the press releases today clinging to the theoretical
plausibility that perhaps tomatoes from near these Mexican
farms might have been involved in the early stages.
I guess that is still possible and we will have to hold
judgment. But my goodness, we now know that the initial month
of activity that said tomatoes are it and, by darn, we are
going to prove tomatoes are it; they did not do it. They just
found tomatoes were not it.
Mr. Shimkus. Mr. Hubbard, you have to agree that as much as
we are focused on FDA it is this issue of the CDC and the
public health departments and why they did not--I am not a
criminal investigator but, you know, when we were doing, I was
doing the prep for this it was my understanding they limited
the suspects instead of having all the suspects like, you know,
everyone in the room instead of they focused on, they focused
on a commodity product not all the commodity products?
Mr. Hubbard. Absolutely. FDA chases the food that the CDC
questionnaire process identifies. And epidemiology is an
inexact science. And I am sure you will hear that from the CDC
folks. I am sure they did the best they could but FDA was
chasing down the results of the CDC recommendation.
Mr. Shimkus. And let me go to Mr. Beckman real quick
because I want to follow up. I think I made my point on the CDC
and the public health departments. But this issue that we did
on tracing the tomatoes to the retail location which was a Jack
In The Box, the Chairman followed up with across state lines.
The question I would ask is smaller mom and pop retail
locations, family restaurants, or tomorrow is Friday, my
American Legion Post 365 does a weekly fish fry. Of course the
only way Illinoisans love to eat fish is cod and it is deep
fried. So and they will have tomatoes. Can this process that we
are talking about, obviously a major retailer, just that whole
debate, have the resources, can do the IT, can do all the
process. What about my local American Legion Post 365 that
really relies on the fish fry to bring in income to help fellow
veterans? Can they do that too?
Mr. Beckman. Well, first let us look at the State of
California and the fact that in the California code all
tomatoes must be traceable at all points in the system. That
includes the smaller players.
But to answer your question as to outside of California,
again referencing the Tomato Supply Chain Guidance document,
what we looked at is where are the weaknesses in the
Bioterrorism Act? Is there a weakness in the fact that an
individual mom and pop restaurant is not required to maintain
such a level of documentation?
Trace-back can simply begin with an invoice, an invoice
that we recommend in this document be held for at least 6
months so that way we know where those tomatoes came from.
There has to be that initial piece of paper. Right now those
outlets are exempt from the Bioterrorism Act recordkeeping
requirements.
Mr. Shimkus. Let me go to Mr. Booth for a second and talk
because you deal with all, you are a grower, you are a
supplier, you are a repackager.
Mr. Booth. Right.
Mr. Shimkus. What about the repacking? Repackaging of the
other thing in our research talked about sizing of tomatoes
from maybe different growers; does that happen? And then how do
you, say you are a repackager and you have a multitude of
growers and so they are coming in your facility, you are
repackaging by size and weight versus where it came from, so
then in that box could there be more than one? And does that
code then does it identify that this came from four different
locations versus one location? Is that how that works?
Mr. Booth. Yes, well maybe I can just take a minute and
just give you an example of how that might work. We will buy at
any given time from multiple growers. Today this minute Delta,
our repack company, is actually purchasing product that we
actually grow in multiple different fields. We are going to be
purchasing this week product from other growers, competitors to
our other baseline company Ace Tomato.
The way we handle and the lot identification is identical
whether it is our product coming from our fields or from
another grower. And that grower could also come from Mexico. So
it is identical.
The product comes in to our repack facility. We run that
product to size and spec, specifications that our customers
give us, by lot. So that one lot goes all the way through our
process. So in a box that I just showed you a few minutes ago
you will have one lot of tomatoes in there, just one.
Commingling has been talked about a lot. And I think that
has been discussed and it is a little bit confusing as what
commingling really is. If you do have multiple lots in one case
you need to make sure that you have got the documentation to
prove that there are multiple fields, multiple lots in that
box. We do not want to do that. We really do not want to mingle
a particular box.
As I showed your congressional investigators, on a pallet
you may have one case out of 80 that is from a different lot
than the other 79 boxes. As long as you have the documentation
that shows that that box came from a particular lot you are OK,
you can trace that back. And if there is an outbreak or if
there is a suspected outbreak of a particular case that goes to
that restaurant you can again follow that all the way back to
the lot.
Mr. Shimkus. My time has expired, Mr. Chairman. Thank you
again. I will want to end by saying CDC, state health
departments, we have to bring them in the loop and empower them
to make some better decisions.
Mr. Stupak. Ms. DeGette for questions.
Ms. DeGette. Thank you very much, Mr. Chairman.
I really want to thank each of you on this panel because
you have really, quite thoroughly explained to us that we can
do traceability, that it is cost effective and we can do it
even with mixed lots.
What I want to talk about is why do we need to have some
kind of a national system of traceability? Now, Commissioner
Bronson, in your State you have mandatory traceability for
tomatoes; correct?
Mr. Bronson. That is correct.
Ms. DeGette. And also, Secretary Kawamura, we have that
mandatory traceability in your State as well for tomatoes;
correct?
Mr. Kawamura. Yes, we do.
Ms. DeGette. And, Mr. Beckman, you talked today and also I
met with you and you talked to me about how quickly and
effectively we can trace tomatoes if we have a traceability
system; right?
Mr. Beckman. Correct.
Ms. DeGette. In fact, the story you wanted to tell Mr.
Stupak was you folks bought some sandwiches at Subway and went
and ran a trace on those tomatoes at Subway and you were able
to do it in a few hours; right?
Mr. Beckman. Correct.
Ms. DeGette. And that is because Subway requires
traceability for its tomatoes; right?
Mr. Beckman.
Ms. DeGette. I am not sure that the whatever it is the fish
fry people might have mandatory traceability. But that----
Mr. Shimkus. No, I do not think we do. That is the whole
point.
Ms. DeGette. Exactly, that is the whole point. And so, Mr.
Stenzel, you might be able to answer this broader. We are
really clear on what is going on with tomato traceability but
part of the problem we have is we do not have national tomato
traceability; right, Mr. Beckman? I mean some industry, some
producers have it, some industries, some states have it. But it
is not a national system; right?
Mr. Beckman. It is fair to say that if you are a major
tomato grower and shipper and want to do business with major
corporations you absolutely must have it. That is not to say
that there are not some growers in some areas of this country
that do not maintain traceability.
Ms. DeGette. But in addition its traceability, it is
vertical traceability not horizontal traceability because it is
traceability for that grower? It is not a national system of
traceability that the national tomato growers have instituted
for everybody?
Mr. Beckman. Well, traceability begins at the grower/
shipper.
Ms. DeGette. Well, can you--I am sorry, I do not have a lot
of time.
Mr. Beckman. OK.
Ms. DeGette. Yes or no?
Mr. Beckman. Please repeat the question.
Ms. DeGette. Is it a national system of traceability that
is interoperable for all of the tomato growers?
Mr. Beckman. It is not a national system, no.
Ms. DeGette. OK. Mr. Stenzel, now you represent broader
numbers of growers. And I understand the way you trade a tomato
may not be the same way that you would trace green beans or
other produce; correct?
Mr. Stenzel. Correct.
Ms. DeGette. But there are other types of traceability
systems that would work for almost any kind of commodity;
correct?
Mr. Stenzel. Yes, ma'am.
Ms. DeGette. And so what I have been thinking about is this
recent Salmonella outbreak. And it appears that what happened
is people, let us step all the way back to the beginning, the
public health sleuths talking to people found out that they had
eaten probably salsa or something that had tomatoes and chili
peppers in it; correct?
Mr. Stenzel. Yes, ma'am.
Ms. DeGette. And so if you were trying to do traceability
on that it would be really helpful if you could break down the
components of that and be able to trace them, whatever the
system was; is that right?
Mr. Stenzel. Certainly in any processed food or a mixture
of different ingredients it gets much more complex, but you
would want to be able to trace the individual ingredients.
Ms. DeGette. And that would have helped us in this
situation if--I mean it would have helped the tomato industry
if the FDA investigators and the CDC would have said, OK, let
us trace all of the tomatoes that were involved in this salsa.
And if you had had a quick system you could have resolved the
tomato problem much more quickly than it was resolved I would
assume?
Mr. Stenzel. Well, I think our concern, Congresswoman, is
that we believe that across the board there are these systems
in place, particularly in the tomato industry and that the
trace-back actually showed that it was not the tomatoes.
Ms. DeGette. OK.
Mr. Stenzel. This was not a matter of inability to track
tomatoes and where they came from.
Ms. DeGette. Right.
Mr. Stenzel. It was the confusion with other ingredients
that perhaps were in the salsa.
Ms. DeGette. Well, let us talk about that. So let us say we
had a traceability system, a trace-back system for jalapeno
peppers and cilantro and the other ingredients, if that would
have moved faster we would have been able to resolve this
situation much more quickly to the benefit of the growers of
the vegetables that were not contaminated; right?
Mr. Stenzel. Our industry had the highest incentive to
resolve these things quickly to protect health and to prevent
damage to the industry.
Ms. DeGette. Exactly.
Mr. Stenzel. If the CDC scientists had had any concerns
about other ingredients they could have been tracked. Once the
investigators started looking----
Ms. DeGette. Do we have the same kind of system for
jalapenos that we do for tomatoes?
Mr. Stenzel. Not nearly as effective. But once they started
looking for jalapenos they have tracked them extremely
effectively.
Ms. DeGette. Right. But if we----
Mr. Stenzel. The fact that the individual farm in Mexico
today with today's traceability with one of the most
complicated small items that does not have these elaborate
systems.
Ms. DeGette. Right. But if we had a national system, not
maybe one type of traceability but if everybody had to do it
and it was interoperable we could have done this much more
quickly; would that not be fair to say?
Mr. Stenzel. I am not convinced that the traceability
investigation of FDA was the lagging factor in this case.
Ms. DeGette. OK.
Mr. Stenzel. We definitely need----
Ms. DeGette. You think it was the identification.
Mr. Stenzel. We need to improve our traceability. And that
is something the industry is taking very, very seriously.
Ms. DeGette. OK.
Mr. Stenzel. And a national program in the tomato industry
I should also say is important.
Ms. DeGette. OK.
Mr. Stenzel. One key----
Ms. DeGette. Excuse me, I am sorry, I do not have much time
and I have one more topic I want to talk about with Mr.
Hubbard.
And welcome back.
Mr. Hubbard. Thank you.
Ms. DeGette. I was just telling staff I feel like we should
just put you on the roster every time we have an FDA hearing.
I want to talk to you about the 2002 Bioterrorism Act
because some people have said that provides us with the federal
tools we need to do traceability. And I know you do not
entirely agree with that and I wanted to explore that with you.
In your testimony you provide a side-by-side analysis, in you
written testimony, of the key weak points introduced into the
original legislation and regulation as it was reviewed and
considered by administration reviewers. So I want to go through
those because I think that kind of gives us some sense why
maybe that act is not helping us trace as much as we want.
What you say is what FDA wanted or needed in the final
rule, that FDA wanted records by all sources and recipients,
but farms and restaurants were excluded; correct?
Mr. Hubbard. That's correct.
Ms. DeGette. And FDA wanted foreign firms as well as U.S.
but the foreign firms were excluded from the final
recommendation?
Mr. Hubbard. In the rulemaking process, yes.
Ms. DeGette. They wanted a complete record of the food's
movement but what ended up, and I think this is maybe the
biggest flaw, is only one step up and one step back; correct?
Mr. Hubbard. That is correct.
Ms. DeGette. They wanted lot numbers for each shipment and
that was denied in the rulemaking; correct, Mr. Hubbard?
Mr. Hubbard. Absolutely. I mean the consumer groups pushed
very hard for that but the industry view was that lot numbers
would be too expensive to maintain.
Ms. DeGette. And the FDA also wanted electronic records for
speed, and that was denied; correct?
Mr. Hubbard. Obviously, yes. If you can just go on the
computer and punch it up you can do it a lot faster than going
through thousands of pieces of paper.
Ms. DeGette. They wanted records access within four hours
and that was extended to 24 hours; is that correct?
Mr. Hubbard. Right. Four hours during normal business
hours, 8 hours if they asked in the middle of the night, but it
got extended to 24.
Ms. DeGette. They wanted a consistent record format, and
that was denied; correct?
Mr. Hubbard. Yes. I mean FDA inspectors----
Ms. DeGette. Now why is that important?
Mr. Hubbard. Well, FDA inspectors are now finding they will
go into a firm and some of them will have great records and
others will have just bills of lading. And I have had anecdotal
examples given to me of people have records on a plain paper
bag or other, you know, all kinds of different formats where
you have got to really search through for the various
information you need instead of it all being there rapidly
accessible.
Ms. DeGette. And that was part of the problem with this
recent Salmonella outbreak is the records problem?
Mr. Hubbard. Absolutely. I mean one anecdote was a Florida
tomato packer I am told literally ran out of supply and could
not get anymore Florida tomatoes so he bought some Mexican
tomatoes. Imagine how that could complicate a trace-back by FDA
to have this foreign product enter into the Florida main, into
the Florida stream when, you know, that could just be a
tremendous fly in the ointment as they say.
Ms. DeGette. Furthermore, the FDA wanted authority to
verify the keeping of records, and that was also denied; right?
Mr. Hubbard. I am sorry, I----
Ms. DeGette. The FDA wanted the authority to verify keeping
of records?
Mr. Hubbard. Yes, the problem here is the way the rule was
set up if an inspector goes in to do a routine food inspection
they say, well, let me see your records in case there is ever
an outbreak, the firm can say, no, you can only see the records
if there is an outbreak. So the inspectors are not able to
confirm that the industry is doing what they need to do to
prepare for when there is an outbreak. And that is kind of nuts
if you ask me but that is the way the rule came out.
Ms. DeGette. Now let me ask you this, when you say the FDA
wanted or needed, that sounds like a pretty good description of
a national traceability system as these gentleman have been
describing today, does it not?
Mr. Hubbard. Oh, absolutely.
Ms. DeGette. If we gave them these authorities, let me just
ask you in your opinion, would this investigation and further
investigations have been expedited so that we could protect
public health and also industry?
Mr. Hubbard. I think that to the extent trace-back was the
issue they could have much more rapidly identified that
tomatoes were being excluded and then the industry would have
been spared a huge expense and they could have gotten to the
peppers more quickly and a lot of people would have been saved
a lot of distress, absolutely.
Ms. DeGette. Thank you very much, Mr. Chairman.
Mr. Stupak. Thank you.
Mr. Burgess for questions, 10 minutes.
Mr. Burgess. Thanks, Mr. Chairman.
Mr. Stenzel, I apologize for being in and out but for the
other hearing going on. In response to a question by Ms.
DeGette of Colorado you said that traceability was not the
lagging factor. You started to tell us what that was, so would
you tell us what that was?
Mr. Stenzel. Yes, sir, thank you.
The initial identification of tomatoes as the sole source
of contamination really sent us down, you know, the wrong path.
As Mr. Hubbard said, it is FDA's responsibility then to
investigate precisely what CDC has already identified as the
villain or the vegetable of interest if you will. In that
process we have heard claims that there was slowness or slow in
traceability. But as you have heard from other witnesses here
on the panel, we do not understand where that slowness would
have occurred. We need to see the specific examples, not the
anecdotal stories.
It is not uncommon for growers to substitute new product
from other regions but they can keep track of that quite well
in the systems that are in place. So we do not understand where
that slowness would have occurred.
The initial time that FDA did a trace-back from someone who
was ill in Virginia and it went to a Florida farm and then they
did a trace-back of someone who was ill in Illinois and it went
to a Mexican farm, they should have known it was not a common
source. That could have happened in the first day, the very
first day we could have done trace-backs, I think we did do
trace-backs. And I would like to understand what trace-backs
were done to confirm that there was not a common source of
contamination.
Why did it then take 3 week or 4 weeks? There was a bias, I
believe, in terms of we must prove it is tomatoes because that
is what CDC has said, that was their epidemiological evidence.
Until we got off that horse and realized that there was
something else that we had not figured out early enough, by
well-meaning scientists but we had not figured it out early
enough that it was really something else causing the illnesses.
Mr. Burgess. We talk a lot up here about things like
mandatory recalls. Going down the wrong path like that, had
there been a mandatory recall it might have in fact been more
deleterious to the industry; is that correct?
Mr. Stenzel. I cannot imagine it would have been worse. We
have a mandatory ban of all tomatoes, so we pretty much
suffered.
Our industry, the produce industry, supports mandatory
recall authority for the FDA. But their press releases are
pretty darn effective too.
Mr. Burgess. OK. Let me, Mr. Hubbard, again, and thank you
for being here. Like Ms. DeGette I feel like you are part of
the committee you are here so frequently. You mentioned in your
testimony, and I was watching it on television upstairs, you
said that we are only as strong as our weakest link, and this
thing under the Bioterrorism Act, the exception for a company
that has 10 or fewer employees keeps coming up. Do you have an
opinion as to how that weak link might be tightened up so that
we do not face these problems?
Mr. Hubbard. Sure. This is an old story at the FDA that
small firms tend to drive rulemaking because even though small
firms, in this case I imagine 90 percent of the fresh produce
is managed by large firms, but there is usually a large number
of small firms and they make a powerful argument that a strict
regulation could drive them out of business or adversely affect
them.
Here I would think with the kind of technology Ms.
DeGette's talking about available I would hope there would be
ways to identify----
Mr. Shimkus. Will the gentleman yield? Off of the record
this is Diana DeGette.
Ms. DeGette. Thank you.
Mr. Hubbard. I apologize.
Mr. Shimkus. So, my colleague from Texas and Mr. Hubbard.
Now we are on the record.
Mr. Hubbard. I apologize.
Ms. DeGette. It kind of sounds more exotic though.
Mr. Burgess. It does. That is why I used it.
Mr. Hubbard. There could be off-the-shelf technology or
other inexpensive ways to give the smaller firms access to the
kind of tracing mechanisms that Ms. DeGette has mentioned as
the proper way to do it and reduce some of those costs. But
clearly the costs are going to drive decision making here
unless we can help the small manufacturers, and in this case
the small produce producers.
Mr. Burgess. Is it an issue of being able to provide them
the funding or the back-up for those systems or is it just
simply getting them into the process?
Mr. Hubbard. Well, I think it is more the latter. Imagine
you are, you know, you are the small producer and you are not
sophisticated in technology, you do not have the funding to
have an expert come in an create a system from scratch, but
someone says, look, there is established software and hardware
that you can purchase and get into the system with the big
guys, I would think that that would much, much lower the cost
for those if they had easily off-the-shelf access to the
technology.
Mr. Burgess. Let me ask another question. I mean you heard
my anxiety about the inability to actually do something
definitive on the Friday where this was all finally sorted out
that peppers are the culprit. And again on T.V. we are hearing
the FDA's recommendation is you ask where the peppers came
from. And that seemed like a fairly incomplete response to be
delivered.
Is there something better we can do when we find there is a
problem? And we talked about mandatory recalls and let us do
everything that they do. But at the same time we have to have a
way, I think, from stopping that stuff from coming in the
country. Our border has to be secure from preventing what we
have now identified as a contaminated product from entering in
the stream of commerce.
Mr. Hubbard. Well, first of all, in terms of communication
to the public, imagine CDC or FDA had said we are 90 percent
certain it is tomatoes, or 80 percent or whatever, and they did
not tell anybody because they wanted to be 100 percent, and it
turned out it was tomatoes. You know, you would be having a
different hearing but you would still be having a hearing.
Mr. Burgess. Sure.
Mr. Hubbard. And it would be really ugly.
Mr. Burgess. In fact, we had that situation with Heparin in
some respects.
Mr. Hubbard. Sure. So I think that the agencies are in a
bind and the key is for them to eliminate a given commodity
very rapidly. And that is where things like trace-back and
recordkeeping come into play so that these investigations do
not run for weeks, they run for days. And then you cut it off
and you are done and, you know, and you have solved the
problem.
Mr. Burgess. OK. That point of cutting it off, again Friday
they found the problem but there was not really the ability to
cut off that product. I mean how do we know how much product
came across the border over the weekend? How do we know that by
Monday morning we had not had more bushel baskets of
contaminated peppers entering the stream of commerce?
Mr. Hubbard. Well, as we discussed, the import problem is a
tremendously problematic one. Conditions on these Mexican farms
can be horrendous with farm animals traipsing through. And I
understand that one of these farms that is the subject here
even though they were told in advance FDA was coming when the
inspectors got there they found all kind of problems, animals
in the irrigation ditches. They only had two port-a-potties for
the entire farm, and one of those had just been stolen. So, you
know, you have got fundamental violations of preventive control
technology that I would hope we do not see in the United States
but we certainly do see in Latin America.
Mr. Burgess. But as far as securing it at the level of the
border is there a authority that the FDA could have that they
are lacking at this point?
Mr. Hubbard. Well, the only authority they have is to
examine the product as it comes across the border. And as the
committee has found, FDA does very little of that. They need
the authority to put preventive controls in place back to the
Mexican producer so that they meet the same standards U.S.
producers make.
Mr. Burgess. And I would not disagree with that except
that, as you correctly point out, time after time there are
violations and the standards do not seem to be where we would
want them. It just seems to me that we have to have a way,
there has to be a failsafe at the border when we discover we
have a problem on a Friday afternoon that we do not just let it
run then for the next couple of days until we can get someone
down there on the farms and inspect it. There has to be, I
think, and I think the American people want us to have the way
to stop that from entering the stream of commerce the minute we
detect that there is a problem. It may only be temporary. We
may have to within a certain time period come back and address
that. But we have to have the ability to stop that when we
discover there is a problem.
And, Mr. Chairman, in the interest of time I am going to
yield back.
Mr. Stupak. We are shocked but great.
Ms. Schakowsky for questions please.
Ms. Schakowsky. Thank you. I apologize very much for not
being here for your testimony. There are a lot of hearings
going on. But through the magic of my assistance from staff I
find myself able to ask questions nonetheless.
So let me start with some questions for you, Mr. Stenzel.
Let me walk you through a key points of your testimony. Is it
true that throughout the outbreak investigation you and your
members really could not determine who was in charge of the
investigation and this left local, State, federal officials
vying for leadership?
Mr. Stenzel. Yes, Congresswoman, in many of our
conversations with officials from both CDC and FDA it was
unclear who was making the decisions on public advisories, at
what point in time which agency had the authority to advise
consumers not to eat these tomatoes or this type of tomato. We
saw repeatedly concerns between those two agencies.
As far as the State and locals, this is probably more that
we have discerned from our members, people doing investigations
in the field who said that sometimes they heard from their
State health departments a disagreement with the federals in
terms of, gosh, we do not think it is tomatoes, I do not know
why we are still chasing this.
Ms. Schakowsky. Is it not also true that as a result of
this various agencies related to this investigation, as you
say, were--well, I guess you answered that--were pursuing
different priorities which added to the confusion. So the
priorities were both instructions for consumers, the source of
the problem, those kinds of things?
Mr. Stenzel. Yes, that is correct.
Ms. Schakowsky. OK. Was not one of your chief concerns in
this outbreak that field investigators across various agencies
were not coordinated so it was difficult for your members to
understand what kind of information authorities were seeking
and what they could do to help the investigation?
Mr. Stenzel. This is another important lesson I think as we
look at trace-back as well. The field investigative staff while
doing their best were not experts in produce, certainly not
experts in produce distribution. We have anecdotal stories, as
Mr. Hubbard told, of an investigator going into a warehouse in
Philadelphia who said that they had been investigating heart
transplant and heart valves the day before and now they are
looking for tomatoes in a warehouse.
We have cases where an investigator on contract to FDA
comes in and says, give me all your records. It almost sounded
like a ``go fish'' game. No wonder we cannot trace it with that
kind of an approach. But with a very targeted, well-organized
effort.
Commissioner Bronson raised an important point I do not
want to forget, the ability to task State departments of
agriculture who are much more familiar with our systems to help
in those investigations might, you know, be a very good lesson
out of this hearing.
Ms. Schakowsky. You suggest that Congress should consider
how to put into place a command and control system with a clear
chain of command during food outbreak investigations. So you
are thinking that we ought to think more broadly and include
state agriculture departments or that we should look at that
chain of command more broadly as well as more efficiently?
Mr. Stenzel. I think realistically we are going to have to
have a collection of different agencies of local, State and
federal working together. I do not simply see, you know, a
total revolution at hand in change in our public health
structure. But there does need to be some type of command
structure I would suggest.
I use the analogy of the National Transportation and Safety
Board investigating an accident. You know that someone who
flies to the scene, that person is in charge. Everything else
flows through that investigation. There is one spokesperson to
the press. The analogy, this one seems to be going in fits and
starts in many directions. How we can pull that together in one
more cohesive fashion.
Ms. Schakowsky. Well, there is also industry expertise. And
I know another primary concern of your members was that the
government failed to use that expertise during the course of
the outbreak investigation. What role should industry experts
play?
Mr. Stenzel. We believe that there has to be a very clear
precaution taken. We do not suggest that industry run an
investigation. But there is a lot of knowledge and expertise.
You can hear it from these tomato people. There is expertise in
jalapenos out there in the industry. And to be able to bring
them in in an appropriate way for FDA and CDC to call on those
resources.
An example would be we mentioned the illnesses. There were
very few in California, there were very few in some of the
Mountain West States. We began to look at the distribution
patterns of food distributors and could start to see why and
where product may have been coming from. The jalapenos we
discerned were probably coming on the east side of Texas, not
the west side of Texas just because of the distribution
patterns coming up through the Mississippi to Illinois. So that
type of expertise.
Ms. Schakowsky. Are there some legal constraints that
regulatory agencies may have in sharing data or that you may
have in sharing data?
Mr. Stenzel. There may be. We are not familiar with what
those are.
Ms. Schakowsky. OK.
Mr. Stenzel. But I think it is something the agencies ought
to look at. And if there are impediments, is there a way that
Congress could help them have a legal means to get that
expertise.
Ms. Schakowsky. I have a few more minutes so let me ask,
Mr. Beckman, you communicated to committee staff that you
believe in the future the FDA should attempt to use industry to
assist in an outbreak investigation because they understand
with regard to players and the complex distribution chain, as
Mr. Stenzel just said. Let me ask your opinion on how you think
industry could help the FDA?
Mr. Beckman. Well, to give you an example, within the first
24 hours of our being informed of this outbreak it was brought
to our attention by FDA that they were interested in
ingredients that went into the production of salsa. There were
follow-up discussions that continued.
We did not fully understand though where this investigation
was going and what information we provided if it would be acted
upon. Really it seemed like there was a greater level of
outreach by FDA but we were not able to ask the important
questions to help connect the dots. There were some but we
tried to shoot blindly----
Ms. Schakowsky. You were not asked?
Mr. Beckman [continuing]. Trying to understand where FDA
was going with this investigation. That was part of the
problem. And it is my understanding that there are
confidentiality issues that prevent them from disclosing
specific points of the trace-back during the investigation.
Ms. Schakowsky. Well, that is what I am wondering in the
recommendations, perhaps both of you, because there are
statutes, including the Trade Secrets Act, portions of the
Federal Food, Drug and Cosmetic Act, even the Freedom of
Information Act that makes it difficult to share information
with industry. So in the face of those information-sharing
limitations that govern the FDA do various associations
represented here in conjunction with other produce industries
plan to consider ways that would allow more industry assistance
during outbreak investigations?
Mr. Beckman. We would welcome any form of involvement that
would include the restriction of the release of any
confidential data. Any involvement that we can possibly have to
help move FDA forward on a trace-back investigation. And we
would welcome being held to any form of confidentiality law
regarding our involvement.
Ms. Schakowsky. OK. Mr. Stenzel?
Mr. Stenzel. If I may, I suggested the possibility of a
security clearance or some type of pre-vetting of industry
experts that could be officially authorized and stand at the
ready that FDA could call. They have already been preapproved
and they would come 24/7 to help in an investigation like this.
Ms. Schakowsky. Mr. Kawamura, did you want to respond as
well?
Mr. Kawamura. I would like to add that in my testimony you
will note in the written testimony that we mentioned the leafy
green marketing agreement which took place in California and
now Arizona as well as a nice template for industry working
collaboratively with governments both at the State level, as
was mentioned earlier, and the federal level, both at USDA and
also with FDA as a partnership to look at how we can bring
those resources together, create standards and practices that
allow for documentation for traceability. And I think that kind
of effort shows that I think all parties want to move forward.
Our discussion today continues to be on what happened in
the past, but in moving forward on what can happen in the
future the diagnostics that we are working with are incredible.
To be able to trace genetically these different strains to a
source back at a watering hole or in the field, these are the
kinds of things that we should really be celebrating in our
system. It is not to say that the system is not perfect, but I
will continue to submit that this system is getting better
because none of the groups that are represented here can
sustain these kind of outbreaks and this kind of damage to the
growers.
I know we have not talked about compensation today for
those growers. When you are unfairly pointed, unfairly
implicated or incorrectly implicated in an outbreak I hope that
becomes part of the testimony today as well. But I think what
we want to do is how do we move forward hand in hand.
I continue to say that for the amazing job that is done
domestically in our country, the misunderstanding still comes
with the lack of confidence or the collapse of confidence. How
do we rebuild confidence with the American public that consumes
ever day a billion meals a day, if you will, how do we
recapture that confidence and show that the system is moving
forward?
Ms. Schakowsky. And you are suggesting that California may
provide some model and some suggestions for us at the federal
level?
Mr. Kawamura. I believe both California and Florida have
some models that can easily be used and put into place.
Ms. Schakowsky. Thank you so much. I yield back.
Mr. Stupak. Thank you.
I have called on the FDA to do a post-mortem here on what
went right and what went wrong with this investigation. Would
you all be willing to serve on that panel if asked?
Mr. Brown. We would love that opportunity.
Mr. Beckman. Absolutely. We are ready to go.
Mr. Stupak. Let me ask this. It came up and I am still a
little confused. Tomatoes is the only one that really has this
traceability that we have? Does jalapenos have them? Does
spinach have it? Some are shaking heads yes, some are shaking
heads no.
Mr. Kawamura. In California the leafy green marketing
agreement takes all those leafy vegetables and they do have a
very comprehensive traceability and identification package.
Mr. Stupak. OK. So the leafy greens, that would be the
spinach that we have had problems with in the past.
Mr. Kawamura. And many other, and many other of our
products as well from California.
Mr. Stupak. OK. Florida?
Mr. Bronson. We do not have a full set yet but we are
working on all the leafy greens to match what we are doing in
tomatoes.
But let me, Mr. Chairman, if I might let me say to you that
even with the new law that has passed on country of origin,
where these groups were found and the reason why we began to
see that Florida was not a part of this was around a restaurant
situation.
Mr. Stupak. Right.
Mr. Bronson. You understand that even with the new country
of origin labelling it does not have to follow to the
restaurant.
Mr. Stupak. Correct.
Mr. Bronson. And that is where one of the problems was in
this outbreak.
Mr. Stupak. Country of origin label is really an old law.
We are just waiting for it to be implemented by the
Administration.
Mr. Bronson. Florida has had it for 20 years.
Mr. Stupak. I know. I know.
Mr. Bronson. That has worked for us.
Mr. Stupak. I know.
Mr. Bronson. I am glad it is coming into place.
Mr. Stupak. I do not know why we cannot get it done up
here.
Let me ask this question. Let me ask this question. Because
I want to go back to what I said earlier about those three
press releases the last 12 hours sort of epitomize this
investigation because we still have so many questions. If I am
growing a tomato--and I am not a farmer, so bear with me--if I
am growing tomatoes to I rotate my crop every other year and
put a different crop in there to keep the ground good? I do
that. What would be the other crop?
Mr. Booth. Absolutely. For tomatoes you will rotate that
every two or three years.
Mr. Stupak. OK. What would I substitute then when I am not
growing tomatoes in that field?
Mr. Booth. It could be wheat. Wheat is a very good, a very
common crop to.
Mr. Stupak. OK.
Mr. Brown. In contrasting it, Congressman, in Florida we
basically grow tomatoes on the same piece of land year after
year after year with the technology we have in place.
Mr. Stupak. OK. Because going back to these press releases
that I mentioned it says, you know, ``previously FDA inspectors
collected a positive sample of jalapeno pepper from a produce
distribution center owned in McAllen, Texas. The FDA continues
to work on pinpointing where and how in the supply chain this
first positive jalapeno pepper sample became contaminated. It
originated from a different farm in Mexico than the positive
samples of serrano pepper and irrigation water.''
So this tells me, OK, we still have not cleared off
tomatoes yet, as we talked about earlier. And the pepper we had
one farm, now we have another farm and it could be the
irrigation. So it could be all the farms that use that
irrigation source or water source; correct?
Mr. Stenzel. That is what it sounds like to us. I think the
FDA panel will obviously be able to answer those questions
better than us.
Mr. Stupak. OK. Because it is a different farm in Mexico
than what the original positive samples back on, what did we
say, July 21. And so, OK.
Mr. Hubbard, you said you had some, what your understanding
is this farm that they had had deplorable conditions, sanitary
conditions?
Mr. Hubbard. Yes, but again I think conditions in Latin
America in produce operations tend to be fairly consistently
substandard. And again, the farm knew they were coming and
still there were substandard conditions. So one would suspect
that perhaps they were even worse earlier.
Mr. Stupak. We have inspectors, FDA inspectors in Mexico,
do we not, doing produce, looking at the farms?
Mr. Hubbard. Usually only for cause. There is not, there is
not normally a routine.
Mr. Stupak. Not a normal routine inspection going on?
Mr. Hubbard. There are lots of attempts to educate though,
good agricultural practices, that sort of thing.
Mr. Stupak. Mr. Booth, you wanted to say something there?
Mr. Booth. Thank you. I just want to make sure that we are
not painting a broad brush with Mexico and other Latin American
countries that they are substandard. There are many, many
exceptional growers in Mexico. We deal with those directly.
Mr. Stupak. Right, and I think some testimony was they have
a trace-back system----
Mr. Booth. Absolutely.
Mr. Stupak [continuing]. In some parts of Mexico.
Mr. Booth. Absolutely.
Mr. Stupak. Depending on the grower and who they are
working with in the United States?
Mr. Booth. Yes, sir, that is right.
Mr. Stupak. OK. Someone said earlier that a major consumer,
let us say like if--who is a major? Jack In The Box, OK, they
would have certain requirements for tomatoes which are more
towards how they are handled, shipped, grown. Are they
different than what you are doing in Florida and California? I
mean are you having trouble with corporations saying, do this?
You say, well, this is not part of our system. Is that a
concern?
Mr. Bronson. Mr. Chairman, we are not having a problem
because we have one of the highest standards, probably the
highest standard in America. So we are not having problem with
any of our people who are buying, major corporations that are
buying our tomatoes.
Mr. Stupak. Well, some of the farmers are telling us that
some of the concerns that some of these corporations are
putting on them in order to buy their tomato or jalapeno or
whatever it is, are things like benzene and things like that
that really has nothing to do with the growing of this tomato.
And so I just want to see if you get push-back from
corporations who are more geared towards risk assessment from
an insurance financial point of view as to risk assessment from
a food safety point of view?
Mr. Bronson. Well, I agree now, now that you have expounded
on that, there are certain companies that will say we do not
want tomatoes that have a certain product or whatever put on
them. And there is usually a third party evaluation of that
tomato before that company will buy that particular tomato.
Mr. Stupak. Sure.
Mr. Bronson. But we have not had problems in Florida.
Whatever the standard is we usually can meet it.
Mr. Stupak. You think no problem in California like that,
Mr. Kawamura?
Mr. Kawamura. That is the same. You may know that
California provides 50 percent of the fruits, vegetables and
nuts that are domestically produced in the United States for
the rest of the country.
Mr. Stupak. Let me ask this question, if you know. I
understand that this type of Salmonella Saintpaul is usually
associated with poultry; is that right?
Mr. Kawamura. Not necessarily.
Mr. Stupak. Not necessarily, OK.
OK, Mr. Stenzel, you mentioned something about who was in
charge, command center. Can you expound a little bit on that?
Should we have, like if you have a natural disaster you have a
command center, someone comes in, boom, you know who is in
charge, very rigid?
Mr. Stenzel. That is precisely the example, Mr. Chairman,
that between CDC and FDA in particular throughout this
investigation we have noted tension, rivalries, defensiveness
between the two positions of individuals within the agencies.
We feel that that is an important thing to look at of putting
someone clearly in charge.
Mr. Stupak. Some kind of an incident command center.
Mr. Stenzel. Where CDC fingers the culprit but then FDA is
left to investigate it whether they agree with it or not, it is
kind of strange.
Mr. Stupak. OK. Thank you.
Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. I am going to be
brief. As I received the testimony I just want to reiterate we
are still looking for this Salmonella-tainted tomato. And once
we focused on peppers 18 days to identify the pepper, four days
to find the location. And had we identified the right vegetable
at the beginning, the losses would have been limited. You still
would have had losses.
Go ahead, Mr. Bronson.
Mr. Bronson. Yes, Congressman, let me say that if we had
been given in Florida, and I am sure all the States involved,
California including, if we had been given the right
information and not withheld information from us we could have
gotten to the point very quickly on how to help them in
Florida. Every State may be a little different but in Florida
if they would have told us what they were looking for, exactly
what their suspicions were we could have gone and verified that
or denied that we had the problem in Florida which would have
cleared it.
Now, I hold a commission with FDA, so does Dr. Brown, so
does Dr. Aller in our laboratory. But I am not sure what that
commission means because I can hear on national news more than
what I was being, we were being told at the state level in
these conferences. So we cannot help if we do not know what we
are supposed to be looking for.
Mr. Shimkus. Mr. Brown, you want to answer in response?
Mr. Brown. Trace-back works wonderfully and that is an
excellent example in the case of the jalapeno. But when you
identify the wrong culprit you cannot ever find the trace-back.
Mr. Shimkus. Right. And I want to follow-up on this.
Because we are going to have a debate about giving the FDA
mandatory recall authority. And when this is touched on and
also recovery of damages, I am not a lawyer. We have some on
the panel. Are any of you all lawyers? What makes a more
convincing case, to get cost recovery from a warning or get
cost recovery because the government did a mandatory recall
that was in error?
I have got to believe that we will be on the hook on a
mandatory recall, especially when it was in error. And I think
that is one of the problems that we might have in this debate
as we move forward.
I think we all are in agreement, transparency,
communication, someone responsible and hold them accountable. I
mean I am a military guy, that is kind of the way it works. You
have to have a chain of command. And this fusion center we call
it in terrorism and connecting the dots, we have heard that
numerous times since September 11. We did not do well. The
State agencies are getting together where you have people in
the same room. That is probably something, Mr. Chairman, we
also ought to consider is making sure that we empower everybody
to help us solve the case sooner rather than later. And I think
we are going to get that in other panels.
So with that I really appreciate it, it is a great panel.
We have more to come. And I yield back my time.
Mr. Stupak. Thank you.
Ms. DeGette, have you got some questions?
Ms. DeGette. I just have a couple quick questions, Mr.
Chairman, thank you.
Mr. Stenzel, your industry has endorsed mandatory recall;
correct?
Mr. Stenzel. Yes, we have.
Ms. DeGette. Mr. Beckman, I think your industry has too;
correct?
Mr. Beckman. Correct.
Ms. DeGette. And just so you know, I think most of the
industries have endorsed mandatory recall. Most consumers think
that we have it now because they read the recall notices and
they think they are mandatory.
Mr. Beckman, I just wanted to ask you quickly about your
document that you flourished during your testimony which is
Exhibit 11 in the notebook. That is someone that your
organization helped create called Commodity Specific Food
Safety Guidelines for the Fresh Tomato Supply Chain. It is my
understanding that this document lays out a number of best
practices to be used throughout all the levels of the tomato
distribution chain, including traceability requirements. Is
that correct?
Mr. Beckman. That is correct.
Ms. DeGette. And it is also my understanding that you
believe that national regulations governing the tomato industry
should be enacted. Is that correct?
Mr. Beckman. That is correct.
Ms. DeGette. And if your document Exhibit 11 were used,
then the whole tomato industry, not just bits and pieces, would
be required to implement comprehensive systems for tracing
their products through the supply chain. Is that correct?
Mr. Beckman. That is correct.
Ms. DeGette. And I also know that the FDA has seen this
document. And you would be in favor of the FDA modeling a
national regulation based on the contents; is that correct?
Mr. Beckman. That is correct.
Ms. DeGette. And, Mr. Stenzel, just to clarify with you, I
think a lot of what you said is really important and has some
nuance that this committee needs to understand. I just want to
clarify one thing. Is it the position of your organization that
more stringent traceability requirements should be enacted
beyond what is currently required in the Bioterrorism Act of
2002?
Mr. Stenzel. We believe that with traceability as well as
preventive food safety controls they need to be commodity-
specific and based on risk. So for the tomato industry we are
the co-author of these----
Ms. DeGette. Right.
Mr. Stenzel [continuing]. Guidelines and certainly support
that in the tomato industry or other products or commodities
that FDA would determine to be at higher risk.
Ms. DeGette. OK. And you think that those requirements
should be more stringent than the Bioterrorism Act of 2002?
Mr. Stenzel. We believe that these requirements in the
tomato guidelines would be more stringent.
Ms. DeGette. And you would support that?
Mr. Stenzel. Yes, ma'am.
Ms. DeGette. Thank you very much, Mr. Chairman.
Mr. Stupak. Thank you.
Ms. Schakowsky, any questions?
Ms. Schakowsky. No further questions.
Mr. Stupak. Well let me thank this panel. It has been most
interesting. You have been most helpful. And appreciate your
time and your attention to this. And as I said earlier, Mr.
Dingell has a bill, most of us are on it, and negotiations are
going on between both sides and industry, and hopefully some of
the suggestions you made can be part of that.
Mr. Shimkus. If the Chairman will yield.
Mr. Stupak. Sure.
Mr. Shimkus. I will now say that we are also in the room
and----
Mr. Stupak. Right.
Mr. Shimkus [continuing]. There are negotiations in good
faith going on on a bipartisan basis.
Mr. Stupak. So hopefully we can get something done here yet
this Congress. So thank you very much. We will dismiss the
panel. Thank you.
[Witnesses excused.]
Mr. Stupak. Our second panel of witnesses come forward. One
our second panel we have Dr. David Acheson, who is Assistant
Commissioner for Food Protection in Food and Drug
Administration, also known as the Food Czar; Dr. Lonnie King,
who is Director of the National Center for Zoonotic and Vector-
Borne, and Enteric Diseases at the Centers for Disease Control
and Prevention; Dr. Kirk Smith, who is the Supervisor of
Foodborne, Vectorborne, and Zoonotic Disease Unit, Acute
Disease Investigation and Control Section at the Minnesota
Department of Health; and Dr. Timothy Jones, who is a State
Epidemiologist for Communicable and Environmental Disease
Services at Tennessee's Department of Health.
Welcome, gentlemen. 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 your testimony.
Do any of you wish to be represented by counsel during your
testimony?
[No response.]
Mr. Stupak. Everyone is shaking their head no, so I will
take that as a no.
So therefore I am going to ask you to please rise and raise
your right hand to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect each witness answered in
the affirmative. They are now under oath.
And we will start with opening statements. If you would
like to submit a longer statement for the record we will
include it in the hearing record but we try to hold it to 5
minutes.
Dr. Acheson, do you want to start, please?
STATEMENT OF DAVID W.K. ACHESON, M.D., ASSISTANT COMMISSIONER
FOR FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Acheson. My pleasure.
Good afternoon, Chairman Stupak and members of the
subcommittee. I am Dr. David Acheson, Associate Commissioner
for Foods at the FDA, which is part of the Department of Health
and Human Services. Thank you for the opportunity to discuss
the recent food-borne illness outbreak associated with fresh
produce contaminated with Salmonella Saintpaul and the measures
FDA is taking to enhance the safety of fresh produce and to
enhance traceability.
There is no question that the Salmonella Saintpaul outbreak
investigation has been one of the most complex in recent
memory. I assure you that FDA is committed to working with all
our food safety partners to expedite trace-backs and to ensure
that America's food supply continues to be amongst the safest
in the world.
For this outbreak alone we are FDA have conducted nearly
450 inspections or investigations together with our State
partners. FDA labs have analyzed nearly 450 samples, including
samples of produce as well as environmental samples. To support
coordination we have hosted or participated in 40
teleconferences with the States as well as CDC.
The number of illnesses associated with fresh produce is a
continuing concern for FDA and we have worked on a number of
initiatives to reduce the presence of pathogens in foods. Some
of these activities include working with industry to develop
guidance on ways to prevent or minimize potential
contamination, conducting educational outreach to consumers on
safe food handling practices, sampling and analyzing both
domestic and imported produce for pathogens, and working with
industry in foreign countries to promote the use of good
growing, harvesting, packing, transporting and processing
practices. We are also conducting research to improve the
identification and detection of disease-causing agents in a
variety of foods.
I would now like to provide a brief description of a
typical trace-back process. CDC along with State and local
officials will through its epidemiological investigations
identify possible food or foods associated with an outbreak.
And at that point CDC notifies FDA.
From that point FDA begins our trace-back investigation to
identify the source of the contamination. We work with industry
and with local, State and Federal officials and, when needed,
foreign governments to identify the source of the
contaminations. We do this by tracing the food suspected of
being the vehicle for transmitting the pathogen back through
the supply chain from the retailer or restaurant and inspecting
or investigating points throughout that supply chain to
determine where the contamination most likely occurred.
Tracing food requires us to find and examine documentation
such as bills of lading and invoices for the product right
throughout the supply chain. We also obtain information on the
practices and conditions under which the product was stored and
handled at each point.
The current outbreak investigation which initially focused
on certain types of raw tomatoes provides an example of one of
the most difficult kinds of trace-back investigations. It was
on May 31 that the CDC advised FDA of the significant
statistical association between the consumption of certain
types of tomatoes and a multi-state outbreak of Salmonella
Saintpaul infections. Raw tomatoes are a perishable commodity
and thus are unlikely to be in a consumer's home after a
consumer becomes ill, obtains a diagnosis, and the outbreak is
identified.
Further, raw tomatoes are often sold loose without any form
of packaging. In the current investigation we learned that many
tomatoes had been shipped to washing, packing and repacking
facilities where they were or might have been commingled with
other tomatoes from different sources.
A further complicating factor was caused by entities in the
supply chain using different terminology to describe the
tomatoes.
Since May 31 many FDA employees in the field and
headquarters have been working on the outbreak investigation to
identify the source. To help the public distinguish tomatoes
not associated with the outbreak, FDA adopted the policy of
specifically designating the types of tomatoes implicated in
the outbreak as well as listing growing areas that were not
part of the outbreak. On July 17 FDA updated its consumer
advice, announced that tomatoes currently on the market are not
considered to be a possible source of illness.
On July 21 FDA announced it had found a genetic match with
an outbreak serotype Salmonella Saintpaul in jalapeno peppers
we tested from a distribution center in Texas. This finding of
a genetic match was an important break in the investigation.
Upon further investigation we determined that the contamination
of the pepper occurred in Mexico, not at the plant in Texas
and, accordingly, on July 25, updated our advisory, announced
that there was no indication that domestically grown jalapeno
or serrano peppers were implicated in the outbreak.
Yesterday FDA laboratory analysis confirmed that both a
sample of serrano peppers and a sample of reservoir water used
for irrigation contained the Salmonella Saintpaul strain that
was a genetic match for the outbreak strain. These samples came
from a farm in Mexico but not the same farm that produced the
first positive jalapeno samples from the distribution center in
Texas.
Our current advice is to consumers to avoid jalapeno and
serrano peppers grown, harvested or packed in Mexico. In
addition, domestically grown raw jalapeno and serrano peppers,
canned, pickled and cooked jalapeno and serrano peppers from
any and all locations are not connected with this outbreak. We
will continue to refine our consumer message as our
investigation continues.
The current trace-back has worked but was slow, requiring
review of many paper records. While sectors of the produce
industry may keep electronic records, as we have just heard on
the previous panel, and be able to do rapid trace-backs, this
is not a uniform practice. And many of the plants FDA visited
only had paper records, bills of lading or invoices. To better
understand the universe of track and trace systems and best
industry practices for traceability FDA has reached out to a
variety of external entities. We plan to hold a public meeting
in the fall to further exchange of information on available
technology and best practices for enhanced traceability.
To enhance safety across a range of imported consumer
products, last November Secretary Leavitt presented to the
President the Action Plan for Import Safety. In conjunction
with the Action Plan, FDA released the Food Protection Plan,
which provides a framework to identify and counter potential
hazards with respect to both domestic and imported food. Both
plans build in safety measures across a product's life cycle,
from the time a food is produced to the time it is distributed,
and encompass the elements of prevention, intervention, and
response.
The Food Protection Plan identified ten legislative
authorities necessary for achieving full implementation. And we
appreciate the work this committee is doing to draft
legislation intended to help provide these authorities. We look
forward to continuing to work with you to develop this
important legislation.
FDA is working hard to ensure the safety of food, in
collaboration with our partners. As a result of this effective
collaboration, the American food supply continues to be amongst
the safest in the world. However, the Salmonella Saintpaul
food-borne illness underscores the challenges that we face. We
have been making progress and we are moving forward with the
implementation of the plans, but more does need to be done. To
that end, FDA is exploring used its Science Board to convene a
group of State, industry and academic and other experts to
examine lessons learned from the outbreak.
I would like to thank you for the opportunity to discuss
FDA's continuing efforts to enhance food safety and
traceability. And I am happy to answer any questions.
Thank you.
[The statement of Dr. Acheson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
Dr. King please, if you will.
STATEMENT OF LONNIE J. KING, D.V.M., DIRECTOR, NATIONAL CENTER
FOR ZOONOTIC, VECTOR-BORNE, AND ENTERIC DISEASES, CENTERS FOR
DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dr. King. Yes. Good afternoon. Chairman Stupak and members
of the committee, thank you for this invitation to address this
subcommittee today. I am Dr. Lonnie King, Director of the
National Center for Zoonotic, Vector-borne, and Enteric
Diseases at the Centers for Disease Control and Prevention.
First let me offer my sympathies to all the families who
have been adversely affected by this outbreak. Also I
understand the frustration of many in the food producing and
serving industries who work so very hard to produce safe
produce that we have heard about today. CDC leads federal
efforts to gather data and to investigate food-borne illnesses.
Much of what CDC does depends on the critical relationships
with a broad range of partners: food safety regulatory
agencies, in particular with FDA and USDA, USDA's Food Safety
and Inspection Service, and with State and local public health
departments.
Salmonella is a group of bacteria with over 2,500 subtypes
that is widespread in the intestines of birds, reptiles and
mammals. Salmonella is the second most common bacterial cause
of food-borne diseases in this country. The current outbreak is
called by Salmonella serotype Saintpaul, a relatively uncommon
serotype causing only about 1 percent of all reported
Salmonella infections each year. This outbreak is the largest
food-borne outbreak in the United States in the past decade.
This investigation ha been especially complex, difficult and
prolonged.
CDC first learned about this outbreak on May 22 in 2008
when New Mexico Department of Health reported illnesses in four
persons confirmed with Salmonella Saintpaul. New Mexico posted
the information about the unusual number of Salmonella
Saintpaul cases through PulseNet, a national network of public
health and regulatory agency laboratories used to detect food-
borne disease outbreaks. This information allowed State
laboratories to compare specific DNA fingerprints found in New
Mexico to their own cases of Salmonella that had been reported
with matching fingerprints.
The next day Texas and Colorado reported cases of matching
fingerprints. Investigators in New Mexico, Texas and CDC began
a multi-state investigation. Epidemiologists conducted in-depth
interviews with ill persons to collect information about what
might be a possible source of infection. Results of this first
series of interviews indicated raw tomatoes were the most
commonly consumed food, leading to the hypothesis that they
were a possible source of this illness.
Following these initial interviews, case control studies
comparing what ill and health persons reported eating were then
conducted. By May 31 preliminary results of the first case
control study showed that the illness was significantly
associated with the consumption of raw tomatoes.
On June 4 CDC received the first report of a possible
cluster or any restaurant cluster and subsequently learned of
additional clusters after that. Between June 18 and June 20
there was a large surge in reported cases in Texas. The
geographic concentration of illness in the Southwest and in
Native American and Hispanic persons, along with a strong
association with the consumption of Mexican-style foods in
restaurants and the apparent continuation of this outbreak
after the alert regarding the tomatoes led to the hypothesis
that a food item commonly consumed with tomatoes could also be
causing this illness.
Investigations then focused on the recently identified
clusters and a second multi-state case control study of persons
who became ill after June 1 was initiated. The results of the
case control study indicated a strong link to fresh produce
items used in Mexican cuisine but did not point clearly to one
specific item. After additional epidemiologic investigations of
a cluster of illness in Texas, the FDA began their trace-backs
on peppers on July 21 and the FDA announced that they had
isolated the outbreak strain of Salmonella Saintpaul from
serrano peppers and water irrigation samples from a farm in
Mexico.
The outbreak investigation unfortunately continues. The
active field investigations by CDC, State and local health
departments, focusing on identifying clusters of cases and the
FDA trace-backs now on jalapenos, serranos, tomatoes and other
possible sources are providing new information daily. This
outbreak has been particularly challenging. First, there is
inherent delay between when persons become ill with Salmonella
infection and when results of the testing are reported to
PulseNet. For half the cases in this outbreak it took more than
16 days from illness onset to posting the test results on
PulseNet.
Second, people have difficulty remembering exactly what
foods they ate. And remembering specific ingredients in those
foods is even more difficult, especially if the dish was
prepared by someone else.
Third, the foods in question are often eaten together so
exposure to one item often means exposure to all the items.
And, finally, perishable foods consumed by ill persons were
often not available for testing.
As of June 29 at 9:00 p.m., 1,319 cases where Salmonella
Saintpaul have been identified in 43 States, the District of
Columbia, 255 persons have been hospitalized, and two deaths
were possibly linked to this outbreak. At present we believe
that jalapeno peppers and serrano peppers are linked to some of
these clusters and could be two of several food vehicles,
including tomatoes and other possible vehicles, as we continue
to explore and investigate. The outbreak is ongoing but there
are fortunately fewer illnesses being reported.
In conclusion, this outbreak illustrates the importance of
existing public health networks: the laboratories performing
PulseNet, fingerprinting, epidemiologists who conduct the
investigations, the multi-disciplinary approach to these
investigations and the close communication and collaboration
among State, local and federal officials. We balance the rapid
release of information on sources of illness against the
potential negative consequences to consumers, food growers,
producers and industry. CDC is prepared to continue to work
with regulatory agencies, State and local partners, food and
environmental microbiologists, and certainly the food industry
to find long-term solutions to this challenging problem.
I thank you for the invitation to testify and will be happy
to answer questions that you may have.
[The statement of Dr. King follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
Dr. Smith please.
STATEMENT OF KIRK SMITH, D.V.M., PH.D., SUPERVISOR, FOODBORNE,
VECTORBORNE, AND ZOONOTIC DISEASE UNIT, ACUTE DISEASE
INVESTIGATION AND CONTROL SECTION, DEPARTMENT OF HEALTH, STATE
OF MINNESOTA
Dr. Smith. Good afternoon. Chairman Stupak and members of
the subcommittee, my name is Kirk Smith, and I am Supervisor of
the Foodborne Diseases Unit at the Minnesota Department of
Health. Thank you for inviting me to speak on our role in the
Salmonella Saintpaul investigation. We were not highly involved
in the national investigation early on. Then, from June 23
through June 27 our State Public Health Laboratory received 10
Salmonella Saintpaul isolates from ill Minnesota residents who
had gone to the doctor and been tested for Salmonella at a
clinical laboratory. Our foodborne disease epidemiology staff
immediately began the process of interviewing these patients.
By June 30, several patients had reported eating at the same
restaurant. That same day, we visited the restaurant to assess
illness in foodworkers, determine the exact ingredients in
various menu items, and request credit card receipts to
identify other potentially exposed individuals to interview.
Ill and non-ill patrons were interviewed in detail about
the menu items and ingredients they had consumed. By
identifying what ingredients were in each menu item we knew if
an individual ate fresh tomatoes, jalapenos, or cilantro, etc.,
even if they could not discern or recall all of the specific
ingredients in a menu item. Then we statistically compared
foods eaten by ill people to those eaten by non-ill people.
The ingredient-specific analysis indicated that diced
jalapenos were the cause of our restaurant outbreak. We sent
our preliminary statistics to CDC on July 3, 3 days after we
identified the restaurant as the source through patient
interviews. Statistics were updated and provided to CDC daily
as the scope of our investigation grew. By July 8, 5 days
later, we had interviewed 19 restaurant-associated cases and 52
non-ill controls, and unequivocally implicated jalapenos.
On our first visit to the restaurant on Jun 30, we also
requested vendor invoices for produce items served on the
implicated meal dates. Those invoices were given to the
Minnesota Department of Agriculture, which conducted trace-
backs. On July 3, we provided CDC and FDA with information on
the possible sources of the jalapenos, all the way back to
farms or distributors in Mexico. This part of the trace-back
took 3 days.
So why were we able to solve our outbreak so quickly in
Minnesota? In short, we have an efficient, rapid, and thorough
system. By law, when a clinical laboratory isolates Salmonella
or another reportable food-borne bacteria from a patient, the
lab is required to submit the isolate to our State Public
Health Laboratory. Our lab confirms, serotypes, and DNA
fingerprints all Salmonella isolated in real time; and this is
not done in many other public health laboratories. There is
excellent communication between our lab and epidemiology staff;
every day the lab provides us with a report of every isolate
they have worked on.
Another reason for our success is that food-borne disease
investigations in Minnesota are centralized at the State level.
We routinely interview all reported Salmonella cases with a
detailed questionnaire, and are able to re-interview patients
with specific questions quickly as needed. In many other
States, Salmonella cases are not routinely interviewed in a
timely manner, and if they are, initial interviews are often
done at the county level and may not contain sufficient detail.
Centralized surveillance and investigations, coordinated at the
level of State or large city health departments, are especially
critical during multi-state outbreaks due to commercially
distributed food items.
Food-borne disease surveillance and investigation in the
U.S. need to be improved. State and federal funding for these
activities in public health departments has decreased
throughout this decade, and I believe that this affected the
national investigation.
State and local health departments need to be able to
rapidly confirm and type every Salmonella and E. coli 0157
isolate that is submitted. This is how we can learn that an
outbreak is happening as early as possible. But many State
public health laboratories cannot currently do this.
Secondly, State and local health departments need to be
able to rapidly interview every patient with Salmonella and E.
coli 0157 with a detailed questionnaire, and to conduct cluster
investigations rapidly. Again, this currently is not being done
in most localities.
As we have heard, the trace-back efforts of federal
agencies can only be as good as the quality and timeliness of
epidemiologic information coming from State and local health
departments.
The investment in food-borne disease surveillance will not
prevent food contamination from happening, but it will enable
outbreaks to be detected and the source identified much
earlier. This will help limit the size of outbreaks, minimize
the impact on the involved food industry, and identify the
types of food products on which to focus our prevention
measures.
Thank you.
[The statement of Dr. Smith follows:]
Statement of Kirk Smith
Chairman Stupak and Members of the Subcommittee,
My name is Kirk Smith, and I am Supervisor of the Foodborne
Diseases Unit at the Minnesota Department of Health. Thank you
for inviting me to speak on our role in the Salmonella
Saintpaul investigation. We were not highly involved in the
national investigation early on. Then, from June 23rd through
June 27th, our state Public Health Laboratory received 10
Salmonella Saintpaul isolates from ill Minnesota residents who
had gone to the doctor and been tested for Salmonella at a
clinical laboratory. My foodborne disease epidemiology staff
immediately began the process of interviewing these patients.
By June 30th, several patients had reported eating at the same
restaurant. That same day, we visited the restaurant to assess
illness in foodworkers, determine the exact ingredients in
various menu items, and request credit card receipts to
identify other potentially exposed individuals to interview.
Ill and non-ill patrons were interviewed in detail about
the menu items and ingredients they had consumed. By
identifying what ingredients were in each menu item, we knew if
an individual ate fresh tomatoes, jalapenos, or cilantro, etc.,
even if they couldn't discern or recall all of the specific
ingredients in a menu item. Then we statistically compared
foods eaten by ill people to those eaten by non-ill people.
The ingredient specific analysis indicated that diced
jalapenos were the cause of our restaurant outbreak. We sent
our preliminary statistics to CDC on July 3rd, 3 days after we
identified the restaurant as the source through patient
interviews. Statistics were updated and provided to CDC daily
as the scope of our investigation grew. By July 8th, 5 days
later, we had interviewed 19 restaurant-associated cases and 52
non-ill controls, and unequivocally implicated jalapenos.
On our first visit to the restaurant on June 30th, we also
requested vendor invoices for produce items served on the
implicated meal dates. Those invoices were given to the
Minnesota Department of Agriculture, which conducted
tracebacks. On July 3rd , we provided CDC and FDA with
information on the possible sources of the jalapenos, all the
way back to farms or distributors in Mexico. This part of the
traceback took 3 days.
Why were we able to solve our outbreak so quickly in
Minnesota? In short, we have an efficient, rapid, and thorough
system. By law, when a clinical laboratory isolates Salmonella
or another reportable foodborne bacteria from a patient, the
lab is required to submit the isolate to our state Public
Health Laboratory. Our lab confirms, serotypes, and DNA
fingerprints all Salmonella isolates in real time; this is not
done in many other public health laboratories. There is
excellent communication between our lab and epidemiology staff;
every day the lab provides us with a report of every isolate
they have worked on.
Another reason for our success is that foodborne disease
investigations in Minnesota are centralized at the state level.
We routinely interview all reported Salmonella cases with a
detailed questionnaire, and are able to re-interview patients
with specific questions quickly as needed. In many other
states, Salmonella cases are not routinely interviewed in a
timely manner, and if they are, initial interviews are often
done at the county level and may not contain sufficient detail.
Centralized surveillance and investigations, coordinated at the
level of state or large city health departments, are especially
crucial during multistate outbreaks due to commercially
distributed food items.
Foodborne disease surveillance and investigation in the
U.S. need to be improved. State and federal funding for these
activities in public health departments has decreased
substantially throughout this decade, and I believe that this
affected the national investigation.
State and local health departments need to be able to
rapidly confirm and type every Salmonella or E. coli O157:H7
isolate that is submitted. This is how we can learn that an
outbreak is happening as early as possible. But many state
public health laboratories cannot currently do this. Secondly,
state and local health departments need to be able to rapidly
interview every patient with Salmonella and E. coli O157:H7
with a detailed questionnaire, and to conduct cluster
investigations rapidly. Again, this currently is not being done
in most localities. The traceback efforts of federal agencies
can only be as good as the quality and timeliness of
epidemiologic information coming from state and local health
departments.
The investment in foodborne disease surveillance will not
prevent food contamination from happening, but it will enable
outbreaks to be detected and the source identified much
earlier. This will help limit the size of outbreaks, minimize
the impact on the involved food industry, and identify the
types of food products on which to focus our prevention
measures.
Thank you.
Summary
A restaurant-associated outbreak of Salmonella Saintpaul
infections occurred in late June in Minnesota. The outbreak was
quickly identified by the Minnesota Department of Health. Diced
jalapeno peppers were implicated and traced back to multiple
possible sources in Mexico within 3 days of the identification
of the outbreak. This information was provided to the CDC and
FDA on July 3. This successful investigation was enabled by a
strong, centralized foodborne disease surveillance and
investigation system at the Minnesota Department of Health,
which collaborated closely with the Minnesota Department of
Agriculture.
The large, nationwide outbreak illustrates that foodborne
disease surveillance and investigation activities in the United
States need to be improved. Effective investigations by federal
regulators depend in large part on the timeliness and quality
of epidemiologic information provided by state and local
investigators. The Minnesota system could act as a model for
foodborne disease surveillance and investigation in the United
States. All state and local health departments should be able
to confirm, serotype (Salmonella) and DNA fingerprint all
submitted Salmonella and E. coli O157 isolates in real time,
and they should be able to interview all cases with a detailed
questionnaire in real time (this currently cannot be done in
most localities). This would help identify outbreaks much more
rapidly, which would limit the size of the outbreaks, minimize
the impact on the involved food industry, and identify the
types of food products on which to focus prevention measures.
----------
Mr. Stupak. Thank you, Dr. Smith.
Dr. Jones, your opening statement please, sir.
STATEMENT OF TIMOTHY JONES, M.D., STATE EPIDEMIOLOGIST,
COMMUNICABLE AND ENVIRONMENTAL DISEASE SERVICES, DEPARTMENT OF
HEALTH, STATE OF TENNESSEE
Dr. Jones. Mr. Chairman and members of the subcommittee,
thank you for the opportunity to be here today.
The recent nationwide outbreak of Salmonella associated
with produce demonstrates challenges and opportunities for
improvement in the nation's food safety infrastructure. A
typical American meal includes foods from six different
countries, and fresh produce travels a mean of 1,500 miles to
get to our plates. Dramatic statistics demonstrate the rapidly
changing environment in which outbreaks are occurring.
Outbreaks increasingly involve multiple States and widely-
distributed products, in part reflecting improvements in
detection and investigation. Recent remarkable successes have
led to high expectations which realistically cannot be met in
all investigations.
Epidemiologists, such as those at State and local health
departments and CDC, and regulatory agencies, must all work
together well for outbreak investigations to be effective. 50
State health departments in the U.S. work under independent
public health laws. A handful of States have successfully
investigated a disproportionately large number of multi-state
outbreaks, reflecting large discrepancies in the resources
available to them to respond. Most outbreaks are detected and
investigated entirely at the State and local levels. As in the
early stages of this Salmonella outbreak, CDC is often in the
position of reviewing and integrating results of investigations
done by State and local agencies rather than doing de novo
investigations.
State and local public health epidemiologist frequently
interact directly with the public during outbreak
investigations, rapidly assessing data to identify the cause.
They do not routinely do things like inspect facilities,
perform trace-backs, and do recalls. Federal regulatory
agencies have very different missions, legal restrictions and
relationships with industry. Investigators must constantly
balance the risk of continuing disease due to delays in action
with the risk of economic damage to the food industry that
might be mitigated by waiting for more specific data. And,
clearly, it is impossible to meet all of these expectations.
Faster product trace-backs would clearly have helped bring
this outbreak to a more satisfying conclusion. Many
epidemiologists I think view federal regulatory agencies as a
black box into which data are sent but from which results are
received frustratingly late or never. Federal regulatory
agencies often must operate under such restrictive legal
constraints that they are unable to share important data such
as trace-back information, names of facilities, and brand names
as quickly and as fully as many of us would like.
In a different outbreak recently, a regulatory agency had
information that would have allowed State public health
officials to contact consumers at risk of disease but were
prohibited from sharing it with us. It is possible for
epidemiologists to become commissioned by the FDA to be allowed
to receive confidential data, but most of my colleagues have
refused to pursue this, specifically to avoid the untenable
moral predicament of having access to data which we would then
be legally unable to act on.
To their credit, USDA and FDA have recently undertaken a
number of regulatory interventions based entirely on
epidemiologic data prior to laboratory confirmation of
pathogens in a food or production facility. And I hope that
these recent experiences will not dissuade those agencies from
acting rapidly on strong epidemiologic data in the future.
My message is not all gloom and doom. Americans today have
access to one of the safest, most diverse, and cheapest food
supplies in the history of mankind. And a variety of groups,
such as the Multi-Agency Council to Improve Foodborne Outbreak
Response, or CIFOR, are working toward the common goal of food
safety. I think there are a number of opportunities for
continued improvement of the nation's food safety
infrastructure. Solutions require addressing barriers at the
local, State and federal levels. Federal regulatory agencies
must have the authority and expectation to share actionable
information with public health partners promptly and fully to
protect the public's health, and that may require changes in
the laws governing them.
It is critical to support development of information
technology adequate to sustain food safety activities,
including improved technology for produce trace-backs, which
was available for the recent packaged spinach outbreak, for
example, but not necessary for the produce involved in this
outbreak. Opportunities for improved coordination with industry
should be explored. Industry has access to food testing data
and information contained in frequent shopper cards, for
example, that is often unavailable to investigators.
And, finally, public health agencies are pitifully under
funded. Outbreak response capacity, at least at the State
level, has been subsidized heavily by funding for successive
waves of high-profile crises from bioterrorism to West Nile
Virus, SARS and, recently, pandemic influenza. And funding for
these is dropping dramatically. Americans eat a billion meals a
day, day in and day out, and 75 million of us fall victim to
food-borne illness every year. Adequate and consistent funding
and resources must be dedicated to sustain effective public
health programs commensurate with the true risks that they
address.
Thank you.
[The statement of Dr. Jones follows:]
Statement of Timothy Jones
Mr. Chairman and Members of the Subcommittee, thank you for
the opportunity to be before you today.
The recent nationwide outbreak of Salmonella associated
with produce, which began in late April, demonstrates
challenges and opportunities for improvement in the nation's
food safety infrastructure. The global distribution, intensive
production, and rapidity of transport of our food supply are
markedly increasing the challenges faced during outbreak
investigations. A typical American meal includes foods from six
different countries, fresh produce travels a mean of 1500 miles
to get to our plates, feedlots can hold 300,000 head of cattle,
outbreaks involving several hundred victims no longer shock us.
a long list of dramatic statistics demonstrate the changing
environment in which outbreaks are occurring. Recognized
foodborne disease outbreaks increasingly involve multiple
states and widely distributed products, including several
recent examples associated with fresh produce. Much of this
change reflects improvements in the surveillance and
investigation of outbreaks, and the capacity of state and local
health departments to successfully identify contaminated foods,
prevent additional illness, and subsequently make the food
supply safer.
Such outbreaks also highlight the interdependence of
multiple agencies at all levels of government in responding to
these events. Epidemiologists (such as those at CDC and state
and local health departments), environmental health programs,
laboratories, and regulatory agencies (such as FDA, USDA and
state Departments of Agriculture) at the local, state and
federal level must all communicate well and coordinate
activities rapidly for outbreak investigations to be effective.
Outbreak investigations typically go through a number of
stages, at which various agencies have different levels of
involvement. Outbreaks are typically recognized by
epidemiologists and laboratories at the state and local levels.
Epidemiologists generally work to identify the contaminated
food, and regulators then participate in further characterizing
the food vehicle and its distribution. Public notification is a
critical part of this, at least for outbreaks that may be
ongoing, and is usually handled by epidemiologists, regulators
or both. It is important to understand that federal agencies
(such as the CDC) do not typically initiate investigations of
this sort. Thus, CDC is often in the position of reviewing and
integrating the results of investigations done by state and
local agencies, rather than doing de novo investigations.
The outbreak being discussed today has been particularly
frustrating for all involved. It demonstrates the complexity of
epidemiologic investigations, difficulties inherent in
investigations of novel foods not typically implicated,
statistical limitations in identifying one food item which is
commonly consumed with other foods (salsa for example),
inherent complexities of tracebacks of fresh produce, and
challenges in public communication. Recent remarkable successes
in investigations of spinach and lettuce-associated outbreaks
and a number of other widely distributed products have led to
high expectations which realistically can't be met in all
investigations.
There are important differences in the ``cultures'' of the
many different agencies that must work together in
investigating outbreaks, with widely disparate missions,
mandates, legal authorities, and organizational structures.
While these are generalizations, state and local public health
epidemiologists frequently interact directly with the public
during outbreak investigations, rapidly assessing data to allow
identification of the cause of an outbreak and make
recommendations for preventing additional disease. Federal
epidemiologists typically collate information from multiple
states, but may not if there are only a few involved. CDC is
generally called upon to assess epidemiologic data before
federal regulatory agencies will act. Epidemiologists do not
routinely do things like inspect facilities, perform
tracebacks, or do product recalls. Epidemiologic, laboratory
and environmental data are used to inform regulatory agencies,
such as the FDA and USDA, in carrying out their functions.
These federal agencies have very different responsibilities,
priorities, relationships with industry, and legal mandates and
restrictions.
Because of the very different ``cultures'' and working
environments of these groups, widely varying perspectives on
the challenges and weaknesses in outbreak investigations are
inevitable. Consumers might be expected to desire immediate
intervention to prevent potential disease, erring on the side
of caution by acting on data that may be quite preliminary. On
the other hand, many food producers would not want to see their
business suffer because of poorly substantiated suspicions, and
would expect public intervention to occur only on the basis of
comparatively definitive data. Investigating agencies must
constantly balance the risk that delays in action might lead to
additional preventable disease, with the risk of economic
damage to large sectors of the food industry that might be
mitigated by waiting for more specific data. Clearly it is
impossible to satisfactorily meet all of these demands and
expectations, and every outbreak requires making judgments
based on unique circumstances and data, quickly and under great
pressure.
While there may be room for improvement, it is important to
acknowledge that there are no rules, policies, or legal or
administrative interventions which will obviate the need for
difficult human decision-making in these situations. Moreover,
it is important to realize that these decisions are not made by
a single federal agency. States can and do act independently
when ongoing risks are suspected, though it would be rare for
that to happen without notification and consultation with
federal agencies, particularly for products that are
distributed across state lines. In addition, communication with
industry may occur at the state or federal level.
There are over 3000 local health departments in this
country, and 50 state health departments working under 50
independent sets of public health laws. Not unexpectedly, there
is tremendous variability in the capacity to respond to disease
outbreaks among different jurisdictions. A cursory review of
outbreaks in recent years will demonstrate that a small handful
of states appear to have successfully investigated a
disproportionately large number of multi-state outbreaks. This
is not an accident, and it is highly unlikely that those states
really have more disease than others. Rather, this reflects
discrepancies in the resources available, as well as the
capacity and inclination to detect and investigate outbreaks.
CDC does not in most cases have jurisdiction to come into
states and investigate outbreaks without invitation. The large
majority of outbreaks are detected and investigated entirely at
the local and state levels, without any need for federal agency
involvement. State health departments of course have very
different thresholds for consulting with federal partners and
requesting their assistance. In this recent Salmonella
outbreak, for example, the initial disease clusters were
recognized and investigated by local and state public health
authorities. As the scope of the outbreak grew, CDC was invited
in, initially to help evaluate data already collected by other
agencies, and subsequently to become increasingly involved in
designing and directing the investigations. Likewise, the FDA
became progressively more deeply involved as the investigation
evolved. At all stages in this fluid continuum, participants
are necessarily dependent on data already collected by others
previously, and must wait as additional data are collected,
which invariably takes more time than any of us would like.
I think that it is safe to say that many public health
epidemiologists view regulatory agencies such as the FDA and
USDA as a ``black box'', into which data are sent, but from
which results are received frustratingly late, or never. There
are many examples of situations in which state health
departments have proceeded with their own product testing or
limited tracebacks, and gathered important data long before
information was available from the federal regulatory agency
involved in the investigation. I don't believe that these
agencies are purposely withholding critical information from
public health partners, but I do think that they are required
to operate under such restrictive legal constraints that they
are unable or unwilling to share data as fully and as quickly
as we would all like, even in urgent situations. Federal
regulatory agencies are frequently prohibited from sharing
proprietary information and ``trade secrets'' obtained during
the course of their investigations, which can include names of
facilities, suppliers, traceback information, brand names, etc.
I also acknowledge that tracebacks and regulatory
investigations are far more time-consuming and complex than
many epidemiologists appreciate, and our expectations of prompt
results from an understaffed, underfunded and overworked agency
are unrealistic. All that being said, I think it is inarguable
that faster product tracebacks and better communication would
have helped bring this outbreak to a more prompt and satisfying
conclusion. In order for this to be possible, however,
investigating agencies must have adequate resources to get the
work done, and the legal authority to collect and share their
data promptly and appropriately.
I was recently involved in another outbreak which
highlights similar limitations. During the investigation of a
contaminated product under the FDA's jurisdiction,
investigators in that agency had information in their
possession that would have allowed state public health
officials to quickly identify and contact consumers at risk of
serious disease. However, because of policies restricting
sharing of proprietary data and information collected through
related mechanisms, they were prohibited from sharing it with
us. The situation was as frustrating for the FDA personnel
involved as it was for us, but we find these types of
restrictions during outbreak investigations unconscionable. Of
note, it is possible for public health epidemiologists to
become ``commissioned'' by the FDA to be allowed to receive
confidential data such as those to which I just referred. Most
of my colleagues have refused to pursue this, expressly to
avoid the untenable moral predicament of having access to data
which they would be legally unable to act upon.
To their credit, it is notable that both FDA and USDA have
undertaken tracebacks and regulatory interventions in a number
of recent outbreaks, based entirely on epidemiologic data,
without first having laboratory confirmation of pathogens in a
food or production facility. This has not been the norm in the
past, and this growing acceptance of epidemiologic data has led
to much prompter interventions to stop outbreaks and prevent
additional disease. Clearly, careful consideration of the
weight and implications of all data is critical, but I hope
that the experience of the outbreak currently under discussion
will not dissuade these federal agencies from acting rapidly on
strong epidemiological data in the future to protect the public
health.
Suspected produce-associated outbreaks are particularly
difficult to investigate, from both the public health and
regulatory perspectives. Typical produce items pass through a
myriad of hands along the ``farm to fork'' continuum. While
large food service corporations and their suppliers often have
excellent quality-control programs with impeccable records,
many other companies don't, and product tracebacks are
susceptible to complete breakdown at the weakest link in the
chain. Produce is generally purchased by consumers unlabeled,
with no information on its origin. Produce from more than one
source is often mixed at different distribution points. Many
consumers have difficulty identifying subtle differences in
varieties of produce. Such items are frequently consumed as
ingredients in other foods (salsa, for example), or in
foodservice establishments where consumers can't know a food's
origin, and may not even be aware of what they are eating. Even
if very detailed information from victims can be supplied by
public health investigators to a regulatory agency (which is
frustratingly difficult in and of itself), the challenges to
performing subsequent tracebacks through such a complex food-
handling chain are formidable.
It is important to delineate the jurisdiction and
responsibilities of various agencies during outbreak
investigations. Food safety is reportedly overseen by 14
federal entities, administering over 35 separate food safety
laws, with the involvement of 28 congressional committees. That
open-faced sandwiches are regulated by one agency and closed-
faced sandwiches another, or jurisdiction differs based on
whether a product contains more or less than 2% meat, can be
complicated. I have been involved in outbreak investigations in
which both FDA and USDA had regulatory authorities within the
same production plant, and indeed the same production line,
depending on the type of food topping being used that day, and
each agency has strikingly different regulatory policies.
A substantial underlying cause of many of the problems I
have described is a limitation of resources available to
agencies responsible for responding to foodborne outbreaks. We
are all familiar with the dramatic statistics describing the
FDA's understaffing and responsibilities far exceeding their
capacity to meet them, including the fact that only 50 staff
are dedicated to inspecting all imported foods, and well under
1% of these products undergoes even cursory examination. CDC
suffers from similar underfunding. More than one outbreak was
occurring at this time, as is usually the case. Even with
excellent staff, the agency simply cannot do its job if
overtaxed. State and local public health agencies are likewise
pitifully underfunded. Although the front line in outbreak
investigations is at the state and local levels, most of those
agencies receive the large majority of their funding from
federal grants.
Our outbreak-response capacity is in large part supported
by funding granted for successive waves of high-profile crises,
from bioterrorism and anthrax, to West Nile virus, followed by
SARS, then pandemic influenza. These resources have subsidized
a wide array of core public health functions, notably disease
surveillance and outbreak investigation activities, which
otherwise would be impossible to sustain. In recent years
``preparedness'' funding has been cut repeatedly, leading not
only to the obvious direct effects, but also to adverse impacts
on our capacity to respond to events like foodborne disease
outbreaks, which do not usually attract national attention but
occur daily and affect millions of Americans annually. I
obviously recognize the importance of disaster preparedness,
but also believe that we need to realistically apportion
resources to address public health threats in a logical manner.
When the ``red phone'' rings for a bioterrorism attack it is
important that we be prepared to respond, but while the
likelihood of such an event is impossible to measure, Americans
eat a billion meals a day, day in and day out, and 75 million
of us fall victim to foodborne disease every year.
My message is not all ``gloom and doom''. Americans today
have access to one of the safest, most diverse and inexpensive
food supplies in the history of mankind. Public health,
regulatory agencies and industry work remarkably well together
toward the common goal of food safety. Huge strides are being
made in our capacity to identify, respond to and prevent
foodborne disease. FoodNet, a cooperative program among 10
states, the Centers for Disease Control and Prevention, USDA's
Food Safety and Inspection Service, and FDA's Center for Food
Science and Nutrition, performs internationally-recognized
studies of a wide variety of foodborne disease issues.
PulseNet, a CDC-based system for sharing of molecular
``fingerprinting'' data from foodborne pathogens with a variety
of agencies has markedly improved disease surveillance and
rapid recognition of foodborne outbreaks. OutbreakNet is a CDC-
coordinated group of foodborne disease epidemiologists from all
50 states, as well as representatives from other food safety
agencies, that is focused on ways to improve communication and
response to outbreaks. Outbreak-response training programs are
available, including Epi-Ready, which is a national effort to
bring environmental health, laboratory, regulatory and
epidemiology personnel together for coordinated training. The
Food Safety Research Consortium is a non-governmental
organization pursuing a variety of projects including a recent
report, ``Harnessing Knowledge to Ensure Food Safety:
Opportunities to Improve the Nation's Food Safety Information
Infrastructure''. A variety of other academic, consumer-
advocacy and industry groups are engaged in similarly important
efforts to address many of the issues that have been discussed
today.
The Council to Improve Foodborne Outbreak Response (CIFOR)
is another important example of successful efforts to address
barriers in the food safety infrastructure. CIFOR is a
multidisciplinary working group convened in 2006 to increase
collaboration among the various public health agencies involved
in the investigation, control and prevention of foodborne
illness. The Council of State and Territorial Epidemiologists
(CSTE) and the National Association of County and City Health
Officials (NACCHO) are co-chairing CIFOR with support from the
Centers for Disease Control and Prevention (CDC). Epidemiology,
laboratory, environmental health and regulatory agencies at the
local, state and federal levels are represented. CIFOR is now
exploring ways to increase involvement of industry
representatives appropriately into its activities. Recent CIFOR
projects have included establishment of an online clearinghouse
of foodborne-disease response resources, development of
guidelines for responding to multi-jurisdictional outbreaks,
development of performance indicators for assessment of
outbreak-response programs, and writing comprehensive
guidelines for multi-agency investigations of foodborne disease
outbreaks.
I believe that there are a number of opportunities for
continued improvement of the Nation's food safety
infrastructure:
-Adequate and consistent funding and resources must be
dedicated explicitly to sustain effective public health and
food safety programs, commensurate with the true risks
associated with the public health threats they address.
-Federal regulatory agencies must have the authority and
expectation to share actionable information with public health
partners promptly and fully, to the extent necessary to protect
the public's health. This may require changes in laws governing
those agencies, and trust among public health partners and
industry that sensitive and propriety information will be used
only for protection of the public's health.
-Though I do not believe that federal public health
epidemiology programs should be merged administratively with
federal regulatory agencies, there is great potential benefit
to reviewing jurisdiction of food types, facilitating improved
communication among these agencies, including developing
mutually accessible databases, ensuring rapid sharing of data
during public health emergencies, and continuing to develop
inter-agency training opportunities.
-It is critical to support development of information
technology adequate to sustain outbreak detection and response
activities. This includes resources for the development of
state-based disease surveillance databases that both serve
state needs and that allow for the sharing of essential
information with other states and federal agencies, electronic
laboratory reporting from commercial laboratories to public
health agencies, and open data standards that allow data
sharing among all food safety and public health agencies.
-Opportunities for improved coordination with food
industries should be explored. Many food industries conduct
testing which could be valuable in identifying the sources and
causes of foodborne illness and outbreaks. Data sharing by
industry should be encouraged. In addition, while outbreak
investigators require appropriate independence, the food
industry has access to data that can be important to
investigations. One example is the detailed information often
contained in ``frequent shopper cards'', which can include
contact information and precise data on dates and products
purchased. A limited number of stores have been very
cooperative in sharing such data with public health
investigators, but unfortunately this is not currently the
norm. Many grocery chains enter into contracts with consumers
that they interpret to prohibit unilateral disclosure of sales
information to public health agencies.
In summary, I believe that our nation's food safety
infrastructure is strong, but substantial barriers to continued
improvement remain. Important strides are being made to improve
foodborne disease outbreak response, and with adequate support
there are many additional opportunities for improvement. I
applaud today's meeting as recognition of the importance of
pursuing these goals. Thank you for the opportunity to discuss
these issues with you today.
Summary
-Improving the nation's food safety infrastructure, and
capacity to respond to outbreaks, will require addressing
barriers in epidemiology, laboratory, environmental health and
regulatory agencies, at the local, state and federal levels.
-Adequate and consistent funding and resources must be
dedicated explicitly to sustain effective public health and
food safety programs, commensurate with the true risks
associated with the public health threats they address.
-Federal regulatory agencies must have the authority and
expectation to share actionable information with public health
partners promptly and fully, to the extent necessary to protect
the public's health.
-Formal mechanisms to facilitate effective communication,
sharing of data, and inter-agency training among agencies, and
with industry, should be developed.
-An adequate information technology infrastructure is
critical to ensuring successful outbreak responses.
-Mechanisms should be developed to support and take maximum
advantage of successful efforts, including those of non-
governmental, academic, consumer and industry organizations, to
improve the food safety infrastructure.
----------
Mr. Stupak. Well, thank you. And thank you all for your
testimonies. Now we will begin questions.
Dr. Acheson, I have been talking about these 3 releases in
the last 12 hours because I think it adds more confusion as to
what was going on. The first one 9:00 o'clock last night was on
jalapenos. The one at 10:15 I think or 10:30 was on cilantro.
And then the one today sort of expands and talks a little bit
about this farm and the location down there in Mexico. And one
of the questions I asked the other one is, the other panel was
you still have not cleared the tomatoes. Are tomatoes still a
suspect or vegetable of interest as we were calling it on the
first panel or are they cleared now?
Dr. Acheson. FDA has investigated tomatoes. We have done a
lot of testing with States and other federal agencies. We have
not found a positive sample. We have inspected farms and----
Mr. Stupak. So why do you not clear the tomato?
Dr. Acheson. At this point there is nothing for FDA to say
that would indicate the evidence that CDC and the States
generated early on in this investigation is incorrect. FDA
based on that information did its trace-back.
Mr. Stupak. Right.
Dr. Acheson. And it is not up to FDA to say that that
original case control study was----
Mr. Stupak. Well, then who clears the tomato then? If it is
not up to the FDA you have no Saintpaul Salmonella or
Salmonella Saintpaul in any tomato product. We have cilantro
suspect and now we have peppers for sure; right?
Dr. Acheson. Right. Correct.
Mr. Stupak. Well, so who would clear it then I mean?
Dr. Acheson. We have made it very clear that there are no
tomatoes that are currently available on the market from
anywhere in the world that are linked to the outbreak.
Mr. Stupak. Currently. But how about tomatoes from the
original suspect? That is what the last panel was concerned
about, that that hangover effect still exists as to tomatoes.
Dr. Acheson. Are you suggesting that FDA go back and say
that that original conclusion was incorrect? Because that is
not FDA's role. FDA picks this up at the point----
Mr. Stupak. OK, so if the FDA makes a mistake you never
say, I might have made a mistake?
Dr. Acheson. Of course we would. But we did not make a
mistake. FDA----
Mr. Stupak. How do you get Saintpaul Salmonella with the
tomato then.
Dr. Acheson. Let me try this again.
Mr. Stupak. Yes.
Dr. Acheson. FDA begins its trace-back----
Mr. Stupak. Correct.
Dr. Acheson [continuing]. Based on information----
Mr. Stupak. From the CDC and others, right.
Dr. Acheson. Right.
Mr. Stupak. All right.
Dr. Acheson. We do that in good faith based on the
science----
Mr. Stupak. Right.
Dr. Acheson [continuing]. That CDC has undertaken.
Mr. Stupak. And in your trace-back you found nothing to
implicate the tomato?
Dr. Acheson. And we have said that. And we have said that
tomatoes that are currently on the market are safe to consume.
Mr. Stupak. On behalf of the tomato, they want their good
name back, I think you should put out something a little more
firmer on that.
Let me ask you this. These farms in Mexico that you now
suspect with the jalapenos----
Dr. Acheson. Yes.
Mr. Stupak [continuing]. Do any of them grow tomatoes?
Dr. Acheson. Yes, they do. There is at least one farm.
Mr. Stupak. OK, at least one. Then the irrigation water
that is suspect is that irrigation water being used on tomatoes
then?
Dr. Acheson. The farm that grows tomatoes also grows
serrano and jalapeno peppers.
Mr. Stupak. OK.
Dr. Acheson. That is the farm where the original peppers
that were positive in McAllen, Texas, traced back to.
Mr. Stupak. OK. That's the one that Minnesota had; right?
No?
Dr. Acheson. That is, the Minnesota part is just one piece
of this.
Mr. Stupak. OK. OK. So the farm, there is at least one farm
in Mexico that grows jalapenos and tomatoes that we have
positive for Salmonella Saintpaul; correct?
Dr. Acheson. Let me try this again. There is----
Mr. Stupak. If I am confused the American people are really
confused.
Dr. Acheson. FDA found a positive sample of jalapeno
peppers at a distribution center in Texas.
Mr. Stupak. Texas.
Dr. Acheson. OK.
Mr. Stupak. You traced it back to a farm in----
Dr. Acheson. We traced--can I finish?
Mr. Stupak. Sure.
Dr. Acheson. That may clarify your confusion. We traced
that positive sample of jalapeno peppers back to a farm in
Mexico. That farm grows jalapenos, serranos and tomatoes.
Mr. Stupak. Tomatoes, OK.
Dr. Acheson. As part of the investigation in Mexico we were
investigating other farms and we took samples on other farms.
Mr. Stupak. Correct.
Dr. Acheson. And found the outbreak strain on a different
farm that grows jalapeno peppers and serrano peppers but does
not grow tomatoes.
Mr. Stupak. OK.
Dr. Acheson. Now one question that is out there, which I
think you are getting at is, is there a connection between
those two farms?
Mr. Stupak. Well, where is the water source coming from?
Dr. Acheson. That is a good question and that is part of
what we would try to determine while we are there.
Mr. Stupak. Would these two farms use the same water
source?
Dr. Acheson. Do not know. Do not know. But what I can tell
you is that those two farms do send their produce through a
single distribution center.
Mr. Stupak. How far apart are these farms?
Dr. Acheson. I believe they are about 3 hours drive but I
do not know specifically how many miles apart they are.
Mr. Stupak. OK. Then let me ask this question I asked of
the previous panel and they were not real clear on it or did
not quite: is Salmonella Saintpaul usually associated with
poultry?
Dr. Acheson. Salmonella, yes, typically with turkey.
Mr. Stupak. Turkey?
Dr. Acheson. Yes.
Mr. Stupak. OK. Are there turkey farms down there near this
area in Mexico?
Dr. Acheson. Not aware of any turkey farms down there.
Mr. Stupak. OK. Let me ask this: any reason why you could
not clear domestically grown tomatoes then?
Dr. Acheson. We have already stated that domestically grown
tomatoes, tomatoes from anywhere are perfectly OK to consume.
Mr. Stupak. OK, let me ask you this. Let me go to Dr.
Smith. You said, and I am going to come right back to you, you
said when you did the jalapeno and you nailed it there you
traced it back to the farms in Mexico?
Dr. Smith. There were multiple possible sources of these
jalapenos and they were all in Mexico.
Mr. Stupak. OK. I am sure you gave that information to the
FDA.
Dr. Smith. Yes.
Mr. Stupak. So are we talking about the same farms then
that Minnesota suspected?
Dr. Acheson. Yes. They crossed into our systems, into what
we were tracing back.
Mr. Stupak. OK. How many farms or possible sources did you
find?
Dr. Smith. Well, we could not get back all the way to the
farm level.
Mr. Stupak. OK.
Dr. Smith. All of the farms. But we had three different
possible trace-back farms.
Mr. Stupak. OK.
Dr. Smith. And they all went back to Mexico and one of them
only could we get back to a distributor.
Mr. Stupak. OK. So you found these three farms you have at
least two farms about 3 hours apart and the water source we are
still not sure about yet; right? Is that correct, Dr. Acheson?
Dr. Acheson. We found two farms, yes, but we have been--
there are many other farm distribution centers that have
crossed over in this trace-back. It is not as simple as just
two farms in a distribution center.
Mr. Stupak. OK. How many, if you know, how many farms use
this water source that has suspect with Salmonella Saintpaul?
Dr. Acheson. I do not know.
Mr. Stupak. OK. OK. Let me ask this question. You mentioned
you are going to have a fall conference, Secretary Leavitt has
called a fall conference. Will the FDA be running a post-mortem
on what went right, what went wrong on this recall? Will you be
doing that?
Dr. Acheson. We are proposing two things: one is a public
meeting in the fall that will be focused on issues around
traceability. We have had a lot of discussion earlier, it is
very important.
Mr. Stupak. OK.
Dr. Acheson. What I said is that right now we are exploring
using our Science Board as a mechanism to set up a subcommittee
of the Science Board that could involve industry, State,
federal, academic experts to help----
Mr. Stupak. Right.
Dr. Acheson [continuing]. Ask questions about what can we
do better? What went wrong? What are the lessons learned?
Mr. Stupak. Why would you not just use the folks involved
in this one because this one is the largest Salmonella outbreak
we have had in the last 10 years, last decade? Why would you
not use the folks in the first panel to help do it as proposed?
Dr. Acheson. We very well may. It just needs to be done
through the mechanisms of the Science Board. As you have raised
earlier or has been raised in terms of information that we can
share and the Federal Advisory Committee Act, laws that are
around, discussions, etc., it has to be done according to the
law.
Mr. Stupak. Right.
Dr. Acheson. And doing it through the Science Board is a
process that allows us to do that.
Mr. Stupak. OK.
Dr. Acheson. The experts----
Mr. Stupak. OK, last Science Board on review in the FDA
though and the things you had there it was limited to they
could not talk about budget, so I would hope that this Science
Board would be given full review of the information so they can
put forth recommendations to help assist with this.
Let me ask you this, with any crisis you learn from your
weaknesses in the existing system. What have you learned from
this investigation that requires legislative changes? Because
in your testimony you said Congress is drafting. We are past
drafting, we are actually negotiating between all the parties,
and I know the FDA has been involved. So and we are getting, we
are on the food part right now on food safety. So what
legislative changes have you learned that we need to help you
with this kind of investigation?
Dr. Acheson. Of the 10 legislative proposals that we have
discussed previously as part of the Food Protection Plan,
probably the one that is most important is the one that
requires preventative controls. I do not think anybody would
disagree that the key answer to this is not to react faster but
is to prevent the problems in the first place. That is
absolutely critical across the board. So that is a very
important one.
There are other components in there in terms of the other
legislative proposals that would help somewhat. Another one,
for example, is the requirement for certification for certain
imported products. That is a federal to federal agreement. But
that is another example that could help us.
And then I think as the questions around lessons learned
unfold here, and we are still focusing on stopping the outbreak
as opposed to focusing on what are the lessons learned after,
but obviously there needs to be lessons learned and discussion
around traceability and whether there needs----
Mr. Stupak. Right.
Dr. Acheson [continuing]. To be a legislative fix around
that.
Mr. Stupak. Well, we had the Bioterrorism Act of 2002 which
was supposed to give the Secretary of HHS the tools necessary
to have rapid trace-back of a food commodity through a
distribution chain. Did the Bioterrorism Act work here?
Dr. Acheson. The Bioterrorism Act worked as written. We
rarely ran into a problem where people were not keeping records
of people who were supposed to. That did not slow it down.
Contrary to what you heard on the first panel, what we learned
in this outbreak is that it was many of the small producers,
the small restaurants, much like Mr. Shimkus' example of the
little restaurant that he goes to on a Friday night that were
involved in this, they do not have electronic systems. The vast
majority of the information we got was paper, it was invoices,
it was bills of lading. That has to be worked through by a
person just working their way through, looking for the
connectivity.
Mr. Stupak. Should not the farm be included in the
Bioterrorism Act? Right now it is exempt, farms and
restaurants. Would that not have really helped you out if they
were part of the Bioterrorism Act?
Dr. Acheson. Currently the Bioterrorism Act does not cover
you from farm----
Mr. Stupak. Right.
Dr. Acheson [continuing]. All the way through to
restaurant.
Mr. Stupak. Right. Should they not be included?
Dr. Acheson. It certainly would expedite the process if
they were.
Mr. Stupak. OK, let me go to Dr. Smith, I have a question
or two. I read from an Associated Press article, and I want to
go back to that, on July 23 Associated Press ran an article
entitled, and I am quoting, ``A Hot Lead in the Hunt of
Salmonella Source: Minnesota Pinpointed jalapenos While Feds
Fruitlessly Chased Tomatoes.'' I presume you have read this
article?
Dr. Smith. Yes.
Mr. Stupak. OK, then let me ask you this. The article
suggests that the State of Minnesota was using certain outbreak
investigation techniques that the CDC and FDA were not using.
Are there certain things that you believe that the State of
Minnesota did in this outbreak that key federal agencies did
not do?
Dr. Smith. Well, first of all I should say you know the
types of things that we do are the types of things that need to
be done in other State and local health departments.
Mr. Stupak. Right. But what about CDC and FDA, should they
be using those things too? And what are they?
Dr. Smith. Well, OK, so what makes I think us so successful
is that our laboratory confirms and types all Salmonella
isolates that they get right away. It takes 2 or 3 days. And
then they give that information to epidemiologists right away.
And then we interview these patients right away.
Mr. Stupak. So that the rapid response from the
investigation of the slide to your local health to the
interviews?
Dr. Smith. I think it is the rapid response. But it is also
the level of response. We get very detailed information from
all of these patients. And I also have epidemiologists who work
only on food-borne disease. They are evaluating clusters every
day and so they are very experienced.
Mr. Stupak. So in the first panel when they said, well,
yesterday I was working on heart stents, today I am working on
tomatoes, that does not lead to good investigative work?
Dr. Smith. Yes, certainly it is better if you have got
people that are just dedicated and focused on one thing. And we
are fortunate to have enough resources to be able to have
epidemiologists that are dedicated to food-borne disease. And a
lot of these resources are from federal programs such as Food
Net.
Mr. Stupak. OK. Just one last question before I turn to Mr.
Shimkus. Dr. Acheson, it came up in the first panel, it sort of
came up here, Dr. Jones mentioned it, if this were bio-
terrorism how would you have acted differently?
Dr. Acheson. If this was deliberate the process would have
been the same.
Mr. Stupak. So even information sharing would have been the
same? There has been complaints about information sharing and
whether a person would be commissioned or non-commissioned
because there is a concern about information sharing. No
command, incident command center, no one was in charge was the
other allegation. So you would handle it the same? That is not
a good idea.
Dr. Acheson. There was a lot of information sharing that
went on, a lot of work was done. In fact, with the State of
Florida, as Commissioner Bronson talked about, we did use
Florida labs, we did use Florida inspectors when we were down
in Florida. So we actually did what he was suggesting that we
did not do.
Mr. Stupak. But Florida is mad at you for banning their
tomatoes when they could provide traceability with a system
that FDA helped develop. So I do not think Florida is
especially happy with the FDA or the way information was
shared. Their traceability would have showed because of the
outbreaks that----
Dr. Acheson. I am pointing out that we did share a lot of
information with Florida and we did use the Florida resources,
as the Commissioner suggested we should. We did, we used their
labs and we used their inspectors.
Mr. Stupak. Well, I hope if we suspect a bio-terrorism we
are not going to treat it the same way, that there would be a
little bit more urgency to it.
Dr. Acheson. The trace-back process would be the same. It
is what it is.
Mr. Stupak. So then it is a major hole in our national
safety, whether it is bio-terrorism or Salmonella Saintpaul?
Dr. Acheson. If somebody has done something deliberate that
is involving the same type of products in the same type of
restaurants and retailers it would be no different, it could
not be different. It is still right now paper, invoices, bills
of lading. You have to go and get them, you have to go and pick
them up. That is what could be a focus of making it faster if
there was a deliberate act.
Now, obviously if this was deliberate there would be
different federal authorities involved. Homeland Security would
have a lead if it was a bio-terrorism event. It would be run
differently. I am simply focusing on FDA's role with the
traceability. It is what it is. I mean and it worked, it was
just slow.
Mr. Stupak. Mr. Shimkus please.
Mr. Shimkus. Thank you, Mr. Chairman.
I want to go back. I think we are pounding on FDA but FDA
spent all this time going after the wrong suspect because it
was not identified properly to begin with. And once we got
identification with the help of a public health department, 18
days plus 4 to find the location. And so I think there are ways
that we think we can make things better. And my questions are
going to be in that.
But we have got to keep this in focus. I think the original
panel identified that. We just got taken off in the wrong
direction and the FDA went. Traceability worked, maybe not as
quickly as would like, but it worked. And the reality is,
Diana, the reality is tomatoes first time for this disease is
infinity. We are still looking, we cannot find it. When it was
identified in peppers, 18 days to find the pepper, 4 days to
find the location. I think that is a success. What went wrong
was that and the issue is the CDC and the public health
department.
So I would like to ask first, we have two public health
departments, how big is the State of Minnesota population-wise?
Dr. Smith. About 5 million people.
Mr. Shimkus. And, sir, your state?
Dr. Jones. Six million.
Mr. Shimkus. And so what is the budget, Dr. Smith, of
yours, of the State Public Health Department?
Dr. Smith. I basically have one food-borne disease
epidemiologist for every million people in the State.
Mr. Shimkus. One for every million. And, Dr. Jones?
Dr. Jones. Same order of magnitude, yes.
Mr. Shimkus. And we do not have to name States, but you
probably know States that have one epidemiologist for how many?
Dr. Smith. Every 24 million people.
Mr. Shimkus. Twenty-four million. And I guess Texas, I mean
and we are talking about this starting in Texas or New Mexico.
I guess Texas was the second point. And I do not want to even
ask about my State. So but if we had a bio-terrorism attack it
would be identified first by who?
Dr. Smith. It would be identified in exactly the same way
as a natural contamination would, exactly.
Mr. Shimkus. And it would go once you had identified the
convergence, the commodity, you would then go to the CDC?
Dr. Smith. Absolutely.
Mr. Shimkus. And then in conjunction we would then have to
raise a concern to start finding where this thing started from.
And again, if we are using this as a case study we just
identified it wrong. So I think part of this debate is public
health, public health departments get them funded, get them
technologically advanced. And then probably, Dr. King, probably
working with CDC to get you all fully funded and up to speed
and staffing, would you not agree?
Dr. King. I certainly agree that many of the states are
under-resourced when it comes to many public health problems,
including food safety. I think that was one of the inherent
problems and lessons learned here is that they were poorly
resourced and could not respond just because they did not have
the resources to put into this.
When you talk about, Congressman, about the States talking
to CDC, there is a system in place called PulseNet. And
PulseNet is in place. All the States have PulseNet
capabilities. There are counties and cities that also have
PulseNet. So concurrently and simultaneously we can through the
States, local and CDC actually look across the 50 States and
even further into those States, into cities, with a system that
is standardized to say, oh, this is Salmonella Saintpaul, this
is the variety that has caused outbreak over New Mexico and
Texas and Illinois. That gives us then the capability to say
this is a multi-state outbreak. There is a source here that we
did not know about.
The CDC's role then--and by the way, the States can look at
this just as quickly as CDC can--CDC then is involved in that
coordination when asked. Last year there was 1,260, right,
outbreaks that came to CDC's notice. Of those, about 120 CDC
was actually involved in giving advice, helping where asked. 12
of those we actually took a lead role. 90 percent of what is
happening in the food safety area is at the local and State
level. 1 percent of the time CDC actually gets involved in a
lead situation. That is why these States need to have proper
resources.
Mr. Shimkus. And I mean this is a tough position because
you make a call, there are people ill. Make the wrong call then
you have got the culprit still out there. People are sick,
people are dying. It is an honorable profession and we applaud
your work, we are just trying to get it better.
Dr. Jones, and this is also in preparation for the hearing,
I want to know what are the barriers, these legal barriers, and
I want to know some specifics of what are the legal barriers
that are limiting our ability to more quickly, clearly identify
culprits and the like? Do you have any that you can
specifically give me?
Dr. Jones. I am not aware of any legal barriers to sharing
epidemiologic data. And I think that that occurs quite rapidly
in both directions and goes to the regulatory agencies fairly
quickly. I guess the examples that I am familiar with have to
do, and again I am not an attorney, have to do with legal
restrictions on federal regulatory agencies not being able to
share potentially, you know, proprietary information.
Mr. Shimkus. Yes, give me an example. We want to, I would
think the committee would want to find out exactly what those
are. And as we are doing legislation to say when there is a
national public health risk we have to tear these down and we
have to ensure that the federal agencies protect the propriety
while we are finding information.
So, Mr. Chairman, as we continue this I think this is a key
area. And I mean does anyone, can anyone share? Dr. Acheson?
Dr. Acheson. Part of the problem here is proprietary
information that is deemed to be commercial confidential. There
is a mechanism through commissioned individuals at the State
level that that can be shared with. And we----
Mr. Shimkus. Well, we heard about commissioned
individuals----
Dr. Acheson. Yes.
Mr. Shimkus [continuing]. In the first panel. And they did
not seem to have much power or control or input.
Dr. Acheson. No, we are able to share information with
commissioned individuals, and we do. And I think to that point
if a commissioned individual in a State is saying, we think
there is something going on and we would like some information,
nothing to stop them picking up the phone and saying, can you
help us here because we have some questions, if they are
commissioned.
Mr. Shimkus. Well, we are going to, I know on our side we
are going to try to dig in, Mr. Chairman, on this issue because
we are the legislative branch. You know, we can--Dr. King, do
you want to add?
Dr. King. There is one piece of information I know the
industry was hoping to get and could not get and was critical
of it, and that was identification of cases by county. And that
is something that through our legal counsel when a State shares
information with us first of all the data and information is
the State's. When it is shared voluntarily with CDC it becomes
part of the federal record. It is also then under the authority
of Privacy Act and also under Freedom of Information Act and
agency policy. And it has been consistent and the
recommendation of our general counsel that when you get down to
the county level that that gets too close and patients, to
protect patients' rights we will not give that information out.
And so there is a case where you get States with very--not
very populated and maybe have one hospital, all right, that is
the information then could actually get back. And those patient
rights need to be protected. So there is a case.
Mr. Shimkus. Yes, again I am going to keep, we are going to
keep following up on this line of work because I think where
there are some legislative fixes here and where we can protect
propriety and carve out provisions because we need information.
And I think the first panel talked about transparency when
there is a national emergency. If we are talking about bio-
terrorism and the risk of millions of people we surely do not
want privacy considerations to trump the health and welfare of
the nation.
So and the Chairman's position also was if we get sent down
the wrong path, as this case is happening, how do we clear the
product that has now lost immediate dollars and potentially
market share, how do we, who calls it and says lay off the
tomatoes? Dr. King.
Dr. King. Thank you, Congressman. You know, we respectfully
disagree that tomatoes were not involved. And so if you give me
a little bit of time to talk about what happened in that case
control study if you would like for me to explain that, to talk
about the science and the epidemiology behind it, that is your
call.
Mr. Shimkus. Well, my time expired. If the Chairman wants
to hear it I would be happy to hear it.
Mr. Stupak. Well, yes, let us hear it. Because how do you
prove a negative? You put a negative out there and you still
cannot prove that negative.
Dr. King. It is an important point to make, so let me go
back. And, you know, I apologize for the terms in the
epidemiology, I do not apologize for the science.
So initially when we had these cases in New Mexico, New
Mexico went ahead and went back to ill people and did what they
call hypothesis-generating interviews. And that hypothesis
generating, I think your committee had copies of this.
Mr. Stupak. It is all right here, Yes.
Dr. King. Absolutely. Was pretty comprehensive. It included
at least 200 different sources of food.
Mr. Stupak. But even at that time you knew tomatoes coming
from South Florida does not go to New Mexico. That is the
traceability thing that they are arguing with you. And if you
will not give them the county they cannot help you.
Dr. King. Yes, sir. You know, it is what you know at that
point in time.
Mr. Stupak. Right.
Dr. King. So, you know, at that point----
Mr. Stupak. Well, you knew that South Florida was the only
place that there was producing tomatoes for distribution in the
United States, there and Mexico. So if Florida has this great
traceability why did you not work with them so they could show
that was not Florida tomatoes to we could have protected the
domestic tomato industry which has lost $100 million and
counting?
Dr. King. So let me just go back and explain the ep--the
trace-backs are part of what FDA does, not what----
Mr. Stupak. Well, that is part of epidemiology, is it not?
Dr. King. It informs trace-backs for sure, absolutely. And
they go together. So you are absolutely right.
So through the hypothesis-generating interviews and through
the case control studies that followed, right, and the case
control studies were done by Texas, New Mexico, and the Indian
Health Service, and the analysis of the data strongly
associated tomatoes as the possible cause of this outbreak. And
when I say strongly associated, you have to understand what
that is in epidemiologic terms. When we did the calculations,
epidemiologist statisticians, right, that means that people
that were ill with this form Salmonella Saintpaul that was in
this particular pulse field were 7 times more likely to have
eaten raw tomatoes.
And when you did further probabilities of the calculation,
right, they do what is called a P value. This is the
probability that came up with .001. That was 10 times greater
in terms of what it would take to publish the scientific data.
So with that information in mind and epidemiologists and
talking to other people that do this and which we have done for
30 years, right, that is a strong association.
Mr. Stupak. Agreed. But when you made that strong
association, May 22 is when CDC and State health officials
identified outbreak of Salmonella Saintpaul, and within a few
days you said tomatoes was the probable one; right?
Dr. King. Had the strongest association.
Mr. Stupak. Sure, strongest association. OK. But then if it
is tomatoes is not the next question where the tomatoes come
from? And we know from all the testimony the only place is
Southern Florida which has the strongest, as they say,
traceable product of tomatoes. And they say you would not work
with them. The first line of Mr. Bronson's testimony. Give me
the first line of that testimony. His first line of his
testimony, written testimony which he gave us was, his first
line was, ``FDA did not share or solicit critical information
from State food safety agencies. State resources could have
augmented FDA's effort.''
So if you are--and I understand epidemiology, I understand
statistics, also understand doing crime scenes. When you got a
crime scene everyone is a suspect but the infant probably can
be cleared immediately because they do not have the means to
cause the harm. So for the tomato industry I guess I am saying
if you knew it was South Florida, you knew it was tomato, South
Florida's tomatoes were not going there, they could trace that,
they could prove that to you, then what went wrong after that?
We just kept focusing on the tomato. I understand that but
domestically-produced tomatoes?
Dr. King. Well, CDC does not do the trace-back by the way,
so.
Mr. Stupak. Agreed. But you do the epidemiology; right?
Dr. King. The epidemiology. We do the lab.
Mr. Stupak. Correct. And you give it to the FDA then do the
trace-back.
Dr. King. And FDA is informed by what we have with that
conversation and it certainly leads them to----
Mr. Stupak. Correct.
Dr. King [continuing]. Some indication of best bets in
terms of trace-back.
Mr. Stupak. Well, what would the information would the FDA
receive from the CDC on tomatoes to make it think it is
domestically-grown tomatoes when we know it is only coming from
a very small part of our company which has trace-back laws?
Dr. Acheson. When we were looking at the clusters and the
sporadic cases that the CDC and the locals were investigating
in the States, that is our start point. And initially in this
outbreak we did not have clusters, we were dealing with
sporadic cases and individuals. You are dependent on their
memory. And they say, well, we bought our tomatoes at such and
such a retail outlet. So we would go there and we would trace
it back.
Mr. Stupak. Correct.
Dr. Acheson. And then we are, to your point, asking where
could those tomatoes have been distributed? This year what we
learned from industry was that because of weather or economic
conditions Florida tomatoes were going all across the United
States, they were going as far as California.
Mr. Stupak. Well that is not what the first panel said.
Dr. Acheson. Well, that was what our information.
Mr. Stupak. And if they are Florida tomatoes would you not
think you would have some sick people in Florida about this
same time? These were only West, right, New Mexico and Texas
was the only two places the first outbreaks were. If it's
Florida tomatoes I would think Florida people would be getting
sick. What did we have 4, 4 people this whole time out of
Florida and 11 in California I think it was, and 500 in Texas
and 100-and-some in New Mexico? Anyway, OK, did you want to add
anything more on that, on what you did there?
Dr. King. Yes, Chairman. Thank you.
Mr. Stupak. Yes.
Dr. King. Just to put it in a little bit of a context, so I
just went back to 2006 and I looked at 10 outbreaks, right: E.
coli in spinach, shredded lettuce botulism, Salmonella in
tomatoes, E. coli in frozen pizza, Salmonella in peanut butter,
Salmonella in----
Mr. Stupak. Yes, we have done all those hearings.
Dr. King. Done all of those hearings.
Mr. Stupak. Yes.
Dr. King. Let me point out that actions were taken on the
basis of epidemiologic investigations on all those in the
advance of any product cultures that were done.
Mr. Stupak. OK.
Dr. King. So the idea that this one is not different than
what we usually find.
Mr. Stupak. I understand you have a suspect, but you have
to put the suspect at the scene of the crime, and you guys sure
did not do a very good job I do not think. And I think that is
where your problem is.
Mr. Shimkus. I will yield back my time here, Mr. Chairman.
Mr. Stupak. Yes. Ms. DeGette for questions.
Ms. DeGette. Dr. Acheson, do you think that the trace-back
in this most recent Salmonella outbreak was done in the best
and most timely way it could have been done?
Dr. Acheson. With the system?
Ms. DeGette. Yes.
Dr. Acheson. With the system that we currently have in
place, yes.
Ms. DeGette. Do you think it is the best system that we
could have?
Dr. Acheson. I think it could be improved in terms of
increasing its speed.
Ms. DeGette. And if it was improved then would we have if
we had a better system, which I will get into, would we have
been able to identify, at least eliminate tomatoes as a
potential source and move and try to identify the sources more
quickly?
Dr. Acheson. I believe that a faster system, and you could
talk about what that would look like, but I believe that a
faster system would allow you to exclude products faster and to
get back to potential areas where factors are crossing over to
give you a source faster.
Ms. DeGette. Now, let me ask you this. We heard on the last
panel that there are a number of voluntary industry
associations for trace-back and also a number of companies have
trace-back systems. Are those going to do the job that you are
talking about for speed and efficiency if they do not link up
with each other and cross-reference each other?
Dr. Acheson. No, not entirely. No.
Ms. DeGette. And is a voluntary trace-back system in which
only some market players participate going to be adequate to
give the speed and comprehensiveness that we need in a trace-
back system?
Dr. Acheson. No.
Ms. DeGette. Now, I have learned in recent months that many
larger companies do have the ability to track their food and
probably in a better way than smaller firms because at larger
companies brand preservation is almost always a key to
survival. So my question is if you have a purely voluntary
trace-back system will that be as successful as it could be if
some market players, particularly smaller market players,
cannot participate in the system?
Dr. Acheson. Like any system it is as strong as its weakest
point. So if you put in a great system and only 99 percent of
the industry is using it and you have a problem with that 1
percent, all bets are off, it is not going to work.
Ms. DeGette. The whole thing falls apart at that point?
Dr. Acheson. It does, yes.
Ms. DeGette. Now, I would like to know if the FDA currently
has the legal authority to do what some of our panelists on the
last panel were talking about which would be to use a numerical
unique identifier that can travel with the product and
instantaneously identify relevant tracking information like
location, time, date, etc., vector in the field. Does the FDA
currently have that authority to develop that comprehensive
system?
Dr. Acheson. Well, bearing in mind that I am not an
attorney but my interpretation of that is that we do not have
explicit authority to require the level of detail that you are
asking for.
Ms. DeGette. OK.
Dr. Acheson. But it may be better if we get you a written
response to that.
Ms. DeGette. You betcha. I would love it.
And I also, not to rag on you because you have been very
cooperative with my office, but I have made about 10 or 12
requests to the FDA, other parts of the agency, in the last
year and I must say I have not gotten responses. So I am sure
you will respond to my question.
Dr. Acheson. I sure will.
Ms. DeGette. Now, I wanted to ask a few questions about the
other end of this, the identification of the food-borne illness
because it seems to me that the problems that we have had in
this investigation it is true we do not have the comprehensive
traceability system that we could or should have, and it is
also true that if we had had a national interoperable system of
traceability I believe we could have identified, we could have
eliminated foods in areas that were not affected which would
have been financially beneficial to those portions of the
industry. And we could have also identified the source of the
contamination more quickly which would be good for public
health.
But the other, so the traceability is what I have been
focusing on in my legislation. But in truth, really the
identification of the situation is of great concern to me and
the rest of us because people started getting sick in April,
and here we are now at the end of July still trying to figure
out exactly where that contamination came from. I think some of
it does come from the CDC and the State health departments, so
I want to focus on that for a few minutes.
And I wanted to ask you, Dr. Jones, is it true that you
believe that there are some sizeable communication problems
between State agencies, which are often on the frontlines of
the outbreaks, and the CDC and the FDA?
Dr. Jones. I do. And I think your point is an important
one. You know, the farm to fork continuum has all along that
continuum there are places for improvement. And there are
States that investigate hundreds of outbreaks every year and
there are States that investigate a half dozen. And, you know,
I think the food is just as safe in both of those States. And
if outbreaks cannot be detected and investigated at the local
level then we will never know we have a multi-state issue on
our hands and be able to even discuss it with CDC or FDA.
Ms. DeGette. And I guess I could ask you, Dr. Smith, and
you, Dr. Jones, the same question. Do you think all States have
enough resources to do that investigation that they need to do?
Dr. Jones. Absolutely not.
Ms. DeGette. Dr. Smith is nodding yes.
Dr. Smith. I agree 100 percent.
Ms. DeGette. And is there something at the CDC, maybe Dr.
King you can answer, or somebody, is there some resource
management at the CDC that works with those States that have
less resources to be able to identify these situations? And if
it is incomplete what can we in Congress do to help improve our
identification system in this country? Dr. Jones?
Dr. Jones. I think there are a number of things. And, yes,
CDC will respond and provide assistance to any State health
department that asks for it. And there is obviously wide
variability in what, you know, when a State will pull the
trigger.
I think there are some very important ways that CDC has
provided a lot of support to State health departments. Both of
our States are among a group of 10 that are in this Food Net
system which gives us, and it all federal resources, it comes
through CDC, which supports the half dozen epidemiologists that
we talked about. I think that if all 50 States had a system
like that that a lot of the problem that we are talking about
today would not exist.
Ms. DeGette. But, you know, I will say that, I will say
that it is all well and good to have the States asking for
resources, but when you are talking about identifying either a
food-borne disease or a bio-terrorist attack if they do not
have the resources to identify the problem in the first place
they do not know, it is a real chicken and an egg kind of a
problem. Dr. Smith is again nodding yes.
You are my favorite witness of the day, you just nod in
agreement but you do not ramble on, so good work.
Dr. Jones, you mentioned in your testimony that a lot of
the reason why critical communication between the federal and
the local health agencies is not occurring because of policies
that restrict the sharing of proprietary data and information
collected in the course of an investigation; is that true?
Dr. Jones. Yes.
Ms. DeGette. I am wondering, Dr. King or Dr. Acheson, if
you can comment on how much of that proprietary information is
hurting your agency's ability to collect data and to find the
causes of these diseases?
Dr. Acheson. Certainly from FDA's perspective we do have a
mechanism through commissioned officers at the State level to
share that information. But I think as we have addressed, if we
can find ways to break down these barriers and these silos, not
just with the State partners but with industry because there is
no question that they have a significant piece to bring to bear
that would be helpful.
Ms. DeGette. You know, but part of the problem is, as Dr.
Jones states in his written testimony, even though public
health epidemiologists can become commissioned by the FDA, he
says, ``Most of my colleagues have refused to pursue this,
expressly to avoid the untenable moral predicament of having
access to data which they would be legally unable to act
upon.''
I am wondering, Dr. Jones or Dr. Acheson or anyone else, if
you would have any comment on how we can solve that problem if
we are going to be able to more quickly to respond to these
issues?
Dr. Acheson. I would suggest that the way is how do we
build these partnerships to be actually successful so that you
are not----
Ms. DeGette. That is a good paraphrase of my questions.
Dr. Acheson. And I think that that is the process that we
have got to address. I do not know what that is going to be. We
have got a process that we are going to begin in August. We are
meeting with States and locals, FDA, with CDC to look at how
can we better build partnerships around protecting the food
supply in the United States. There is a lot to b e done.
Ms. DeGette. Does anybody else have an idea how we can
break some of those problems? This is not very encouraging to
me because it seems to me that one of the keys towards
identifying towards having State and federal agencies working
together to identify these issues is, is there going to be
coordination? If we have barriers right now we need to figure
out how to break that. And we sit here as a Congress ready to
help you, but you are the experts, so I think that we need to
figure out how to break these barriers.
One last question, Dr. Jones. Do you have examples of
actual cases where the barriers of data sharing or other forms
of communication between State public health agencies and these
federal agencies, the CDC and the FDA, made it difficult to
rapidly solve a food outbreak case or quickly act in the
interests of public health?
Dr. Jones. Yes. and I think I alluded to one fairly
generally in my testimony. But, you know, we did have a recent
situation where a federal regulatory agency had collected the
names of people who had purchased a product which we knew was
contaminated. And I know that this frustrated them as much as
it did us, but they were not able to hand us the list of the
contact information of those patients, victims, for us to be
able to call them and talk to them.
Ms. DeGette. Thank you very much.
Thank you very much, Mr. Chairman.
Mr. Stupak. But you were the front line collecting that
information; right?
Dr. Jones. Some. This came through a mechanism where----
Mr. Stupak. Sure.
Dr. Jones [continuing]. Consumers can call in to the FDA
hotline----
Mr. Stupak. Right.
Dr. Jones [continuing]. And ask them questions. And we do
not have access to that system.
Mr. Stupak. Mr. Dingell for questions, please.
Mr. Dingell. Mr. Chairman, again I thank you for your
courtesy and commend you for your labors in this matter.
These questions to Dr. Acheson. These will be yes or no
questions. FDA had over 4,000 field investigators in the year
2003 to investigate contamination of food outbreaks and inspect
food facilities; true or false?
Dr. Acheson. In 2003?
Mr. Dingell. In 2003, had 4,000.
Dr. Acheson. I would have to check.
Mr. Dingell. Please check.
And in 2008, FDA's field force of investigators had been
reduced to about 3,300 investigators, that is a loss of 700
investigators; true or false?
Dr. Acheson. I believe that is true.
Mr. Dingell. Tracking food-borne contamination outbreaks is
labor intensive?
Dr. Acheson. I am sorry, say again?
Mr. Dingell. Tracking food-borne contamination outbreaks is
very labor intensive?
Dr. Acheson. Yes, agree.
Mr. Dingell. What level of food-related resources,
inspectors, scientists, etc., do you believe that Food and Drug
currently needs? You may submit that, the response to that
question for the record. But it would be fair to say that the
number is rather larger than you have now, is it not true?
Dr. Acheson. I would agree.
Mr. Dingell. We are now learning that the probable or
possible source of contamination in the jalapeno peppers and
tomatoes is Mexico; is that true?
Dr. Acheson. Correct.
Mr. Dingell. FDA has minimal resources to inspect food
imports at the border?
Dr. Acheson. It depends how you define minimal.
Mr. Dingell. Minimal. All right, is Food and Drug's
resources in these matters adequate?
Dr. Acheson. No.
Mr. Dingell. They can inspect, as I understand it, about 1
percent of----
Dr. Acheson. That is correct.
Mr. Dingell [continuing]. The food?
Dr. Acheson. That is correct.
Mr. Dingell. Clearly that is not adequate; is that right?
Dr. Acheson. That is correct. But as we said before, you
cannot inspect your way through this. It has got to be a risk-
based approach.
Mr. Dingell. All right. Now, it is also true that Food and
Drug has almost no resources that it can dedicate to inspect
foreign firms, foreign farms that handle food; is that true?
Dr. Acheson. In 2007 the FDA conducted about 95 inspections
of those types of facilities.
Mr. Dingell. Do you know how many facilities there are?
Dr. Acheson. There are a little over 200,000 that are part
of the bio-terrorism registration database.
Mr. Dingell. And you inspected, as I understand, 95 of
those 200,000?
Dr. Acheson. Correct. And do not ask me the percentage
because I cannot work that out in my head, please.
Mr. Dingell. Is a fair comment minimal?
Dr. Acheson. It depends how you define minimal.
Mr. Dingell. All right. Now, if Food and Drug had had
sufficient resources for inspecting imported produce or actual
sources of that produce we could have detected this contaminant
much sooner, could we not?
Dr. Acheson. I suspect not.
Mr. Dingell. Suspect no?
Dr. Acheson. No. I think not, because inspections and
sampling as a mechanism to ensure that it is safe is not
realistic. You just could not sample enough to make it
realistic.
Mr. Dingell. Right.
Dr. Acheson. The answer is the preventative controls; that
is the fix.
Mr. Dingell. Now, would you agree that FDA needs
considerably more resources to conduct foreign and domestic
inspection of food processors?
Dr. Acheson. Yes. And we are getting some of those in 2008
and hopefully 2009.
Mr. Dingell. Now, does Food, would you agree that Food and
Drug needs considerably more resources to inspect actual
imports at the border?
Dr. Acheson. Yes.
Mr. Dingell. If you turn to page--I am sorry. I guess that
constitutes my questions. Mr. Chairman, I thank you for your
courtesy. Thank you, sir.
Dr. Acheson. Thank you.
Mr. Stupak. Thank you.
Mr. Inslee for questions, please.
Mr. Inslee. Thank you. I think we all agree that our trace-
back and investigatory systems are inadequate. But I want to
ask what is more inadequate, our after-the-fact trace-back
investigatory system or preventative systems of agricultural
practices that prevent, and packaging and distribution
practices that would prevent these instances from happening?
What is sicker? What is more ailing? What is more porous? What
is most, what is the most glaring weakness between those two
approaches, either pre- or post-injury?
Dr. Acheson. If I could respond first I would say the most
critical is the preventative controls. That is what counts the
most, building the safety in up front so whether it be a
domestically grown or an imported product, manufactured,
whatever it is, build that safety in up front to a standard
that is adequate. You have obviously got to have strong
reactive capabilities when things do go wrong. But having a
reactive system, however well it works, is just not a good way
to protect public health.
Mr. Inslee. Well, I would agree with that. And that is why
I hope those who are interested in this subject will be very
anxious, as I am, to get legislation through to finally adopt
best practices in the industry in the field and in the farm and
in the packaging plant to prevent these repeated instances. I
have to tell you this is very frustrating to sit at this dais
time after time after time to see these incidents and we still
have not successfully got the industry totally to agree to
standards that will prevent these things from happening.
So I hope that this continued incident will encourage
others to work with us as soon as humanly possible to pass
practices that will prevent this from happening. We know this
can happen. We have had substantial improvement in the meat
industry. We have not had improvement in the produce industry
in practices in the field. And I just hope that others agree
with Dr. Acheson and myself on the importance of those
preventative measures so we can move forward.
Dr. Jones, I want to ask you about State measures. I think
even a cursory review would show that a relatively small
handful of States have been most successful in investigating a
disproportionate number of these incidents. And I just want to
ask you to, to the extent you can, tell us what do those States
have in common, what have they done well? Is it resources? Is
it practices? Is it, you know, gubernatorial leadership? What
is it and what can we do to get more states to either emulate
those efforts or federally remove the necessity of them?
Dr. Jones. Unfortunately I think the basic answer is
resources. You know, Dr. Smith has mentioned some other things.
I mean States that have a very centralized public health and
epidemiology structure tend to get information a little bit
faster. Laboratories that are well funded and can do their
testing quickly and get their results to epidemiologists
quickly help. But all of that requires manpower and resources.
Mr. Inslee. We were looking for an easier answer actually.
Dr. Jones. Sorry.
Mr. Inslee. I appreciate that.
Dr. Smith, your team had a relatively rapid identification
of jalapenos through genetic systems. And, you know, basically
what did they do differently than the FDA? What can we do to
replicate that on a federal level?
Dr. Smith. Right. Well, again I think it needs to be
replicated more on the State level because I mean CDC and FDA
are kind of limited by the information they are getting from
State health departments. And so I think our system or
something like it needs to be implemented more at different
state levels.
Again, our laboratory is confirming and typing bacteria in
real time, giving that information to our epidemiologists right
away. And our epidemiologist are interviewing these patients
extensively, again in real time. And so we are asking people
about what they ate 2 weeks ago. And that is hard to get
detailed information at that point. But it is much easier and
you get much better information than if you waited until you
ask them about 4 weeks ago or 6 weeks ago.
And that is what happens in some States is like some
laboratories physically cannot type all the bacteria in real
time and so they can only do it once every 2 weeks or once
every month. And then by the time they do that and get that
information to their epidemiologists, you know, it is 4 or 6
weeks later, you know, when the interviews are being started.
So the whole key is just, you know, it is not really that
hard, it is the resources to do stuff right away and to do it
in detail and that will get you the detailed interview
information that you need to solve an investigation.
Mr. Inslee. So what would you say to the federal
government, the agencies, to match that State input early? Is
there something that has to change?
Dr. Smith. Well, I mean I know for a fact that CDC could
use more resources in PulseNet to track all the isolates that
are being submitted by State health departments into that. And
I also know there are epidemiologists that are helping to
coordinate multi-state outbreaks get stretched awfully thin.
And so, again, I know that they could use more resources at the
federal level to go ahead and assimilate the information that
is coming in from the States.
Mr. Inslee. Anyone else want to add to that?
[No response.]
Mr. Inslee. With that, thank you very much, I yield back.
Mr. Stupak. Ms. DeGette had a question?
Ms. DeGette. Mr. Chairman, I just had a follow-up question.
I am trying to, I am still trying to think about how we could
improve our identification of these outbreaks. And, Dr. King, I
wanted to ask you in particular about this Salmonella outbreak.
Now, patients were given or people who we thought ate the
tainted foods were given questionnaires by the State of New
Mexico and also the CDC; is that correct?
Dr. King. Yes.
Ms. DeGette. We have been provided copies of these
questionnaires by the CDC and I am wondering are these
confidential, these forms? I know the ones filled out are
confidential. But I am looking at them, I see no reason why
these would be confidential in any way.
Dr. King. The forms?
Ms. DeGette. Yes.
Dr. King. No, not at all.
Ms. DeGette. OK. And the first form, which is a very
extensive form that was provided by New Mexico to patients,
talked about fresh tomatoes and it had a long list of different
foods. And it did not highlight jalapeno peppers or serrano
peppers, just simply had a space for other peppers.
And then the form that was given out by the CDC, which is a
form much more targeted at the salsa that was suspected asked
questions about salsa, homemade salsa, store bought salsa. It
talked about onions, tomatoes, where you ate tomatoes, a lot of
questions about tomatoes. That form never asked one question
about peppers. And I am wondering why? Or, for that matter, any
other ingredients other than onions that are in salsa.
Dr. King. There are two different forms. The first one is
this hypothesis generating form.
Ms. DeGette. It is the larger form provided by New Mexico
which has a whole bunch of stuff on it.
Dr. King. Right. And I think red peppers, green peppers or
other peppers.
Ms. DeGette. Correct.
Dr. King. Also, the people doing the interviews it was
open-ended so you would also ask people are there other things
are not on this list that you could remember that you had. So
that is one thing.
Ms. DeGette. OK.
Dr. King. When you get down into case control, which is the
second form----
Ms. DeGette. OK.
Dr. King [continuing]. It also was done by the State,
actually two States.
Ms. DeGette. And that is like a smaller format.
Dr. King. The difference then is that because the
hypothesis has been generated, right, then we are able to focus
into this looks like it is food, looks like this type of food.
And so the questionnaire then becomes more focused based on
that information to try to pinpoint more accurately the
different types of foods and ingredients.
Ms. DeGette. That makes sense to me. So who develops that
second form? And that is like a follow-up set of questions that
is asked?
Dr. King. Yes, ma'am. That is correct, Congresswoman.
Ms. DeGette. And who develops that form?
Dr. King. Well, the States will actually have some changes
in those depending on what they do. There is kind of a template
that is being used but States will add to those as they----
Ms. DeGette. So the State of New Mexico would have
developed that second form?
Dr. King. They would have.
Ms. DeGette. OK.
Dr. King. For the case control study we actually were
involved in helping them with that.
Ms. DeGette. Well, and the reason I am concerned is this:
it may be that after the initial survey that people did not
focus in on pepper. However, if you look at this second follow-
up form they were focused in on salsa; right? Now, I will tell
you as someone who myself is from the Southwest, I never made
salsa without putting peppers in it. That is one of the key
ingredients of salsa. So if in fact salsa was suspected and you
ask the question tomatoes, and extensively tomatoes and onions,
why was not the question about peppers asked on that follow-up
questionnaire? It may have helped you much more quickly
identify the serranos and the jalapenos?
Dr. King. Now I have to look at the questionnaire. Again it
was--no, I understand that you are looking at that. So I would
look at the second----
Ms. DeGette. I will tell you----
Dr. King. Yes.
Ms. DeGette [continuing]. Without misleading you that
peppers are not mentioned whatsoever on this second form. There
are many questions about tomatoes. Did you eat any raw
tomatoes? Did you eat tomatoes at a restaurant? Where did you
purchase them? It seems like what happens was the State of New
Mexico and the CDC focused right in laser-like on tomatoes. But
yet, if they thought the problem was salsa maybe they should
not have, maybe they went off down the wrong road too fast.
Dr. King. That is, you know, that is part of something we
would look at. The second case control study certainly did
focus at peppers as we gained more information as we went.
Ms. DeGette. OK. I do not think we have that in our--oh
here. Here is Mexican food exposure. Then would that have been
the next thing after that?
Dr. King. That is correct.
Ms. DeGette. OK. When was that given to them, after the
tomatoes were eliminated as a suspect?
Dr. King. As we gained more information then we were able
then to focus more and peppers became something of more concern
for us and with stronger association. And consequently the
questioning and the questionnaires reflected it.
Ms. DeGette. Do you think we might have been better off if
we focused on all the ingredients of salsa right at the time
that we thought salsa might be a problem rather than just going
down the tomato road?
Dr. King. It may have been. And I can certainly go back and
review that.
Ms. DeGette. Thank you very much.
Mr. Stupak. Dr. Acheson, you have indicated then, and I
know we have been down this pass before on Heparin and China
and all this with the FDA, but you said that the best way to
handle these issues is to build up the safety first, in other
words make sure the farm is growing a healthy product; correct?
Dr. Acheson. A safe product, yes.
Mr. Stupak. Safe product. How many inspectors, full-time
inspectors do you have in Mexico then checking farms?
Dr. Acheson. Nobody is, no FDA employees are permanently
stationed in Mexico.
Mr. Stupak. So then the only chance to make sure that you
have the safety of the product coming in is catching it at the
border then; right?
Dr. Acheson. Under the current system, yes. It is based on
inspection and sampling at the border. As part of the Food
Protection Plan, FDA beyond our borders, we are looking at
establishing FDA presence in a number of countries which would
include Central and South America.
Mr. Stupak. OK. But you are establishing it in China, are
you not?
Dr. Acheson. Yes, we are in the process.
Mr. Stupak. Did you not have the memorandum that was on the
pet food?
Dr. Acheson. We are in the process of establishing an
office in China, that is correct, yes.
Mr. Stupak. So do you have any food inspectors outside the
borders of the United States?
Dr. Acheson. Not currently, no. Not permanently. Not
permanently. They would go out usually for cause. If we know of
a problem that needs to be checked on.
Mr. Stupak. Correct. There has to be a problem first before
you will send them off over shores, offshores?
Dr. Acheson. Typically, yes, there does.
Mr. Stupak. So but to get to your safety, build up the
safety, as you have said----
Dr. Acheson. Yes.
Mr. Stupak [continuing]. You really should have the
inspectors in other countries, especially like in the winter
months we know we get most of our produce at least south of our
border.
Dr. Acheson. It is not all about inspections, it is about
building in the preventative controls. So we have got to set
the standards, we have got to work with industry to do that,
and we have to find a way to ensure that they are meeting those
standards. Some of that would be FDA inspections. As I know you
are aware, an area that we are exploring as a mechanism here is
an FDA-audited third party certification system.
Mr. Stupak. Correct.
Dr. Acheson. Simply because, as I said to Congressman
Dingell, we are looking at 200,000 foreign manufacturers. And
it is like let us focus on those that are high risk and let us
leverage every possible mechanism to be able to ensure that
they are building the safety in up front.
Mr. Stupak. OK. Now, Dr. King, if I may ask you, who is in
charge of coming up with the source here of the Salmonella, the
vegetable of interest if you will, the CDC?
Dr. King. The original epidemiology CDC is actually, that
is our responsibility.
Mr. Stupak. OK. So CDC told FDA look at tomatoes?
Dr. King. Yes.
Mr. Stupak. OK. Then who made the call to change the focus
to peppers, CDC or FDA?
Dr. King. It came through further investigations. By the
way, we do not do this kind of by ourselves, we do this through
conversations back and forth.
Mr. Stupak. Correct.
Dr. King. Our investigations and the epidemiology led us to
look more and more toward peppers. And I know Dr. Acheson and
folks at FDA. That was from our investigations then that led
them to further trace-backs down that track.
Mr. Stupak. OK. Who is the agency in charge then when you
have a food-borne illness outbreak, CDC or FDA?
Dr. King. It depends on what part of the outbreak. So we do
surveillance, we do epidemiology, we do outbreak investigation
and the laboratory. We do not do the trace-backs.
Mr. Stupak. Right.
Dr. King. So that is the bifurcation. FDA does the trace-
backs, the work on the food, or USDA depending on what the
product is, and so they are clearly in charge of that part of
it. We are clearly in charge of the other part of it. We talk
all the time, meet all the time. But that is how the
delineation is.
Mr. Stupak. You say you talk all the time but yet when I
hear Dr. Jones talk it sounds like no one talks to the State
officials who are really the frontline people, who really do
your epidemiology and stuff that Ms. DeGette went over, the
forms. Because I am still bemused by the fact that Dr. Jones
testified if they have an outbreak you know the names and
addresses, or FDA does, of the people who are being sick but
they cannot tell the frontline people, Dr. Jones, to warn them
or to try to at the local level take care of the issue. I just
find that amazing.
Dr. King. Thank you. And I will talk to Dr. Jones about
that. And I am sure he has good reasons to say that.
There are three systems that we have kind of in effect. One
is called Outbreak Net where we actually have the
epidemiologists in every state and CDC involved. The other are
daily conference calls during this outbreak with all the States
involved. And the other is CIFOR, which is this council to
improve food outbreaks. And that involves States and
epidemiologists. So there are three systems in place where I
think the dialogue continues fairly readily.
Mr. Stupak. Three systems in place. So would it not really
indicate that you need an incident command center that would
include State, local, federal, industry reps, science experts,
especially when you get an outbreak as big as this, 43 States,
District of Columbia, Canada?
Dr. King. I think that is something to take a look at. And
I appreciate your observation on that.
Mr. Stupak. Go ahead, Mr. Shimkus.
Mr. Shimkus. Yes. And just if this was a bio-terrorism
attack and then that is, and this is what we are all, a lot of
us are concerned with and you, we have said the system works
the same, but as far as the command and incident center does
the Department of Homeland Security get involved in that debate
then?
Dr. King. Yes.
Mr. Shimkus. Is that the command and control center that we
lack here?
Dr. Acheson. If there is--well, thankfully we have not had
to deal with one of those since----
Mr. Shimkus. That is true. But I mean we have to be--
hopefully we do not--but we need to start, we cannot shy away
from the risk and we have to ask these questions.
Dr. Acheson. Yes.
Mr. Shimkus. And this case study is a good case study to
help us look at that.
Dr. Acheson. If it was a deliberate act and we knew it was
deliberate, and I want to add that if somebody was putting
Salmonella in the food supply the chances are that they would
be treated exactly the same as this because it happens,
unfortunately, too often. If it was anthrax, which clearly
happens never, then it would be, the suspicion would be much
higher, law enforcement would be involved very early, and I
think the whole thing would be different.
Mr. Shimkus. But they would call upon you all for your
expertise in the public health departments?
Dr. Acheson. Oh yes.
Mr. Shimkus. In your trace-back?
Dr. Acheson. Yes.
Mr. Shimkus. And CDC.
Dr. Acheson. But I think your point and Chairman Stupak's
point is an incident command type approach for dealing with
these is one that seriously needs to be looked at as a
mechanism that involves at the very least the regulatory
individuals that are seated here, and others. The industry
piece is more complex because of the sharing of confidential
information. And I would love for us to break down those
barriers, it could only help.
Mr. Shimkus. And that is what we want to do.
Mr. Stupak. But following up on that question, if it is a
bio-terrorism attack how does--does law enforcement then and
security of our country trump those privacy concerns we have?
Does it trump the Privacy Act? Does it trump the agency chief
counsel who do not allow you to share that information? When
reading the Bioterrorism Act I do not see an exception for
that. So it would have been done the same way, not sharing
information.
Dr. Acheson. From FDA's perspective I do not think anything
changes. It may be different for Department of Justice, law
enforcement and FDA. I just----
Mr. Stupak. But you do not have any opportunity though if
it is a bio-terrorism attack to waive the privacy law, the
confidentiality, the trade secrets, whatever you want to call
it, proprietary interests I think was the words used earlier?
Dr. Acheson. Not that I am aware of but I will take that
back.
Mr. Stupak. No, I have not seen it either, so.
Dr. Acheson. And if there is something in the act to that
effect then I will obviously get back to you.
Mr. Stupak. And, Doctor, you quoted a legal opinion. Can
you provide that to the committee for the record?
Dr. King. I would be glad to. That has to do with the
county information, yes.
Mr. Stupak. Right. That is kind of the direction we want to
head. So thanks.
Let me thank this panel and thank you again for your time
and testimony. And we will continue on this issue.
[Witnesses excused.]
Mr. Stupak. I would like to invite our third panel of
witnesses to come forward.
On our third panel we have Mr. Michael R. Taylor, J.D., who
is the Research Professor of Health Policy at George Washington
University School of Public Health and Health Services; Mr.
Hank Giclas, who is Vice President for Strategic Planning,
Science and Technology at Western Growers Association; Dr.
Donna Garren, who is Vice President for Health and Safety
Regulatory Affairs at National Restaurant Association; and Dr.
Robert Brackett, who is the Senior Vice President and Chief
Science and Regulatory Affairs Officer at the Grocery
Manufacturers Association.
Thank you all for coming. 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 four wish to be represented by counsel at this time?
[No response.]
Mr. Stupak. Everyone indicating no. Then I will ask you to
please rise, raise your right hand, take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect the witnesses applied in
the affirmative. You are each now under oath. We will now hear
your opening statement, 5-minute opening statement. You may
submit a longer statement for inclusion in the hearing record.
Professor Taylor, let us start with you, sir.
STATEMENT OF MICHAEL R. TAYLOR, J.D., RESEARCH PROFESSOR OF
HEALTH POLICY, THE GEORGE WASHINGTON UNIVERSITY, SCHOOL OF
PUBLIC HEALTH AND HEALTH SERVICES
Mr. Taylor. Thank you, Mr. Chairman, I appreciate the
opportunity to testify today. I have submitted a written
statement, the purpose of which was to demonstrate that we have
a system problem here. And I think it is fair to say that the
testimony you have heard so far really demonstrates that, I
think really demonstrates we need a system solution. And I look
forward hopefully this panel can have some time to talk about
some of those solutions. But in my written testimony I tick off
really 7 elements of preparedness and planning for outbreak
response and investigation that are really lacking in the
current system. And I think we have heard about all of these
today:
And it is focused federal leadership and accountability, it
is somebody being in charge.
It is well-defined institutional roles across the system,
federal, State, and local, which we really do not have
formalized today, it is very ad hoc.
Adequate expertise in capacity, the funding issue that we
have talked about; clearly an element of this.
Prompt trace-back. And I think we can talk about some
specifics there. This issue of standardized data collection and
seamless data sharing I mean I think is really central to being
able to manage these outbreaks and also to deal with prevention
in a systematic way. And we do not have that provided for.
We have also heard about the need for active industry
engagement, which I absolutely agree with. And then coordinated
public communication is obviously essential.
I guess one thing I really want to emphasize is that
Congress has to act to address these problems. I think these
problems are built into our current system, the current
fragmentation organizationally in our food safety system at the
national level. It goes beyond outbreak investigation and
response, it really goes to the whole way in which we manage
our food safety system and it needs to be transformed.
As this committee well knows, we are operating at FDA under
a food safety law that is 70 years old that contains no mandate
for prevention, it contains no mandate to take an integrated
systems approach. I think the legislation you are working on
will address that.
The other element, of course, of the broader problem is
resources. We have talked about that today.
I would just like to emphasize the organizational issue.
And there has been an extensive study of this by the Government
Accountability Office, by the National Academy of Sciences, the
fragmented structure of the government's food safety system,
particularly at the federal level, but then also as we have
heard today, State and local agencies. It is health departments
at State and local level, it is regulatory agencies, it is
Departments of Agriculture, all of whom play roles without any
sense of how we or any clear directive. It could be a national
leadership role in seeing that entities work in an integrated
way.
So Congress really has to address this organizational, this
structural issue and really drive the development of an
integrated system. I would start that organizational reform at
the Department of Health and Human Services personally. Within
HHS we have food safety agencies, multiple components really of
the Food and Drug Administration as well as CDC, you know, all
of which work in their own traditional ways with their own
particular charges. They have their own cultures and ways of
dealing. None of them have the charge or the stature within the
government system to really exert leadership, nationally and
internationally for that matter, towards a more integrated
preventive approach.
So one of the things I would hope this committee would
consider in due course is unifying and elevating within HHS all
of the components of HHS working on food safety so that single
office, a single official can be in charge and accountable for
all HHS food safety activities, including outbreak response and
investigation, but going beyond that to include all the things
we need to do to build a preventive, integrated food safety
system in the country.
So with that I look forward to the opportunity to discuss
any of these ideas and solutions to some of the problems that
have been identified here today.
[The statement of Mr. Taylor follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
Mr. Giclas please.
STATEMENT OF HENRY GICLAS, VICE PRESIDENT, STRATEGIC PLANNING,
SCIENCE AND TECHNOLOGY, WESTERN GROWERS ASSOCIATION
Mr. Giclas. Thank you, Chairman Stupak, members of the
committee. Western Growers is a trade association representing
growers, shippers and handlers of fresh fruits, nuts and
vegetables in California and Arizona. Our 3,000 members produce
approximately half of the United States' total production of
fresh fruits, nuts and vegetables. We appreciate the
opportunity to speak before you today on our activity and
learnings related to food safety.
The industry has a long history of implementing and
improving our food safety programs and defense capabilities to
protect public health as well as business interests. In the
early 1990s we led to develop the first ever Good Agricultural
Practices document that recommended key areas and strategies
for reducing risk. These guidelines addressed production,
harvest, cooling, processing, transportation, and retail and
food service handling. They later became the basis for the
FDA's Guide to Minimized Microbial Food Safety Standards for
Fresh Fruits and Vegetable--excuse me, Hazards. Today that is
the baseline for all food safety guidance.
When the Guide was published our emphasis shifted to one of
education of extension. A cottage industry of third party food
safety consulting and auditing firms began to grow. These
programs have driven a high level of implementation as buyers
demand audits as a condition of doing business in the
marketplace. This benchmark set of guidelines and food safety
paradigm has evolved significantly over the last few years for
select commodities. Today, commodity-specific guidance has been
developed for lettuce and leafy greens, tomatoes as you saw
this morning, and cantaloupes. And there is work under way on
green onions and herbs. These are each grounded in the FDA
Guide and utilize an approach based on hazard identification,
assessment and control.
Despite the continuing improvement in guidance there have
also been continuing outbreaks. The 2006 outbreak in spinach
drove the industry to move far beyond existing paradigms to
even more prescriptive sets of best practices. California and
Arizona now have established uniform GAPs and a corresponding
verification program that requires implementation of food
safety measures developed in concert with public health
authorities and private sector experts. These newer generation
guidelines include specific requirements for risk assessment,
sampling and analysis of inputs, safety response measures and
requirements for documentation. Compliance with these
requirements is verified by government inspectors in the field.
And we believe this model should provide direction for broader
national and international efforts to improve food safety.
The model program brings together the strengths of State
and federal government, the national and international research
community and the industry itself in a coordinated fashion to
ensure science-based best practices for preventing or reducing
the potential for contamination. The Health and Human Service
agencies are in a key position to identify the areas that
industry must address based on the data and information they
have gathered and analyzed in epidemiological investigations
and trace-back. Addressing these risks in turn becomes the
focus for enhanced best practices.
Verification can rely on inspectors who are already in
place throughout the country. FDA is exploring this option by
evaluating how third parties might assist in providing ``boots
on the ground'' for verification and inspection.
Western Growers firmly believes that prevention is our
strongest tool in efforts to reduce food-borne illness
associated with produce. But a model program also must address
the response to any discovery of contaminated product in the
marketplace or outbreak of food-borne illness.
Collaboration is equally important in efforts to respond.
The FDA and CDC have an army of industry personnel at the
ready. A formal recognition of this industry expertise and a
commitment to strengthen communication with industry during an
outbreak will both help protect the public and minimize
economic damage to the industry.
We believe the time has come to cease operating in silos
and work hand-in-hand using the strengths, talents, and
expertise of all parties to improve food safety. The program
for leafy greens adopted in California and Arizona is moving
the industry closer to achieving our common goal of minimizing
the incidence of food-borne illness associated with the
consumption of fresh product. We encourage this committee to
assist the industry to build on and extend the success of these
efforts.
I appreciate the opportunity to testify today on behalf of
Western Growers. I look forward to any questions you might have
regarding our efforts.
[The statement of Mr. Giclas follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
Dr. Garren, your testimony please.
STATEMENT OF DONNA GARREN, PH.D., VICE PRESIDENT, HEALTH AND
SAFETY REGULATORY AFFAIRS, NATIONAL RESTAURANT ASSOCIATION
Dr. Garren. Chairman Stupak and members of the
subcommittee, thank you for this opportunity to testify before
you today on the recent Salmonella outbreak.
The National Restaurant Association, founded in 1919, is
the leading business association for the restaurant industry,
which is comprised of 945,000 restaurant and food service
outlets and a work force of 13.1 million employees, generating
estimated sales of $558 billion in 2008. Nationwide, the
industry serves 133 million guests every day.
Food safety is the utmost importance to the restaurant
industry. Restaurants have taken the lead in assuring food
safety within the four walls of our restaurants. The National
Restaurant Association and our members are making multi-billion
dollar investments in improving food safety and developing
state of the art food safety education programs. We are
especially proud of ServSafe, the food safety education program
that sets the standard for our industry. More than 3 million
food service professionals have been certified through our
ServSafe Food Protection Manager Certification exam.
The current Salmonella outbreak is one of the largest in
U.S. history. Of particular concern was the over 2-month period
of time needed to identify the source of the outbreak and the
mid-course change in focus of the cause of the outbreak. We are
at a critical time in food safety, and all of us have a road to
play.
This highlights, the outbreak highlights the need to re-
evaluate our food safety system and implement needed
improvements. Of particular concern is the complexity of the
food distribution channels for fresh produce and the challenges
presented when a finished product served to customers contains
a number of ingredients. This complexity presents challenges to
the public health officials leading the efforts to resolve this
outbreak in timely manner. In moving forward, we need a better
approach. We need a farm-to-table approach.
We build confidence by showing people that we are always
ready, always vigilant. For the purpose of this hearing we
would like to focus on key areas of moving our food safety
efforts forward. Adequate funding for FDA, improved
collaboration and communication, stronger standards and
practices for produce, and additional tools that include recall
authority, traceability, improved epidemiological
investigations, and private sector certification.
The recent outbreak highlighted the need to provide FDA
with adequate resources to do its job. We are encouraged by the
Fiscal Year 2008 supplemental increase for FDA of $150 million,
further increases recommended for Fiscal Year 2009 budget as
well. However, this can only be a down payment on a sustained
effort to increase the agency's appropriated base.
This outbreak also highlights the need for increased
collaboration and communication between industry and
government. The fact that fresh produce is commingled and
repacked at various steps in the chain should not present an
insurmountable problem. There are industry experts who
specialize in the distribution of these types of products.
There should be a mechanism that allows the agency to tap into
this expertise to facilitate a more meaningful investigation of
the crisis at hand. While we recognize that conducting an
outbreak investigation is a governmental function, we would
urge a greater level of collaboration and communication between
government and industry, as we all benefit from a rapid
resolution.
Effective communication guides the public, the news media,
healthcare providers, and industry in responding appropriately
to outbreak situations. There are certain challenges and
hurdles inherent in developing materials to inform and educate
the public about potential health and safety risks in an
accurate and timely manner. We must overcome these obstacles
and improve how we communicate health and safety information.
It would be a serious error to underestimate the importance
of developing, by consensus among stakeholders, the final
version of risk communication strategy and plan. Communications
professionals in the public and private sectors need to ensure
strong and well-integrated working relationships that will help
sustain communications resources as an outbreak evolves. The
planning, preparation, and practice must begin now.
Over the past several----
[Bells.]
Mr. Stupak. Stop. Soon as we start again.
Go ahead.
Dr. Garren. OK. Over the past several years, there have
been repeated calls for stronger safety standards for fresh
produce. This outbreak reinforces the importance and urgency of
that task. The produce industry has taken positive, proactive
steps to establish standards. Now it is time for the FDA to
take the next step.
The first goal of any food safety system must be
prevention. FDA's good agriculture practices, developed a
decade ago, should be updated and made mandatory. The National
Restaurant Association supports the FDA in setting mandatory
general standards for produce as well as commodity-specific
standards for commodities the FDA deems as posing a higher
risk.
Prevention alone cannot guarantee safety and so emphasis
must be placed on rapid response when an outbreak does occur.
This leads directly to the issue of traceability. The produce
industry has made important strides in recent years to improve
traceability, yet more can be done. We must apply our best
collective knowledge, expertise, and emerging technology so
that finding the source of contaminated produce is a matter of
hours or days, not weeks or months.
Traceability systems may need to be developed commodity by
commodity to address varying supply chains. A one-size-fits-all
strategy may not work for all sectors and stakeholders. In
addition, any credible traceability system should be effective
for all stakeholders and routinely tested to determine
potential flaws prior to a crisis event.
The National Restaurant Association supports granting the
FDA the authority to recall a food product that poses serious
adverse public health risk and the company refuses to complete
a voluntary recall. Enhanced and coordinated recall
notification should be developed to better inform the consumer
so that the FDA is communicating these notices to the public in
a consistent manner.
We also believe that there should be better resources for
investigating outbreaks at the State level. The epidemiology of
food-borne illness is sophisticated and always changing. Many
States lack the manpower and resources to do it well. Poorly
managed investigations can be catastrophic, as we most recently
demonstrated by this particular outbreak.
We must ensure States have the necessary funding available
to access this information and implement better investigations
related to food.
Increasingly, our members are relying on private sector to
ensure compliance by suppliers with food safety standards. This
approach provides consistency of standards and quality across b
orders, cost efficiency in the supply chain, and less
duplication of certification processes, and simpler buying. We
believe the FDA should support the use of third party
certification as a way to leverage the agency's limited
resources.
In conclusion, the ongoing Salmonella outbreak has been
long, costly and frustrating for all concerned. We must do
better. This means taking a new look at our food safety system
to ensure we have a comprehensive farm-to-table strategy. We
must look for ways for government at all levels to collaborate
more closely with industry experts during the course of an
outbreak investigation. And we must establish stronger
standards and practices that move us towards continuous
improvement in produce safety.
Thank you for this opportunity to testify.
[The statement of Dr. Garren follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Dr. Garren.
Dr. Brackett, your testimony please, sir.
STATEMENT OF ROBERT E. BRACKETT, PH.D., SENIOR VICE PRESIDENT
AND CHIEF SCIENCE AND REGULATORY AFFAIRS OFFICER, GROCERY
MANUFACTURERS ASSOCIATION
Mr. Brackett. Thank you, Chairman Stupak and other member
of the subcommittee.
The Grocery Manufacturers Association represents the
world's leading food, beverage and consumer product companies,
and the members of GMA share your commitment to ensuring the
safety of our nation's food supply. Product safety is the
foundation of that consumer trust.
The recent investigation into the food-borne illnesses
outbreaks due to Salmonella Saintpaul is the latest event to
challenge our whole food safety system. The inability of the
current food safety system to rapidly and accurately determine
the source of Salmonella Saintpaul in this outbreak is a major
contributor to the erosion of consumer confidence in the safety
of the nation's food supply.
The topic of this hearing is what we have learned as a
result of the Salmonella outbreak. And we have learned three
things. Clearly, the first thing we have learned is that FDA is
in dire need of additional resources to carry out its mission
of protecting the public from food-borne hazards, and not just
money but in terms of scientific expertise and IT
infrastructure. And all of that goes along with protecting the
food supply.
Secondly, we have learned that the ability to trace a
product is meaningless if the epidemiological data implicates
the wrong product. This highlights the need for more resources
at the State and local levels as well so that we can more
rapidly and thoroughly investigate these food-borne illnesses
if they occur.
Third, we have learned the need to do more to prevent food
safety incidents in the first place.
The GMA has led the effort to provide current guidance to
the food industry, both domestically and abroad, by issuing the
GMA Food Safety Chain Supply Handbook this past April in 2008.
And I have a copy of that here for you. This reference manual
represents a tool chest for companies in search of examples of
successful management practices for suppliers to consider. The
GMA Handbook clearly states that at a minimum, suppliers and
transporters should consider their ability to trace back and
trace forward the movement of ingredients and finished goods
through the whole supply chain.
But traceability was not the real issue in the Salmonella
Saintpaul outbreak that we are discussing today. We really need
to modernize our entire food safety system. GMA continues to
propose that Congress modernize our food safety system by
making risk and prevention of contamination the focus of our
food safety strategies going forward. GMA CEO Cal Dooley and I
have testified many times before Congress on the issue of
improving food safety. We have consistently proposed the
following reforms, many of which are included in legislation
already introduced in both the House and the Senate. These
include first:
One, that we urge you to give FDA the power to establish
mandatory safety standards for fruits and vegetables. In
particular, give FDA the power to establish food safety
standards for those fruits and vegetables that have repeatedly
been involved in food safety incidents.
Two, we urge you to require food companies to have a food
safety plan. In particular, every food company selling food in
the U.S. should conduct a food safety risk evaluation that
identifies potential sources of contamination, identifies
appropriate food safety controls, and verifies that those
controls are effective, and then documents those controls in
the food safety plan subject to FDA review.
Now, with respect to trace-backs, Congress and the FDA
should evaluate the trace-back requirements in the Bioterrorism
Act to determine whether it should be extended to farms, given
these recent developments.
In addition, there is also one inadvertent outcome from the
Bioterrorism Act. The law clearly requires food companies to
keep the ``one up-one down'' records that have been discussed
so far. However, there appears to be some ambiguity as to
whether the law gives FDA the express authority to check during
a routine investigation to see if a company is, in fact,
keeping such records. We believe Congress should clarify FDA's
authority. By expressly granting FDA such authority, FDA can
better assess whether companies are properly prepared to trace
product when a food-borne incident does occur.
Third, require every food importer to police their foreign
suppliers. In particular, Congress should require that all food
importers document the food safety measures and controls being
implemented by their foreign suppliers and should require food
importers to make their foreign supplier food safety plan
available to FDA.
And, four, build the capacity of foreign governments and
enlist the help of the private sector. In particular, Congress
should direct FDA to develop a plan to help build the
scientific and regulatory capacity of major exporters to the
U.S. and should create a registry of private laboratories that
meet FDA standards.
Mr. Chairman, we are grateful for the opportunity to work
with you and promote a risk-based approach to food safety
regulation and to allow FDA the flexibility to respond to
emerging risks in the manner that most efficiently uses the
agency's precious resources. We look forward to working with
you to develop and implement improvements that will make risk
and prevention the focus of our nation's food systems.
This concludes my oral testimony. And my written
testimonies have been submitted for the record.
[The statement of Dr. Brackett follows:]
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Mr. Stupak. Thank you. And thank you all for you testimony.
Unfortunately, as you know, with the bells ringing we have
votes. We have 5 minutes left on the floor for us to go vote.
We have six votes. I want to say 3:15 we will come back and we
will go with questions. I hate to ask you to stay another hour
but we want to get the questions in. So let us come back here
at 3:15.
OK, the committee will be in recess until 3:15.
[Recess.]
Mr. Stupak. I thank you for staying with us. And sorry, we
thought it was going to be a short deal. There was a special
motion on the floor, took a little bit of time, that is why we
are an hour late, or for those of us who live in Central Time
Zone we are right on time, 3:15. But we will start with some
questions here.
Let me ask this, Mr. Giclas, when this outbreak first
occurred and tomatoes were named as a possible source of
Salmonella, large portions of Florida or in this case the
entire State of California were not in production and,
therefore, it would have been impossible for Salmonella to be
in the tomatoes. Nonetheless, almost the entire growing
industry has been broadly painted, and still is today, with the
same brush, at least in the eyes of consumers.
Is there anything with respect to CDC or FDA's messaging to
the public that can be improved so not to hurt certain parts of
industries that are not responsible for outbreaks?
Mr. Giclas. Mr. Chairman, my response to that would be I
think there is a lot of room for improvement in the messaging
in a couple of different ways.
First of all, I think that CDC and FDA ought to just tell
people what they know when they know it and, you know, not get
into a position where they are speculating on what other
products or what other commodities or what other regions. I
think, I also think that the frequency of communication was
problematic in this particular outbreak because there was, you
know, a series of media calls that were held over and over and
over with really nothing new to report other than an update on
the numbers, but no significant findings, if you will.
Mr. Stupak. OK. Dr. Garren, Dr. Brackett, in the
Bioterrorism Act of 2002 both the restaurants and the farms
were exempt. Would you now agree that we should put them in the
Bioterrorism Act so we can do traceability better? On behalf of
the restaurants, Dr. Garren, what would you do, would you agree
you should be part of this process?
Dr. Garren. We definitely believe that there should be a
farm-to-table strategy.
Mr. Stupak. How about restaurants?
Dr. Garren. Excuse me?
Mr. Stupak. Restaurants?
Dr. Garren. We want to work with FDA. Right now we would
say that, you know, we represent a very diverse industry that
goes from the small, independent operator all the way to the
multi-unit operators.
Mr. Stupak. Agreed.
Dr. Garren. And in this particular case, you know, I would
say in regards to the Bioterrorism Act I would say we already
voluntarily comply with it in that we were able to in this
particular case supply information to FDA in a timely manner.
It might have been purchasing records for those small unit
operators. Those small unit operators that is how they may
make----
Mr. Stupak. Yes, but one of the problems is that you may
be, if you are not part of the act maybe the records you are,
and we have seen this throughout this whole investigation,
records you are providing may be something different than what
the distributors gave to you. I think and when we were dealing
with the other panels you almost need a seamless form system
where we are all using the same systems, otherwise it just
burdens everybody. You have paper, they have electronic, they
have something else, bill of lading, some are on back of a
brown bag they said, that is some of their records.
Dr. Garren. Right. We would want to work with the
stakeholders involved, including government, to come out with
an approach that works to integrate commodity to commodity, and
incorporate the needs of different stakeholders. I think a one-
size-fits-all strategy for traceability might not be working
for every particular business type. We need to take into
account where we move from here. But we definitely welcome the
opportunity to work to move in that direction.
Mr. Stupak. Dr. Brackett, do you want to add anything on
the behalf of the Grocery Manufacturers?
Mr. Brackett. Yes, I would make a comment specifically on
the farm side of it. This this is in this particular group of
products, those that are high-risk products, most of the
problems have been in the past the fact that they have not been
able to track back to the farms. And so if you are going to
have a farm-to-table approach I think they would have to be
included. And I think the industry is well on its way to doing
that already.
Mr. Stupak. Mr. Taylor? Professor Taylor, do you want to
add anything on that?
Mr. Taylor. Well, I think as long as you are in the mode of
having a system that is dependent upon government investigation
of company records and you want a farm-to-table system you have
to extend it to restaurants and farms. I guess I would
encourage consideration of a completely different approach
though. Because in a public health context it seems to me what
FDA needs to be able to do is rapidly get trace-back
information that the companies have and give answers to FDA as
to where a product came from instead of creating company
records that then still rely on FDA to do the investigation. So
rather than rely on those internal records, you know, I would
suggest, for example, as I did in my testimony, creating a
performance standard if you will.
Mr. Stupak. Right.
Mr. Taylor. Having Congress legislate or authorize FDA to
do commodity-specific rulemaking that would say based on
available technologies everyone in that supply chain should be
able to tell FDA within 4 hours, 8 hours, 12, whatever you
judge or FDA judges is technologically feasible, the duty is to
provide that information within a certain period of time. And
then the companies can figure out what specific technology or
set of practices work for that commodity or that business model
and not get the government into the business of trying to
create the trace-back system but set the performance standard
that every company has to meet.
Mr. Stupak. Or at least some minimum standards that we need
for trace-back?
Mr. Taylor. Yes.
Mr. Stupak. And then let the industry by commodity work on
it?
Mr. Taylor. Yes. And based on an assessment of what is
technology feasible and can be done in a cost-effective way but
then leave it to the companies to innovate the specific systems
that meet that performance standard for timeliness of
disclosure of where a product came from.
Mr. Stupak. Mr. Giclas, you indicate that Arizona and
California have standards they have developed together for
what, leafy greens, tomatoes?
Mr. Giclas. Well, the first panel this morning spoke
specifically about the standards for tomatoes in California and
Florida. My testimony was about the leafy greens program in
California and Arizona.
Mr. Stupak. Could that be replicated throughout the U.S.? I
mean you are the only two States that are doing it right now.
Mr. Giclas. It absolutely can be replicated. And it is one
of the things that, you know, we are bringing forward as a
potential model. It is very similar to what is being done in
tomatoes in both California and Florida on the part of the
tomato industry. So it is an example of some of the commodities
that have been deemed to have higher risk like leafy greens,
tomatoes, cantaloupes, there are some others, where industry is
coming forward to put these best practices, if you will, in
place. And I think what we need to do is provide that line of
sight to FDA and to others.
Mr. Stupak. I asked the other panel, and I guess it was
only I think the other panel said, the first panel, was a penny
to print on the box the code. But like to implement this, do
you have any cost estimates what would it cost to implement
this? I mean that goes out the system I realize from farm to
table, but.
Mr. Giclas. Well, leafy greens there's a couple of
different costs that are associated with it. There is a 2 cent
per carton assessment levied on the industry to support the
verification program and the administration of the leafy greens
programs. That cost is borne by everybody but it is not--there
are also additional costs for every individual firm in terms of
ramping up to meet the requirements of the leafy greens metrics
or best practices, if you will. And those have been estimated
to be, you know, on the order of 25 cents a carton. There is
the significant investment in this program. It has probably
tripled through safety investments in California and doubled
the number of staff that are focused on food safety. It is a
very significant expenditure ultimately.
Mr. Stupak. Dr. Brackett, do you have any estimates, or
Restaurant Association estimates what something like this would
cost if we had sort of like uniform standards throughout the
nation, had to do it? I would take it you would be in favor of
uniform standards maybe promulgated by the federal government,
FDA, whatever, but let industry implement it to a minimum
standard. And what would the cost estimates be, if you have any
costs, Mr. Brackett?
Mr. Brackett. Well, Mr. Chairman, I do not know what the
cost is. We have been down that. Many of the industry already
have systems in place already so they have already bought those
costs, those systems already.
But I agree with Mr. Taylor that having a performance-based
system where the requirement is what the government expects or
what the regulatory agency expects in terms of response in
order to trace back and then allowing the industry to adopt to
whatever the best technology is at the time is probably what we
would support.
Mr. Stupak. OK. Let me ask this, and whoever can answer it.
Industry, like Jack In The Box, they had a problem one year.
And they started putting in a system that made demand their
growers do certain things. Some of the other, McDonald's I know
do, and others. Has that worked? And what is the benefit of
that as opposed to having the government put in something?
Anyone want to comment on that?
I mean I heard two things: number one, it can work. Even if
the tomatoes are being grown in Mexico, if you are McDonald's
you are a big enough corporate player you can say, you will do
it this way, and get compliance even in a foreign country. And
I have heard from other farmers who will say, well, these
corporations while they are concerned about the safety of the
food but they are putting other restrictions on us which are
more risk management like fences and things like that, that
have nothing to do with growing or protection. Can you shed a
little light on that? Mr. Giclas, you are nodding your head?
Mr. Giclas. Well, I would be happy to honor or to answer
that part of the question. I am sorry. This has been a
significant point of frustration for many, many growers. We
have worked very, very hard and in close collaboration with the
public health community to identify, you know, a set of best
practices that we believe are prudent, science-based and
feasible and implementable in the field. Those best practices
are, you know, part of this program for leafy greens. And yet,
there are individual buying companies that will say, for
example, if you are estimating an approximate safe distance
between a livestock operation and a produce operation, which
you should keep separate----
Mr. Stupak. Right.
Mr. Giclas [continuing]. We might say that a quarter mile
is a safe distance. Or the distance may vary based on the risk;
is it uphill, is it downhill, are there barriers in between
that might, you know, prevent some escape of. Anyways, I guess
the point is if we say a quarter mile and that has been vetted
by science, there may be others who say a mile or 2 miles or 3
miles is better. Every single one of those new requirements has
a cost to it. It takes valuable production land out of the
equation and it jeopardizes people's ability to continue to
farm. It may not be science based.
So those are the kinds of things that we are dealing with
with these extra requirements.
Mr. Stupak. Professor Taylor?
Mr. Taylor. Yes. Mr. Chairman, I was administrator of the
Food Safety and Inspection Service----
Mr. Stupak. Right.
Mr. Taylor [continuing]. For USDA in the aftermath of the
Jack In The Box E. coli outbreak and saw what happened in the
industry after that and also the efforts we made in the
government to try to improve standards. And the first thing I
would say is that, I mean Jack In The Box in particular, but
also other major retailers went through enormous transformation
in terms of their own management of their supply chain putting
specifications on suppliers. The beef industry really got with
that program and has gone through enormous positive change to
bring technology into the processing. And I think they have
made real progress, all based on the principle of preventive
controls. And so industry innovation has been critical to
progress on food safety.
But the other side of that--Go ahead.
Mr. Stupak. But then what happened to the beef industry?
Because we had the largest recall ever, 143 million pounds of
beef here. And we had a hearing on that.
Mr. Taylor. Yes.
Mr. Stupak. And I mean did it just get sloppy or what?
Mr. Taylor. Part of the, well, one part of the reality is
that the E. coli problem is not a problem you solve on one day
and it stays solved.
Mr. Stupak. Right.
Mr. Taylor. Because that bacteria changes, it is a very
dynamic problem.
But the other point I wanted to make is that while
innovation gets driven and really created in food safety by
industry practices typically, there is an essential role for
government regulation to set standards and ensure that it is
not just the good actors who have the market incentive to do
that, to make the changes, but that everybody makes. And that
you bring the lower performers up to an acceptable, a socially
acceptable level. And you also achieve the objective of having
a common sense based standard so that their, you know,
businesses can plan. And I think it would help probably address
some of the concerns that Mr. Giclas raised.
So again I think you have to look to both, you know,
industry, private sector innovation to really drive progress,
but then government standard setting and hopefully in a
performance standard way so that, again, you see what is
possible through innovation the industry itself has done and
you set government performance standards to ensure that
everybody meets that standard that has been demonstrated to be
feasible.
Mr. Stupak. Mr. Giclas, one more and my time is up. But,
you know, Salinas Valley we have had, what, 20 outbreaks in 10
years. And why can we not seem to resolve that issue? It seems
like every 9 months or so we have a spinach or a leafy problem
with E. coli or Salmonella coming out of that particular area.
If we have learned from all these different experiences why can
we not solve that Salinas Valley problem? Any suggestions? I
throw it out to all my panels.
Mr. Giclas. Well, what I can say is that after the 2006
outbreak in spinach we really as an industry focused in on, you
know, looking at these practices, what we could do. And now we
have gone a full season without an outbreak. This program is in
place. We are hopeful that this program has resolved these
issues and this problem.
As has been pointed out, you cannot get to zero but we can
do everything we can to minimize. We think we have the best
program in place to do that now.
Mr. Stupak. All right, thanks. I guess only Dole and
Natural Select are the only ones really aggressively doing the
program that has been put forth by industry; right? In that
spinach area in the Salinas Valley?
Mr. Giclas. This program is subscribed to by 120 different
companies I believe.
Mr. Stupak. OK.
Mr. Giclas. Representing 99.9 percent of the volume of----
Mr. Stupak. The Salinas Valley.
Mr. Giclas. Yes.
Mr. Stupak. OK. Mr. Burgess for questions, please.
Mr. Burgess. I thank everyone's indulgence for what is
turning into a very long afternoon.
Professor Taylor, if I could just ask you, again I
apologize for being absent for part of your testimony, but on
the part where you discuss some of the problems within the food
safety program at the FDA, and one of the things you allude to
is that because of the bifurcated mission of the FDA, drugs and
devices get more attention, and perhaps it is even the presence
of a user fee that may drive attention in the direction of
drugs and devices.
I know we are going to have at some point the opportunity
to discuss a draft here at some level at this committee, and I
got a feeling that user fees are going to come up. So what is
your feeling about the presence of user fees as it pertains to
the food safety side of the FDA's bifurcated mission?
Mr. Taylor. Well, I think I mean user fees on the drug side
has served a very useful purpose of providing adequate funding
for that drug review program. And that is now a program that
has demonstrated that with adequate resources FDA can manage
efficiently a timely drug review program. So it has worked in
that sense.
And my point in the testimony, of course, was that that has
had a bit of a distorting effect, unintended, on management
attention and the allocation of resources within FDA. And so
user fees are a complicated issue and potentially a mixed
blessing.
On the food side, you know, I am of the old school that
says that ideally we would fund public health programs through
appropriated resources. And I think ideally that is what should
happen. I----
Mr. Burgess. Just for the record, I agree with you. That is
the fundamental purpose of the Food and Drug Administration and
should be the fundamental purpose of our appropriations.
Mr. Taylor. And I think philosophically that makes all the
sense in the world. I think the issue though is in the world in
which we live and in which you live, I mean how, the core issue
for food safety is how do we provide an adequate, stable,
predictable base of resources for FDA? That need for food
safety at FDA, and that need has to be met. And so it may not
be an ideal world and maybe there is a fee that could be done
that will generate revenues.
And I think I would personally be willing to compromise on
the philosophy point if we could find a way to get a base of
resources that was fair and not too onerous but would generate
a sufficient, you know, core of resource for FDA so that it
could do its work and, again, and maintain the independence and
all that I think is important for its food safety public health
function.
Mr. Burgess. I will just ask if anyone else on the panel
has a feeling about that, about what Professor Taylor just
alluded to. I will tell you, philosophically I have difficulty
with it. It is almost like we are abrogating our responsibility
to provide the protection where it belongs which is within the
food safety aspect of the FDA. But does anyone else have an
opinion about that?
Dr. Garren. We do not support user fees. We do, as you
mentioned, believe that food safety is a common benefit to all
and should be out of the general revenue fund and be
appropriate to fund FDA so they can do their job.
Mr. Burgess. Mr. Giclas, let me just ask you, you talked
about a 1 to 2 cent charge for the tracking code on the box. In
a sense that is a user fee, is it not?
Mr. Giclas. It is, sir. It does fund the program. But the
program is industry designed. It has industry at the heart of
it in the sense of, you know, oversight on funding and spending
and administration. ? So it is something that was willingly
subscribed to.
Mr. Burgess. And you can sleep peacefully at night knowing
that 1 to 2 cents is not going to grow the government into some
other aspect or some other place in your life.
Mr. Giclas. Absolutely.
Mr. Burgess. Very good.
Dr. Brackett, let me just ask you a question on the--and we
have heard a lot about this today from various sources, but
what is the role for the food companies and the importers in
the prevention of food-borne illness?
Mr. Brackett. Well, it is the food companies that actually
provide the safe food to the public. And it is their
responsibility to actually make sure that those preventative
controls that have been mentioned several times today are
actually implemented. And I quite agree with Professor Taylor
that it is the role of government to set those standards, and
then if you allow the industry to actually meet those standards
they will find ways to do that.
Mr. Burgess. And then what, in the event of an outbreak or
in the event of a problem what should the role be?
Mr. Brackett. Well, I think the role should be to assist
the regulatory agencies as much as they can. And again I would
like to repeat what has been said elsewhere that if the
regulatory agency and CDC do not have, either do not or do not
have the ability to tap into the resources that the industry
has in terms of scientific expertise and information I think
they are missing the boat.
Mr. Burgess. Let me ask a question in regards to what we
have heard a lot about today in the 2002 Bioterrorism Act. And
earlier we heard a lot from the standpoint of the importers.
But as far as restaurants are concerned, the ability to opt out
of the reporting and the recording requirements, in light of
what we have learned with this outbreak and what we have
learned today is it still reasonable to allow restaurants to
opt out of the requirement when we have 130 people visiting
these establishments every year?
Dr. Garren. Thank you for the opportunity. We, while we are
exempt from the Bioterrorism Act I would say that we are
voluntarily complying now and that we keep the necessary
records to know where we are getting product from. You know, I
often say, you know, follow the money. I mean people know who
they are buying product from. They have to pay the bills. And,
you know, so they know that when FDA comes, even a small
independent operator, it may be a paper-based system but they
are maintaining those records because they have to financially
to know who they are paying product to.
So we would say that, you know, they are supplying the
information needed to FDA. We need to come up with an approach
and we welcome the opportunity to work with all the
stakeholders, including federal and state food safety agencies
and all the stakeholders along the supply chain to look at
approaches that will work for all stakeholders involved, taking
into account different business types, and in some cases taking
into commodity types, because one-size-fits-all approach
strategy may not work for everyone.
Mr. Burgess. But in this instance would it not have been
better if it was rather than voluntary compliance that it was
required compliance?
Dr. Garren. I would offer that in this particular case
that, you know, the restaurants that were involved, even the
small operators were able to supply the necessary information
to facilitate a rapid response from them. FDA's ability to then
go through and assess the amount of paperwork that they had to
work through to build a case, you know, in regards to I guess
collection of data, evidence and, you know, securing that
information made a complicated and frustrating investigation.
Again, we are, you know, willing to work with creating a
program that works for all.
Mr. Burgess. So it was more the FDA's inability to ask the
correct question at the correct time of the correct person, not
the inability of the small restaurant to provide the needed
data when it was requested?
Dr. Garren. They were supplying the information. And I
think the earlier panels did indicate that, you know, we were
looking down the wrong path too. So that also made the length
of this outbreak, you know, they were supplying information on
tomatoes. When asked about jalapeno peppers they quickly were
able to supply the information needed to facilitate trace-back.
Mr. Burgess. But realistically, how burdensome would it be
to require the restaurants to participate in a trace-back
system?
Dr. Garren. You know, I do not know what the actual costs
associated with that. And again, we would be willing to look at
different strategies. I think if we are looking at the
diversity of our industry you have a breadth of, you know,
small independent operators collecting data on paper all the
way through very sophisticated electronic tracking systems
through the distribution chain, distributors that supply to our
operators as well as large chains that have systems.
We need to make sure that they take into account the
different business types and we need to create a new system.
Mr. Burgess. Mr. Giclas, let me ask you this because it
came up during some of our other hearings where we were
actually talking about food-borne illnesses in Asian countries.
And the statement was made by one of the suppliers that if they
found that one of their suppliers was providing a product that
was somehow damaged that they didn't feel compelled to report
it to other businesses in the area, this was just something
they kept to themselves. And in fact they didn't even feel
compelled to report it to the FDA who is responsible for
ensuring the food safety. And the issue came up around the
issue of maintaining a competitive advantage.
Well, do you think members from your organization would be
willing to sacrifice some or to provide some leniency on trade
secrets, provide information, provide that collaborative role
with public health officials in the event of an outbreak or
during the course of an investigation? How closely held are
those trade secrets and would you be willing to relax those
somewhat during the course of an investigation of an outbreak?
Mr. Giclas. Well, I think in the investigation of an
outbreak the industry would comply fully and does comply fully
with, you know, the requirements, the law. I mean in terms of
learning from an outbreak I think we are all willing to sit
down with FDA and others and share information, including what
might be confidential business information. That is an
individual company decision. But I mean I am certain that
people would be willing to collaborate, you know, to improve on
trace-back and to improve on those types of things.
The leafy greens program that we have in California and
Arizona if you are actually sourcing product from somebody who
is not compliant that would be communicated to others so that
they would know that there is a non-compliant supplier out
there and not be able to--or not go to them to, you know, to
source product if you will. So there are some additional
preventive steps that are in place in this construct that we
have for the leafy greens industry.
Mr. Burgess. Thank you. And thank you, Mr. Chairman, for
your indulgence. I actually if I could submit some questions in
writing to the panel, just would like to get some follow-up on
the issue of if we are ever able to close our border in the
event of an outbreak, again the finding of this problem on a
Friday morning and not being able to do anything about it for
several days is pretty frustrating to the American people I
think.
Mr. Stupak. Sure, no problem. We will at the end there when
we close out this hearing we will leave the record open for 30
days for additional written questions then.
Mr. Burgess. Thank you.
Mr. Stupak. Mr. Giclas, in the last question from Mr.
Burgess you indicated sure we would like to sit down with the
FDA if there was an outbreak and we would all share our records
and the proprietary interests would probably be--it would not
be burdensome. But I got the impression in listening to the
three panels today, and especially Florida and California, like
in this whole Salmonella Saintpaul no one ever sat down with
the growers or producers to say we have this problem. We
referred to it throughout today as an incident command. Like
you think you would sit down with the growers, distributors,
the wholesalers, the local health department, State health
department and say, OK, where are we going with this? It seems
like everything was stovepipe we call it the information was;
this one does not talk here and that, and they use these ideas
like Privacy Act, proprietary information as not to do that. I
think the American people think that when you have an outbreak
you are all sitting around a big table like we have in front of
us saying, OK, where do we go? How do we do this? Could the
tomatoes possibly come from Florida? Was it the growing season?
I take it the industry would be willing to work and sit
around a table and get this thing resolved instead of having it
go on for a few months like we have now and 1,300 people
becoming ill?
Mr. Giclas. That is absolutely correct. I mean we would
very much, and we have encouraged in other testimony and at
other times setting up some type of a formal recognition of
industry expertise to assist in trace-backs. And I can tell
you, now having been involved in trace-backs for numerous
commodities for a number of years, we have consistently asked
FDA, tell us what went wrong. Tell us what is the obstacle in
trace-back. Tell us what information you are missing, what form
do you want it in. And we have yet to really get a response to
those questions such that we can change our industry systems to
meet their needs which is, I mean trace-back is vitally
important to use because it minimizes the scope of the economic
damages right away.
Mr. Stupak. Sure. Thanks.
Dr. Brackett, I guess it would only be fair to ask you. I
asked some of the other panels on the Associated Press story
that we have seen and we have talked a little bit about. And it
in the binder there by Mr. Giclas, it is number 5 if you want
to see it, but it was the article is entitled, ``Food Industry
Bitten by its Own Lobbying Success.'' You were at the FDA at
the time during the development of the regulations that
resulted in the Bioterrorism Act which is designed to enhance
product traceability; is that correct?
Mr. Brackett. That is correct.
Mr. Stupak. OK. In the article referring to the latest
Salmonella outbreak investigation you are quoted as saying,
``If they,'' the regulations, ``had been broader and a bit more
far-reaching it could have helped us.'' Is that correct?
Mr. Brackett. Well, yes. That was the statement. And if I
could, I would like to put it in context of what it was.
Mr. Stupak. Sure.
Mr. Brackett. And in fact there were two parts to that, one
of which was something that I have said already today which is
if it had included the agricultural industry, the farms, that
would have helped a lot too.
Mr. Stupak. Right.
Mr. Brackett. And the second half is now, several years
later, after technology has changed and the market has changed,
if we had the ability to go back in a time machine and change
things we could probably think of a way to fit this situation.
But we do not have that sort of luxury. But the main part was
the fact that the farm-to-table inclusion in the Bioterrorism
Act would have been helpful.
Mr. Stupak. OK. Anything else, Mr. Burgess?
I have no further questions. I want to thank you for coming
and thanks for your patience. Once in a while we get pulled out
for votes, and I thought we were going to make it. We were
pretty close to getting it all completed before the votes.
Maybe we will start it earlier than 10:00 o'clock so we can get
them in before votes.
But thank you for being here. Thank you for your help. And
I know Mr. Burgess will have further questions; we will submit
them to you. I am sure other members will too. As I said
earlier, there were two sets of hearings going on today besides
oversight investigations. So thank you.
That concludes all questions. I want to thank all of our
witnesses for coming today and for their testimony. I ask for
unanimous consent that the hearing record will remain open for
30 days for additional questions for the record. Without
objection the record will remain open.
I ask unanimous consent that the contents of our document
binder be entered in the record.
I also ask unanimous consent that the binder containing
questionnaires used by the States and the CDC be made available
for review at the committee office upon request. Without
objection, the documents will be entered in the record and the
consent or questionnaires will be in the office.
[The information appears at the conclusion of the hearing]
Mr. Stupak. That concludes our hearing. Without objection
this meeting of the subcommittee is adjourned.
[Whereupon, at 4:50 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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