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

                              ----------                              
                                                                   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:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    
    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:]
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    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:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    
    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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